The PI Is Leaving and the Storage Room Is Being Cleared
A single-site academic study of an investigational device-drug combination is closing after the last subject's final visit on 30 September. The PI moves to another institution on 15 January; the research office lease ends 31 December and the department wants the storage room cleared. The sponsor asks that all records be shipped to its central archive in another country by 31 December. The site holds paper source documents that are also the hospital's legal medical record, a paper regulatory binder, an EDC system with audit trails, 200 unresolved queries, and the only filed copies of signed consent forms. The sponsor's retention policy requires 15 years; the institution's policy requires 25 years; local law is silent; the marketing application is not yet approved. Three subjects have unresolved adverse events.
1. Who must retain which records, and for how long? Calculate the governing period.
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ICH E6 requires essential documents be retained until at least 2 years after the last approval of a marketing application in an ICH region and until there are no pending or contemplated applications, or at least 2 years after formal discontinuation of clinical development. US IND rules are comparable. That is a floor, and the marketing application here is not yet approved, so the clock has not even started.
Where multiple requirements apply, the longest governs. The institution's 25-year policy exceeds the sponsor's 15-year policy and cannot be shortened by the sponsor's contract. Local law being silent means it imposes nothing additional - it does not lower the institutional obligation.
Allocation:
- Institution retains: the regulatory binder and essential documents, original signed consent forms, and its own copies of source/medical records, for 25 years from the applicable start point.
- Source documents that are the legal medical record belong to the hospital and do not leave; the sponsor may receive certified copies.
- Sponsor holds the clinical database and audit trail; the site should retain a copy of data it generated if its policy requires.
- The PI's departure does not transfer custody. The institution appoints a named record custodian in writing before 15 January.
2. What can legally leave the site, and how should any transfer be executed?
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- Originals of the legal medical record stay. Provide certified copies with a cover statement of what was copied and by whom.
- Original signed consent forms normally stay at the site; the sponsor receives copies. Losing the only originals offshore is not an acceptable close-out.
- Subject identifiers should not be shipped to another country without a written agreement addressing confidentiality and any required authorization. De-identified or coded data are preferable.
- Any shipment needs a dated, signed inventory and receipt listing box contents, plus a written custody agreement covering who owns the records, who may access them, the retention period (the 25-year institutional period controls), and the conditions and documentation required for eventual destruction.
- The EDC audit trail must be locked/frozen with a final data extract provided to the institution so that the site is not dependent on the sponsor's system for 25 years.
Do not ship anything before the custodian is appointed and the agreement is signed - records in transit with no owner are the classic close-out failure.
3. What must be resolved before the final monitoring visit can be considered complete?
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The study is not closable on 30 September as described:
- 200 open queries must be resolved or formally documented as unresolvable with a reason and PI sign-off. Locking a database with unexplained open queries is not acceptable.
- Three unresolved AEs must be followed until resolution or stabilisation, or documented as ongoing with a plan for who will follow them after close-out and how the sponsor will be informed. The AE reporting obligation does not end with the last visit.
- Investigational product/device accountability reconciled to zero: returned, destroyed, or retained with written sponsor authorisation and documentation.
- Final IRB report and notification of PI change and record custodian, with the IRB's acknowledgement filed.
- Final monitoring report listing every outstanding item with an owner and due date.
- A written close-out confirmation to the sponsor, and confirmation that the archive location is secure, access-controlled, and known to the institution.
If the record custodian and archive are not settled before the lease ends, escalate within the institution - this is a sponsor-independent institutional obligation.