Policy Update – Results Information Reporting for Applicable Clinical Trials (ACTs)

  Institutional Review Board Human Research Protections (HRP)   Policy Update – Results Information Reporting for Applicable Clinical Trials (ACTs) (NOT-OD-20-147) Version August 18, 2020   Update: A Federal court has held that Section 801 of the Food and Drug Administration Amendments Act of 2007 (“FDAAA”) requires submission of results information for any “applicable clinical…

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