Standard Operating Procedure for Translation and Back-Translation of Consent Forms in BA/BE Studies
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/023/2025 |
| Supersedes | SOP/BA-BE/023/2022 |
| Page No. | Page 1 of 12 |
| Issue Date | 17/04/2025 |
| Effective Date | 20/04/2025 |
| Review Date | 17/04/2026 |
1. Purpose
To establish a standard process for the translation and back-translation of Informed Consent Forms (ICFs) and Subject Information Sheets (SIS) into regional languages for use in Bioavailability/Bioequivalence (BA/BE) studies, ensuring clarity, accuracy, and cultural appropriateness.
2. Scope
This SOP applies to all BA/BE studies involving human participants where consent documents must be provided in local languages to ensure informed decision-making by trial subjects.
3. Responsibilities
- Medical Writing: Provides source English documents and initiates translation.
- Regulatory Affairs: Reviews final translations for consistency and compliance.
- Certified Translator: Translates the document from English to regional language.
- Independent Back-Translator: Translates the regional version back into English for verification.
4. Accountability
The Head of Medical Affairs is accountable for ensuring that all translated ICFs used in the study are accurate, ethically appropriate, and approved by the respective Ethics Committee.
5. Procedure
5.1 Initiating Translation
- Request translation once the English ICF and SIS are finalized and internally approved.
- Select a qualified and experienced translator for each language (Annexure-1: Translator Qualification Log).
- Provide the translator with:
- English ICF/SIS in editable format
- Protocol summary for reference
5.2 Quality of Forward Translation
- Translator prepares regional language version, ensuring:
- Simple, lay language (8th-grade level)
- Retention of study purpose, risks, and rights
- Appropriate use of local medical terminology
- Initial review conducted by Medical Writer and PI fluent in that language.
5.3 Back-Translation
- Engage a different translator (independent from the first) to conduct back-translation.
- Compare back-translated version with original English ICF line-by-line.
- Document any discrepancies in Annexure-2: Translation Comparison Log.
- Resolve inconsistencies through consensus with translators and Medical Writing.
5.4 Ethics Committee Submission
- Submit the finalized regional language and English versions to the EC along with:
- Certification of accuracy from translator (Annexure-3)
- Back-translation verification report
5.5 Archiving and Version Control
- Label each language version with version number and approval date.
- Maintain the master tracker in Annexure-4: Consent Translation Master Log.
- Store signed/stamped EC-approved versions in the eTMF and site files.
6. Abbreviations
- ICF: Informed Consent Form
- SIS: Subject Information Sheet
- EC: Ethics Committee
- eTMF: Electronic Trial Master File
- SOP: Standard Operating Procedure
7. Documents
- Translator Qualification Log – Annexure-1
- Translation Comparison Log – Annexure-2
- Certification of Translation Accuracy – Annexure-3
- Consent Translation Master Log – Annexure-4
8. References
- ICH E6(R2) – Good Clinical Practice
- Schedule Y – Drugs and Cosmetics Rules
- ICMR National Ethical Guidelines
- 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: Translator Qualification Log
| Name | Language | Qualification | Experience (Years) | Approved By |
|---|---|---|---|---|
| Ravi Sharma | Hindi | MA Linguistics | 8 | Dr. A. Sinha |
Annexure-2: Translation Comparison Log
| Section | Original English | Back-Translated Text | Discrepancy Noted | Resolution |
|---|---|---|---|---|
| Risks | Nausea is a common effect | Nausea is sometimes expected | Yes | Revised to match original |
Annexure-3: Certification of Translation Accuracy
| Translator Name | Language | Date | Certification Statement |
|---|---|---|---|
| Seema Reddy | Telugu | 10/04/2025 | This translation is accurate and culturally appropriate |
Annexure-4: Consent Translation Master Log
| Study Code | Language | Version | EC Approval Date | Status |
|---|---|---|---|---|
| BE-033 | Hindi | V1.0 | 15/04/2025 | Approved |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 10/01/2022 | 1.0 | Initial SOP | New SOP release | QA Head |
| 17/04/2025 | 2.0 | Updated annexures and added back-translation process detail | Regulatory update | QA Head |