- 2024-10-24
FDA Finalizes Part 11 Electronic Signature Guidance for US Clinical Investigations
The US Food and Drug Administration (FDA) recently finalized updated guidance addressing the use of electronic signatures and records in clinical investigations, as detailed in an article by Cooley LLP. This guidance clarifies compliance requirements for electronic records and signatures, reflecting technological advancements and increased reliance on digital health tools. The FDA’s updated approach includes considerations for international studies and emphasizes the integrity and accountability of electronic data.