Oracle® Clinical

Stable Interface Technical Reference Manual

Release 4.6
A83796-04

January 2010
Oracle Clinical Stable Interface, Release 4.6

A83796-04

Copyright © January, 2010 Oracle. All rights reserved.

The Programs (which include both the software and documentation) contain proprietary information; they
are provided under a license agreement containing restrictions on use and disclosure and are also protected
by copyright, patent, and other intellectual and industrial property laws. Reverse engineering, disassembly,
or decompilation of the Programs, except to the extent required to obtain interoperability with other
independently created software or as specified by law, is prohibited.
The information contained in this document is subject to change without notice. If you find any problems in
the documentation, please report them to us in writing. This document is not warranted to be error-free.
Except as may be expressly permitted in your license agreement for these Programs, no part of these
Programs may be reproduced or transmitted in any form or by any means, electronic or mechanical, for any
purpose.

If the Programs are delivered to the United States Government or anyone licensing or using the Programs on
behalf of the United States Government, the following notice is applicable:

U.S. GOVERNMENT RIGHTS Programs, software, databases, and related documentation and technical data
delivered to U.S. Government customers are "commercial computer software" or "commercial technical data"
pursuant to the applicable Federal Acquisition Regulation and agency-specific supplemental regulations. As
such, use, duplication, disclosure, modification, and adaptation of the Programs, including documentation
and technical data, shall be subject to the licensing restrictions set forth in the applicable Oracle license
agreement, and, to the extent applicable, the additional rights set forth in FAR 52.227-19, Commercial
Computer Software--Restricted Rights (June 1987). Oracle Corporation, 500 Oracle Parkway, Redwood City,
CA 94065

The Programs are not intended for use in any nuclear, aviation, mass transit, medical, or other inherently
dangerous applications. It shall be the licensee's responsibility to take all appropriate fail-safe, backup,
redundancy and other measures to ensure the safe use of such applications if the Programs are used for such
purposes, and we disclaim liability for any damages caused by such use of the Programs.

Oracle is a registered trademark of Oracle Corporation and/or its affiliates. Other names may be trademarks
of their respective owners.

The Programs may provide links to Web sites and access to content, products, and services from third
parties. Oracle is not responsible for the availability of, or any content provided on, third-party Web sites.
You bear all risks associated with the use of such content. If you choose to purchase any products or services
from a third party, the relationship is directly between you and the third party. Oracle is not responsible for:
(a) the quality of third-party products or services; or (b) fulfilling any of the terms of the agreement with the
third party, including delivery of products or services and warranty obligations related to purchased
products or services. Oracle is not responsible for any loss or damage of any sort that you may incur from
dealing with any third party.
 Contents

Preface ................................................................................................................................................................ vii

Intended Audience..................................................................................................................................... vii
Documentation Accessibility .................................................................................................................... vii
About This Book ........................................................................................................................................ viii
Conventions ............................................................................................................................................... viii
Related Documents ..................................................................................................................................... ix

What's New ........................................................................................................................................................ xi

New in Release 4.6....................................................................................................................................... xi
New in Release 4.5...................................................................................................................................... xii

1 About the Stable Interface

Overview.................................................................................................................................................... 1-1
Synonyms................................................................................................................................................... 1-2
Accessing Oracle Clinical data .............................................................................................................. 1-3
Table Queries ...................................................................................................................................... 1-3
Global Library and Study Objects ................................................................................................... 1-3
Self-Journaling Tables........................................................................................................................ 1-4
Determining Object Ownership ....................................................................................................... 1-5
Standard Attributes.................................................................................................................................. 1-6
Audit Attributes ................................................................................................................................. 1-6
STATUS_CODE ................................................................................................................................. 1-6
DOMAIN............................................................................................................................................. 1-7
_FLAG (always Y/N) ........................................................................................................................ 1-7
REPLICATION_IND ......................................................................................................................... 1-7
Reference Codelists.................................................................................................................................. 1-7
Question and Question Group Attribute Hierarchy ......................................................................... 1-8

2 Table Definitions
About the Stable Interface Tables ......................................................................................................... 2-1
ACTUAL_EVENTS(T)............................................................................................................................. 2-2
BATCH_DM_RUNS ................................................................................................................................ 2-4
CLINICAL_PLANNED_EVENTS......................................................................................................... 2-5
CLINICAL_STUDIES.............................................................................................................................. 2-7
CLINICAL_SUBJECTS ........................................................................................................................... 2-9

iii
 DATA_CLARIFICATION_FORMS ................................................................................................... 2-10
DCF_PAGES ........................................................................................................................................... 2-12
DCI_BOOK_DCI_CONSTRAINTS .................................................................................................. 2-13
DCIS......................................................................................................................................................... 2-14
DCI_BOOKS .......................................................................................................................................... 2-16
DCI_BOOK_PAGES ............................................................................................................................. 2-18
DCI_BOOK_PHYSICAL_PAGES ...................................................................................................... 2-19
DCI_FORM_VERSIONS ..................................................................................................................... 2-20
DCI_MODULES .................................................................................................................................... 2-22
DCI_MODULE_PAGES ....................................................................................................................... 2-24
DCMS ...................................................................................................................................................... 2-25
DCM_QUESTIONS .............................................................................................................................. 2-30
DCM_QUES_REPEAT_DEFAULTS .................................................................................................. 2-35
DCM_SCHEDULES.............................................................................................................................. 2-37
DISCREPANCY_ENTRIES(T) ............................................................................................................ 2-38
DISCREPANCY_ENTRY_REVIEW_HIST(T).................................................................................. 2-42
DISCRETE_VALUES ............................................................................................................................ 2-44
DISCRETE_VALUE_GROUPS ........................................................................................................... 2-45
FORM_LAYOUT_TEMPLATES ......................................................................................................... 2-49
LABS ........................................................................................................................................................ 2-50
LAB_TEST_QUESTION_UNITS ....................................................................................................... 2-52
LAB_RANGE_SUBSETS ..................................................................................................................... 2-53
LAB_UNITS............................................................................................................................................ 2-54
LAB_UNIT_CONVERSIONS ............................................................................................................. 2-55
MV_EXECUTION_LOG ...................................................................................................................... 2-56
OCL_INVESTIGATORS(T) ................................................................................................................ 2-57
OCL_ORGANIZATION_UNITS ....................................................................................................... 2-58
OCL_PROGRAMS................................................................................................................................ 2-59
OCL_PROJECTS.................................................................................................................................... 2-60
OCL_SITES............................................................................................................................................. 2-61
OCL_STUDIES ...................................................................................................................................... 2-62
OCL_STUDY_SITES ............................................................................................................................ 2-63
OCL_STUDY_SITE_ROLES(T) .......................................................................................................... 2-64
ORACLE_ACCOUNTS ........................................................................................................................ 2-65
PATIENT_POSITIONS(T) ................................................................................................................... 2-67
PATIENT_STATUSES........................................................................................................................... 2-70
PLANNED_STUDY_INTERVALS ..................................................................................................... 2-71
PREFERRED_LAB_UNITS.................................................................................................................. 2-73
PROCEDURES....................................................................................................................................... 2-74
PROCEDURE_DETAILS .................................................................................................................... 2-76
PROCEDURE_QUESTION_GROUPS ............................................................................................. 2-78
QUESTIONS .......................................................................................................................................... 2-81
QUESTION_CATEGORY_RELATIONS .......................................................................................... 2-84
QUESTION_GROUPS ......................................................................................................................... 2-85
QUESTION_GROUP_QUESTIONS................................................................................................. 2-86
RANGES ................................................................................................................................................. 2-89
RDCI_HISTORY(T) .............................................................................................................................. 2-91

iv
 RECEIVED_DCIS(T) ............................................................................................................................ 2-93
RECEIVED_DCMS(T).......................................................................................................................... 2-96
RECEIVED_PAGES(T) ......................................................................................................................... 2-99
RECEIVED_PAGE_HISTORY(T)..................................................................................................... 2-100
REFERENCE_CODELISTS ............................................................................................................... 2-101
REFERENCE_CODELIST_VALUES................................................................................................ 2-102
REGIONS.............................................................................................................................................. 2-103
RESPONSES(T) ................................................................................................................................... 2-104
STUDY_SITE_PATIENT_POSITIONS(T)...................................................................................... 2-107
TREATMENT_PATTERNS................................................................................................................ 2-108
VALIDATION_REPORTED_VALUES(T) ...................................................................................... 2-109

3 Release 4.6 Flexible Studies Tables

DCI_BOOK_RULES ................................................................................................................................ 3-3
DCI_BOOK_RULE_TGT_INTERVALS ............................................................................................... 3-5
DCI_BOOK_RULE_TGT_DCIS............................................................................................................ 3-6
PP_EXPECTED_INTERVALS(T) ........................................................................................................... 3-7
PP_EXPECTED_INTERVALS$JN.......................................................................................................... 3-8
PP_EXPECTED_CPES(T) ........................................................................................................................ 3-9
PP_EXPECTED_CPES$JN.................................................................................................................... 3-10
PP_EXPECTED_DCIS(T) ..................................................................................................................... 3-11
PP_EXPECTED_DCIS$JN.................................................................................................................... 3-12

4 View Definitions
About the Stable Interface Views ......................................................................................................... 4-1
ACTUAL_EVENTSV(T).......................................................................................................................... 4-2
CHECK_RANDOMIZATIONS ............................................................................................................. 4-3
DISCREPANCY_MANAGEMENT(T) ................................................................................................. 4-4
FULL_STUDIES........................................................................................................................................ 4-6
PATIENTS.................................................................................................................................................. 4-8
PROGRAM_SUBSTANCES................................................................................................................ 4-10
TREAT_ASSIGN_ALL_VIEW ........................................................................................................... 4-11

5 Entity Relationship Diagram

A Journal and History Tables

Self-journaling tables ............................................................................................................................. A-1
Journal Table Columns........................................................................................................................... A-2
Tables Newly Audited in Oracle Clinical 4.5..................................................................................... A-2
History Tables .......................................................................................................................................... A-4
CLINICAL_STUDY_HISTORY....................................................................................................... A-4
DCMS_FFL_XML_HIST................................................................................................................... A-5
FORM_LAYOUT_TEMPLATES_XML_HIST ............................................................................... A-6
PATIENT_POSITIONS_HISTORY ................................................................................................. A-6
RECEIVED_PAGES_HISTORY....................................................................................................... A-7

v
vi
 Preface

This preface describes the intended audience for this technical reference manual, the
documentation accessibility requirements for Oracle documentation, and provides an
overview of the manual.

Intended Audience
This manual is intended for users who are capable of building applications that use
Oracle Clinical data for reporting purposes.

Documentation Accessibility
Our goal is to make Oracle products, services, and supporting documentation
accessible to all users, including users that are disabled. To that end, our
documentation includes features that make information available to users of assistive
technology. This documentation is available in HTML format, and contains markup to
facilitate access by the disabled community. Accessibility standards will continue to
evolve over time, and Oracle is actively engaged with other market-leading
technology vendors to address technical obstacles so that our documentation can be
accessible to all of our customers. For more information, visit the Oracle Accessibility
Program Web site at http://www.oracle.com/accessibility/.

Accessibility of Code Examples in Documentation

Screen readers may not always correctly read the code examples in this document. The
conventions for writing code require that closing braces should appear on an
otherwise empty line; however, some screen readers may not always read a line of text
that consists solely of a bracket or brace.

Accessibility of Links to External Web Sites in Documentation

This documentation may contain links to Web sites of other companies or
organizations that Oracle does not own or control. Oracle neither evaluates nor makes
any representations regarding the accessibility of these Web sites.

Deaf/Hard of Hearing Access to Oracle Support Services

To reach Oracle Support Services, use a telecommunications relay service (TRS) to call
Oracle Support at 1.800.223.1711. An Oracle Support Services engineer will handle
technical issues and provide customer support according to the Oracle service request
process. Information about TRS is available at
http://www.fcc.gov/cgb/consumerfacts/trs.html, and a list of phone numbers is
available at http://www.fcc.gov/cgb/dro/trsphonebk.html.

vii
About This Book
This technical reference manual contains five chapters and one appendix.

Chapter 1, "About the Stable Interface"

This chapter provides an overview of what the stable interface synonyms are, and how
you can use them to gain access to Oracle Clinical data. The chapter also includes
descriptions of reference codelists and standard attributes, describes the mechanics of
journaling for audit purposes, and explains the questions and question group
hierarchy.

Chapter 2, "Table Definitions"

This chapter describes every synonym table in the Oracle Clinical stable interface.
Each description includes an overview of the table's main purpose, all of its columns,
and where applicable, the table's primary key and foreign keys and related tables.

Chapter 3, "Release 4.6 Flexible Studies Tables"

This chapter describes the tables we added to the Stable Interface for Release 4.6's
Flexible Studies functionality.

Chapter 4, "View Definitions"

This chapter describes every synonym view in the Oracle Clinical stable interface.
Each description includes an overview of the view's main purpose and all of its
columns.

Chapter 5, "Entity Relationship Diagram"

This chapter displays the Oracle Clinical stable interface table map, a graphical
depiction of the relationships between the tables in the stable interface. The table map
is color-coded and shaded to highlight which tables belong to particular Oracle
Clinical subsystems, and the connections between tables describe the relationships as
one-to-one, one-to-many, or many-to-many.

Appendix A, "Journal and History Tables"

This appendix describes in more detail how the system audits changes to many of the
Oracle Clinical synonym tables. This description includes a explanation of the
difference between journal tables and history tables, a list of all stable interface
synonym tables that are audited (and which ones are newly audited in this release),
and a full description of the history tables.

Conventions
The following text conventions are used in this document:

Convention Meaning
boldface Boldface type indicates graphical user interface elements associated
with an action, or terms defined in text or the glossary.
italic Italic type indicates book titles, emphasis, or placeholder variables for
which you supply particular values.
monospace Monospace type indicates commands within a paragraph, URLs, code
in examples, text that appears on the screen, or text that you enter.

viii
Related Documents
This section lists the manuals for all Oracle Pharmaceutical Applications products. You
can order printed manuals from the Oracle iStore. From the iStore, search for the part
number in parentheses.

Oracle Clinical Documentation

The Oracle Clinical documentation set (A83790) includes:
■ Oracle Clinical Administrator's Guide (A83791)
■ Oracle Clinical Getting Started (B12308)
■ Interfacing from Oracle Clinical (A83793)
■ Oracle Clinical Conducting a Study (A85201)
■ Oracle Clinical Creating a Study (A85200)
■ Oracle Clinical Installation Guide (A83779)

Oracle Thesaurus Management System (TMS) Documentation

The TMS documentation set (A83789) includes:
■ Oracle Thesaurus Management System User's Guide (A82842)
■ Oracle Thesaurus Management System Installation Guide (A83780)

ix
x
 What's New

This section describes the changes and additions to the stable interface. The new stable
interface synonyms include all the columns, with the same datatypes and null options,
that were included in those synonyms in Release 4.5. Thus, applications created to
read data from Oracle Clinical 4.5.0 through 4.5.3 databases work properly in this
release as well.

New in Release 4.6

This section describes the changes to the Oracle Clinical Stable Interface for Release
4.6. It includes these topics:
■ Changes to Synonym RDCI_HISTORY_V45
■ New Synonyms Introduced in Release 4.6
■ "New Columns Added to Existing Tables in Release 4.6" on page xii

Changes to Synonym RDCI_HISTORY_V45

The RDCI_HISTORY_V45 synonym changed in release 4.6. The data it queries
excludes records where TRANS_TYPE = AUDIT (see Bug 10176208) or TRANS_TYPE is
like SYS%, RETAIN%, REVERSE% (see Bug 10176237). The synonym should include
AUDIT records and should exclude SYS%, RETAIN% and REVERSE% records only if you
have not applied patches 4.5.3.11 and 4.5.3.12 before upgrading to Release 4.6.

New Synonyms Introduced in Release 4.6

The Oracle Clinical Release 4.6 Stable Interface adds the new DCI and Patient Position
tables that support flexible study design. This is the list of new tables and
corresponding synonyms. See Chapter 3, "Release 4.6 Flexible Studies Tables" for
details.

SYNONYM_NAME TABLE_NAME
DCI_BOOK_RULES_V46 DCI_BOOK_RULES
DCI_BOOK_RULE_TGT_DCIS_V46 DCI_BOOK_RULE_TGT_DCIS
DCI_BOOK_RULE_TGT_INTERVAL_V46 DCI_BOOK_RULE_TGT_INTERVALS
PP_EXPECTED_CPEST_V46 PP_EXPECTED_CPEST
PP_EXPECTED_CPES_V46 PP_EXPECTED_CPES
PP_EXPECTED_DCIST_V46 PP_EXPECTED_DCIST
PP_EXPECTED_DCIS_V46 PP_EXPECTED_DCIS

xi
 SYNONYM_NAME TABLE_NAME
PP_EXPECTED_INTERVALST_V46 PP_EXPECTED_INTERVALST
PP_EXPECTED_INTERVALS_V46 PP_EXPECTED_INTERVALS

New Columns Added to Existing Tables in Release 4.6

Oracle modified the following stable interface tables and their synonyms for Release
4.6, and their synonyms for previous releases in a 4.6 database.

DCI_BOOKS
VALIDATION_STATUS NOT NULL VARCHAR2(20)
Indicates whether the DCI Book needs validating to ensure its rules and pages are
consistent with each other. The value defaults to NOT APPLICABLE.
VALIDATION_RESULTS NULL CLOB
The results from the current Validate DCI Book run for this DCI Book.
VALIDATION_TS NULL DATE
The timestamp of the last successful Validate DCI Book run.
REVISION_SN NULL NUMBER(3)
The revision sequence number of the DCI Book at the last successful Validate DCI
Book run.

DISCREPANCY_ENTRIES and DISCREPANCY_ENTRIEST

LAST_CHANGE_TS NULL DATE
Indicates the last time that the multivariate discrepancy was modified. Used for
inclusion in data replication. The value defaults to TO_DATE
(19000101000000,'YYYYMMDDHH24MISS').
LAST_VRV_CHANGE_TS NULL DATE
Indicates the last time the Validation Reported Values associated with this multivariate
discrepancy were modified. Used for inclusion in data replication. The value defaults
to TO_DATE (19000101000000,'YYYYMMDDHH24MISS').

DCM_QUESTIONS
HAS_GRAPHIC_BLOCKS_FLAG NULL VARCHAR2(10)
Indicates whether target blocks are defined for the DCM question in the graphic
layout. The value CB denotes a conditional block is defined for the question, and a
value TB denotes that an indicator block is defined for the question.

PATIENT_POSITIONST and PATIENT_POSITIONS

DISC_ENTRY_DEL_LAST_BATCH_TS NULL DATE
The timestamp of the last batch validation on the source location at which multivariate
discrepancies for a procedure version were deleted. This is used in patient data
replication.

New in Release 4.5

Two synonyms in Release 4.5 have differences between their version for an earlier
release (ending either in _V32 or _V40) and the current version (ending in _V45). See
"Differences in RDCI_HISTORY synonyms" for an explanation of differences between
RDCI_HISTORY_V40 and RDCI_HISTORY_V45, and see "Differences in
DISCREPANCY_MANAGEMENT synonyms" for an explanation of differences

xii
between DISCREPANCY_MANAGEMENT_V32 and DISCREPANCY_
MANAGEMENT_V45.
This section also summarizes new tables that have been added to the stable interface
for Release 4.5. See "New synonyms introduced in Release 4.5" on page -xii for a
description of tables that store information for all releases, and "New NLS synonyms
introduced in Release 4.5" on page -xii for tables that are included for NLS users only.
The rest of this section describes differences between the columns that were included
in the _V40 synonym in the Release 4.0 and the same synonym in Release 4.5. As
stated earlier, applications created to read data from these synonyms in Release 4.0
will still work; these additions provide access to columns that are either newly
revealed to the stable interface or newly added to the Oracle Clinical data model.

Differences in RDCI_HISTORY synonyms

RDCI_HISTORY_V40 and RDCI_HISTORY_V45 have two differences: the data they
query and the columns they include.

Querying
The _V40 version excludes records where the TRANS_TYPE column is "AUDIT." The
Release 4.5 synonym includes audit records.

Columns
RDCI_HISTORY_V45 includes two columns that are not in RDCI_HISTORY_V40.
They appear below:
CLINICAL_STUDY_ID NOT NULL VARCHAR2(200)
ID of the clinical study to which this received DCI belongs. This column enables you to
focus your queries to received DCIs from one study, or a more discrete set of studies.
DATA_CHANGE_REASON_TYPE_CODE NULL VARCHAR2(15)
The reason that a change was made to this RDCI record.

Differences in DISCREPANCY_MANAGEMENT synonyms

DISCREPANCY_MANAGEMENT_V32 has many fewer columns than
DISCREPANCY_MANAGEMENT_V45, and the current version excludes one column
that is in the _V32 version: DCF_COMMENT_TEXT.

New synonyms introduced in Release 4.5

This section describes the global language tables added for release 4.5. These tables
exist in all Oracle Clinical 4.5 databases, whether the NLS Option is installed or not.

DCI_BOOK_DCI_CONSTRAINTS
This new table stores DCI Book Constraint records, which determine the DCIs in a DCI
book that you can use to create Received RDCIs for unplanned events.

DCI_FORM_VERSIONS
This new table stores DCI Forms records, which are data entry-enabled PDF CRFs that
you can create if you are implementing the RDC PDF Option. Each DCI Form is a
versioned object, so this table stores information about each version of each DCI Form
in this database.

xiii
 FORM_LAYOUT_TEMPLATES
This new table stores definitions for DCI Form Layout Templates, from which DCI and
DCM graphic layouts inherit their shape.

RDCI_HISTORYT
RDCI_HISTORYT is a new test table for release 4.5 that corresponds to the existing
stable interface table RDCI_HISTORY.

New NLS synonyms introduced in Release 4.5

This section describes the new local language tables added for release 4.5, which
implement the graphic (PDF) layouts functionality for NLS users. These tables are
created when you install the NLS Option in a Release 4.5 database or upgrade an
existing NLS database to Release 4.5.

DCIS_NLS
This new table stores information about local language graphic layouts.

DCI_BOOK_DCI_CONSTRAINTS_NLS
This new table stores information about DCI Book Constraints for NLS studies.

DCI_MODULES_NLS
This new table stores DCI module information for NLS studies. A DCI module records
a DCM assignment to a DCI with additional information, such as whether the DCM
should collect time, if the DCM is qualified, what the qualification value is, and
whether the DCM is to be collected at a particular visit.

DCI_FFL_XML_NLS_HIST
This new history table is populated with the current local language graphical layout
whenever it is made available (its Available? column is set to Y).

TRANSLATABLE_REFERENCE_CODELISTS
This new NLS view displays translation values for translatable reference codelists; that
is, reference codelists for which you can provide local language translations for some
codelist values.

New columns introduced to existing tables in Release 4.5

This section describes new columns that have been added to stable interface
synonyms. If you have used any of the synonyms listed here in an earlier version of
Oracle Clinical, you will in this release see columns that were not included in the
earlier version. These changes do not require you to change any of your existing code
that was written for the Release 3.2. or 4.0 stable interfaces. However, you may want to
use these new columns in new applications.

DCIS
FL_NEEDS_GENERATION_FLAG NOT NULL VARCHAR2(1)
Indicates whether the DCI Module definition has changed since the last DCI Form
Layout was generated, and requires regeneration.
FL_NEEDS_EDIT_FLAG NOT NULL VARCHAR2(1)
Indicates whether the provisional form layout, if it exists, needs to be edited before
you can use it to generate a DCI Form. If there are no provisional layouts and the box
is checked, there are post-edit updates.

xiv
FL_NEEDS_UPDATE_FLAG NOT NULL VARCHAR2(1)
Indicates whether there were changes to one of the constituent DCM graphic layouts
after the last editing of a layout.
ORIGINAL_DCI_ID NULL NUMBER(10)
Preserves the ID of the DCI from which this DCI originally derives. This field is NULL
when a DCI is created from scratch, and is populated during DCI copy operations.

DCI_BOOKS
UNPLANNED_ALLOWED_FLAG NOT NULL VARCHAR2(1)
Indicates whether you can enter data for this DCI against any clinical planned event.

DCI_MODULES
SHOW_QUALIFYING_VALUE_FLAG NULL VARCHAR2(1)
Indicates whether Oracle Clinical will display a Qualifying Value in the DCM header.
SHOW_LAB_FLAG NULL VARCHAR2(1)
Indicates whether Oracle Clinical will display the lab in the DCM header.
SHOW_VISIT_CODE NULL VARCHAR2(15)
The Visit Code that Oracle Clinical displays in the DCM header.
SHOW_DATA_COMMENT_FLAG NULL VARCHAR2(1)
Indicates whether Oracle Clinical will display the Data Comment in the DCM header.
SHOW_DATE_FLAG NULL VARCHAR2(1)
Indicates whether Oracle Clinical will display the date in the DCM header.
SHOW_TIME_FLAG NULL VARCHAR2(1)
Indicates whether Oracle Clinical will display the time in the DCM header.
SHOW_BLANK_FLAG NULL VARCHAR2(1)
Indicate whether Oracle Clinical will display a blank flag in the DCM header.
SHOW_COMMENT_FLAG NULL VARCHAR2(1)
Indicates whether Oracle Clinical will display the Comment in the DCM header.

DCMS
FFL_EDITED_FLAG NOT NULL VARCHAR2(1)
Indicates whether this DCM graphic layout has been edited since it was last generated.
FFL_NEEDS_EDIT_FLAG NOT NULL VARCHAR2(1)
Indicates whether you must edit this DCM graphic layout before you can add it to a
DCI Form Layout.
FFL_NEEDS_UPDATE_FLAG NOT NULL VARCHAR2(1)
Indicates whether there have been changes to the DCM definition since the DCM
graphic layout was last reconciled with the DCM definition. If Y, you must open the
DCM graphic layout in the editor, and save it, for the system to perform the required
reconciliation.
FFL_AVAILABLE_FLAG NOT NULL VARCHAR2(1)
Indicates whether you can incorporate the DCM graphic layout into a DCI Form
Layout.
FFL_BLOCK_WIDTH NULL NUMBER(6,1)
The width of all blocks of this DCM graphic layout.
FFL_FIRST_BLOCK_HEIGHT NULL NUMBER(6,1)
The height of the first block of this DCM graphic layout. This value overrides the
Maximum Allowed Height for the first block only, and can be adjusted in the Layout
Editor.

xv
 FFL_MAX_ALLOWED_HEIGHT NULL NUMBER(6,1)
The maximum height that any of the blocks within the graphic layout can attain.
FFL_ACTUAL_MAX_HEIGHT NULL NUMBER(6,1)
The actual height of the tallest block in the layout.
FFL_LAST_BLOCK_HEIGHT NULL NUMBER(10)
The height of the last block in the layout.
FLT_ID NULL NUMBER(6,1)
ID of the Form Layout Template used to initialize the values for the DCM graphic
layout's Standard Block Width and Height.
FFL_XML NULL CLOB
A character large object that stores this DCM graphic layout.
FFL_XML_GENERATION_TS NULL DATE
Date and time when this DCM graphic layout was first generated.
FFL_XML_GENERATED_BY NULL VARCHAR2(30)
User who first generated the DCM graphic layout.
FFL_XML_MODIFICATION_TS NULL DATE
Date and time when this DCM Form layout was last modified. Modifications include
edits, updates, and generations.
FFL_XML_MODIFIED_BY NULL VARCHAR2(30)
User who last modified the DCM Form Layout.
CHECKBOX_SHAPE NULL VARCHAR2(30)
Shape of checkbox generated by default at generation time. You can change the shape
of an individual checkbox in the layout editor.
CHECKBOX_SIZE NULL NUMBER(6)
Size of the checkbox generated by default at generation time. You can change the size
of an individual checkbox in the layout editor.

DISCRETE_VALUE_GROUPS
DISPLAY_TYPE_CODE NOT NULL VARCHAR2(15)
The Display Type of a DVG Subset determines how the Subset is laid out if the Subset
is used by a Question that is incorporated in a Graphical Layout.
CHECKBOX_LAYOUT_CODE NULL VARCHAR2(15)
Determines the orientation in which checkboxes are laid out (Horizontal or Vertical)
and the position of the value labels relative to the checkboxes (Left or Right). Only
meaningful when DISPLAY_TYPE_CODE is CBG.
CHECKBOX_LABEL_SOURCE_CODE NULL VARCHAR2(15)
Determines whether the label for each checkbox is to drawn from the Value or Long
Value corresponding to the checkbox. Note that when this column is Y, the checkbox
always transmits the Value, regardless of the wording of the label.
CHECKED_FLAG_VALUE NULL VARCHAR2(80)
If the DISPLAY_TYPE_CODE of the DVG Subset is FLAG, this column determines
which of the two active values for the DVG Subset is transmitted to the database when
the Flag's checkbox is checked during data entry.

ORACLE_ACCOUNTS
LAST_CLINICAL_STUDY_ID NULL NUMBER(10)
ID of the last clinical study accessed by this user through RDC.

xvi
RECEIVED_DCIS(T)
VERSION_SN NULL NUMBER(3)
Version number of the DCI Form used for collecting data in PDF mode.
VERSION_SN_NLS NULL NUMBER(3)
Version number of the Local Language DCI Form used for collecting data in PDF
mode.

New columns introduced to existing NLS tables in Release 4.5

This section describes new columns that have been added to stable interface synonyms
for NLS tables. If you have used any of the synonyms listed here in an earlier version
of Oracle Clinical, you will in this release see columns that were not included in the
earlier version. These changes do not require you to change any of your existing code
that was written for the Release 3.2. or 4.0 stable interfaces. However, you may want to
use these new columns in new applications.

All existing study-related NLS tables

The CLINICAL_STUDY_ID column was added to any study-related NLS table that
did not include the column in earlier releases. This column enables you to focus your
queries in study-related NLS tables to records within a particular study.

DISCRETE_VALUE_GROUPS_NLS
In addition to the new columns below, this table now has a one-to-one relationship
with the DISCRETE_VALUE_GROUPS table.
DISCRETE_VAL_GRP_SUBSET_NUM NOT NULL NUMBER(3)
A number to identify the DVG subset. A DVG with Number 0 is called the base subset.
DISPLAY_TYPE_CODE NOT NULL VARCHAR2(15)
Determines for NLS DVG Subsets how the Subset is laid out if the Subset is used by a
Question that is incorporated in a Graphical Layout.
CHECKBOX_LAYOUT_CODE NULL VARCHAR2(15)
For local language graphic layouts, this column determines the orientation in which
checkboxes are laid out (Horizontal or Vertical) and the position of the value labels
relative to the checkboxes (Left or Right). Only meaningful when DISPLAY_TYPE_
CODE is CBG.
CHECKBOX_LABEL_SOURCE_CODE NULL VARCHAR2(15)
For local language graphical layouts, determines whether the label for each checkbox
is to drawn from the Value or Long Value corresponding to the checkbox. Note that
when this column is Y, the checkbox always transmits the Value, regardless of the
wording of the label.
CHECKBOX_FLAG_VALUE NULL VARCHAR2(80)
If the DISPLAY_TYPE_CODE of the DVG Subset is FLAG, this column determine, for
the local language graphic layout, which of the two active values for the DVG Subset
is transmitted to the database when the Flag's checkbox is checked during data entry.

DCMS_NLS
The new columns are listed below. For most columns listed here, you should refer to
the corresponding column in the global language table for a description. Two columns,
however, require explanation: the CLINICAL_STUDY_ID enables you to focus your
query of study-related NLS records within a particular study; and the QUAL_
QUESTION_ID stores the ID of the qualifying question for this DCM.
FFL_EDITED_FLAG VARCHAR2(1) DEFAULT 'N' NOT NULL
, FFL_NEEDS_EDIT_FLAG VARCHAR2(1) DEFAULT 'N' NOT NULL

xvii
 , FFL_NEEDS_UPDATE_FLAG VARCHAR2(1) DEFAULT 'N' NOT NULL
, FFL_AVAILABLE_FLAG VARCHAR2(1) DEFAULT 'N' NOT NULL
, CLINICAL_STUDY_ID NUMBER(10)
, FFL_BLOCK_WIDTH NUMBER(6,1)
, FFL_FIRST_BLOCK_HEIGHT NUMBER(6,1)
, FFL_MAX_ALLOWED_HEIGHT NUMBER(6,1)
, FFL_ACTUAL_MAX_HEIGHT NUMBER(6,1)
, FFL_LAST_BLOCK_HEIGHT NUMBER(6,1)
, FLT_ID NUMBER(10,0)
, FFL_XML CLOB
, FFL_XML_GENERATION_TS DATE
, FFL_XML_GENERATED_BY VARCHAR2(30)
, FFL_XML_MODIFICATION_TS DATE
, FFL_XML_MODIFIED_BY VARCHAR2(30)
, CHECKBOX_SHAPE VARCHAR2(30)
, CHECKBOX_SIZE NUMBER(6)
, QUAL_QUESTION_ID NUMBER(10)

DCM_QUESTIONS_NLS
The column START_PAGE_NO was dropped for this release. The following columns
were added:
CLINICAL_STUDY_ID NUMBER(10) NOT NULL
MAXIMUM_REPEATS_EXPECTED NUMBER(3) NOT NULL

MAXIMUM_REPEATS_EXPECTED is used by batch synchronization to determine if

the ffl_needs_update_flag and ffl_needs_edit_flag of the DCM need to be set.

DCM_QUES_REPEAT_DEFAULTS_NLS
PROCEDURE_DETAILS_NLS
TEMPLATE_COLUMNS_NLS
CLINICAL_PLANNED_EVENTS_NLS
PATIENT_POSITIONS_NLS
The CLINICAL_STUDY_ID column (NOT NULL, NUMBER(10)) was added to each of
these NLS tables.

xviii
 1
1 About the Stable Interface

The term stable interface in this document refers to a subset of the Oracle Clinical
database that appears to remain unchanged, or stable, through at least two subsequent
releases of Oracle Clinical. This subset consists of a set of synonyms that point to the
tables and views. (See "Synonyms" on page 1-2.)
If you are building applications that read data from Oracle Clinical, the stable interface
provides:
■ easier access to data held within Oracle Clinical
■ smooth transition from one version of Oracle Clinical to the next
■ upgrade timing flexibility
The term stable views in this document refers to the views obtained via the stable
interface; it does not refer to the stable views obtained in the Data Extract subsystem of
Oracle Clinical.
The stable interface supports read-only access to data. Updates to the Oracle Clinical
database should always be performed in the Oracle Clinical client.

Note: Tables and views not documented as part of the stable

interface are not part of it and are therefore subject to change
without notice. External use of the tables not included in the stable
interface is not supported by Oracle Corporation unless a separate
agreement is reached with Oracle Consulting Services.

Overview
The stable interface allows external reports and applications to run against Oracle
Clinical without change when Oracle Clinical is upgraded. By following some general
rules for accessing data within Oracle Clinical, it is not necessary to simultaneously
upgrade all applications that read from Oracle Clinical. Instead, you may choose when
to migrate to the new layout. Each new release of Oracle Clinical includes an upgrade
and instructions to upgrade the stable interface.
You do not have to upgrade to the newest version of the stable interface. Each version
of the stable interface provides a set of synonyms that point to a table or view. In most
cases, the synonym that reflects an earlier release points to the same underlying table
or view as the synonym in the current release. For example, in Oracle Clinical 4.6, the
synonyms ACTUAL_EVENTS_V40, ACTUAL_EVENTS_V45 and ACTUAL_
EVENTS_V46 all point to the same table in the database.

About the Stable Interface 1-1

Synonyms

Note: Release 4.6 of the Stable Interface does not support _V32
synonyms.

You can choose to continue to use the existing stable interface synonyms or upgrade to
the new synonyms. We recommend that you use the new synonyms for new
interfacing applications because they will be supported through one more release of
Oracle Clinical than the older synonyms, but the older synonyms will work as well.
Some synonyms do not correspond exactly between the different versions. "Changes to
Synonym RDCI_HISTORY_V45" on page -xi explains the differences in this synonym
between releases 4.5 and 4.6, and "Differences in RDCI_HISTORY synonyms" on
page -xiii explains the differences between the RDCI_HISTORY_V40 and _V45
synonyms. For all other synonyms in this release, the V40, _V45, and V46 synonyms
match exactly.
While the stable interface hides changes to the database layout or business meaning in
the release, Oracle cannot guarantee that exactly the same business information is
provided. For example, if the length of a field is increased in a new version of Oracle
Clinical, the stable interface truncates the contents of the field and provides existing
users of the stable interface with a field of the original length. This truncation means
that customers who want to view all the information in a new field must upgrade to
the latest version of the stable interface.

Synonyms
The stable interface includes a set of synonyms that point to the underlying Oracle
Clinical tables and views. All programs that access Oracle Clinical data should use
these synonyms.
Synonym names typically consist of the table name concatenated with a version
number. For example, the synonym for the CLINICAL_STUDIES table in Oracle
Clinical is CLINICAL_STUDIES_V40 in the stable interface for version 4.0. These
synonyms are supported in this release of the stable interface.
Some synonyms follow another naming convention, or have retained the naming
convention of the previous release of the stable interface. Refer to Table 1–1 for the
exceptions to the standard synonym naming convention.

Table 1–1 Exceptions to standard synonym naming convention

Table Name Synonym

CLINICAL_PLANNED_EVENTS LIVE_CLINICAL_PLANNED_EVE_V40
DISCREPANCY_ENTRY_REVIEW_HIST DISCREPANCY_ENTRY_REVIEW_V40
DISCREPANCY_ENTRY_REVIEW_HISTT DISCREPANCY_ENTRY_REVIEWT_V40
PATIENT_POSITIONS LIVE_PATIENT_POSITIONS_V40
PLANNED_STUDY_INTERVALS LIVE_PLANNED_STUDY_INTERV_V40
QUESTION_CATEGORY_RELATIONS QUESTION_CATEGORY_RELATIO_V40
RESPONSES RESPONSE_ATTRIBUTES_V40
RESPONSEST RESPONSE_ATTRIBUTEST_V40
STUDY_SITE_PATIENT_POSITIONS STUDY_SITE_PATIENT_POSIT_V40

1-2 Oracle Clinical Stable Interface

 Accessing Oracle Clinical data

Table 1–1 (Cont.) Exceptions to standard synonym naming convention

Table Name Synonym

STUDY_SITE_PATIENT_POSITIONST STUDY_SITE_PATIENT_POSITT_V40
TREATMENT_PATTERNS LIVE_TREATMENT_PATTERNS_V40
VALIDATION_REPORTED_VALUES VALIDATION_REPORTED_VALU_V40
VALIDATION_REPORTED_VALUEST VALIDATION_REPORTED_VALUT_V40

Subsequent releases of Oracle Clinical will include new synonyms that follow both
naming conventions described above. Version numbers are updated to reflect the
version number for the most recent release.

Accessing Oracle Clinical data

This section describes general rules and techniques for accessing data within
Oracle Clinical.

Table Queries
Use the *SELECT syntax to query a table only when you are certain of the sequence of
columns within the table. If you do not know the order of the columns, it is
recommended that you avoid the *SELECT syntax and instead include a specific
column name in the query, for example:
SELECT Region_Code

Note: The sequence of columns within a table is not guaranteed.

As Oracle Clinical is upgraded, the column sequence may change.
In addition, in the table and column definitions, some columns are
for information only. Although Oracle has defined the expected
meaning for these columns, the text the user will add to these
columns cannot be guaranteed. For example, a column named
Region could be populated with tax code information.

Global Library and Study Objects

A number of objects in Oracle Clinical are associated with two levels: the Global
Library level and the Study level. Internally, both levels are held in the same tables.
Objects belonging to an individual study include a clinical study ID; objects in the
Global Library have a clinical study ID of 0. The objects that follow this convention
are:
■ DCIs
■ DCMs
■ Procedures
■ View definitions
To select objects in the Global Library, select where clinical study ID = 0. To select
objects for a specific study, use the appropriate clinical study ID.

About the Stable Interface 1-3

Accessing Oracle Clinical data

Self-Journaling Tables
Oracle Clinical saves a copy of a self-journaling table each time you modify the table.
This generated history enables you to track changes in data over time. RESPONSES,
RECEIVED_DCMS, and RECEIVED_DCIS are all self-journaling tables.
This section describes joining tables and updating them, including deleting records
from tables. For a list of the journal tables added to this release, see Appendix A,
"Journal and History Tables".

Joining Tables
When self-journaling tables are joined to each other, they must be individually
restricted to the record instance that existed at the time you want to view the data. You
do not join on the entry timestamp, even though it is part of the concatenated primary
key of the tables.

Example 1–1 Joining Self-journaling Tables

The following chart illustrates how to join self-journaling tables. Tables A and B are
self-journaling tables that have a foreign key relationship from B back up to A. The
following state could exist after one year.

Table A Table B
ID Entry Timestamp ID Entry Timestamp Foreign Key
123 01-JAN-1998 789 10-JAN-1998 123
123 01-APR-1998 789 15-MAR-1998 123
123 10-JUN-1998 789 20-SEP-1998 123
123 20-DEC-1998

All three records in Table B have a foreign key that points to all four records in Table A.
The following SELECT statement brackets the date 01-MAR-1998, selecting where:
■ Timestamps for Table A cover 01-MAR-2009.
■ Timestamps for Table B cover 01-MAR-2009.
■ The foreign key links B to A.
SELECT A.*, B.*
FROM A, B
WHERE A.ID = B.FOREIGN_KEY
AND A.ENTRY_TIMESTAMP <=
TO_DATE('01-MAR-1998 12:00:00', 'DD-MON-YYYY HH24:MI:SS')
AND A.END_TS >
TO_DATE('01-MAR-1998 12:00:00', 'DD-MON-YYYY HH24:MI:SS') AND
B.ENTRY_TIMESTAMP <=
TO_DATE('01-MAR-1998 12:00:00', 'DD-MON-YYYY HH24:MI:SS')
AND B.END_TS >
TO_DATE('01-MAR-1998 12:00:00', 'DD-MON-YYYY HH24:MI:SS)

This action retrieves one record from each table as it appeared on the requested date.

About Timestamps
Oracle Clinical timestamps are precise to the second. A record may be updated more
than once during a day. To ensure you select a specific record, choose an explicit time.

1-4 Oracle Clinical Stable Interface

 Accessing Oracle Clinical data

For example, if you want to view a record from June 20, 1997, decide if you want to
view the record at the start, middle, or end of the day. Alternatively, you can select
without a time and manage the possibility of multiple results.
Many Oracle Clinical processes use the timestamp of the start of a successfully
completed batch validation process as a discrete point of time to view data. These time
points are recorded in the table BATCH_DM_RUNS.
To access the current record:
SELECT ...
where end timestamp = to_date(3000000,J)
and ...

To access data as it existed at a given point in time:

SELECT ...
where entry timestamp <= the required date
and end_timestamp > required date
and ...

Simple User Updates

For tables containing the clinical data in Oracle Clinical, simple user updates are
converted into an update and an insertion. Internally, Oracle Clinical performs the
following steps:
1. Sets an end timestamp on the current record.
2. Inserts a new version of the record with the changes.
The new record has the same ID as the original record. In addition, it has an entry
timestamp equivalent to the end timestamp on the previous record and an end
timestamp in the year 3,000,000.

Deleting Records
There are two ways to delete records from a self-journaling table.

Soft Delete A record is deleted from a self-journaling table by means of Key Changes
or another standard data entry process. The end timestamp of the current record is
updated to the current timestamp; no new version of the record is created.

Hard Delete A record is deleted from a self-journaling table by means of the Study
Data Deletion utility; the record is deleted from the database with no audit trail.

Determining Object Ownership

Most objects within Oracle Clinical are regarded as being owned by a particular
database instance. Other instances can have read-only copies, but they will only be as
up to date as the last time replication was executed.
If you require the most recent state of a particular type of data, you should access it at
the instance that owns it. This rule applies to the following types of data:
■ Global Library
■ study designs and definitions at individual locations
■ Patient Positions and their received data
■ Sites

About the Stable Interface 1-5

Standard Attributes

■ Investigators
Only one location in a replication installation owns the Global Library. The Global
Library owning location is listed in a reference codelist called OCL_INSTALLATION.
For the short value GLIB_LOCATION, the long value (for example, LONDON) is the
library owning location.
In the following occurrences, the owning location is held in the OWNING LOCATION
column:

Study designs and definitions Ownership is controlled by the owning location of

the clinical studies record in the CLINICAL_STUDIES table.

Patient Positions and their received data Ownership is controlled by the owning
location on the patient positions record in the PATIENT_POSITIONS table. This means
that although a study has only one owning location (for example, LONDON), patient
records in the study may have separate owning locations (for example, NEW YORK).

Sites and Investigators Each has a unique owning location.

Note: The owning location for studies and patients can be

changed from within Oracle Clinical up to the point when all
clinical data has been collected.

To find out where you are within Oracle Clinical, select the short value LOCATION_
CODE on the reference codelist called OCL_STATE. The long value indicates where
you are.

Standard Attributes
Many tables have one or more of the following standard attributes.

Audit Attributes
Every record within Oracle Clinical, except for the self-journaling tables, comes with
the following four standard audit attributes:
CREATION_TS: the date the record was created.
CREATED_BY: person who created the record.
MODIFICATION_TS: date the record was last modified
MODIFIED_BY: person who last modified the record.

STATUS_CODE
Many objects in Oracle Clinical include a status. The STATUS_CODE is always
P (Provisional), A (Active), or R (Retired). For a given requirement you must choose an
appropriate status. If the status is:
■ P or Provisional, the object may be changed, deleted, or used in a limited context.
In addition, provisional objects may be used for test data entry.
■ A or Active, very limited changes are allowed; this object may not be deleted. The
object may be used for Production data entry.

1-6 Oracle Clinical Stable Interface

 Reference Codelists

■ R or Retired, no changes are allowed; this object may not be deleted nor may it be
used. Retired objects are retained to support existing data.

RETIREMENT_REASON_TYPE_CODE
Records that have a STATUS_CODE of R also have a code to indicate why the status
was set to retired.

STATUS_COMMENT_TEXT
Records that have a STATUS_CODE include free form text to describe why the status
was changed.

LAST_STATUS_CHANGE_TS
Records that have a STATUS_CODE include a timestamp that indicates when the
status was changed.

DOMAIN
The Global Library is partitioned into domains. Object names within domains are
unique; across domains they need not be unique. Partitioning allows for objects with
the same name to have different definitions. Because, for example, an Adverse Event
DCM could have several definitions, it is necessary to specify an Adverse Event DCM
as being in a domain called, for example, STANDARD; it is not sufficient to specify the
Adverse Event DCM without its domain.
Users may be limited to accessing certain domains, depending upon their privileges.
In tables containing both Global Library and study information, the name of the
domain for study information is the same as the study, because names of objects
within a study must be unique.

_FLAG (always Y/N)

Attributes that end in _FLAG are either Y or N indicators.

REPLICATION_IND
Most replicated tables come with an indicator to show that the record was created by
replication. Tables in the Design subsystem do not have a replication indicator.

Reference Codelists
Reference codelists appear to end users as simple lookup tables. However, within
Oracle Clinical they are all held within the following two tables.

REFERENCE_CODELISTS Holds a list of codelists and some of their basic attributes.

REFERENCE_CODELIST_VALUES Holds the actual values for all lists. The value is
held in a column called Short Value. The short value is guaranteed to be unique only
within the context of a particular codelist.
Most reference codelists are used to validate code values and to supply descriptions of
the codes for reports and screens. However, in a few reference codelists the long value
has a processing significance.

About the Stable Interface 1-7

Question and Question Group Attribute Hierarchy

Question and Question Group Attribute Hierarchy

Some attributes for Questions and Question Groups are repeated at different levels.
Oracle Clinical includes business rules that control the field values that may be
overwritten as well as the valid override values. For example, the maximum length of
a Question could be increased at the study level. The basic principles are that:
■ The highest order contains the most general values.
■ Values become more restricted at the study level.
■ Lower-level values override the values from the level above.
Attributes at the higher order are used as defaults when the object is used at the next
level. If no lower-level value exists, the value is derived from the higher-level value.
In the following list, Questions is the highest order, so Question Group Questions
default from and are constrained by Questions, while DCM Question Group Questions
default from and are constrained by Question Group Questions:
■ Questions
■ Question Group Questions
■ DCM Question Group Questions
In this list, Question Groups is the highest order, so DCM Question Groups default
from and are constrained by Question Groups:
■ Question Groups
■ DCM Question Groups

1-8 Oracle Clinical Stable Interface

 2
2 Table Definitions

This chapter describes each table supported by the stable interface. You should access
these tables only by their synonyms, which are described in Chapter 1.

About the Stable Interface Tables

Many of the tables in the stable interface have test database counterparts that can be
used to enter test data. Test data is stored separately from the production data, so test
tables enable you to modify data in ways not allowed in the production interface. In
this section, tables that have test data counterparts are designated by a (T) at the end of
the table's title. ACTUAL_EVENTS(T) therefore describes the production table
ACTUAL_EVENTS and the test table ACTUAL_EVENTST.
Each table description includes the following information:
■ A general description of the table.
■ The table's primary key.
■ The table's unique keys, where applicable.
■ A listing of related tables and foreign keys and other functional relations.
■ Descriptions of the columns in the tables.

Note: A number of fields within Oracle Clinical are optional — for

example, the clinical phase of a planned study. In this section their
expected meaning is given; however, there can be no guarantee that
they will be maintained or used as expected.

Table Definitions 2-1

ACTUAL_EVENTS(T)

ACTUAL_EVENTS(T)

A study design includes a set of clinical planned events (CPEs). These are defined once
for a study. An actual event is created the first time data is collected about a patient at
a CPE. Actual events are also identified by a sub-event number. The actual event
corresponding to the CPE is referred to as Actual Event 0 (zero) and is identified by
sub-event number 0. If the patient returns for additional unplanned visits and
additional CRFs are completed for the patient, they are recorded as different sub-event
numbers, or actual events, or visits x.1, x.2, etc., where visit x is the nearest previous
planned actual event.
Actual events are used in Validation Procedures to associate DCMs that occur at the
same event. Actual events can also be used to label events for future reference — for
instance, to describe why an unplanned visit occurred. When the last data record that
references an actual event is soft-deleted, the associated actual event is soft-deleted by
setting its end timestamp to the date of deletion. If all data that references an actual
event is hard-deleted, the actual event is hard-deleted as well. Refer to "Self-journaling
tables" on page 1-5 for more information.
The test table for ACTUAL_EVENTS is ACTUAL_EVENTST.

Primary key ACTUAL_EVENT_ID

Unique Keys PATIENT_POSITION_ID, CLIN_PLAN_EVE_ID, SUBEVENT_

NUMBER

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table
CLINICAL_STUDIES CLINICAL_STUDY_ID CLINICAL_STUDY_ID

PATIENT_POSITIONS PATIENT_POSITION_ID PATIENT_POSITION_ID

CLINICAL_PLANNED_EVENTS CLIN_PLAN_EVE_ID CLIN_PLAN_EVE_ID

RECEIVED_DCIS ACTUAL_EVENT_ID ACTUAL_EVENT_ID

RECEIVED_DCMS ACTUAL_EVENT_ID ACTUAL_EVENT_ID

DISCREPANCY_ENTRIES ACTUAL_EVENT_ID ACTUAL_EVENT_ID

ACTUAL_EVENTS Column Descriptions

Column Name Null? Type Column Description

ACTUAL_EVENT_ID Not null NUMBER(10) A unique, system-generated ID for the actual event.

CREATION_TS Not null DATE Date and time when this actual event record was created.

CREATED_BY Not null VARCHAR2(30) User who created this actual event record.

PATIENT_POSITION_ID Not null NUMBER(10) The ID of the patient position for the patient who attended
the actual event.

CLINICAL_STUDY_ID Not null NUMBER(10) The ID of the clinical study to which the actual event
belongs.

END_TS Not null DATE Date and time that this actual event record was changed. This
column is for journaling purposes.
CLIN_PLAN_EVE_ID Not null NUMBER(10) The ID of the clinical planned event to which the actual event
is assigned.

2-2 Oracle Clinical Stable Interface

 ACTUAL_EVENTS(T)

Column Name Null? Type Column Description

SUBEVENT_NUMBER Not null NUMBER(2) A sequence number for this actual event within the set of
actual events linked to a particular clinical planned event. By
convention, the sub-event number is equal to 0 for the
planned actual event.
COMMENT_TEXT Null VARCHAR2(200) Freeform text about the actual event.

MODIFICATION_TS Null DATE Date and time when this actual event was last modified.

MODIFIED_BY Null VARCHAR2(30) User who last modified this actual event.

Table Definitions 2-3

BATCH_DM_RUNS

BATCH_DM_RUNS

A record of batch validation (or Data Management) runs. The most recent record for a
particular clinical study can be identified by Current Flag = Y. The batch start
timestamp of successful runs is used to define stable data extract views and data
extract snapshots. The batch start timestamp of the most recent successful run is
frequently referred to in other tables as LAST_BATCH_TS.

Primary Key CLINICAL_STUDY_ID, CREATION_TS

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

CLINICAL_STUDIES CLINICAL_STUDY_ID CLINICAL_STUDY_ID

BATCH_DM_RUNS Column Descriptions

Column Name Null? Type Column Description

CLINICAL_STUDY_ID Not null NUMBER(10) The ID of the clinical study in which the batch validation
process was run.

CREATION_TS Not null DATE Date and time when this batch validation process
occurred.

CREATED_BY Not null VARCHAR2(30) User who initiated this batch validation process.
BATCH_END_TS Not null DATE The date and time that the batch validation process
successfully completed.

SUCCESS_FLAG Not null VARCHAR(1) A flag to show whether the batch validation process
ended successfully.

MODIFIED_PATIENT_COUNT Not null NUMBER(7) The number of patients processed by the batch
validation process.
BATCH_START_TS Not null DATE The date and time the process started. Used as the
reference timestamp for other parts of Oracle Clinical,
such as Data Extract, which rely upon the successful
completion of the batch validation to ensure consistency
between entered data and derived data.
CURRENT_FLAG Not null VARCHAR2(1) A flag to indicate if this is the most recent record for the
clinical study.

DATA_REVISION_SN Not null NUMBER(10) A study-specific sequence number used to identify the
batch validation run. Used to identify the latest batch
validation in which a patient was processed.

LAST_DCD_REPLICATION_TS Null DATE At non-owning locations of distributed studies, the most

recent previous replication timestamp of study definition
(data collection definition) information. Used to ensure
that changes made to study definitions at the owning
location are applied to data at the non-owning location.

LOCATION_CODE Not null VARCHAR2(15) A code for the instance where the batch job was run.

2-4 Oracle Clinical Stable Interface

 CLINICAL_PLANNED_EVENTS

CLINICAL_PLANNED_EVENTS

Clinical planned events (CPEs) represent points in the timeline of a study when data is
scheduled to be collected. They normally equate to visits. Each clinical planned event
must have either the offsets from interval start or the offsets from previous event
defined.

Primary Key CLIN_PLAN_EVE_ID

Unique Keys CLINICAL_STUDY_ID, VISIT_NUMBER

CLINICAL_STUDY_ID, NAME

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

CLINICAL_STUDIES CLINICAL_STUDY_ID CLINICAL_STUDY_ID

PLANNED_STUDY_INTERVALS PLAN_STUDY_INTERVAL_ID PLAN_STUDY_INT_ID

DISCREPANCY_ENTRIES CLIN_PLAN_EVE_ID CLIN_PLAN_EVE_ID

PROCEDURE_QUESTION_GROUPS NAME CPE_BEGIN_ACCESS_NAME

PROCEDURE_QUESTION_GROUPS NAME CPE_END_ACCESS_NAME

DCI_MODULES CLIN_PLAN_EVE_ID CLIN_PLAN_EVE_ID

RECEIVED_DCIS CLIN_PLAN_EVE_ID CLIN_PLAN_EVE_ID

RECEIVED_DCMS CLIN_PLAN_EVE_ID CLIN_PLAN_EVE_ID

ACTUAL_EVENTS CLIN_PLAN_EVE_ID CLIN_PLAN_EVE_ID

DCM_SCHEDULE CLIN_PLAN_EVE_ID CLIN_PLAN_EVE_ID

DCI_BOOK_PAGES CLIN_PLAN_EVE_ID CLIN_PLAN_EVE_ID

CLINICAL_PLANNED_EVENTS Column Descriptions

Column Name Null? Type Column Description

CLIN_PLAN_EVE_ID Not null NUMBER(10) A code for the instance where the batch job was run.

PLAN_STUDY_INTERVAL_ Not null NUMBER(10) The ID of the planned study interval to which the CPE is
ID assigned.

CLIN_PLAN_PROCESSES_ID Not null NUMBER(10) The ID of the clinical planned process to be performed at the
CPE.

CLIN_STUDY_ID Not null NUMBER(10) The ID of the clinical study to which the CPE belongs.

CLIN_STUDY_VERSION_ Not null NUMBER(10) The ID of the clinical study version to which the CPE belongs.
ID

CLIN_PLAN_EVE_TYPE_ Not null VARCHAR2(7) The type of CPE. From the reference codelist CLIN_PLAN_
CODE EVE_TYPE_CODE. The only valid value at the moment is
VISIT.

OPTIONAL_FLAG Not null VARCHAR2(1) A flag to show if the CPE is optional for patients in the study. If
a CPE is flagged as optional, then the DCIs for that CPE are
never considered missing.

NAME Not null VARCHAR2(16) A free form text name of the clinical planned event. It is unique
within the study.

CLIN_PLAN_EVE_SN Not null NUMBER(5) Subevent number of the CPE.

Table Definitions 2-5

CLINICAL_PLANNED_EVENTS

Column Name Null? Type Column Description

DISPENSING_VISIT_FLAG Not null VARCHAR2(1) A flag to show whether medication is to be dispensed to

patients in the study at the clinical planned event (visit).
CREATED_BY Not null VARCHAR2(30) User who created this CPE record.

CREATION_TS Not null DATE Date and time when this CPE was created.

VISIT_NUMBER Null NUMBER(5) Within this study, a unique integer number that is associated
with the clinical planned event.

DESCRIPTION Null VARCHAR2(70) A freeform text description, in mixed case, of the clinical
planned event (visit).

TRIGGER_EVENT Null VARCHAR2(200) A free form text description, in mixed case, of the conditions
that trigger an optional clinical planned event to occur.

MIN_OFFSET_FROM_START Null NUMBER(10) The minimum length of time before this clinical planned event
(visit) can occur from the start of the interval to which it is
assigned. The time unit is defined by the time unit of the
interval.

MAX_OFFSET_FROM_START Null NUMBER(10) The maximum length of time by which this clinical planned
event (visit) must occur from the start of the interval to which it
is assigned. The time unit is defined by the time unit of the
interval.

MIN_OFFSET_FROM_PREV Null NUMBER(10) The minimum length of time before this clinical planned event
(visit) can occur from the end of the previous clinical planned
event. The time unit is defined by the time unit of the interval.

MAX_OFFSET_FROM_PREV Null NUMBER(10) The maximum length of time by which this clinical planned
event (visit) must occur from the end of the previous clinical
planned event. The time unit is defined by the time unit of the
interval.

MIN_OFFSET_IN_STUDY Null NUMBER(10) The minimum length of time before this clinical planned event
(visit) can occur from the start of the study. This derived
number is always calculated in days.
MAX_OFFSET_IN_STUDY Null NUMBER(10) The maximum length of time by which this clinical planned
event (visit) must occur from the start of the study. This derived
number is always calculated in days.

TERMINATION_VISIT_ Null VARCHAR2(15) A code to indicate the normal termination visit and the visit to
TYPE_CODE jump to in the case of an early termination. Other CPEs have a
null value. Valid values are NORMAL TERM (which means the
normal termination visit) and EARLY TERM (for the early
termination visit).

LABEL_CODE Null VARCHAR2(10) A freeform text code for labels, to identify this clinical planned
event — for example, all supplies handed out at the first visit
could be labeled with an A, at the second visit with a B. This is
done to help prevent mistakes in dispensing supplies.

MODIFIED_BY Null VARCHAR2(30) User who last modified this CPE record.

MODIFICATION_TS Null DATE Date and time when this CPE was last modified.

2-6 Oracle Clinical Stable Interface

 CLINICAL_STUDIES

CLINICAL_STUDIES

Clinical study records contain basic information about the study. The primary key of a
clinical study is the clinical study ID; the primary key of an OCL study is the task ID.
They are normally the same but may differ in some cases. They should be joined by
using the study code.

Primary Key CLINICAL_STUDY_ID

Unique Key STUDY

SHORT_TITLE

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

OCL_STUDIES STUDY STUDY

Many child tables CLINICAL_STUDY_ID STUDY

CLINICAL_STUDIES Column Descriptions

Column Name Null? Type Column Description

CLINICAL_STUDY_ID Not null NUMBER(10) A unique, system-generated ID for the clinical study.
STUDY Not null VARCHAR2(15) A unique code for the clinical study.

SHORT_TITLE Not null VARCHAR2(80) A unique short title of the study.

RAND_ACC_STAT_TYPE_CODE Not null VARCHAR2(7) A code to indicate who can access the study's
randomization. Possible values come from the
reference codelist RAND_ACC_STAT_TYPE_
CODE.Values for RAND_ACC_STAT_TYPE_CODE are
OPEN (everyone has always had access), CLOSED
(only privileged users have access), ACCESS (access to
named users while in this state), RELEASE (everyone
has access at end of study) and MULT (access
controlled at the Phase level).

STUDY_STATUS_TYPE_CODE Not null VARCHAR2(7) A user-defined code for the status of the study in terms
of planning, operation, or analysis.

FDA_PACKAGE_FLAG Not null VARCHAR2(1) A flag to indicate if the study is intended for inclusion
in the FDA filing package.

PIVOTAL_STUDY_FLAG Not null VARCHAR2(1) A flag to indicate if the study is a pivotal part of the
program. Pivotal parts of the program are those whose
successful outcome to the study is required to continue
work on the new compound.

CREATED_BY Not null VARCHAR2(30) User who created this study.

CREATION_TS Not null DATE Date and time when this study was created.

STUDY_SUB_TYPE_CODE Not null VARCHAR2(4) A code for the type of study. Clinical studies have a
type of 1.

AVAIL_FOR_REPLICATION_ Not null VARCHAR2(1) A flag to show if the study can be replicated to other
FLAG locations.

PHONE_RANDOMIZATION_ Not null VARCHAR2(1) A flag to show if the randomization in the study can be
FLAG made available to a phone randomization system.

REPLICATED_TO_OTHER_ Not null VARCHAR2(1) A flag to show if the study has actually been replicated
SITES_FLAG to another location.

Table Definitions 2-7

CLINICAL_STUDIES

Column Name Null? Type Column Description

RAND_REPLICATED_FLAG Not null VARCHAR2(1) A flag to show if the randomization in the study has
actually been replicated to another location.
OWNING_LOCATION Not null VARCHAR2(15) A code for the location that owns the study.

TITLE Null VARCHAR2(2000) A long title for the study.

INTERNATIONAL_UNIQUE_ Null VARCHAR2(30) An alternative code for the study.

CODE

SOURCE_STUDY Null VARCHAR2(15) The code of the source study, if the study was created
by copying another study.

MODIFIED_BY Null VARCHAR2(30) User who last modified this study.

MODIFICATION_TS Null DATE Date and time when this study was last modified.

GIVING_LOCATION Null VARCHAR2(15) The system uses this column during a change of
owning location. When the owner of a study changes,
Oracle Clinical sets the giving location to the current
location (that is, the previous owner). Thus, when the
study is being given away, the giving location equals
the current location. After the ownership change is
complete, the system sets this column to null.

2-8 Oracle Clinical Stable Interface

 CLINICAL_SUBJECTS

CLINICAL_SUBJECTS

CLINICAL_SUBJECTS acts as a place holder to link patient positions together. The

patients can be within the same study or across studies. This concept can be used to
combine screening data recorded against a screening patient position number with
randomized data recorded against a regular patient position number. It can also be
used to link data from a short-term and rollover study.
Many of the column descriptions in this table refer to the "most accepted" attribute for
a patient, such as "most accepted date of birth" or "most accepted last name." This
phrasing is used because records of patient attributes may differ between patient
positions. Using a most accepted value — a value generally recommended for this
patient position — therefore enables researchers to link patient positions despite data
inaccuracies.

Primary Key CLINICAL_SUBJECT_ID

Related Tables and Foreign Keys

Related table Foreign key Name in this table Foreign Key Name in the Related Table

PATIENT_POSITIONS CLINICAL_SUBJECT_ID CLINICAL_SUBJECT_ID

CLINICAL_SUBJECTS Column Descriptions

Column Name Null? Type Column Description

CLINICAL_SUBJECT_ID Not null NUMBER(10) A unique, system-generated ID for the clinical

subject.

CHILD_BEARING_POTENTIAL_ Not null VARCHAR2(1) A flag to show if the patient has child-bearing
FLAG potential.

RETIRED_FLAG Not null VARCHAR2(1) Not used.

SYSTEM_GENERATED_FLAG Not null VARCHAR2(1) Not used.

CREATED_BY Not null VARCHAR2(30) User who created this clinical subject.

CREATION_TS Not null DATE Date and time when this clinical subject was created.

BIRTH_DATE Null DATE The most accepted date of birth for the patient
positions linked together.

FIRST_NAME Null VARCHAR2(15) The most accepted first name for the patient positions
linked together.

SEX Null VARCHAR2(1) The most accepted gender for the patient positions
linked together. Values are M for male and F for
female.

LAST_NAME Null VARCHAR2(20) The most accepted last name for the patient positions
linked together.

INITIALS Null VARCHAR2(4) The most accepted initials for the patient positions
linked together.

DATE_LAST_PREGNANCY_ Null DATE The date that the patient last reported becoming
STARTED pregnant.

MODIFIED_BY Null VARCHAR2(30) User who last modified this clinical subject.

MODIFICATION_TS Null DATE Date and time when this clinical subject was last
modified.

Table Definitions 2-9

DATA_CLARIFICATION_FORMS

DATA_CLARIFICATION_FORMS

Data Clarification Forms (DCFs) provide a structure for organizing discrepancies into
groups based on a user defined selection criteria such as patient, DCM, investigator, or
site. You specify criteria, or, select specific discrepancies and Oracle Clinical creates
one DCF for each patient that has selected discrepancy records. A DCF report is based
on a single DCF. DCF reports are created to facilitate communication between CRAs
and investigators. The CRA and investigator can use the DCF and DCF reports to
organize and track progress in resolving discrepancies.
Specifically, DCFs provides a means to:
■ group discrepancies, clarify the information needed, and produce DCF reports
■ track progress in analyzing and resolving discrepancies
■ more efficiently handle decisions related to the grouped discrepancies

Primary Key DCF_ID

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

OCL_SITES SITE_ID SITE_ID

PATIENT-POSITIONS PATIENT_ID PATIENT_POSITION_ID

OCL_INVESTIGATORS INVESTIGATOR_ID INVESTIGATOR_ID

CLINICAL_STUDIES CLINICAL_STUDY_ID CLINICAL_STUDY_ID

Column Descriptions

Column Name Null? Type Column Description

DCF_ID Not Null NUMBER(10) A unique, system-generated ID for the data clarification
form.

INVESTIGATOR_STATUS Null VARCHAR2(60) The optionally specified constraint when the DCF was
created to included Discrepancies only associated with a
particular Discrepancy Status.

PASSIVE_STATUS Null VARCHAR2(60) The optionally specified constraint when the DCF was
created to additionally include related Discrepancies
associated with a particular Discrepancy Status, but that
should not be included on the DCF itself.

RESOLVED_STATUS Null VARCHAR2(60) The optionally specified constraint when the DCF was
created to additionally include related Discrepancies
associated with a particular Discrepancy Status, but that
should not be included on the DCF itself.

INVESTIGATOR_ID Null NUMBER(10) The optionally specified constraint when the DCF was
created to included Discrepancies only associated with a
particular Investigator.

SITE_ID Null NUMBER (10) The optionally specified constraint when the DCF was
created to included Discrepancies only associated with a
particular Site.

PATIENT_ID Null NUMBER(10) The specified constraint when the DCF was created to
included Discrepancies only associated with a particular
Patient.

2-10 Oracle Clinical Stable Interface

 DATA_CLARIFICATION_FORMS

Column Name Null? Type Column Description

PATIENT_RANGE Null VARCHAR2(60) Specifies the manner in which the patient constraints were
selected, such as No Range Specified or Multi-Select (when
the Discrepancies, and thereby the Patients, are selected in
this way from the Discrepancy Management screen).
CLINICAL_STUDY_ID Not Null NUMBER(10) The ID of the Clinical Study.

CURRENT_STATUS Null VARCHAR2(30) The status of the DCF (Sent, Received, etc.)

LAST_PRINT_DATE Null DATE The last date/time that the DCF was printed.

LAST_PRINT_BY Null VARCHAR2(30) The username of the person that last printed the DCF.

DATABASE_MODE Null VARCHAR2(1) Specifies whether or not the DCF was created in Test or
Production mode.

INVESTIGATOR Null VARCHAR2(10) The name of the Investigator if Investigator_Id is

populated.
SITE Null VARCHAR2(10) The name of the Site if Site_Id is populated.

PATIENT Null VARCHAR2(10) The name of the Patient if Patient_Id is populated.

CREATION_TS Null DATE Date and time when this DCF was created.

CREATED_BY Null VARCHAR2(30) User who created the DCF.

MODIFICATION_TS Null DATE Date and time when the DCF was last modified.

MODIFIED_BY Null VARCHAR2(30) User who last modified the DCF.

OWNING_USER Null VARCHAR2(30) The username of the person to whom ownership of the
DCF has been granted.
DESCRIPTION Null VARCHAR2(200) The detailed description of the reason for which the DCF
was created.

HEADER_TEXT Null VARCHAR2(2000) The text that appears as the header of the DCF when the
DCF is printed and sent out.

FOOTER_TEXT Null VARCHAR2(2000) The text that appears as the footer of the DCF when the
DCF is printed and sent out.

Table Definitions 2-11

DCF_PAGES

DCF_PAGES

The system uses this table to track the pages of a DCF report. The system populates
the table when the DCF status changes to SENT or REPRINT.
The DCF_PAGES table resides in the RXC_DISC_TSPA tablespace.

Primary Key DCF_PAGE_ID

Related Tables and Foreign Keys

Foreign key name in the related

Name of related table Foreign key name in this table table

DATA_CLARIFICATION_FORMS DCF_ID DCF_ID

CLINICAL_STUDIES CLINICAL_STUDY_ID CLINICAL_STUDY_ID

DCF_PAGES Column Descriptions

Column Name Null? Type Column Description

CLINICAL_STUDY_ID Not Null NUMBER(10) The ID of a the clinical study to which all DCF pages belong.

DCF_PAGE_ID Not Null NUMBER(10) The ID of the DCF page.

DCF_ID Not Null NUMBER(10) The ID of the DCF to which all DCF pages belong.

PAGE_NO Not Null NUMBER(10) The physical page number of the DCF that was printed.

RELEASE_NO Not Null NUMBER(10) The version number of the DCF that was printed.

STATUS Not Null VARCHAR2(10) The status of the page (Sent, Received, etc.).

STATUS_TS Not Null DATE Date and time of the latest status change.

CREATED_BY Not Null VARCHAR2(30) User who created the DCF Page.

CREATION_TS Not Null DATE Date and time when the DCF Page was created.

PAGE_REFERENCE_ Null VARCHAR2(20) An optional, free-form field for specifying imaging codes
NUMBER associated with the page.

MODIFIED_BY Null VARCHAR2(30) User who last modified the DCF Page.

MODIFICATION_TS Null DATE Date and time when the DCF Page was last modified.

2-12 Oracle Clinical Stable Interface

 DCI_BOOK_DCI_CONSTRAINTS

DCI_BOOK_DCI_CONSTRAINTS

DCI Book Constraints determine which DCIs in a DCI book you can use to create
Received RDCIs for unplanned events. For the Graphic layout system, constraints
settings allows you to specify the preferred version of the DCI Form. The preferred
version is used to select a version of the DCI form when first logging in data in RDC
PDF, and when migrating data.
This table is replicated throughout an Oracle Clinical installation.

Primary Key DCI_BOOK_ID, DCI_ID

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

DCI_BOOKS DCI_BOOK_ID DCI_BOOK_ID

DCIS DCI_ID DCI_ID

DCI_BOOK_DCI_CONSTRAINTS Column Descriptions

Column Name Null? Type Column Description

DCI_BOOK_ID Not Null NUMBER(10) The ID of the DCI Book.

CLINICAL_STUDY_ID Not Null NUMBER(10) The ID of the clinical study.

DCI_ID Not Null NUMBER(10) The ID of the DCI.

UNPLANNED_ Not Null VARCHAR2(1) If Y, you can enter data for this DCI against any clinical planned
ALLOWED_FLAG event. If N and the DCI is planned, you can enter data only
against the clinical planned events specified in DCI Book Pages. If
N and the DCI is unplanned, you cannot enter data for that DCI.

PREFERRED_VERSION_SN Not Null NUMBER(3) Number of the preferred DCI Form version of this DCI to
associate with this DCI Book. The Preferred DCI Form version is
used for RDC PDF data entry.
CREATION_TS Not Null DATE The date and time that the DCI Book DCI Constraint was created.

CREATED_BY Not Null DATE The username of the person who created the DCI Book DCI
Constraint.

MODIFICATION_TS Null DATE The date and time that the DCI Book DCI Constraint was last
modified.

MODIFIED_BY Null VARCHAR2(30) The username of the person who last modified the DCI Book DCI
Constraint.

Table Definitions 2-13

DCIS

DCIS

Data collection instruments (DCIs) are the definition of physical collections of data. A
DCI could be a CRF or a block of data in a batch file. Its primary function is to manage
the data collection process. It has no significance to the actual data analysis.
A DCI associates one or more data collection modules (DCMs) that are collected
together via its child table, DCI_MODULES. The DCI and its child tables have two
functions: to structure the order of data entry, and to define the relationship between
the data defined in DCMs, and the physical pages that the data is collected upon,
through the DCI_MODULE_PAGES.

Primary Key DCI_ID

Unique Keys NAME, DOMAIN

SHORT_NAME, DOMAIN

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table
CLINICAL_STUDIES CLINICAL_STUDY_ID CLINICAL_STUDY_ID

DCI_MODULES DCI_ID DCI_ID

RECEIVED_DCIS DCI_ID DCI_ID

DCI_BOOK_PAGES DCI_ID DCI_ID

DCIS Column Descriptions

Column Name Null? Type Column Description

DCI_ID Not null NUMBER(10) A unique, system-generated ID for the DCI.

CREATION_TS Not null DATE Date and time when this DCI was created.
CREATED_BY Not null VARCHAR2(30) User who created this DCI.

NAME Not null VARCHAR2(30) The name of the DCI. The name is unique within the
domain that the DCI belongs to.

DOMAIN Not null VARCHAR2(15) A Global Library object-naming convention that

facilitates the unique naming or grouping of objects.

DCM_DCI_QG_TYPE_CODE Not null VARCHAR2(15) A user-defined code to classify the DCI according to
the type of data collected by that DCI.

DCI_STATUS_CODE Not null VARCHAR2(15) A code to control usage and attributes of the DCI.
Values are P for provisional, A for active, or R for
retired.

LAST_STATUS_CHANGE_TS Not null DATE The date and time that the DCI_STATUS_CODE was
last changed.

SHORT_NAME Not null VARCHAR2(10) A shortened name for the DCI,used during Log-In. The
short name is unique within the DCI's domain.

SAFETY_FLAG Not null VARCHAR2(1) A user-defined flag to show if the DCI collects safety
data.

CLINICAL_STUDY_ID Not null NUMBER(10) The ID of the clinical study to which the DCI belongs.

2-14 Oracle Clinical Stable Interface

 DCIS

Column Name Null? Type Column Description

COLLECT_TIME_FLAG Not null VARCHAR2(1) A flag to indicate whether the time of a clinical
planned event should be collected. If this field is Y, the
user must complete the DCI date and DCI time fields
during the DCI Log-In process. If this field is N, only
the DCI date field appears on the DCI Log-In screen.

CRF_PAGE_TRACKING_ Not null VARCHAR2(1) A flag to show whether page tracking is enabled for
ENABLED_FLAG the DCI.

DCI_DATE_REQUIRED_FLAG Not Null VARCHAR(1) Flag to indicate if the DCI date is required. If Y, the
DCI date is required.

FL_NEEDS_EDIT_FLAG Not null VARCHAR2(1) If Y, the provisional form layout, if it exists, needs to be
edited before you can use it to generate a DCI Form. If
there are no provisional layouts and the box is
checked, there are post-edit updates.

FL_NEEDS_UPDATE_FLAG Not null VARCHAR2(1) Equals Y if there were changes to one of the constituent
DCM graphic layouts after the last editing of a layout.
If there is a provisional layout, editing and saving a
provisional layout updates the layouts with the
updated DCM graphic layouts, and changes clears this
checkbox. If there are no provisional layouts, this
indicates that none of the existing layouts reflect
changes made to the constituent DCM graphic layouts
after the last editing of a layout.

FL_NEEDS_GENERATION_ Not null VARCHAR2(1) If Y, the DCI Module definition has changed since the
FLAG last DCI Form Layout was generated, and requires
regeneration.

RETIREMENT_REASON_ Null VARCHAR2(15) A code to indicate why a retired DCI was retired.
TYPE_CODE

STATUS_COMMENT_TEXT Null VARCHAR2(200) Freeform text, in mixed case, containing

supplementary information about why the DCI's status
did or did not change.
HELP_TEXT Null VARCHAR2(200) Freeform help text, in mixed case, available for display
during data entry.

MODIFICATION_TS Null DATE Date and time when this DCI was last modified.

MODIFIED_BY Null VARCHAR2(30) User who last modified this DCI.

REPLICATION_IND Null VARCHAR2(1) A flag to show if the DCI has been replicated from
another location. Values are Y if yes, and null if not
replicated.

DEFAULT_PAGE_ Null VARCHAR2(15) A code for the default page numbering scheme used
NUMBERING_SCHEME by page tracking if it is enabled.

EXPECTED_NUMBER_OF_ Null NUMBER(4) The number of pages expected to be entered for the
PAGES DCI.

UNEXP_PAGE_NUMBERING_ Null VARCHAR2(15) A code for the numbering scheme to use when
SCH unexpected pages have to be recorded.

ORIGINAL_DCI_ID Null NUMBER(10) This field preserves the ID of the DCI from which this
DCI originally derives. This field is NULL when a DCI
is created from scratch, and is populated during DCI
copy operations. Subsequent copies of DCIs that
already have this field populated preserve the original
ID.

Table Definitions 2-15

DCI_BOOKS

DCI_BOOKS

This table represents a physical collection of DCIs or CRF pages. A DCI can be defined
in more than one way — for example, pages can be made to fit European and US
paper sizes. The table defines the sequence in which data should be entered during
data entry. It is also used by the page tracking feature to assign actual page numbers
(physical pages) to a patient's data when it is entered.

Primary Key DCI_BOOK_ID

Unique Key NAME, CLINICAL_STUDY_ID

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

PATIENT_POSITIONS DCI_BOOK_ID DCI_BOOK_ID

DCI_BOOK_PAGES DCI_BOOK_ID DCI_BOOK_ID

DCI_BOOK_PHYSICAL_PAGES DCI_BOOK_ID DCI_BOOK_ID

DCI_BOOKS Column Descriptions

Column Name Null? Type Column Description

DCI_BOOK_ID Not Null NUMBER(10) Unique, system-generated ID for this DCI Book.

CREATED_BY Not Null VARCHAR2(30) User who created this DCI Book.

CREATION_TS Not Null DATE Date and time when this DCI Book was created.

CLINICAL_STUDY_ID Not Null NUMBER(10) ID of the clinical study with which this DCI Book is
associated.

NAME Not Null VARCHAR2(30) Name of the DCI Book.

DEFAULT_FLAG Not Null VARCHAR2(1) If Y, this DCI Book is the default book for the study and
comes up automatically in data entry, provided Entry by
DCI Book is enabled.
DESCRIPTION Null VARCHAR2(200) Freeform text describing the DCI Book.

MODIFIED_BY Null VARCHAR2(30) User who last modified this DCI Book.

MODIFICATION_TS Null DATE Date and time when this DCI Book was last modified.
REPLICATION_IND Null VARCHAR2(1) A flag to show if the DCI book has been replicated from
another location.

DCI_BOOK_STATUS_CODE Not null VARCHAR2(15) A code to show if the DCI book is Provisional (P), Active
(A), or Retired (R).

RETIREMENT_REASON_TYPE_ Null VARCHAR2(15) A code to indicate why a retired DCI book was retired.
CODE

STATUS_COMMENT_TEXT Not null VARCHAR2(200) A comment about why the DCI_BOOK_STATUS_CODE

was changed.

UNPLANNED_ALLOWED_FLAG Not null VARCHAR2(1) If Y, then for any DCI is not listed in DCI Book DCI
Constraints, you can enter data for the DCI. Any
planned DCIs are automatically listed in DCI Book
Constraints, so this column only applies to unplanned
DCIs.

2-16 Oracle Clinical Stable Interface

 DCI_BOOKS

Column Name Null? Type Column Description

VALIDATION_STATUS Not Null VARCHAR2(20) Indicates whether the DCI Book needs validating to
ensure its rules and pages are consistent with each other.
The value defaults to NOT APPLICABLE.

VALIDATION_RESULTS Null CLOB The results from the current Validate DCI Book run for
this DCI Book.

VALIDATION_TS Null DATE The timestamp of the last successful Validate DCI Book
run.

REVISION_SN Null NUMBER(3) The revision sequence number of the DCI Book at the
last successful Validate DCI Book

Table Definitions 2-17

DCI_BOOK_PAGES

DCI_BOOK_PAGES

A DCI book page represents an individual page within a DCI book. It corresponds to
an actual page of a CRF. If the DCIs are made up of more than one page, the DCI_
BOOK_PAGE references the first page of the DCI — for instance, if the Demography
DCI were two pages long and the pages were numbered 3 and 4, there would be a
single DCI_BOOK_PAGE record with a START_PAGE_NUMBER of 3. The child table
DCI_BOOK_PHYSICAL_PAGES contains the number of each page making up DCIs
within the DCI_BOOK.

Primary Key DCI_BOOK_PAGE_ID

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

CLINICAL_PLANNED_EVENTS CLIN_PLAN_EVE_ID CLIN_PLAN_EVE_ID

DCI_BOOKS DCI_BOOK_ID DCI_BOOK_ID

DCI_BOOK_PHYSICAL_PAGES DCI_BOOK_PAGE_ID DCI_BOOK_PAGE_ID

DCIS DCI_ID DCI_ID

DCI_BOOK_PAGES Column Descriptions

Column Name Null? Type Column Description

CLINICAL_STUDY_ID Not null NUMBER(10) The ID of the clinical study to which the DCI book page belongs.

DCI_BOOK_PAGE_ID Not null NUMBER(10) A unique, system-generated ID for the DCI book page.

DCI_BOOK_ID Not null NUMBER(10) The ID of the DCI book to which the DCI book page belongs.

DCI_ID Not null NUMBER(10) The ID of the DCI that the DCI book page collects.

START_PAGE_NUMBER Not null VARCHAR2(15) Alphanumeric page number in the CRF book where the data for
this instance of the DCI starts.

CLIN_PLAN_EVE_ID Null NUMBER(10) For visit-oriented DCIs, the ID of the CPE assigned to this DCI
book page is collected.

CREATED_BY Null VARCHAR2(30) User who created this DCI Book Page.

CREATION_TS Null DATE Date and time when this DCI Book Page was created.

MODIFIED_BY Null VARCHAR2(30) User who last modified this DCI Book Page.

MODIFICATION_TS Null DATE Date and time when this DCI Book Page was last modified.

REPLICATION_IND Null VARCHAR2(1) A flag to show if this DCI book page has been replicated from
another location.

DISPLAY_SN Not null NUMBER(4) A sequence number indicating the placement of the DCI book
page within the DCI.

2-18 Oracle Clinical Stable Interface

 DCI_BOOK_PHYSICAL_PAGES

DCI_BOOK_PHYSICAL_PAGES

A DCI book physical page records the entry of each CRF page in a DCI book. Oracle
Clinical ensures the first physical page for each DCI book page has the same BOOK_
PAGE label as the START_PAGE_NUMBER. The number of DCI book physical pages
is determined by the number of pages defined for the DCI.

Primary Key DCI_BOOK_PHYSICAL_PAGE_ID

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

DCI_BOOKS DCI_BOOK_ID DCI_BOOK_ID

DCI_BOOK_PAGE DCI_BOOK_PAGE_ID DCI_BOOK_PAGE_ID

DCI_BOOK_PHYSICAL_PAGES Column Descriptions

Column Name Null? Type Column Description

DCI_BOOK_PHYSICAL_ Not null NUMBER(10) A unique, system-generated ID for the DCI book physical
PAGE_ID page.

CLINICAL_STUDY_ID Not null NUMBER(10) The ID of the clinical study to which the DCI book physical
page belongs.
DCI_BOOK_ID Not null NUMBER(10) The ID of the DCI book to which the DCI book physical page
belongs.

DCI_BOOK_PAGE_ID Not null NUMBER(10) The ID of the DCI book page that this actual page relates to.

BOOK_PAGE Not null VARCHAR2(15) The label or page code used to identify this page within the
DCI book.

RELATIVE_TO_DCI_PAGE Not null NUMBER(4) The order of this physical page relative to all the physical
pages spanned by this physical page's DCI.

CREATED_BY Not null VARCHAR2(30) User who created this DCI Book Physical Page.

CREATION_TS Not null DATE Date and time when this DCI Book Physical Page was created.

PAGE_DESCRIPTION Null VARCHAR2(200) Freeform text describing the physical page.

MODIFIED_BY Null VARCHAR2(30) User who last modified this DCI Book Physical Page.

MODIFICATION_TS Null DATE Date and time when this DCI Book Physical Page was last
modified.

REPLICATION_IND Null VARCHAR2(1) A flag to show if the DCI book physical page has been
replicated from another location.

Table Definitions 2-19

DCI_FORM_VERSIONS

DCI_FORM_VERSIONS

DCI Forms are data entry-enabled PDF CRFs that you can create if you are
implementing the RDC PDF Option. Each DCI Form is a versioned object, so this table
stores information about each version of each DCI Form in this database.

Primary Key DCI_ID, VERSION_SN

Related Tables and Foreign Keys

Foreign key name in the related

Name of related table Foreign key name in this table table

DCIS DCI_ID DCI_ID

FORM_LAYOUT_TEMPLATES FLT_ID FLT_ID

DCI_FORM_VERSIONS Column Descriptions

Column Name Null? Type Column Description

DCI_ID Not Null NUMBER(10) The ID of the DCI for which this DCI Form is used.

VERSION_SN Not Null NUMBER(3) Version number of this layout. Oracle Clinical creates
version 1 from your first generation. A new version is
created when you generate a provisional layout, if there
are no existing provisional layouts.

LANGUAGE Not Null VARCHAR2(20) The name of the language for this version of the DCI form.

CLINICAL_STUDY_ID Not Null NUMBER(10) Unique ID for the clinical study for which this form
version is being used.

FLT_ID Not Null VARCHAR2(30) ID of the template for this version of the DCI Form.

FL_GENERATION_TS Null DATE Date and time when this form layout was generated.

FL_GENERATED_BY Null VARCHAR2(30) User who generated this form layout.

FL_STATUS Null VARCHAR2(1) The current status of this form layout. The status can be P
(Provisional), A (Active) or R (Retired). RDC uses the
active layout if the preferred version for the DCI in the
DCI book is CURRENT.
A DCI form can have at most:
One Provisional Form Layout Version (editable and
updatable) at most one Active Form Layout Versions (Can
render output) zero or more Retired Form Layout
Versions.

FL_EDITED_FLAG Null VARCHAR2(1) If Y, this DCI form layout has been edited since its
generation.

DESCRIPTION Null VARCHAR2(120) Further information to identify this version.

FL_XML Null CLOB This Character Large OBject (CLOB) stores the actual XML
that describes this DCI Form Version.

FL_XML_MODIFICATION_ Null DATE Date and time when the generated XML was last
TS modified.

FL_XML_MODIFIED_BY Null VARCHAR2(30) User who last modified the generated XML.

FL_XML_REFRESH_TS Null DATE Date and time when the XML was last refreshed.

FL_XML_REFRESHED_BY Null VARCHAR2(30) User who last refreshed the XML.

PDF_GENERATION_TS Null DATE Date and time when the PDF was first generated.

2-20 Oracle Clinical Stable Interface

 DCI_FORM_VERSIONS

Column Name Null? Type Column Description

PDF_GENERATED_BY Null VARCHAR2(30) User who first generated this PDF.

PDF Null BLOB This Binary Large OBject (or BLOB) column stores the
actual.

CHECKBOX_SHAPE Null VARCHAR2(30) Either CIRCLE or SQUARE. Circular checkboxes are radio
buttons, which restrict you to choosing one item from a
group. Square checkboxes are shown as actual checkboxes,
and allow you to select and deselect each item in the
group.

CHECKBOX_SIZE Null NUMBER(6) The size of the checkbox, usually in points.

FL_PDF_PAGE_ Null VARCHAR2(15) Name of the template used for generation of the PDF.
DEFINITION_CODE

FL_PDR_PAGE_ Null VARCHAR2(15) Name of the template used for generation of the PDR.
DEFINITION_CODE

FL_HEIGHT Null NUMBER(6,1) Overall height (in points) of the DCI Form Layout.
FL_WIDTH Null NUMBER(6,1) Overall width (in points) of the DCI Form Layout.

Table Definitions 2-21

DCI_MODULES

DCI_MODULES

A DCI module records a DCM assignment to a DCI with additional information, such
as whether the DCM should collect time, if the DCM is qualified, what the
qualification value is, and whether the DCM is to be collected at a particular visit.

Primary Key DCI_MODULE_ID

Unique Keys

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

DCMS DCM_ID DCM_ID

DCMS DCM_SUBSET_SN DCM_SUBSET_SN

DCMS DCM_LAYOUT_SN DCM_LAYOUT_SN

DCIS DCI_ID DCI_ID

CLINICAL_PLANNED_EVENTS CLIN_PLAN_EVE_ID CLIN_PLAN_EVE_ID

DCI_MODULE_PAGES DCI_MODULE_ID DCI_MODULE_ID

DCI_MODULES Column Descriptions

Column Name Null? Type Column Description

DCI_MODULE_ID Not null NUMBER(10) A unique, system-generated ID for the DCI module.

CREATION_TS Not null DATE Date and time when this DCI Module was created.

CREATED_BY Not null VARCHAR2(30) User who created this DCI Module.
DCI_ID Not null NUMBER(10) The ID of the DCI to which the DCI module belongs.

DCM_ID Not null NUMBER(10) The ID of the DCM assigned to the DCI by this DCI module.

DCM_SUBSET_SN Not null NUMBER(3) The subset number of the DCM assigned to the DCI by this
DCI module.
DCM_LAYOUT_SN Not null NUMBER(3) The layout number of the DCM assigned to the DCI by this
DCI module.

DCM_MODULE_SN Not null NUMBER(3) A serial number indicating the order of the module within
the parent DCI.

EVENT_DATE_IS_DCI_DATE_ Not null VARCHAR2(1) A flag indicating whether the clinical planned event's time
FLAG and date should be collected separately for received DCMs
entered for this DCI module or whether they should be
regarded as those entered for the received DCI.

COLLECT_EVENT_TIME_FLAG Not null VARCHAR2(1) A flag indicating whether the clinical planned event's time
should be collected for this DCI module.

OPTIONAL_FLAG Not null VARCHAR2(1) A flag to indicate whether the DCM can have more than one
instance created for this module at entry. If the flag is Y, the
module is optional. Only a single DCI module can exist in a
DCI if this flag is marked as optional. At entry, the operator
can manually invoke creation of additional received DCMs
for optional DCI module. The DCI module must also allow
entry of either the qualifying value or the clinical planned
event to be marked as optional.

CLINICAL_STUDY_ID Not null NUMBER(10) The ID of the clinical study to which the DCI belongs.

2-22 Oracle Clinical Stable Interface

 DCI_MODULES

Column Name Null? Type Column Description

QUAL_QUESTION_VALUE_TEXT Null VARCHAR2(80) If the DCM for this DCI module is qualified by a particular
question, this column specifies the matching value for that
question for this module.

CLIN_PLAN_EVE_ID Null NUMBER(10) The ID of the clinical planned event assigned to the DCI
module.

CLIN_PLAN_EVE_NAME Null VARCHAR2(20) The name of the clinical planned event assigned to the DCI
module.

MODIFIED_BY Null VARCHAR2(30) User who last modified this DCI module.

MODIFICATION_TS Null DATE Date and time when this DCI Module was last modified.

REPLICATION_IND Null VARCHAR2(1) A flag to show if the DCI book physical page has been
replicated from another location.

START_PAGE Null NUMBER(4) The first physical page number spanned by the DCM
(associated with the DCI module) within the parent DCI.

END_PAGE Null NUMBER(4) The last physical page number spanned by the DCM
(associated with the DCI module) within the parent DCI.

SHOW_QUALIFYING_VALUE_ Null VARCHAR2(1) If Y, Oracle Clinical displays a Qualifying Value in the DCM
FLAG header.

SHOW_LAB_FLAG Null VARCHAR2(1) If Y, Oracle Clinical displays the lab in the DCM header.
SHOW_VISIT_CODE Null VARCHAR2(15) The Visit Code controls how the DCI Form displays the visit
name and subevent number. The available options are:
NAME ONLY – Only the Visit Name appears on the DCI
Form.
NAME+SUB# – The Visit Name and Subevent Number
appear as one field with a period separator (for instance,
CHECKUP.1).
NAME/SUB# – The Visit Name and Subevent Number
appear as separate fields.
HIDDEN – Both the Visit Name and Subevent number are
hidden in the DCM Header. If there is no defined clinical
planned event, or the "Use DCI Date" setting is unchecked,
you cannot select value HIDDEN for the Visit Display.

SHOW_DATA_COMMENT_FLAG Null VARCHAR2(1) If Y, Oracle Clinical shows the Data Comment in the DCM
header.

SHOW_DATE_FLAG Null VARCHAR2(1) If Y, Oracle Clinical displays the date in the DCM header.
SHOW_TIME_FLAG Null VARCHAR2(1) If Y, Oracle Clinical displays the time in the DCM header.

SHOW_BLANK_FLAG Null VARCHAR2(1) If Y, Oracle Clinical displays a blank flag in the DCM header.

SHOW_COMMENT_FLAG Null VARCHAR2(1) If Y, Oracle Clinical displays the Comment in the DCM
header.

Table Definitions 2-23

DCI_MODULE_PAGES

DCI_MODULE_PAGES

DCI_Module_Pages contains page tracking information about DCI Modules.

Primary Key DCI_MODULE_PAGE_ID

Related Tables and Foreign Keys

Foreign key name in the related

Name of related table Foreign key name in this table table

DCI_MODULES DCI_MODULE_ID DCI_MODULE_ID

DCI_MODULE_PAGES Column Descriptions

Column Name Null? Type Column Description

DCI_MODULE_PAGE_ID Not null NUMBER(10) A unique, system-generated ID for the DCI module page.

DCI_MODULE_ID Not null NUMBER(10) The ID of the DCI module to which this DCI module page is
assigned.

CLINICAL_STUDY_ID Not null NUMBER(10) The ID of the clinical study to which this DCI module page is
assigned.
RELATIVE_TO_DCI_PAGE Not null NUMBER(4) The ID of the clinical study to which this DCI module page is
assigned.

LAST_DCM_QUESTION_ID Null NUMBER(10) The ID of the last DCM question on this DCI module page.

DCI_ID Not null NUMBER(10) The ID of the DCI to which this DCI module page is assigned.
DCI_MODULE_SN Not null NUMBER(3) The subset number of the DCI module to which this DCI
Module Page is assigned.

CREATED_BY Not null VARCHAR2(30) User who created this DCI Module Page.

CREATION_TS Not null DATE Date and time when this DCI Module Page was created.
LAST_QUE_REPEAT_NUM_ Null NUMBER(4) If this question belongs to a repeating question group, this
ON_PAGE column stores the ID of last repeat instance that appears on the
page. Leave this column blank if the question is not repeating.

REPLICATION_IND Null VARCHAR2(1) A flag to show if the DCI module page has been replicated
from another location.

MODIFIED_BY Null VARCHAR2(30) User who last modified this DCI Module Page.

MODIFICATION_TS Null DATE Date and time when this DCI Module page was last modified.

2-24 Oracle Clinical Stable Interface

 DCMS

DCMS

A data collection module (DCM) is a logically related set of questions consisting of one
or more DCM question groups that are collected at a single visit or about a particular
subject (defined by qualifying value) within a visit. The primary use of the DCM is to
specify the logical collections of data in data collection and analysis. Oracle Clinical
enforces that one and only one instance of a DCM (irrespective of DCM subset and
DCM layout) can be collected at an actual event, unless the DCM is qualified (see
QUALIFYING_QUESTION), in which case one instance for each unique qualifying
value is allowed.
The DCM table and its child tables all use a concatenated primary key consisting of the
object ID and the DCM_SUBSET_SN and DCM_LAYOUT_SN. The DCM_SUBSET_SN
defines variants of the DCM that might collect different subsets of the DCM questions
specified for the DCM. The DCM_LAYOUT_SN defines variants of a DCM subset
which are functionally equivalent in what they collect, but differ in the data entry
properties. When working with DCMs, particular care must be taken to fully qualify
upon these keys if a unique instance of a DCM and its children are required.
By convention, the base DCM subset is the DCM with DCM_SUBSET_SN = 1 and
DCM_LAYOUT_SN = 1. For attributes that are not subset- and layout-specific, this
base DCM subset and its children can be referenced. These DCM-wide attributes are
labeled "DCM-WIDE" in the column descriptions. By convention, the base DCM layout
for each DCM subset is the DCM subset with DCM_LAYOUT_SN = 1, and each DCM
subset has at least one DCM layout = 1. These DCM subset-wide attributes are labeled
"SUBSET-WIDE" in the column descriptions. For attributes that are not layout specific,
this base DCM Layout and its children can be referenced. Attributes that can change
for each DCM layout are labeled "LAYOUT-SPECIFIC" in the column descriptions.

Primary Key DCM_ID, DCM_SUBSET_SN, DCM_LAYOUT_SN

Unique Keys NAME, DCM_SUBSET_SN, DCM_LAYOUT_SN

SHORT_NAME, DCM_SUBSET_SN, DCM_LAYOUT_SN

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

CLINICAL_STUDIES CLINICAL_STUDY_ID CLINICAL_STUDY_ID

DCM_QUESTION_GROUPS DCM_ID DCM_ID

DCM_QUESTION_GROUPS DCM_SUBSET_SN DCM_QUE_GRP_DCM_

SUBSET_SN

DCM_QUESTION_GROUPS DCM_LAYOUT_SN DCM_QUE_GRP_DCM_

LAYOUT_SN

DCMS ORIGINAL_DCM_ID DCM_ID

DCMS ORIGINAL_DCM_SUBSET_SN DCM_SUBSET_SN

DCMS ORIGINAL_DCM_LAYOUT_SN DCM_LAYOUT_SN

QUESTIONS QUAL_QUESTION_ID QUESTION_ID

DCI_MODULES DCM_ID DCM_ID

DCI_MODULES DCM_SUBSET_SN DCM_SUBSET_SN

DCI_MODULES DCM_LAYOUT_SN DCM_LAYOUT_SN

Table Definitions 2-25

DCMS

Name of related table Foreign key name in this table Foreign key name in the related table

RECEIVED_DCMS DCM_ID DCM_ID

RECEIVED_DCMS DCM_SUBSET_SN DCM_SUBSET_SN

RECEIVED_DCMS DCM_LAYOUT_SN DCM_LAYOUT_SN

DISCRETE_VALUE_GROUPS DISCRETE_VAL_GRP_ID DISCRETE_VALUE_GRP_ID

DISCRETE_VALUE_GROUPS DISCRETE_VAL_GRP_SUBSET_NUM DISCRETE_VAL_GRP_SUBSET_NUM

DISCRETE_VALUES DISCRETE_VAL_GRP_ID DISCRETE_VALUE_DVG_ID

DISCRETE_VALUES DISCRETE_VAL_GRP_SUBSET_NUM DISCRETE_VAL_GRP_SUBSET_NUM

DISCRETE_VALUES DISCRETE_VAL_GRP_IND_VAL DISCRETE_VALUE_VALUE

DCMS Column Descriptions

Column Name Null? Type Column Description

DCM_ID Not null NUMBER(10) DCM-wide: A unique, system-generated ID for the DCM.
DCM_SUBSET_SN Not null NUMBER(3) Subset-wide: A sequence number for a DCM subset. A DCM
subset can be used to collect only some of the questions assigned
to the base DCM. The base or initial DCM has a sequence number
of 1.

DCM_LAYOUT_SN Not null NUMBER(3) Layout-specific: The DCM layout number. Layouts provide a way
to present the same DCM subset in different formats for data
entry — for instance, a DCM subset can have an English and a
Japanese layout. Within a subset, the layouts are numbered
starting with 1.

CREATION_TS Not null DATE Layout-specific: The date and time when this layout was created
for this DCM subset.

CREATED_BY Not null VARCHAR2(30) Layout-specific: The user who created this layout for this DCM
subset.
NAME Not null VARCHAR2(16) DCM-wide: A name for the DCM. Names are unique within a
domain.

DOMAIN Not null VARCHAR2(15) DCM-wide: A Global Library object-naming convention that
facilitates the unique naming or grouping of objects. Domains
also provide a mechanism for limiting access to objects.

SUBSET_NAME Not null VARCHAR2(8) Subset-wide: Subset name; unique among the subsets of this
DCM.

DCM_STATUS_CODE Not null VARCHAR2(15) Layout-specific: A code to control where the DCM can be used
and which attributes can be changed. This status has one of three
values: provisional (P), active (A), or retired (R).

LAST_STATUS_CHANGE_TS Not null DATE Layout-specific: The date and time that the DCM_STATUS_CODE
was last changed.

SHORT_NAME Not null VARCHAR2(4) DCM-wide: The short name is used as the basis for constructing
the names of the default Oracle and SAS views associated with
the DCM. Non-repeating DCM question groups are available in a
default view named by the DCM short name; repeating question
groups are available in a view named by the DCM short name
concatenated with the DCM question group short name.
DESCRIPTION Not null VARCHAR2(70) Layout-specific: Freeform text, in mixed case, used to describe the
DCM and its clinical and/or medical use.

CLINICAL_STUDY_ID Not null NUMBER(10) DCM-wide: The ID of the clinical study to which the DCM
belongs.

2-26 Oracle Clinical Stable Interface

 DCMS

Column Name Null? Type Column Description

DCM_DCI_QG_TYPE_CODE Not null VARCHAR2(15) DCM-wide: A user-defined code to classify a DCM according to
the type of data collected by that DCM.
COLLECTS_LAB_TESTS_ Not null VARCHAR2(1) DCM-wide: A system-derived flag to show if the DCM collects
FLAG lab data. This flag is set to Y if any DCM question in the DCM is
based on a Global Library question of type LAB_TEST.

LAYOUT_EDITED_FLAG Not null VARCHAR2(1) Layout-specific: A system-derived flag to indicate if the DCM's
layout has been edited with the layout editor.

LAYOUT_REGENERATION_ Not null VARCHAR2(1) Layout-specific: A system-derived flag to indicate if the DCM
REQ_FLAG layout needs regeneration or edit with the layout editor. A
regeneration is required if changes made to the DCM or
underlying DCM questions would change the data entry screen
layout — for instance, adding a new, enterable DCM question to a
DCM sets the flag.

FFL_EDITED_FLAG Not null VARCHAR2(1) If Y, this DCM graphic layout has been edited since it was last
generated. The default value is N.

FFL_NEEDS_EDIT_FLAG Not null VARCHAR2(1) If Y, you must edit this DCM graphic layout before you can add it
to a DCI Form Layout.

FFL_NEEDS_UPDATE_ Not null VARCHAR2(1) This flag indicates whether there have been changes to the DCM
FLAG definition since the DCM graphic layout was last reconciled with
the DCM definition. If Y, you must open the DCM graphic layout
in the editor, and save it, for the system to perform the required
reconciliation. Since editing is necessary, the system enters Y
places a check in the FFL_NEEDS_EDIT_FLAG column whenever
it enters Y in the FFL_NEEDS_UPDATE_FLAG column. After
you edit and save the layout, the system sets this column to N.

FFL_AVAILABLE_FLAG Not null VARCHAR2(1) If Y, you can incorporate the DCM graphic layout into a DCI
Form Layout. This column cannot be Y if the DCM graphic layout
does not exist, if the Needs Edit is checked, or if the DCI Form
Definition is not enabled. The system sets this column to N when
the Needs Update or Needs Edit flags are Y.
DEFAULT_PAGE_WIDTH Not null NUMBER(3) Character layout-specific: A number that defines, in characters,
the width of the page created with the default layout generator.
The page width will be between 80 and 240 characters and may
be different from the width of the window that displays the page.

DEFAULT_PAGE_HEIGHT Not null NUMBER(3) Character layout-specific: A number that defines, in lines, the
height of the page created with the default layout generator. The
page height will be between 22 and 80 lines and may be different
from the height of the window that displays the page.

WINDOW_WIDTH Not null NUMBER(3) Layout-specific: Not currently in use.

WINDOW_HEIGHT Not null NUMBER(3) Layout-specific: Not currently in use.

ORIGINAL_DCM_ID Null NUMBER(10) DCM-wide: Together with ORIGINAL_DCM_SUBSET_SN and

ORIGINAL_DCM_LAYOUT_SN, this field preserves the ID of the
DCM from which this DCM originally derives. This field is NULL
when a DCM is created from scratch, and is populated during
DCM copy operations. Subsequent copies of DCMs that already
have this field populated preserve the original ID.

ORIGINAL_DCM_LAYOUT_ Null NUMBER(3) Preserves the ID for the DCM layout from which this DCM
SN originally derives.
ORIGINAL_DCM_SUBSET_ Null NUMBER(3) Preserves the ID for the DCM subset from which this DCM
SN originally derives.

DCM_QUAL_VALUE_TEXT Null VARCHAR2(80) Subset-wide: The value to which the system constrains the
qualifying question for all received DCMs created for the
DCM/DCM subset. The qualifying value must be a value in the
qualifying DVG. If this value is NULL for a DCM with a
qualifying question, the value can be supplied either in the DCI
definition or, if NULL there, when the received DCM is created.

QUAL_QUESTION_ID Null NUMBER(10) DCM-wide: The ID of the question used to qualify the DCM.

Table Definitions 2-27

DCMS

Column Name Null? Type Column Description

DISPLAY_SN Null NUMBER(3) Layout-specific: The order in which DCM subsets are displayed
in the DCM schedule maintenance application.
LAYOUT_GENERATION_TS Null DATE Layout-specific: The last time the data entry screen layout
underwent generation or editing with the layout editor. If this
field is blank, the DCM data entry screen layout has never been
generated.

RETIREMENT_REASON_ Null VARCHAR2(15) Layout-specific: A code to indicate why a retired DCM was
TYPE_CODE retired.

STATUS_COMMENT_TEXT Null VARCHAR2(200) Layout-specific: Supplementary information about why the

DCM's status did or did not change.
HELP_TEXT Null VARCHAR2(200) Layout-specific: Freeform text, in mixed case, available for
display during data entry.

DATE_ORDER_CODE Null VARCHAR2(15)

Layout-specific: A code that controls the entry-time display of
date questions for this DCM layout. If the DATE_ORDER_CODE
is DYNAMIC, the behavior is governed by the data entry
preference for date display. If it is a specific value, the DCM
layout uses the value to override the data entry preference.
Possible values come from the reference codelist DATE_ORDER_
CODE. Values are:
■ DYNAMIC – Use Data Entry preference
■ EUROPEAN – Use DD-MM-YYYY
■ SWEDISH – Use YYYY-DD-MM
■ US – Use MM-DD-YYYY
■ STANDARD – Use DD-MON-YYYY

QUAL_QUESTION_DVG_ID Null NUMBER(10) DCM-wide: The ID of the DVG to be used for the qualifying
question. This field will be blank when a qualifying question is
not specified.

QUAL_QUESTION_DVG_ Null NUMBER(3) DCM-wide: The subset number of the DVG to be used for the
SUBSET_NUM qualifying question. This field will be blank when a qualifying
question is not specified.

QUAL_QUESTION_PROMPT Null VARCHAR2(60) DCM-wide: Text on the data entry DCM header screen that asks
for data input to the qualifying question. The prompt, in mixed
case, is a freeform text field.

PROD_GENERATION_TS Null DATE Layout-specific: The date and time when this DCM subset layout
became available for production data entry. If this field is blank or
if the PROD_GENERATION_TS is earlier than the
GENERATION_TS, the DCM layout is not available for
production data entry.

MODIFICATION_TS Null DATE Date and time when this DCM subset/layout combination was
last modified.

MODIFIED_BY Null VARCHAR2(30) The user who last modified this DCM subset/layout
combination.

REPLICATION_IND Null VARCHAR2(1) A flag to show if the DCM has been replicated from another
location.

LAYOUT_VER_NUM Null NUMBER(2) An internal version tracking field not currently in use.

FFL_BLOCK_WIDTH Null NUMBER(6,1) The width (in points) of all blocks of this DCM graphic layout.

FFL_FIRST_BLOCK_HEIGHT Null NUMBER(6,1) The height (in points) of the first block of this DCM graphic
layout. This value overrides the Maximum Allowed Height for
the first block only, and you can adjust it in the Layout Editor.

2-28 Oracle Clinical Stable Interface

 DCMS

Column Name Null? Type Column Description

FFL_MAX_ALLOWED_ Null NUMBER(6,1) The maximum height (in points) that any of the blocks within the
HEIGHT graphic layout can attain. Each block may be shorter than this
maximum; a block's size depends on its content. You can change
the height of blocks in the layout editor; however, no block may
be made taller than the value reflected in this field.
The maximum allowed height is determined by the height of the
DCM Layout Region of the Form Layout Template that you select
when generating the DCM Graphic Layout. Choose a template
that is large enough for your expected needs.

FFL_ACTUAL_MAX_HEIGHT Null NUMBER(6,1) The actual height (in points) of the tallest block in the layout. The
Editor updates this value whenever you save an edited DCM
graphic layout. This information can be useful in determining
which Form Layout Template to use when incorporating this
DCM into a DCI.

FFL_LAST_BLOCK_HEIGHT Null NUMBER(6,1) The height (in points) of the last block in the layout. This value
may be useful in deciding the height you assign to the first block
of another DCM Graphic Layout that you intend to fit on a DCI
page after this DCM.

FLT_ID Null NUMBER(10) ID of the Form Layout Template used to initialize the values for
the DCM graphic layout's Standard Block Width and Height.

FLT_XML Null CLOB A Character Large OBject (CLOB) that stores this DCM graphic
layout.

FLT_XML_GENERATION_TS Null DATE Date and time when this DCM graphic layout was first generated.

FLT_XML_GENERATED_BY Null VARCHAR2(30) User who first generated the DCM graphic layout.
FLT_XML_MODIFICATION_ Null DATE Date and time when this DCM Form layout was last modified.
TS Modifications include edits, updates, and generations.

FLT_XML_MODIFIED_BY Null VARCHAR2(30) User who last modified the DCM Form Layout.

CHECKBOX_SHAPE Null VARCHAR2(30) Shape of the checkbox generated by default at generation time.
You can change the shape of an individual checkbox in the layout
editor.
CHECKBOX_SIZE Null NUMBER(6) Size of the checkbox generated by default at generation time. You
can change the size of an individual checkbox in the layout editor.

Table Definitions 2-29

DCM_QUESTIONS

DCM_QUESTIONS

This table records the assignment of a question in the Global Library to a DCM
question group.
For the column definitions in this section, DCM-wide attributes are labeled
"DCM-WIDE," DCM subset-wide attributes are labeled "SUBSET-WIDE," and
attributes that can change for each DCM layout are labeled "LAYOUT-SPECIFIC."
Refer to the introduction to the DCM table for the full definitions of these attributes.

Primary Key DCM_QUESTION_ID, DCM_QUE_DCM_SUBSET_SN,

DCM_QUE_DCM_LAYOUT_SN

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

DCMS DCM_ID DCM_ID

DCMS DCM_QUE_DCM_SUBSET_SN DCM_SUBSET_SN

DCMS DCM_QUE_DCM_LAYOUT_SN DCM_LAYOUT_SN

DCM_QUESTION_GROUPS DCM_QUESTION_GROUP_ID DCM_QUESTION_GROUP_ID

DCM_QUESTION_GROUPS DCM_QUE_DCM_SUBSET_SN DCM_QUE_GRP_DCM_

SUBSET_SN

DCM_QUESTION_GROUPS DCM_QUE_DCM_LAYOUT_SN DCM_QUE_GRP_DCM_

LAYOUT_SN

QUESTIONS QUESTION_ID QUESTION_ID

QUESTION_GROUPS QUESTION_GROUP_QUESTION_ QUESTION_GROUP_
ID QUESTION_ID

CLINICAL_STUDIES CLINICAL_STUDY_ID CLINICAL_STUDY_ID

DISCRETE_VALUE_GROUPS DISCRETE_VAL_GRP_ID DISCRETE_VALUE_GRP_ID

DISCRETE_VALUE_GROUPS DISCRETE_VAL_GRP_SUBSET_ DISCRETE_VAL_GRP_
NM SUBSET_NM

DCM_QUES_REPEAT_ DCM_QUESTION_ID DCM_QUESTION_ID

DEFAULTS

DCM_QUESTIONS Column Descriptions

Column Name Null? Type Column Description

DCM_QUESTION_ID Not null NUMBER(10) DCM-wide: A unique, system-generated ID for the DCM
question. Part of the concatenated primary key.

DCM_QUE_DCM_SUBSET_SN Not null NUMBER(3) DCM-wide: A unique, system-generated ID for the DCM
question. Part of the concatenated primary key.

DCM_QUE_DCM_LAYOUT_SN Not null NUMBER(3) Layout-specific: The layout number of the DCM to which the
DCM question belongs. Part of the concatenated primary key.

CREATED_BY Not null VARCHAR2(30) Layout-specific: The user who created this layout for this DCM
subset.

CREATION_TS Not null DATE Layout-specific: The date and time when this layout was
created for this DCM subset.
DCM_ID Not null NUMBER(10) DCM-wide: The ID of the DCM to which the DCM question
belongs.

2-30 Oracle Clinical Stable Interface

 DCM_QUESTIONS

Column Name Null? Type Column Description

DCM_QUESTION_GROUP_ID Not null NUMBER(10) DCM-wide: The ID of the DCM question group to which the
DCM question belongs.
DISPLAY_SN Not null NUMBER(3) Layout-specific: A sequence number to control the order of the
DCM questions in the DCM maintenance application; the order
in the default layout for the DCM subset layout; and, for the
base DCM, the order in the defaulted data extract views.

DVG_MODIFIABLE_FLAG Not null VARCHAR2(1) DCM-wide: A flag to control whether the discrete value group
(DVG) Name field for the question can be modified. If this field
is Y, the current value of the DVG name can be modified
(including from null to a value). Constrained to be N in the
DCM maintenance application if the value of the corresponding
DCM_MODIFIABLE_FLAG is N in the Global Library question
group question, or, if none, the Global Library question.

MANDATORY_FLAG Not null VARCHAR2(1) DCM-wide: A flag to control whether a response to the
question must be entered. If this field is Y, a response to the
question must be entered during data entry or batch data load,
or a univariate mandatory discrepancy is created.

QUESTION_NAME Not null VARCHAR2(20) DCM-wide: Name of the question in the Global Library that
was copied to the DCM when a question group was added to
the DCM or when an individual Global Library question was
added to the DCM. Defaulted from questions; not modifiable in
the DCM.

OCCURRENCE_SN Not null NUMBER(3) DCM-wide: A sequence number to indicate the instance
number when there is more than one instance of the same
Global Library question in the same DCM QUESTION_GROUP.
By convention, the OCCURRENCE_SN is 0 when there is only
a single instance. When there are multiple instances, they are
numbered sequentially from 1. The system enforces that the
numbering remains sequential when instances are added or
removed.

QUESTION_DATA_TYPE_ Not null VARCHAR2(15) DCM-wide: A code for the type of data expected as a response
CODE to the Global Library question. This type of data is defaulted
from questions, and is not modifiable in the DCM.

INDICATOR_FLAG Not null VARCHAR2(1) DCM-wide: A flag to control whether the question is an
indicator question. If this field is Y, the question is an indicator
question and the value in the DISCRETE_VAL_IND_VALUE
field specifies that the other questions in the question group are
expected to have responses during data entry. In a repeating
DCM question group, only a single response is collected for the
indicator question so that in Oracle Clinical data entry, the
indicator question is treated as a non-repeating question. In the
batch validation process, Oracle Clinical creates indicator-type
discrepancies when the value for the indicator question is
inconsistent with the presence or absence of responses to the
other questions in the question group.

REQUIRED_FLAG Not null VARCHAR2(1) DCM-wide: A flag to show if the question is required in the
DCM question group. Defaulted from question group
questions; not modifiable in the DCM. If this field is Y, the
COLLECTED_FLAG can not be changed to N.

SIGHT_VERIFICATION_FLAG Not null VARCHAR2(1) Layout-specific: A flag to control second pass data entry. If this
field is Y, the system completes the second pass data entry
response field with the response from the first pass, allowing
the response to be visually verified instead of being re-keyed. If
this field is N, the second pass field is left blank and requires
reentry.

Table Definitions 2-31

DCM_QUESTIONS

Column Name Null? Type Column Description

VALIDATION_CHANGE_TS Not null DATE Subset-specific: A system-maintained timestamp that records

the last time that an attribute affecting the discrepancy status of
the DCM question was changed. These attributes include:
UPPER_BOUND, LOWER_BOUND, MANDATORY_FLAG,
LENGTH, DECIMAL_PLACES, DERIVED_FLAG, DISCRETE_
VAL_GRP_ID, and DATE_TIME_TYPE_CODE, which are all
DCM-wide, and DISCRETE_VAL_GRP_SUBSET_NM, which is
subset-wide.
DERIVED_LOCK_FLAG Not null VARCHAR2(1) Not currently used.

ENTERABLE_FLAG Not null VARCHAR2(1) Layout-specific: A flag to control whether responses to a

question can be entered during data entry. If this field is Y, a
response to the question can be entered through the interactive
data entry screen. Even if the field is not enterable, a value can
be supplied by the DEFAULT_RESPONSE_TEXT field.

DISPLAYED_FLAG Not null VARCHAR2(1) Layout-specific: A flag to control whether responses to the
question are displayed on the data entry screen. If this field is Y,
the responses are displayed on the data entry screens. This is
most relevant to derived questions where the value is not to be
entered but the derived value can be seen.

COLLECTED_FLAG Not null VARCHAR2(1) DCM-wide: A flag to control whether the question is collected
in the clinical study. This field must be Y if the Required In
DCM Ques Group? field is Y. If this field is N, the question is
not collected in the clinical study, so it does not appear either
on the data entry screens or in the data extract views.

AUTOSKIP_FLAG Not null VARCHAR2(1) DCM-wide: A flag to control whether the question is collected
in the clinical study. This field must be Y if the Required In
DCM Ques Group? field is Y. If this field is N, the question is
not collected in the clinical study, so it does not appear either
on the data entry screens or in the data extract views.

DERIVED_FLAG Not null VARCHAR2(1) DCM-wide: A flag to control whether responses to the question
are derived. If this field is Y, responses to the question are
entered and modified exclusively through a Derivation
Procedure. Responses cannot be entered or modified through
the data entry subsystem.

QUESTION_ID Not null NUMBER(10) DCM-wide: The ID of the question (from the Questions table)
corresponding to the DCM question.
UPPER_CASE_FLAG Not null VARCHAR2(1) Layout-specific: A flag to indicate whether the data entry screen
forces all character input for the DCM question to capital
letters. If this field is N, no character is forced to uppercase;
mixed-case characters retain the case in which they were
entered.

SAS_NAME Not null VARCHAR2(8) DCM-wide: An identifier for the DCM question when accessed
through the SAS package, after creating the data extract views.
The SAS name defaults from the question's SAS_NAME, but
the system modifies it by appending the OCCURRENCE_SN
when multiple occurrences are created. This field is not
user-modifiable.

SAS_LABEL Not null VARCHAR2(40) DCM-wide: Text description of the question supplied to the
SAS Labels field in the SAS views. Defaulted from question
group questions. Freeform text field, in mixed case.
LENGTH Not null NUMBER(3) DCM-wide: The maximum number of characters for responses
to the question. Defaulted from question group questions and
constrained to be at least as long as the corresponding
question's length. Once increased, a DCM question's length can
not be decreased.

2-32 Oracle Clinical Stable Interface

 DCM_QUESTIONS

Column Name Null? Type Column Description

COLLECTED_IN_SUBSET_ Not null VARCHAR2(1) Subset-wide: A flag to control whether the question is collected
FLAG in this DCM subset. This flag must be Y if the Required In DCM
Quest Grp? field is Y and cannot be Y if the Collect in Study?
field is N. If this field is N, the question is not collected in the
DCM subset, so it cannot appear on the data entry screens. The
question does appear in the data extract views with a null value
for data entered for this DCM subset.

CLINICAL_STUDY_ID Not null NUMBER(10) DCM-wide: The ID of the clinical study to which the DCM
question belongs.

DISCRETE_VAL_IND_VALUE Null VARCHAR2(80) DCM-wide: The value for the indicator question that indicates
that other questions in the DCM question group should have
responses. See INDICATOR_FLAG.

DISCRETE_VAL_GRP_ID Null NUMBER(25) DCM-wide: The ID of the discrete value group associated with
this DCM question. Modifiable only if the DVG_
MODIFIABLE_FLAG is Y.

DISCRETE_VAL_GRP_SUBSET_ Null NUMBER(3) Subset-wide: Specifies the number of the DVG subset
NM associated with this DCM question.

HELP_TEXT Null VARCHAR2(200) Layout-specific: Freeform text, in mixed case, available for
display during data entry.

UPPER_BOUND Null VARCHAR2(45) DCM-wide: Specifies the highest inclusive value allowed for
the DCM question without causing a univariate discrepancy.
VALIDATION_FAILURE_TYPE_ Null VARCHAR2(15) DCM-wide: A code to specify the severity of a univariate
CODE discrepancy if one is created.

DATA_ENTRY_DISPLAY_ Null NUMBER(3) Layout-specific: The width of the field, in number of characters,
LENGTH displayed for input on the data entry screen. Used by default
screen layout generation and modified by field length changes
made through the layout editor. This number cannot be greater
than the DCM question length.

DEFAULT_PROMPT Null VARCHAR2(60) Layout-specific: Freeform text, in mixed case, that is used by
the default screen layout generation to create the default data
entry screens. Also used to describe the DCM question in some
applications.

DECIMAL_PLACES Null NUMBER(2) DCM-wide: Specifies the expected maximum number of digits
to the right of the decimal point for a response to a number
question. Entry of a larger number of digits causes a univariate
PRECISION discrepancy.

DEFAULT_RESPONSE_TEXT Null VARCHAR2(200) Layout-specific: Default response displayed at entry time.

Constrained by the system to be compatible with the DCM
question's data type.

LOWER_BOUND Null VARCHAR2(45) DCM-wide: Specifies the lowest inclusive value allowed for the
DCM question without causing a univariate discrepancy.

QUESTION_GROUP_ Null NUMBER(10) DCM-wide: The ID of the question group question

QUESTION_ID corresponding to this DCM question. Null if the DCM question
was created by adding a single question directly to the DCM
question group.
DVG_SUB_TYPE_CODE Null VARCHAR2(15) DCM-wide: A code for the type of DVG assigned to the DCM
question. Defaulted from the DVG associated with the DCM
question; not modifiable in the DCM.

X_POSITION Null NUMBER(3) Layout-specific: The x-coordinate on the data entry screen
where the question should start.

Y_POSITION Null NUMBER(3) Layout-specific: The y-coordinate on the data entry screen
where the question should start.

Table Definitions 2-33

DCM_QUESTIONS

Column Name Null? Type Column Description

PAGE_NUM Null NUMBER(3) Layout-specific: The data entry screen number where this DCM
question will appear. This field is not related to the page
numbering attributes defined in DCI_BOOKS and DCIS that
are used for page tracking.
DATE_TIME_TYPE_CODE Null VARCHAR2(3) DCM-wide: A code to specify the expected precision of the data
for a question with data type of DATE or TIME. Valid values
are: DMY, MY, Y for dates, and HMS or HM for times. Entry of
a date or time with less information than specified results in the
creation of a univariate PARTIAL_DATE discrepancy.

MODIFICATION_TS Null DATE Layout-specific. The date and time when this layout was last
modified for this DCM subset.

MODIFIED_BY Null VARCHAR2(30) Layout-specific. The user who last modified this layout for this
DCM subset.

REPLICATION_IND Null VARCHAR2(1) v

HAS_REPEAT_DEFAULTS_ Not null VARCHAR2(1) Subset-wide: A system-maintained flag to indicate if default

FLAG values have been specified for the various repeats of the DCM
question. These repeating defaults are in the DCM_QUES_
REPEAT_DEFAULTS table. All layouts of the same DCM subset
are constrained to have the same set of repeating defaults.

DCM_QUE_SUB_GROUP_SN Not null NUMBER(4) Layout-specific: An internal, system-maintained column used

to track when DCM questions from one DCM question group
are moved in the DCM layout editor to appear both before and
after another DCM question group.

HAS_CONDITIONAL_ Not null VARCHAR2(1) Layout-specific: A system-maintained flag to indicate if

BRANCH_FLAG conditional branching has been specified. The conditional
branch information is in the table DCM_CONDITIONAL_
BRANCHES.

DATE_TIME_FORMAT_CODE Not null VARCHAR2(15) Layout-specific: A code to control which portions of the date or
time question to display on data entry screens. Possible values
come from the reference codelist DATE_TIME_FORMAT_
CODE. Values are DMY (Day Month Year), MY (Month Year), Y
(Year), HMS (Second), and HM (Hour Minute).

SCREEN_ITEM_NUM Not null NUMBER(3) Layout-specific: An internal, system-maintained column that

specifies the display order of data entry fields within the data
entry screen page. This number reflects the actual field number
left-to-right, top-to-bottom on the screen, counting repeating
instances of the fields on the data entry screen. Thus the
sequence has gaps when a repeating question group that
displays multiple repeats precedes the DCM question on the
entry screen.

ALPHA_DVG_MODIFIABLE_ Not null VARCHAR2(1) Flag to indicate if the alpha discrete value group assigned to
FLAG this question is modifiable.
ALPHA_DVG_ID Not null NUMBER(10) The ID of the alpha discrete value group assigned to this
question.

ALPHA_DVG_SUBSET_NUM Not null NUMBER(3) The subset number of the alpha discrete value group assigned
to this question.

HAS_GRAPHIC_BLOCKS_ Null VARCHAR2(10) Indicates whether target blocks are defined for the DCM
FLAG question in the graphic layout. The value CB denotes a
conditional block is defined for the question, and a value TB
denotes that an indicator block is defined for the question.

2-34 Oracle Clinical Stable Interface

 DCM_QUES_REPEAT_DEFAULTS

DCM_QUES_REPEAT_DEFAULTS

This table holds default responses to repeating questions in a repeating question

group; for example, 1:00, 2:00, 4:00, and 6:00 could be default values for a repeating
PLANNED_TIME question. The DCM maintenance application ensures that all
layouts of the same DCM subset have the same repeating default values. Repeating
defaults are not used by batch data load.
For the column definitions in this section, DCM-wide attributes are labeled
"DCM-WIDE," DCM subset-wide attributes are labeled "SUBSET-WIDE," and
attributes that can change for each DCM layout are labeled "LAYOUT-SPECIFIC."
Refer to the introduction to the DCM table for the full definitions of these attributes.

Primary Key DCM_QUES_REP_DFTS_ID

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

DCM_QUESTIONS DCM_QUESTION_ID DCM_QUESTION_ID

DCM_QUESTIONS DCM_SUBSET_SN DCM_QUE_DCM_SUBSET_SN

DCM_QUESTIONS DCM_LAYOUT_SN DCM_QUE_DCM_LAYOUT_SN

CLINICAL_STUDIES CLINICAL_STUDY_ID CLINICAL_STUDIES

DCM_QUES_REPEAT_DEFAULTS Column Descriptions

Column Name Null? Type Column Description

DCM_QUES_REP_DFTS_ID Not null NUMBER(10) Layout-specific: A unique, system-generated ID for the DCM
question repeat default.

CLINICAL_STUDY_ID Not null NUMBER(10) DCM-wide: The ID of the clinical study to which the DCM
question repeat default belongs.

DCM_QUESTION_ID Not null NUMBER(10) Subset-wide: The ID of the DCM question to which the default is
assigned.

DCM_SUBSET_SN Not null NUMBER(2) Subset-wide: The subset number of the DCM to which the DCM
repeat default belongs.

DCM_LAYOUT_SN Not null NUMBER(2) Layout-specific: The layout number of the DCM to which the
DCM repeat default belongs.

REPEAT_SN Not null NUMBER(4) Subset-wide: A sequence number for the default within the
repeating question.

CREATION_TS Not null DATE Subset-wide: the date and time when this DCM question repeat
default was created.

CREATED_BY Not null VARCHAR2(30) Subset-wide: the user who created this DCM question repeat
default.

DEFAULT_VALUE_TEXT Null VARCHAR2(200) Subset-wide: The value displayed for the specified repeat of the
question. If the question is associated with a DVG, only that
DVG's values can be entered as the defaults.

REPLICATION_IND Null VARCHAR2(1) A flag to show if the DCM repeating question default has been
replicated from another location.

MODIFIED_BY Null VARCHAR2(30) Subset-wide: the user who last modified this DCM question
repeat default.

Table Definitions 2-35

DCM_QUES_REPEAT_DEFAULTS

Column Name Null? Type Column Description

MODIFICATION_TS Null DATE Subset-wide: the date and time when this DCM question repeat
default was last modified.

2-36 Oracle Clinical Stable Interface

 DCM_SCHEDULES

DCM_SCHEDULES

A DCM schedule records at which clinical planned event a DCM subset is planned to
be collected. It is used to drive the Missing and Overdue DCMs report. Since the DCM
schedule is specific to a DCM subset and not to a particular DCM layout, there is only
a partial foreign key to DCMS.
Rows exist in this table only where the DCM subset is scheduled; there are no rows
where the SCHEDULE_TYPE_CODE is null.

Primary Key DCM_SCHEDULE_DCM_ID, DCM_SCHEDULE_DCM_SUBSET_SN,

CLIN_PLAN_EVE_ID

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

CLINICAL_STUDIES CLINICAL_STUDY_ID CLINICAL_STUDY_ID

CLINICAL_PLANNED_EVENTS CLIN_PLAN_EVE_ID CLIN_PLAN_EVE_ID

DCMS (partial) DCM_SCHEDULE_DCM_ID DCM_ID

DCMS (partial) DCM_SCHEDULE_DCM_ DCM_SUBSET_SN

SUBSET_SN

DCM_SCHEDULES Column Descriptions

Column Name Null? Type Column Description

DCM_SCHEDULE_DCM_ID Not null NUMBER(10) The ID of the DCM scheduled by the DCM schedule.

DCM_SCHEDULE_DCM_ Not null NUMBER(3) The subset number of the DCM scheduled by the DCM
SUBSET_SN schedule.

CLIN_PLAN_EVE_ID Not null NUMBER(10) The ID of the clinical planned event at which the DCM is
scheduled.
CREATION_TS Not null DATE Date and time when this DCM schedule was created.

CREATED_BY Not null VARCHAR2(30) User who created this DCM schedule.

CLINICAL_STUDY_ID Not null NUMBER(10) The ID of the clinical study to which the DCM schedule belongs.

SCHEDULE_TYPE_CODE Not null VARCHAR2(15) A code to indicate if the DCM is expected or optional. Possible
values come from the reference codelist SCHEDULE_TYPE_
CODE. Values are E (Expected) and O (Optional).

MODIFICATION_TS Not null DATE Date and time when this DCM schedule was last modified.

MODIFIED_BY Not null VARCHAR2(30) User who last modified this DCM schedule.

REPLICATION_IND Not null VARCHAR2(1) A flag to show if the DCM schedule has been replicated from
another location.

Table Definitions 2-37

DISCREPANCY_ENTRIES(T)

DISCREPANCY_ENTRIES(T)

A discrepancy entry is created each time a univariate or multivariate validation test

fails. It can be cleared by either changing the received data or changing the validation
test concerned.
The test table for DISCREPANCY_ENTRIES is DISCREPANCY_ENTRIEST.

Primary Key DISCREPANCY_ENTRY_ID

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

CLINICAL_STUDIES CLINICAL_STUDY_ID CLINICAL_STUDY_ID

PATIENT_POSITIONS PATIENT_POSITION_ID PATIENT_POSITION_ID

PROCEDURES PROCEDURE_ID PROCEDURE_ID

PROCEDURES PROCEDURE_VER_SN PROCEDURE_VER_SN

PROCEDURE_DETAILS PROCEDURE_DETAIL_ID PROCEDURE_DETAIL_ID

RECEIVED_DCMS RECEIVED_DCM_ID RECEIVED_DCM_ID

RECEIVED_DCMS RECEIVED_DCM_ENTRY_TS RECEIVED_DCM_ENTRY_TS

RESPONSES RESPONSE_ID RESPONSE_ID

RESPONSES RESPONSE_ENTRY_TS RESPONSE_ENTRY_TS

DCM_QUESTIONS (partial) DCM_QUESTION_ID DCM_QUESTION_ID

OCL_INVESTIGATORS INVESTIGATOR_ID INVESTIGATOR_ID

OCL_SITES SITE_ID SITE_ID

ACTUAL_EVENTS ACTUAL_EVENT_ID ACTUAL_EVENT_ID

CLINICAL_PLANNED_EVENTS CLIN_PLAN_EVE_ID CLIN_PLAN_EVE_ID

DISCREPANCY_ENTRY_REVIEW_HIST DISCREPANCY_ENTRY_ID DISCREPANCY_ENTRY_ID

VALIDATION_REPORTED_VALUES DISCREPANCY_ENTRY_ID DISCREPANCY_ENTRY_ID

DISCREPANCY_ENTRIES Column Descriptions

Column Name Null? Type Column Description

DISCREPANCY_ENTRY_ID Not null NUMBER(10) A unique, system-generated ID for the discrepancy.

CREATED_BY Not null VARCHAR2(30) User who created the discrepancy.

CREATION_TS Not null DATE Date and time when this discrepancy was created.

CLINICAL_STUDY_ID Not null NUMBER(10) The ID of the clinical study to which the discrepancy belongs.

INVESTIGATOR_ID Not null NUMBER(10) The ID of the investigator responsible for the discrepancy.

SITE_ID Not null NUMBER(10) The ID of the investigator responsible for the discrepancy.

PATIENT_POSITION_ID Not null NUMBER(10) The ID of the patient that the discrepancy belongs to.

DE_SUB_TYPE_CODE Not null VARCHAR2(15) System-controlled classification of the discrepancy according to

how the discrepancy was generated. Possible values come from the
system reference codelist DE SUB_TYPE_CODE. Values are
UNIVARIATE, MULTIVARIATE, MANUAL, and INDICATOR.

2-38 Oracle Clinical Stable Interface

 DISCREPANCY_ENTRIES(T)

Column Name Null? Type Column Description

DISCREPANCY_STATUS_ Not null VARCHAR2(15) System-controlled status that indicates whether the discrepancy is
CODE current or obsolete. Possible values come from the system codelist
DISCREPANCY_STATUS_CODE. Values are CURRENT and
OBSOLETE.
DISCREPANCY_REV_ Not null VARCHAR2(15) Current status of the discrepancy in the discrepancy management
STATUS_CODE process. A new univariate discrepancy is automatically
UNREVIEWED, while the initial review status for multivariate
discrepancies is dictated by the originating Procedure definition
(details block). These and other values used in the discrepancy life
cycle come from the installation reference codelist
DISCREPANCY_REV_STATUS_CODE. If a discrepancy is resolved
by Oracle Clinical — for instance, due to a validation or data
change — Oracle Clinical puts the value CLOSED in this field.

SUSPECT_FLAG Not null VARCHAR2(1) A flag used internally during the batch validation process. Its
value has no significance outside of this process.

IRRESOLVABLE_FLAG Not null VARCHAR2(1) A flag to show whether the discrepancy is being regarded as
irresolvable, or in need of further processing. This flag is
maintained by the system when a DISCREPANCY_RESOLU_
TYPE_CODE is selected that has a long value of IRRESOLVABLE.
FIRST_PASS_ERROR_FLAG Not null VARCHAR2(1) Not used.

DISCREPANCY_TYPE_CODE Null VARCHAR2(15) A code to classify the type of discrepancy. For univariate
discrepancies, possible values come from the system reference
codelist DISCREPANCY_TYPE_CODE.
Values for the DISCREPANCY_TYPE_CODE are:
DVG
DATA TYPE
LOWERBOUND
SCT_MISSING
DVG SUBSET
LENGTH
PRECISION
PARTIAL DATE
THESAURUS
UPPERBOUND
PT_MISSING
TMS_EVAL
For multivariate discrepancies, values come from the installation
codelist PROCEDURE_TYPE_CODE.
RECEIVED_DCM_ID Null NUMBER(10) Not used.

DCM_QUESTION_ID Null NUMBER(10) The ID of the DCM question that caused the discrepancy.

RECEIVED_DCM_ENTRY_TS Null DATE The entry timestamp of the received DCM that contains the
discrepancy.

PROCEDURE_DETAIL_ID Null NUMBER(10) The ID of the Procedure Detail that raised the discrepancy.

PROCEDURE_ID Null NUMBER(10) The ID of the Procedure that raised the discrepancy.

PROCEDURE_VER_SN Null NUMBER(3) The version number of the Procedure that raised the discrepancy.

RESPONSE_ID Null NUMBER(10) The ID of the response that has the discrepancy against it.

RESPONSE_ENTRY_TS Null DATE The entry timestamp of the response that has the discrepancy
against it.

Table Definitions 2-39

DISCREPANCY_ENTRIES(T)

Column Name Null? Type Column Description

DISCREPANCY_RESOLU_ Null VARCHAR2(15) A code to clarify the discrepancy review status. When the Review
TYPE_CODE Status field has a value of UNREVIEWED, this field is blank. When
the discrepancy is closed by the system, this field is automatically
completed with an appropriate value. Values come from the
installation reference codelist DISCREPANCY_RESOLU_TYPE_
CODE. If the long value of the value in the codelist contains the
value IRRESOLVABLE, the system also sets the value of the
IRRESOLVABLE_FLAG to Y. If a discrepancy is resolved by Oracle
Clinical — due to a validation or data change, for example —
Oracle Clinical puts the following codes in this field:
DATA CHANGE – Data change
VALID. CHANGE – Validation change
VALID. RETIRED – Validation retired
DVG – Discrete value group
DVG SUBSET – Discrete value group subset
THESAURUS – Thesaurus discrete value group
DATA REMOVED – RDCI/RDCM/response was deleted

DISCREPANCY_CHG_ Null VARCHAR2(15) (Obsolete)

REASON_TYPE

COMMENT_TEXT Null VARCHAR2(200 Freeform text to hold a comment about the discrepancy. It is by
0) default populated with either the DISCREPANCY_TYPE_CODE
for univariate discrepancies, or the message text as defined in the
originating Procedure Detail for multivariate discrepancies.

CLIN_PLAN_EVE_ID Null NUMBER(10) The ID of the clinical planned event to which the discrepancy is
linked.

ACTUAL_EVENT_ID Null NUMBER(10) The ID of the actual event to which the discrepancy is linked.

DCM_ID Null NUMBER(10) The ID of the DCM that has the discrepancy against it.

SUBEVENT_NUMBER Null NUMBER(2) Together with CLIN_PLAN_EVE_ID, the identifier of the actual
event to which the discrepancy is linked.

MODIFICATION_TS Null DATE Timestamp for the last modification of this discrepancy, if any.

MODIFIED_BY Null VARCHAR2(30) User who last modified this discrepancy, if any.

DCF_ID Null NUMBER(10) The ID of the most recent DCF created to resolve the discrepancy.

ASSOCIATED_ID Null NUMBER(10) The ID of another discrepancy entry with which the current
discrepancy has been manually associated, usually to indicate that
the discrepancy entry is probably caused by the same data
anomaly and is being passively reviewed through a query on the
associated discrepancy.

CRF_PAGE_NUMBER Null VARCHAR2(20) The page number of the DCI book page containing the question
that caused the discrepancy.

DCF_COMMENT Null VARCHAR2(200 The comment on the most recent DCF created to resolve the
) discrepancy.

INTERNAL_COMMENT_ Null VARCHAR2(200 Field allowing entry of E-mail like comments between data
TEXT 0) managers. Includes date, time, and username.

RESOLUTION_TEXT Null VARCHAR2(200 The text specified on the DCF to request clarification of the
0) discrepancy.

OWNING_GROUP_TYPE_ Null VARCHAR2(15) Specifies the type of owning group, such as DM or CRA that is
CODE associated with the Discrepancy.
CRF_PAGE_NUMBER_SORT Null VARCHAR2(100 Specifies the sort order for CRF pages, regardless of the CRF Page
) Number value.

FLEX_FIELD1 Null VARCHAR2(15) Field allowing entry of value for company-specified question.

FLEX_FIELD2 Null VARCHAR2(15) Field allowing entry of value for company-specified question.

LAST_CHANGE_TS Null DATE Indicates the last time that the multivariate discrepancy was
modified. Used for inclusion in data replication. The value
defaults to TO_DATE
(19000101000000,'YYYYMMDDHH24MISS').

2-40 Oracle Clinical Stable Interface

 DISCREPANCY_ENTRIES(T)

Column Name Null? Type Column Description

LAST_VRV_CHANGE_TS Null DATE Indicates the last time the Validation Reported Values associated
with this multivariate discrepancy were modified. Used for
inclusion in data replication. The value defaults to TO_DATE
(19000101000000,'YYYYMMDDHH24MISS')

Table Definitions 2-41

DISCREPANCY_ENTRY_REVIEW_HIST(T)

DISCREPANCY_ENTRY_REVIEW_HIST(T)

This table holds an audit trail of discrepancy review status, discrepancy resolution
status, and discrepancy comment changes over time. The table contains an entry for
the current values in the discrepancy as well as all previous values.
The test table for DISCREPANCY_ENTRY_REVIEW_HIST is DISCREPANCY_
ENTRY_REVIEW_HISTT.

Primary Key DISCREPANCY_ENTRY_ID, DISCREPANCY_REV_STATUS_CODE,

CREATION_TS

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

DISCREPANCY_ENTRIES DISCREPANCY_ENTRY_ID DISCREPANCY_ENTRY_ID

DISCREPANCY_ENTRY_REVIEW_HIST(T) Column Descriptions

Column Name Null? Type Column Description

DISCREPANCY_ENTRY_ID Not null NUMBER(10) The ID of the discrepancy to which the discrepancy
history belongs.

DISCREPANCY_REV_STATUS_ Not null VARCHAR2(15) Current status of the discrepancy in the discrepancy
CODE management process. A new univariate discrepancy is
automatically UNREVIEWED, while the initial review
status for multivariate discrepancies are dictated by the
originating Procedure definition (details block). These
and other values used in the discrepancy life cycle come
from the installation reference codelist DISCREPANCY_
REV_STATUS_CODE. If a discrepancy is resolved by
Oracle Clinical — for instance, due to a validation or
data change — Oracle Clinical puts the value CLOSED in
this field.

CREATED_BY Not null VARCHAR2(30) User who created this discrepancy history entry.
CREATION_TS Not null DATE Date and time when this discrepancy history entry
record was created.

COMMENT_TEXT Null VARCHAR2(2000) Freeform text to hold a comment about the discrepancy.
It is by default populated with either the
DISCREPANCY_TYPE_CODE for univariate
discrepancies, or the message text as defined in the
originating Procedure Detail for multivariate
discrepancies.

NEXT_DISCREPANCY_REV_ Null VARCHAR2(15) Null for the current record for each discrepancy, this
STATUS field contains the value the DISCREPANCY_REV_
STATUS_CODE changed to on the next update. This
column supports summarization of status change
transitions.

NEXT_STATUS_TS Null DATE The timestamp of the superseding update, above.

Facilitates duration calculations for review statuses.
CURRENT_FLAG Null VARCHAR2(1) Shows if this history record reflects the value of the
current discrepancy entry.

2-42 Oracle Clinical Stable Interface

 DISCREPANCY_ENTRY_REVIEW_HIST(T)

Column Name Null? Type Column Description

DISCREPANCY_RESOLU_TYPE_ Null VARCHAR2(15) A code to clarify the discrepancy review status. When
CODE the review status field has a value of UNREVIEWED,
this field is blank. When the discrepancy is closed by the
system, this field is automatically completed with an
appropriate value. Values come from the installation
reference codelist DISCREPANCY_RESOLU_TYPE_
CODE. If the long value of the value in the codelist
contains the value IRRESOLVABLE, the system also sets
the value of the IRRESOLVABLE_FLAG to Y. If a
discrepancy is resolved by Oracle Clinical — due to a
validation or data change, for example — Oracle Clinical
puts the following codes in this field:
■ DATA CHANGE – Data change
■ VALID CHANGE (Validation change)
■ VALID RETIRED – Validation retired
■ DVG
■ DVG SUBSET – Discrete value group subset
■ THESAURUS (Thesaurus DVG)
■ DATA REMOVED – RDCI/RDCM/response was
deleted

CLINICAL_STUDY_ID Not null NUMBER(10) The ID of the clinical study to which the discrepancy
belongs.

DE_SUB_TYPE_CODE Not null VARCHAR2(15) Denormalized from discrepancy entries.

INTERNAL_COMMENT_TEXT Null VARCHAR2(2000) Field allowing entry of E-mail like comments between
data managers. Includes date, time, and username.

RESOLUTION_TEXT Null VARCHAR2(2000) The text specified on the DCF to request clarification of
the discrepancy.

FLEX_FIELD1 Null VARCHAR2(15) Field allowing entry of value for company-specified

question.

FLEX_FIELD2 Null VARCHAR2(15) Field allowing entry of value for company-specified

question.

Table Definitions 2-43

DISCRETE_VALUES

DISCRETE_VALUES

Discrete values are predefined values a question can have. Discrete values are grouped
into discrete value groups (DVGs). To avoid duplication of values, subsets of a discrete
value group can be defined. The superset of values is referred to as the base DVG.

Primary Key DISCRETE_VALUE_DVG_ID, DISCRETE_VALUE_VALUE,

DISCRETE_VALUE_DVG_SUBSET_NM

Related Tables and Foreign Keys

Foreign key name in the

Name of related table current table Foreign key name in the related table

DISCRETE_VALUE_GROUPS DISCRETE_VALUE_DVG_ID DISCRETE_VAL_GRP_ID

DISCRETE_VALUE_GROUPS DISCRETE_VALUE_DVG_SUBSET_NM DISCRETE_VAL_GRP_SUBSET_NUM

QUESTION_GROUP_QUESTIONS DISCRETE_VALUE_VALUE DISCRETE_VALUE_GRP_IND_VALUE

DCM_QUESTIONS DISCRETE_VALUE_VALUE DISCRETE_VALUE_GRP_IND_VALUE

DISCRETE_VALUES Column Descriptions

Column Name Null? Type Column Description

DISCRETE_VALUE_DVG_ID Not null NUMBER(10) The ID of the discrete value group to which the
discrete value belongs.

DISCRETE_VALUE_DVG_SUBSET_NM Not null NUMBER(3) A number to identify the DVG subset. A DVG with
Number 0 is called the base subset.

DISCRETE_VALUE_VALUE Not null VARCHAR2(80) An acceptable response to the question associated with
this DVG. The value must be unique within the DVG.
DISPLAY_SN Not null NUMBER(3) A positive or negative integer that controls the order
the system presents discrete values during data entry.
System-enforced to be sequential positive integers
starting at 1 if the attribute RESEQUENCE_FLAG = Y.

ACTIVE_FLAG Not null VARCHAR2(1) A flag to control if the discrete value appears in the list
of values for data entry. A response matching a value
with N in the active field creates a univariate DVG
discrepancy.

LONG_LABEL_DESCRIPTION Null VARCHAR2(200) Freeform text, in mixed case, that describes the discrete
value.

REPLICATION_IND Null VARCHAR2(1) A flag to indicate if the discrete value has been
replicated to another location.
CREATE_MAND_DISCREP_FLAG Not Null VARCHAR(1) Flag to indicate if a mandatory discrepancy should be
created.

2-44 Oracle Clinical Stable Interface

 DISCRETE_VALUE_GROUPS

DISCRETE_VALUE_GROUPS

Discrete value groups (DVGs) are sets of possible values a question can have. To avoid
duplication of values, subsets of a discrete value group can be defined. The superset of
values is referred to as the base DVG.

Primary Key DISCRETE_VALUE_GRP_ID, DISCRETE_VAL_GRP_SUBSET_NUM

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

QUESTIONS DISCRETE_VALUE_GRP_ID DISCRETE_VALUE_GRP_ID

QUESTIONS DISCRETE_VAL_GRP_SUBSET_NUM DISCRETE_VAL_GRP_SUBSET_NUM

DCMS DISCRETE_VALUE_GRP_ID QUAL_QUESTION_DVG_ID

DCMS DISCRETE_VAL_GRP_SUBSET_NUM QUAL_QUESTION_DVG_SUBSET_NUM

QUESTION_GROUP_QUESTIONS DISCRETE_VALUE_GRP_ID DISCRETE_VAL_GRP_ID

QUESTION_GROUP_QUESTIONS DISCRETE_VAL_GRP_SUBSET_NUM DISCRETE_VAL_GRP_SUBSET_NUM

DCM_QUESTIONS DISCRETE_VALUE_GRP_ID DISCRETE_VAL_GRP_ID

DCM_QUESTIONS DISCRETE_VAL_GRP_SUBSET_NUM DISCRETE_VAL_GRP_SUBSET_NUM

DCM_QUESTIONS DISCRETE_VALUES DISCRETE_VALUE_GRP_ID

DISCRETE_VALUE _DVG_ID DISCRETE_VAL_GRP_SUBSET_NUM DISCRETE_VALUE_DVG_

SUBSET_NUM

DISCRETE_VALUE_GROUPS Column Descriptions

Column Name Null? Type Column Description

DISCRETE_VALUE_GRP_ID Not null NUMBER(10) A unique, system-generated ID for the discrete value
group.

DISCRETE_VAL_GRP_SUBSET_ Not null NUMBER(3) A number for the DVG subsets. A DVG with Number 0 is
NUM called the base subset. The associated discrete values for
DVGs with subset numbers greater than 0 are constrained
to be within the set of discrete values for the DVG with the
same DISCRETE_VALUE_GRP_ID and a subset number of
0. DVGs with a DVG_SUB_TYPE_CODE of THESAURUS
are constrained to have only a single subset, 0.

CREATION_TS Not null DATE Date and time when the DVG was created.

CREATED_BY Not null VARCHAR2(30) User who created this DVG.

NAME Not null VARCHAR2(30) Unique identification, within a domain, of the discrete
value group (DVG), which is a grouping of acceptable
responses to a question of data.

DOMAIN Not null VARCHAR2(15) A Global Library object-naming convention that facilitates
the unique naming or grouping of objects.

Table Definitions 2-45

DISCRETE_VALUE_GROUPS

Column Name Null? Type Column Description

DVG_SUB_TYPE_CODE Not null VARCHAR2(15) A code to specify the location of DVG values as either
INTERNAL or THESAURUS. Possible values come from
the reference codelist DVG_SUB_TYPE_CODE. Values are:
INTERNAL (Uses an internal list of values), or
THESAURUS (Uses tables and columns to access external
information).
The values of INTERNAL type DVGs are contained in the
DISCRETE_VALUES table. The values of THESAURUS
type DVGs are in a separate table or view named in the
THES_VIEW_NAME field.

DESCRIPTION Not null VARCHAR2(70) Freeform text, in mixed case, describing the discrete value
group.

DISCRETE_VAL_GRP_STATUS_ Not null VARCHAR2(15) A code to show if the discrete value group is provisional
CODE (P), active (A), or retired (R).
DISCRETE_VAL_GRP_TYPE_CODE Not null VARCHAR2(15) A user-defined code to classify the DVG. Valid values are
maintained in the installation reference codelist
DISCRETE_VAL_GRP_TYPE_CODE.

LAST_STATUS_CHANGE_TS Not null DATE The date and time that the DISCRETE_VAL_GRP_
STATUS_CODE was last changed.

SUBSETTABLE_FLAG Not null VARCHAR2(1) A flag to control if you can group some of the DVG's values
into subsets.
EXPANDABLE_FLAG Not null VARCHAR2(1) A flag to control if you can add new values to an active
internal DVG.

ALLOW_ENTRY_BY_SEQUENCE_ Not null VARCHAR2(1) A flag to control if data entry's response to a question
FLAG associated with the internal DVG can be the DVG sequence
number rather than the value itself. Usually used when the
values of the DVG themselves can be numeric and entry of
sequence numbers might be ambiguous.

UPPER_CASE_FLAG Not null VARCHAR2(1) A flag to control if the values of the response to the DVG
are forced to uppercase.

MAX_VALUE_LENGTH Not null NUMBER(3) The maximum number of characters, between 1 and 80, for
each value of an internal DVG.

RETIREMENT_REASON_TYPE_ Not null VARCHAR2(15) A code to show why a retired DVG was retired.
CODE

STATUS_COMMENT_TEXT Null VARCHAR2(200) Freeform text, in mixed case, about why the DVG's status
did or did not change.

THES_VIEW_NAME Null VARCHAR2(30) THESAURUS subtype only: The name of the Oracle table
or view that contains the values available as responses to a
question associated with this thesaurus DVG.
THES_TERM_COL Null VARCHAR2(30) THESAURUS subtype only: The name of the column in the
Oracle table or view that contains the values available as
responses for this thesaurus DVG. During data entry,
operators with appropriate privileges can use the List
function for acceptable values.

THES_TERM_LEN Null NUMBER(3) THESAURUS subtype only: The number of character

spaces available in the column of the Oracle table or view.

THES_DECODE_VIEW_NAME Null NUMBER(3) THESAURUS subtype only: The name of the Oracle table
or view the system uses in Data Extract to translate (or
decode) the text response to a question.

THES_DECODE_TERM_COL Null VARCHAR2(30) THESAURUS subtype only: The name of the column in the
Oracle table or view in which the system searches for the
text response being decoded.

THES_DECODE_TERM_LEN Null NUMBER(3) THESAURUS subtype only: The number of character

spaces available in the column of the Oracle table or view
for this thesaurus DVG.

2-46 Oracle Clinical Stable Interface

 DISCRETE_VALUE_GROUPS

Column Name Null? Type Column Description

THES_DECODE_LABEL_COL1 Null VARCHAR2(30) THESAURUS subtype only: The name of the column in the
table or view to use when returning the first decode value
in Data Extract.

THES_DECODE_LABEL_COL2 Null VARCHAR2(30) THESAURUS subtype only: The name of the column in the
table or view to use when returning the second decode
value in Data Extract.

THES_DECODE_LABEL_IDCHAR1 Null VARCHAR2(1) THESAURUS subtype only: Identifies, with a single

character, the derived question corresponding to the Label
1 column of the Oracle table or view that contains the first
decoded value. The system concatenates the short label
with the SAS name of the question associated with this
DVG to create the SAS name of the decoded value.

THES_DECODE_LABEL_LEN2 Null NUMBER(3) THESAURUS subtype only: The number of character

spaces available in the Label 1 column of the Oracle table
or view that contains the second decoded value for a
derived question.

THES_DECODE_LABEL_IDCHAR2 Null VARCHAR2(1) THESAURUS subtype only: Identifies, with a single

character, the derived question corresponding to the Label
2 column of the Oracle table or view that contains the
second decoded value. The system concatenates the short
label with the SAS name of the question associated with
this DVG to create the SAS name of the decoded value.

THES_DECODE_LABEL_LEN1 Null NUMBER(3) THESAURUS subtype only: The number of character

spaces available in the Label 1 column of the Oracle table
or view that contains the first decoded value for a derived
question.

THES_DECODE_LABEL_COL3 Null VARCHAR2(30) THESAURUS subtype only: The name of the column in the
table or view to use when returning the third decode value
in Data Extract.

THES_DECODE_LABEL_LEN3 Null NUMBER(3) THESAURUS subtype only: The number of character

spaces available in the Label 3 column of the Oracle table
or view that contains the first decoded value for a derived
question.

THES_DECODE_LABEL_IDCHAR3 Null VARCHAR2(1) THESAURUS subtype only: Identifies, with a single

character, the derived question corresponding to the Label
2 column of the Oracle table or view that contains the third
decoded value. The system concatenates the short label
with the SAS name of the question associated with this
DVG to create the SAS name of the decoded value.

MODIFICATION_TS Null DATE Date and time when the DVG was last modified.

MODIFIED_BY Null VARCHAR2(30) User who last modified this DVG.

REPLICATION_IND Null VARCHAR2(1) A flag to show if the discrete value group has been
replicated to another site.

RESEQUENCE_FLAG Not null VARCHAR2(1) A flag to indicate if the discrete values can be re-sequenced
once the user provides a sequence number for each of the
values.

DISPLAY_TYPE_CODE Not null VARCHAR2(15) The Display Type of a DVG Subset determines how the
Subset is laid out if the Subset is used by a Question that is
incorporated in a Graphical Layout:
LOV means that the Question is laid out to be entered as a
text field. The Active values of the DVG Subset will be
displayed on demand, as an LOV, during data entry; CBG
means that the Question will be represented as checkboxes,
one for each of the Active values in the DVG Subset; FLAG
means that the Question will be represented as one
checkbox, which will signify one value when checked, and
another when subsequently unchecked.

Table Definitions 2-47

DISCRETE_VALUE_GROUPS

Column Name Null? Type Column Description

CHECKBOX_LAYOUT_CODE Null VARCHAR2(15) Checkbox Layout. This field is only meaningful if

DISPLAY_TYPE_CODE is CBG. The value of this field
determines the orientation in which checkboxes are laid out
(Horizontal or Vertical) and the position of the value labels
relative to the checkboxes (Left or Right).

CHECKBOX_LABEL_SOURCE_ Null VARCHAR2(15) Checkbox Label Source. If this DVG Subset is used in a
CODE Graphic Layout, the value of this field determines whether
the label for each checkbox is to be drawn from the Value
or Long Value corresponding to the checkbox.

CHECKED_FLAG_VALUE Null VARCHAR2(80) If the DISPLAY_TYPE_CODE of the DVG Subset is FLAG,

this column determines which of the two active values for
the DVG Subset is transmitted to the database when the
Flag's checkbox is checked during data entry. If the
checkbox is subsequently unchecked, the form will
transmit the other Active value. For instance, if the active
values are Yes and No, and Display Type is FLAG, and
Checked Flag Value is Yes, then checking the flag's
checkbox during data entry will transmit Yes, and
subsequently clearing it will transmit No. The flag's initial
value is NULL.

2-48 Oracle Clinical Stable Interface

 FORM_LAYOUT_TEMPLATES

FORM_LAYOUT_TEMPLATES

DCI and DCM graphic layouts inherit their shape from a DCI Form Layout Template.
It defines the work area, which is the area between the header and footer, and the size
of the header and footer when previewing the layout or when generating the DCI
Form. This area is used for the DCM and response related fields when generating the
DCM and DCI layouts. The contents of this area can be edited in the DCM or DCI
layout editor.
This table is replicated throughout an Oracle Clinical installation.

Primary Key FLT_ID

FORM_LAYOUT_TEMPLATES Column Descriptions

Column Name Null? Type Column Description

FLT_ID Not Null NUMBER(10) Unique ID of this form layout template.

LANGUAGE Not Null VARCHAR2(20) Language for this form layout template. Language values are
commonly listed in "en_US" format, which uses two-letter
abbreviations for language and country.

FLT_NAME Not Null VARCHAR2(30) The name of the form layout template.

CREATION_TS Not Null DATE Date and time when this form layout template was created.

CREATED_BY Not Null VARCHAR2(30) User who created this form layout template.

FL_WIDTH Not Null NUMBER(6,1) Width (in points) of the FLT.

HEADER_HEIGHT Not Null NUMBER(6,1) Height (in points) of the FLT header.
DCM_REGION_HEIGHT Not Null NUMBER(6,1) Height (in points) of the FLT's DCM region.

FOOTER_HEIGHT Not Null NUMBER(6,1) Height (in points) of the FLT's footer.

FLT_HEIGHT Not Null NUMBER(6,1) Height (in points) of the whole FLT.

FLT_XML Not Null CLOB A character large object that stores the XML for this form layout
template.

STATUS Not Null VARCHAR2(1) Possible values: A (Active), P (Provisional), or R (Retired). Only
active layouts can be selected when specifying the Form Layout
Template when generating DCM Graphic Layouts or DCI Form
Version Layouts.

UPDATE_ALLOWED_FLAG Not Null VARCHAR2(1) If Y, the Form Layout Template is updatable. This field is
unchecked for form layout templates that are shipped and
cannot be changed. If you want to change a Form Layout
Template that has been shipped, you need to copy the Form
Layout Template and modify the copy.

DESCRIPTION Null VARCHAR2(120) Further information about this FLT. The description is
displayed in LOVs when defining Form Layout Template for
generating DCM graphic layouts and DCI graphic layouts.

FL_XML_MODIFICATION_ Null DATE Date and time when the XML for this FLT was last modified.
TS

FL_XML_MODIFIED_BY Null VARCHAR2(30) User who last modified the XML for this FLT.

MODIFICATION_TS Null DATE Date and time when this FLT definition was last modified.

MODIFIED_BY Null VARCHAR2(30) User who last modified this FLT definition.

Table Definitions 2-49

LABS

LABS

A lab record contains basic details about a laboratory being used for clinical studies.

Primary Key LAB_ID

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

RANGES LAB_ID LAB_ID

LAB_RANGE_SUBSETS LAB_ID LAB_ID

FORMAT_MASKS MASK_ID MASK_ID

LABS Column Descriptions

Column Name Null? Type Column Description

LAB_ID Not null NUMBER(10) A unique, system-generated ID for the lab.

LAB Not null VARCHAR2(10) Unique external identifier of the lab.

LAB_NAME Not null VARCHAR2(60) Unique descriptive designation of the lab.

CREATION_TS Not null DATE Date and time when this lab was created.

CREATED_BY Not null VARCHAR2(30) User who created this lab.

ACTIVE_FLAG Not null VARCHAR2(1) A flag to show if the lab is available to supply lab ranges for
the lab data entered or batch loaded for a study.

MODIFICATION_TS Null DATE Date and time when this lab was last modified.
MODIFIED_BY Null VARCHAR2(30) User who last modified this lab.

CONTACT_FIRST_NAME Null VARCHAR2(15) The first name of the principal contact at the lab; in mixed
case.

CONTACT_LAST_NAME Null VARCHAR2(30) The last name of the principal contact at the lab; in mixed
case.

CONTACT_VOICE_PHONE Null VARCHAR2(25) The phone number of the principal contact at the lab; in
mixed case.
CONTACT_FAX_PHONE Null VARCHAR2(25) The fax number of the principal contact at the lab; in mixed
case.

LAB_MAIL_NAME Null VARCHAR2(40) The name of the lab for mail; in mixed case.

ADDRESS1 Null VARCHAR2(40) Line 1 of the lab's mailing address; in mixed case.

ADDRESS2 Null VARCHAR2(40) Line 2 of the lab's mailing address; in mixed case.

ADDRESS3 Null VARCHAR2(40) Line 3 of the lab's mailing address; in mixed case.

CITY Null VARCHAR2(25) The city in the lab's mailing address; in mixed case.

STATE_PROVINCE Null VARCHAR2(20) The state or province in the lab's mailing address.

POSTAL_CODE Null VARCHAR2(10) The postal code or US zip code in the lab's mailing address;
in mixed case.

COUNTRY Null VARCHAR2(20) The country where the lab is located; in mixed case.

ACCREDITATION_START_ Null DATE Start date of the period during which the lab is accredited.
DATE

ACCREDITATION_END_DATE Null DATE End date of the period during which the lab was accredited.
If this field is blank, there is no cut-off date.

2-50 Oracle Clinical Stable Interface

 LABS

Column Name Null? Type Column Description

CERTIFYING_AGENCY_NAME Null VARCHAR2(60) Name of certifying authority that accredits the lab.

CERTIFICATE_NUMBER Null VARCHAR2(20) Identification number of certificate issued by certifying

agency.

LAB_COMMENT Null VARCHAR2(240) Freeform text, in mixed case, containing supplementary

information about the lab.

LAST_REPLICATION_TS Null DATE Date and time this lab was last replicated from the Oracle
Clinical owning location.

OWNING_LOCATION Not null VARCHAR2(15) Name of the Oracle Clinical database that owns this lab data.

REPLICATE_FLAG Not null VARCHAR2(1) Flag set at locations that do not own the lab data to indicate
that lab ranges for this lab are to be included in lab range
replication.

MASK_ID Not null NUMBER(10) ID of the batch data load format mask to use for this lab's
data.

Table Definitions 2-51

LAB_TEST_QUESTION_UNITS

LAB_TEST_QUESTION_UNITS

This table holds the mapping of acceptable units for use with particular Global Library
questions.

Primary Key QUESTION_ID, LAB_UNIT_CODE

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

LAB_UNITS LAB_UNIT_CODE LAB_UNIT_CODE

QUESTIONS QUESTION_ID QUESTION_ID

LAB_TEST_QUESTION_UNITS Column Descriptions

Column Name Null? Type Column Description

QUESTION_ID Not null NUMBER(10) ID of the Global Library question with which you are mapping an
acceptable lab test question unit.

LAB_UNIT_CODE Not null VARCHAR2(40) A code for the lab unit.

CREATION_TS Not null DATE Date and time when this mapping between Global Library question and
lab test question unit was created.

CREATED_BY Not null VARCHAR2(30) User who created this mapping between Global Library question and lab
test question unit.

MODIFICATION_TS Null DATE Date and time when this mapping was last modified.
MODIFIED_BY Null VARCHAR2(30) User who last modified this mapping.

ACTIVE_FLAG Not null VARCHAR2(1) A flag to show if the lab unit is still available for use.

2-52 Oracle Clinical Stable Interface

 LAB_RANGE_SUBSETS

LAB_RANGE_SUBSETS

A lab range subset allows for different ranges for the same questions at the same lab.
For example, it could accommodate an alternative set of ranges for diabetic patients.

Primary Key LAB_ID, LAB_RANGE_SUBSET_NUM

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

LABS LAB_ID LAB_ID

RANGES LAB_RANGE_SUBSET_NUM LAB_RANGE_SUBSET_NUM

LAB_RANGE_SUBSETS Column Descriptions

Column Name Null? Type Column Description

LAB_ID Not null NUMBER(10) The ID of the lab to which the subset belongs.

LAB_RANGE_SUBSET_NUM Not null NUMBER(10) A sequence number for the subset within the lab.
LAB_RANGE_SUBSET_CODE Not null VARCHAR2(15) A code to identify the lab range subset. The code will exist in
the reference codelist table called LAB_RANGE_SUBSET_
CODE.

NAME Not null VARCHAR2(70) A name for the subset.

ACTIVE_FLAG Not null VARCHAR2(1) A flag to show if the subset is still active or if it has been
retired.
CREATION_TS Not null DATE Date and time when this lab range subset was created.

CREATED_BY Not null VARCHAR2(30) User who created this lab range subset.

MODIFICATION_TS Null DATE Date and time when this lab range subset was last modified.

MODIFIED_BY Null VARCHAR2(30) User who last modified this lab range subset.

LAST_LR_MOD_TS Not null DATE(1) This timestamp is updated when a change is made to the lab
range data within the lab and subset.

Table Definitions 2-53

LAB_UNITS

LAB_UNITS

This table holds lists of units used to measure lab results.

Primary Key LAB_UNIT_CODE

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

PREFERRED_LAB_UNITS LAB_UNIT_CODE LAB_UNIT_CODE

LAB_UNITS Column Descriptions

Column Name Null? Type Column Description

LAB_UNIT_CODE Not null VARCHAR2(40) A code for the lab unit.

CREATION_TS Not null DATE Date and time when this lab unit was created.

CREATED_BY Not null VARCHAR2(30) User who created this lab unit.
REPRESENTATIVE_LAB_UNIT_ Not null VARCHAR2(40) These codes enable you to define lab units as equivalent in
CODE the system. For example, because the Lab Units mg/ml and
mg/cc are equivalent, you can define mg/ml as their
common Representative Lab Unit Code.
If you are defining a lab unit for which you do not want to
specify a representative lab unit code, enter the LAB_UNIT_
CODE in this column.

ACTIVE_FLAG Not null VARCHAR2(1) A flag to show if the lab unit is still available for use.
MODIFICATION_TS Null DATE Date and time when this lab unit was last modified.

MODIFIED_BY Null VARCHAR2(30) User who last modified this lab unit.

LAB_UNIT_NAME Null VARCHAR2(45) A name for the lab unit.

LAB_UNIT_PRONUNCIATION Null VARCHAR2(60) A phonetic name for the lab unit.

2-54 Oracle Clinical Stable Interface

 LAB_UNIT_CONVERSIONS

LAB_UNIT_CONVERSIONS

This table defines how data measured in one lab unit should be converted into a
different lab unit. Conversions of the form y = ax + b (a multiplication factor combined
with the addition of a constant) are supported.

Primary Key QUESTION_ID, LAB_UNIT_CODE_CONVERT_FROM,

LAB_UNIT_CODE_CONVERT_TO

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

QUESTIONS QUESTION_ID QUESTION_ID

LAB_UNIT_CONVERSIONS Column Descriptions

Column Name Null? Type Column Description

QUESTION_ID Not null NUMBER(10) The ID of the question to which the conversion applies.

LAB_UNIT_CODE_CONVERT_ Not null VARCHAR2(40) The code of the unit of measure to convert from. For
FROM example, if you are converting temperature values from
Fahrenheit to Celsius, this column stores the Fahrenheit
value.

LAB_UNIT_CODE_CONVERT_TO Not null VARCHAR2(40) The code of the unit of measure to convert to. For example,
if you are converting temperature values from Fahrenheit
to Celsius, this column stores the Celsius value.
CREATION_TS Not null DATE Date and time when this lab unit conversion was created.

CREATED_BY Not null VARCHAR2(30) User who created this lab unit conversion.

MULTIPLIER Not null NUMBER The factor to multiply the "from code" by to compute the
"to code".
MODIFICATION_TS Null DATE Date and time when this lab unit conversion was last
modified.

MODIFIED_BY Null VARCHAR2(30) User who last modified this lab unit conversion.

LAB_UNIT_CONVERSION_ Null VARCHAR2(240) A comment about the conversion.

COMMENT

COEFFICIENT0 Not null NUMBER A fixed value to be added to the result of the
multiplication.

CONVERSION_SOURCE Not null VARCHAR2(15) A code for the method used to convert from one unit to
another.

Table Definitions 2-55

MV_EXECUTION_LOG

MV_EXECUTION_LOG

This table holds execution status information for multivariate validation jobs launched
via the immediate execution API. Each submitted job will create one entry, which gets
subsequently updated to reflect execution status and results.

Primary Key JOB_ID

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

PATIENT_POSITIONS PATIENT_POSITION_ID PATIENT_POSITION_ID

DCMS DCM_ID DCM_ID

MV_EXECUTION_LOG Column Descriptions

Column Name Null? Type Column Description

JOB_ID Not null NUMBER(10) A unique, system-generated ID for the job.

SESSION_ID Not null NUMBER(10) A unique identifier of the user session.

EXECUTION_STATUS Not null VARCHAR2(15) The current execution status of the job. Possible values to
be included in a reference codelist are: SUBMITTED,
EXECUTING, and COMPLETED.

OUTCOME_STATUS Null VARCHAR2(15) Reflects the outcome of the execution. Possible values to be
included in a reference codelist are: SUCCESS, WARNING,
and FAILURE.

EXECUTION_SUBMITTED_TS Not null DATE Date and time when the job was submitted.

EXECUTION_START_TS Not null DATE Date and time when that the job started to run.

EXECUTION_END_TS Null DATE Date and time when the job finished executing.

EXECUTION_CONTEXT Not null VARCHAR2(15) A code for the mode in which the Procedure was executed.
Values come from the reference codelist PROC_EXEC_
CONTEXT_EXECUTION.

PROCEDURE_ID Not null NUMBER(10) A code for the mode in which the Procedure was executed.
Values come from the reference codelist PROC_EXEC_
CONTEXT_EXECUTION.

PROCEDURE_VERSION_SN Not null NUMBER(3) The sequence number of the Procedure being executed.

PATIENT_ID Not null NUMBER(10) The ID of the patient for whom the job is executed.

DCM_ID Null NUMBER(10) The ID of the DCM for which the job is executed. This field
is only filled when execution is requested for a particular
DCM.

TOT_NEW_DISC Null NUMBER(10) Number of new discrepancies created after the job
execution.

TOT_SAME_DISC Null NUMBER(10) Number of discrepancies that remained the same after the
job execution.

TOT_OBS_DISC Null NUMBER(10) Number of discrepancies that were made obsolete as a

result of the job execution.

2-56 Oracle Clinical Stable Interface

 OCL_INVESTIGATORS(T)

OCL_INVESTIGATORS(T)

OCL_INVESTIGATORS records basic details about an investigator. The test table for
OCL_INVESTIGATORS is OCL_INVESTIGATORST.

Primary Key INVESTIGATOR_ID

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

OCL_STUDY_SITE_ROLES INVESTIGATOR_ID INVESTIGATOR_ID

RECEIVED_DCIS INVESTIGATOR_ID INVESTIGATOR_ID

RECEIVED_DCMS INVESTIGATOR_ID INVESTIGATOR_ID

DISCREPANCY_ENTRIES INVESTIGATOR_ID INVESTIGATOR_ID

REGIONS STATE REGION_CODE

REGIONS COUNTRY REGION_CODE

OCL_INVESTIGATORS Column Descriptions

Column Name Null? Type Column Description

INVESTIGATOR_ID Not null NUMBER(10) A unique, system-generated ID for the investigator.

INVESTIGATOR Not null VARCHAR2(10) An external unique code for the investigator.

FIRST_NAME Not null VARCHAR2(15) The first name of the investigator.

LAST_NAME Not null VARCHAR2(20) The last name of the investigator.

ACTIVE_FLAG Not null VARCHAR2(1) A flag to show if the investigator is still available for new studies.

CREATED_BY Not null VARCHAR2(30) User who created this investigator.

CREATION_TS Not null DATE Date and time when this investigator was created.
PHONE_NUMBER Not null VARCHAR2(25) The phone number of the investigator.

OWNING_LOCATION Not null VARCHAR2(15) The code for the location that owns or manages the investigator. Only
the owning location can modify the investigator record of the
investigator.

COUNTRY Null VARCHAR2(7) A code for the country where the investigator is located.

STATE Null VARCHAR2(7) A code for the state or province where the investigator is located.
CITY Null VARCHAR2(25) The city where the investigator is located.

ADDRESS_NAME Null VARCHAR2(40) A name to start the investigator's address.

ADDRESS_LINE_1 Null VARCHAR2(40) The first line of the investigator's address.

ADDRESS_LINE_2 Null VARCHAR2(40) The second line of the investigator's address.

ADDRESS_LINE_3 Null VARCHAR2(40) The third line of the investigator's address.

POSTAL_CODE Null VARCHAR2(15) A postal or zip code of the investigator's address.

TITLE Null VARCHAR2(40) A title for the investigator.

INITIALS Null VARCHAR2(4) The initials of the investigator.

MODIFIED_BY Null VARCHAR2(30) User who last modified this investigator record.

MODIFICATION_TS Null DATE(4) Date and time when this investigator record was last modified.

Table Definitions 2-57

OCL_ORGANIZATION_UNITS

OCL_ORGANIZATION_UNITS

Organization units represent parts of a company that can sponsor clinical studies.

Primary Key ORGANIZATION_UNIT_ID

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

OCL_STUDIES ORGANIZATION_UNIT_ID ORGANIZATION_UNIT_ID

OCL_ORGANIZATION_UNITS Column Descriptions

Column Name Null? Type Column Description

ORGANIZATION_UNIT_ID Not null NUMBER(10) A unique, system-generated ID for the organization unit.

CREATED_BY Not null VARCHAR2(30) User who created this organization unit.

CREATION_TS Not null DATE Date and time when this organization unit was created.
CODE Not null VARCHAR2(10) A unique code for the organization unit.

DESCRIPTION Not null VARCHAR2(70) A description of the organization unit.

END_DATE Null DATE The date the organization unit ceased to be valid.

MODIFIED_BY Null VARCHAR2(30) User who last modified this organization unit.

MODIFICATION_TS Null DATE Date and time when this organization unit was last modified.

NAME Null VARCHAR2(60) A name for the organization unit.

START_DATE Not null DATE The date that the organization unit became valid.

2-58 Oracle Clinical Stable Interface

 OCL_PROGRAMS

OCL_PROGRAMS

Programs are groups of studies that are usually related to the same compound.

Primary Key PROGRAM_CODE

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

OCL_PROJECTS PROGRAM_CODE PROGRAM_CODE

OCL_PROGRAMS Column Descriptions

Column Name Null? Type Column Description

PROGRAM_CODE Not null VARCHAR2(15) A code for the program.

CREATED_BY Not null VARCHAR2(30) User who created this program.

CREATION_TS Not null DATE Date and time when this program was created.
DESCRIPTION Not null VARCHAR2(70) A freeform text description of the program.

ACTIVE_FLAG Not null VARCHAR2(1) A flag to show if the program is still active (A) or if it has been
retired (R).

MODIFIED_BY Null VARCHAR2(30) User who last modified this program.

MODIFICATION_TS Null DATE Date and time when this program was last modified.

Table Definitions 2-59

OCL_PROJECTS

OCL_PROJECTS

Projects are groups of studies within a program. One example of a project is all of the
studies in a particular indication. Projects are particularly important if Oracle
Thesaurus Management System (TMS) is being used. Clinical studies are processed by
TMS based upon the project to which they belong, so that all of the studies in a project
will be processed in the same way.

Primary Key PROJECT_CODE

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

OCL_PROGRAMS PROGRAM_CODE PROGRAM_CODE

OCL_STUDIES PROGRAM_CODE PROGRAM_CODE

OCL_STUDIES PROJECT_CODE PROJECT_CODE

OCL_PROJECTS Column Descriptions

Column Name Null? Type Column Description

PROJECT_CODE Not null VARCHAR2(15) A unique code for the project.

DESCRIPTION Not null VARCHAR2(70) A freeform text description of the project.

START_DATE Not null DATE The date that the project started.

CREATED_BY Not null VARCHAR2(30) User who created this project.

CREATION_TS Not null DATE Date and time when this project was created.

PROGRAM_CODE Not null VARCHAR2(15) The code of the program to which the project belongs.

END_DATE Null DATE The date the project finished. If null, the project is ongoing.

MODIFIED_BY Null VARCHAR2(30) User who last modified this project.

MODIFICATION_TS Null DATE Date and time when this project was last modified.

2-60 Oracle Clinical Stable Interface

 OCL_SITES

OCL_SITES

Sites are places at which patients can be seen and treated in a clinical study. Sites do
not necessarily correspond to a street address; a hospital could contain a site for each
ward, or even an abstract site such as a particular doctor's set of patients in a large
ward.

Primary Key SITE_ID

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

OCL_STUDY_SITES SITE_ID SITE_ID

RECEIVED_DCIS SITE_ID SITE_ID

RECEIVED_DCMS SITE_ID SITE_ID

DISCREPANCY_ENTRIES SITE_ID SITE_ID

REGIONS STATE REGION_CODE

REGIONS COUNTRY REGION_CODE

OCL_SITES Column Descriptions

Column Name Null? Type Column Description

SITE_ID Not null NUMBER(10) A unique, system-generated ID for the site.

ACTIVE_FLAG Not null VARCHAR2(1) A flag to show if the site is still available to conduct studies.

ADDRESS_LINE_1 Not null VARCHAR2(40) The first line of the site's address.

CITY Not null VARCHAR2(25) The city where the site can be found.

CREATED_BY Not null VARCHAR2(30) User who created this site.

CREATION_TS Not null DATE Date and time when this site was created.

NAME Not null VARCHAR2(60) A name for the site.

POSTAL_CODE Not null VARCHAR2(15) A postal code or US zip code for the site.
STATE Not null VARCHAR2(7) A code for the state or province where the site can be found.

SITE Not null VARCHAR2(10) An external unique code for the site.

PHONE_NUMBER Not null VARCHAR2(25) A phone number for the site.

COUNTRY Not null VARCHAR2(7) A code for the country where the site can be found.

OWNING_ Not null VARCHAR2(15) A code for the location that owns the site.
LOCATION

ADDRESS_LINE_2 Null VARCHAR2(40) The second line of the site's address.

ADDRESS_LINE_3 Null VARCHAR2(40) The third line of the site's address.

MODIFICATION_TS Null DATE Date and time when this site was last modified.

MODIFIED_BY Null VARCHAR2(30) User who last modified this site.

Table Definitions 2-61

OCL_STUDIES

OCL_STUDIES

This table contains a list of studies that are being performed or that are planned to be
performed.

Primary Key TASK_ID

Unique Keys

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

CLINICAL_STUDIES STUDY STUDY

OCL_PROGRAMS PROGRAM_CODE PROGRAM_CODE

OCL_PROJECTS PROGRAM_CODE PROGRAM_CODE

OCL_PROJECTS PROJECT_CODE PROJECT_CODE

OCL_ORGANIZATION_UNITS ORGANIZATION_UNIT_ID ORGANIZATION_UNIT_ID

REGIONS REGION_ID REGION_ID

OCL_STUDIES Column Descriptions

Column Name Null? Type Column Description

TASK_ID Not null NUMBER(10) A unique, system-generated ID for the OCL study. TASK_ID is
normally the same as the corresponding CLINICAL_STUDY_
ID, but not in all cases. The join from OCL_STUDIES to
CLINICAL_STUDIES should be done with the STUDY code.

STUDY Not null VARCHAR2(15) An external, unique code for the study.

CREATED_BY Not null VARCHAR2(30) User who created this study.

CREATION_TS Not null DATE Date and time when this study was created.

ORGANIZATION_UNIT_ID Not null NUMBER(10) The ID of the organization unit responsible for the study.

PROJECT_CODE Not null VARCHAR2(15) A code for the project to which the study belongs.
PROGRAM_CODE Not null VARCHAR2(15) A code for the program to which the study belongs.

TITLE Null VARCHAR2(2000) A long title for the study. This is often the title of the protocol.

INVESTIGATORS_PLANNED Null NUMBER(10) The number of investigators expected to work on the study.
EXPTL_DESIGN_TYPE_ Null VARCHAR2(5) A code for the type of design to be used for the randomization
CODE in the study.

REGION_ID Null NUMBER(10) The ID of the primary region in which the study will be
conducted. It must be a country.

CLINICAL_PHASE Null VARCHAR2(10) A code for the clinical phase to which the study belongs.
MODIFIED_BY Null VARCHAR2(30) User who last modified this study.

MODIFICATION_TS Null DATE Date and time when this study was last modified.

2-62 Oracle Clinical Stable Interface

 OCL_STUDY_SITES

OCL_STUDY_SITES

A study site represents the assignment of a site to a clinical study. A site can only be
assigned to a clinical study once.

Primary Key SITE_ID, CLINICAL_STUDY_ID

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

OCL_SITES SITE_ID SITE_ID

CLINICAL_STUDIES CLINICAL_STUDY_ID CLINICAL_STUDY_ID

STUDY_SITE_PATIENT_POSITIONS SITE_ID SITE_ID

STUDY_SITE_PATIENT_POSITIONS CLINICAL_STUDY_ID CLINICAL_STUDY_ID

STUDY_SITE_ROLES SITE_ID SITE_ID

STUDY_SITE_ROLES CLINICAL_STUDY_ID CLINICAL_STUDY_ID

OCL_STUDY_SITES Column Descriptions

Column Name Null? Type Column Description

SITE_ID Not null NUMBER(10) The ID of the site corresponding to the study site.

CLINICAL_STUDY_ID Not null NUMBER(10) The ID of the clinical study corresponding to the study site.

DATA_FREEZE_FLAG Not null VARCHAR2(1) A flag to show whether the data at the study site has been frozen.

CREATED_BY Not null VARCHAR2(30) User who created this study site.

CREATION_TS Not null DATE Date and time when this study site was created.

OK_TO_SHIP_FLAG Not null VARCHAR2(1) A flag to show if regulatory affairs has approved shipment of clinical
supplies to this site.

OWNING_LOCATION Not null VARCHAR2(15) A code for the location that owns the study site.

STUDY_SITE Not null VARCHAR2(10) A code for the study site.

START_DATE Null DATE The date that the site became active.

END_DATE Null DATE The date that the site ceased being active.

MODIFIED_BY Null VARCHAR2(30) User who last modified this study site.

MODIFICATION_TS Null DATE Date and time when this study site was last modified.

Table Definitions 2-63

OCL_STUDY_SITE_ROLES(T)

OCL_STUDY_SITE_ROLES(T)

A study site role records the assignment of an investigator to a study site.

The test table for OCL_STUDY_SITE_ROLES is OCL_STUDY_SITE_ROLEST.

Primary Key CLINICAL_STUDY_ID, SITE_ID, INVESTIGATOR_ID

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

OCL_SITES SITE_ID SITE_ID

OCL_INVESTIGATORS INVESTIGATOR_ID INVESTIGATOR_ID

OCL_STUDY_SITES CLINICAL_STUDY_ID CLINICAL_STUDY_ID

OCL_STUDY_SITES SITE_ID SITE_ID

OCL_STUDY_SITE_ROLES Column Descriptions

Column Name Null? Type Column Description

CLINICAL_STUDY_ID Not null NUMBER(10) The ID of the clinical study to which the study site role belongs.

SITE_ID Not null NUMBER(10) The ID of the site assigned to the study site role.

INVESTIGATOR_ID Not null NUMBER(10) The ID of the investigator assigned to the study site role.

CREATED_BY Not null VARCHAR2(30) User who created this study site role.

CREATION_TS Not null DATE Date and time when this study site role was created.

CURRENT_FLAG Not null VARCHAR2(1) A flag to show if this is the current investigator assigned to the
study site.
START_DATE Not null DATE The date that the investigator became responsible for the study
site.

NUMBER_OF_PATIENTS_ Null NUMBER(10) The number of patients the investigator is expected to recruit.
REQUIRED

CONTRACT_DATE Null DATE The date that the investigator's contract was signed.

TERMINATION_DATE Null DATE The date that the investigator was terminated from the study.

DISCONTINUATION_ Null DATE The date that the investigator was sent a letter informing him/her
LETTER_DATE that they were being discontinued from the study

MODIFICATION_TS Null DATE Date and time when this study site role was last modified.

MODIFIED_BY Null VARCHAR2(30) User who last modified this study site role.

2-64 Oracle Clinical Stable Interface

 ORACLE_ACCOUNTS

ORACLE_ACCOUNTS

This table contains details about users of Oracle Clinical and groups of users. Groups
of users can be defined to simplify assigning access to studies. Most of the attributes
apply only to individual user entries.

Primary Key ORACLE_ACCOUNT_NAME

Related Tables and Foreign Keys

Foreign key name in the

Name of related table Foreign key name in this table related table

DCI_BOOKS DCI_BOOK_DFLT_IN_DE_IND DCI_BOOK_ID

ORACLE_ACCOUNTS Column Descriptions

Column Name Null? Type Column Description

ORACLE_ACCOUNT_NAME Not null VARCHAR2(30) The name of the Oracle account.

CREATION_TS Not null DATE Date and time when this Oracle account was created.

CREATED_BY Not null VARCHAR2(30) User who created this Oracle account.
MODIFICATION_TS Null DATE Date and time when this Oracle account was last modified.

MODIFIED_BY Null VARCHAR2(30) User who last modified this Oracle account.

ALL_STUDY_ACCESS_FLAG Not null VARCHAR2(1) A flag to show if the user should be allowed access to all studies.

FIRST_NAME Not null VARCHAR2(30) The first name of the person.

LAST_NAME Not null VARCHAR2(40) The last name of the person.

OA_SUB_TYPE_CODE Not null VARCHAR2(6) A code for the type of account. Possible values come from the
reference codelist OA_SUB_TYPE_CODE. Values are ORACLE
(for an individual Oracle Clinical user) and GROUP (a name for
a group of users).

USER_LOG_DIR Null VARCHAR2(60) The directory where the user's log files should be written to.

UNIVARIATE_ALERT_IND Null VARCHAR2(1) A flag to show if the user should be given warnings when
univariate discrepancies are being created.

SECOND_PASS_ALERT_IND Null VARCHAR2(1) A flag to show if the user should be given warnings when
univariate discrepancies are being created during second pass
data entry.

THESAURUS_LOV_IND Null VARCHAR2(1) A flag to show if a thesaurus LOV is available to the user during
data entry.
MANUAL_DISC_IN_ Null VARCHAR2(1) A flag to show if the user is allowed to raise manual
BROWSE_IND discrepancies while browsing data.

DISC_RESOLVE_IN_DE_IND Null VARCHAR2(1) A flag to show if the user is allowed to resolve discrepancies
during data entry.

DCI_BOOK_DFLT_IN_DE_ Null VARCHAR2(1) The ID of the default DCI book for the user.
IND

PRIVILEGED_UPDATE_IND Null VARCHAR2(1) A flag to show if the user is allowed to perform Privileged
Update.

UNENROLLED_ALERT_IND Null VARCHAR2(1) A flag to show if the system alerts users if they try to enter data
for a patient who has not enrolled.

PASS2_NOT_BY_PASS1_IND Null VARCHAR2(1) A flag to prevent the person who did first pass data entry from
doing second pass entry for the same CRF.

Table Definitions 2-65

ORACLE_ACCOUNTS

Column Name Null? Type Column Description

OCL_THES_DISC_AT_DE_ Null VARCHAR2(1) A flag to show if the user should be alerted of a Thesaurus
IND discrepancy at data entry time.
OCL_THES_LOV_IND Null VARCHAR2(1) A flag to show if the user has access to a LOV of Thesaurus
values at data entry time.

ACCESS_ONLY_IN_BROWSE_ Null VARCHAR2(1) A flag to restrict access in Browse mode to accessible received
IND DCIs only.

DEFAULT_DE_PAGE_HEIGHT Null NUMBER(3) The page height for the user.

DEFAULT_DE_PAGE_WIDTH Null NUMBER(3) The page width for the user.

AUTO_SKIP_PREF_FLAG Null VARCHAR2(1) A flag to show if control should automatically jump to the next
field after the current field is filled.

AUTO_FILL_PREF_FLAG Null VARCHAR2(1) A flag to show if, after enough characters have been entered to
achieve a unique value, the rest of the field should be filled in
automatically.

UNIV_BEEP_PREF_FLAG Null VARCHAR2(1) A flag to show if the user should be given a beep each time a
univariate discrepancy is raised.

COMP_BEEP_PREF_FLAG Null VARCHAR2(1) A flag to show if the system beeps each time a comparison
failure occurs in second pass entry.

END_FORM_BEEP_PREF_ Null VARCHAR2(1) A flag to show if the user should be given a beep at the end of
FLAG each data entry page.

DATE_INPUT_FORMAT Null VARCHAR2(15) The format the user wishes to use when entering dates during
data entry.
DATE_DISPLAY_FORMAT Null VARCHAR2(15) The format the user wishes to see when viewing dates.

RDCI_ORDER_PREF Null VARCHAR2(15) The sort order the user wishes to use when querying received
DCIs in data entry.

DCDCOM_FLAG Null VARCHAR2(1) For internal system use only.

DCDCOM_COMMAND Null VARCHAR2(80) For internal system use only.

DCDCOM_DCM_ID Null NUMBER(10) For internal system use only.

DCDCOM_SUBSET_SN Null NUMBER(10) For internal system use only.

DCDCOM_LAYOUT_SN Null NUMBER(10) For internal system use only.

DCDCOM_SESSION_ID Null NUMBER(10) For internal system use only.

DCI_DATE_REQUIRED_IN_ Null VARCHAR2(1) A flag to show if a date must be given for a DCI during Log-In.
DE_IND
RS_RXC_LOG Null VARCHAR2(35) A flag to show if a date must be given for a DCI during Log-In.

DEFAULT_PRINTER_QUEUE Null VARCHAR2(50) Default printer for PSUB jobs for this user.

DEFAULT_PSUB_QUEUE Null VARCHAR2(50) Default PSUB queue for this user.

DEFAULT_REPORT_RS Null VARCHAR2(50) Default Reports Server when doing report jobs and generating a
DCI Form.

DEFAULT_JOB_SET_RS Null VARCHAR2(50) Default Reports Server when running a job set.

DEFAULT_PSUB_SCHEDULE_ Null VARCHAR2(50) Default Reports Server when scheduling a PSUB job.
RS
DEFAULT_RS_PRINTER Null VARCHAR2(50) Default printer for the Reports Server.

OC_CUSTOM_DOC_DIR Null VARCHAR2(200) This user's custom documentation directory. If a location is

specified in this column, this user will view custom help files
from the location specified. If this column is null, this user will
view custom help files from the location specified by the Oracle
Clinical Web Server.

DEFAULT_PROFILE_ID Null NUMBER(10) ID of the profile assigned to this user.

LAST_CLINICAL_STUDY_ID Null NUMBER(10) ID of the last clinical study accessed by this user through RDC.

2-66 Oracle Clinical Stable Interface

 PATIENT_POSITIONS(T)

PATIENT_POSITIONS(T)

Patient positions record details about people taking part in a clinical study.

Primary Key PATIENT_POSITION_ID

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

CLINICAL_STUDIES CLINICAL_STUDY_ID CLINICAL_STUDY_ID

DCI_BOOKS DCI_BOOK_ID DCI_BOOK_ID

TREAT_ASSGN_ALL_VIEW PATIENT_POSITION_ID PATIENT_POSITION_ID

ACTUAL_EVENTS PATIENT_POSITION_ID PATIENT_POSITION_ID

RECEIVED_DCIS PATIENT_POSITION_ID PATIENT_POSITION_ID

RECEIVED_DCMS PATIENT_POSITION_ID PATIENT_POSITION_ID

DISCREPANCY_ENTRIES PATIENT_POSITION_ID PATIENT_POSITION_ID

STUDY_SITE_PATIENT_ PATIENT_POSITION_ID PATIENT_POSITION_ID

POSITIONS

TREAT_ASSGN_ALL_VIEW PATIENT_POSITION_ID PATIENT_POSITION_ID

PATIENT_STATUSES PATIENT_POSITION_ID PATIENT_POSITION_ID

CLINICAL_SUBJECTS CLINICAL_SUBJECT_ID CLINICAL_SUBJECT_ID

MV_EXECUTION_LOG PATIENT_POSITION_ID PATIENT_POSITION_ID

PATIENT_POSITIONS Column Descriptions

Column Name Null? Type Column Description

CLINICAL_STUDY_ID Not null NUMBER(10) The ID of the clinical study to which the patient
position belongs.

CLINICAL_STUDY_VERSION_ID Not null NUMBER(10) The version ID of the clinical study to which the
patient position belongs.

PATIENT_POSITION_ID Not null NUMBER(10) A unique, system-generated ID for the patient position.

PATIENT Not null VARCHAR2(10) A unique code for the patient position within the
clinical study.

DATA_MODIFIED_FLAG Not null VARCHAR2(1) A flag to show if the patient has received data that has
been changed since the last batch validation run.
Usually modified only during the course of batch
validation, it does not directly reflect the modification
status of a patient between batch validations.

DATA_REVISION_SN Not null NUMBER(10) The latest batch validation run sequence number in
which the patient had modified data and was included
in incremental validation. This number corresponds
to the DATA_REVISION_SN in the BATCH_DM_
RUNS table.

LAST_REPLIC_BATCH_TS Null DATE The date and time of the most recent batch validation
run for which changes to data were detected that
would result in the patient's data being included in
data replication.

LAST_BATCH_TS Null DATE The date and time that batch validation last validated
this patient due to data changes.

Table Definitions 2-67

PATIENT_POSITIONS(T)

Column Name Null? Type Column Description

LAST_DATA_DELETION_TS Null DATE The date and time that data was last batch deleted for
this patient. This timestamp is only updated in the
course of a batch validation session and does not
reflect deletions until the batch validation session
following the deletion.

LAST_LAB_MODIFICATION_TS Null DATE The most recent date and time that a lab association to
the patient's data was modified.

LAST_LAB_BATCH_TS Null DATE The date and time of the most recent batch validation
in which the lab-related Procedures were run, either
alone — due to changes to lab association or lab range
changes — or due to data changes.

DCI_BOOK_ID Null NUMBER The ID of the DCI book to be used for this patient.
HAS_DATA_FLAG Not null VARCHAR2(2) A flag to show if any received data has ever been
received for this patient. Can not be used to determine
whether patient currently has data, since soft data
deletions (such as by patient transfer or the remove
function in data entry) do not clear the flag.

OWNING_LOCATION Not null VARCHAR2(15) The code of the database location that owns this
patient position.

FREEZE_FLAG Not null VARCHAR2(1) A flag to show if the system prevents any changes to
the data for this patient.
INC_IN_EFF_ANALYSIS_FLAG Not null VARCHAR2(1) A flag to indicate if this patient's data is included in an
efficacy analysis.

INC_IN_SAFETY_ANALYSIS_FLAG Not null VARCHAR2(1) A flag to indicate if this patient's data is included in a
safety analysis.

REPLACEMENT_POSITION_FLAG Not null VARCHAR2(1) A flag to indicate if this patient position is assigned to
this study as a replacement patient position.

SCREENING_POSITION_FLAG Not null VARCHAR2(1) A flag to indicate if this patient position is assigned to
this study for screening purposes.
CREATION_TS Not null DATE Date and time when the patient position was created.

CREATED_BY Not null VARCHAR2(30) User who created the patient position.

CREATED_LATE_FLAG Not null VARCHAR2(1) Not used.

PATIENT_DROPPED_FLAG Not null VARCHAR2(1) Not used.

EARLY_TERMINATION_FLAG Not null VARCHAR2(1) A flag to show if the patient was terminated early from
the study.

PATIENT_ENROLLMENT_DATE Null DATE Date and time when this patient was enrolled in this
study.

CLINICAL_SUBJECT_ID Null NUMBER(10) The ID of the clinical subject that links this patient
position to other patient positions.

EXCLUDE_FROM_EFFICACY_ Null VARCHAR2(200) Freeform, mixed-case description of the reason for

REASON excluding the patient's data from an efficacy analysis.

INCLUSION_EXCLUSION_DATE Null DATE The date when the decision was made to include or
exclude a patient's data in efficacy or safety analyses.
EXCLUDE_FROM_SAFETY_REASON Null VARCHAR2(200) Freeform, mixed-case description of the reason for
excluding the patient's data from a safety analysis.
Normally the only valid reason is that no study
medication was taken by the patient.

REPORTED_FIRST_NAME Null VARCHAR2(15) The patient's first name, in mixed case.

REPORTED_LAST_NAME Null VARCHAR2(20) The patient's last name, in mixed case.

REPORTED_SEX Null VARCHAR2(1) The patient's gender. Values are M for male and F for
female. The system may use the value in this field to
determine the appropriate normal range for a patient's
laboratory responses.

2-68 Oracle Clinical Stable Interface

 PATIENT_POSITIONS(T)

Column Name Null? Type Column Description

REPORTED_PATIENT_REFERENCE Null VARCHAR2(25) The patient's reported code identification from a

previous study.
REPORTED_INITIALS Null VARCHAR2(4) The patient's initials, in mixed case.

REPORTED_BIRTH_DATE Null DATE The patient's date of birth. The system may use the
value in this field to determine the appropriate normal
range for a patient's laboratory responses.

REPORTED_DEATH_DATE Null DATE The date that the patient was reported to have died.

RANDOMIZATION_COMMENT Null VARCHAR2(200) A freeform comment about the particular

randomization for this patient.

REPORTED_DATE_LAST_PREGNANCY Null DATE The date the patient was last pregnant.

FIRST_SCREENING_DATE Null DATE The date the patient passed screening.

TERMINATION_DATE Null DATE The date the patient was terminated from this clinical
study.

MODIFICATION_TS Null DATE Date and time when this patient position was last
modified.

MODIFIED_BY Null VARCHAR2(30) User who last modified this patient position.
DISC_ENTRY_DEL_LAST_BATCH_TS Null DATE The timestamp of the last batch validation on the
source location at which multivariate discrepancies for
a procedure version were deleted. This is used in
patient data replication.

Table Definitions 2-69

PATIENT_STATUSES

PATIENT_STATUSES

This table contains a record of user-defined situations that have occurred for patients
in the study. This table is maintained during batch validation through the use of the
RXC_PAT_STAT package.

Primary Key PATIENT_POSITION_ID, PATIENT_STATUS_CODE

Related Tables and Foreign Keys

Foreign key name in the related

Name of related table Foreign key name in this table table

PATIENT_POSITIONS PATIENT_POSITION_ID PATIENT_POSITION_ID

PATIENT_STATUSES Column Descriptions

Column Name Null? Type Column Description

CLINICAL_STUDY_ID Not null NUMBER(10) The ID of the clinical study to which the patient position belongs.

SITE_ID Not null NUMBER(10) The ID of the site to which the patient is assigned.

PATIENT_POSITION_ID Not null NUMBER(10) The ID of the patient position concerned.

PATIENT_STATUS_CODE Not null VARCHAR2(15) A user-defined code for the state that is being recorded.

STATUS_DATE Not null DATE The date that the state was achieved.

STATUS_COMMENT Null VARCHAR2(200) Optional comment to provide more information about this patient
status record.

2-70 Oracle Clinical Stable Interface

 PLANNED_STUDY_INTERVALS

PLANNED_STUDY_INTERVALS

Planned study intervals represent the planned experience of one patient in the study.
They form a tree structure. At the top is a system-generated interval called study time
with a subtype code of 0. This represents the entire length of time a patient can be in
the study.
The study time can be divided into phases. Phases have a subtype code of 1 and
represent major segments of the study, such as screening, dosing, and follow-up. Each
phase has pointers to the study time and to the next and previous phase.
A phase can, in turn, be divided into periods. Periods have subtype code of 2 and
represent segments of a period — for example, the dosing phase could be divided into
periods for dose A, dose B, and dose C. Each period has pointers to its parent phase
and to the next and previous period within the phase.
A period can be divided into sub-periods. Sub-periods have subtype code of 3 and
represent small changes within the period — for example, the dosing periods for dose
A could be a one-day washout sub-period followed by six days of treatment. Each
sub-period has pointers to its parent period and the next and previous sub-period
within the period.

Primary Key PLAN_STUDY_INT_ID

Related Tables and Foreign Keys

Foreign key name in the related

Name of related table Foreign key name in this table table

CLINICAL_STUDIES CLINICAL_STUDY_ID CLINICAL_STUDY_ID

CLINICAL_PLANNED_EVENTS PLAN_STUDY_INT_ID PLAN_STUDY_INT_ID

PLANNED_STUDY_INTERVALS Column Descriptions

Column Name Null? Type Column Description

CLINICAL_STUDY_ID Not null NUMBER(10) The ID of the clinical study to which the patient position belongs.

CLINICAL_STUDY_VERSION_ Not null NUMBER(10) The ID of the clinical study version to which the patient position
ID belongs.

PLAN_STUDY_INT_ID Not null NUMBER(10) A unique, system-generated ID for the planned study interval.

NAME Not null VARCHAR2(60) The name of the planned study interval.

PLAN_STUDY_INT_TYPE_ Not null VARCHAR2(7) A code for the general business type of the planned study
CODE interval.

PLSTIN_SUB_TYPE_CODE Not null VARCHAR2(4) The type of planned study interval. Valid values are PHASE,
PERIOD, and SUB-PERIOD.

OPTIONAL_FLAG Not null VARCHAR2(1) A flag to show if patients must complete the planned study
interval.

TIME_UNIT_TYPE_CODE Not null VARCHAR2(7) A code for the unit of time used to measure the duration of the
planned study interval.

RANDOMIZATION_ENDED_ Not null VARCHAR2(1) A flag to show if defining and creating the randomization in the
FLAG interval has been completed. This flag only applies to intervals of
type PHASE.

SHORT_NAME Null VARCHAR2(20) A short code for the planned study interval.

Table Definitions 2-71

PLANNED_STUDY_INTERVALS

Column Name Null? Type Column Description

CREATED_BY Not null VARCHAR2(30) User who created the planned study interval.

CREATION_TS Not null DATE Date and time when the planned study interval was created.

BLIND_TYPE_CODE Not null VARCHAR2(7) A code for the type of blinding applied to the randomization in
the planned study interval. Valid values come from the
installation codelist called BLIND_TYPE_CODE.

END_DATE Null DATE The date by which the last patient must complete this planned
study interval. This column would only be relevant in a
long-term study where the study was finally being terminated.
RAND_ACC_STAT_TYPE_ Null VARCHAR2(7) A code for the current access allowed to the randomization in the
CODE planned study interval. Possible values come from the reference
codelist RAND_ACC_STAT_TYPE_CODE. Values are OPEN
(everyone has always had access), CLOSED (only privileged
users have access), ACCESS (access to named users while in this
state), RELEASE (everyone has access at the end of the study),
and MULT (access controlled at the Phase level).

PARENT_INTERVAL_ID Null NUMBER(10) The ID of the planned study interval to which this one belongs.

NEXT_INTERVAL_ID Null NUMBER(10) The ID of the next planned study interval of the current interval.

PREVIOUS_INTERVAL_ID Null NUMBER(10) The ID of the previous planned study interval of the current
interval.

MINIMUM_DURATION . Null NUMBER(14,4) The minimum length of time that the interval can last for a
patient

MAXIMUM_DURATION Null NUMBER(14,4) The maximum length of time that the interval can last for a
patient.

PLSTIN_SEQ_NUM Null NUMBER(10) A system-maintained sequence number for the interval within the
set of all intervals in the study.

MIN_OFFSET_IN_STUDY Null NUMBER(10) The minimum length of time from the start of the study that this
interval can start.

MAX_OFFSET_IN_STUDY Null NUMBER(10) The maximum length of time from the start of the study by which
time this interval must start.

MODIFIED_BY Null VARCHAR2(30) User who last modified this planned study interval.

MODIFICATION_TS Null DATE Date and time when this planned study interval was last
modified.

2-72 Oracle Clinical Stable Interface

 PREFERRED_LAB_UNITS

PREFERRED_LAB_UNITS

This table records the preferred lab unit to use for a question.

Primary Key PREF_LAB_UNIT_GROUP_ID, QUESTION_ID

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

LAB_UNITS LAB_UNIT_CODE LAB_UNIT_CODE

QUESTIONS QUESTION_ID QUESTION_ID

PREFERRED_LAB_UNITS Column Descriptions

Column Name Null? Type Column Description

PREF_LAB_UNIT_GROUP_ID Not null NUMBER(10) Unique, system-generated ID for this preferred conversion
group.

QUESTION_ID Not null NUMBER(10) The ID of the question for which a preferred lab unit has
been defined.
CREATION_TS Not null DATE Date and time when this preferred lab unit record was
created.

CREATED_BY Not null VARCHAR2(30) User who created this preferred lab unit record.

LAB_UNIT_CODE Not null VARCHAR2(40) A code for the lab unit assigned to this question as its
preferred lab unit.

MODIFICATION_TS Null DATE Date and time when this preferred lab unit record was last
modified.

MODIFIED_BY Null VARCHAR2(30) User who last modified this preferred lab unit record.

PREFERRED_LAB_UNIT_ Null VARCHAR2(240) A comment with supplementary information about using

COMMENT this preferred lab unit for this group.

DECIMAL_PLACES Not null NUMBER(1) The number of decimal places that you want reports
displaying this value to use.

Table Definitions 2-73

PROCEDURES

PROCEDURES

There are two types of Procedure: Validation Procedures and Derivation Procedures.
Validation Procedures are intended to validate received data, and return either a true
or false value for each specified detail. If TRUE is returned a multivariate discrepancy
is produced. A Derivation Procedure is used to derive a new value from received data.
This value is stored as a derived response.
Both types of Procedure are defined and stored in the same way.

Primary Key PROCEDURE_ID, PROCEDURE_VER_SN

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

CLINICAL_STUDIES CLINICAL_STUDY_ID CLINICAL_STUDY_ID

PROCEDURE_QUESTION_GROUPS PROCEDURE_ID PROCEDURE_ID

PROCEDURE_QUESTION_ PROCEDURE_VER_SN PROC_QUE_GRP_PROC_VER_SN

GROUPS

DISCREPANCY_ENTRIES PROCEDURE_ID PROCEDURE_ID

DISCREPANCY_ENTRIES PROCEDURE_VER_SN PROCEDURE_VER_SN

PROCEDURES Column Descriptions

Column Name Null? Type Column Description

PROCEDURE_ID Not null NUMBER(10) A unique, system-generated ID for the Procedure.

PROCEDURE_VER_SN Not null NUMBER(3) A display-only number automatically assigned to

each new version of a Procedure after its creation.

CREATION_TS Not null DATE Date and time when this procedure was created.

CREATED_BY Not null VARCHAR2(30) User who created this procedure.

NAME Not null VARCHAR2(30) Name of the Procedure; unique within a domain.
The name, whether of a Validation or Derivation
Procedure, is listed in the discrepancy database as
PROC NAME.

DOMAIN Not null VARCHAR2(15) A Global Library object-naming convention that

facilitates the unique naming or grouping of similar
objects. Domains also provide a mechanism for
limiting access to objects.

PRO_SUB_TYPE_CODE Not null VARCHAR2(5) A code to show if the Procedure is for validation or
derivation. Possible values come from the system
reference codelist PRO_SUB_TYPE_CODE. Values
are DERIVATION and VALIDATION.

DESCRIPTION Not null VARCHAR2(70) Freeform text, in mixed case, describing the
Procedure.

EDITED_FLAG Not null VARCHAR2(1) A flag to show whether the generated Procedure
text has been edited.

COMPILED_FLAG Not null VARCHAR2(1) A flag to show whether the Procedure has been
successfully compiled.

PROCEDURE_STATUS_CODE Not null VARCHAR2(15) A code to show the state of the Procedure. Values
are provisional (P), active (A), or retired (R).

2-74 Oracle Clinical Stable Interface

 PROCEDURES

Column Name Null? Type Column Description

PROCEDURE_TYPE_CODE Not null VARCHAR2(15) A code to classify the Procedure according to the
type of data it handles. Values come from the
installation reference codelist PROCEDURE_TYPE_
CODE.
CLINICAL_STUDY_ID Not null NUMBER(10) The ID of the clinical study to which the Procedure
belongs.

NEEDS_GENERATION_FLAG Not null VARCHAR2(1) A flag to show whether the Procedure needs to be
generated.

CANNOT_PRESERVE_DISC_FLAG Not null VARCHAR2(1) A system-set flag that indicates that changes to the
Procedure preclude preserving existing
discrepancies.

PRESERVE_DISC_FLAG Not null VARCHAR2(1) A user-set flag indicating whether the user wants to
preserve existing discrepancies after upgrade.

ALL_PATS_VALIDATED_FLAG Not null VARCHAR2(1) Not currently used.

LAST_GENERATION_TS Null DATE Date and time this Procedure code was last
generated. If it is blank, the Procedure code has not
been successfully generated.

LAST_STATUS_CHANGE_TS Null DATE The date and time that the Procedure status was last
changed.

EDIT_COMMENT Null VARCHAR2(200) Freeform text, in mixed case, containing

supplementary information about how and why the
generated Procedure code was edited.

STATUS_COMMENT Null VARCHAR2(200) Freeform text, in mixed case, containing

supplementary information about how and why the
Procedure's status did or did not change.

RETIREMENT_REASON_TYPE_CODE Null VARCHAR2(15) A code to summarize why the Procedure has been
retired. Values come from the installation reference
codelist RETIREMENT_REASON_TYPE_CODE.
MODIFICATION_TS Null DATE Date and time when this procedure was last
modified.

MODIFIED_BY Null VARCHAR2(30) User who last modified this procedure.

REPLICATION_IND Null VARCHAR2(1) A flag to show if the Procedure has been replicated
from another location.
SORT_ORDER Null NUMBER(10) A positive integer that controls the order in which
the Derivation Procedures are executed.

VER_31_FLAG Not null VARCHAR2(1) A flag to indicate if this is a V3.1-style Procedure or

a pre-3.1-style Procedure. V3.1-style Procedures are
more speedily executed and include features not
available in the older style, including more custom
code locations and differentiated settings for every
variable in every detail.

LAB_DEPENDENT_FLAG Not null VARCHAR2(1) A user-defined flag to indicate if the system sees this
Procedure as affected by changes in lab ranges. If
this flag is set, Oracle Clinical will include this
Procedure for patients that are re-validated due to
changes to lab ranges or lab or data associations
since the last batch validation.
EXECUTION_CONTEXT Not null VARCHAR2(15) A code that indicates, for the Data Capture API
immediate procedure execution feature, whether the
procedure should be run immediately for a
particular DCM(ON-LINE/DCM), immediately for
a patient-as-a-whole (ON-LINE), or only during
batch validation (OFF-LINE). Note that all
procedures execute again at the higher levels as
well. For instance, all ON-LINE procedures also
execute during batch validation.

Table Definitions 2-75

PROCEDURE_DETAILS

PROCEDURE_DETAILS

Procedure Details hold the individual steps that constitute a Procedure. There are two
types of Procedure, Derivation Procedures and Validation Procedures.
The steps in a Validation Procedure produce a result of TRUE or FALSE. A value of
TRUE will result in the creation of a multivariate discrepancy. Some of the steps in a
Derivation Procedure produce a result to be stored in a derived response. A
Derivation Procedure can include steps that perform tests and create multivariate
discrepancies.

Primary Key PROCEDURE_DETAIL_ID, PROCEDURE_DETAIL_PROC_VER_SN

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

PROCEDURES PROCEDURE_ID PROCEDURE_ID

PROCEDURES PROCEDURE_DETAIL_ PROCEDURE_VER_SN
PROC_VER_SN

PROCEDURE_QUESTIONS PROCEDURE_QUESTION_ID PROC_QUES_ID

PROCEDURE_DETAILS Column Descriptions

Column Name Null? Type Column Description

PROCEDURE_DETAIL_ID Not null NUMBER(10) An internally derived, unique ID for the Procedure
Detail. Part of concatenated primary key. Value stays
the same for all Procedure versions.

PROCEDURE_DETAIL_PROC_VER_SN Not null NUMBER(3) This is the PROCEDURE_VER_SN of the parent

Procedure. Part of concatenated primary key.

CREATION_TS Not null DATE Date and time when this procedure detail was
created.

CREATED_BY Not null VARCHAR2(30) User who created this procedure detail.

PROCEDURE_ID Not null NUMBER(10) ID of this procedure to which this procedure detail
applies.

PD_SUB_TYPE_CODE Not null VARCHAR2(15) A code for the type of Procedure Detail. Valid values
come from the reference codelist PD_SUB_TYPE_
CODE. Valid values are CALCULATION (where the
Procedure Detail derives a value) and TEST (where
the Procedure Detail returns TRUE or FALSE).

TEST_ORDER_SN Not null NUMBER(3) A sequence number to control the order in which the
Procedure Details are be executed.

EXPRESSION Not null VARCHAR2(2000) The expression contains a syntactical expression to

produce either TRUE or FALSE for TEST details or a
derived value for CALCULATION details. The
syntax of the expression is not guaranteed to be
stable across Oracle Clinical releases.

TEST_NOT_NULL_ONLY_FLAG Null VARCHAR2(1) A flag to indicate if the Procedure Detail should be

executed even if the input value it is manipulating is
NULL. Only applicable to pre-Version 3.1-style
Procedures.

2-76 Oracle Clinical Stable Interface

 PROCEDURE_DETAILS

Column Name Null? Type Column Description

VALIDATION_FAILURE_TYPE_CODE Null VARCHAR2(15) A code for the type of multivariate discrepancy to be

produced if the test succeeds. Valid values come from
the user-defined reference codelist VALIDATION_
FAILURE_TYPE_CODE.
VT_CONTINUE_ON_DISCREP_FLAG Not null VARCHAR2(1) A flag to indicate if a Validation Procedure should
continue to execute after raising a discrepancy in this
Procedure Detail.

CLINICAL_STUDY_ID Not null NUMBER(10) The ID of the clinical study that the Procedure Detail
belongs to.

VT_FAILURE_MESSAGE Null VARCHAR2(200) A freeform text message to be assigned to the

discrepancy if one is created. The syntax of
embedding information in the messages is not
guaranteed to be stable across Oracle Clinical
releases.

PROCEDURE_QUESTION_ID Null NUMBER(10) The ID of the Procedure question derived by this

Procedure Detail. The only application is to
CALCULATION details.

DESCRIPTION Null VARCHAR2(70) A freeform text description of the Procedure Detail.

MODIFICATION_TS Null DATE(70) Date and time when this procedure detail was last
modified.

MODIFIED_BY Null VARCHAR2(30) User who last modified this procedure detail.

REPLICATION_IND Null VARCHAR2(1) A flag to indicate if the Procedure Detail has been
replicated from another location.

EXTERNALLY_DERIVED_FLAG Not null VARCHAR2(1) Not currently used.

INIT_DISCR_REVIEW_STATUS_CODE Null VARCHAR2(15) The code to be associated with the discrepancy in the
discrepancy database according to your company's
policy.
CONTINUE_AT_DETAIL_ID Null NUMBER(10) If INIT_DISCR_REVIEW_STATUS_CODE is Y, you
can specify in this column the detail at which detail
you want the Procedure to continue. For example, if
a discrepancy exists on the first Question in a
Question Group, you might want to skip any details
that process related Questions and start again at the
first detail for a new Question Group.

DISC_MSG_VAR_COUNT Not null NUMBER(10) For internal use only.

Note: The meaning of the expression and the failure message is

covered by the Stable Interface; however, the stability of their syntax is
not guaranteed.

Table Definitions 2-77

PROCEDURE_QUESTION_GROUPS

PROCEDURE_QUESTION_GROUPS

Procedure question groups record the assignment of DCM question groups to a

Procedure.

Primary Key PROC_QUE_GRP_ID, PROC_QUE_GRP_PROC_VER_SN

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

PROCEDURES PROCEDURE_ID PROCEDURE_ID

PROCEDURES PROCEDURE_DETAIL_PROC_VER_SN PROCEDURE_VER_SN

DCM_QUESTION_GROUPS DCM_QUE_GRP_ID DCM_QUESTION_GRP_ID

DCM_QUESTION_GROUPS DCM_QUE_GRP_DCM_SUBSET_SN DCM_QUE_GRP_DCM_SUBSET_SN

DCM_QUESTION_GROUPS DCM_QUE_GRP_DCM_LAYOUT_SN DCM_QUE_GRP_DCM_LAYOUT_SN

CLINICAL_PLANNED_EVENTS CPE_BEGIN_ACCESS_NAME NAME

CLINICAL_PLANNED_EVENTS CPE_END_ACCESS_NAME NAME

PROCEDURE_QUESTION_GROUPS Column Descriptions

Column Name Null? Type Column Description

PROC_QUE_GRP_ID Not null NUMBER(10) A unique, system-generated ID for the Procedure

question group.

PROC_QUE_GRP_PROC_VER_SN Not null NUMBER(3) The version of the parent Procedure.

CREATION_TS Not null DATE Date and time when this procedure question group was
created.
CREATED_BY Not null VARCHAR2(30) User who created this procedure question group.

ALIAS Not null VARCHAR2(4) A short name for the Procedure question group that
uniquely identifies the question group and its questions
in Procedure Details and in correlated question groups.

DCM_QUE_GRP_ID Not null NUMBER(10) The ID of the DCM question group that corresponds to
this Procedure question group.

DCM_QUE_GRP_DCM_SUBSET_SN Not null NUMBER(3) The subset sequence number of the DCM question group
that corresponds to this Procedure question group.

DCM_QUE_GRP_DCM_LAYOUT_SN Not null NUMBER(3) The layout sequence number of the DCM question group
that corresponds to this Procedure question group.

PROCEDURE_ID Not null NUMBER(10) The ID of the Procedure to which the Procedure question
group belongs.

AGGREGATE_FLAG Not null VARCHAR2(1) A flag to indicate if an aggregate function is applied to

the responses of all questions in the DCM question
group.

ORDER_SN Not null NUMBER(3) Internal use only. Used by the front-end to display the
Procedures question groups in order.

CREATE_PLACEHOLDER_FLAG Not null VARCHAR2(1) A flag to show if the Procedure creates a null record
when a clinical planned event is missing from the DCM
question group. Not used in Derivation Procedures or in
aggregate types of question groups.

2-78 Oracle Clinical Stable Interface

 PROCEDURE_QUESTION_GROUPS

Column Name Null? Type Column Description

PRIMARY_REFERENCE_FLAG Not null VARCHAR2(1) A flag to indicate that within this Procedure this DCM
question group is the primary reference; any
discrepancies found are associated with this DCM in the
discrepancy database, a derived responses can be created
only in this DCM question group.

CORREL_ACTUAL_EVENT_FLAG Null VARCHAR2(1) Used in pre-3.1 style Procedures only. If this DCM
question group is to be correlated with another DCM
question group (the Correlate W/Alias field has a value),
a Y in this field indicates the Procedure will correlate
responses to questions in the two DCM question groups
based on the value of a particular actual event. That is,
the Procedure will fetch responses from only that actual
event.

CORREL_QUALIFYING_QUES_ Not null VARCHAR2(1) A flag to show if this DCM question group is to be
FLAG correlated with another DCM question group (the
Correlate W/Alias field has a value), a Y in this field
indicates the Procedure will correlate responses to
questions in the two DCM question groups based on the
value of their DCM qualifying questions. That is, the
Procedure fetches responses only if the value of their
qualifying question is the same.

EVENT_ORDER Not null VARCHAR2(50) The event sort order criteria used by the Procedure
question group. Possible values come from the reference
codelist PROC_QG_EVENT_ORDER. Values are:
■ VISIT ASC ASC (RECEIVED_DCMS.VISIT_
NUMBER, ASC; RECEIVED_DCMS.SUBEVENT_
NUMBER, ASC)
■ VISIT ASC DESC (RECEIVED_DCMS_VISIT_
NUMBER ASC, RECEIVED_DCMS.SUBEVENT_
NUMBER DESC)
■ VISIT DESC ASC (RECEIVED_DCMS.VISIT_
NUMBER DESC, RECEIVED_DCMS.SUBEVENT_
NUMBER ASC)
■ VISIT DESC DESC (RECEIVED_DCMS.VISIT_
NUMBER DESC, RECEIVED_DCMS.SUBEVENT_
NUMBER DESC)
■ DATE ASC ASC (RECEIVED_DCMS.DCM_DATE
ASC, RECEIVED_DCMS.DCM_TIME ASC)
■ DATE ASC DESC (RECEIVED_DCMS.DCM_DATE
ASC, RECEIVED_DCMS.DCM_TIME DESC)
■ DATE DESC ASC (RECEIVED_DCMS.DCM_DATE
DESC, RECEIVED_DCMS.DCM_TIME ASC)
■ DATE DESC DESC (RECEIVED_DCMS.DCM_
DATE DESC, RECEIVED_DCMS.DCM_TIME
DESC)

CLINICAL_STUDY_ID Not null NUMBER(10) The ID of the clinical study to which this Procedure
belongs.

CPE_BEGIN_ACCESS_NAME Null VARCHAR2(20) Name of the first clinical planned event the Procedure
processes (aka Event Range/First by the front-end
application). If this field is blank, the Procedure processes
the first clinical planned event for the specified patient. If
both Event 1 and Event 2 fields are left blank, the
Procedure processes the data collected at all patient
visits. Not used in Derivation Procedures.

CPE_END_ACCESS_NAME Null VARCHAR2(20) Name of the last clinical planned event the Procedure
processes (aka Event Range/Last by the front-end
application). If this field blank, the Procedure continues
processing down to the last clinical planned event for the
specified patient. If both Event 1 and Event 2 fields are
left blank, the Procedure processes the data collected at
all patient visits. Not used in Derivation Procedures.

Table Definitions 2-79

PROCEDURE_QUESTION_GROUPS

Column Name Null? Type Column Description

OTHER_PQG_CORREL_PQG_ID Null NUMBER(10) This field is a self-join to another Procedure question

group in the same Procedure. If defined, it means that
values of this Procedure question group are constrained
to match values of the correlated Procedure question
group (see CORREL_ACTUAL_EVENT_FLAG,
CORREL_QUALIFYING_QUES_FLAG, and CORREL_
WITH_EVENT_TYPE). In the front-end application, the
reference to the other Procedure question group is
defined via its alias.

FIRST_LAST_EVENT Null VARCHAR2(5) A value in this field indicates that the Procedure limits
processing to either the first or last actual event per
patient when processing the responses to the questions in
this question group. Not used in Derivation Procedures.

MODIFIED_BY Null VARCHAR2(30) User who last modified this procedure question group.

MODIFICATION_TS Null DATE Date and time when this procedure question group was
last modified.
REPLICATION_IND Null VARCHAR2(1) A flag to show if the Procedure question group has been
replicated from another location.

QUALIFYING_EXPRESSION Null VARCHAR2(2000) A PL/SQL statement of up to 2000 characters of

mixed-case text that limits the retrieval of records for
processing by the Procedure. Not used in Derivation
Procedures.

CORREL_WITH_EVENT_TYPE Null VARCHAR2(8) If this DCM question group is to be correlated with

another DCM question group (the correlate w/alias field
in the front-end application, OTHER_PQG_CORREL_
PQG_ID in the table, has a value), a
PREVIOUS/ACTUAL/NEXT value in this field indicates
the Procedure will correlate responses to questions in the
two DCM question groups based on the value of the
previous, actual, or next event.

EVENT_ORDER_EXTENSION Not null VARCHAR2(2000) Freeform text that specifies the innermost Sort criteria.
The default is REPEAT_SN ASC, or, where the
corresponding DCM has a qualifying question,
QUALIFYING_VALUE ASC, REPEAT_SN ASC.
SINGLE_REPEATS_ONLY_FLAG Not null VARCHAR2(1) A flag to show if only the first fetched repeating instance
of a repeating question group will be processed.

WHERE_EXTENSION Null VARCHAR2(200) A PL/SQL statement with mixed-case text that limits the
retrieval of records for processing by the Procedure. Not
used in Derivation Procedures.

2-80 Oracle Clinical Stable Interface

 QUESTIONS

QUESTIONS

Questions are the foundation of data definition. They represent single pieces of
information that can be captured and recorded.

Primary Key QUESTION_ID

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

QUESTION_CATEGORY_RELATIONS QUESTION_ID QUESTION_ID

PREFERRED_LAB_UNITS QUESTION_ID QUESTION_ID

RANGES QUESTION_ID QUESTION_ID

LAB_UNIT_CONVERSIONS QUESTION_ID QUESTION_ID

DISCRETE_VALUE_GROUPS DISCRETE_VAL_GRP_ID DISCRETE_VALUE_GRP_ID

DISCRETE_VALUE_GROUPS DISCRETE_VAL_GRP_SUBSET_NUM DISCRETE_VAL_GRP_SUBSET_NUM

QUESTION_GROUP_QUESTIONS QUESTION_ID QUESTION_ID

DCM_QUESTIONS QUESTION_ID QUESTION_ID

DCMS QUESTION_ID QUAL_QUESTION_ID

QUESTIONS Column Descriptions

Column Name Null? Type Column Description

QUESTION_ID Not null NUMBER(10) A unique, system-generated ID for the question.

CREATION_TS Not null DATE Date and time when the question was created.

CREATED_BY Not null VARCHAR2(30) User who created the question.

NAME Not null VARCHAR2(20) The unique identification, within a domain, of a

question.

DOMAIN Not null VARCHAR2(15) Global Library object-naming that facilitates the unique
naming or grouping of objects.
QUE_SUB_TYPE_CODE Not null VARCHAR2(15) A code to specify how the system applies the question
and constrains the question's data type. Possible values
come from the reference codelist QUE_SUB_TYPE_
CODE. Values are UNIT, LAB TEST, DATE TIME,
NON-LAB, COMPLEX, CHAR (for character), THES
VALIDATED (Thesaurus validated), and QUESTION
SET.

SAS_NAME Not null VARCHAR2(8) A name supplied to the SAS Name field in the SAS
views and SAS datasets, to describe the question. This
will be unique within the domain of the question.

SAS_LABEL Not null VARCHAR2(40) Freeform text field, in mixed case, supplied to the SAS
Label field in the SAS views and SAS datasets, to
describe the question.

LAST_STATUS_CHANGE_TS Not null DATE The date and time that the question's status last
changed.

QUESTION_DATA_TYPE_CODE Not null VARCHAR2(15) A code to specify the expected data type of a response to
the question. Possible values come from the reference
codelist QUESTION_DATA_TYPE_CODE. Values are
NUMBER, CHAR, DATE, and TIME.

Table Definitions 2-81

QUESTIONS

Column Name Null? Type Column Description

DERIVED_FLAG Not null VARCHAR2(1) A flag to indicate if this is a derived question. You can
only enter or change responses to the question through a
Derivation Procedure; you cannot enter or modify
responses through the data entry or discrepancy
management subsystems.

INTENT Not null VARCHAR2(200) Freeform text, in mixed case, to describe the information
the question will collect.

DERIVED_LOCK_FLAG Not null VARCHAR2(1) Not used.

PROTOCOL_FLAG Not null VARCHAR2(1) Not used.

QUESTION_STATUS_CODE Not null VARCHAR2(15) A code to control the attributes and usage of a Question.
Values are Provisional (P), Active (A), Retired (R).

DVG_MODIFIABLE_FLAG Not null VARCHAR2(1) A flag to indicate if you can modify either the values in
the discrete value group (DVG), or the name of the DVG
assigned to this question. Applies only to questions with
a data type of CHAR and not to safety questions.

SAFETY_QUESTION_FLAG Not null VARCHAR2(1) A flag to indicate if the system always records the
responses to this question in a corporate safety database.

SIGHT_VERIFICATION_FLAG Not null VARCHAR2(1) A flag to indicate that the system completes the second
pass data entry response field with the response from
the first pass, allowing the response to be visually
verified instead of being re-keyed. If this field is N, the
second pass field is left blank and requires reentry.

UPPER_CASE_FLAG Not null VARCHAR2(1) A flag to indicate if responses to the question are forced
to uppercase.

VALIDATION_FAILURE_TYPE_CODE Not null VARCHAR2(15) A code to specify the severity of a univariate

discrepancy associated with a response to this question.

LENGTH Not null NUMBER(5) The maximum number of allowable characters for a
response to the question. The following values are the
lengths for each type of data: 200 characters for type
CHAR; 40 characters for type NUMBER; 8 characters for
type DATE; 6 characters for type TIME. For a question of
type NUMBER, a negative sign or a decimal point is not
included as part of the length. The number in the
decimal places field is part of this number.
STATUS_SAS_NAME Null VARCHAR2(8) A name, unique within a domain, of the SAS name
when you access the data validation status codes
through the SAS package.

DISCRETE_VAL_GRP_ID Null NUMBER(10) The ID of the discrete value group (DVG) associated
with this question.

DISCRETE_VAL_GRP_SUBSET_NUM Null NUMBER(3) The subset number of the discrete value group (DVG)
associated with this question.

DECIMAL_PLACES Null NUMBER(2) The expected maximum number of digits to the right of
the decimal point for a response to a number question.
The number in this field counts as part of the total
number in the length field. It will be 0 for an integer
response.

DEFAULT_PROMPT Null VARCHAR2(60) Freeform text, up to 60 characters in mixed case, that

appears on the data entry screens as the default prompt
for data input.

LOWER_BOUND Null VARCHAR2(45) The lowest inclusive value allowed as a response to the
DCM question. This field is only available for questions
of type NUMBER, DATE, or TIME.

UPPER_BOUND Null VARCHAR2(45) The highest inclusive value allowed as a response to the
DCM question. This field is available only for questions
of type NUMBER, DATE, or TIME.

MEDICAL_EVAL_TYPE_CODE Null VARCHAR2(15) A code to classify the question according to how the
responses are medically evaluated.

2-82 Oracle Clinical Stable Interface

 QUESTIONS

Column Name Null? Type Column Description

RETIREMENT_REASON_TYPE_CODE Null VARCHAR2(15) A code of a summary of why a retired question was

retired.
STATUS_COMMENT_TEXT Null VARCHAR2(200) A comment about why the status of the question was
changed.

DATE_TIME_TYPE_CODE Null VARCHAR2(3) A code to specify the expected precision of the response
for a question with data type of DATE or TIME.

MODIFICATION_TS Null DATE Date and time when this question was last modified.

MODIFIED_BY Null VARCHAR2(30) User who last modified this question.

REPLICATION_IND Null VARCHAR2(1) A flag to show if the question has been replicated to
another location.

DATE_TIME_FORMAT_CODE Null VARCHAR2(15) A code to control how much to display of a response to a

date or time question.

QUESTION_SET_ID Null NUMBER(10) The ID of the question set to which the question belongs.

QS_PARENT_QUESTION_ID Null NUMBER(10) The ID of the parent question for a question in a

question set.

QUESTION_SET_QUESTION_ID Null NUMBER(10) The ID of the question set question that corresponds to
the question in a question set.

EXTRACT_MACRO_NAME Null VARCHAR2(30) The name of the extract macro associated with this
question.

ALPHA_DVG_MODIFIABLE_FLAG Not VARCHAR2(1) Flag to indicate if the alpha discrete value group
Null assigned to this question is modifiable.

ALPHA_DVG_ID Null NUMBER(10) The ID of the alpha discrete value group assigned to this
question.

ALPHA_DVG_SUBSET_NUM Null NUMBER(3) The subset number of the alpha discrete value group
assigned to this question.

Table Definitions 2-83

QUESTION_CATEGORY_RELATIONS

QUESTION_CATEGORY_RELATIONS

When you define a question, you can associate it with one or more categories, which
are general search classifications for the question. This table stores the relationships
between questions and their categories; each row entered in this table records a
category to which the question belongs.

Primary Key QUESTION_ID, QUESTION_CATEGORY_TYPE_CODE

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

QUESTIONS QUESTION_ID QUESTION_ID

QUESTION_CATEGORY_RELATIONS Column Descriptions

Column Name Null? Type Column Description

QUESTION_ID Not null NUMBER(10) The ID of the question to which the category applies.

QUESTION_CATEGORY_TYPE_ Not null VARCHAR2(15) The type of question category. Valid values come from the
CODE installation reference codelist QUESTION_CATEGORY_TYPE_
CODE.

CREATION_TS Not null DATE Date and time when this question category relation record was
created.

CREATED_BY Not null VARCHAR2(30) User who created this question category relation record.

MODIFICATION_TS Null DATE Date and time when this question category relation record was
last modified.

MODIFIED_BY Null VARCHAR2(30) User who last modified this question category relation record

REPLICATION_IND Not null VARCHAR2(1) A flag to show if the question category has been replicated
from another location.

2-84 Oracle Clinical Stable Interface

 QUESTION_GROUPS

QUESTION_GROUPS

Question groups are sets of related questions.

Primary Key QUESTION_GROUP_ID

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

DCM_QUESTION_GROUPS QUESTION_GROUP_ID QUESTION_GROUP_ID

QUESTION_GROUP_QUESTIONS QUESTION_GROUP_ID QUESTION_GROUP_ID

QUESTION_GROUPS Column Descriptions

Column Name Null? Type Column Description

QUESTION_GROUP_ID Not null NUMBER(10) A unique, system-generated ID for the question group.

CREATION_TS Not null DATE Date and time when this question group was created.
CREATED_BY Not null VARCHAR2(30) User who created this question group.

NAME Not null VARCHAR2(30) A name for the question group.

DOMAIN Not null VARCHAR2(15) The Global Library domain to which the question group
belongs.
QUESTION_GROUP_STATUS_ Not null VARCHAR2(15) The status of the question group. Values are P (Provisional),
CODE A (Active), and R (Retired).

DCM_DCI_QG_TYPE_CODE Not null VARCHAR2(15) A code for the medical use of the question group. Valid
values come from the installation reference codelist DCM_
DCI_QG_TYPE_CODE.

DESCRIPTION Not null VARCHAR2(70) A freeform text description of the question group.
LAST_STATUS_CHANGE_TS Not null DATE The date and time that the question group's status was last
changed.

EXPANDABLE_FLAG Not null VARCHAR2(1) A flag to indicate if you can add questions to the question
group.

RETIREMENT_REASON_ Null VARCHAR2(15) A code for why a retired question group was retired.
TYPE_CODE

STATUS_COMMENT_TEXT Null VARCHAR2(200) A freeform text description of why the question group's
status was last changed.
MODIFICATION_TS Null DATE Date and time when this question group was last modified.

MODIFIED_BY Null VARCHAR2(30) User who last modified this question group.

REPLICATION_IND Null VARCHAR2(1) A flag to show if the question group has been replicated from
another location.

Table Definitions 2-85

QUESTION_GROUP_QUESTIONS

QUESTION_GROUP_QUESTIONS

This view holds the assignment of questions to question groups.

Primary Key QUESTION_GROUP_QUESTION_ID

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

QUESTION_GROUPS QUESTION_GROUP_ID QUESTION_GROUP_ID

QUESTIONS QUESTION_ID QUESTION_ID

DISCRETE_VALUE_GROUPS DISCRETE_VAL_GRP_ID DISCRETE_VAL_GRP_ID

DISCRETE_VALUE_GROUPS DISCRETE_VAL_GRP_SUBSET_NUM DISCRETE_VAL_GRP_SUBSET_NUM

DISCRETE_VALUES DISCRETE_VAL_GRP_ID DISCRETE_VALUE_DVG_ID

DISCRETE_VALUES DISCRETE_VAL_GRP_SUBSET_NUM DISCRETE_VALUE_DVG_

SUBSET_NUM

DISCRETE_VALUES DISCRETE_VALUE_IND_VALUE DISCRETE_VALUE_VALUE

DCM_QUESTIONS QUESTION_ID QUESTION_ID

QUESTION_GROUP_QUESTIONS Column Descriptions

Column Name Null? Type Column Description

QUESTION_GROUP_QUESTION_ID Not null NUMBER(10) A unique, system-generated ID for the question group
question.

CREATION_TS Not null DATE Date and time when this question group question was
created.

CREATED_BY Not null VARCHAR2(30) User who created this question group question.

QUESTION_NAME Not null VARCHAR2(20) Denormalized from the QUESTIONS table. The unique
identification, within a domain, of a question.

OCCURRENCE_SN Not null NUMBER(3) The number of times the Question reoccurs in the
Question Group.

DISPLAY_SN Not null NUMBER(3) The order in which this question should be displayed in
the Question Group during data entry. When you add a
Question to the Question Group, it is assigned, by
default, the next available sequence number. You can
change this value only for Provisional and Active DCMs.

INDICATOR_FLAG Not null VARCHAR2(1) Denormalized from the QUESTIONS table. The unique
identification, within a domain, of a question.

MANDATORY_FLAG Not null VARCHAR2(1) A flag to show if a response to this question is required.
If no value is given a univariate discrepancy will be
created.

UPPER_CASE_FLAG Not null VARCHAR2(1) A flag to indicate if responses to the question are forced
to uppercase.

SIGHT_VERIFICATION_FLAG Not null VARCHAR2(1) Override to the value at the question level. A flag to
indicate that the system completes the second pass data
entry response field with the response from the first pass,
allowing the response to be visually verified instead of
being re-keyed. If this field is N, the second pass field is
left blank and requires reentry.

2-86 Oracle Clinical Stable Interface

 QUESTION_GROUP_QUESTIONS

Column Name Null? Type Column Description

SAS_LABEL Not null VARCHAR2(40) Freeform text field, in mixed case, supplied to the SAS
Labels field in the SAS views and SAS datasets, to
describe the question.

REQUIRED_FLAG Not null VARCHAR2(1) A flag to show if the question is required in the question
group.

DVG_MODIFIABLE_FLAG Not null VARCHAR2(1) Override to the value at the question level. A flag to
indicate if you can modify either the values in the
discrete value group (DVG), or the name of the DVG,
assigned to this question. Applies only to questions with
a data type of CHAR and not to safety questions.

QUESTION_ID Not null NUMBER(10) The ID of the question assigned to this question group by
the question group question.
QUESTION_GROUP_ID Not null NUMBER(10) The ID of the question group concerned.

DISCRETE_VAL_GRP_ID Null NUMBER(10) The ID of the discrete value group (DVG) associated with
this question. Modifiable if the DVG_MODIFIABLE_
FLAG = Y at the question level.

DISCRETE_VAL_GRP_SUBSET_NUM Null NUMBER(3) The subset number of the discrete value group (DVG)
associated with this question. Modifiable if the DVG_
MODIFIABLE_FLAG = Y at the question level.
COLLECTED_FLAG Not null VARCHAR2(1) A flag to indicate if the system collects responses to the
question.

AUTOSKIP_FLAG Not null VARCHAR2(1) A flag to indicate if data entry jumps the cursor to the
next field after the current field has been completed.

LENGTH Not null NUMBER(3) Override to the value from the question level. The
maximum number of allowable characters for a response
to the question. The following values are the maximum
lengths for each type of data: 200 characters for type
CHAR; 40 characters for type NUMBER; 8 characters for
type DATE; 6 characters for type TIME. For a question of
type NUMBER, a negative sign or a decimal point is not
included as part of the length. The number in the decimal
places field is part of this number.

VALIDATION_FAILURE_TYPE_CODE Not null VARCHAR2(15) A code to specify the severity of a univariate discrepancy
if one is created.
DATA_ENTRY_DISPLAY_LENGTH Null NUMBER(3) The number of characters available for the data entry
response to this question.

DISCRETE_VALUE_IND_VALUE Null VARCHAR2(40) The value for the indicator question, which indicates that
other questions in the question group should have
responses. See INDICATOR_QUESTION_FLAG.

UPPER_BOUND Null VARCHAR2(45) Specifies the highest inclusive value that is allowed for
the question without causing a univariate discrepancy.

LOWER_BOUND Null VARCHAR2(45) Specifies the lowest inclusive value allowed for the
question without causing a univariate discrepancy.

HELP_TEXT Null VARCHAR2(200) Freeform text, in mixed case, available for display during
data entry.

DEFAULT_RESPONSE_TEXT Null VARCHAR2(200) Default response displayed at entry time. Constrained by

the system to be compatible with the DCM question's
data type.

DEFAULT_PROMPT Null VARCHAR2(60) Freeform text, in mixed case, for use by the default screen
layout generation to create the default data entry screens.
Also used to describe the question in some applications.

DECIMAL_PLACES Null NUMBER(2) The expected maximum number of digits to the right of
the decimal point for a response to a number question.
The number in this field counts toward the total number
in the length field. This number will be 0 for an integer
response.

Table Definitions 2-87

QUESTION_GROUP_QUESTIONS

Column Name Null? Type Column Description

DATE_TIME_TYPE_CODE Null VARCHAR2(3) A code to specify the expected precision of the response
for a question with data type of DATE or TIME.
MODIFICATION_TS Null DATE(3) Date and time when this question group question was
last modified.

MODIFIED_BY Null VARCHAR2(30) User who last modified this question group question.

REPLICATION_IND Null VARCHAR2(1) A flag to show if the question group question has been
replicated from another location.

DERIVED_FLAG Not null VARCHAR2(1) A flag to indicate if this is a derived question. You can
only enter or change responses to the question through a
Derivation Procedure; you cannot enter or modify
responses through the data entry or discrepancy
management subsystems.

DATE_TIME_FORMAT_CODE Null VARCHAR2(15) A code to control how much to display of a response to a

date or time question.

ALPHA_DVG_MODIFIABLE_FLAG Not Null VARCHAR2(1) Flag to indicate if the alpha discrete value group
assigned to this question is modifiable.

ALPHA_DVG_ID Null NUMBER(10) The ID of the alpha discrete value group assigned to this
question.

ALPHA_DVG_SUBSET_NUM Null NUMBER(3) The subset number of the alpha discrete value group
assigned to this question.

2-88 Oracle Clinical Stable Interface

 RANGES

RANGES

Ranges store lower and upper normal bounds for the response to a particular question
at a lab. The ranges can be used to compare lab results from different labs.

Primary Key RANGE_ID

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

LABS LAB_ID LAB_ID

LAB_RANGE_SUBSETS LAB_RANGE_SUBSET_NUM LAB_RANGE_SUBSET_NUM

QUESTIONS QUESTION_ID QUESTION_ID

RANGES Column Descriptions

Column Name Null? Type Column Description

RANGE_ID Not null NUMBER(10) A unique, system-generated ID for the range.

LAB_ID Not null NUMBER(10) The ID of the lab to which the range belongs.

QUESTION_ID Not null NUMBER(10) The ID of the question to which the range applies.

RANGE_TYPE Not null VARCHAR2(15) A code for the type of range. Possible values come from the
reference codelist LR_RANGE_TYPE. Values are LAB and
TEXTBOOK.

RANGE_STATUS_TYPE Not null VARCHAR2(15) A code for the current status of the range. Possible values come
from the reference codelist LR_RANGE_STATUS. Values are
APPROVED, SUSPICIOUS, UNAPPROVED, and MISSING.
MISSING is a system-maintained code used when the lab unit
and the minimum and maximum values are not specified.

CREATION_TS Not null DATE Date and time when this range was created.

CREATED_BY Not null VARCHAR2(30) User who created this range.

MINIMUM_AGE_DAYS Not null NUMBER(10) The minimum age of a patient in days to which the range
applies.
MAXIMUM_AGE_DAYS Not null NUMBER(10) The maximum age of a patient in days to which the range
applies.

EFFECTIVE_START_DATE Not null DATE The date that the range became available.

EFFECTIVE_END_DATE Not null DATE The date the range stopped being available.
GENDER Not null VARCHAR2(15) The sex of patients to whom this range applies. Possible values
come from the system reference codelist LR_GENDER. Values
are M (Male), F (Female), or B (Both).

MODIFICATION_TS Null DATE Date and time when this range was last modified.

MODIFIED_BY Null VARCHAR2(30) User who last modified this range.

LAB_UNIT_CODE Null VARCHAR2(40) Lab units of the lab test question.

MINIMUM_AGE Null NUMBER(3) Minimum age to which the range applies.

MINIMUM_AGE_UNIT_TYPE Null VARCHAR2(15) Unit of the minimum age. Possible values come from the system
reference codelist LR_AGE_UNIT. Values are DAYS, MONTHS,
and YEARS.

MAXIMUM_AGE Null NUMBER(3) Maximum age to which the range applies.

Table Definitions 2-89

RANGES

Column Name Null? Type Column Description

MAXIMUM_AGE_UNIT_TYPE Null VARCHAR2(15) Unit of the maximum age. Possible values come from the system
reference codelist LR-AGE-UNIT. Values are DAYS, MONTHS,
and YEARS.

MINIMUM_VALUE Null NUMBER The lower value of the range.

MAXIMUM_VALUE Null NUMBER The upper value of the range.

RANGE_COMMENT Null VARCHAR2(240) Freeform text, in mixed case, containing supplementary

information about the range.

LAB_RANGE_SUBSET_NUM Not null NUMBER(10) Lab range subset associated with the range.

SUBSET_USAGE_INDICATOR Not null VARCHAR2(240) Internal flag to keep track of the subset and the ranges
association.

2-90 Oracle Clinical Stable Interface

 RDCI_HISTORY(T)

RDCI_HISTORY(T)

The RDCI_HISTORY table stores history records for three types of transaction:
■ Approvals and Verifications of Records in RDC
■ Records of the Reason for Change when Changing an RDCI or RDCM
■ Populating RDCI_HISTORY from the API
In all three of these transactions, Oracle Clinical bases the CREATION_TS and
CREATED_BY values on the date that the RDCI_HISTORY record is created. The
system uses the same CLINICAL_STUDY_ID as the RDCI record.

Note: Oracle Clinical 4.6 includes the following functional

enhancements related to the RDCI_HISTORY table:
■ Users with lock privilege can specify the list of users to unlock.
■ The system tracks approval and verification records.
■ The system tracks reversals for changes in data entry after
approvals and verifications.
■ The system tracks retaining or reversing approvals and
verifications during form version migration.

Approvals and Verifications of Records in RDC

When you use Oracle Remote Data Capture to approve or verify a record (or to undo
approval or verification), the system populates five records in the RDCI_HISTORY
table. The RECEIVED_DCI_ID, TRANS_TS, and TRANS_BY columns are populated
with the values in the current RDC environment; the user cannot set these values
manually. The TRANS_TYPE reflects the RDC action the user selects: VERIFY,
APPROVAL, UNDO VERIFY, or UNDO APPROVAL. The COMMENT_TEXT stores
the user's comment about this change in approval or verification status.

Records of the Reason for Change when Changing an RDCI or RDCM

Oracle Clinical populates the DATA_CHANGE_REASON_TYPE_CODE column only
when you make a change to an RDCI record. The system validates this value against
one of two reference codelists:
■ RDCI_CHANGE_REASON_TYPE_CODE for log in form and API
■ RDCI_CHANGE_REASON2_TYPE_CODE for additional values for API
In either case, the TRANS_TYPE used is AUDIT.

Populating RDCI_HISTORY from the API

You can populate the same five columns as in approvals and verifications, but the
TRANS_TYPE selection is set by the API.

Primary Key RECEIVED_DCI_ID, TRANS_TS, TRANS_BY, TRANS_TYPE

Table Definitions 2-91

RDCI_HISTORY(T)

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

RECEIVED_DCIS RECEIVED_DCI_ID RECEIVED_DCI_ID

RDCI_HISTORY Column Descriptions

Column Name Null? Type Column Description

RECEIVED_DCI_ID Not null NUMBER(10) The RECEIVED_DCI_ID of the RDCI record for which
this audit record was created.

TRANS_TS Not null DATE The transaction timestamp set by the front end
through its call of SetExternalContext().

TRANS_BY Not null VARCHAR2(30) The transaction user set by the front end through its
call of SetExternalContext().

TRANS_TYPE Not null VARCHAR2(15) The transaction type set by the front end through its
call of SetExternalContext(). It contains one of the
values of the reference codelist EXTERNAL_TRANS_
TYPE.

CREATION_TS Not null DATE Date and time when this audit record was created.

CREATED_BY Not null VARCHAR2(30) User who created this audit record.

CLINICAL_STUDY_ID Not null NUMBER(10) ID of the clinical study to which this received DCI
belongs. This column enables you to focus your
queries to received DCIs from one study, or a more
discrete set of studies.
DATA_CHANGE_REASON_TYPE_CODE Null VARCHAR2(15) The reason that a change was made to this RDCI
record.

COMMENT_TEXT Null VARCHAR2(200) Freeform text set by the front end through its call of
SetExternalContext().

2-92 Oracle Clinical Stable Interface

 RECEIVED_DCIS(T)

RECEIVED_DCIS(T)

This table records the receipt of an actual DCI. The table is self-journaling.
The test table for RECEIVED_DCIS is RECEIVED_DCIST.

Primary Key RECEIVED_DCI_ID, RECEIVED_DCI_ENTRY_TS

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

CLINICAL_STUDIES CLINICAL_STUDY_ID CLINICAL_STUDY_ID

OCL_SITES SITE_ID SITE_ID

OCL_INVESTIGATORS INVESTIGATOR_ID INVESTIGATOR_ID

PATIENT_POSITIONS PATIENT_POSITION_ID PATIENT_POSITION_ID

ACTUAL_EVENTS ACTUAL_EVENT_ID ACTUAL_EVENT_ID

CLINICAL_PLANNED_EVENTS CLIN_PLAN_EVE_ID CLIN_PLAN_EVE_ID

DCIS DCI_ID DCI_ID

RECEIVED_PAGES RECEIVED_DCI_ID RECEIVED_DCI_ID

RECEIVED_DCMS RECEIVED_DCI_ID RECEIVED_DCI_ID

DATA_FILES DATA_FILE_ID DATA_FILE_ID

RECEIVED_DCIS Column Descriptions

Column Name Null? Type Column Description

RECEIVED_DCI_ID Not null NUMBER(10) A unique, system-generated ID for the received DCI.

RECEIVED_DCI_ENTRY_ Not null DATE The date and time that the received DCI record version was created.
TS

DCI_ID Not null NUMBER(10) The ID of the DCI corresponding to the received DCI.

ENTERED_BY Not null VARCHAR2(30) The name of the person who created the received DCI record
version.
END_TS Not null DATE The time until this version of the record is active. Defaulted to to_
date (3000000, 'J') for a new document. Equal to the entry timestamp
of the next version of this record (if any) if not equal to the default.

CLINICAL_STUDY_ID Not null NUMBER(10) The ID of the clinical study to which the DCI belongs.

INVESTIGATOR_ID Not null NUMBER(10) The ID of the investigator who completed the DCI.

INVESTIGATOR Not null VARCHAR2(10) The code of the investigator who completed the DCI.

SITE_ID Not null NUMBER(10) The ID of the site where the DCI was completed.

SITE Not null VARCHAR2(10) The name of the site where the DCI was completed.
PATIENT_POSITION_ID Not null NUMBER(10) The ID of the patient for whom the DCI was completed.

PATIENT Not null VARCHAR2(10) The code of the patient for whom the DCI was completed.

ACTUAL_EVENT_ID Not null NUMBER(10) The ID of the actual event at which this received DCI was collected.

Table Definitions 2-93

RECEIVED_DCIS(T)

Column Name Null? Type Column Description

RECEIVED_DCI_STATUS_ Not null VARCHAR2(15) System-generated. Indicates the status of the received DCI. Possible
CODE values come from the reference codelist RECEIVED_STATUS_DCI_
CODE. Values are:
■ RECEIVED – Received
■ PASS 1 STARTED – 1st Pass Started
■ PASS 1 COMPLETE – 1st Pass Complete
■ PASS 2 STARTED – 2nd Pass Started
■ PASS 2 COMPLETE – 2nd Pass Complete
■ PASS 2 PENDING – Awaiting reconciliation of Pass 1 and Pass
2
■ REMOVED – Removed
■ BATCH – Batch Loaded

LOG_IN_TS Not null DATE Date and time when the original record was logged in. Stays
constant across journaled versions of the record.

DOCUMENT_NUMBER Not null VARCHAR2(20) The external, unique key for the received DCI. Unique only in
combination with RECEIVED_DCI_ENTRY_TS. DOCUMENT_
NUMBER can change across versions of the DCI.

DATA_LOCK_FLAG Not null VARCHAR2(1) Flag indicating if it is acceptable to change data for this received DCI
without privileged update.

ACCESSIBLE_TS Not null DATE Timestamp indicating at what time this received DCI became
available to the external world for processing in Procedures and,
after the subsequent batch validation, via the stable data extract
views. Defaulted to to_date (3000000, 'J') and set to SYSDATE at
either the completion of Pass 1 or at Pass 2, depending on whether
Pass 2 is specified as required for the study.

BLANK_FLAG Not null VARCHAR2(1) Flag indicating if there is any data for this received DCI. Constrained
by the system to be consistent with the blank flag on the associated
received DCMs.

CLIN_PLAN_EVE_ID Not null NUMBER(10) The ID for the clinical planned event for this received DCI.

CLIN_PLAN_EVE_NAME Not null VARCHAR2(20) The external identifier for the clinical planned event for this received
DCI.

SUBEVENT_NUMBER Not null NUMBER(2) A number marking unplanned events, if any, occurring after the
planned event recorded on this received DCI, but before the next
planned event. Defaulted to 0 for the planned event itself.

DCI_DATE Null VARCHAR2(8) Date at which the DCI was collected.

DCI_TIME Null VARCHAR2(6) Time at which the DCI was collected.

DATA_FILE_ID Null NUMBER(10) Identifier for the external electronic data source (if any) for this
received DCI.

DATA_LOCK_TS Null DATE If data lock flag is set, the date and time at which it was set. Can be
used in conjunction with the Last Change timestamp to report on
potential changes made after locking.

LAST_STATUS_CHANGE_ Null DATE Time at which the received DCI had a status code change.
TS

LAST_NEW_VERSION_TS Null DATE Time at which the received DCI had the receipt of a new version
specified in key changes. In this context, a new version means the
acknowledgment that a modified version of the associated CRF has
been received. Can be used to track that after the logging of the new
version, a subsequent data change was made to reflect the changes
on the new version. This external use of version is not to be confused
with the internal use of the term new versions, which describes the
creation of modified records used to implement self-journaling.

COMMENT_TEXT Null VARCHAR2(200) Internal comment, if any, for this received DCI. Changes do not
trigger audit by self-journaling.

IMAGE_DOCUMENT_ Null VARCHAR2(20) Not currently used.

NUMBER

2-94 Oracle Clinical Stable Interface

 RECEIVED_DCIS(T)

Column Name Null? Type Column Description

IMAGE_INDEX_DATE Null DATE Not currently used.

MODIFICATION_TS Null DATE Date and time when this received DCI was last modified.

MODIFIED_BY Null VARCHAR2(30) User who last modified this received DCI.

VISIT_NUMBER Not null NUMBER(5) A numeric representation of the planned event for this received DCI.

FIRST_BOOK_PAGE Null VARCHAR2(15) The book page at which this received DCI starts in the DCI book.

NUMBER_OF_PAGES Null NUMBER(4) The number of pages spanned by the received DCI in the DCI book.
Populated only if CRF page tracking is enabled.

DCI_BOOK_ID Null NUMBER(10) ID identifying the DCI book from which the DCI was chosen for
data entry. Populated only if CRF page tracking is enabled.

LAST_CHANGE_TS Null DATE Timestamp to track the last time any data changed for the received
DCI or any of its associated received DCMs or responses. Used for
inclusion in data replication.

VERSION_SN Null NUMBER(3) Version number of the DCI Form used for collecting data in PDF
mode.

VERSION_SN_NLS Null NUMBER(3) Version number of the Local Language DCI Form used for collecting
data in PDF mode.

Table Definitions 2-95

RECEIVED_DCMS(T)

RECEIVED_DCMS(T)

This table records the receipt of an actual DCM. The table is self-journaling.
The test table for RECEIVED_DCMS is RECEIVED_DCMST.

Primary Key RECEIVED_DCM_ID, RECEIVED_DCM_ENTRY_TS

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

CLINICAL_STUDIES CLINICAL_STUDY_ID CLINICAL_STUDY_ID

OCL_SITES SITE_ID SITE_ID

OCL_INVESTIGATORS INVESTIGATOR_ID INVESTIGATOR_ID

PATIENT_POSITIONS PATIENT_POSITION_ID PATIENT_POSITION_ID

ACTUAL_EVENTS ACTUAL_EVENT_ID ACTUAL_EVENT_ID

CLINICAL_PLANNED_EVENTS CLIN_PLAN_EVE_ID CLIN_PLAN_EVE_ID

LABS LAB_ID LAB_ID

DCMS DCM_ID DCM_ID

DCMS DCM_SUBSET_SN DCM_SUBSET_SN

DCMS DCM_LAYOUT_SN DCM_LAYOUT_SN

DISCREPANCY_ENTRIES RECEIVED_DCM_ID RECEIVED_DCM_ID

DISCREPANCY_ENTRIES RECEIVED_DCM_ENTRY_TS RECEIVED_DCM_ENTRY_TS

RESPONSES RECEIVED_DCM_ID RECEIVED_DCM_ID

RECEIVED_DCMS Column Descriptions

Column Name Null? Type Column Description

RECEIVED_DCI_ID Not null NUMBER(10) A unique, system-generated ID for the received DCM.

RECEIVED_DCM_ENTRY_TS Not null DATE The date and time that the received DCM record version was
created.

ENTERED_BY Not null VARCHAR2(30) The name of the person who created the received DCM
record version.

END_TS Not null DATE The time until this version of the record is active. Defaulted
to to_date (3000000, 'J') for a new document. Equal to the
entry timestamp of the next version of this record (if any) if
not equal to the default.

RECEIVED_DCI_ID Not null NUMBER(10) ID for the received DCI to which this received DCM belongs.

SN Not null NUMBER(3) Serial number of the received DCM within other received
DCMs belonging to the same parent received DCI.
Constrained to match the DCM_MODULE_SN of the DCI_
MODULE of the DCI that was used to enter this received
DCM.

INVESTIGATOR_ID Not null NUMBER(10) The ID of the investigator who completed the DCM.

INVESTIGATOR Not null VARCHAR2(10) The code of the investigator who completed the DCM.

SITE_ID Not null NUMBER(10) The ID of the site where the DCM was completed.

SITE Not null VARCHAR2(10) The code of the site where the DCM was completed.

2-96 Oracle Clinical Stable Interface

 RECEIVED_DCMS(T)

Column Name Null? Type Column Description

DCM_ID Not null NUMBER(10) The ID of the DCM that corresponds to this received DCM.

DCM_SUBSET_SN Not null NUMBER(3) The subset number of the DCM subset that corresponds to
this received DCM.

DCM_LAYOUT_SN Not null NUMBER(3) The layout number of the DCM layout used to enter this
received DCM.

ACTUAL_EVENT_ID Not null NUMBER(10) The ID for the actual event for this received DCM.

ACCESSIBLE_TS Not null DATE Timestamp indicating at what time this received DCM is
available to the external world for processing in Procedures
and, after the subsequent batch validation, via the stable data
extract views. Defaulted to to_date(3000000, 'J') and set to
SYSDATE at either the completion of Pass 1 or at Pass 2,
depending on whether Pass 2 is specified as required by the
study.

DATA_LOCK_FLAG Not null VARCHAR2(1) Flag indicating if it is acceptable to change data for this
received DCM without privileged update.

RECEIVED_DCM_STATUS_CODE Not null VARCHAR2(15) System-generated. Indicates the status of the received DCM.
Possible values come from the reference codelist RECEIVED_
DCM_STATUS_CODE.
Values for the RECEIVED_DCM_STATUS_CODE are:
RECEIVED – Received
PASS 1 STARTED – 1st Pass Started
PASS 1 COMPLETE – 1st Pass Complete
PASS 2 STARTED – 2nd Pass Started
PASS 2 COMPLETE – 2nd Pass Complete
PASS 2 PENDING – Awaiting reconciliation of Pass 1 and
Pass 2
REMOVED – Removed
BATCH – Batch Loaded

BLANK_FLAG Not null VARCHAR2(1) Flag indicating if there is any data for this received DCM.
PATIENT_POSITION_ID Not null NUMBER(10) The ID of the patient for whom the DCM was completed.

PATIENT Not null VARCHAR2(10) The code of the patient for whom the DCM was completed.

CLINICAL_STUDY_ID Not null NUMBER(10) The ID of the clinical study to which the DCM belongs.

CLIN_PLAN_EVE_ID Not null NUMBER(10) The ID for the clinical planned event for this received DCM.

CLIN_PLAN_EVE_NAME Not null VARCHAR2(20) The external identifier for the clinical planned event for this
received DCM.

SUBEVENT_NUMBER Not null NUMBER(2) A number marking unplanned events, if any, occurring after
the planned event recorded on this received DCI, but before
the next planned event. Defaulted to 0 for the planned event
itself.
DCM_DATE Null VARCHAR2(8) Date at which the DCM was collected.

DCM_TIME Null VARCHAR2(6) Time at which the DCM was collected.

LAB_ID Null NUMBER(10) The ID of the lab where the DCM was completed.

LAB Null VARCHAR2(10) The code of the lab where the DCM was completed.

LAB_ASSIGNMENT_TYPE_CODE Null VARCHAR2(15) A system-defined value that records how the lab associated
with this received DCM was specified. Possible values come
from the reference codelist LR_LAT. Values are:
UNKNOWN – No lab specified
CRITERION – Defaulted via lab assignment criteria
LOGIN – Manually entered by data entry
SYSTEM – Not currently used
USER – Explicitly entered through RDCM screen in LAC
Maintenance

LAB_MODIFICATION_TS Null DATE The date and time that the last change to the lab fields was
made.

Table Definitions 2-97

RECEIVED_DCMS(T)

Column Name Null? Type Column Description

QUALIFYING_VALUE Null VARCHAR2(70) The value for the qualifying question associated with the
DCM that is used to identify a particular instance of a DCM
within an actual event (or visit). Received DCMs for the same
DCM must have only one instance at an actual event
(irrespective of subset or layout) unless the received DCM is
qualified by a qualifying value, in which case, one unique
occurrence of the DCM is allowed for each unique qualifying
value.
DATA_LOCK_TS Null DATE If data_lock_flag is set, the time at which it was set. Can be
used together with the LAST_DATA_CHANGE_TS to detect
received DCMs that have had data modifications since the
received DCM was locked.

LAST_STATUS_CHANGE_TS Null DATE Time at which the received DCM had a status code change.

COMMENT_TEXT Null VARCHAR2(200) Internal comment, if any, for this received DCM. Changes to
the COMMENT_TEXT are not audited. They do not cause a
new record version to be created.
LAST_DATA_CHANGE_TS Null DATE Timestamp to track the last time any data changed for
responses associated with the received DCM. Used for
inclusion in batch validation and replication. Not modified
by changes to the received DCM itself.

PASS_ONE_TS Null DATE Date and time of first pass data entry for this received DCM.

PASS_ONE_BY Null VARCHAR2(30) Operator who performed first pass data entry for this
received DCM.

PASS_TWO_TS Null DATE Date and time of second pass data entry for this received
DCM.
PASS_TWO_BY Null VARCHAR2(30) Operator who performed second pass data entry for this
received DCM.

DATA_COMMENT_TEXT Null VARCHAR2(200) A comment that is part of the data — for instance, text that
the investigator writes in the margin of the CRF and that
applies to the DCM as a whole. Changes to the DATA_
COMMENT_TEXT are audited. They cause new record
version creation.

MODIFICATION_TS Null DATE Date and time when this RDCM records was last modified.
MODIFIED_BY Null VARCHAR2(30) User who last modified this RDCM record.

DOCUMENT_NUMBER Not null VARCHAR2(20) The external unique key for the received DCM.

VISIT_NUMBER Not null NUMBER(5) A numeric representation of the clinical planned event for
this received DCM.
LOG_IN_TS Not null DATE The date and time of original entry. Denormalized from the
LOG_IN_TS of the associated received DCI.

LAB_RANGE_SUBSET_NUM Not null NUMBER(10) The identifier, within a lab, of a particular lab range subset
that should be used when combining data on this received
DCM with lab range information. The base, or default, lab is
subset 0.

LAST_RESPONSE_ Not null DATE Timestamp to track the last time any responses changed for
MODIFICATION_TS the received DCM for inclusion in replication. This
timestamp changes due to internal changes to responses —
such as re-derivation of derived responses, re-computation of
response validation status, or changes to responses due to
re-execution of univariate validation during batch validation.

DCI_ID Not null NUMBER(10) The ID of the DCI corresponding to the received DCI
associated with this received DCM.

2-98 Oracle Clinical Stable Interface

 RECEIVED_PAGES(T)

RECEIVED_PAGES(T)

The RECEIVED_PAGES table contains tracking or status information about the

physical CRF pages associated with a received DCI. The table is populated only if CRF
page tracking is enabled for a study. The system automatically populates the table
when received DCIs are created in Log-In. The system automatically derives the page
status and determines whether the page contains data by using a user-configurable
database package. The page status can be manually modified, constrained by
validation logic defined in the same database package. Only the current status of
received pages is reflected in this table; the RECEIVED_PAGE_HISTORY table records
changes to the received pages over time.
The test table for RECEIVED_PAGES is RECEIVED_PAGEST.

Primary Key RECEIVED_PAGE_ID

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

RECEIVED_DCIS RECEIVED_DCI_ID RECEIVED_DCI_ID

RECEIVED_PAGE_HISTORY RECEIVED_PAGE_ID RECEIVED_PAGE_ID

RECEIVED_PAGES Column Descriptions

Column Name Null? Type Column Description

RECEIVED_PAGE_ID Not null NUMBER(10) A unique, system-generated ID for the received page.

RECEIVED_DCI_ID Not null NUMBER(10) The unique identifier of the received DCI to which this received
page belongs

CLINICAL_STUDY_ID Not null NUMBER(10) The ID of the clinical study to which the DCI book page belongs.

PAGE_STATUS Not null VARCHAR2(15) The status of the received page. Valid values are defined in the
installation reference codelist CRF_PAGE_STATUS_CODES. By
default, the system uses the following modifiable statuses values:
UNKNOWN, RECEIVED, PASS 1 COMPLETE, PASS 2
COMPLETE, PASS 2 PENDING, REMOVED, MISSING and
BLANK.

HAS_DATA_FLAG Not null VARCHAR2(1) A system-derived flag indicating whether the received page has any
non-null response data on it.

RELATIVE_TO_DCI_PAGE Not null NUMBER(4) The order of this received page within the group of pages allocated
to the same received DCI.

BOOK_PAGE Not null VARCHAR2(15) The unique, user-defined identifier of the DCI book page to which
this received physical page corresponds.

COMMENT_TEXT Null VARCHAR2(200) Freeform text describing the received page.

CREATED_BY Not null VARCHAR2(30) User who created this received page.

CREATION_TS Not null DATE Date and time when this received page was created.

MODIFIED_BY Null VARCHAR2(30) User who last modified this received page.

MODIFICATION_TS Null DATE Date and time when this received page was last modified.

Table Definitions 2-99

RECEIVED_PAGE_HISTORY(T)

RECEIVED_PAGE_HISTORY(T)

The received page history tracks changes to received pages over time. This table
includes records the current received page values as well as a record for each previous
change to those values.
The test table for RECEIVED_PAGE_HISTORY is RECEIVED_PAGE_HISTORYT.

Primary Key RECEIVED_PAGE_ID, CREATION_TS

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

RECEIVED_PAGES RECEIVED_PAGE_ID RECEIVED_PAGE_ID

RECEIVED_PAGE_HISTORY Column Descriptions

Column Name Null? Type Column Description

RECEIVED_PAGE_ID Not null NUMBER(10) A unique, system-generated ID for the received page.

RECEIVED_DCI_ID Not null NUMBER(10) The unique identifier of the received DCI to which this
received page belongs.

CLINICAL_STUDY_ID Not null NUMBER(10) The ID of the clinical study to which the DCI book page
belongs.
PAGE_STATUS Not null VARCHAR2(15) The status of the received page.

HAS_DATA_FLAG Not null VARCHAR2(1) A flag indicating whether the received page has any
non-null response date.

RELATIVE_TO_DCI_PAGE Not null NUMBER(4) The order of this received page within the group of pages
allocated to the same DCI.

BOOK_PAGE Not null VARCHAR2(15) The unique system identifier of the DCI book page to which
this received page belongs.

COMMENT_TEXT Null VARCHAR2(200) Freeform text describing the received page.

CREATED_BY Not null VARCHAR2(30) User who created this received page history record.

CREATION_TS Not null DATE Date and time when this received page history record was
created.

2-100 Oracle Clinical Stable Interface

 REFERENCE_CODELISTS

REFERENCE_CODELISTS

Reference codelists are simple sets of values a particular code can have.

Primary Key REFERENCE_CODELIST_NAME

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

REFERENCE_CODELIST_VALUES REFERENCE_CODELIST_NAME REFERENCE_CODELIST_NAME

REFERENCE_CODELISTS Column Descriptions

Column Name Null? Type Column Description

REFERENCE_CODELIST_ Not null VARCHAR2(30) A name for the reference codelist.

NAME

CREATION_TS Not null DATE Date and time when this reference codelist was created.

CREATED_BY Not null VARCHAR2(30) User who created this reference codelist.

ACTIVE_FLAG Not null VARCHAR2(1) A flag to show if the reference codelist is active or retired.

MAX_LONG_VALUE_LENGTH Not null NUMBER(2) The maximum allowed length of the long value for each entry.

MAX_SHORT_VALUE_LENGTH Not null NUMBER(2) The maximum allowed length of the short value for each entry.
RC_TYPE_CODE Not null VARCHAR2(15) The type of reference codelist. Valid values are:
■ LOCAL – User-defined values for the instance; for
example, printers
■ INSTALLATION – User-defined for all instances that
share the same Global Library
■ SYSTEM – Oracle-defined values

RC_DATA_TYPE_CODE Not null VARCHAR2(15) Data type of short value. Valid values are CHAR, NUMBER,
and DATE.

DESCRIPTION Null VARCHAR2(70) A freeform text description of the reference codelist.

DEFAULT_SHORT_VALUE Null VARCHAR2(15) The default short value for the reference codelist.

MODIFICATION_TS Null DATE Date and time when this reference codelist was last modified.

MODIFIED_BY Null VARCHAR2(30) User who last modified this reference codelist.

REPLICATION_IND Null VARCHAR2(1) A flag to show if the reference codelist has been replicated from
another site.

APPLICATION_SYSTEM_NAME Not null VARCHAR2(30) A code for the sub-system that owns the reference codelist.
Oracle Clinical uses RXC, RXA_DES, and RXA_LR.

Table Definitions 2-101

REFERENCE_CODELIST_VALUES

REFERENCE_CODELIST_VALUES

Reference codelist values are particular values within a reference codelist that a code
field can have.

Primary Key REFERENCE_CODELIST_NAME, REF_CODELIST_VALUE_SHORT_

VAL

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

REFERENCE_CODELISTS REFERENCE_CODELIST_NAME REFERENCE_CODELIST_NAME

REFERENCE_CODELIST_VALUES Column Descriptions

Column Name Null? Type Column Description

REF_CODELIST_NAME Not null VARCHAR2(30) A name for the reference codelist to which this
individual value belongs.

REF_CODELIST_VALUE_SHORT_VAL Not null VARCHAR2(15) A short code for the value. Unique within the reference
codelist.

CREATION_TS Not null DATE(15) Date and time when this reference codelist value was
created.

CREATED_BY Not null VARCHAR2(30) User who created this reference codelist value.

ACTIVE_FLAG Not null VARCHAR2(1) A flag to show if the value is still active.

LONG_VALUE Null VARCHAR2(60) A long value for the code.

DESCRIPTION Null VARCHAR2(70) A description of the code.

DISPLAY_SN Null NUMBER(3) A sequence number to control the display order in

LOVs.

MODIFICATION_TS Null DATE Date and time when this reference codelist value was
last modified.
MODIFIED_BY Null VARCHAR2(30) User who last modified this reference codelist value.

REPLICATION_IND Null VARCHAR2(1) User who last modified this reference codelist value.

2-102 Oracle Clinical Stable Interface

 REGIONS

REGIONS

Regions are areas where studies can be conducted. They can be generally recognized
political or geographic regions, but they can also be more general, user-defined names,
such as Northern Europe.

Primary Key REGION_ID

Unique Key REGION_CODE

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

OCL_INVESTIGATORS REGION_CODE STATE

OCL_INVESTIGATORS REGION_CODE COUNTRY

OCL_SITES REGION_CODE STATE

OCL_SITES REGION_CODE COUNTRY

OCL_STUDIES REGION_ID REGION_ID

REGIONS Column Descriptions

Column Name Null? Type Column Description

REGION_ID Not null NUMBER(10) A unique, system-generated ID for the region.

REGION_CODE Not null VARCHAR2(7) A unique code for the region.

DESCRIPTION Not null VARCHAR2(200) A description for the region. This is most applicable when a
user-defined region has been defined.

CREATED_BY Not null VARCHAR2(30) User who created this region record.

CREATION_TS Not null DATE Date and time when this region was created.

START_DATE Not null DATE The date that the region became active.

NAME Not null VARCHAR2(60) A name for the region.

END_DATE Null DATE The date that the region stopped being active.

REGION_TYPE_CODE Not null VARCHAR2(7) The type of region. Valid values are CONTINENT, COUNTRY, and
STATE. The code is optional and can be left blank for abstract
user-defined regions.

MODIFIED_BY Null VARCHAR2(30) User who last modified this region.

MODIFICATION_TS Null DATE Date and time when this region was last modified.

Table Definitions 2-103

RESPONSES(T)

RESPONSES(T)

Responses record the data values for a particular instance of a DCM question. The
table is self-journaling, and its test table is RESPONSEST.

Accessing data in the RESPONSES table following response index changes

Include CLINICAL_STUDY_ID in all access to the responses table. Since responses are
in a partition on the basis of CLINICAL_STUDY_ID, the query optimizer can restrict
its search to the proper partition if the query contains CLINICAL_STUDY_ID. This is
called partition pruning. In order of preference, this reference to CLINICAL_STUDY_ID
can be a constant, a bind variable in an aqua-join, or a join from another table.
The primary access path is the concatenated index RESPONSE_RDCM_NFK_IDX that
is prefixed with CLINICAL_STUDY_ID in order to force responses from different
studies in the same partition to be physically grouped together, and to optimize certain
partition accesses. Even in a non-partitioned database, the index begins with
CLINICAL_STUDY_ID.
Redirect all previous queries on DCM_QUESTION_ID or DCM_QUESTION_GROUP_
ID to use a join through the RECEIVED_DCMS table so that they can use the
concatenated index. Since there are no longer indexes with DCM_QUESTION_ID or
DCM_QUESTION_GROUP_ID as leading keys, these are no longer efficient access
paths. Much access involving these keys is already done in the context of a Received
DCM, so the query retuning is usually minimal. In some cases, it might be necessary to
add joins to DCM_QUESTIONS or DCM_QUESTION_GROUPS, and then through
RECEIVED_DCMS via DCM_ID.

Primary Key RESPONSE_ID, RESPONSE_ENTRY_TS

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table
RECEIVED_DCMS RECEIVED_DCM_ID RECEIVED_DCM_ID

DISCREPANCY_ENTRIES RESPONSE_ID RESPONSE_ID

DISCREPANCY_ENTRIES RESPONSE_ENTRY_TS RESPONSE_ENTRY_TS

CLINICAL_STUDIES CLINICAL_STUDY_ID CLINICAL_STUDY_ID

VALIDATION_REPORTED_VALUES RESPONSE_ID RESPONSE_ID

VALIDATION_REPORTED_VALUES RESPONSE_ENTRY_TS RESPONSE_ENTRY_TS

DCM_QUESTION_GROUPS DCM_QUESTION_GRP_ID DCM_QUESTION_GRP_ID

DCM_QUESTIONS DCM_QUESTION_ID DCM_QUESTION_ID

RESPONSES Column Descriptions

Column Name Null? Type Column Description

RESPONSE_ID Not null NUMBER(10) A unique, system-generated ID for the response.

RESPONSE_ENTRY_TS Not null DATE The date and time that the response was entered.

ENTERED_BY Not null VARCHAR2(30) The name of the person who entered the response.

RECEIVED_DCM_ID Not null NUMBER(10) ID for the received DCM to which this response belongs.

2-104 Oracle Clinical Stable Interface

 RESPONSES(T)

Column Name Null? Type Column Description

DCM_QUESTION_ID Not null NUMBER(10) ID of the DCM question to which the response belongs.

DCM_QUESTION_GROUP_ID Not null NUMBER(10) ID of the DCM question group to which the DCM question for
the response belongs.

CLINICAL_STUDY_ID Not null NUMBER(10) The ID of the clinical study to which the response belongs.

REPEAT_SN Not null NUMBER(3) The repeat or logical row number within the DCM question
group for the response.

END_TS Not null DATE The time until this version of the record is active. Defaulted to
to_date (3000000, 'J') for a new document. Equal to the entry
timestamp of the next version of this record (if any) if not equal
to the default.

VALIDATION_STATUS Not null VARCHAR2(3) Three-part indicator showing whether univariate, multivariate,
or manual discrepancies are present for the response and what
the status of those discrepancies are. Values for resolved
discrepancies are derived from the user-defined long value in
the reference codelist DISCREPANCY_RESOLU_TYPE_CODE.
In the case of multivariate discrepancies (which also include
indicator discrepancies) multiple discrepancies can be associated
with the response. The value reflects the highest status as defined
by the order below. Depending on the long value of the
reference codelist entry for the VAL_STATUS in the codelist
OCL_OPTIONS_TYPE_CODE, the validation status can be
optionally maintained with full auditing as of each batch
validation (the default), maintained only for the current
response value (NO_AUDIT), or not maintained at all (NONE).
The possible values of the indicator are:
O – Open, status CURRENT, no resolution
I – Irresolvable, queried but no further resolution possible
K – Confirmed by query
C – Closed, status OBSOLETE — due to either a data change or
validation change
N – No discrepancy

SECOND_PASS_INDICATOR Null VARCHAR2(1) Indicates the status of the data of the response about whether
first, second, reconciliation and/or update passes has been done
on this response and whether data was updated in the passes.
Possible values are:
N – Pass 2 not performed
Y – Pass 2 comparison successfully performed
1 – Pass 2 comparison failed, Pass 2 value accepted
2 – Pass 2 comparison failed, Pass 1 value accepted
3 – Response modified in update mode
4 – Response created in update mode by repeat creation
5 – Response modified in reconciliation mode
6 – Response created in reconciliation mode by repeat creation

VALUE_TEXT Null VARCHAR2(200) The actual text for the response.

DISCREPANCY_INDICATOR Null VARCHAR2(1) Flag indicating whether a univariate discrepancy, a manual

discrepancy, or both exists for the response. Possible values are
U, M, and B, respectively.

DATA_CHANGE_REASON_ Null VARCHAR2(15) Code indicating reason a new version of the response was
TYPE_CODE created. Value is populated on the version prior to the new
version, or, in the case of deletions, on the final version.

DATA_COMMENT_TEXT Null VARCHAR2(200) Investigator comment, if any, for the response.

Table Definitions 2-105

RESPONSES(T)

Column Name Null? Type Column Description

AUDIT_COMMENT_TEXT Null VARCHAR2(200) If the record was updated after it was made accessible in the
Update mode of data entry, the comment, if any, added by the
operator. Value is populated on the version prior to the new
version, or, in the case of deletions, on the final version.
EXCEPTION_VALUE_TEXT Null VARCHAR2(200) The full value of the response is stored in this column if a
discrepancy has been created of the type that indicates that the
value is inconsistent with the database use of the DCM question.
In particular:
■ Datatype discrepancies store the value here with the value
text null.
■ Length discrepancies store the full value here with the
value text containing null for numbers and containing the
text truncated to the DCM question length for characters.

2-106 Oracle Clinical Stable Interface

 STUDY_SITE_PATIENT_POSITIONS(T)

STUDY_SITE_PATIENT_POSITIONS(T)

Study site patient positions record the assignment of patient positions to study sites.
The test table for this table is STUDY_SITE_PATIENT_POSITIONST.

Primary Key SITE_ID, CLINICAL_STUDY_ID, PATIENT_POSITION_ID

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

PATIENT_POSITIONS PATIENT_POSITION_ID PATIENT_POSITION_ID

OCL_STUDY_SITES SITE_ID SITE_ID

CLINICAL_STUDIES CLINICAL_STUDY_ID CLINICAL_STUDY_ID

STUDY_SITE_PATIENT_POSITIONS Column Descriptions

Column Name Null? Type Column Description

SITE_ID Not null NUMBER(10) The ID of the site assigned to the study.
CLINICAL_STUDY_ID Not null NUMBER(10) The ID of the study concerned.

PATIENT_POSITION_ID Not null NUMBER(10) The ID of the patient assigned to the study site.

START_DATE Not null DATE The date that the patient assignment started.

CURRENT_FLAG Not null VARCHAR2(1) A flag to show if this is the current or most recent assignment for the
patient.

CREATED_BY Not null VARCHAR2(30) User who created the study site patient position record.

CREATION_TS Not null DATE Date and time when this study site patient position record was created.
END_DATE Null DATE The date that the patient assignment ended.

MODIFIED_BY Null VARCHAR2(30) User who last modified this study site patient position record.

MODIFICATION_TS Null DATE Date and time when this study site patient position record was last
modified.

Table Definitions 2-107

TREATMENT_PATTERNS

TREATMENT_PATTERNS

Treatment patterns describe the medication to be given to a patient during the study.

Primary Key TREATMENT_PATTERN_ID

Unique Keys CLINICAL_STUDY_ID, NAME

CLINICAL_STUDY_ID, PATTERN_CODE

Related Tables and Foreign Keys

Name of related table Foreign key name in this table Foreign key name in the related table

CLINICAL_STUDIES CLINICAL_STUDY_ID CLINICAL_STUDY_ID

PATTERNS PATTERN_CODE PATTERN_CODE

TREAT_ASSIGN_ALL_VIEW TREATMENT_PATTERN_ID TREATMENT_PATTERN_ID

TREATMENT_PATTERNS Column Descriptions

Column Name Null? Type Column Description

TREATMENT_PATTERN_ID Not null NUMBER(10) A unique, system-generated ID for the treatment pattern.

CLINICAL_STUDY_ID Not null NUMBER(10) The ID of the study to which the treatment pattern belongs.

CLINICAL_STUDY_VERSION_ID Not null NUMBER(10) The ID of the study version to which the treatment pattern
belongs.
PATTERN_CODE Not null VARCHAR2(15) A code for the treatment.

NAME Not null VARCHAR2(60) A name for the treatment pattern.

CREATED_BY Not null VARCHAR2(30) User who created the treatment pattern.

CREATION_TS Not null DATE Date and time when the treatment pattern was created.

NUMBER_OF_KITS_REQUIRED Null NUMBER(10) The number of treatment assignments to be created for this
treatment pattern.

NUMBER_OF_RPL_KITS_REQUIRED Null NUMBER(10) The number of replacement treatment assignments to be

created for this treatment pattern.
LABEL_CODE Null VARCHAR2(20) A code to print on labels for this treatment pattern.

STARTING_KIT_CODE Null VARCHAR2(10) A code from which to start coding the treatment
assignments.

STARTING_RPL_KIT_CODE Null VARCHAR2(10) A code from which to start coding the replacement
treatment assignments.

MODIFIED_BY Null VARCHAR2(30) User who last modified the treatment pattern.

MODIFICATION_TS Null DATE Date and time when the treatment pattern was last
modified.

2-108 Oracle Clinical Stable Interface

 VALIDATION_REPORTED_VALUES(T)

VALIDATION_REPORTED_VALUES(T)

Validation Report Values (VRVs) record the values that are associated with a particular
validation failure for a Validation Procedure. For Pre-3.1-style Procedures, every
failure for a particular Procedure has the same set of values. For 3.1-style Procedures,
each Procedure Detail specifies which values to report. The relation to a particular
Procedure and Procedure Detail is determined via the relation to a particular
discrepancy, which has the IDs of the Procedure and Procedure Detail.
The test table for VALIDATION_REPORTED_VALUES is VALIDATION_REPORTED_
VALUEST.

Primary Key DISCREPANCY_ENTRY_ID, PROC_VARIABLE_NAME

Related tables and foreign keys

Name of related table Foreign key name in this table Foreign key name in the related table

RESPONSES RESPONSE_ID RESPONSE_ID

RESPONSES RESPONSE_ENTRY_TS RESPONSE_ENTRY_TS

DISCREPANCY_ENTRIES DISCREPANCY_ENTRY_ID DISCREPANCY_ENTRY_ID

VALIDATION_REPORTED_VALUES Column Descriptions

Column Name Null? Type Column Description

DISCREPANCY_ENTRY_ID Not null NUMBER(10) The ID of the multivariate discrepancy entry with which this
validation reported value is associated.

PROC_VARIABLE_NAME Not null VARCHAR2(30) The Procedure variable name is unique within a particular
Procedure and uniquely associates the validation reported value to a
particular source within the Procedure definition.

RESPONSE_ID Null NUMBER(10) If the VRV corresponds to a unique response, as contrasted to a

calculated or auxiliary value, this points to the response that
participated in the test.

RESPONSE_ENTRY_TS Null DATE Part of foreign key to responses, above. Maintained by system when
new versions of responses are created that do not change the value
of the response, such as a change to a data comment. For 3.1-style
Procedures, if the response value changes, but the value is only
reported but not part of the test, the RESPONSE_ENTRY_TS
continues to refer to the version of the response that existed at the
time of discrepancy creation.

VALUE_TEXT Null VARCHAR2(200) Value of validation reported value which was used in the test. This
field is populated both for response-based values and other values.
DCF_INCLUDE Null VARCHAR2(1) An indicator of whether to include the VRV in DCF. Value is Y to
include, NULL if not included.

Table Definitions 2-109

VALIDATION_REPORTED_VALUES(T)

2-110 Oracle Clinical Stable Interface

 3
3Release 4.6 Flexible Studies Tables

Oracle Clinical Release 4.6 introduces an enhanced DCI Book form that allows you to
create rules that define the required decision points in a flexible study. You can have
multiple valid sequences of allowable visits and pages in chronological order through
the study schedule for different Patient groups. In addition, the data required for
Patients can vary based on their actual data at planned decision points.
There are new tables for the DCI Book to hold the rule definitions. The new DCI Book
tables are:
"DCI_BOOK_RULES" on page 3-3
"DCI_BOOK_RULE_TGT_INTERVALS" on page 3-5
"DCI_BOOK_RULE_TGT_DCIS" on page 3-6
DCI_BOOK_RULES is the master table. DCI_BOOK_RULE_TGT_INTERVALS and
DCI_BOOK_RULE_TGT_DCIS are child tables. However, DCI_BOOK_RULE_TGT_
INTERVALS and DCI_BOOK_RULE_TGT_DCIS are mutually exclusive in their
relationship to DCI_BOOK_RULES: For a given RULE_ID in DCI_BOOK_RULES, the
child rows are either in DCI_BOOK_RULE_TGT_INTERVALS or DCI_BOOK_RULE_
TGT_DCIS. Which one is present is determined by the value of RULE_TYPE in the
DCI_BOOK_RULES table.
There are also new tables for Patient Positions. They are:
"PP_EXPECTED_INTERVALS(T)" on page 3-7
"PP_EXPECTED_INTERVALS$JN" on page 3-8
"PP_EXPECTED_CPES(T)" on page 3-9
"PP_EXPECTED_CPES$JN" on page 3-10
"PP_EXPECTED_DCIS(T)" on page 3-11
"PP_EXPECTED_DCIS$JN" on page 3-12
Each new Patient Position table has a foreign key to PATIENT_POSITIONS and to the
object of the expectedness they track: PP_EXPECTED_INTERVALS to PLAN_
INTERVAL_ID, PP_EXPECTED_CPES to CLIN_PLAN_EVE_ID, and PP_EXPECTED_
DCIS to DCI_ID. The PP_EXPECTED_DCIS also has a foreign key to the Clinical
Planned Event (CPE) because DCIs are expected at a CPE. There is a row in the tables
if the object is expected, none, if it is not expected — with the caveat that intervals and
CPEs will have a row present even if they are not expected if the BYPASSED_FLAG
field indicates that they have been skipped due to a Bypass To rule..

Release 4.6 Flexible Studies Tables 3-1

 Note: Tables that have test data counterparts are designated by a (T)
at the end of the table's title. PP_EXPECTED_INTERVALS(T) therefore
describes the production table PP_EXPECTED_INTERVALS and the
test table PP_EXPECTED_INTERVALST.

3-2 Oracle Clinical Stable Interface

 DCI_BOOK_RULES

DCI_BOOK_RULES

DCI Book rules are created within a DCI Book for a flexible study. Each rule has a set
of trigger conditions and a set of target conditions. The target or targets of a rule are
conditional and only become expected when the trigger conditions are met. The DCI_
BOOK_RULES table contains the trigger conditions (the data definition and data value
or values), for a rule. A trigger may be the existence of a particular received DCI at a
Clinical Planned Event, or it may be as specific as a particular response to a question in
a qualified DCI module at a Clinical Planned Event. A DCI Book rule applies for the
selected DCI Trigger at every CPE(s) at which it exists in the DCI Book.
■ Interval rules specify the conditions for the CPEs in an entire study Interval (or
Intervals) to be required. There are two different types of Interval rule; the Enable
rule, which sets the DCI – CPE combinations within the Interval as expected, or
the Bypass To rule, which also causes all DCI – CPE combinations after the CPE of
the data entry point — including DCI-CPE in the rest of the current interval — up
to the target Interval to be non-expected.
■ DCI rules specify the criteria for a DCI to be required There are two different types
of DCI rule; the 'Enable Within CPE' type applies to the target DCI(s) only at the
same CPE as defined in the Trigger, and the 'Enable Across CPEs' applies to the
target DCI(s) whenever it is collected in the DCI Book.
The details of the targets for a DCI Book rule are found in either the DCI_BOOK_
RULE_TGT_INTERVALS table or the DCI_BOOK_RULE_TGT_DCIS table.

Primary Key RULE_ID

DCI_BOOK_RULES Related tables and foreign keys

Name of related table Foreign key name in this table Foreign key name in the related table

DCI_BOOKS DCI_BOOK_ID DCI_BOOK_ID

DCI_BOOK_RULES Columns

Column Null? Type Column Description

RULE_ID Not null NUMBER(10) The rule ID value.

DCI_BOOK_ID Not null NUMBER(10) The ID of the DCI Book.

RULE_TYPE Not null VARCHAR2(20) Specifies whether the rule triggers Intervals or DCIs. Values
are INTERVAL or DCI.

RULE_TARGET_ACTION Not null VARCHAR2(20) Specifies the rule subtype. For Interval rules, the subtypes are
Enable and Bypass To. For DCI rules, the subtypes are Across
CPEs and Within CPE.

TRIGGER_DCI_ID Not null NUMBER(10) ID of the DCI containing the data evaluated by the rule

TRIGGER_DCM_ID Null NUMBER(10) ID of the DCM within the trigger DCI containing the data
evaluated by the rule. The special value of 0 indicates that
simply the presence of the DCI with a status of Pass 1
Complete or higher causes the rule to evaluate to TRUE.

TRIGGER_DCM_MODULE_SN Null NUMBER(3) A serial number indicating the order of the trigger DCM
module within the parent DCI
TRIGGER_DCM_QUALIFIER Null VARCHAR2(80) Value of the Qualifying Question that identifies the particular
DCM within the trigger DCI.

Release 4.6 Flexible Studies Tables 3-3

DCI_BOOK_RULES

Column Null? Type Column Description

TRIGGER_DCM_QG_ID Null NUMBER(10) ID of the DCM Question Group within the trigger DCI/DCM
containing the data evaluated by the rule.
TRIGGER_DCM_QUE_ID Null NUMBER(10) ID of the DCM Question within the trigger DCI/DCM
containing the data evaluated by the rule.

TRIGGER_VALUES Null VARCHAR2(2000) List of the Response values which cause the rule to evaluate
to TRUE. Delimited by the non-printing character with ASCII
value 31.

CLINICAL_STUDY_ID Not null NUMBER(10) The ID of the clinical study.

CREATED_BY Not null VARCHAR2(30) The username of the person who created the DCI Book rule.

CREATION_TS Not null DATE Creation Timestamp

MODIFIED_BY Null VARCHAR2(30) User who last modified this DCI book rule.

MODIFICATION_TS Null DATE The Modification Timestamp.

RULE_DESCRIPTION Null VARCHAR2(200) Describes the rule's function for the end user. The description
appears on the Interval and the DCI rule screens.

3-4 Oracle Clinical Stable Interface

 DCI_BOOK_RULE_TGT_INTERVALS

DCI_BOOK_RULE_TGT_INTERVALS

This table contains the target Interval(s) for an Interval rule in a DCI Book. The target
can be one or more Intervals in the Study schedule, or the pseudo value [Next
Interval], which is used, for example, in a study design where patients continue on
cycles of treatment until an end point is reached.
When the Interval rule trigger conditions are met, all CPEs in the target Interval(s)
become expected. All DCIs collected at those CPEs also become expected, if they are
not the target of a DCI rule. For a Bypass To Interval rule, all DCI – CPE combinations
after the CPE at which the trigger DCI meets the trigger conditions, up to the expected
target Interval also become Non-expected.

Primary Key RULE_ID, INTERVAL_ID

DCI_BOOK_RULE_TGT_INTERVALS Related tables and foreign keys

Name of related table Foreign key name in this table Foreign key name in the related table

DCI_BOOK_RULES RULE_ID RULE_ID

DCI_BOOK_RULE_TGT_INTERVALS Column Descriptions

Column Null? Type Column Description

RULE_ID Not null NUMBER(10) The rule ID.

INTERVAL_ID Not null NUMBER(10) The target interval ID.

DCI_BOOK_ID Not null NUMBER(10) The ID of the DCI Book.

CLINICAL_STUDY_ID Not null NUMBER(10) The ID of the clinical study.

CREATED_BY Not null VARCHAR2(30) The username of the person who created the DCI Book target
interval.

CREATION_TS Not null DATE The creation timestamp.

MODIFIED_BY Null VARCHAR2(30) User who last modified this DCI book rule target interval.

MODIFICATION_TS Null DATE The modification timestamp.

Release 4.6 Flexible Studies Tables 3-5

DCI_BOOK_RULE_TGT_DCIS

DCI_BOOK_RULE_TGT_DCIS

This table contains the DCI(s) which are defined as the target of a DCI rule in a DCI
Book. All DCIs that are not the target of a DCI rule are expected if the Interval, and
therefore the CPEs, in which they are defined is, or becomes, expected. In addition, if a
DCI is the target of a DCI rule, the rule trigger conditions must also be met for the DCI
to become expected.

Primary Key RULE_ID, DCI_ID

DCI_BOOK_RULE_TGT_DCIS Related tables and foreign keys

Name of related table Foreign key name in this table Foreign key name in the related table

DCI_BOOK_RULES RULE_ID RULE_ID

DCI_BOOK_RULE_TGT_DCIS Column Descriptions

Column Null? Type Column Description

RULE_ID Not null NUMBER(10) The rule ID.

DCI_ID Not null NUMBER(10) The ID of the DCI to which the DCI module belongs.

DCI_BOOK_ID Not null NUMBER(10) The ID of the DCI Book.

CLINICAL_STUDY_ID Not null NUMBER(10) The ID of the clinical study.

CREATED_BY Not null VARCHAR2(30) The username of the person who created the DCI Book rule target DCI.

CREATION_TS Not null DATE The creation timestamp.

MODIFIED_BY Null VARCHAR2(30) User who last modified this DCI book rule target DCI.

MODIFICATION_TS Null DATE The modification timestamp.

3-6 Oracle Clinical Stable Interface

 PP_EXPECTED_INTERVALS(T)

PP_EXPECTED_INTERVALS(T)

PP_EXPECTED_INTERVALS tracks the current expectedness of Intervals for a

particular Patient. If the Interval is expected for the Patient, there is an entry in this
table with the BYPASSED_FLAG = N. If the Interval is not expected for the Patient,
there is either no row or the entry has the BYPASSED_FLAG = Y.

Primary Key PATIENT_POSITION_ID, PLAN_INTERVAL_ID

PP_EXPECTED_INTERVALS Related tables and foreign keys

Name of related table Foreign key name in this table Foreign key name in the related table

PATIENT_POSITIONS PATIENT_POSITION_ID PATIENT_POSITION_ID

PP_EXPECTED_INTERVALS Column Descriptions

Column Name Null? Type Column Description

CLINICAL_STUDY_ID Not null NUMBER(10) The ID of the clinical study.

PATIENT_POSITION_ID Not null NUMBER(10) Patient Position ID

PLAN_INTERVAL_ID Not null NUMBER(10) Plan Interval ID

BYPASSED_FLAG Null VARCHAR2(1) Indicates whether Interval has been bypassed by Bypass To Interval
rule. Values are Y or N.

Release 4.6 Flexible Studies Tables 3-7

PP_EXPECTED_INTERVALS$JN

PP_EXPECTED_INTERVALS$JN

The PP_EXPECTED_INTERVALS table is audited by the PP_EXPECTED_

INTERVALS$JN journal table. See the Column Descriptions in the table below.

Primary Key JN_SN

PP_EXPECTED_INTERVALS$JN Related tables and foreign keys

Name of related table Foreign key name in this table Foreign key name in the related table

PATIENT_POSITIONS PATIENT_POSITION_ID PATIENT_POSITION_ID

PP_EXPECTED_INTERVALS$JN Column Descriptions

Column Name Null? Type Column Description

JN_SN Not null NUMBER(10) Journal Sequence.

JN_OPERATION Not null VARCHAR2(3) Journal Operation INS, UPD or DEL

JN_ORACLE_USER Not null VARCHAR2(30) Oracle User who modified the data.
JN_TIMESTAMP Not null DATE Journal Timestamp.

CLINICAL_STUDY_ID Not null NUMBER(10) The ID of the clinical study.

PATIENT_POSITION_ID Not null NUMBER(10) Patient Position ID.

PLAN_INTERVAL_ID Not null NUMBER(10) Plan Interval ID.

BYPASSED_FLAG Null VARCHAR2(1) Bypassed Flag.

3-8 Oracle Clinical Stable Interface

 PP_EXPECTED_CPES(T)

PP_EXPECTED_CPES(T)

PP_EXPECTED_CPES tracks the current expectedness of clinical planned events for a

particular Patient. If the clinical planned event is expected for the Patient, there is an
entry in this table with the BYPASSED_FLAG = N. If the clinical planned event is not
expected for the Patient, there is either no row or the entry has the BYPASSED_FLAG
= Y.

Primary Key PATIENT_POSITION_ID, CLIN_PLAN_EVE_ID

PP_EXPECTED_CPES Related tables and foreign keys

Name of related table Foreign key name in this table Foreign key name in the related table

PATIENT_POSITIONS PATIENT_POSITION_ID PATIENT_POSITION_ID

PP_EXPECTED_CPES Column Descriptions

Column Name Null? Type Column Description

CLINICAL_STUDY_ID Not null NUMBER(10) The ID of the clinical study.

PATIENT_POSITION_ID Not null NUMBER(10) Patient Position ID

CLIN_PLAN_EVE_ID Not null NUMBER(10) Clinical planned event ID

BYPASSED_FLAG Null VARCHAR2 (1) Indicates whether CPE has been bypassed by a Bypass
To Interval rule. Values are Y or N.

LAST_EXPECTEDNESS_MOD_TS Null DATE Timestamp of last modification of expectedness for a

DCI assigned to this CPE in the DCI Book. It is updated
whenever a DCI assigned to this CPE is added or
removed from the PP_EXPECTED_DCIS table.

Release 4.6 Flexible Studies Tables 3-9

PP_EXPECTED_CPES$JN

PP_EXPECTED_CPES$JN

The PP_EXPECTED_CPES table is audited by the PP_EXPECTED_CPES$JN journal

table. See the Column Descriptions in the table below.

Primary Key JN_SN

Related tables and foreign keys

Name of related table Foreign key name in this table Foreign key name in the related table

PATIENT_POSITIONS PATIENT_POSITION_ID PATIENT_POSITION_ID

PP_EXPECTED_CPES$JN Column Descriptions

Column Name Null? Type Column Description

JN_SN Not null NUMBER(10) The Journal Sequence number.

JN_OPERATION Not null VARCHAR2(3) Journal Operation INS, UPD, or DEL

JN_ORACLE_USER Not null VARCHAR2(30) Oracle User who modified the data
JN_TIMESTAMP Not Null DATE Journal Timestamp

CLINICAL_STUDY_ID Not null NUMBER(10) The ID of the clinical study.

PATIENT_POSITION_ID Not null NUMBER(10) Patient Position ID

CLIN_PLAN_EVE_ID Not null NUMBER(10) Clinical planned event ID

BYPASSED_FLAG Null VARCHAR2(1) Bypassed Flag

LAST_EXPECTEDNESS_MOD_TS Null DATE Timestamp of last modification of expectedness for a DCI

assigned to this CPE in the DCI Book. It is updated whenever
a DCI assigned to this CPE is added or removed from the PP_
EXPECTED_DCIS table.

Note: A journal row is not added if the only update is

LAST_EXPECTEDNESS_MOD_TS.

3-10 Oracle Clinical Stable Interface

 PP_EXPECTED_DCIS(T)

PP_EXPECTED_DCIS(T)

PP_EXPECTED_DCIS tracks the current expectedness of DCIs at Clinical Planned

Events for a particular Patient. If the DCI is expected at a Clinical Planned Event for
the Patient, there is an entry in this table. If the DCI is not expected, there is no entry.

Primary Key PATIENT_POSITION_ID, CLIN_PLAN_EVE_ID, DCI_ID

Related tables and foreign keys

Name of related table Foreign key name in this table Foreign key name in the related table

PATIENT_POSITIONS PATIENT_POSITION_ID PATIENT_POSITION_ID

PP_EXPECTED_DCIS Column Descriptions

Column Name Null? Type Column Description

CLINICAL_STUDY_ID Not null NUMBER(10) The ID of the clinical study.

PATIENT_POSITION_ID Not null NUMBER(10) Patient Position ID

CLIN_PLAN_EVE_ID Not null NUMBER)10) Clinical planned event ID

DCI_ID Not null NUMBER(10) The ID of the DCI to which the expected DCI belongs.

CREATION_TS Not null DATE The creation timestamp.

Release 4.6 Flexible Studies Tables 3-11

PP_EXPECTED_DCIS$JN

PP_EXPECTED_DCIS$JN

The PP_EXPECTED_DCIS table is audited by the PP_EXPECTED_DCIS$JN journal

table. See the Column Descriptions in the table below.

Primary Key JN_SN

Related tables and foreign keys

Name of related table Foreign key name in this table Foreign key name in the related table

PATIENT_POSITIONS PATIENT_POSITION_ID PATIENT_POSITION_ID

PP_EXPECTED_DCIS$JN Column Descriptions

Column Name Null? Type Column Description

JN_SN Not null NUMBER(10) Journal Sequence

JN_OPERATION Not null VARCHAR2(3) Journal Operation INS, UPD or DEL

JN_ORACLE_USER Not null VARCHAR2(30) Oracle User who modified the data

JN_TIMESTAMP Not null DATE The journal timestamp.

CLINICAL_STUDY_ID Not null NUMBER(10) The ID of the clinical study.

PATIENT_POSITION_ID Not null NUMBER(10) Patient Position ID

CLIN_PLAN_EVE_ID Not null NUMBER(10) Clinical planned event ID

DCI_ID Not null NUMBER(10) The ID of the DCI to which the expected DCI belongs.
CREATION_TS Not null DATE The creation timestamp.

3-12 Oracle Clinical Stable Interface

 4
4 View Definitions

This chapter provides a description of each view that can be found within the stable
interface. You should access these views only by their synonyms, which are described
in Chapter 1.

About the Stable Interface Views

The following views supply packages of information about some of the major concepts
in the Oracle Clinical system. Views make simple queries easier to code, but require
more processing than straight table accesses and should therefore be avoided in
production applications.
The columns in each stable interface view are described in terms of the tables and
columns from which they are derived. In each case the column name in the view is
given, followed by the table and column from which it is derived. For a definition of
the field, refer to the corresponding table definition in Chapter 2, "Table Definitions".

View Definitions 4-1

ACTUAL_EVENTSV(T)

ACTUAL_EVENTSV(T)

This is a view of actual events with internal IDs translated into user-recognizable
codes.
The test view for ACTUAL_EVENTSV is ACTUAL_EVENTSVT.

Name of column in the ACTUAL_ Name of column in underlying

EVENTSV(T) view Name of underlying table table
ACTUAL_EVENT_ID ACTUAL_EVENTS ACTUAL_EVENT_ID
PATIENT_POSITION_ID ACTUAL_EVENTS PATIENT_POSITION_ID
CLINICAL_STUDY_ID ACTUAL_EVENTS CLINICAL_STUDY_ID
CLIN_PLAN_EVE_ID ACTUAL_EVENTS CLIN_PLAN_EVE_ID
CPE_NAME CLINICAL_PLANNED_EVENTS NAME
VISIT_NUMBER CLINICAL_PLANNED_EVENTS VISIT_NUMBER
SUBEVENT_NUMBER ACTUAL_EVENTS SUBEVENT_NUMBER
COMMENT_TEXT ACTUAL_EVENTS COMMENT_TEXT
START_DATE RECEIVED_DCMS DCM_DATE
END_DATE RECEIVED_DCMS DCM_DATE

4-2 Oracle Clinical Stable Interface

 CHECK_RANDOMIZATIONS

CHECK_RANDOMIZATIONS

This view shows information about when a randomization was created. This view
hides the seed number used, because this value is blinded information.

Column Name Null? Type

PERFORMED_BY Not null VARCHAR2(30)
TIMESTAMP_OCCURRED Not null DATE
RANDOMIZATION_TYPE_CODE Not null VARCHAR2(7)
CREATED_BY Not null VARCHAR2(30)
CREATION_TS Not null DATE
MODIFIED_BY Null VARCHAR2(30)
MODIFICATION_TS Null DATE
CLINICAL_STUDY_ID Not null NUMBER(10)
CLINICAL_STUDY_VERSION_ID Not null NUMBER(10)

View Definitions 4-3

DISCREPANCY_MANAGEMENT(T)

DISCREPANCY_MANAGEMENT(T)

A view of discrepancies and associated information.

The test view for DISCREPANCY_MANAGEMENT is DISCREPANCY_
MANAGEMENTT.

Name of Column in the

DISCREPANCY_MANAGEMENT(T) Name of column in underlying
view Name of underlying table table
DISCREPANCY_ENTRY_ID DISCREPANCY_ENTRIES DISCREPANCY_ENTRY_ID
CLINICAL_STUDY_ID DISCREPANCY_ENTRIES CLINICAL_STUDY_ID
STUDY_SITE OCL_STUDY_SITES STUDY_SITE
INVESTIGATOR OCL_INVESTIGATORS INVESTIGATOR
INV_NAME OCL_INVESTIGATORS LAST_NAME, FIRST_NAME
SITE OCL_SITES SITE
PATIENT PATIENT_POSITIONS PATIENT
REPORTED_INITIALS PATIENT_POSITIONS REPORTED_INITIALS
CREATION_TS DISCREPANCY_ENTRIES CREATION_TS
CREATED_BY DISCREPANCY_ENTRIES CREATED_BY
MODIFICATION_TS DISCREPANCY_ENTRIES MODIFICATION_TS
MODIFIED_BY DISCREPANCY_ENTRIES MODIFIED_BY
DISCREPANCY_STATUS_CODE DISCREPANCY_ENTRIES DISCREPANCY_STATUS_CODE
DE_SUB_TYPE_CODE DISCREPANCY_ENTRIES DE_SUB_TYPE_CODE
DISCREPANCY_TYPE_CODE DISCREPANCY_ENTRIES DISCREPANCY_TYPE_CODE
DCM_ID DCMS DCM_ID
NAME DCMS NAME
DCM_QUESTION_ID DISCREPANCY_ENTRIES DCM_QUESTION_ID
QUESTION_NAME DCM_QUESTIONS QUESTION_NAME
OCCURRENCE_SN DCM_QUESTIONS OCCURRENCE_SN
DISCREPANCY_REV_STATUS_ DISCREPANCY_ENTRIES DISCREPANCY_REV_STATUS_
CODE CODE
DISCREPANCY_RESOLU_TYPE_ DISCREPANCY_ENTRIES DISCREPANCY_RESOLU_TYPE_
CODE CODE
COMMENT_TEXT DISCREPANCY_ENTRIES COMMENT_TEXT
RECEIVED_DCM_ID DISCREPANCY_ENTRIES RECEIVED_DCM_ID
RECEIVED_DCM_ENTRY_TS DISCREPANCY_ENTRIES RECEIVED_DCM_ENTRY_TS
RESPONSE_ID DISCREPANCY_ENTRIES RESPONSE_ID
RESPONSE_ENTRY_TS DISCREPANCY_ENTRIES RESPONSE_ENTRY_TS
PROCEDURE_ID DISCREPANCY_ENTRIES PROCEDURE_ID
PROCEDURE_VER_SN DISCREPANCY_ENTRIES PROCEDURE_VER_SN

4-4 Oracle Clinical Stable Interface

 DISCREPANCY_MANAGEMENT(T)

(Cont.) Name of Column in the

DISCREPANCY_MANAGEMENT(T) Name of column in underlying
view Name of underlying table table
PROCEDURE_DETAIL_ID DISCREPANCY_ENTRIES PROCEDURE_DETAIL_ID
IRRESOLVABLE_FLAG DISCREPANCY_ENTRIES IRRESOLVABLE_FLAG
CLIN_PLAN_EVE_ID CLINICAL_PLANNED_EVENTS CLIN_PLAN_EVEN_ID
SUSPECT_FLAG DISCREPANCY_ENTRIES SUSPECT_FLAG
CLIN_PLAN_EVE_SN CLINICAL_PLANNED_EVENTS CLIN_PLAN_EVE_SN
EVENT_NAME CLINICAL_PLANNED_EVENTS NAME
SUBEVENT_NUMBER DISCREPANCY_ENTRIES SUBEVENT_NUMBER
DCF_ID DISCREPANCY_ENTRIES DCF_ID
ASSOCIATED_ID DISCREPANCY_ENTRIES ASSOCIATED_ID
CRF_PAGE_NUMBER DISCREPANCY_ENTRIES CRF_PAGE_NUMBER
DCF_COMMENT DISCREPANCY_ENTRIES DCF_COMMENT
PATIENT_POSITION_ID DISCREPANCY_ENTRIES PATIENT_POSITION_ID
SITE_ID DISCREPANCY_ENTRIES SITE_ID
INVESTIGATOR_ID DISCREPANCY_ENTRIES INVESTIGATOR_ID

View Definitions 4-5

FULL_STUDIES

FULL_STUDIES

A view of planned studies, clinical studies, and the live clinical study version
attributes.

Name of column in the FULL_

STUDIES view Name of underlying table Name of column in underlying table
STUDY OCL_STUDIES STUDY
CLINICAL_STUDY_ID CLINICAL_STUDIES CLINICAL_STUDY_ID
ORGANIZATION_CODE OCL_ORGANIZATION_UNITS CODE
Derived from the Organization Unit ID on OCL_STUDIES.
PROJECT_CODE OCL_STUDIES PROJECT_CODE
PROGRAM_CODE OCL_STUDIES PROGRAM_CODE
PRIMARY_COUNTRY_CODE REGIONS REGION_CODE
SHORT_TITLE CLINICAL_STUDIES SHORT_TITLE
AVAIL_FOR_REPLICATION_FLAG CLINICAL_STUDIES AVAIL_FOR_REPLICATION_FLAG
PHONE_RANDOMIZATION_FLAG CLINICAL_STUDIES PHONE_RANDOMIZATION_FLAG
OWNING_LOCATION CLINICAL_STUDIES OWNING_LOCATION
CLINICAL_PHASE OCL_STUDIES CLINICAL_PHASE
RAND_ACC_STAT_TYPE_CODE CLINICAL_STUDIES RAND_ACC_STAT_TYPE_CODE
STUDY_STATUS_TYPE_CODE CLINICAL_STUDIES STUDY_STATUS_TYPE_CODE
EXPTL_DESIGN_TYPE_CODE OCL_STUDIES EXPTL_DESIGN_TYPE_CODE
PAT_RPL_RULE_TYPE_CODE CLINICAL_STUDY_VERSIONS PAT_RPL_RULE_TYPE_CODE
TIME_UNIT_TYPE_CODE CLINICAL_STUDY_VERSIONS TIME_UNIT_TYPE_CODE
FDA_PACKAGE_FLAG CLINICAL_STUDIES FDA_PACKAGE_FLAG
PIVOTAL_STUDY_FLAG CLINICAL_STUDIES PIVOTAL_STUDY_FLAG
TYPE_I_ERROR CLINICAL_STUDY_VERSIONS TYPE_I_ERROR
POWER CLINICAL_STUDY_VERSIONS POWER
MAXIMUM_STUDY_DURATION CLINICAL_STUDY_VERSIONS MAXIMUM_STUDY_DURATION
MAXIMUM_TREATMENT_ CLINICAL_STUDY_VERSIONS MAXIMUM_TREATMENT_
DURATION DURATION
EXPECTED_ENROLLMENT_COST CLINICAL_STUDY_VERSIONS EXPECTED_ENROLLMENT_COST
EXPECTED_ENROLLMENT_RATE CLINICAL_STUDY_VERSIONS EXPECTED_ENROLLMENT_RATE
ACTUAL_PATIENTS_ENROLLED FULL_STUDIES ACTUAL_PATIENTS_ENROLLED
A count of patient positions for which the patient's enrollment date is not null.
ACTUAL_PATIENTS_WITH_DATA FULL_STUDIES ACTUAL_PATIENTS_WITH_DATA
A count of patient positions for which the patient's Has Data Flag = 'Y'.
INVESTIGATORS_PLANNED OCL_STUDIES INVESTIGATORS_PLANNED
NUMBER_OF_PAT_TO_ENROLL CLINICAL_STUDY_VERSIONS NUMBER_OF_PAT_TO_ENROLL
NUMBER_OF_PAT_TO_ANALYSE CLINICAL_STUDY_VERSIONS NUMBER_OF_PAT_TO_ANALYSE

4-6 Oracle Clinical Stable Interface

 FULL_STUDIES

(Cont.) Name of column in the

FULL_STUDIES view Name of underlying table Name of column in underlying table
TITLE CLINICAL_STUDIES TITLE
INTERIM_ANALYSIS_TRIGGER CLINICAL_STUDY_VERSIONS INTERIM_ANALYSIS_TRIGGER
DESIGN_DESCRIPTION CLINICAL_STUDY_VERSIONS DESIGN_DESCRIPTION
RANDOMIZATION_DESCRIPTION CLINICAL_STUDY_VERSIONS RANDOMIZATION_DESCRIPTION
CREATED_BY CLINICAL_STUDIES CREATED_BY
CREATION_TS CLINICAL_STUDIES CREATION_TS
MODIFIED_BY CLINICAL_STUDIES MODIFIED_BY
MODIFICATION_TS CLINICAL_STUDIES MODIFICATION_TS

View Definitions 4-7

PATIENTS

PATIENTS

A view of patient positions, strata, treatment pattern, current site, current investigator,
and DCI book information. This is a particularly large view and should only be used
when the additional information is required. For basic patient information, the patient
positions table should be used.

Name of Column in the Name of column in underlying

PATIENTS view Name of underlying table table
STUDY CLINICAL_STUDY_VERSIONS STUDY
PATIENT PATIENT_POSITIONS PATIENT
ORDER_BY_PATIENT PATIENT_POSITIONS ORDER_BY_PATIENT
A derived column that sorts for numeric patient codes.
CLINICAL_STUDY_ID PATIENT_POSITIONS CLINICAL_STUDY_ID
PATIENT_POSITION_ID PATIENT_POSITIONS PATIENT_POSITION_ID
CLINICAL_SUBJECT_ID PATIENT_POSITIONS CLINICAL_SUBJECT_ID
DCI_BOOK DCI_BOOKS DCI_BOOK
HAS_DATA_FLAG PATIENT_POSITIONS HAS_DATA_FLAG
OWNING_LOCATION PATIENT_POSITIONS OWNING_LOCATION
CURRENT_SITE PATIENT_POSITIONS CURRENT_SITE
Derived from the current assignment of the patient to a site.
CURRENT_INVESTIGATOR PATIENT_POSITIONS CURRENT_INVESTIGATOR
Derived from the current assignment of the patient to an investigator.
STRATUM PATIENT_POSITIONS STRATUM
Derived from the strata assigned to a patient.
TREATMENT_PATTERN_CODE PATIENT_POSITIONS TREATMENT_PATTERN_CODE
Derived from the treatment pattern assigned to a patient.
FREEZE_FLAG PATIENT_POSITIONS FREEZE_FLAG
REPLACEMENT_POSITION_ PATIENT_POSITIONS REPLACEMENT_POSITION_
FLAG FLAG
SCREENING_POSITION_FLAG PATIENT_POSITIONS SCREENING_POSITION_FLAG
EARLY_TERMINATION_FLAG PATIENT_POSITIONS EARLY_TERMINATION_FLAG
FIRST_SCREENING_DATE PATIENT_POSITIONS FIRST_SCREENING_DATE
PATIENT_ENROLLMENT_DATE PATIENT_POSITIONS PATIENT_ENROLLMENT_DATE
TERMINATION_DATE PATIENT_POSITIONS TERMINATION_DATE
REPORTED_FIRST_NAME PATIENT_POSITIONS REPORTED_FIRST_NAME
REPORTED_LAST_NAME PATIENT_POSITIONS REPORTED_LAST_NAME
REPORTED_SEX PATIENT_POSITIONS REPORTED_SEX
REPORTED_PATIENT_ PATIENT_POSITIONS REPORTED_PATIENT_
REFERENCE REFERENCE
REPORTED_INITIALS PATIENT_POSITIONS REPORTED_INITIALS

4-8 Oracle Clinical Stable Interface

 PATIENTS

(Cont.) Name of Column in the Name of column in underlying

PATIENTS view Name of underlying table table
REPORTED_BIRTH_DATE PATIENT_POSITIONS REPORTED_BIRTH_DATE
REPORTED_DEATH_DATE PATIENT_POSITIONS REPORTED_DEATH_DATE
RANDOMIZATION_COMMENT PATIENT_POSITIONS RANDOMIZATION_COMMENT
REPORTED_DATE_LAST_ PATIENT_POSITIONS REPORTED_DATE_LAST_
PREGNANCY PREGNANCY
INC_IN_EFF_ANALYSIS_FLAG PATIENT_POSITIONS INC_IN_EFF_ANALYSIS_FLAG
INC_IN_SAFETY_ANALYSIS_ PATIENT_POSITIONS INC_IN_SAFETY_ANALYSIS_
FLAG FLAG
EXCLUDE_FROM_EFFICACY_ PATIENT_POSITIONS EXCLUDE_FROM_EFFICACY_
REASON REASON
INCLUSION_EXCLUSION_DATE PATIENT_POSITIONS INCLUSION_EXCLUSION_DATE
EXCLUDE_FROM_SAFETY_ PATIENT_POSITIONS EXCLUDE_FROM_SAFETY_
REASON REASON
CREATION_TS PATIENT_POSITIONS CREATION_TS
CREATED_BY PATIENT_POSITIONS CREATED_BY
MODIFICATION_TS PATIENT_POSITIONS MODIFICATION_TS
MODIFIED_BY PATIENT_POSITIONS MODIFIED_BY

View Definitions 4-9

PROGRAM_SUBSTANCES

PROGRAM_SUBSTANCES

A view of programs and their primary active substance.

Name of column in the Name of column in underlying

PROGRAM_SUBSTANCES view Name of underlying table table
PROGRAM_CODE OCL_PROGRAMS PROGRAM_CODE
DESCRIPTION OCL_PROGRAMS DESCRIPTION
ACTIVE_FLAG OCL_PROGRAMS PROGRAM_CODE
PRIMARY_ACTIVE_ OCL_PROGRAM_PRODUCT_ PM_ID
SUBSTANCE_ID MASTERS
CREATED_BY OCL_PROGRAMS CREATED_BY
CREATION_TS OCL_PROGRAMS CREATION_TS
MODIFIED_BY OCL_PROGRAMS MODIFIED_BY
MODIFICATION_TS OCL_PROGRAMS MODIFICATION_TS

4-10 Oracle Clinical Stable Interface

 TREAT_ASSIGN_ALL_VIEW

TREAT_ASSIGN_ALL_VIEW

The main reason for this view is to manage the blinding of a study. While the study is
blinded, the view will provide a dummy treatment code. This code has no relation to
the real treatment to which the patient has been randomized. After the randomization
is released, the view will show the true treatment patterns. Because the underlying
table (TREATMENT_ASSIGNMENTS) is not part of the documented interface, the
columns in the view are defined here. The TREATMENT_ASSIGNMENTS table is at
the clinical study version level, but this view limits the data presented to the live
version of the study.

Primary key
TREAT_ASS_ID

Unique key
CLINICAL_STUDY_ID, TREATMENT

Foreign key name in the Foreign key name in the

Name of related table current table related table
CLINICAL_STUDIES CLINICAL_STUDY_ID CLINICAL_STUDY_ID
TREATMENT_PATTERNS TREAT_PATTERN_ID TREATMENT_PATTERN_ID
PATTERNS PATTERN_CODE CODE
RANDOMIZATIONS RANDOM_PERFORMED_BY RANDOM_PERFORMED_BY
RANDOMIZATIONS RANDOM_TIMESTAMP_ RANDOM_TIMESTAMP_
OCCURRED OCCURRED
RANDOMIZATION_BLOCKS RANDOM_BLOCK_ID RANDOMIZATION_BLOCK_
ID
OCL_SITES SITE_ID SITE_ID
STRATA STRATUM_ID STRATUM_ID
PATIENT_POSITIONS PATIENT_POSITION_ID PATIENT_POSITION_ID

Columns

Column name Null? Type

TREAT_ASS_ID A unique, system-generated ID for the treatment Not null NUMBER(10)
assignment.
CLINICAL_STUDY_ID The ID of the clinical study to which the treatment Not null NUMBER(10)
assignment belongs.
TREATMENT A code for the treatment assignment, unique within the Not null VARCHAR2(10)
clinical study.
LOCKED_FLAG A flag to show if the randomization where the treatment Not null VARCHAR2(1)
assignment belongs has been locked.
TREAT_PATTERN_ID The ID of the treatment pattern for the treatment Not null NUMBER(10)
assignment.
NAME The name of the treatment pattern for the treatment assignment. Not null VARCHAR2(60)

View Definitions 4-11

TREAT_ASSIGN_ALL_VIEW

Column name (Cont.) Null? Type

PATTERN_CODE The pattern code of the treatment pattern that the Not null VARCHAR2(15)
treatment assignment is for.
LATEST_FLAG A flag to show if this is the latest or current treatment Not null VARCHAR2(1)
assignment for the patient.
REPLACEMENT_FLAG A flag to show if this is intended as a replacement Not null VARCHAR2(1)
treatment assignment in the study. A replacement treatment assignment is
used only if a patient drops out of the study.
RANDOM_PERFORMED_BY The user name of the person who ran the Not null VARCHAR2(30)
randomization process that created this treatment assignment.
RANDOM_TIMESTAMP_OCCURRED The date and time that the Not null DATE
randomization process that created this treatment assignment was run.
CREATED_BY Not null VARCHAR2(30)
CREATION_TS Not null DATE
RANDOM_BLOCK_ID If this treatment assignment is part of a blocked Null NUMBER(10)
randomization, this column is the ID of the randomization block to which the
treatment assignment belongs.
SITE_ID The ID of the site to which the treatment assignment has been Null NUMBER(10)
assigned.
ASSIGNMENT_DATE The date and time that the treatment assignment Null DATE
was assigned to a patient.
TREAT_CHG_REASON_TYPE_CODE A code that indicates why the Null VARCHAR2(15)
treatment pattern of the treatment assignment was changed.
TREAT_CHG_REASON_DESCRIPTION A freeform text description Null VARCHAR2(200)
explaining why the treatment pattern of the treatment assignment was
changed.
STRATUM_ID The ID of the stratum to which the patient who has been Null NUMBER(10)
assigned this treatment assignment belongs.
PATIENT_POSITION_ID The ID of the patient position that has been Null NUMBER(10)
assigned this treatment assignment.
MODIFIED_BY Null VARCHAR2(30)
MODIFICATION_TS Null DATE

4-12 Oracle Clinical Stable Interface

 5
5 Entity Relationship Diagram

The diagram on the following two pages describes the relationships between tables in the Oracle Clinical
Stable Interface Technical Reference Manual. In using this map as a programming guide, be sure to use the
synonyms that point to the listed names, and not the underlying names themselves, to access data from
Oracle Clinical. Synonym names are listed in Chapter 1.
An asterisk (*) indicates that a table is related to CLINICAL_STUDIES through the Clinical Study ID.

Entity Relationship Diagram 5-1

 Oracle Clinical Release 4.6 Stable Interface

QUESTION_CATEGORY_RELATIONS CLINICAL_STUDIES

DCM_QUESTION_ DCM_SCHEDULES *
QUESTION_GROUPS PROCEDURES *
GROUPS *

QUESTIONS

PROCEDURE_
QUESTION_
QUESTION_GROUP_QUESTIONS GROUPS *
DCI_BOOK_
DCI_CONSTRAINTS *

DCIS *

DCM_ DCI_FORM_
QUES_ VERSIONS *
REPEAT_
DEFAULTS *
PROCEDURE_
DETAILS *

FORM_
LAYOUT_
TEMPLATES
DCM_QUESTIONS *

DCMS *
DISCRETE_VALUES

DISCRETE_VALUE_GROUPS

RANGES to RECEIVED_DCMS

DISCREPANCY_ENTRIES *
LABS

VALIDATION_REPORTED_VALUES * DISCREPANCY_ENTRY_REVIEW_HIST *
LAB_RANGE_SUBSETS

RESPONSES * to RECEIVED_DCMS

LAB_TEST_QUESTION_UNITS REFERENCE_CODELISTS

LAB_UNIT_CONVERSIONS REFERENCE_CODELIST_VALUES

LAB_UNITS ORACLE_ACCOUNTS

PREFERRED_LAB_UNITS

5-2 Oracle Clinical Stable Interface

 OCL_PROGRAMS OCL_PROJECTS
OCL_STUDIES
OCL_ORGANIZATION_UNITS

CLINICAL_STUDIES (continued)

CLINICAL_PLANNED_EVENTS * PLANNED_STUDY_ BATCH_DM_RUNS *

INTERVALS *

DCI_BOOK_RULES DCI_BOOK_RULE_
PATTERNS
TGT_INTERVALS

RECEIVED_PAGE_ TREATMENT_PATTERNS *
HISTORY *
DCI_BOOK_PAGES * DCI_BOOKS *

DCI_BOOK_
RECEIVED_PAGES * TREAT_ASSIGN_ALL_VIEW *
PHYSICAL_PAGES *

DCI_BOOK_RULE_
TGT_DCIS
OCL_SITES

DCI_MODULES * ACTUAL_ RECEIVED_DCIS *

EVENTS *

RECEIVED_DCMS *

DCI_MODULE_PAGES *

PP_EXPECTED_
DCIS

OCL_
INVESTIGATORS
PP_EXPECTED_ PP_EXPECTED_
CPES INTERVALS
REGIONS

OCL_STUDY_
SITE_ROLES *

to TREAT_ASSIGN_ALL_VIEW

tto CLINICAL_STUDIES
PATIENT_POSITIONS *

CLINICAL_SUBJECTS STUDY_SITE_ OCL_STUDY__SITES *

PATIENT_POSITIONS *

PATIENT_STATUSES *
MV_EXECUTION_LOG *

Entity Relationship Diagram 5-3

5-4 Oracle Clinical Stable Interface
 A
A Journal and History Tables

Journal and history tables store audit records that enable you to track changes to
Oracle Clinical data over time. Each type of auditing table is used in a particular
situation:
Journal tables are used to track changes when the base table will have a relatively low
volume of changes. For example, all NLS tables that store translations have journal
tables, because translations are not frequently changed. The journal table keeps current
and previous values of all columns in the base table. The journal table gets populated
with a record when the operations INSERT, UPDATE or DELETE are carried out on
the base table. Tables can also be self-journaling. See "Self-journaling tables".
High volume tables will either be self-auditing or will use history tables. Each history
and self-auditing table has rules particular to that table, while journal tables all follow
the same rules. History tables do not capture all changes to a table, only those changes
that are considered critical. Self-auditing tables also only capture changes to
user-entered fields. Internal status tracking fields are not audited.
In general, tables are not journaled if they store any of the following:
■ Temporary, test, or derived data.
■ Data used to drive a data change if this data has not yet been used to do a data
change.
■ Encrypted password data.
■ Data that cannot be manipulated from the Oracle Clinical front end.
■ Data that is used for system configuration but does not affect clinical data. For
example, tables that specify directory mapping to allow users to view their job
output.
■ Data for tracking internal status.
This appendix lists each table that has changes audited by a journal or history table.

Note: There are no newly journaled tables in Oracle Clinical 4.6.

Self-journaling tables
Self-journaling tables store their own audit histories by storing the end timestamp of
records. Data with an end timestamp of 3,000,000 Julian (15-AUG-3501) is considered
current; other records with an END_TS value are audit records.

Journal and History Tables A-1

Journal Table Columns

Any base table with an END_TS column is self-journaling. The stable interface
synonym tables that are self journaling are ACTUAL_EVENTS(T), RECEIVED_
DCIS(T), RECEIVED_DCMS(T), and RESPONSES(T).

Journal Table Columns

All journal table names end with the suffix $JN. Journal tables include all of the
columns in their base table, as well as the following columns specific to journaling:

Column Name Null? Datatype

JN_OPERATION The type of operation carried Not Null VARCHAR2(3)
out on the base table. Possible values are: 'INS' for
insert, 'UPD' for update and 'DEL' for delete.
JN_TIMESTAMP The date and time of this Not Null DATE
audit record. Populated with SYSDATE value.
JN_SN The journal sequence number, which is Not Null NUMBER(10)
unique for every operation.
JN_ORACLE_USER User who last modified the Not Null VARCHAR2(30)
base table.
SYMMETRIC_REPLICATION_IND This Null VARCHAR2(1)
column indicates whether the base table that this
this journaling table audits is involved in
symmetric replication.

Tables Newly Audited in Oracle Clinical 4.5

This section lists each Oracle Clinical base table that is audited for the first time in this
release, and the name of the journal or history table that records its audit records. For
journal tables, the journal table's name is usually the base table name concatenated
with $JN; however, for some long base table names, the journal table uses a shortened
version of the base table name (with the $JN suffix) to fit the table name length
requirements of the Oracle database.

Note: There are no newly journaled tables in Oracle Clinical 4.6.

Table A–1 lists the new journal and history tables for this release, and the base tables
they audit. The five new history tables (whose names end in _HIST or _HISTORY
instead of $JN) are described in more detail in "History Tables" on page A-4 or with the
base tables in Chapter 2, "Table Definitions".

Table A–1 New Journal and History Tables For Oracle Clinical 4.5
Newly audited in Oracle
Base table Journal table Clinical 4.5?
CLINICAL_PLANNED_EVENTS CLINICAL_PLANNED_EVENTS$JN Yes
CLINICAL_STUDIES CLINICAL_STUDY_HISTORY No
CLINICAL_SUBJECTS CLINICAL_SUBJECTS$JN Yes
DATA_CLARIFICATION_FORMS DATA_CLARIFICATION_FORMS$JN No
DCF_PAGES DCF_PAGES$JN No
DCIS DCIS$JN No

A-2 Oracle Clinical Stable Interface

 Tables Newly Audited in Oracle Clinical 4.5

Table A–1 (Cont.) New Journal and History Tables For Oracle Clinical 4.5
Newly audited in Oracle
Base table Journal table Clinical 4.5?
DCI_BOOK_DCI_CONSTRAINTS DCI_BOOK_DCI_CONSTRAINTS$JN Yes
DCI_BOOKS DCI_BOOKS$JN No
DCI_BOOK_PAGES DCI_BOOK_PAGES$JN No
DCI_BOOK_PHYSICAL_PAGES DCI_BOOK_PHYSICAL_PAGES$JN No
DCI_FORM_VERSIONS DCI_FORM_VERSIONS$JN Yes
DCI_MODULES DCI_MODULES$JN No
DCI_MODULE_PAGES DCI_MODULE_PAGES$JN No
DCMS DCMS$JN No
DCMS DCMS_FFL_XML_HIST Yes, by this history table
DCM_QUESTIONS DCM_QUESTIONS$JN No
DCM_QUESTION_GROUPS DCM_QUESTION_GROUPS$JN No
DCM_QUES_REPEAT_DEFAULTS DCM_QUES_REPEAT_DEFAULTS$JN No
DCM_SCHEDULES DCM_SCHEDULES$JN No
DISCREPANCY_ENTRIES(T) DISCREPANCY_ENTRY_REVIEW_ No
HIST(T)
DISCRETE_VALUES DISCRETE_VALUES$JN No
DISCRETE_VALUE_GROUPS DISCRETE_VALUE_GROUPS$JN No
FORM_LAYOUT_TEMPLATES FORM_LAYOUT_TEMPLATES$JN Yes
FORM_LAYOUT_TEMPLATES FORM_LAYOUT_TEMPLATES_XML_ Yes
HIST
LAB_RANGE_SUBSETS LAB_RANGE_SUBSETS$JN Yes
LAB_TEST_QUESTION_UNITS LAB_TEST_QUESTION_UNITS$JN Yes
LAB_UNIT_CONVERSIONS LAB_UNIT_CONVERSIONS$JN Yes
LAB_UNITS LAB_UNITS$JN Yes
LABS LABS$JN Yes
OCL_INVESTIGATORS(T) OCL_INVESTIGATORS$JN Yes
OCL_ORGANIZATION_UNITS OCL_ORGANIZATION_UNITS$JN Yes
OCL_PROGRAMS OCL_PROGRAMS$JN Yes
OCL_PROJECTS OCL_PROJECTS$JN Yes
OCL_SITES OCL_SITES$JN Yes
OCL_STUDIES OCL_STUDIES$JN Yes
OCL_STUDY_SITE_ROLES(T) OCL_STUDY_SITE_ROLES$JN Yes
OCL_STUDY_SITES OCL_STUDY_SITES$JN Yes
ORACLE_ACCOUNTS ORACLE_ACCOUNTS$JN No
PATIENT_POSITIONS PATIENT_POSITIONS_HISTORY Yes
PLANNED_STUDY_INTERVALS PLANNED_STUDY_INTERVALS$JN Yes
PREFERRED_LAB_UNITS PREFERRED_LAB_UNITS$JN Yes

Journal and History Tables A-3

History Tables

Table A–1 (Cont.) New Journal and History Tables For Oracle Clinical 4.5
Newly audited in Oracle
Base table Journal table Clinical 4.5?
PROCEDURES PROCEDURES$JN No
PROCEDURE_DETAILS PROCEDURE_DETAILS$JN No
PROCEDURE_QUESTION_ PROCEDURE_QUESTION_GROUPS$JN No
GROUPS
QUESTIONS QUESTIONS$JN No
QUESTION_CATEGORY_ QUESTION_CATEGORY_RELATIONS$JN No
RELATIONS
QUESTION_GROUPS QUESTION_GROUPS$JN No
QUESTION_GROUP_QUESTIONS QUESTION_GROUP_QUESTIONS$JN No
RANGES RANGES$JN Yes
RECEIVED_PAGES(T) RECEIVED_PAGE_HISTORY(T) No
REFERENCE_CODELISTS REFERENCE_CODELISTS$JN No
REFERENCE_CODELIST_VALUES REFERENCE_CODELIST_VALUES$JN No
REGIONS REGIONS$JN Yes
STUDY_SITE_PATIENT_ STUDY_SITE_PATIENT_POSITION$JN Yes
POSITIONS
TREATMENT_PATTERNS TREATMENT_PATTERNS$JN Yes
VALIDATION_REPORTED_ VALIDATION_REPORTED_VALUES$JN Yes
VALUES

History Tables
This section describes the history tables that audit changes in Oracle Clinical base
tables that are not documented in Chapter 2, "Table Definitions".

CLINICAL_STUDY_HISTORY
This table provides a record of certain major system-defined events in the course of a
study as well as arbitrary user-recorded event about a clinical study.
Unless a description is provided next to the column name, the column stores the same
information as its counterpart in the base table, CLINICAL_STUDIES.

Column Name Null? Datatype

CLIN_STUDY_ID ID of the clinical study to which this Not Null NUMBER(10)
history record applies.
CLIN_STUDY_HISTORY_ID Unique ID of this history Not Null NUMBER(10)
record.
DATE_OCCURRED Date when this change to the study Not Null DATE
occurred.
CLIN_STUDY_HISTORY_TYPE_CODE This column Not Null VARCHAR2(7)
stores a value from the CLIN STUDY HISTORY TYPE
CODE reference codelist. The special code USERDEF
identifies the user-created history records, while the other
codes are for history records that are automatically created
when the matching event occurs for the study.

A-4 Oracle Clinical Stable Interface

 History Tables

Column Name (Cont.) Null? Datatype

TEXT Description of the event. Not Null VARCHAR2(200)
CREATED_BY User who generated this history record; Not Null VARCHAR2(30)
that is, the user who modified the clinical study record
identified by the clin_study_id.
CREATION_TS Date and time when this history record Not Null DATE
was generated; that is, the user who modified the clinical
study record identified by the clin_study_id.
END_DATE Date and time when this version of the Null DATE
clinical study record was changed.
PLANNED_STUDY_INTERVAL_ID ID of the study Null NUMBER(10)
interval in the study schedule that is associated with the
occurrence of the history record – specifically for the
SECURIN type of CLIN_STUDY_HISTORY_TYPE_CODE.
RAND_ACC_STAT_TY_CODE_OLD The RAND_ Null VARCHAR2(7)
ACC_STAT_TYPE_CODE value before the change to this
record. This code indicates who can access the study's
randomization.
RAND_ACC_STAT_TY_CODE_NEW The RAND_ Null VARCHAR2(7)
ACC_STAT_TYPE_CODE value after the change to this
record. This code indicates who can access the study's
randomization.
STUDY_STAT_TY_CODE_OLD The STUDY_STATUS_ Null VARCHAR2(7)
TYPE_CODE value before the change to this record. This
code indicates the status of the study in terms of planning,
operation, or analysis.
STUDY_STAT_TY_CODE_NEW The STUDY_STATUS_ Null VARCHAR2(7)
TYPE_CODE value before the change to this record. This
code indicates the status of the study in terms of planning,
operation, or analysis.
MODIFIED_BY User who modified this clinical study Null VARCHAR2(30)
record.
MODIFICATION_DATE Date and time when this Null DATE
clinical study record was modified.

DCMS_FFL_XML_HIST
This history table is populated with the current graphical layout whenever it is made
available (its Available? column is set to Y).

Column Name Null? Datatype

DCM_ID DCM-wide: A unique, system-generated ID for Not Null NUMBER(10)
the DCM.
DCM_SUBSET_SN Subset-wide: A sequence number for a Not null NUMBER(3)
DCM subset. A DCM subset can be used to collect only some
of the questions assigned to the base DCM. The base or
initial DCM has a sequence number of 1.
DCM_LAYOUT_SN Layout-specific: The DCM layout Not null NUMBER(3)
number. Layouts provide a way to present the same DCM
subset in different formats for data entry — for instance, a
DCM subset can have an English and a Japanese layout.
Within a subset, the layouts are numbered starting with 1.

Journal and History Tables A-5

History Tables

Column Name (Cont.) Null? Datatype

CLINICAL_STUDY_ID DCM-wide: The ID of the clinical Not null NUMBER(10)
study to which the DCM belongs.
FLT_XML A character large object that stores this DCM Not null CLOB
graphic layout.
FLT_XML_MODIFICATION_TS Date and time when this Not null DATE
DCM Form layout was last modified. Modifications include
edits, updates, and generations.
FLT_XML_MODIFIED_BY User who last modified the Not null VARCHAR2(30)
DCM Form Layout.

FORM_LAYOUT_TEMPLATES_XML_HIST
This history table is populated with current graphical layout and related information
when status is set to A.

Column Name Null? Datatype

FLT_ID Unique ID of this form layout template. Not Null NUMBER(10)
FLT_XML A character large object that stores Not Null CLOB
the XML for this form layout template.
FL_XML_MODIFICATION_TS Date and time Not Null DATE
when the XML for this FLT was last modified.
FL_XML_MODIFIED_BY User who last Not Null VARCHAR2(30)
modified the XML for this FLT.

PATIENT_POSITIONS_HISTORY
This history table records changes to the records in the PATIENT_POSITIONS(T) table.
In release 4.5, it tracks changes to four columns that were not previously audited: DCI_
BOOK_ID, FREEZE_FLAG, REPLACEMENT_POSITION_FLAG, and SCREENING_
POSITION_FLAG.
Unless a description is provided next to the column name, the column stores the same
information as its counterpart in the base table, PATIENT_POSITIONS(T).

Column Name Null? Datatype

CLINICAL_STUDY_ID Not null NUMBER(10)
PATIENT_POSITION_ID Not null NUMBER(10)
PATIENT Not null VARCHAR2(10)
CLINICAL_STUDY_VERSION_ID Not null NUMBER(10)
DCI_BOOK_ID Null NUMBER
FREEZE_FLAG Null VARCHAR2(1)
INC_IN_EFF_ANALYSIS_FLAG Null VARCHAR2(1)
INC_IN_SAFETY_ANALYSIS_FLAG Null VARCHAR2(1)
REPLACEMENT_POSITION_FLAG Null VARCHAR2(1)
SCREENING_POSITION_FLAG Null VARCHAR2(1)
EARLY_TERMINATION_FLAG Null VARCHAR2(1)

A-6 Oracle Clinical Stable Interface

 History Tables

Column Name (Cont.) Null? Datatype

PATIENT_ENROLLMENT_DATE Null DATE
CLINICAL_SUBJECT_ID Null NUMBER(10)
INCLUSION_EXCLUSION_DATE Null DATE
EXCLUDE_FROM_EFFICACY_REASON Null VARCHAR2(200)
REPORTED_FIRST_NAME Null VARCHAR2(15)
REPORTED_LAST_NAME Null VARCHAR2(20)
REPORTED_SEX Null VARCHAR2(1)
REPORTED_PATIENT_REFERENCE Null VARCHAR2(25)
REPORTED_INITIALS Null VARCHAR2(4)
REPORTED_BIRTH_DATE Null DATE
REPORTED_DEATH_DATE Null DATE
RANDOMIZATION_COMMENT Null VARCHAR2(200)
REPORTED_DATE_LAST_PREGNANCY Null DATE
FIRST_SCREENING_DATE Null DATE
TERMINATION_DATE Null DATE
MODIFICATION_TS Null DATE
AUDIT_COMMENT Identifies the audit row as Null VARCHAR2(10)
an update ('UPG') or a deletion ('DEL').

RECEIVED_PAGES_HISTORY
This history table records changes to the records in the RECEIVED_PAGES(T) table.
Unless a description is provided next to the column name, the column stores the same
information as its counterpart in the base table, RECEIVED_PAGES(T).

Column Name Null? Datatype

RECEIVED_PAGE_ID Not null NUMBER(10)
RECEIVED_DCI_ID Not null NUMBER(10)
CLINICAL_STUDY_ID Not null NUMBER(10)
PAGE_STATUS Not null VARCHAR2(15)
HAS_DATA_FLAG Not null VARCHAR2(1)
RELATIVE_TO_DCI_PAGE Not null NUMBER(4)
BOOK_PAGE Not null VARCHAR2(15)
COMMENT_TEXT Null VARCHAR2(200)
CREATED_BY Not null VARCHAR2(30)
CREATION_TS Not null DATE

Journal and History Tables A-7

History Tables

A-8 Oracle Clinical Stable Interface