Guidance on Electronic Signatures in Clinical Investigations

FDA has issued a draft guidance with questions and answers providing guidance to sponsors, clinical investigators, institutional review boards, contract research organizations, and other interested parties on using electronic records and electronic signatures in clinical investigations of medical products. The document clarifies, updates, and expands upon recommendations in a 2003 guidance.

The goals of the guidance are to (1) update recommendations for applying Part 11 requirements in the current environment of electronic systems used in clinical investigations; (2) clarify and further expand on the risk-based approach described in the 2003 Part 11 guidance to validation, audit trails, and archiving of records; and (3) encourage and facilitate the use of electronic records and systems to improve the quality and efficiency of clinical investigations.