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.
| Who | What the guideline says |
|---|---|
| Investigator or institution | Keep the essential records for the retention period required by applicable regulations, or until the sponsor says they are no longer needed, whichever is longest (Annex 1, 2.12.12). Tell the sponsor who is responsible for them, for example when the investigator leaves (2.12.13). |
| Sponsor | Keep the sponsor's essential records as the applicable regulations require, and tell investigators in writing how long to keep records and when they are no longer needed (Annex 1, 3.16.3). |
| Both | Keep records available, accessible and readable, and protect them from unauthorized access and premature destruction (Annex 1, 2.12.12 and Appendix C). |
Where the rule comes from
ICH E6(R3) Principle 9.5 says essential records should be retained securely by sponsors and investigators for the required period under applicable regulatory requirements. The guideline does not set a number of years; the law that applies to the trial does. For example, under US FDA rules (21 CFR 312.62(c)) an investigator keeps drug trial records for 2 years after the marketing application is approved for the indication, or, if no application is filed or it is not approved, for 2 years after the investigation is discontinued and FDA is notified.
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