New FDA Guidance on Use of Electronic Systems, Records and Signatures in Clinical Investigations
This month, the U.S. Food and Drug Administration (FDA) issued a new broad-reaching guidance document for clinical investigation sponsors, clinical investigators, institutional review boards (IRB), contract research organizations (CRO), and other interested parties on the use of electronic systems, electronic records, and electronic signatures in clinical investigations. See FDA guidance document entitled “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations – Questions and Answers: Guidance for Industry” (October 2024) (Guidance). Adopted by all FDA Centers, the Guidance applies to clinical investigations of human medical devices, drugs and biological products, new animal drugs, foods and tobacco products.
The Guidance is the first time FDA has updated its Agency-wide recommendations in this area since August 2003. The update is driven by advances and improvements in technology, such as automated date and time stamps, audit trails, and the ability to generate complete and accurate copies of clinical investigation records and retain them, which have expanded the uses and capabilities of electronic systems used in clinical investigations since 2003. Moreover, FDA states that electronic systems and technologies are now used and managed in new ways, such as electronic system services which are shared or contracted between organizations, increasing the electronic data flow between electronic systems in clinical investigations.
The Guidance provides updated recommendations regarding compliance with the requirements of 21 C.F.R. Part 11 during clinical investigations and insights into when FDA considers electronic systems, electronic records, and electronic signatures to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures. Among other topics, the Guidance addresses:
- Additional recommendations regarding the risk-based approach to electronic system validation described in the August 2003 FDA guidance document in furtherance of ensuring the authenticity, integrity, and confidentiality of clinical investigation electronic data and records;
- The applicability of Part 11 requirements for electronic systems and information technology (IT) services used to create, modify, maintain, archive, retrieve, or transmit an electronic clinical investigation record; and
- The use of digital health technologies to remotely acquire data during a clinical investigation.
Please let Neil O’Flaherty or Evan Phelps know if you have any questions about the Guidance and/or need assistance implementing the recommendations.
