Revised Guidance for Computer Systems Used in FDA Clinical Trials
In October 2024, the U.S. FDA issued guidance titled “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers.”
This guidance replaces the May 2007 guidance, Computerized systems Used in Clinical Investigation.
This FDA guidance provides recommendations for the use of electronic systems, electronic records, and electronic signatures in clinical trials.
- The main points are as follows
- It describes the requirements for ensuring the reliability and authenticity of electronic records and electronic signatures.
- It emphasizes the importance of security measures such as electronic system validation, audit trails, and access control.
- Provides recommendations for contracting with IT service providers and supervising their services.
- Detailed guidance on IT service providers has been added, including considerations for the use of IT services such as cloud computing.
- It describes considerations for collecting data using digital health technology (DHT).
- Provides detailed guidance on the use and requirements for electronic signatures.
- It recommends that a risk-based approach be adopted and that appropriate controls be put in place depending on the importance and complexity of the clinical trial.
- Emphasizes the importance of procedures and processes to ensure data integrity, authenticity, and confidentiality.
- It explains the documents and records that are required during FDA inspections.
The guidance is intended to assist sponsors, investigators, IRBs, CROs, and other stakeholders to efficiently utilize electronic systems while meeting the requirements of 21 CFR Part 11.
In response to technological advances, the document provides the latest recommendations, reflecting advances in electronic systems and technologies since the 2003 FDA Guidance for Industry: Part 11, Electronic Records, Electronic Signatures – Scope and Application guidance.
This guidance adopts a Q&A format to provide more specific and practical guidelines.
- The table of contents of this guidance is as follows
- I. INTRODUCTION
- II. BACKGROUND
- III. QUESTIONS AND ANSWERS
- Electronic Records
- Electronic Systems Deployed by Regulated Entities
- Information Technology Service Providers and Services
- Digital Health Technologies
- Electronic Signatures
- GLOSSARY
APPENDIX: RELEVANT FDA REFERENCES A Japanese translation of this guidance is available here.
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