FDA Guidance Document: Computerized Systems Used In Clinical Investigations

There is an increasing use of computerized systems in clinical trials to generate and maintain source data and source documentation on each clinical trial subject. Such electronic source data and source documentation must meet the same fundamental elements of data quality (e.g., attributable, legible, contemporaneous, original,5 and accurate) that are expected of paper records and must comply with all applicable statutory and regulatory requirements. FDA's acceptance of data from clinical trials for decision-making purposes depends on FDA's ability to verify the quality and integrity of the data during FDA on-site inspections and audits. (21 CFR 312, 511.1(b), and 812).

In March 1997, FDA issued 21 CFR part 11, which provides criteria for acceptance by FDA, under certain circumstances, of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper. After the effective date of 21 CFR part 11, significant concerns regarding the interpretation and implementation of part 11 were raised by both FDA and industry. As a result, we decided to reexamine 21 CFR part 11 with the possibility of proposing additional rulemaking, and exercising enforcement discretion regarding enforcement of certain part 11 requirements in the interim.

This guidance finalizes the draft guidance for industry entitled Computerized Systems Used in Clinical Trials, dated September 2004 and supplements the guidance for industry entitled Part 11, Electronic Records; Electronic Signatures – Scope and Application (Scope and Application Guidance), dated August 2003. The Scope and Application Guidance clarified that the Agency intends to interpret the scope of part 11 narrowly and to exercise enforcement discretion with regard to part 11 requirements for validation, audit trails, record retention, and record copying. However, other Part 11 provisions remain in effect.

The approach outlined in the Scope and Application Guidance, which applies to electronic records generated as part of a clinical trial, should be followed until such time as Part 11 is amended.