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 |