-
24th Jul 2012, 05:02 PM
#2
Access the TMF in order to add or remove documentation should be controlled. So in that sense access is controlled and restricted at all times before, during and after a trial. However when to restrict access so that only an archivist can have direct access , as you say, is not explicitly stated, but a risk-adapted approach might be useful. Having controls in place for placing or removing documentation from the TMF whilst the trial is in progress would be a good idea. The TMF must be kept up to date, regulation 31A(3) of SI 2004/1031 states that ‘The master file shall at all times contain the essential documents relating to that clinical trial’. TMFs after the trial has completed should be ‘complete and legible’ (regulation 31A(7) of SI 2004/1031). There should be a process to ensure that any changes to documents in the TMF are traceable regulation 31A(6) of SI 2004/1031.
Posting Permissions
- You may not post new threads
- You may not post replies
- You may not post attachments
- You may not edit your posts
-
Forum Rules