FDA's Q&A Paper on Electronic Systems & Electronic Data in Clinical Trials

Recommendation

21/22 November 2023

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The FDA issued a new version of the draft guidance on electronic systems in clinical Investigations. The document provides information on the use of electronic systems, electronic records, and electronic signatures in clinical trials. The guidance revises the draft Questions and Answers from June 2017. When finalized, the Q&As will supersede the guidance for industry Computerized Systems Used in Clinical Investigations (May 2007). Other related guidances are included in the Appendix of the paper. The draft Q&A document is open for comments until 15 May 2023.

With the evolving use of electronic systems in clinical trials, the agency is providing this draft guidance to:

• Update recommendations for applying and implementing data integrity and data security controls, including the use of audit trails and the protection of records in the current environment of electronic systems used in clinical investigations.
• Provide additional recommendations on the risk-based approach to validation of electronic systems described in the guidance for industry Part 11, Electronic Records; Electronic Signatures.
• Facilitate the use of electronic systems, electronic records, and electronic signatures to improve the quality and efficiency of clinical investigations.

More detailed information is available in the draft guidance entitled Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers.