21/22 November 2023
The FDA issued a new version of the draft guidance on electronic systems in clinical Investigations.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With the evolving use of electronic systems in clinical trials, the agency is providing this draft guidance to:
More detailed information is available in the draft guidance entitled Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers.