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26th Jun 2014, 08:00 AM
#1
Responsibility of PI when Study Archived
We have a number of studies in which a specific PI has now left the Trust, these studies have been archived for a few years. However we have been advised that there is a possibility that the FDA may want to audit these studies (we are not the Sponsor of these studies) . The PI has now left the Organisation and was the delegated named PI for these studies, what is the process when PI leaves and study is closed out but FDA may require contact with them?
Thanks
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