25.1 Close-Out, Archiving and Continuing Obligations

Close-Out, Archiving and Continuing Obligations

The monitor verifies that all central laboratory collection kits have been utilized, returned, or disposed of according to biohazard protocols. Sponsor-loaned equipment—such as dedicated clinical trial laptops, electronic tablets, automated blood pressure cuffs, or calibrated 12-lead ECG devices—are sanitized, decontaminated, and shipped back to the sponsor or equipment vendor.

Confidential linkage and continuing access

Retain the participant identification code list securely at the investigator/institution as appropriate. It must support authorised traceability while preventing inappropriate disclosure. A sealed envelope is one possible paper method, not a universal ICH requirement. Controlled electronic storage can also be appropriate. Record the custodian and retrieval route.

Final Notification to the Institutional Review Board (IRB/IEC)

Under ICH E6(R3), upon completion of the trial, the investigator must inform the institution and promptly provide the IRB/IEC with a summary of the trial's outcome. The PI transmits a formal Final Study Closure Report to the IRB, summarizing the total number of subjects enrolled, completed, discontinued, and any late-emerging safety events. Retain the submission and any relevant acknowledgement or decision under the applicable process.

Record Retention and Archiving

Once the Site Close-Out Visit is complete, relevant clinical trial records—including the ISF, signed informed consent forms, original medical charts, laboratory printouts, and pharmacy logs—must remain securely retained for the required period, including in appropriate existing systems.

Retention and controlled destruction

E6(R3) requires investigator/institution records to be retained for the period required by applicable regulations or until the sponsor says they are no longer needed, whichever is longer. Do not substitute an old R2 two-year mnemonic for the current rule or infer that two years after site close-out is sufficient.

At closure document the custodian, location, retrieval process, permitted access and continued readability of paper and electronic records. Protect against unauthorised access, accidental loss and premature destruction. Record a transfer of custody or relocation and inform relevant parties. Data, metadata and audit trails needed for reconstruction belong in the retention plan.

Before destruction, confirm that all applicable retention periods, sponsor requirements and relevant holds have ended, obtain the required authorisation and document the disposition. Sponsor release cannot override a longer applicable legal period. A storage invoice or expired software licence is not authority to delete records.

Physical Archival Requirements

Archived records should be stored with suitable protection, which can include:

• Environmental controls (climate, humidity, and pest control).
• Physical fire suppression systems and flood protection.
• Locked, access-restricted entry permitted only to designated archival custodians.
• Written contractual commitment from the investigator that records will not be destroyed, relocated, or transferred to another institution without prior written authorization from the sponsor.

Early closure and outstanding obligations

An under-enrolling site can be closed before the global trial ends. Confirm whether it has participants requiring continued care or follow-up, unresolved safety cases, outstanding data questions or product needing disposition. Assign these obligations explicitly and preserve appropriate system/source access. A close-out visit records the situation and plan; it does not make unfinished work disappear.

When a site has no participants, some participant-level checks will be inapplicable, but agreements, approvals, supplies, system access and essential-record obligations can still matter. Document why a record or activity is not applicable rather than filling a generic checklist with unsupported completion marks. Retain a useful route for later inspection and questions.

If records or responsibility transfer to another person or institution, identify the custodian and confirm continuity before removing old access or returning equipment containing necessary information. Acknowledged handover and retrievable evidence are stronger than an email saying the study is closed. Verify completion of agreed follow-up through the responsible functions.

Closure starts a continuing records obligation

Essential records must remain complete, readable, retrievable and protected after routine trial activity ends. E6(R3) requires investigator/institution records to be retained for the period required by applicable regulations or until the sponsor informs the institution that they are no longer needed, whichever is longer. Do not use an old two-year R2 mnemonic or count a universal period from the close-out visit.

The retention plan should identify the records, responsible custodian, locations, formats, access arrangements and applicable periods. Include source, essential correspondence, data and relevant metadata/audit trails. Sponsor, site and service-provider responsibilities need to be clear. A portal used during the study may close before the required retention period ends, so continued access cannot depend on an untested promise.

Official sources

Checked October 18, 2026: ICH E6(R3), Principles and Annex 1.