Part 11 Final Guide has Broader Applicability: Attorneys
A recently released FDA final guidance on electronic records and systems used in clinical trials has a broader scope than proposed in an earlier draft guidance, according to an analysis by attorneys at Hogan Lovells. The prior version, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers, indicated that it applied to electronic systems “owned or controlled by” sponsors or other regulated entities. But in the final version, the document “broadens the range to systems ‘deployed by’ regulated entities,” the attorneys say. “In addition, the broader term ‘regulated entities’ is often used in the final to replace the draft’s use of the term ‘sponsors.’”
The 10/2-released guidance provides recommendations about the regulatory requirements that FDA uses to consider electronic systems, records, and signatures to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. It is intended for sponsors, clinical investigators, institutional review boards, contract research organizations, and other interested parties using electronic systems, records, and signatures in clinical investigations of medical products, new animal drugs, foods, and tobacco.
Regarding the assessment of real-world data compliance with 21 CFR Part 11 requirements, FDA is backing off this if the data are “pre-electronic data capture,” according to the attorneys. They note that FDA does not intend to assess the Part 11 regulatory compliance of an electronic health record system or other electronic systems that are sources of real-world data. However, if the electronic record is recorded by a sponsor's electronic data capture system, FDA plans to assess compliance with Part 11, they say.
Additionally, the attorneys note that the guidance states that FDA’s focus during inspections will be on “records related to training study staff on electronic systems, and procedures and controls governing system access, data creation, data modification, and data maintenance. Additionally, FDA will likely review documentation demonstrating that users have appropriate access rights that can be revoked and terminated by sponsors as needed, and that backup, recovery, or contingency plans for source records exist.”
The attorneys’ analysis also covers issues pertaining to retaining source data information, validation regulatory flexibility, information technology service provider quality agreements, and foreign clinical trials.