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“headline”: “SOP for FDAAA 801 Registration/Results Posting (PRS Compliance)”,
“description”: “This SOP defines procedures for registering clinical trials and posting results on ClinicalTrials.gov to ensure compliance with FDAAA 801 and PRS requirements. It covers timelines, sponsor responsibilities, CRO oversight, quality control, and inspection readiness.”,
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Published on 22/12/2025
Standard Operating Procedure for FDAAA 801 Registration/Results Posting (PRS Compliance)
| SOP No. | CR/OPS/129/2025 |
| Supersedes | NA |
| Page No. | 1 of 71 |
| Issue Date | 26/08/2025 |
| Effective Date | 01/09/2025 |
| Review Date | 01/09/2026 |
Purpose
The purpose of this SOP is to establish procedures for registering clinical trials and posting results on ClinicalTrials.gov in compliance with the FDA Amendments
Scope
This SOP applies to sponsors, investigators, CROs, regulatory affairs teams, and data managers responsible for ClinicalTrials.gov submissions. It covers registration before trial initiation, updates during the trial, results posting upon completion, and handling of FDA inspections.
Responsibilities
- Sponsor: Ensures all applicable trials are registered and results are submitted within timelines.
- Investigator: Provides accurate study information and ensures data integrity.
- Regulatory Affairs: Prepares, reviews, and submits PRS entries to ClinicalTrials.gov.
- CRO: Supports PRS compliance activities and conducts quality reviews.
- QA: Audits PRS processes and ensures inspection readiness.
Accountability
The Sponsor’s Regulatory Affairs Lead is accountable for compliance with FDAAA 801 PRS requirements. Investigators are accountable for providing complete and accurate study data.
Procedure
1. Trial Registration
1.1 Register applicable clinical trials on ClinicalTrials.gov within 21 days of first subject enrollment.
1.2 Record in PRS Registration Log (Annexure-1).
2. Updates During the Trial
2.1 Update trial information within 30 days of protocol amendments or recruitment status changes.
2.2 Maintain updates in PRS Amendment Log (Annexure-2).
3. Results Posting
3.1 Submit summary results within 12 months of primary completion date.
3.2 Include baseline data, outcomes, adverse events, and protocol.
3.3 Record in PRS Results Posting Log (Annexure-3).
4. Quality Control
4.1 Perform internal QC checks before PRS submission.
4.2 Address ClinicalTrials.gov QC comments within 25 days.
4.3 Record in PRS QC Log (Annexure-4).
5. Compliance Monitoring
5.1 Maintain tracking of registration and results timelines.
5.2 Document compliance in PRS Compliance Log (Annexure-5).
6. Inspection Readiness
6.1 Ensure PRS records are inspection-ready.
6.2 Conduct mock inspections documented in PRS Inspection Readiness Log (Annexure-6).
Abbreviations
- SOP: Standard Operating Procedure
- PRS: Protocol Registration and Results System
- FDA: Food and Drug Administration
- FDAAA: Food and Drug Administration Amendments Act
- CRO: Contract Research Organization
- QA: Quality Assurance
- TMF: Trial Master File
- ISF: Investigator Site File
Documents
- PRS Registration Log (Annexure-1)
- PRS Amendment Log (Annexure-2)
- PRS Results Posting Log (Annexure-3)
- PRS QC Log (Annexure-4)
- PRS Compliance Log (Annexure-5)
- PRS Inspection Readiness Log (Annexure-6)
References
- ClinicalTrials.gov PRS User Guide
- FDA – FDAAA 801 Requirements
- 42 CFR Part 11 – Clinical Trials Registration and Results Submission
- ICH GCP – Transparency and Disclosure Standards
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: PRS Registration Log
| Date | Protocol ID | Registration Completed | Submitted By | Status |
|---|---|---|---|---|
| 01/09/2025 | FDA-TRIAL-01 | Yes | Reg Affairs | Filed |
Annexure-2: PRS Amendment Log
| Date | Protocol ID | Amendment | Submitted To PRS | Status |
|---|---|---|---|---|
| 02/09/2025 | FDA-TRIAL-01 | Recruitment Status Update | Yes | Completed |
Annexure-3: PRS Results Posting Log
| Date | Protocol ID | Results Submitted | Submitted By | Status |
|---|---|---|---|---|
| 03/09/2025 | FDA-TRIAL-01 | Yes | Data Manager | Filed |
Annexure-4: PRS QC Log
| Date | Protocol ID | QC Performed By | Comments Addressed | Status |
|---|---|---|---|---|
| 04/09/2025 | FDA-TRIAL-01 | QA Officer | Yes | Cleared |
Annexure-5: PRS Compliance Log
| Date | Protocol ID | Compliance Status | Reviewed By |
|---|---|---|---|
| 05/09/2025 | FDA-TRIAL-01 | Compliant | QA Officer |
Annexure-6: PRS Inspection Readiness Log
| Date | Agency | Inspection Simulation | Performed By | Status |
|---|---|---|---|---|
| 06/09/2025 | FDA | Mock Inspection | QA Team | Completed |
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