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September 26, 2023 at 10:19 am
#5103
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Participant
Hi Sarah,
Remember that the TMF is a trial-specific repository. So whilst the records you mention need to be retained and could be reviewed in an inspection, they would not be expected in the TMF. Most companies have a separate system in which they maintain validation records and records of system management, such as user access requests, change requests etc.
Kind regards,
Eldin.