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Standard Operating Procedure for Data Sharing with Regulators and Repositories

Purpose

The purpose of this SOP is to define procedures for the secure and compliant sharing of clinical trial data with regulators and public repositories. Data sharing enhances transparency, facilitates regulatory review, and supports global scientific collaboration while protecting subject confidentiality.

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

1. Data Sharing Plan Log (Annexure-1)
2. Data Preparation Log (Annexure-2)
3. Regulatory Submission Log (Annexure-3)
4. Repository Sharing Log (Annexure-4)
5. 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

Annexures

Annexure-1: Data Sharing Plan Log

Annexure-2: Data Preparation Log

Annexure-3: Regulatory Submission Log

Annexure-4: Repository Sharing Log

Annexure-5: Data Sharing QC Log

Revision History

For more SOPs visit: Pharma SOP