DATA MANAGEMENT
PLAN
DR. ANKITA SUMAN
DATA MANAGEMENT PLAN
• The data management plan describes the activities to be
conducted in the course of processing data. Key topics to cover
include the SOPs to be followed, clinical data management
system to be used, description of data sources, data handling
processes, data transfer formats and process, and quality control
procedures to be applied.
What is a DMP (Data Management
GUIDANCE
Plan)?DOCUMENT TO FOLLOW AND
COMPLY WITH THE GCDMP
The data manager should ensure all of the tasks and sections of
Clinical Data Management are completed according to GCDMP
(good clinical data management practices).
It helps in adhering to good clinical data management practices for
all phases of study.
A well-designed DMP provides a road map of how to handle
data under any foreseeable circumstances and establishes
processes for how to deal with unforeseen issues.
The DMPPrimary Requisites
is an auditable document/ often
Minimum
asked forStandards
by regulatory
inspectors and should be written in a manner that is professional and
of high quality.
During an audit, the inspectors may also seek to ascertain the degree
to which the project team adheres to the processes described in the
DMP.
DMP draft should be completed prior to enrollment of the first
subject.
Ensure the DMP supports compliance with applicable regulations and
oversight agencies.
Identify and define the personnel and roles involved with decision
making, data collection, data handling and data quality control.
Best
∙DevelopPractices
the DMP in collaboration with all stakeholders to ensure that all
responsible parties understand and will follow the processes and guidelines
put forth in the DMP from study initiation to database closeout.
∙Develop and maintain a DMP template for the organization that ensures
consistency and standardization across all projects.
∙Ensure the DMP for each study is kept current, including proper
versioning, and that all responsible parties are aware of and agree to the
current content.
∙Ensure that an approved, signed version of the DMP is completed prior to
starting on the work it describes. The job functions or titles that must
approve and sign the DMP may vary between organizations and
depending on the type of study.
PURPOSE OF THE DMP
∙ Documentation of processes and procedures employed by organizations.
• Helps to promote consistent, efficient and effective data management
practices for each individual study by communicating to all stakeholders
the necessary knowledge to create and maintain a high-quality database
ready for analysis.
∙ Compliance with all applicable regulatory guidelines.
Applicable regulatory guidelines viz (e.g., FDA, ICH, GCP) or local
laws of the country; as well as the standard operating procedures
(SOPs) of the organization.
∙ To address any procedural or protocol updates that are made during
conduct of the study.
CREATION AND MAINTENANCE
Creation of DMP
• The DMP should be created during the setup phase of each study by a
CDM personnel and should contain information relating to all aspects
of data management activities to be performed [viz. protocol, work
scope, contract, analysis plans, dataflows, case report forms (CRFs),
other supporting documents, and data management standards and
practices].
• Before data collection begins, all clinical studies should have a DMP in
place to document the relevant conventions for that particular study.
• Many people will be involved in handling data throughout the course of
a clinical study, so it is imperative that all parties refer to the DMP for a
consistent approach to the processes and guidelines for conducting data
management activities.
Maintenance of DMP:
• The DMP should be considered a living document throughout the life
cycle of a study, capturing any changes impacting data management
made to the protocol or processes being used.
• The DMP must be uniquely identifiable, carry such identification on
each page (e.g., study code/title) and be subject to version control. Each
version should be documented and include date, author, reason for
version change and an individual version identifier.
DMP COVERS
[Link] Study Project Overview:
It includes study protocol, describing the duration and visit
schedule, type of blind of the study, whether placebo controlled,
name of the drug evaluated (for safety and potency), the disease or
disorder for which the drug is being evaluated and the critical data
analysis variables.
3. Project Communication Flow:
3.1 Project Team Contact List ()
Sponsor Address Tel/Fax/e-mail
CRO Address Tel/Fax/e-mail
3.2 Kick- off Meeting
CRO will conduct Data Management discussion meeting on a
mutually accepted date. The meeting agenda will be
distributed in <insert number> working days to all the
participants before the meeting.
3.3 Post Meeting Activities
The meeting minutes will be distributed to all the participants in
2 working days after the meeting.
4. Project Time-lines:
(A study specific document would be prepared for this study:
Please refer Project Milestone Template)
5 Project Specific Training:
For team members assigned after the start of a project, the Project
Manager (PM) or designee ensures that the initial project specific
training is provided, which includes but is not limited to CRF and
protocol review, DMP and project specific guidelines, timelines
and the database used. In addition to the initial training, the PM
or designee identifies or addresses ongoing project.
6. CRF Design and Development:
The PM or the CRF team lead shall obtain any client specific
requirements for the development of CRF and communicate
those requirements to the CRF design team lead. CRF design and
development would be done as per the SOP.
7. Data Processing:
7.1 CRF Flow
7.2 Data Entry
7.3 Validation of Data
7.4 Study Specific Edit Checks
A study specific Edit Check Document would be prepared for
this study.
7.5 Manual Check
Manual Check points would be mentioned in Edit Check
Document.
8 Query Generation and Resolution Process:
8.1 Data Validation Process
8.2 Self Evident Correction Guidelines
The Data Coordinator will use the “Self Evident Correction
Guidelines” as the reason for data changes made and for any
flag/comments raised by Data Entry Operator.
8.3 Data Queries- Discrepancy Tracking.
8.4 Discrepancy Resolutions
The Data Coordinator reviews and updates discrepancy statuses as
necessary.
9 Laboratory Contact Person in this Study.
10 Serious Adverse Event Reconciliation.
11 Medical Dictionary Coding.
12 Data Coding Guidelines.
Data Coding is performed according to standard coding guidelines,
unless otherwise specified by the Sponsor.
13. Data Transfers.
A detailed project specific Data Transfer Guidelines would be
prepared for this study.
13.1 Periodic Data Transfer during Study
✔ Transfer Interval(s) : <Fill in the interim transfer
interval(s)>.
✔ Format: SAS <choose one, if format is SAS, indicate the
version number.>
✔ Status of Data at Interim Transfer: <Specify status of data
(clean/not clean) of data at each transfer.>
✔ Person responsible for transfer: <specify who is
responsible to transfer the data – DM Programmer /
Statistical Programmer.>
13.2 Final Data Transfer at End of Study
✔ < All CRF and Non CRF data are transferred to the
Sponsor at the end of [Link]: SAS
14 Project Status Reports:
Types of project status reports to be provided to the client.
Number of pages received, entered and validated
Total number of CRFs received by CRO vs those entered in
the database
Number of CRF pages saved complete and incomplete
Total number of DCFs generated to date
Total number of DCFs sent to site
Number of outstanding DCFs
Number of DCFs outstanding over 30 days
Number of SAE cases in the safety database
Number of SAE DCFs or discrepancies issued
Number of SAE DCFs or discrepancies outstanding
Number of clean subjects
15 Quality Assurance/Control Processes
16 Audit Plans
17 Metrics:
✔ CRF Page Tracking (Received and Entered)
✔ Discrepancy and DCF aging analysis
✔ Number of queries raised and resolved
✔ Last Patient Last Visit to DB Lock
✔ Client Specific Metrics and Project Specific Metrics
18 Database Lock
19 Return of Study Documentation
20 Study Archiving
21 Archiving Electronic File
22 Project Close Out:
PM/designee will ensure that all study closeout activities are
done, sign off Study Responsibilities Log and all outstanding
tasks are complete.
ORGANIZATION OF A DMP
• Approval Page • Database Security
• Protocol Summary • Data Entry and Processing
• Dictionary and Coding • Data Validation and UAT
Management • SAE Data Reconciliation
• Definitions and Acronyms • Quality Assurance/Control
• Personnel/Role Processes
Identification/Training • External Data Transfers
• Timelines • Audit Plans
• Case Report Forms • Metrics
• Database Design, Creation and • Reports
Maintenance • Communications
• Database Archive • Other Processes
• Database Roles and Privileges
TOPICS AND COMPONENTS OF A DMP
Timelines:
✔ Protocol finalization
✔ CRF development
✔ Database design and UAT
✔ Data validation, programming and UAT
✔ First patient first visit
✔ Last patient last visit
✔ Last CRF/data element received/entered
✔ Last query/discrepancy form received/completed
✔ Final SAE reconciliation completed
✔ Medical coding completed and approved
✔ Interim analysis, when applicable
✔ Database audit
✔ Database lock
✔ Study data and documentation archiving
