-
19th Jan 2012, 03:15 PM
#1
Archiving of training records
Hello
could somebody please advise if it is a requirement to archive training records from a GCP perspective once an individual leaves an organisation.
Thank You
-
19th Jan 2012, 08:50 PM
#2
If you have a staff member who has worked on a trial, or a number of trials, one would expect their details to appear in the Investigator Site File (either CV or on a delegation of authority form).
You might not keep full training records in the ISF, and so one would expect that those records could be accessed in the future if a study were inspected or a problem came to light later. Therefore I would not destroy GCP training records when someone leaves, I would keep them in the department (orm taking a pragmatic approach, scan them and save them electronically somewhere).
Of course this is assuming that you are talking about study site staff. However the same probably applies regardless of role.
CTU
-
20th Jan 2012, 12:37 PM
#3
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