Date: <dd/mm/yyyy> / Clinical Data Management / SOP-R-G-3-06
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May not be used, divulged, published or otherwise disclosed without the consent of
The Director, Clinical Research Centre.
Standard Operating Procedure
Clinical Data Management
Document number: / SOP-R-G-3-06Date registered: / <dd/mm/yyyy>
Revision number: / 0
Date revised:
Version number: / 1
Date of version: / <dd/mm/yyyy>
Electronic hyperlink:
Number of pages: / 5
Control status: / CONTROLLED
Controlled copy number: / Master
Document author(s): / Reviewed and approved by
Signature:______
<Name>
Date: <dd/mm/yyyy> / Signature:______
<Name>
Date: <dd/mm/yyyy>
REVISION HISTORY
Rev # / Section / Revision Date / Reason for Revision / Signature of Head Of QA UnitTABLE OF CONTENTS
#
/ /Page #
/REVISION HISTORY
/1
TABLE OF CONTENTS /2
/ PURPOSE / 3/ SCOPE / 3
/ ABBREVIATIONS / 3
/ GLOSSARY / 3
/ RESPONSIBILITY / 3
/ REQUIRED AND RELATED DOCUMENTS / 3
/ PROCEDURE / 4
/ FLOWCHART / 5
/ REFERENCE / 5
/ APPENDIX / 5
1.Purpose
This standard operating procedure (SOP) describes the datamanagementprocesseswhen conducting a clinical trial that includes data entry, data validation, data protection and database lock. This SOP also describes the use of independent data monitoring committees (DMC) for interim analyses of study data.
2.Scope
This SOP applies to management of primary and secondary data for all research that involves Ministry of Health (MOH) personnel or that is to be conducted in MOH facility or to be funded by sponsor.
3.ABBREVIATIONS
CRC / Clinical Research Centre
CRF / Case Report Form
DCM / Data Monitoring Committee
MOH / Ministry of Health
PI / Principal Investigator
SOP / Standard Operating Procedure
ISR / Industry Sponsored Research
4.GLOSSARY
Term / Definition
Case report form / A printed, optical, or electronic document designed to record all of the protocol-required information to be reported to the sponsor on each trial subject1-2.
Data monitoring committee / A committeeof individuals establishedto assess at intervals the progress of a clinical trial, thesafety data, and the critical efficacy endpoints, and to recommendwhether to continue, modify, or stop a trial1-2.If those individuals are independent of the investigators then the committee is also referred to as Independent Data Monitoring Committee.
5.Responsibility
It is the responsibility of the principal investigator (PI) to manage clinical data. PI may delegate this task to other member of the study team and the delegation has to be recorded in adelegation log. PI has to ensure that the delegated member has been properly informed about the research and trained on how to manage clinical data.
6.REQUIRED AND RELATED DOCUMENTS
# / Documents title
/ SOP-R-G-4-02: Study Archiving
/ WI-G-3-06-01: Work Instruction For Clinical Data Management
7.PROCEDURE
Step # / Process / Responsibility
/ Determines whether DMC is required. For industry sponsored research (ISR), DMC will be established by sponsor if required.
a)If required, go to next step;
OR
b)If not required, go to step 3. / PI
/ Establishes DMC by referring to WI-G-3-06-01. / PI
/ Where relevant, establishes study database according to protocol requirement. / Study team
/ Conducts research and records study data in relevant case report form (CRF) or other relevant data form. / Study team
/ Checks for completeness of CRF and data form. Obtains missing information or records presence of missing information according to protocol. / Study team
/ Transfers data from completed CRF or data form to database. / Study team
/ Verify data in database according to protocol or method described in WI-G-3-06-01. / PI
/ Locks studydatabase. Provides the locked database to sponsor (if applicable) for ISR. / PI
/ Conducts analysis of data (if applicable). / Study team
/ Archives study documents and data according to SOP-R-G-4-02. / PI
8.FLOWCHART
9.REFERENCES
1) Guideline For Good Clinical Practice E6 (R1)
(
2) Malaysian Guideline For Good Clinical Practice (3rd Edition)
(
10. APPENDIX
None
1