The US Food and Drug Administration (FDA) on Wednesday revised its draft guidance on electronic systems, records and signatures in clinical trials. While the new guidance continues to use the questions and answers format of the previous version, the topics addressed have been updated to account for technological advances.
The document updates a previous draft guidance issued in 2017, and builds on the recommendations in FDA’s 2003 guidance on electronic records and signatures under CFR Part 11. FDA said the draft guidance, when finalized, will also supersede its 2007 guidance on computerized systems in clinical investigations. FDA said it recognizes that technology has advanced over the last two decades, necessitating the updated guidance. (RELATED: FDA Issues Draft Q&A on Electronic Systems in Clinical Investigations, Regulatory Focus 20 June 2017)…
