Standard Operating Procedures for Clinical Research at Kent State University
DOCUMENT CONTROL MANAGEMENT
SOP#: 105 Effective Date: Version: 1.0
PURPOSE: The purpose of this Standard Operating Procedure (SOP) is to ensure that controlled
documents related to clinical research are appropriately managed at KSU. The purpose of
"control" is to assure that documents used in more than one location are a) properly situated
where needed, and b) can be withdrawn and re-issued when changed, assuring that only current,
non-obsolete versions of the documents are in place.
SCOPE: This SOP encompasses all documents used to control the management and processes
associated with clinical research studies at KSU.
RESPONSIBILITY: The Principal Investigator is responsible for determining which documents
need to be controlled. The Research or Regulatory Coordinator is responsible for implementing
and maintaining document control system that includes the following:
Coordinates reviews and revisions of quality system documents
Maintains Master File to ensure active and revised documents are provided
to staff that must contain Document Number, Title, Revision Level and
Review date
Archives superseded or obsolete documents
Reviews SOP prior to use
Ensures that all routine operations and activities are documented by SOPs
Creates or delegates creation of documents
Other Designated Research Personnel are responsible for the following:
Verifying that the official version of the document is used
Review and determine need for new procedures or its revision and to convey
that need to their immediate supervisor
DEFINITIONS:
Controlled Document: A document is considered "controlled" when its distribution is identified
by means of a written list or log that gives the document a title and the identity of the location
where it is situated (which may be a list of names or physical locations).
PROCEDURE:
1. Research staff will be knowledgeable of various types of controlled documents used for
clinical research. Examples of controlled documents include the following:
Clinical protocol (including monitoring plan)
Protocol amendments
Case report forms (CRFs)
Informed consent form (ICF)
Investigator Brochure
Standard Operating Procedures for Clinical Research at Kent State University
DOCUMENT CONTROL MANAGEMENT
SOP#: 105 Effective Date: Version: 1.0
PROCEDURE (cont.):
Equivalent medical device study documents (Investigational Plan, Report of
Prior Investigations)
Adverse event (AE) reporting form
Certain other FDA documents: All other documents that are developed for
clinical study purposes are considered non-controlled.
2. Version Control and Naming Convention:
2.1. All controlled documents need to be dated and/or versioned in sequential order and
systematically named, especially if they belong to a series or set of documents e.g.
protocol, informed consent form.
2.2. The first draft of the protocol should be labelled with a version number and dated, for
example ‘Draft version 0.1 and dated. Further draft versions should be labelled ‘Draft
version 0.2, 0.3’ etc. and dated.
2.3. The final original version of the protocol may be labelled ‘Final Version 1.0’ and
dated before being submitted for the appropriate approvals.
2.4. If amendments are necessary following review of the protocol then subsequent
versions of the protocol may be labelled ‘Draft Version 1.1, 1.2’ while still being
drafted and reviewed and the version re-submitted for approval should be labelled
‘Final Version 2.0’ and dated.
2.5. If the protocol is then amended again during the study then the version submitted for
approval of the amendment will be labelled ‘Final Version 3.0’ and so on.
2.6. Other considerations that should be on the document when appropriate:
Effective date and expiry date or next review dates if applicable. It may be
necessary to also include date issued and date printed.
Page numbers – It is recommended that pages are numbered as “Page X of
Y”
Confidential – If the document is confidential, mark “Confidential”
Document identification- e.g. a title, department name
Approvals - It may be necessary to include signature and date of Author,
Reviewer and Authorizer with titles of signatories e.g. for SOPs, protocols.
Copyright as appropriate – Insert copyright information if necessary.
Reason for Change – If it is a revision of the control document, state reason
for change and list changes.
Standard Operating Procedures for Clinical Research at Kent State University
DOCUMENT CONTROL MANAGEMENT
SOP#: 105 Effective Date: Version: 1.0
PROCEDURE (cont.):
Referencing - When reference is made to another controlled document, you
may use the instruction “see/refer to Document Title”. The version number
may be excluded.
3. Document Initiation and Approval Procedures:
3.1. The PI or designated research personnel will use the procedures below for the
drafting, review, approval and revision of controlled documents.
3.2. Determine which documents are needed for developing regulatory submissions,
collecting data or other study information, and/or performing any other study-
related function.
3.3. Determine who will draft the first version of a given document (the author) and
any related appendices (list of attachments) to be included with the document.
3.4. Determine who must review and approve the first and succeeding draft
3.5. Use templates or other available guidelines for developing new documents where
available, and initiate the document drafting process.
3.6. Complete the document control noting version date in the document number
section and in the footer of the document.
3.7. Circulate the draft if it needs continued review securing signature/review date,
comments and suggestions from all specified reviewers.
3.8. Revise the document per initial review process, and if any revisions are not
incorporated, he/she will notify the affected reviewer(s) of the reason(s) for not
including the revision(s), and negotiate a resolution, documenting any significant
differences in the space provided on the Document Control Form.
3.9. Continue to circulate the revised document to all signatories until the review
process is complete. The document will have a version date for each review and
then a final version date.
3.10. Ensure all required reviewer approvals are indicated by entries in the Signature
and Approval Date boxes on the controlled document.
3.11. Upon final signature of the last reviewer, the authorized person should sign and
date the controlled document in the space provided to indicate responsibility for
that document.
4. Following final approval, the research designee will assign all newly approved documents a
version number and effective date.
5. The original approved document and Document Control Form(s) will be retained in the
appropriate archive file or section of the Regulatory Master File.
6. For new, non-controlled documents, there are no specific required procedures to follow for
development, but department administration must approve the development of new
documents and their final version.
Standard Operating Procedures for Clinical Research at Kent State University
DOCUMENT CONTROL MANAGEMENT
SOP#: 105 Effective Date: Version: 1.0
PROCEDURE (cont.):
7. Document Review/ Change Procedures:
7.1. Each respective department will review controlled documents periodically or as
needed by circumstances (e.g., new federal or state regulation, new University or
institutional policy or procedure, or need for update of Investigational Brochure,
etc).
7.2. If revisions are needed in a controlled document, the research designee will do
the following:
Have the author of the change(s) circulate the revised draft with a copy of the
original, clearly noting the changes, using the Document Control Form as its
cover
Continue to give updated and revised controlled documents a new version
number (01, 02, etc.) and a current effective date
Document periodic review and updating by maintaining an accurate Table of
Modifications Form for each controlled document
Watermark prior version of the controlled document "Obsolete" and save
copy for the appropriate archive file or section of the Regulatory Master File
Update any related tables or indices, as appropriate (refer to the current OHR
policy for details).
8. Revision of Non-Controlled Documents:
8.1. When revisions are needed in a non-controlled document, the author of the non-
controlled document or a designee will do the following:
Make the change(s) and circulate the revised draft with a copy of the original,
clearly noting the changes and why they are needed.
Continue to give updated and revised non-controlled documents a new
version number (01, 02, etc.) and current effective date. .
Mark prior version of the document "Obsolete" and save copy for the
appropriate archive file (see specific SOP for location).
Update any related tables or appendices, as appropriate
9. Document Implementation Procedures:
9.1. The Investigator will ensure that all appropriate staff is trained in the proper use
of the new or revised document.
9.2. The Investigator will make a list of all affected parties and appropriate regulatory
authorities (IRB, FDA) who must be notified of changes to applicable documents
and notify them in writing when the changes are implemented (or prior to
implementing, if appropriate).
9.3. The research designee will provide the updated version of appropriate
documents to affected parties.
Standard Operating Procedures for Clinical Research at Kent State University
DOCUMENT CONTROL MANAGEMENT
SOP#: 105 Effective Date: Version: 1.0
PROCEDURE (cont.):
10. Storage and Archiving:
10.1. Controlled documents should be stored in an area or room restricted to
authorized individuals only. If the controlled documents are part of essential
documents, they should be part of the Research Master/Regulatory File (see
SOP 201: Regulatory Documentation) and archived appropriately (see SOP: 504
Archiving Study Records).
10.2. Old versions of controlled documents must be archived in a separate file.
Obsolete documents that are retained for reference or legal obligations are
water marked “OBSOLETE” and kept separate from active documents.
Obsolete electronic documents are removed from the network and stored in
media that are only accessible to authorized personnel. Any obsolete
documents that need to be reactivated must be reviewed, approved and
released in the same manner as newly established documents.
At least one copy of all obsolete documents must be archived.
10.3. The PI will maintain a master list of all SOPs. This file or database will indicate
the SOP number, version number, effective date, title, author, status, and any
historical information regarding past versions.
10.4. Documents will be archived in electronic storage to:
Prevent their continued use
Facilitate easier access for retrieval purposes
Limit documents to a read-only format to protect them against unauthorized
changes made to the document as well as to be available for historical data
review
Standard Operating Procedures for Clinical Research at Kent State University
DOCUMENT CONTROL MANAGEMENT
SOP#: 105 Effective Date: Version: 1.0
REFERENCES: 21 CFR 812.100 General Responsibilities of Investigators
ICH E6, 2.13 The Principles of ICH GCP
ICH E6, 5.1 Quality Assurance and Quality Control
ICH E6, 5.5 Trial Management, Data Handling and Record Keeping
RELATED
POLICIES:
APPENDICES:
REVISION HISTORY: Keep a running history of all revision dates.
Approval Date Effective Date Review/Revision Date
01/29/2017
