FDA Updates Q&A Appendix of Medical Products During COVID-19 Public Health Emergency

The U.S. Food and Drug Administration (FDA) added content to the question-and-answer appendix in its guidance titled “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.” This guidance is intended for industry, investigators, and institutional review boards.

The updated guidance has a new question-and-answer on Part 11 compliance for electronic systems that are used to generate electronic signatures on clinical trial records. The guidance cites the COVID MyStudies App as an example of an electronic method for obtaining informed consent securely when face-to-face contact is not possible. In addition, the guidance further expands on an existing question-and-answer about remote clinical outcomes assessments (COAs) to include four types of COAs: performance outcomes, interview-based clinician-reported outcomes, patient-reported outcomes, and observer-reported outcomes.

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 biological products. 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 trial subjects 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, the trial design, and in what region(s) the study is being conducted, 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.