Standard Operating Procedure for Responding to Ethics Committee Queries in BA/BE Studies

Department	BA-BE Studies
SOP No.	SOP/BA-BE/017/2025
Supersedes	SOP/BA-BE/017/2022
Page No.	Page 1 of 12
Issue Date	17/04/2025
Effective Date	20/04/2025
Review Date	17/04/2026

1. Purpose

To define a systematic and compliant process for addressing Ethics Committee (EC) or Institutional Review Board (IRB) queries related to Bioavailability/Bioequivalence (BA/BE) studies to ensure timely resolution, protocol integrity, and ethical compliance.

2. Scope

This SOP applies to all BA/BE studies involving EC/IRB submissions, including initial reviews, amendments, and continuing reviews across global and Indian clinical research centers.

3. Responsibilities

• Regulatory Affairs: Coordinates response preparation and ensures all communications are aligned with regulatory standards.
• Clinical Study Team: Provides data, documents, or clarifications needed for EC query resolution.
• Medical Writer: Drafts written responses or updates to protocols/ICFs as applicable.
• Principal Investigator (PI): Reviews and signs response packages before submission.

4. Accountability

The Head of Clinical Operations is accountable for ensuring that all EC queries are responded to within stipulated timelines and tracked for regulatory and audit readiness.

5. Procedure

5.1 Query Receipt and Acknowledgment

1. Receive query communication from the EC via email, portal, or physical letter.
2. Enter query details in Annexure-1: Ethics Committee Query Log.
3. Acknowledge receipt within 1–2 working days to the EC (if acknowledgment requested).

5.2 Query Review and Assignment

1. Assign responsible personnel for each query category:
   • Protocol-related – Medical Affairs / Clinical Team
   • Informed Consent – Medical Writer / Legal
   • Site Documentation – Regulatory / PI
2. Discuss complex queries in a cross-functional meeting.

5.3 Response Preparation

1. Draft responses in clear, concise, and scientifically valid language.
2. Include supporting documentation (highlighted and version-controlled).
3. Maintain version history in Annexure-2: Query Response Compilation Sheet.

5.4 Review and Approval

1. Clinical team and Regulatory Affairs review the final response package.
2. PI to review and sign cover letter or relevant forms.

5.5 Submission to Ethics Committee

1. Submit via EC’s preferred method (physical, email, portal).
2. Track submission status in Annexure-3: EC Response Submission Tracker.

5.6 Post-Submission Documentation

1. File all queries, responses, and approvals in the electronic Trial Master File (eTMF).
2. Document EC feedback, conditional approvals, or further clarifications.

6. Abbreviations

• EC: Ethics Committee
• IRB: Institutional Review Board
• PI: Principal Investigator
• eTMF: Electronic Trial Master File
• SOP: Standard Operating Procedure

7. Documents

1. Ethics Committee Query Log – Annexure-1
2. Query Response Compilation Sheet – Annexure-2
3. EC Response Submission Tracker – Annexure-3

8. References

• ICH E6(R2) – Good Clinical Practice
• Schedule Y – Drugs and Cosmetics Rules, India
• WHO GCP 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: Ethics Committee Query Log

Date Received	EC Name	Study Code	Query Summary	Assigned To
12/04/2025	Institutional EC – Delhi	BE-027	Clarify sample size calculation	Dr. Ramesh Sinha

Annexure-2: Query Response Compilation Sheet

Query No.	Query	Response	Version	Date
1	ICF lacks SAE reporting details	Added SAE clause in Section 6	V2.0	13/04/2025

Annexure-3: EC Response Submission Tracker

Submission Date	Study Code	Method	Status	Remarks
15/04/2025	BE-027	Email	Under EC Review	Submitted with revised ICF

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
15/01/2022	1.0	Initial release	New SOP	QA Head
17/04/2025	2.0	Added annexures, clarified cross-functional responsibilities	Process Improvement	QA Head