Author: admin

New FDA Guidance Explains Electronic Record Requirements for Medical Device Clinical Trials
July 25, 2017
By admin

US Food and Drug Administration medical device regulators have published new draft guidance recommending proper use of electronic records and signatures in clinical investigations. The new guidance applies to clinical trial sponsors and investigators as well as Institutional Review Boards (IRB) and clinical research organizations (CRO) that must comply with 21 CFR Part 11 regulations pertaining to electronic records and signatures. The FDA requires that electronic records and signatures are reliable and trustworthy, and that validations of electronic systems are carried out using risk-based approaches. Types of electronic records covered by the