By Dr. Wendy Tate, Director of Research Operations
When thinking about clinical trial documentation compliance, 21 CFR Part 11 usually comes to mind. For those unfamiliar with the Code of Federal Regulations designation, 21 CFR Part 11 provides criteria for electronic records, electronic signatures and handwritten signatures applied to electronic records. However, the criteria covered in 21 CFR Part 11 are not the only requirements that should be considered for compliant document management associated with clinical trials. Multiple other regulations require maintenance of general and trial-specific documents in regards to human subjects protection (45 CFR 46, 21 CFR 56, and 21 CFR 50), privacy and security (HIPAA, 45 CFR 160 and 45 CFR 164), financial disclosure of clinical investigators (21 CFR 54), new drug development (21 CFR 312), and device development (21 CFR 812).
Regardless of whether you are a sponsor or an investigative site, it is imperative that you have a reliable system and associated policies for storage and upkeep of documents surrounding trial conduct.