are retained in accordance with global regulatory requirements. This protects subject rights, preserves data integrity, and maintains inspection readiness.

Scope

This SOP applies to sponsors, investigators, CROs, QA, and archival vendors managing Trial Master Files (TMFs), Investigator Site Files (ISFs), pharmacovigilance records, laboratory data, and all essential documents. It covers paper, electronic, and hybrid records.

Responsibilities

• Sponsor: Defines retention timelines and authorizes destruction after expiry.
• Investigator: Maintains site-level records and ensures no premature destruction.
• Archivist: Secures archives and prevents unauthorized disposal.
• QA: Audits archival systems and verifies compliance with regulatory timelines.
• Vendors: Require sponsor authorization before destruction of stored records.

Accountability

The Sponsor is accountable for defining and approving destruction timelines. QA is accountable for verifying compliance, investigating deviations, and ensuring corrective and preventive actions (CAPA).

Procedure

1. Retention Compliance
1.1 Retain records according to global regulations (FDA, EMA, CDSCO, WHO).
1.2 Retention timelines must be documented in Record Retention Log (Annexure-1).

2. Authorization for Destruction
2.1 No records may be destroyed without formal sponsor authorization.
2.2 Maintain Destruction Authorization Form (Annexure-2).
2.3 Both QA and Sponsor sign off before destruction occurs.

3. Vendor Oversight
3.1 Archival vendors must not destroy records without written approval.
3.2 Maintain Vendor Destruction Oversight Log (Annexure-3).

4. Electronic Records
4.1 eArchives must have system-based retention controls.
4.2 Implement access restrictions to prevent accidental deletion.
4.3 Perform quarterly backup verification.

5. Deviation Management
5.1 Record all premature destruction incidents in Destruction Deviation Log (Annexure-4).
5.2 Conduct root cause analysis and implement CAPA.

6. Training
6.1 Archivists and staff must be trained in retention policies.
6.2 Document training in Training Log (Annexure-5).

Abbreviations

• SOP: Standard Operating Procedure
• TMF: Trial Master File
• ISF: Investigator Site File
• QA: Quality Assurance
• CRO: Contract Research Organization
• CAPA: Corrective and Preventive Action
• GDPR: General Data Protection Regulation
• HIPAA: Health Insurance Portability and Accountability Act

Documents

1. Record Retention Log (Annexure-1)
2. Destruction Authorization Form (Annexure-2)
3. Vendor Destruction Oversight Log (Annexure-3)
4. Destruction Deviation Log (Annexure-4)
5. Training Log (Annexure-5)

References

• ICH E6(R2/R3) – Essential Document Retention
• FDA – Record Retention and Destruction Guidance
• EMA – Record Preservation Standards
• CDSCO – Record Retention Rules
• WHO – Clinical Trial Record Management

Version: 1.0

Approval Section

Prepared By	Ravi Kumar, Clinical Archivist
Checked By	Sunita Reddy, QA Officer
Approved By	Dr. Anil Sharma, Head Clinical Quality

Annexures

Annexure-1: Record Retention Log

Date	Record Type	Retention Duration	Location	Responsible
01/09/2025	TMF Documents	25 years	Central Archive	Archivist

Annexure-2: Destruction Authorization Form

Date	Record Type	Requested By	QA Approval	Sponsor Approval
15/09/2035	Old ISF Records	Archivist	Approved	Approved

Annexure-3: Vendor Destruction Oversight Log

Date	Vendor	Records Destroyed	Authorization	Witness
20/09/2035	ABC Archival Pvt Ltd	ISF Paper Records	Sponsor Approval	QA Officer

Annexure-4: Destruction Deviation Log

Date	Record Type	Deviation	Action Taken	Status
10/09/2026	Lab Data	Accidental disposal	CAPA initiated	Closed

Annexure-5: Training Log

Date	Name	Role	Training Topic	Trainer
01/09/2025	Meena Sharma	Archivist	Retention SOP	QA Officer

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
26/08/2025	00	Initial version	New SOP creation	Head Clinical Quality

For more SOPs visit: Pharma SOP