1
Clinical Data
Management
Priyanka Vijayvargiya
PGDCTM, Cliniminds
Bhopal
2
Data & Database
• A collection of factual information derived from
measurement or research
• Collection of data is known as Database.
3
Clinical data Management
• Clinical data management involves the
collection, data entry, validation, clinical coding
and transfer of clinical trial data.
• To provide clean data in useable format in timely
manner.
• To provide a database fit for managing clinical
data.
4
Need for CDM
Ensures integrity & quality of data being
transferred from trial subjects to a database
system.
To provide consistent, accurate & valid clinical
data.
To support accuracy of final conclusions &
report.
5
Data Management Process
• Protocol development
• Data management plan
• CRF designing
• Database designing
• Data entry
• Data review & validation
• Discrepancy management
• Data base closure
• QA/ QC
• Data storage & archival
6
Clinical Data Management Process
Protocol Data Management Plan CRF Design
Database
Data review & validation Data Entry designing
Discrepancy Management Database Closure OA/QC
Data Storage & archival
7
Data Management Plan
It helps to assess & plan for
the study specific data
management process.
It forms the backbone of
overall quality system of data
management.
8
CRF designing
• Before finalization, a pilot is carried out with
dummy CRFs to identify potential problems.
• Filled in by the investigator & forwarded to data
management unit for entry & review.
9
Database designing
• It involves:
▫ Data flow into system either manually or electronically.
▫ Creating global database
▫ Validation/ derivation procedures
▫ Data extraction programs & reporting
• Also:
▫ Integration of dictionaries
▫ AE reporting systems
To capture & store clinical data
accurately.
10
Data entry
• Transferring data from paper CRF to database.
• Also known as transcribing the data.
• 2 types of data entry:
▫ Double entry- entry of same CRF page by 2
independent personnel
▫ Single entry- entry by single data entry personnel.
It is extensively used in EDC/ RDC systems.
11
Cont.
• Other type of data entry
involves:
▫ Local data entry- done at
site & transmitted
periodically to the central
database.
▫ Online data entry- data
entry directly into central
database via internet
12
Data review & validation
• Reviewed by data editor to address & resolve the
discrepancy.
• Validation refers to data cleaning.
13
Types of checks:
• Point-by-point checks
• Missing data/ blank field checks
• Data consistency checks
• Laboratory data & range checks
• Hematology record
• AE record
• Discrete value group discrepancy checks
• Header inconsistency checks
• Missing pages check or CRF tracking
• Protocol violation checks
• Dates out of sequence checks
• Continuity of data checks
• Coding checks
• External data checks
• Duplicate data checks
• Textual data checks
• SAE reconciliation checks
14
Discrepancy management
• Following actions can be taken based on project
specific guidelines:
▫ Closing discrepancy per internal correction
▫ Generating a query to the investigator
Creating queries
Sending queries
Tracking queries
Resolving queries
Re-querying
15
Database Closure
• To prevent unauthorized or inadvertent changes
to the database.
• Also known as soft-locking.
• Done after last patient last visit (LPLV).
• Change control procedures in case of database
unlocking.
• Finally, the database is closed.
16
QA/QC
• To ensure compliance with protocol, GCP, SOPs
& applicable regulatory requirements.
• Two types:
▫ Interim analysis- while the study is ongoing.
▫ Final analysis- done after completion of LPLV.
17
Data Storage & Archival
• Open formats such as CDISC or PDF are
recommended.
18
Software used in CDM
• OpenClinica
• Aris Global software solutions for life sciences
• SyMetric Sciences
• Oracle
• DMSys
• Progeny Clinical
19
2 elements of data management
• A validated computer system
• Highly professional specialist staff
20
CROs involved in Data Management
21
22
