{
“@context”: “https://schema.org”,
“@type”: “Article”,
“mainEntityOfPage”: {
“@type”: “WebPage”,
“@id”: “https://www.clinicalstudies.in/sop-for-ictrp-trial-registration-alignment-who-registry-expectations”
},
“headline”: “SOP for ICTRP Trial Registration Alignment (WHO Registry Expectations)”,
“description”: “This SOP defines procedures for aligning clinical trial registration with the WHO International Clinical Trials Registry Platform (ICTRP). It establishes responsibilities for sponsors, CROs, and investigators to ensure transparency, compliance, and public accessibility of trial data.”,
“author”: {
“@type”: “Organization”,
“name”: “ClinicalStudies.in”
},
“publisher”: {
“@type”: “Organization”,
“name”: “ClinicalStudies.in”,
“logo”: {
“@type”: “ImageObject”,
“url”: “https://www.clinicalstudies.in/logo.png”
}
},
“datePublished”: “2025-08-26”,
“dateModified”: “2025-08-26”
}

Standard Operating Procedure for ICTRP Trial Registration Alignment (WHO Registry Expectations)

Purpose

The purpose of this SOP is to outline procedures for aligning clinical trial registration with the World Health Organization’s 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

Annexures

Annexure-1: Registry Selection Log

Annexure-2: Registration Log

Annexure-3: Amendment Registration Log

Annexure-4: Result Posting Log

Annexure-5: Registry Audit Log

Revision History

For more SOPs visit: Pharma SOP