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Thread: Archiving of training records

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  1. #1
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    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

  2. #2
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    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

  3. #3
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    Many Thanks

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