What’s inside the DMP? It includes all elements of Data management process It specifies: • What is the work to be performed? • Who is responsible for work? • Which SOP’s or guidelines will be applicable? • What documentation and output will be collected or produces from trial? Topics to cover in DMP • CRF/eCRF creation • Database design and structure • Edit Check specification • Study database testing and release • Data or paper workflow • Reports and Metrics • Query management • Managing lab data • Management of other non-crf data • Coding of reported terms • Handling of SAE’s • Transferring data • Study database lock DMP provides: • Clear history for long term studies which has to go through complex lifecycle • Provides location for documenting details on computer system to collect trial data recommended by FDA guidance document. • As per the FDA guidance document: for “computerised system used in clinical investigation.” • The section IV. F recommends: • For each study the documentation should identify what software and hardware will be used to create, modify, maintain, archive, retrieve or transmit clinical data. • This is not submitted to FDA but retained as part of study record. • It needs to be made available for inspection by FDA • Some companies have detailed DMP’s while some have concise with pointer to reference documents Authorisation of DMP • For internal CDM groups the lead, Clinical data manager, or senior data managers for study creates documents and signs it. • Companies having contract between CDM group and other groups will have their representatives reviewing and DMP along with lead DM. Revision of DMP • During the course of an average phase II and phase III study, some critical data management process or a key computer application may change. • DMP can be revised whenever there is a significant change. • Any revision in DMP needs to be reviewed and verified by authorizing official. DMP’s with CRO • Sponsor may outsource CRO for some or all parts of DMP can be used. • CRO’s may have more comprehensive DMP as compared to sponsor and most of the times the CRO’s DMP is used. • An experienced DM from sponsor is supposed to review the DMP by sponsors. • CRO collectively works with sponsor for any revisions in DMP. • Sponsor should provide resources for creating DMP.

1. Data
Management
Plan
By: Barka Binmazi

2. Content:
● Introduction
● History
● What is inside the DMP?
● Authorisation of DMP
● Revision of DMP
● DMP’s with CRO
● How to create a data management plan?
2

3. Introduction
● The DMP is the documented result of decisions about data definition,
collection, processing and storage that have been made as the study
workflow and data flow were designed.
● Data Management Plan is created by Clinical Data Management team.
These documents define how the data management for the study will be
carried out?
● It is not required by the law but it is considered as an auditable
document by the biopharmaceutical companies.
After SOP’s and training records the auditor will review the Data Management Plan.
3

4. Data managers setup studies
Collected/Entered Data
Cleaned Data
Processed Data until ready for analysis
{until: “If you didn’t document it, it
wasn’t done,” became the Law}
History
● Data managers documented key
points to provide evidence of Good
Practise.
● Documents were filed together as Data
Management Study File.
● It was used a reference document to
answer auditors about past conduct of
study.
● Since 1990’s the DM’s started creating
DMP’s and by mid 90’s it became
more common.
● From 2000’s it was considered as an
auditable document.
4

5. What’s inside the DMP?
5
It includes all elements of Data management process
It specifies:
• What is the work to be performed?
• Who is responsible for work?
• Which SOP’s or guidelines will be applicable?
• What documentation and output will be collected or
produces from trial?

6. Topics covered in DMP
6
 CRF/eCRF creation
 Database design and structure
 Edit Check specification
 Study database testing and release
 Data or paper workflow
 Reports and Metrics
 Query management
 Managing lab data
 Management of other non-crf data
 Coding of reported terms
 Handling of SAE’s
 Transferring data
 Study database lock

7. DMP provides:
7
 Clear history of studies with complex lifecycle
 Helps in locating documents on computer system for collection of trial data
recommended by FDA guidance document.
 As per the FDA guidance document: for “computerised system used in clinical
investigation.”
 The section IV. F recommends:
 For each study the documentation should identify what software and hardware
will be used to create, modify, maintain, archive, retrieve or transmit clinical
data.
 This is not submitted to FDA but retained as part of study record.
 It needs to be made available for inspection by FDA
 Some companies have detailed DMP’s while some have concise with pointer to
reference documents

8. Authorisation of DMP
8
 Individuals with expertise in statistics, clinical operations, project
management, or data management, commonly have review
responsibility or approval authority for DMPs.
 The actual roles will differ from organization to organization
 For internal CDM groups the lead, Clinical data manager, or
senior data managers for study creates documents and signs it.
 Companies having contract between CDM group and other
groups will have their representatives reviewing and DMP along
with lead DM.

9. Revision of DMP
9
 During the course of an average phase II and phase III study,
some critical data management process or a key computer
application may change.
 DMP can be revised whenever there is a significant change.
 Any revision in DMP needs to be reviewed and verified by
authorizing official.

10. DMP’s with CRO
10
 Sponsor may outsource CRO for some or all parts of DMP can be used.
 CRO’s may have more comprehensive DMP as compared to sponsor
and most of the times the CRO’s DMP is used.
 An experienced DM from sponsor is supposed to review the DMP by
sponsors.
 CRO collectively works with sponsor for any revisions in DMP.
 Sponsor should provide resources for creating DMP.

11. 11
How To Create A Data
Management Plan?

12. 12
1.Information needed before a DMP can be drafted
Common information used as input to the DMP
are:
• Regulatory guidance and other sponsor requirements.
• Database standards being considered for use including:
database structure, formats, or code lists, should be
available.
• The final, or close-to-final, study protocol including, a
study schedule of events, should be available.
• Access to, and input into, the study timeline and budget.
• For data management services done under contract, a
scope of work.

13. 2. Approach for format and structure of the DMP
13
• The DMP should be written in a manner that can be
effectively used as a job aid and work reference.
• Thus, process documentation should be concise and
written in clear language that is easily understood and
followed. (ICH E6 R2)
• The DMP may contain or reference the procedures for data
collection and handing.
• If the latter approach is followed, procedures should be in
place to ensure that the correct version or links are
referenced.

14. 14
3. Treat DMP as a controlled document
Elements of Document Control Applicable to Data
Management Plans:
• Identification and description of the DMP: title; date;
version; author; study; unique document identifier;
• Format: template for the DMP; standard sections;
• Review and approval criteria and processes;
• Protection from unintended alterations;
• Distribution, access, retrieval and use;
• Storage and preservation of data
• Change or version control;
• DMP retention and disposition

15. 15
DMP Contents -
a) Documentation of Approval
All versions of the DMP or components thereof should carry an indication of approval on each
version.
b) Definitions & Acronyms
c) Protocol Summary
d) Scope of data management operations covered by the DMP
This section of the DMP should state which study stages, data, and activities are
covered by the DMP.
e) Data sources
The DMP should address all data sources for a study
f) Personnel
The personnel section of the DMP should list, or reference a list of, project personnel, duration of
their association with the project, their roles, responsibilities, training and other qualifications (ICH
E6 R2 4.1.5. 5.5.1, 5.5.3 e).

16. 16
g) Risk Identification and Management
Whether a risk-based approach is used or not, the DMP should include the
identification of processes and data that are critical to ensure human
subject protection and the reliability of trial results (ICH E6 R2 5.0.1).
h) Project management
i) CRF
j) The CRFs, form completion guidelines and data dictionaries should be
managed as 19 controlled documents (ICH E6 R2 8.0).
k) Data mapping
l) Data systems used and their version(s) of each system used
m) Software Development Lifecycle procedures
n) Change Control
o) System security
p) Back-up and recovery
q) Database Lock and Unlock
r) Data Archival

17. 17
Table of content
for DMP

18. References
Evaldas Lebedys, PhD, CCDM1 Carolyn Famatiga-Fay, MPH, CCDM2 Priyanka Bhatkar, MSc, CCDM,3 Derek Johnson, CCDM,4 Gayathri
Viswanathan, MS,5 Meredith Nahm Zozus, PhD, CCDM6
1: Scope International AG, 2: Amgen Inc., 3: IQVIA, 4: Inflamax Research Inc., 5: Icon Plc., 6: University of Arkansas for Medical Sciences
Organization, review, and administration of cooperative studies (Greenberg Report): a report from the Heart Special Project Committee to the
National Advisory Heart Council, May 1967. Control Clin Trials. 1988 Jun;9(2):137-48.
Evaldas Lebedys, PhD, CCDM1 Carolyn Famatiga-Fay, MPH, CCDM2 Priyanka Bhatkar, MSc, CCDM,3 Derek Johnson, CCDM,4 Gayathri
Viswanathan, MS,5 Meredith Nahm Zozus, PhD, CCDM6
2. Knatterud GL. Methods of quality control and continuous audit procedures for controlled clinical trials. Control Clin Trials. 1981;1(4):327-332.
3. McBride R, Singer SW. Introduction to the 1995 clinical data management special issue of Controlled Clinical Trials. Control Clin Trials
1995;16:1s-3s.
4. McBride R, Singer SW. Interim reports, participant closeout, and study archives. Control Clin Trials. 1995;16:1s-3s.
5. Jones C, Bicarregui J, Singleton P. JISC/MRC Data Management Planning: Synthesis Report. Sciences and Facilities Technology Council
(STFC). Open archive for STFC research publications. 2011. http://purl.org/net/epubs/work/62544. Accessed April 30, 2016.
6. Knight G. Funder Requirements for Data Management and Sharing. Project Report: London School of Hygiene and Tropical Medicine; 2012;
London, UK. http://researchonline.lshtm.ac.uk/208596/. Accessed April 30, 2016.
7. Brand S, Bartlett D, Farley M, Fogelson M, Bart Hak J, Hu G, Montana OD, Pierre JH, Proeve J, Qureshi S, Shen A, Stockman P, Chamberlain R,
Neff K. A model data
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THANK
YOU