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April 16, 2020

FDA Issues Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Emergency

April 16, 2020—The FDA has posted its updated guidance on the conduct of clinical trials of medical products during the COVID-19 public health emergency.

The document outlines general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice, and minimizing risks to trial integrity. An appendix to the guidance further explains those general considerations by providing answers to questions that the FDA has received about conducting clinical trials during the COVID-19 public health emergency.

This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the United States Department of Health and Human Services.

According to the FDA, this guidance for industry, investigators, and institutional review boards (IRBs) has been implemented without previous public comment because FDA has determined that public participation for this guidance is not feasible or appropriate as defined by law. This guidance document is being implemented immediately, but it remains subject to comment in accordance with the FDA’s good guidance practices. Information on submitting comments is included in the document.

The document states that—in general, and if policies and procedures are not already in place for applicable trials—sponsors, clinical investigators, and IRBs should consider establishing and implementing policy and procedures (or revising existing policy and procedures) to describe approaches to use to protect trial participants and manage study conduct during possible disruption of the study as a result of COVID-19 control measures at study sites.

Questions on clinical trial conduct during the COVID-19 public health emergency can be directed to the FDA by email at clinicaltrialconduct-COVID19@fda.hhs.gov.

The FDA website dedicated to providing the latest information on the COVID-19 emergency, including guidance documents, temporary policies, and daily briefings, can be found here.

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