How long do you need to keep study records?
Regulatory agencies often have varying requirements about how long records must be kept, where they can be stored, and how they should be disposed of when they are eligible for destruction.
Records retention guidance for common regulatory agencies include:
- Human Research Protection Program Department (HRPP)/IRB: Section 8.3 describes documentation requirements, storage, and maintenance of records for the Human Research Protection Program Department.
- FDA: CFR - Code of Federal Regulations Title 21 Part 58, Subpart J details record retention requirements.
Note: For industry-sponsored trials, check with the sponsor regarding their specific retention requirements.
The UTSW Library (utsouthwestern.edu) has guidance on recordkeeping best practices, including specific guidance on Records retention at UT Southwestern Medical Center (UTSW log-in only) and the UT Southwestern Medical Center Records Retention Schedule (UTSW log-in only), as well as methods for appropriately destroying records when they are eligible for destruction.