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“description”: “This SOP describes the procedures for registering clinical trials and posting results in public registries including ClinicalTrials.gov, EU CTR/CTIS, and WHO ICTRP. It ensures compliance with FDAAA 801, EMA, WHO, CDSCO, and ICH GCP requirements for trial transparency.”,
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Standard Operating Procedure for Public Trial Registration and Results Posting (ClinicalTrials.gov/EU/WHO)

Purpose

The purpose of this SOP is to outline procedures for registering clinical trials and posting results in publicly accessible registries such as ClinicalTrials.gov, EU CTR/CTIS, and WHO ICTRP. This ensures regulatory compliance, promotes transparency, and supports global commitments to public disclosure of trial information.

Scope

This SOP applies to sponsors, CROs, regulatory affairs, and clinical operations staff responsible for registering clinical trials and posting results globally. It covers initial registration, updates, result posting, quality control, and compliance monitoring.

Responsibilities

• Sponsor: Ensures trial registration and result posting is performed within required timelines.
• Regulatory Affairs: Prepares, submits, and maintains trial information in registries.
• CROs: Support sponsor in registry submissions and ensure accuracy of data.
• QA: Audits registry submissions and verifies compliance with disclosure obligations.
• Data Management: Provides final datasets and results for posting.

Accountability

The Sponsor’s Regulatory Affairs Head is accountable for ensuring that trial registration and results posting are completed accurately and within global regulatory timelines.

Procedure

1. Initial Trial Registration
1.1 Register clinical trial prior to first subject enrollment.
1.2 Use ClinicalTrials.gov, EU CTR/CTIS, and WHO ICTRP depending on region and scope.
1.3 Maintain Registry Submission Log (Annexure-1).

2. Registry Updates
2.1 Update records within 30 days of protocol amendments or changes in status.
2.2 Document changes in Registry Update Log (Annexure-2).

3. Results Posting
3.1 Post results within 12 months of primary completion date (unless otherwise defined by regulations).
3.2 Include safety, efficacy, and statistical outcomes as per registry requirements.
3.3 Document in Results Posting Log (Annexure-3).

4. Quality Control
4.1 Regulatory Affairs performs QC review of all submissions.
4.2 Address queries or rejections from registry administrators promptly.

5. Disclosure Oversight
5.1 Establish oversight process for monitoring registry compliance.
5.2 Include disclosure status in Sponsor Oversight Report (Annexure-4).

6. Archiving
6.1 Archive registry submission records, approvals, and confirmations in TMF.
6.2 Retain per global regulatory timelines.

Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• CRO: Contract Research Organization
• TMF: Trial Master File
• EU CTR: European Union Clinical Trials Regulation
• CTIS: Clinical Trials Information System
• ICTRP: International Clinical Trials Registry Platform
• CSR: Clinical Study Report

Documents

1. Registry Submission Log (Annexure-1)
2. Registry Update Log (Annexure-2)
3. Results Posting Log (Annexure-3)
4. Sponsor Oversight Report (Annexure-4)

References

• ClinicalTrials.gov – Registration and Results Posting
• EU CTR/CTIS – Transparency Rules
• WHO ICTRP – Trial Registration Standards
• FDAAA 801 Requirements
• CDSCO – Indian Clinical Trial Registry (CTRI)

Version: 1.0

Approval Section

Annexures

Annexure-1: Registry Submission Log

Annexure-2: Registry Update Log

Annexure-3: Results Posting Log

Annexure-4: Sponsor Oversight Report

Revision History

For more SOPs visit: Pharma SOP