BA-BE Studies: SOP for Protocol Amendment Approval Process – V 2.0

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Standard Operating Procedure for Protocol Amendment Approval Process in BA/BE Studies

Department	BA-BE Studies
SOP No.	SOP/BA-BE/019/2025
Supersedes	SOP/BA-BE/019/2022
Page No.	Page 1 of 13
Issue Date	17/04/2025
Effective Date	20/04/2025
Review Date	17/04/2026

1. Purpose

To define the procedure for initiating, reviewing, approving, and implementing protocol amendments in BA/BE clinical studies, ensuring compliance with regulatory guidelines, Good Clinical Practice (GCP), and Ethics Committee (EC) requirements.

2. Scope

This SOP applies to all protocol amendments in ongoing or planned BA/BE studies sponsored or supported by the organization, including substantial and non-substantial changes impacting subject safety, data integrity, or study design.

3. Responsibilities

Clinical Research Team: Identifies need for protocol change and drafts amendment.
Medical Writer: Revises protocol document and synopsis with track changes and clean version.
Regulatory Affairs: Prepares amendment cover letter and coordinates submission to EC and regulatory authorities.
Quality Assurance: Verifies version control and maintains documentation in eTMF.

4. Accountability

The Clinical Trial Manager is accountable for ensuring that no changes to the protocol are implemented prior to approval by the EC/IRB and applicable regulatory authorities, unless necessary to eliminate immediate hazards to study subjects.

5. Procedure

5.1 Identification of Need for Amendment

Document any required changes to protocol due to:
- New safety data
- Operational feasibility
- Regulatory feedback
- Scientific developments
Record reason in Annexure-1: Amendment Justification Form.

5.2 Drafting the Protocol Amendment

Medical Writer prepares:
- Revised protocol with tracked changes
- Clean revised version
- Updated synopsis (if applicable)
Ensure new version number (e.g., V 2.0 to V 3.0) and revision date are applied.

5.3 Internal Review and Approval

Circulate amendment for internal review by:
- Medical Affairs
- Biostatistics
- Clinical Operations
- QA
Document internal sign-offs in Annexure-2: Internal Amendment Approval Log.

5.4 Ethics Committee and Regulatory Submission

Submit amendment package including:
- Cover letter
- Revised protocol versions
- Highlight of changes
- Updated ICF (if required)
- Investigator communication
Track submission and approval timelines in Annexure-3: Amendment Submission Tracker.

5.5 Implementation and Communication

Upon approval:
- Notify sites and provide updated documents
- Train site personnel on changes
- Update all systems and databases

5.6 Archiving

Store all versions and approval letters in the eTMF.
Maintain amendment version history table in protocol appendix.

6. Abbreviations

EC: Ethics Committee
IRB: Institutional Review Board
GCP: Good Clinical Practice
eTMF: Electronic Trial Master File
SOP: Standard Operating Procedure

7. Documents

Amendment Justification Form – Annexure-1
Internal Amendment Approval Log – Annexure-2
Amendment Submission Tracker – Annexure-3

8. References

ICH E6 (R2) – Good Clinical Practice
USFDA – Protocol Amendments Guidance
EMA – GCP Compliance 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: Amendment Justification Form

Date	Protocol No.	Change Summary	Reason for Amendment
10/04/2025	BE/029/2024	Change in PK sampling window	Scientific rationale update

Annexure-2: Internal Amendment Approval Log

Department	Reviewed By	Date	Remarks
Clinical	Dr. Rajesh Mehta	11/04/2025	Approved

Annexure-3: Amendment Submission Tracker

Submission Date	EC Name	Status	Approval Date	Remarks
12/04/2025	IEC Pune	Approved	15/04/2025	Clean version filed

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
15/01/2022	1.0	Initial version	New SOP	QA Head
17/04/2025	2.0	Included tracker, eTMF reference, clarified substantial changes	GCP Alignment	QA Head