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Contains Nonbinding Recommendations
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they reach a clear understanding of their respective roles to avoid confusion and to ensure
appropriate responsibility for and access to the documents.
There may be circumstances when the original IRB reaches an agreement with the
receiving IRB to retain some of the documentation for the transferred trials, yet may not
be able to commit to retaining the documents for at least 3 years after the completion of
the research. For instance, if an IRB ceases operations but retains responsibility for some
records for trials that are still ongoing, either by physically maintaining these records or
by reaching a storage arrangement with a responsible third party. In this instance, we
recommend that the original IRB contact FDA to discuss possible retention
arrangements.
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In this situation, the original IRB should make arrangements to transfer
the documents to the receiving IRB or to another, responsible party.
(3) Establishing an effective date for transfer of oversight, including records, for the
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