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“headline”: “SOP for Ethics Committee and IRB Continuing Review and Renewals”,
“description”: “This SOP outlines the regulatory-compliant process for EC/IRB continuing review and renewals to maintain ethical oversight of clinical trials, aligned with ICH GCP, FDA, EMA, CDSCO, and WHO guidelines.”,
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Published on 26/12/2025
Standard Operating Procedure for EC/IRB Continuing Review and Renewals
| Department | Clinical Research |
| SOP No. | CR/ETH/007/2025 |
| Supersedes | NA |
| Page No. | 1 of 21 |
| Issue Date | 26/08/2025 |
| Effective Date | 01/09/2025 |
| Review Date | 01/09/2026 |
Purpose
The purpose of this SOP is to describe the process for conducting Ethics Committee (EC) and Institutional Review Board (IRB) continuing reviews and renewals of clinical trials.
Scope
This SOP applies to all clinical research staff, investigators, regulatory affairs personnel, and quality assurance officers involved in the preparation, submission, and follow-up of EC/IRB continuing review and renewal applications for clinical trials.
Responsibilities
- Principal Investigator (PI): Prepares progress reports and renewal documents for submission to EC/IRB.
- Regulatory Affairs Manager: Coordinates submissions and ensures compliance with regional requirements.
- Clinical Research Associate (CRA): Collects site-level data and ensures accuracy of reports.
- Quality Assurance Officer: Reviews documents for completeness and compliance with applicable guidelines.
- Head of Clinical Research: Approves submissions before dispatch to EC/IRB.
Accountability
The Regulatory Affairs Head is accountable for ensuring that continuing review and renewal applications are submitted on time, complete, and compliant. Failure to maintain approvals may result in trial suspension or regulatory non-compliance.
Procedure
1. Identification of Renewal Requirement
Determine the renewal due date based on EC/IRB initial approval letter.
Notify PI and study team at least 60 days before renewal deadline.
2. Preparation of Renewal Package
Include protocol progress report, enrollment status, safety summary (AE/SAE reports), deviations, amendments since last approval, and updated Investigator’s Brochure if applicable.
Ensure all documents are updated and signed by responsible personnel.
3. Internal Review
QA reviews renewal package for completeness.
Head of Clinical Research reviews and approves the package.
4. Submission to EC/IRB
Submit renewal package in electronic or paper form as per EC/IRB requirements.
File proof of submission in Regulatory Communication Log.
5. Approval Tracking
Maintain EC/IRB Renewal Tracker with submission and approval dates.
Follow up until approval is received.
6. Post-Approval Implementation
Communicate approval to trial sites and sponsor.
Implement EC/IRB conditions, if any, prior to continuing the trial.
Abbreviations
- SOP: Standard Operating Procedure
- EC: Ethics Committee
- IRB: Institutional Review Board
- PI: Principal Investigator
- CRA: Clinical Research Associate
- QA: Quality Assurance
- AE: Adverse Event
- SAE: Serious Adverse Event
- TMF: Trial Master File
Documents
- EC/IRB Renewal Checklist (Annexure-1)
- EC/IRB Renewal Tracker (Annexure-2)
- Regulatory Communication Log (Annexure-3)
References
- ICH E6(R2) – Good Clinical Practice
- US FDA 21 CFR Part 56 – IRB Requirements
- EMA Clinical Trial Regulation (EU No. 536/2014)
- WHO Guidelines for Ethics Committees
- CDSCO Clinical Trial Rules, India (2019)
Version: 1.0
Approval Section
| Prepared By | Rajesh Kumar, Regulatory Affairs Specialist |
| Checked By | Sunita Reddy, QA Officer |
| Approved By | Dr. Anil Sharma, Head of Clinical Research |
Annexures
Annexure-1: EC/IRB Renewal Checklist
| Document | Included (Yes/No) | Remarks |
|---|---|---|
| Protocol Progress Report | Yes | Covering Jan–Jun 2025 |
| Safety Summary | Yes | All SAEs included |
| Updated Investigator’s Brochure | Yes | Version 5.0 submitted |
Annexure-2: EC/IRB Renewal Tracker
| Submission Date | EC/IRB Name | Approval Date | Status | Remarks |
|---|---|---|---|---|
| 05/09/2025 | Metro Ethics Committee | 25/09/2025 | Approved | Annual renewal granted |
Annexure-3: Regulatory Communication Log
| Date | Authority | Query | Response | Responsible Person |
|---|---|---|---|---|
| 15/09/2025 | Metro EC | Provide SAE follow-up details | Submitted updated safety table | Rajesh Kumar |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 26/08/2025 | 00 | Initial version | New SOP creation | Head, Clinical Research |
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