Archiving Requirements for Clinical Trial TMFs: Compliance, Retention, and Best Practices
TMF Archiving Requirements dictate how clinical trial documents must be preserved after study completion. Regulations such as ICH E6 (R2), FDA 21 CFR, and EMA guidelines mandate long-term retention to allow for regulatory inspections, litigation defense, and future product evaluations. Whether managing paper TMFs, electronic TMFs (eTMFs), or hybrid systems, sponsors must ensure secure, compliant, and retrievable storage solutions that withstand the test of time.
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