(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

Prepared By	Ravi Kumar, Regulatory Affairs Specialist
Checked By	Sunita Reddy, QA Officer
Approved By	Dr. Anil Sharma, Head Clinical Operations

Annexures

Annexure-1: Trial Registration Log

Date	Registry	Protocol ID	Registered By	Status
01/09/2025	CTRI	PHE-2025-01	Reg Affairs	Registered

Annexure-2: Interim Data Sharing Log

Date	Data Shared	Recipient	Shared By	Status
05/09/2025	Safety Data	WHO	PV Officer	Submitted

Annexure-3: Final Results Disclosure Log

Date	Results Published	Platform	Submitted By	Status
15/09/2025	Trial Report	Open Access Journal	Sponsor	Completed

Annexure-4: Communication Log

Date	Audience	Communication Type	By	Status
10/09/2025	Community	Public Meeting	Investigator	Completed

Annexure-5: Data Archiving Log

Date	Data Type	Archived By	Location	Status
20/09/2025	Safety & Results	QA	TMF	Archived

Revision History

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

For more SOPs visit: Pharma SOP