Standard Operating Procedure for IEC/IRB Continuing Review Applications in BA/BE Studies
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/018/2025 |
| Supersedes | SOP/BA-BE/018/2022 |
| Page No. | Page 1 of 12 |
| Issue Date | 17/04/2025 |
| Effective Date | 20/04/2025 |
| Review Date | 17/04/2026 |
1. Purpose
To outline the procedure for preparing and submitting Continuing Review Applications (CRA) to Institutional Ethics Committees (IEC) or Institutional Review Boards (IRB) for BA/BE studies that exceed the initial approval period or are ongoing.
2. Scope
This SOP applies to all ongoing BA/BE studies conducted by or for the sponsor, requiring annual or periodic ethics review as per ICH GCP, Schedule Y,
and institutional EC/IRB policies.
3. Responsibilities
- Regulatory Affairs: Prepares and compiles the continuing review package and ensures timely submission.
- Clinical Study Team: Provides current enrollment, study progress, and safety updates.
- Principal Investigator (PI): Reviews, signs, and submits the CRA to the IEC/IRB.
- Quality Assurance: Ensures all continuing review documents are archived and tracked.
4. Accountability
The Head of Clinical Operations is accountable for ensuring that all studies maintain uninterrupted IEC/IRB approval through timely submission of continuing review documents.
5. Procedure
5.1 Tracking of Review Timelines
- Record the initial IEC/IRB approval date in Annexure-1: Review Calendar Tracker.
- Set alert reminders 60 and 30 days prior to expiration of IEC/IRB approval.
5.2 Compilation of Continuing Review Package
- Prepare following documents:
- Completed Continuing Review Application Form (CRA)
- Current protocol version
- Updated Investigator Brochure (if applicable)
- Participant status report (enrolled, completed, withdrawn)
- Summary of SAEs/SUSARs and deviations
- Updated insurance certificate
- Any new scientific information
- Ensure all documents are signed and version-controlled.
5.3 Internal Review and Approvals
- Regulatory Affairs reviews for completeness and compliance.
- PI reviews and signs cover letter and CRA form.
5.4 Submission to IEC/IRB
- Submit within the timeline specified by the respective IEC/IRB (usually 30 days prior to expiry).
- Track date of submission and acknowledgment in Annexure-2: CRA Submission Log.
5.5 Response to IEC/IRB Comments
- Address any follow-up queries received from IEC/IRB within stipulated timelines.
- Document changes and correspondence in Annexure-3: CRA Communication Tracker.
5.6 Approval and Documentation
- On receipt of IEC/IRB approval:
- Verify dates of extended approval period
- Distribute to clinical team and file in eTMF
6. Abbreviations
- IEC: Institutional Ethics Committee
- IRB: Institutional Review Board
- CRA: Continuing Review Application
- SAE: Serious Adverse Event
- eTMF: Electronic Trial Master File
7. Documents
- Review Calendar Tracker – Annexure-1
- CRA Submission Log – Annexure-2
- CRA Communication Tracker – Annexure-3
8. References
- ICH E6(R2) – Good Clinical Practice
- Schedule Y – Drugs and Cosmetics Rules
- Institutional EC Guidelines
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Review Calendar Tracker
| Study Code | Initial Approval Date | Expiry Date | Reminder Sent | CRA Due Date |
|---|---|---|---|---|
| BE-031 | 10/05/2024 | 09/05/2025 | Yes | 09/04/2025 |
Annexure-2: CRA Submission Log
| Submission Date | Study Code | EC Name | Acknowledgment Received | Status |
|---|---|---|---|---|
| 05/04/2025 | BE-031 | IEC-Ahmedabad | Yes | Under Review |
Annexure-3: CRA Communication Tracker
| Date | Study Code | Query Summary | Response Submitted | Remarks |
|---|---|---|---|---|
| 08/04/2025 | BE-031 | Clarification on AE reporting | 10/04/2025 | Revised CRA form attached |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 14/01/2022 | 1.0 | Initial SOP Release | New Procedure | QA Head |
| 17/04/2025 | 2.0 | Added trackers, clarified timelines, harmonized with ICH GCP | Audit Compliance | QA Head |