FDA Updates the Guidance for Electronic Records in Clinical Trials
(Thursday, March 16, 2023)
Electronic Records are an integral part of clinical practice and hence also of clinical trial source documents. In its 2017 Guidance on using electronic records in clinical trials FDA provided several suggestions on best practices for sponsors and clinical research organizations. This week FDA released an updated Guidance that expands on the original guidance to address the technological advances in the last 20 years whereby automation of key measures for the assessment of the authenticity, integrity and reliability of electronic data has made electronic data more acceptable to the Agency in support of INDs and market approval applications. The Guidance provides recommendations for the validation of electronic systems, the applicability of Part 11 regulations, and the use of remotely acquired data in clinical trials. The Q & A format answers common questions that should help users of electronic health records in clinical trials. For example, FDA accepts real-world data (RWD) generated using systems that might not be Part 11 complaint so long as the sponsor provides alternate evidence of the quality and integrity of the electronic records. Data generated at foreign sites must also be generated on Part 11 compliant systems. Sponsors can maintain electronic records only and do not need to print the records at the completion of the trial for long-term storage. FDA would need the data in the “human readable” form during audits. Emails do not need to be certified for Part 11, although integrity of communications records is the sponsor’s responsibility. SOPs related to electronic records should be available at the clinical sites. Clinical sites should be trained in cybersecurity measures and supervised for compliance with these measures. Audit trails must capture all changes made to the electronic record, the individuals making the changes, the date and time of the changes, and the reasons for the changes. Original information must not be obscured by the use of audit trails or other security measures. Audit trails should be protected from modification and from being disabled. FDA does not certify any system; the compliance with Part 11 and other common sense risk-based measures are the responsibility of the sponsor. These and several other common issues for the use of electronic records in clinical trials can be found in this Guidance document, which should be a must read for all clinical trial professionals.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC