1. Purpose

To define the activities required to close a study at the site and the retention, storage and destruction of study records afterwards.

2. Scope

Applies to all studies at completion, early termination or sponsor withdrawal, and to all associated paper and electronic records.

3. Responsibilities

• Data Management Lead: Coordinates close-out activities and the records inventory.
• Regulatory Affairs: Submits closure notification to the IRB and archives essential documents.
• Investigational Pharmacy and Laboratory: Complete final product and specimen reconciliation and disposition.
• Quality Assurance: Approves the close-out checklist and authorises any record destruction.

4. Definitions

Close-out visit

The final monitoring visit at which all records are reconciled and outstanding items resolved.

Retention period

The minimum period for which records must be kept, determined by regulation, the clinical trial agreement and institutional policy, whichever is longest.

Archive

Controlled long-term storage from which records can be retrieved for audit or inspection.

Certificate of destruction

The documented evidence that records or product were destroyed, by whom, when and by what method.

5. Procedure

1. Initiate close-out when the last subject completes follow-up, or on notification of early termination, and open a close-out checklist.
2. Resolve all outstanding data queries and obtain investigator sign-off on the case report forms for every subject.
3. Complete final investigational product reconciliation, return or destruction per CON-003, and file the certificate.
4. Complete final specimen reconciliation and disposition per CON-004 and the consent document.
5. Reconcile the deviation log, adverse event log, screening and enrolment log, and the delegation of authority log, closing out end dates.
6. Notify the IRB of study closure per REG-002 and file the acknowledgment.
7. Compile the final essential document inventory, documenting any missing item with a note to file explaining the circumstances.
8. Retain records for at least two years after the marketing application is approved for the indication, or two years after the investigation is discontinued and the FDA notified, and never less than the period required by the clinical trial agreement or institutional policy.
9. Retain records containing protected health information for at least six years from creation or last effective date where the HIPAA documentation requirement applies.
10. Store archived records in a secure, environmentally controlled, access-logged location, and index them so any record can be retrieved within two business days.
11. Ensure archived electronic records remain readable, verifying accessibility at least annually and migrating formats before obsolescence, per DAT-002.
12. Obtain written sponsor authorisation and Quality Assurance approval before destroying any study record, and retain the certificate of destruction permanently.
13. Destroy records containing protected health information by cross-cut shredding, pulping or certified secure destruction, and never by placing them in ordinary refuse or recycling.

6. References

• 21 CFR Part 312.62(c) — Record retention
• 21 CFR Part 812.140 — Records (devices)
• 45 CFR 164.316 — Policies and procedures and documentation requirements
• ICH E6(R3) Good Clinical Practice
• CON-003 Investigational Product Receipt, Storage, Accountability & Destruction

7. Revision History

• v2.0 · Jan 08, 2024 — Added electronic archive readability verification.
• v2.1 · Apr 14, 2025 — Added secure destruction methods for PHI records.