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“headline”: “SOP for Data Sharing with Regulators and Repositories”,
“description”: “This SOP defines procedures for sharing clinical trial data with regulators and repositories, ensuring compliance with FDA, EMA, WHO, CDSCO, and ICH GCP guidelines. It includes data anonymization, formatting, submission portals, timelines, and retention requirements.”,
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Published on 21/12/2025
Standard Operating Procedure for Data Sharing with Regulators and Repositories
| SOP No. | CR/OPS/105/2025 |
| Supersedes | NA |
| Page No. | 1 of 49 |
| Issue Date | 26/08/2025 |
| Effective Date | 01/09/2025 |
| Review Date | 01/09/2026 |
Purpose
The purpose of this SOP is to define procedures for the secure and compliant sharing of clinical trial data with regulators and public
Scope
This SOP applies to sponsors, CROs, regulatory affairs, data management, statisticians, and QA staff responsible for preparing and submitting trial data. It covers sharing of clinical study reports (CSRs), patient-level data, anonymized datasets, safety data, and genomic or specialty datasets with regulatory authorities and repositories.
Responsibilities
- Sponsor: Ensures data sharing obligations are met in line with regulatory requirements.
- Regulatory Affairs: Manages submissions through portals such as FDA CDER NextGen, EMA Data Sharing, and WHO ICTRP repositories.
- Data Management: Prepares anonymized datasets and metadata for submission.
- Statisticians: Generate analysis outputs and ensure integrity of statistical datasets.
- QA: Conducts QC checks on data packages prior to submission.
Accountability
The Sponsor’s Regulatory Head is accountable for ensuring accurate and timely data sharing with regulators and repositories. QA is accountable for verifying data integrity and compliance with GCP and privacy regulations.
Procedure
1. Planning
1.1 Develop Data Sharing Plan outlining obligations, datasets, repositories, and timelines.
1.2 Maintain Data Sharing Plan Log (Annexure-1).
2. Data Preparation
2.1 Extract data post-database lock.
2.2 Anonymize patient-level data in compliance with GDPR and HIPAA.
2.3 Prepare standardized datasets (e.g., CDISC SDTM, ADaM).
2.4 Maintain Data Preparation Log (Annexure-2).
3. Regulatory Submissions
3.1 Submit datasets through regulatory portals (FDA, EMA, CDSCO).
3.2 Upload supporting documents such as CSR, protocols, and SAP.
3.3 Maintain Regulatory Submission Log (Annexure-3).
4. Repository Sharing
4.1 Share trial data with WHO ICTRP and approved repositories where applicable.
4.2 Document repository submissions in Repository Sharing Log (Annexure-4).
5. Quality Control
5.1 QA verifies completeness, accuracy, and anonymization adequacy of data packages.
5.2 Document QC in Data Sharing QC Log (Annexure-5).
6. Archiving
6.1 Archive submitted datasets, logs, and confirmation receipts in TMF.
6.2 Retain in compliance with global archiving standards.
Abbreviations
- SOP: Standard Operating Procedure
- CSR: Clinical Study Report
- QA: Quality Assurance
- CRO: Contract Research Organization
- TMF: Trial Master File
- CDISC: Clinical Data Interchange Standards Consortium
- SDTM: Study Data Tabulation Model
- ADaM: Analysis Data Model
- EMA: European Medicines Agency
- FDA: Food and Drug Administration
- WHO: World Health Organization
- CDSCO: Central Drugs Standard Control Organization
- HIPAA: Health Insurance Portability and Accountability Act
- GDPR: General Data Protection Regulation
Documents
- Data Sharing Plan Log (Annexure-1)
- Data Preparation Log (Annexure-2)
- Regulatory Submission Log (Annexure-3)
- Repository Sharing Log (Annexure-4)
- Data Sharing QC Log (Annexure-5)
References
- ICH E6(R2/R3) – Data Sharing Requirements
- FDA – Study Data Standards and Submissions
- EMA – Policy on Clinical Data Publication
- CDSCO – Clinical Data Sharing Regulations
- WHO – Data Sharing Standards
Version: 1.0
Approval Section
| Prepared By | Ravi Kumar, Data Manager |
| Checked By | Sunita Reddy, QA Officer |
| Approved By | Dr. Anil Sharma, Head Regulatory Affairs |
Annexures
Annexure-1: Data Sharing Plan Log
| Date | Trial ID | Obligation | Responsible | Status |
|---|---|---|---|---|
| 01/09/2025 | Study-456 | CSR + IPD Sharing | Regulatory Affairs | Planned |
Annexure-2: Data Preparation Log
| Date | Dataset | Activity | Prepared By | Status |
|---|---|---|---|---|
| 05/09/2025 | ADaM Efficacy Dataset | Anonymized | Data Manager | Completed |
Annexure-3: Regulatory Submission Log
| Date | Agency | Data Package | Submitted By | Status |
|---|---|---|---|---|
| 10/09/2025 | FDA | CSR + SDTM Datasets | Regulatory Affairs | Accepted |
Annexure-4: Repository Sharing Log
| Date | Repository | Data Shared | Submitted By | Status |
|---|---|---|---|---|
| 15/09/2025 | WHO ICTRP | Anonymized IPD | Data Manager | Submitted |
Annexure-5: Data Sharing QC Log
| Date | Package | Reviewed By | QC Findings | Status |
|---|---|---|---|---|
| 20/09/2025 | EMA Data Package | QA Officer | No findings | Approved |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 26/08/2025 | 00 | Initial version | New SOP creation | Head Regulatory Affairs |
For more SOPs visit: Pharma SOP