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FDA Conduct of Clinical Trials During COVID-19

Apr 14, 2020, 13:45 PM by Melodi Moore
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FDA has issued guidance titled FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic Guidance for Industry, Investigators, and Institutional Review Boards to provide general considerations to assist in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity during the COVID-19 pandemic. The appendix to this guidance further explains those general considerations by providing answers to questions about conducting clinical trials that the FDA has received during the COVID-19 pandemic.

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