The document outlines the components and significance of a Data Management Plan (DMP) for clinical trials, detailing its purpose, creation process, involved roles, and benefits such as ensuring compliance and quality of data management. It emphasizes that the DMP should be a dynamic document that captures changes throughout the study's lifecycle and must be approved by responsible parties before the study begins. Additionally, the document lists essential components for a DMP, including protocol summary, personnel identification, timelines, and data management processes.

1. P R E S E N T E D B Y – D R . G E E T U M O H A N , V I N AY K A S A R E & G AYAT R I T I K A R
DATA MANAGEMENT PLAN
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2. CONTENT
 What is DMP
 Purpose
 Roles Involved
 Benefits
 Creation and finalization
 Components
 Milestones
 References
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3. WHAT IS DMP
What is Data Management Plan?
• A Data Management Plan or DMP is a formal document that outlines how data
are to be handled both during and after the clinical trial is completed.
• DMP describes the activities to be conducted in the course of processing data.
• Before the study goes live, all clinical studies should have DMP in place.
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4. PROCESS FLOW
Study is awarded to
CRO
Kick off meeting
CDM Team is
selected
Prepare first draft of
DMP
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5. PURPOSE
• To define procedures, timelines, responsibility, and documentation of clinical data
management for the study.
• To promote consistent, efficient, and effective clinical data management activities
for the study.
• To provide a guide that will ensure compliance with Good Clinical Practice (GCP)
• Requirements and ensure that the study database is accurate, secure, reliable, and
• Ready for analysis.
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6. ROLES INVOVED
Medical
writer
Sponsor
representative
Study
statisticin
Data
manager
Project
manager
Standalone studies:
• For standalone studies, responsible role will be as per the scope.
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7. BENEFITS
• Serves as a document which will be helpful in proper planning, training, communication and
execution of data management activities
• Ensures compliance with good clinical data management practices throughout the trial and thus
assures production of quality data during trial
• Makes personnel involved in data management activities aware about their respective roles and
responsibilities which enhance the smoothness of process
• Maintains a record of data handling activities by different individuals during study
• Provides continuity for data management activities when personnel in data management team
changes or study goes on for long duration
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8. CREATION AND FINALIZATION
• For each new study, clinical data management (CDM) personnel should compose a detailed DMP
based on the protocol, work scope, contract, analysis plans, data flows, case report forms (CRFs),
other supporting documents, and data management standards and practices.
• The entire DMP should be drafted and approved by all responsible parties prior to commencement
of the work it describes.
• The clinical data manager should ensure the DMP is kept current, including proper
• Version control, and that all parties involved agree with the content.
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9. CREATION AND FINALIZATION
• 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.
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10. COMPONENTS (CONSIDERED WHILE CREATING DMP)
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Sr.No. Components
1 Protocol Summary
2 Definitions & Acronyms
3 Points of contact
4 Personnel/Role Identification/Training
5 Timelines
6 Dictionary & Coding Management
7 Frequencies of important documents and activities
8 Data entry process
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11. COMPONENTS (CONSIDERED WHILE CREATING DMP)
• Includes synopsis of study protocol, visit schedule or critical data analysis
variables within DMP
• Gives a broad overview of protocol
• Includes list of acronyms that are protocol specific & DMP.
• Provides definitions of terms that may be misinterpreted/misunderstood.
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12. COMPONENTS (CONSIDERED WHILE CREATING DMP)
Name & contact details of primary & secondary point of contact for every
trial.
Should specify key personnel with roles & responsibilities OR may refer to
external documents OR SOPs OR refer to documents related to project
related training requirements
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13. COMPONENTS (CONSIDERED WHILE CREATING DMP)
Lists expected completion targets for all deliverables .
May vary based on study parameters (paper based or EDC based studies)
 Should indicate with medical coding dictionaries.
Eg: MedRA, WHO DD, SNOMED
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14. COMPONENTS (CONSIDERED WHILE CREATING DMP)
Mention frequencies at which reports & data listings to be shared with
sponsor team.
Also defines reconciliation frequency that are to be performed during conduct
phase.
Should maintain type of data entry
Should specify data transfer & data tracking process.
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15. MILESTONES
(APPEAR ON STUDY TIMELINE)
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Protocol
finalization
CRF/eCRF
creation
Database
designing
Edit check
specification
UAT
1st patient 1st visit
&
last patient last
visit
Query
management
Lab Data
management
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16. HOW TO HANDLE CHANGES AFTER GO-LIVE?
• Required changes should be made & shared with internal team for review.
• Draft DMP should be shared with sponsor after incorporating comments from
internal team.
• Once all concerned members approve the changes, document can be
finalized & version will be revised
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17. REFERENCES
• https://www.clinicaltrials.gov/ProvidedDocs/14/NCT01602614/SAP_001.pdf
• https://scdm.org/wp-content/uploads/2019/12/GCDMP-Data-Management-
Plan-2019-Edition.pdf
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