BA-BE Studies: SOP for Developing Informed Consent Documents – V 2.0

Standard Operating Procedure for Developing Informed Consent Documents in BA/BE Studies

Department	BA-BE Studies
SOP No.	SOP/BA-BE/022/2025
Supersedes	SOP/BA-BE/022/2022
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 process for developing, reviewing, and finalizing informed consent documents (ICDs) including Informed Consent Forms (ICFs), Subject Information Sheets (SIS), and other relevant materials for use in BA/BE studies, in accordance with ICH GCP, Schedule Y, and EC requirements.

2. Scope

This SOP applies to all personnel involved in the preparation of consent documents for BA/BE studies conducted in India or other regions where ethics

approval is required before human subject participation.

3. Responsibilities

Medical Writer: Drafts the ICF and SIS based on protocol and regulatory requirements.
Regulatory Affairs: Reviews the document for compliance with local and international guidelines.
Legal/Compliance: Reviews indemnity and compensation clauses.
Principal Investigator (PI): Reviews site-specific content and confirms readability and comprehension.

4. Accountability

The Head of Clinical Operations is accountable for ensuring that informed consent documents are complete, understandable, approved by the Ethics Committee, and used only after formal approval.

5. Procedure

5.1 Initial Drafting of the ICF

Use a company-approved template that includes:
- Title of the study
- Purpose and procedures
- Study duration
- Risks and benefits
- Confidentiality
- Compensation details
- Voluntary participation and withdrawal
Draft the Subject Information Sheet (SIS) in simple, lay language (8th-grade level or below).
Ensure consistency between ICF and protocol objectives.

5.2 Review and Translation

Medical Writing and Regulatory Affairs jointly review the draft ICF and SIS for accuracy and regulatory compliance.
Upon internal approval, initiate translation into local languages (Hindi, Marathi, Tamil, etc.).
Perform back-translation to confirm accuracy.
Track document versions and translation approvals in Annexure-1: ICF Review and Translation Log.

5.3 Ethics Committee Submission

Submit both English and regional language ICFs and SIS to the EC for review and approval.
Address EC queries and update documents accordingly.
File EC approval letters in the trial master file.

5.4 Version Control and Distribution

Assign version numbers to each language version (e.g., V1.0, V1.1).
Maintain master list of all approved versions in Annexure-2: ICF Version Control Log.
Distribute only EC-approved and stamped copies to sites.

5.5 Amendments and Revisions

Update ICFs when:
- Protocol is amended
- New safety data becomes available
- Compensation policy changes
Follow full review and approval cycle for revised versions.

6. Abbreviations

ICF: Informed Consent Form
SIS: Subject Information Sheet
EC: Ethics Committee
PI: Principal Investigator
SOP: Standard Operating Procedure

7. Documents

ICF Review and Translation Log – Annexure-1
ICF Version Control Log – Annexure-2

8. References

ICH E6(R2) – Good Clinical Practice
Schedule Y – Drugs and Cosmetics Rules
CDSCO Guidelines on Informed Consent
Declaration of Helsinki – Ethical Principles for Medical Research

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: ICF Review and Translation Log

Language	Version	Translator	Back-Translator	Date Approved
Hindi	V1.0	Ravi Sharma	Seema Nair	12/04/2025

Annexure-2: ICF Version Control Log

ICF Version	Date Finalized	Study Code	Status
V1.0	10/04/2025	BE-032	Approved

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
10/01/2022	1.0	Initial SOP	New Implementation	QA Head
17/04/2025	2.0	Added annexures and clarified translation process	Regulatory Alignment	QA Head