FDA finalizes Q&A guidance on electronic records in clinical trials
Regulatory News | 02 October 2024 |
The US Food and Drug Administration (FDA) on Tuesday finalized a guidance to assist sponsors and clinical investigators comply with the electronic records regulations for clinical trials under 21 CFR Part 11.
The guidance revises a draft version that was released for comment last year by clarifying the applicability of Part 11 to real-world data (RWD) submitted to the agency as part of a marketing application. (RELATED: FDA revises guidance on electronic systems and signatures in clinical trials, Regulatory Focus 15 March 2023).
The guidance applies to the use of electronic systems in clinical investigations of medical products, foods, tobacco products, and new animal drugs. It includes 29 questions and answers on electronic records, electronic systems deployed by regulated entities, information technology service providers, and digital health technologies, as well as a glossary and an appendix covering FDA references.
FDA said the guidance updates recommendations for applying and implementing data integrity and data security controls and expands on the recommendations on the risk-based approach to validation of electronic systems described in the August 2003 guidance on electronic signatures.
Some of the changes made to the guidance include clarifying the applicability of part 11 to real-world data sources submitted to FDA, and clarifying the applicability of part 11 to clinical investigations conducted outside of the United States.
In Question 1, FDA clarifies that electronic records from RWD sources submitted to FDA as part of a marketing application are subject to Part 11 requirements, yet the use of Electronic Health Record (EHR) data used in clinical investigations will not be subject to Part 11.
These EHRs may include hospital admission records, pharmacy records, laboratory records, and imaging records created during the course of patient care that are used to support marketing applications or other submissions. Yet once the electronic record enters the sponsor’s electronic data capture (EDC) system, FDA intends to assess compliance with part 11.
The guidance also adds a new Question 29 on whether users of electronic signatures are required to submit a letter of non-repudiation to FDA certifying that an electronic signature is the legally binding equivalent of a traditional handwritten signature.
FDA said the answer is yes, and that “users of electronic signatures must submit a letter of non-repudiation to FDA to certify that the electronic signature is intended to be the legally binding equivalent of a traditional handwritten signature. Organizations may submit one letter of non-repudiation to cover all the electronic signatures used by that organization. Information on how to submit the certification either electronically or by mail is on FDA’s web page on letters of non-repudiation agreement.”
Final guidance
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