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New FDA Draft Guidance on Part 11 in Clinical Investigations
Session Chair(s)
Ron Fitzmartin, PhD, MBA
Senior Informatics Advisor, Office of Regulatory Operations, CBER
FDA, United States
In 1997, FDA published a final rule (21 CFR Part 11) to establish criteria that must be met when a record required by predicate rule is created, modified, maintained, archived, retrieved, or transmitted in electronic form. In 2003 the FDA published the final guidance on the scope and applications of Part 11. The final guidance provided for a narrow and practical interpretation of Part 11. In June 2017 FDA issued a new draft guidance on the use of electronic records and electronic signatures in clinical investigations under 21 CFR Part 11. This guidance is the first look at Part 11 since the 2003 Scope and Applications guidance. The guidance acknowledges that technology has progressed significantly and that FDA should clarify the Part 11 controls that sponsors and regulated entities must implement, as appropriate, in the current technological environment. The goal of the new guidance is to describe how FDA intends to exercise enforcement discretion with regard to certain Part 11 requirements during the re-examination of Part 11.
This session will review the new guidance, the public comments, discuss next steps and hear from the audience on the topics presented.
Learning Objective : Describe the new 21 CFR Part 11 guidance in clinical investigations; Evaluate the purpose of the new Part 11 guidance; Identify the key components of the guidance.
Speaker(s)
Panelist
Leonard Sacks, MD
FDA, United States
Director, Clinical Methodologies,Office of Medical Policy, CDER
Panelist
Cheryl Grandinetti, PharmD
FDA, United States
Clinical Pharmacologist, OSI, OC, CDER
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