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Published on 23/12/2025

Chinese Language Consent and Document Localization SOP

Department	Clinical Research
SOP No.	CS/NMPA-DOC/180/2025
Supersedes	N.A.
Page No.	1 of 24
Issue Date	28/08/2025
Effective Date	05/09/2025
Review Date	05/09/2027

Purpose

This SOP defines the process for preparing, translating, and quality-assuring Chinese language informed consent forms (ICFs) and other essential trial documents. It ensures participants fully understand trial information in their native language and that sponsors comply with NMPA and ICH GCP requirements for subject comprehension and regulatory submissions.

Scope

This SOP applies to all subject-facing materials (ICFs, patient information sheets, diaries) and regulatory essential documents requiring Chinese translation for trials conducted in China. It covers forward translation, back-translation, quality assurance (QA), reconciliation, and storage of bilingual documents in Trial Master File (TMF) and Investigator Site File (ISF).

Responsibilities

• Sponsor: Ensures translated documents are available before subject enrollment.
• Principal Investigator (PI): Verifies participants have understood consent content and maintains signed Chinese ICFs.
• Clinical Research Coordinator (CRC): Supports the consent process and provides translated subject materials.
• Regulatory Affairs (RA): Submits translated essential documents to NMPA and Ethics Committees.
• Quality Assurance (QA): Reviews translation processes and ensures adherence to ALCOA+ principles.
• Translation Vendors: Provide certified translations and back-translations of critical documents.

Accountability

The Sponsor is accountable for ensuring availability and accuracy of Chinese translations for subject-facing documents. The PI is accountable for ensuring subjects are provided with comprehensible documents prior to informed consent.

Procedure

1. Identification of Documents Requiring Translation

1. Identify subject-facing materials (ICFs, patient instructions, diaries).
2. Identify essential regulatory documents requiring bilingual versions for submission to NMPA or ECs.
3. Document requirements in Translation Requirement Log (Annexure-1).

2. Forward Translation

1. Engage certified translators with medical and clinical trial expertise.
2. Translate documents into Simplified Chinese ensuring readability for lay participants.
3. File Certificate of Translation Accuracy in TMF.

3. Back-Translation

1. Conduct back-translation into English for critical documents (ICFs, safety narratives).
2. Reconcile differences between forward and back-translation versions.

4. Quality Assurance (QA) Review

1. QA reviews both versions to ensure medical accuracy and alignment with source content.
2. Document review outcome in Translation QA Log.

5. Ethics and Regulatory Submissions

1. Submit final bilingual versions to Ethics Committees and NMPA with CTA package.
2. File acknowledgment letters in TMF and ISF.

6. Informed Consent Process

1. Provide participants with Chinese ICFs during the consent process.
2. Ensure subjects understand trial risks, benefits, and procedures using interpreters if necessary.
3. Collect signed ICFs and maintain in ISF.

7. Archiving

1. Archive all bilingual documents and translation logs for at least 15 years or per NMPA requirements.

Abbreviations

• NMPA: National Medical Products Administration
• ICF: Informed Consent Form
• CRC: Clinical Research Coordinator
• PI: Principal Investigator
• RA: Regulatory Affairs
• QA: Quality Assurance
• TMF: Trial Master File
• ISF: Investigator Site File

Documents

1. Translation Requirement Log (Annexure-1)
2. Translation QA Log (Annexure-2)
3. Certificate of Translation Accuracy (Annexure-3)

References

• National Medical Products Administration (NMPA)
• ICH E6(R2) Good Clinical Practice
• ICH Efficacy Guidelines

Version: 1.0

Approval

Prepared By	Checked By	Approved By
Name: Rajesh Kumar Date: 20/08/2025 Signature: __________	Name: Sunita Reddy Date: 22/08/2025 Signature: __________	Name: Dr. Meera Iyer Date: 28/08/2025 Signature: __________

Annexures

Annexure-1: Translation Requirement Log

Date	Document	Language	Status	Reviewer
05/08/2025	ICF v1.0	Chinese	Completed	Rajesh Kumar

Annexure-2: Translation QA Log

Date	Document	Discrepancy	Resolution	Reviewer
07/08/2025	ICF v1.0	“Adverse event” mistranslation	Corrected to “不良事件”	Sunita Reddy

Annexure-3: Certificate of Translation Accuracy

Document	Translator	Date	Reviewer
ICF v1.0	Wei Zhang	06/08/2025	Rajesh Kumar

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
28/08/2025	1.0	Initial SOP for Chinese language consent and document localization.	New SOP created for NMPA compliance and subject comprehension.	Head of Clinical Research

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