FDA's final Q&A Document on Electronic Systems & Data in Clinical Trials

Following the draft paper issued in 2023 the FDA now published the final version of the Question and Answers (Q&A) document on Electronic Systems, Records, and Signatures in Clinical Investigations. The guidance provides information for sponsors, clinical investigators, institutional review boards (IRBs), contract research organizations (CROs), and other interested parties. 

Background

Good clinical practice (GCP) is an international ethical and scientific standard for designing, conducting, recording, and reporting clinical investigations that involve the participation of human subjects (see ICH E6 Good Clinical Practice). Compliance with the GCP regulations provides assurance that the rights, safety, and welfare of participants are protected and that the clinical trial data are credible. The appropriate use of electronic systems is an important component of GCP.

The final FDA guidance provides recommendations regarding the requirements to which FDA considers electronic systems, records, and signatures to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. The document expands upon recommendations in the FDA guidance for industry Electronic Records; Electronic Signatures — Scope and Application that pertain to clinical trials. Other related FDA guidances are listed in the Appendix of the document.

The final guidance document contains the following Q&A sections:

• Electronic Records
• Electronic Systems Deployed by Regulated Entities
• Information Technology Service Providers and Services
• Digital Health Technologies (DHTs)
• Electronic Signatures

For more information please see FDA's Guidance Document on Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers.