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

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 Submission Log

Date	Registry	Submission Type	Submitted By	Status
01/09/2025	ClinicalTrials.gov	Initial Registration	Regulatory Specialist	Completed

Annexure-2: Registry Update Log

Date	Registry	Update Type	Updated By	Status
10/09/2025	EU CTR	Protocol Amendment	Regulatory Affairs	Completed

Annexure-3: Results Posting Log

Date	Registry	Results Type	Submitted By	Status
20/09/2025	WHO ICTRP	Primary Results	Data Manager	Submitted

Annexure-4: Sponsor Oversight Report

Date	Trial	Registry	Status	Reviewed By
25/09/2025	Study-123	ClinicalTrials.gov	Results Posted	QA Officer

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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