Purpose
To ensure appropriate trial oversight, it is important to keep track of the essential documents used for the trial, and their latest approved version. Overviews must be provided to those performing quality checks at sites, e.g. on-site monitoring. This template can be used for this purpose.
/ Document Title/ID(e.g. protocol, consent form) / Document Title/ID
(e.g. protocol, consent form) / Document Title/ID
(e.g. protocol, consent form) / Document Title/ID
(e.g. protocol, consent form) / Document Title/ID
(e.g. protocol, consent form) / Document Title/ID
(e.g. protocol, consent form) /
Initial
Document
Version
(first used by Site) / Version Number and Date
Date of Regulatory Approval[i]
Date of NHS Approval[ii]
Amendment
Ref (1): / Version Number and Date
Date of Regulatory Approvali
Date of NHS Approvalii
Amendment
Ref (2): / Version Number and Date
Date of Regulatory Approvali
Date of NHS Approvalii
Amendment
Ref (3): / Version Number and Date
Date of Regulatory Approvali
Date of NHS Approvalii
Amendment
Ref (4): / Version Number and Date
Date of Regulatory Approvali
Date of NHS Approvalii
Amendment
Ref (5): / Version Number and Date
Date of Regulatory Approvali
Date of NHS Approvalii
Amendment
Ref (6): / Version Number and Date
Date of Regulatory Approvali
Date of NHS Approvalii
Amendment
Ref (7): / Version Number and Date
Date of Regulatory Approvali
Date of NHS Approvalii
Amendment
Ref (8): / Version Number and Date
Date of Regulatory Approvali
Date of NHS Approvalii
Amendment
Ref (9): / Version Number and Date
Date of Regulatory Approvali
Date of NHS Approvalii
Acknowledgements
We would like to acknowledge the Wellcome Trust Clinical Research Facility at University Hospital Birmingham for sharing the first version of this template
i Including REC, MHRA etc.: either list last approval date or ‘N/A’ if not required
ii Either list date, have Site list date or enter ‘Not required’
UoB-CLN-ESD-QCD-006 Version Control Log v1.0 / Update to Page ____ of ____ ; here Page 1 of 3File original in the Trial Master File, and forward copies of updated / completed Logs to the participating sites for their files.
[i]
[ii]