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Standard Operating Procedure for Data Sharing/Transparency in Public Health Emergencies

Purpose

The purpose of this SOP is to establish structured procedures for timely data sharing and transparency in clinical trials conducted during public health emergencies (e.g., pandemics, epidemics). It aligns with WHO guidance to ensure that trial results contribute rapidly to public health decision-making, while maintaining ethical and regulatory compliance.

Scope

This SOP applies to sponsors, CROs, investigators, regulatory affairs teams, and data managers involved in trials conducted during emergencies. It covers trial registration, expedited data sharing, publication requirements, and communication with regulators, WHO, and the public.

Responsibilities

• Sponsor: Ensures timely data release to WHO and national authorities.
• CRO: Facilitates operational aspects of emergency data sharing.
• Investigator: Ensures accurate and real-time reporting of trial data.
• Regulatory Affairs: Coordinates communication with health authorities and WHO.
• QA: Audits emergency data sharing records for compliance.

Accountability

The Sponsor’s Regulatory and Clinical Heads are accountable for ensuring that trial data are rapidly and transparently shared with global health authorities during emergencies.

Procedure

1. Trial Registration
1.1 Register trial in WHO ICTRP-recognized registry prior to enrollment.
1.2 Ensure registry updates every 30 days.
1.3 Document in Trial Registration Log (Annexure-1).

2. Interim Data Sharing
2.1 Submit interim safety and efficacy results to WHO and regulators within agreed timelines.
2.2 Share aggregated anonymized data with public health stakeholders.
2.3 Record in Interim Data Sharing Log (Annexure-2).

3. Final Results Disclosure
3.1 Publish trial results within 6 months of study completion in open-access platforms.
3.2 Notify WHO and regulators of data availability.
3.3 Document in Final Results Disclosure Log (Annexure-3).

4. Communication
4.1 Provide regular updates to trial participants and affected communities.
4.2 Maintain transparency through press releases, websites, or public dashboards.
4.3 Document in Communication Log (Annexure-4).

5. Archiving
5.1 Archive shared data, communications, and reports in TMF and ISF.
5.2 Record details in Data Archiving Log (Annexure-5).

Abbreviations

• SOP: Standard Operating Procedure
• WHO: World Health Organization
• ICTRP: International Clinical Trials Registry Platform
• CRO: Contract Research Organization
• QA: Quality Assurance
• TMF: Trial Master File
• ISF: Investigator Site File

Documents

1. Trial Registration Log (Annexure-1)
2. Interim Data Sharing Log (Annexure-2)
3. Final Results Disclosure Log (Annexure-3)
4. Communication Log (Annexure-4)
5. Data Archiving Log (Annexure-5)

References

• WHO – Data Sharing in Public Health Emergencies
• WHO ICTRP
• ICH GCP Guidelines

Version: 1.0

Approval Section

Annexures

Annexure-1: Trial Registration Log

Annexure-2: Interim Data Sharing Log

Annexure-3: Final Results Disclosure Log

Annexure-4: Communication Log

Annexure-5: Data Archiving Log

Revision History

For more SOPs visit: Pharma SOP