<Trial identifier>
Version Control Log
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.
Initial
Document
Version
(first used by
Site)
Document
Title/ID
Document
Title/ID
Document
Title/ID
Document
Title/ID
Document
Title/ID
Document
Title/ID
(e.g. protocol,
consent form)
(e.g. protocol,
consent form)
(e.g. protocol,
consent form)
(e.g. protocol,
consent form)
(e.g. protocol,
consent form)
(e.g. protocol,
consent form)
Version Number and
Date
Date of Regulatory
Approvali
Date of NHS Approvalii
Version Number and
Date
Amendment
Ref (1):
Date of Regulatory
Approvali
Date of NHS Approvalii
Version Number and
Date
Amendment
Ref (2):
Date of Regulatory
Approvali
Date of NHS Approvalii
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’
Document1
File original in the Trial Master File, and forward copies of updated / completed Logs to the participating sites for their files.
Update to Page ____ of ____ ; here Page 1 of 4
<Trial identifier>
Version Control Log
Document
Title/ID
Document
Title/ID
Document
Title/ID
Document
Title/ID
Document
Title/ID
Document
Title/ID
(e.g. protocol,
consent form)
(e.g. protocol,
consent form)
(e.g. protocol,
consent form)
(e.g. protocol,
consent form)
(e.g. protocol,
consent form)
(e.g. protocol,
consent form)
Version Number and
Date
Amendment
Ref (3):
Date of Regulatory
Approvali
Date of NHS Approvalii
Version Number and
Date
Amendment
Ref (4):
Date of Regulatory
Approvali
Date of NHS Approvalii
Version Number and
Date
Amendment
Ref (5):
Date of Regulatory
Approvali
Date of NHS Approvalii
Version Number and
Date
Amendment
Ref (6):
Date of Regulatory
Approvali
Date of NHS Approvalii
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’
Document1
File original in the Trial Master File, and forward copies of updated / completed Logs to the participating sites for their files.
Update to Page ____ of ____ ; here Page 2 of 4
<Trial identifier>
Version Control Log
Document
Title/ID
Document
Title/ID
Document
Title/ID
Document
Title/ID
Document
Title/ID
Document
Title/ID
(e.g. protocol,
consent form)
(e.g. protocol,
consent form)
(e.g. protocol,
consent form)
(e.g. protocol,
consent form)
(e.g. protocol,
consent form)
(e.g. protocol,
consent form)
Version Number and
Date
Amendment
Ref (7):
Date of Regulatory
Approvali
Date of NHS Approvalii
Version Number and
Date
Amendment
Ref (8):
Date of Regulatory
Approvali
Date of NHS Approvalii
Version Number and
Date
Amendment
Ref (9):
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’
Document1
File original in the Trial Master File, and forward copies of updated / completed Logs to the participating sites for their files.
Update to Page ____ of ____ ; here Page 3 of 4
<Trial identifier>
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’
Document1
File original in the Trial Master File, and forward copies of updated / completed Logs to the participating sites for their files.
Version Control Log
Update to Page ____ of ____ ; here Page 4 of 4