The FDA has released final guidance titled “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers.” This document offers updated recommendations for sponsors, clinical investigators, institutional review boards, contract research organizations, and other stakeholders on using electronic systems, records, and signatures in clinical trials involving foods, medical products, tobacco products, and animal drugs. It emphasizes ensuring the trustworthiness, reliability, and equivalence of electronic systems to paper records.
The guidance focuses on several key areas: strengthening data integrity and security through updated controls, including audit trails; enhancing the risk-based approach to electronic system validation; providing advice on engaging information technology service providers; and facilitating the use of digital health technologies for data collection. It also aims to streamline the use of electronic signatures, thereby improving the efficiency and quality of clinical investigations.
The finalized version of the guidance incorporates public feedback on the draft version, resulting in clarifications on the applicability of part 11 regulations to real-world data and international clinical trials, as well as recommendations for system validation, IT service agreements, and data collection from digital tools. Additional editorial revisions were made for clearer communication. Overall, this guidance reflects the FDA’s current stance on the use of electronic records and systems in clinical research, aiming to enhance efficiency, data integrity, and regulatory compliance.
Read the Guidance Document here.
