Study Close-out, Documentation, and Records Retention
Close-out confirms that obligations are discharged and the record is complete. At the close-out visit the CRA verifies final IP accountability and destruction or return, outstanding queries and data lock readiness, final SAE reconciliation, device return, notification of the IRB, resolution of all open action items, and storage arrangements for records.
Essential documents
ICH E6 Section 8 lists essential documents generated before, during, and after the trial; they live in the investigator site file and the sponsor's trial master file. The two must be consistent: the site's IRB approvals, delegation log, training records, temperature logs, monitoring reports, and accountability records should mirror what the sponsor holds. Missing documents are findings even where the work was done correctly.
Retention - the numbers candidates misremember
- 21 CFR 312.62(c): the investigator retains records for 2 years after the marketing application is approved, or 2 years after the investigation is discontinued and FDA is notified.
- ICH E6 4.9.0: records kept until at least 2 years after the last site approval and until the sponsor states no further need.
- Contracts and local law often require longer - the EU Clinical Trials Regulation calls for long-term archiving of the trial master file (25 years).
So the rule is: the longest applicable period governs, and records must remain retrievable and legible for that whole time. Before destroying anything, obtain written sponsor authorisation; if an investigator relocates or retires, records stay with the institution and the sponsor is notified.
Traps
- Treating "2 years" as permission to destroy early.
- Assuming the sponsor's retention obligation releases the site from its own.
- Closing the IRB file without documenting the final report and study status.
Rule of thumb: if the sponsor, an auditor, or an inspector asked for it tomorrow, it must exist, be retrievable, and be self-explanatory.