trials. It ensures that data is transferred, stored, and retained securely without loss of integrity, guaranteeing compliance with global regulatory standards including ICH GCP, FDA 21 CFR Part 11, EMA, CDSCO, and WHO requirements. This SOP also aims to establish long-term accessibility, auditability, and regulatory inspection readiness.

Scope

This SOP applies to all eClinical systems and databases, including Clinical Data Management Systems (CDMS), Electronic Data Capture (EDC), pharmacovigilance databases, safety reporting systems, laboratory systems, eTMF, and ISF-related archives. It covers migration between systems, archiving of completed trial data, validation of transfers, and secure long-term retention.

Responsibilities

• System Owner: Ensures proper planning and execution of data migration and archiving activities.
• Data Manager: Verifies completeness, accuracy, and consistency of migrated/archived data.
• IT Administrator: Implements migration tools, ensures data encryption, and maintains system access logs.
• Principal Investigator (PI): Confirms site-level records are properly archived.
• Sponsor/CRO: Provides oversight and ensures global compliance with data retention policies.
• QA Officer: Audits migration and archiving processes for compliance with SOP and regulatory standards.

Accountability

The sponsor and system owner are accountable for ensuring that data migration and archiving follow validated, documented, and regulatory-compliant processes. Data managers are accountable for validation, reconciliation, and traceability of archived data.

Procedure

1. Planning for Migration and Archiving
Develop a Data Migration and Archiving Plan (DMAP) before initiating migration.
Define scope (systems, datasets, timeframe) and assign responsibilities.
Conduct risk assessment and identify potential risks such as data loss, corruption, or incompatibility.

2. Pre-Migration Activities
Perform a full backup of source data before migration.
Lock down source system for data entry to prevent changes during migration.
Verify availability of required hardware, software, and secure storage media.

3. Data Migration Process
Use validated tools for migration, ensuring all metadata, audit trails, and timestamps are preserved.
Transfer data in encrypted format to target system or archive repository.
Document migration details in Data Migration Log (Annexure-1).

4. Post-Migration Verification
Validate migrated data by comparing record counts, field-level accuracy, and consistency against source.
Resolve discrepancies immediately and document corrective actions.
File verification reports in TMF (Annexure-2).

5. Archiving of Completed Trial Data
Archive trial data once database is locked and trial reports are finalized.
Store in secure repositories with redundancy (onsite, offsite, and cloud, if validated).
Maintain long-term access controls and user logs.

6. Access and Retrieval
Access to archived data must be authorized by PI or sponsor only.
Retrieval requests must be logged and justified in Access Log (Annexure-3).

7. Retention Timelines
Retain archived trial data for a minimum of 15 years or per regional regulations (e.g., EU 25 years, US 15 years).
Document retention policies in DMAP.

8. Disaster Recovery for Archives
Maintain duplicate archives in secure offsite storage.
Test retrieval from archives at least once annually.
Document results in Archive Verification Log (Annexure-4).

9. Documentation and Auditing
Maintain complete logs of migration, validation, and archiving activities.
QA must perform annual audits of archived data integrity and retrievability.

10. Archiving of Paper Records
Paper ISF and TMF documents must be archived in fireproof, humidity-controlled storage.
Indexes must be maintained for quick retrieval.

Abbreviations

• SOP: Standard Operating Procedure
• PI: Principal Investigator
• CRO: Clinical Research Organization
• QA: Quality Assurance
• TMF: Trial Master File
• ISF: Investigator Site File
• CDMS: Clinical Data Management System
• EDC: Electronic Data Capture
• LIMS: Laboratory Information Management System
• DMAP: Data Migration and Archiving Plan

Documents

1. Data Migration Log (Annexure-1)
2. Data Verification Report (Annexure-2)
3. Archive Access Log (Annexure-3)
4. Archive Verification Log (Annexure-4)

References

• ICH E6(R2) – Good Clinical Practice
• US FDA – 21 CFR Part 11
• EMA – Data Archiving and System Migration Guidelines
• CDSCO – Clinical Data Archiving Requirements
• WHO – Data Retention and Archiving Standards

Version: 1.0

Approval Section

Prepared By	Rajesh Kumar, Data Manager
Checked By	Sunita Reddy, QA Officer
Approved By	Dr. Anil Sharma, Principal Investigator

Annexures

Annexure-1: Data Migration Log

Date	System	Dataset	Transferred By	Remarks
12/09/2025	EDC	Visit Data	IT Admin	Successful
13/09/2025	Safety DB	SAE Reports	Data Manager	Validated

Annexure-2: Data Verification Report

Date	System	Records Verified	Discrepancies	Action Taken
14/09/2025	EDC	1,250	2	Corrected
15/09/2025	Safety DB	512	0	N/A

Annexure-3: Archive Access Log

Date	User	Accessed Dataset	Reason	Authorized By
16/09/2025	Ravi Kumar	Subject 101 CRF	Regulatory Query	PI
17/09/2025	Sunita Reddy	SAE Log	QA Audit	Sponsor

Annexure-4: Archive Verification Log

Date	System	Verification Method	Result	Reviewed By
18/09/2025	EDC	Test Restore	Valid	QA Officer
19/09/2025	eTMF	Random Retrieval	Successful	Data Manager

Revision History

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

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