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Published on 22/12/2025

Data Localization and Cross-Border Transfer Governance SOP

Department	Clinical Research
SOP No.	CS/NMPA-DATA/179/2025
Supersedes	N.A.
Page No.	1 of 24
Issue Date	28/08/2025
Effective Date	05/09/2025
Review Date	05/09/2027

Purpose

The purpose of this SOP is to establish requirements for the localization of clinical trial data in China and define governance measures for cross-border transfer of trial data. It ensures compliance with Chinese laws, NMPA regulations, and data protection standards to safeguard participant information and trial integrity.

Scope

This SOP applies to all clinical trial data generated, stored, or transferred in China. It covers electronic and paper data, Trial Master File (TMF), Investigator Site Files (ISF), Case Report Forms (CRFs), and electronic trial data systems. It also applies to sponsor, CRO, and investigator obligations for cross-border data transfer approvals and monitoring.

Responsibilities

• Sponsor: Ensures trial data is stored on servers located in China and oversees requests for data export approvals.
• Principal Investigator (PI): Maintains localized site-level data and ensures no unauthorized transfers occur.
• Regulatory Affairs (RA): Submits applications for cross-border data transfer approvals when required by NMPA or the Cyberspace Administration of China (CAC).
• Data Management Team: Implements secure data storage systems and ensures data access is restricted per SOP.
• Quality Assurance (QA): Audits compliance with data localization and export restrictions, ensuring inspection readiness.

Accountability

The Sponsor’s Head of Clinical Data Management is accountable for compliance with Chinese data localization and export control regulations. The PI is accountable for ensuring local site adherence to these requirements.

Procedure

1. Data Localization

1. All trial data, including electronic records and CRFs, must be stored on servers located in China.
2. Ensure storage systems comply with NMPA electronic data integrity guidelines and ALCOA+ principles.
3. Restrict access to authorized personnel with role-based permissions.

2. Cross-Border Data Transfer Approval

1. Identify whether trial requires transfer of anonymized datasets outside China for global analysis.
2. Prepare Data Export Application including anonymization plan, justification, and recipient details.
3. Submit application to NMPA or CAC for approval before transfer.

3. Data Export Controls

1. Implement strong encryption for any data approved for export.
2. Ensure de-identification of participant data before transfer.
3. Maintain Data Export Log capturing date, dataset, recipient, and approval reference.

4. Monitoring and Compliance

1. Conduct quarterly audits of data storage and transfer activities.
2. Document findings in Data Localization Audit Log.
3. Report deviations to QA and implement CAPAs promptly.

5. Archiving

1. Archive localized trial data for 15 years or as per NMPA requirements.
2. Ensure exported datasets and approvals are archived in TMF.

Abbreviations

• NMPA: National Medical Products Administration
• CAC: Cyberspace Administration of China
• CRF: Case Report Form
• TMF: Trial Master File
• ISF: Investigator Site File
• PI: Principal Investigator
• RA: Regulatory Affairs
• QA: Quality Assurance

Documents

1. Data Export Application Form (Annexure-1)
2. Data Export Log (Annexure-2)
3. Data Localization Audit Log (Annexure-3)

References

• National Medical Products Administration (NMPA)
• Cyberspace Administration of China (CAC)
• ICH E6(R2) Good Clinical Practice
• ICH Efficacy Guidelines

Version: 1.0

Approval

Prepared By	Checked By	Approved By
Name: Rajesh Kumar Date: 20/08/2025 Signature: __________	Name: Sunita Reddy Date: 22/08/2025 Signature: __________	Name: Dr. Meera Iyer Date: 28/08/2025 Signature: __________

Annexures

Annexure-1: Data Export Application Form

Protocol No.	Dataset	Recipient	Approval Ref	Status
CHN-2025-01	De-identified Safety Dataset	Global HQ	CAC-EXP-001	Approved

Annexure-2: Data Export Log

Date	Protocol No.	Dataset	Recipient	Approval Ref	Exported By
15/09/2025	CHN-2025-01	Safety Dataset	Global HQ	CAC-EXP-001	Sunita Reddy

Annexure-3: Data Localization Audit Log

Date	Site	Finding	CAPA	Auditor
20/09/2025	Beijing Clinical Center	Server patching overdue	Patch applied on 21/09/2025	Rajesh Kumar

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
28/08/2025	1.0	Initial SOP for data localization and cross-border transfer governance.	New SOP created for compliance with NMPA and CAC requirements.	Head of Clinical Research

For more SOPs visit: Pharma SOP.