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

1. Record the initial IEC/IRB approval date in Annexure-1: Review Calendar Tracker.
2. Set alert reminders 60 and 30 days prior to expiration of IEC/IRB approval.

5.2 Compilation of Continuing Review Package

1. 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   • Participant status report (enrolled, completed, withdrawn)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
2. Ensure all documents are signed and version-controlled.

5.3 Internal Review and Approvals

1. Regulatory Affairs reviews for completeness and compliance.
2. PI reviews and signs cover letter and CRA form.

5.4 Submission to IEC/IRB

1. Submit within the timeline specified by the respective IEC/IRB (usually 30 days prior to expiry).
2. Track date of submission and acknowledgment in Annexure-2: CRA Submission Log.

5.5 Response to IEC/IRB Comments

1. Address any follow-up queries received from IEC/IRB within stipulated timelines.
2. Document changes and correspondence in Annexure-3: CRA Communication Tracker.

5.6 Approval and Documentation

1. 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

1. Review Calendar Tracker – Annexure-1
2. CRA Submission Log – Annexure-2
3. 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