Archiving

In Oversight, quality & inspection

Also known as: record retention

Archiving is the secure, long-term storage of trial records after the trial ends, so they remain complete, readable, and retrievable. Retention periods are set by regulation and by the sponsor, and are often 25 years or more in the EU for trials under the Clinical Trials Regulation. Records must survive changes of staff, systems, and premises.

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Educational reference only. Where regional rules differ, follow the regulation and the written procedures that apply where you work.