FDA Addresses Inquiry About Re-monitoring Data After the Pandemic in its Question-and-Answer Appendix in Guidance on Clinical Trials of Medical Products During COVID-19

Receive this email as a forward? Subscribe to CDER SBIA industry updates. FDA | CDER | Small Business and Industry Assistance INDUSTRY NEWS . FDA Addresses Inquiry About Re-monitoring Data After the Pandemic in its Question-and-Answer Appendix in Guidance on Clinical Trials of Medical Products During COVID-19    The U.S. Food and Drug Administration has added content to the question-and-answer appendix in its guidance, "Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency." The updated guidance includes a new question –and answer relevant to sponsors who used remote monitoring to oversee study conduct during the COVID-19 pandemic. The new language addresses whether data that were initially monitored remotely should be re-monitored on-site after pandemic-related restrictions are lifted.   FDA issued this guidance because we recognize that the COVID-19 public health emergency may impact the conduct of clinical trials of medical products, including drugs, devices, and biologics. For example, challenges may arise from isolation practices, site closures, travel limitations, interruptions to the supply chain for the investigational product, or other considerations if site personnel or clinical trial participants become infected with SARS-CoV-2, the virus that causes COVID-19. These challenges may lead to difficulties in conducting the clinical trials.    FDA is aware that protocol modifications may be required, and that there may be unavoidable protocol deviations due to COVID-19. Although the impact of COVID-19 on trials will vary depending on factors such as the nature of disease under study and the trial design, FDA's guidance 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. The appendix further explains those considerations by responding to related questions the agency has received.  The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research  provides guidance, education and updates for regulated industry. Subscribe to CDER SBIA Email Updates Register for Upcoming Training View 2021 Recordings on YouTube Follow on LinkedIn Follow on Twitter This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, contact us at CDERSBIA@fda.hhs.gov or 1-866-405-5367 or (301) 796-6707.  SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

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