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Part 11 Q&A Guidance August 10, 2017

Posted by Michael Hamrell in Uncategorized.
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In August 2017, the FDA released a draft guidance that provides recommendations to sponsors, clinical investigators, IRBs, CROs, and other interested parties on the use of electronic records and electronic signatures under Part 11 in clinical investigations of medical products. Part 11 is the FDA regulation, published in 1997, on the use of electronic records/electronic signatures. The guidance is the first update to guidance and information regarding Part 11 compliance in clinical trials in a number of years. It clarifies, updates, and expands upon the recommendations in the 2007 Part 11 guidance that pertains to FDA-regulated clinical investigations conducted under parts 312 and 812. The guidance attempts to clarify and update recommendations for applying and implementing part 11 requirements in the current environment of electronic systems used in clinical investigations. It also encourages the use of electronic records and systems to improve the quality and efficiency of clinical investigations. The guidance also discusses the use of a risk-based approach when deciding to validate electronic systems, implement audit trails for electronic records, and archive records that are pertinent to clinical investigations conducted under parts 312 and 812. Since the use of computers in clinical trials is the norm these days the recommendations in this guidance should be helpful to everyone engaged in clinical trials.