This document provides guidance to sponsors, clinical investigators, institutional review boards (IRBs), contract research organizations (CROs), and other interested parties on the use of electronic records and electronic signatures in clinical investigations of medical products under 21 CFR part 11, Electronic Records; Electronic Signatures.
This guidance clarifies, updates, and expands upon recommendations in the guidance for industry Part 11, Electronic Records; Electronic Signatures – Scope and Application (referred to as the 2003 part 11 guidance) that pertain to clinical investigations conducted under 21 CFR parts 312 and 812. Thus, this guidance is limited to outlining the scope and application of part 11 requirements for clinical investigations of medical products.
This guidance discusses the following:
- Procedures that may be followed to help ensure that electronic records and electronic signatures meet FDA requirements and that the records and signatures are considered trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper
- The use of a risk-based approach when deciding to validate electronic systems, implement audit trails for electronic records, and archive records that are pertinent to clinical investigations conducted under parts 312 and 812
The goals of this guidance are as follows:
- Update recommendations for applying and implementing part 11 requirements in the current environment of electronic systems used in clinical investigations
- Clarify and further expand on the risk-based approach described in the 2003 part 11 guidance to validation, audit trails, and archiving of records
- Encourage and facilitate the use of electronic records and systems to improve the quality and efficiency of clinical investigations
The Glossary in Appendix II defines many of the terms used in this guidance. Words or phrases found in the Glossary appear in bold italics at first mention.