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Clinical Research Coordinator
Full course · Monitoring, Close-Out & the Modern CRC
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The full CRC track covers 8 courses from study start-up to close-out — the skills sponsors actually look for.
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Identify applicable record retention requirements from ICH E6(R3) Annex 1, Section 3.16.3, FDA regulations (21 CFR 312.62), and institutional policies, determining the longest applicable retention period and understanding when retention obligations begin.
A clinical trial concludes in 2026. The last participant has completed the final visit. The data have been cleaned, locked, and analyzed. The close-out monitoring visit is scheduled. And then someone asks the question that, in my experience, surfaces at almost exactly this moment: "How long do we have to keep all of this?"
The question sounds simple. The answer is not.
The retention period for clinical trial records depends on at least four overlapping sets of requirements: ICH E6(R3), FDA regulations, institutional policies, and sponsor contractual obligations. Each source may specify a different duration. Each may define the starting point differently. And for drugs that never receive marketing approval -- which, it is worth remembering, describes the majority of investigational products that enter clinical trials -- the retention obligation may have no defined endpoint at all.
Getting this wrong carries real consequences. Destroy records too early, and the site has eliminated evidence that a regulatory authority may still have the legal right to inspect. Retain them too long, and the site bears the cost of storage, management, and security for records that no one will ever need again. The CRC who understands retention requirements can navigate this tension with confidence. The one who does not is guessing -- and guessing, in a regulated environment, is never acceptable.
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