Data management plan (important components and best practices) final v 1.0

Data Management Plan
(Important Components and Best Practices)
Vinayak Thorat
Clinical Data Manager
vinayak.thorat@ancillarie.com

“ Data Management Plan is like
Roadmap:
It shows the final destination and
Standard way to go there!!!

TOC
▸Introduction
▸Scope of Topic
▸Minimum Standards
▸Best Practices
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Why is Data
Management Plan is
necessary?
Introduction
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Why is Data Management Plan is necessary?
A data management plan (DMP) is a formal document which gives guidance to all the
stakeholders regarding how to handle the data both during research & after the project
is completed.
 DMP provide guidance to
• How to handle data under regular circumstances
• Establish the process for to deal with unforeseen issues
 DMP considers all the necessary Data Management aspects e.g.:
• Data Cleaning,
• Metadata generation,
• Data preservation,
• Data Analysis,
• Archival.
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Introduction
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Why is Data Management Plan is necessary?
DMP is authoritative resource for documenting
• Data management practices
• Decision that are taken at study initiation
DMP should comply with
• Regulatory guidance (FDA, ICH GCP etc.)
• Local laws of the country
• SOP’s of the organisation.
DMP should also contain/document/record
• Change in procedure
• Protocol amendment during the conduct of study.
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Introduction
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Clinical Data Manager creates Data Management Plan (DMP) to ensures & document,
all the processes mentioned under DMP adhere to Good Clinical Data Management
Practice (GCDMP).
DMP should be in place before data collection begins to document relevant
convention for particular studies.
All the study stakeholder who handle the data must follow DMP for :
 Consistence approach to the process
 Guidance for conducting data management activity
Introduction
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 DMP is live Document and cover all the changes in the processes throughout
study life cycle;
Hence, DMP is Version Controlled – each document should be documented and
include date, author, reason for version change & individual version identifier.
 DMP is auditable document; During inspection, inspector may also ascertain
degree to which the project team adhere to process.
 DMP should be created during setup phase based on:
 Protocol
 Scope
 Contract
 Analysis Plan
 Dataflow
 CRF
 Other Supporting Documents
Introduction
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We will cover Minimal Components that should be addressed within the overall study
documentation.
Scope
Minimum Standards:
 Complete Draft of DMP should present to ensure all the Data Management Processes
are defined and described from study initiation till close out.
 Ensure DMP adhere to compliance with regulations and Supervisory Agencies.
 Identify and Define personnel & their role involved in decision making of
• Data Collection
• Data Handling
• Data Quality Control
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Components of DMP
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 Approval Page
 Protocol summary
 Dictionary & coding
management
 Definition & acronyms
 Personnel/Role
identification/Training
 Timelines
 Case report Forms
 Database design,
creation & Maintenance
 Database archive
 Database role &
privileges
 Database security
 Data entry & Processing
 Data Validation & UAT
 SAE Data Reconciliation
 Quality Assurance/
Control Processes
 External Data transfers
 Audit Plans
 Metrics
 Reports
 Communications
 Other Processes
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Minimum Standards: Components of DMP
 Ap p roval Page:
It (minimum) mainly contains
• Study Identifier
• Primary Reviewers/ Signatories
• Date of Approval
• It may also contains version number
 Protocol Su mmary:
It is advisable to include short synopsis of study protocol which covers
• Visit schedule
• Visit Assessment
• Critical Data Analysis variable & Version within DMP
• It may also include protocol amendments and versions.
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 Dictionary and Coding Management :
DMP or referred document should include
• Which dictionary and version will be used (e.g.: MedDRA, WHO Drug, SNOMED etc.)
DMP or referred document should provide instruction for how to handle
• Dictionary updates or changes
• Define all quality control measures
• Validation & UAT processes
DMP or referred document should describe
• Auto-coding
• Any study Specific conventions are used
Examples of coding are Medical Coding, Adverse Event Coding, Medical History Coding,
Non-AE event coding, Physical examination coding
*Details will be covered under Dictionary Maintenance, Safety Data Management & Reporting chapters
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 Defin ition s & Acron yms :
DMP should include list of Acronyms that are specific to protocol and DMP covers all
definitions of terms
 Pers on n el/Role id en tifier/T rain in g :
DMP should specify;
• Personnel, their role & responsibilities
• External documents or SOP which contains this information
• Any project specific training required for various roles and functions
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 T imelin es :
The timeline included in DMP or document referred by DMP lists the expected
completion targets for all deliverables
Following are examples of milestones that may appear on study timeline and to be
detailed in DMP or in associated documentation.
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 Protocol finalization
 CRF Development
 Database design & UAT
 Data validation, programming and UAT
 First Subject First Visit
 Last Subject Last Visit
 Last Data Entry
 Last Discrepancy Resolved
 Final SAE reconciliation completed
 Medical Coding completed & Approved
 Interim Analysis
 Database Audit
 Database lock
 Study Data documentation Archiving
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 Cas e Rep ort F o rm s
CRF is defined as “a printed, optical or electronic document designed to record
protocol required information to be reported to the sponsor on each trial subject”.
Following area should be explained into DMP or the document referred by DMP
• CRF design : Provide detailed description of CRF designed process or referred to
organization’s SOPs relating to CRF design and development
• CRF instruction : It provides general CRF completion guidelines & protocol
specific guidelines
• CRF changes : Describe the process for managing changes to CRF/eCRF
design or reference the organization’s SOP
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 Datab as e Des ign , Creation an d Main ten an ce :
DMP should contain;
• Database creation Plan
• Validation Plan
• Maintenance plan
• Description of the system that holds Data (InForm, Oracle Clinical, Medrio etc.)
• Table and Naming conventions
According to 21 CFR part 11 procedure & control should be in place to ensure
• Appropriate control access to documentation
• Revision & Change control procedure to maintain audit trail of modification of documents
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 Datab as e Arch ive
Specific information regarding the organization’s procedures for archiving the electronic
records should be present in DMP.
 Datab as e Roles an d Privileges
• The DMP should include or a reference should be made to a document where the roles are
described.
• Database roles (profiles available)
• Assign privileges to roles based upon the duties performed in the study.
• At minimum the roles should be listed in document; As a best practice a details of each role
and the associated privileges should be described in DMP.
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 Datab as e Secu rity:
The DMP or referred documents (Organization’s SOP) should describe Security of
• Networked Equipment
• Servers
• Clinical Data Management System (CDMS).
User Roles and Access:
DMP should also address procedure(s) or refer to the organization’s SOPs which define,
create, maintain and revoke system user access.
Database backup: The DMP or refer to documents should describe
• Database backup procedure
• Frequencies
• Routines
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 Data En try an d Proces s in g
The DMP or referenced documents should define;
• Data entry guidelines: It should describe proper handling of:
Data, Data Anomalies, Notation of self-evident changes, Abbreviations & Symbols
• Data discrepancy conventions:
Guidelines to provide consistency in classifying and processing data discrepancies.
• Data receipt:
Describes the type of receipt (paper CRF or EDC), frequency and how data receipt tracking
will be performed. This also applicable to data transfers from any third-party vendors.
• Data processing:
Describes processing plan at the organization (either electronic or paper-based data).
• Data entry:
This document will describe who will perform data entry and whether single or double entry
will be used. Continued…
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• Self-evident correction :
A self-evident correction is a change to data or resolution of a query that can easily and
obviously be made on the basis of other existing information on the CRF without sending a
query to the investigative site. e.g.: Spelling Errors
• It must be clearly documented and audited via the audit trail.
• A list of approved self-evident corrections must be included in the DMP or exist in a
separate document to be attached or referenced.
• Ensure the investigators associated with the study are in agreement with the self-evident
correction process and that the method of additional documentation (e.g., generation of
reports for sign off) is thoroughly described.
• Self-evident corrections might not be applicable to all data management systems and types
of data (e.g., source records).
Continued…
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• Data reconciliation:
Provide details about the data fields and external databases requiring reconciliation per the
study protocol.
• Database lock:
Provides details defining the
• Criteria for database lock
• Responsible personnel/team for database lock
• Processes that will be employed in locking the database
• Refer to the organization’s SOPs on study closeout the unlocking and relocking processes
if required
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 Data V alid atio n an d UAT
• The DMP or a separate document should be present which defines validation test
procedures to ensure integrity of study-specific components such as
• Programming/algorithms,
• Data entry/EDC screens,
• Online logic/data-checking routines,
• Security, backups, and archiving.
• Checks need to identify, appropriate and verified programs are created to help
identify discrepancies and ensure entered data is correct, allowable, valid, and
consistent.
Data quality checks include:
• Manual review specifications
• Discrepancy management
• Electronic data discrepancy management
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 SAE Data Recon ciliation
The DMP should describe or refer to documents that describe the protocol specific SAE
reconciliation plan.
 Q u ality As s u ran ce/Con trol Proces s es
ICH E6 defines, quality control is “the operational techniques and activities undertaken
within the quality assurance system to verify that the requirements for quality of the
study-related activities have been fulfilled.”
Different studies have of different levels of regulatory importance. Sometimes study
may not follow any SOPs in place or may only follow some of them. In such case
complete an SOP compliance checklist indicating which SOPs are applicable to the study
and provide detail justification for opting out of all or part of the SOPs. Continued on next page…
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 Q u ality As s u ran ce/Con trol Proces s es
• The DMP should address:
• Level of checks:
Required level of checking dependent on regulatory requirement and it need to be decided
prior to data collection begins.
• Frequency of quality control checks:
According to ICH E6, “Quality control should be applied to each stage of data handling to
ensure that all data are reliable and have been processed correctly.” Frequency should be
specified in DMP.
• QC check documentation processes:
Define the means by which QC checks are documented and how this documentation is
maintained throughout the course of the study.
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 Ex tern al Data T ran s fers :
• DMP should describe the
• Process for collecting, handling, cleaning & reporting of errors present (if any) in the external data
• Data type (e.g., safety data, lab data etc.)
• Person/organization providing or receiving the data
• Any applicable agreements.
• Specific data transfer details may include, but are not limited to, the following
• Variable/element specifications
• Format of transfer (SAS datasets, ASCII files, XML files, etc.)
• Method of transfer (encrypted e-mail, FTP, CD, DVD, etc.)
• Recipient of data (site, sponsor, data safety monitoring board (DSMB), statisticians, etc.)
• Frequency of transfer
• Quality control/validation steps performed to maintain integrity
• As a good practice established data transfer plan and also it is recommended that to conduct a
test data transfer prior to the need for a live transfer.
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 Au d it Plan s :
• As defined by ICH E6, quality assurance is “all those planned and systematic actions
that are established to ensure that the study is performed and the data are
generated, documented (recorded), and reported in compliance with GCP and the
applicable regulatory requirements(s).”
• The DMP should either define the on-site audit and corrective action plans, or refer
to those documents that do cover these processes.
• The DMP should also define how often during the course of a study QA will take
place.
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 Metrics :
The DMP should include the metrics that will be used for the study.
 Rep orts :
• The DMP should include a list of available reports for the study.
• For each report, specify the target audience, content, level of details, date of data
extraction, frequency of generation and the mechanism used for distribution
(e.g., e-mail, posting electronically).
• Additions and deletions to the report listing may occur throughout the life of the
study and should be updated in subsequent versions of the DMP.
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 Commu n ication s
The DMP should describe
• The types of communications or correspondence (paper or electronic)
• Detail where records of these communications will be saved or any associated archiving
requirements
• Frequency of communication
• Medium (e.g., face-to-face vs. conference call vs. Web conference)
• Escalation process
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 Oth er P ro c es s es :
If a study involves other processes, they should always be described in detail
somewhere within the protocol or DMP.
Some additional processes are:
• DSMB requirement:
Describe any requirements pertaining to DSMB meetings that may occur during the
course of the study
• What preparation is expected to be performed prior to these meetings?
• Will this preparation be treated as a lock in regards to having all data clean and reported
upon prior to the meeting?
• Will the DSMB be focusing on a sample of the data or the complete data set?
Continued…
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 Oth er Proces s es :
• Business rule:
Specify business rules that may have an impact on data handling or data integrity in the
DMP. For example,
• Regularly scheduled IT maintenance that limits server access
• Organization wise holidays
• Anticipated change of address during the course of the study may affect data handling
• Problems and resolutions:
Document the process of identifying, discussing, resolving and filing problems arising and resolved
during the study.
• Change control processes:
Evaluate if other change control processes may be encountered during the course of the study and
describe them in the DMP.
• Blind data review specifications:
Describe the expectation from data management if a blind data review will be conducted.
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Best Practices
 Organization should Develop and maintain DMP template to ensure Consistency &
Standardization across all the projects.
 Development of DMP should be in collaboration with all the stakeholders who
handles the data and must understand & follow the processes & guidance recorded
under the DMP from the study initiation till closeout.
 DMP for each study should be kept
• Current DMP with proper version
• All the stakeholders must be aware and agree to the current content of the DMP
 DMP should/must be approved & signed prior to starting on the work it described.
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References
• International Conference on Harmonisation. Guideline for Good Clinical Practice, E6: Good
Clinical Practice; Consolidated Guideline. Geneva, Switzerland: Author; 1996.
• Code of Federal Regulations, Title 21, Volume 1, Part 11. Washington, DC: US Government
Printing Office; 1998.
• Guidance for Industry: Computerized Systems Used in Clinical Investigations. U.S. Department
of Health and Human Services, Food and Drug Administration (FDA), Office of the
Commissioner (OC); May 2007.
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