4/17/2020
The FDA released new topics in the FAQ section of the guidance document for conducting clinical trials during the COVID-19 pandemic. The rapidly changing environment of the crisis has made it challenging to continue conducting and monitoring clinical trials in the traditional manner due to restrictions on travelling, dispensing investigational products, and social gathering. New questions continue to arise as the logistics of monitoring and conducting clinical trials become apparent.
Two interesting new questions of note are:
Q: How do you obtain informed consent when electronic informed consent is not feasible?
Summary of Answer: As long as the consent process includes adequate time for the subject to ask questions and there is documentation that the consent took place before study procedures, other methods may be used. Specific examples are included in the FAQ.
Q: What are the recommendations for monitors to perform remote source document review?
Summary of Answer: The FDA guidance is a reminder that the regulations require monitoring of the progress of the study but do not specify exactly how this must be done. Remote monitoring using a risk-based approach for prioritization of sites and determining which are the critical data points is recommended.
You may be interested in our popular “Remote Monitoring Operations While Maintaining HIPAA, GCP, and COVID-19 Restrictions” webinar recording, now available for purchase. A FAQ document complied from the live webinars is available as a free companion document with the webinar recording for a limited time.
- The Clinical Pathways Team
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