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

1. Request translation once the English ICF and SIS are finalized and internally approved.
2. Select a qualified and experienced translator for each language (Annexure-1: Translator Qualification Log).
3. Provide the translator with:
   • English ICF/SIS in editable format
   • Protocol summary for reference

5.2 Quality of Forward Translation

1. 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
2. Initial review conducted by Medical Writer and PI fluent in that language.

5.3 Back-Translation

1. Engage a different translator (independent from the first) to conduct back-translation.
2. Compare back-translated version with original English ICF line-by-line.
3. Document any discrepancies in Annexure-2: Translation Comparison Log.
4. Resolve inconsistencies through consensus with translators and Medical Writing.

5.4 Ethics Committee Submission

1. 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

1. Label each language version with version number and approval date.
2. Maintain the master tracker in Annexure-4: Consent Translation Master Log.
3. 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

1. Translator Qualification Log – Annexure-1
2. Translation Comparison Log – Annexure-2
3. Certification of Translation Accuracy – Annexure-3
4. 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