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Wednesday, June 27 • 10:30am - 11:45am
#341: New FDA Draft Guidance on Part 11 in Clinical Investigations

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-650-L04-P; CME 1.25; IACET 1.25; RN 1.25

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 In June 2017 FDA issued a new draft guidance on the use of electronic records and electronic signatures in clinical investigations under 21 CFR Part 11.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 Objectives

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.


Ron D. Fitzmartin


Leonard Sacks, MD

Cheryl A. Grandinetti, PharmD

avatar for Ron Fitzmartin

Ron Fitzmartin

Senior Informatics Advisor, Office of Regulatory Operations, CBER, FDA, United States
Ron Fitzmartin is Senior Informatics Advisor, Office of Regulatory Operations, Center for Biologics Evaluation and Research, Food and Drug Administration. In this role Ron provides policy and strategy consultation and support on a wide range of topics focused on electronic regulatory... Read More →
avatar for Cheryl Grandinetti

Cheryl Grandinetti

Clinical Pharmacologist, OSI, OC, CDER, FDA, United States
Dr. Grandinetti is a reviewer in the Good Clinical Practice Assessment Branch of the Division of Clinical Compliance Evaluation /Office of Scientific Investigations in CDER/FDA. She provides regulatory and scientific oversight for CDER-assigned bioresearch monitoring activities and... Read More →
avatar for Leonard Sacks

Leonard Sacks

Associate Director for Clinical Methodology, Office of Medical Policy, CDER, FDA, United States
Leonard Sacks is an Associate Director for Clinical Methodology in the Office off Medical Policy, CDER, FDA, where he has worked on integrating IT opportunities into drug development. He has extensive experience with clinical trials, both as a clinical investigator and subsequently... Read More →

Wednesday June 27, 2018 10:30am - 11:45am EDT
Room 204AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Forum