Lexology March 28, 2023
On March 15, the U.S. Food and Drug Administration (FDA) issued revised draft guidance summarizing how it intends regulate the use of electronic systems, records, and signatures in clinical investigations to account for advances in digital health technologies. The guidance applies to clinical trial sponsors, investigators, Institutional Review Boards (IRBs), and Contract Research Organizations (CROs), and it provides advice on implementing data integrity and data security controls, including the use of audit trails and the protection of electronic records. We have analyzed below how the new version of the agency’s guidance: highlights the importance of compliance with Good Clinical Practice (GCP) standards; warns that electronic records from Real-World Data (RWD) sources are subject to part 11 regulations; prioritizes oversight of...
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