International Clinical Trials Registry Platform (ICTRP). It ensures transparency, ethical compliance, and accessibility of trial data to the global scientific community and public health stakeholders.

Scope

This SOP applies to sponsors, CROs, investigators, and regulatory affairs teams responsible for clinical trial registration. It covers registration with WHO ICTRP-recognized primary registries, updates, result postings, and inspection readiness for compliance with WHO and ICMJE requirements.

Responsibilities

• Sponsor: Ensures timely registration and posting of trial data in ICTRP-recognized registries.
• CRO: Coordinates registration process and maintains compliance on behalf of the sponsor.
• Investigator: Provides accurate trial information for registry submissions.
• Regulatory Affairs: Tracks registration timelines and compliance with country-specific registries.
• QA: Audits registry submissions for accuracy and completeness.

Accountability

The Sponsor is accountable for ensuring alignment with WHO ICTRP trial registration and result posting requirements, even when delegated to CROs.

Procedure

1. Trial Identification
1.1 Identify registry platform recognized by WHO ICTRP (e.g., ClinicalTrials.gov, EU CTR, CTRI).
1.2 Record details in Registry Selection Log (Annexure-1).

2. Initial Registration
2.1 Register trial before enrollment of the first subject.
2.2 Include WHO Trial Registration Data Set (TRDS) elements.
2.3 Document in Registration Log (Annexure-2).

3. Updates and Amendments
3.1 Submit updates within 30 days of protocol amendments.
3.2 Document updates in Amendment Registration Log (Annexure-3).

4. Result Posting
4.1 Post trial results within 12 months of trial completion.
4.2 Archive results in TMF.
4.3 Record in Result Posting Log (Annexure-4).

5. Inspection Readiness
5.1 Ensure registry entries are accurate and up-to-date.
5.2 Maintain inspection-ready records in Registry Audit Log (Annexure-5).

Abbreviations

• SOP: Standard Operating Procedure
• WHO: World Health Organization
• ICTRP: International Clinical Trials Registry Platform
• ICMJE: International Committee of Medical Journal Editors
• TRDS: Trial Registration Data Set
• CRO: Contract Research Organization
• QA: Quality Assurance
• TMF: Trial Master File

Documents

1. Registry Selection Log (Annexure-1)
2. Registration Log (Annexure-2)
3. Amendment Registration Log (Annexure-3)
4. Result Posting Log (Annexure-4)
5. Registry Audit Log (Annexure-5)

References

• WHO ICTRP
• ClinicalTrials.gov
• CTRI – Clinical Trials Registry India

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: Registry Selection Log

Date	Registry Selected	Protocol ID	Verified By	Status
01/09/2025	CTRI	CTA-2025-04	Reg Affairs	Confirmed

Annexure-2: Registration Log

Date	Registry	Protocol ID	Submitted By	Status
02/09/2025	CTRI	CTA-2025-04	Reg Affairs	Registered

Annexure-3: Amendment Registration Log

Date	Amendment	Protocol ID	Submitted By	Status
05/09/2025	Substantial Amendment	CTA-2025-04	Reg Affairs	Updated

Annexure-4: Result Posting Log

Date	Registry	Protocol ID	Posted By	Status
10/09/2025	CTRI	CTA-2025-04	Reg Affairs	Results Posted

Annexure-5: Registry Audit Log

Date	Audit Type	Performed By	Status
15/09/2025	WHO Registry Compliance Check	QA	Compliant

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

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