Standard Operating Procedure for Ethics Committee Submission Requirements in BA/BE Studies

Department	BA-BE Studies
SOP No.	SOP/BA-BE/016/2025
Supersedes	SOP/BA-BE/016/2022
Page No.	Page 1 of 13
Issue Date	17/04/2025
Effective Date	20/04/2025
Review Date	17/04/2026

1. Purpose

To establish a systematic procedure for compiling, reviewing, and submitting required documentation to Ethics Committees (ECs) or Institutional Review Boards (IRBs) to obtain ethical clearance for conducting Bioavailability/Bioequivalence (BA/BE) studies.

2. Scope

This SOP is applicable to all BA/BE studies conducted at clinical research centers and covers the preparation, submission, and tracking of documents required for EC/IRB approval.

3. Responsibilities

• Regulatory Affairs: Prepares and reviews EC submission packages.
• Clinical Study Coordinator: Assists in documentation collation and submission.
• Medical Writer: Provides study synopsis and protocol documents.
• Principal Investigator (PI): Signs relevant forms and ensures site compliance.

4. Accountability

The Head of Clinical Operations is accountable for ensuring timely and complete submissions to the EC/IRB and that no study activities begin without valid EC approval.

5. Procedure

5.1 Identification of EC Requirements

1. Contact the designated EC to obtain submission guidelines and timelines.
2. Verify:
   • Meeting schedules
   • Format (physical/electronic)
   • Required number of hard copies
3. Record EC details in Annexure-1: Ethics Committee Contact Log.

5.2 Compilation of Submission Dossier

1. Ensure inclusion of:
   • Study Protocol (signed and dated)
   • Investigator’s Brochure (IB)
   • Informed Consent Form (ICF) in English and local language
   • Study Synopsis
   • Insurance Certificate
   • Clinical Trial Agreement (if applicable)
   • PI’s CV (updated within last 12 months)
   • Site infrastructure and IEC registration details
2. Use checklist in Annexure-2: EC Submission Document Checklist.

5.3 Submission and Acknowledgment

1. Submit documents per EC schedule.
2. Obtain acknowledgment receipt (physical stamp or email confirmation).
3. Update status in Annexure-3: EC Submission Tracker.

5.4 Communication and Query Resolution

1. Track EC response timeframes.
2. Respond to EC queries promptly, submitting revised documents as necessary.
3. Maintain records of all correspondence and clarifications.

5.5 Final Approval and Archiving

1. Upon receipt of EC approval letter:
   • Verify approval period and conditions (if any)
   • Share copies with QA, PI, and sponsor
2. File signed approval letter in the study master file and eTMF.

6. Abbreviations

• EC: Ethics Committee
• IRB: Institutional Review Board
• PI: Principal Investigator
• ICF: Informed Consent Form
• eTMF: Electronic Trial Master File

7. Documents

1. Ethics Committee Contact Log – Annexure-1
2. EC Submission Document Checklist – Annexure-2
3. EC Submission Tracker – Annexure-3

8. References

• ICH E6 (R2) – Good Clinical Practice
• Schedule Y – Drugs and Cosmetics Rules
• Declaration of Helsinki

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 Contact Log

EC Name	Contact Person	Email	Phone	Submission Mode
Institutional EC – Mumbai	Dr. R. Mehra	ec@mumbai-institute.in	022-23456789	Physical

Annexure-2: EC Submission Document Checklist

Document	Submitted (Y/N)	Remarks
Protocol	Yes	Signed by PI
ICF (English)	Yes	Version 2.0
Insurance Certificate	Yes	Valid for 1 year

Annexure-3: EC Submission Tracker

Study Code	Submission Date	EC Name	Acknowledgment Received	Status
BE-025	12/04/2025	Institutional EC – Mumbai	Yes	Under Review

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
12/01/2022	1.0	Initial release	New SOP	QA Head
17/04/2025	2.0	Updated to reflect EC digital submissions and added annexures	Process Harmonization	QA Head