New USFDA Draft Guideline on Electronic Records and Signatures

Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 - Questions and Answers

The draft guidance provides recommendations to sponsors, clinical investigators, IRBs, CROs, and other interested parties on the use of electronic records and electronic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. The draft guidance clarifies, updates, and expands upon recommendations in the 2003 part 11 guidance for recommendations that pertain to FDA-regulated clinical investigations conducted under parts 312 and 812. Thus, the guidance is limited to the scope and application of part 11 requirements to such clinical investigations.

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