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Published on 22/12/2025

Japanese Language Consent and Essential Document Localization SOP

Department	Clinical Research
SOP No.	CS/PMDA-DOC/170/2025
Supersedes	N.A.
Page No.	1 of 20
Issue Date	28/08/2025
Effective Date	05/09/2025
Review Date	05/09/2027

Purpose

This SOP defines the process for preparing, translating, reviewing, and controlling Japanese language informed consent forms (ICFs) and essential clinical trial documentation. It ensures participant comprehension, regulatory compliance with PMDA and J-GCP, and alignment with ICH guidelines on subject information and documentation governance.

Scope

This SOP applies to all subject-facing documents (ICFs, patient information leaflets, recruitment materials) and essential sponsor documents (protocols, Investigator’s Brochures, safety narratives, REB submissions) that require localization into Japanese. It covers translation, back-translation, quality verification, and filing of bilingual versions in the Trial Master File (TMF) and Investigator Site Files (ISFs).

Responsibilities

• Principal Investigator (PI): Ensures subjects receive Japanese language ICFs and can demonstrate comprehension prior to enrollment.
• Clinical Research Coordinator (CRC): Provides ICFs to participants, documents comprehension checks, and maintains site-level bilingual records.
• Regulatory Affairs (RA): Ensures all CTA and amendment submissions include Japanese versions of essential documents.
• Translation Vendors: Provide certified translations and back-translations with certificates of accuracy.
• Quality Assurance (QA): Conducts audits of translations, verifies compliance with SOPs, and ensures inspection readiness.

Accountability

The Sponsor’s Head of Clinical Research holds overall accountability for ensuring accurate localization of essential documents. PIs are accountable for ensuring subject-facing documents are comprehensible and approved by REBs prior to implementation.

Procedure

1. Identification of Documents for Localization

1. Identify all essential documents requiring Japanese versions (ICFs, IBs, safety updates, REB submissions).
2. Log documents in the Translation Requirement Log.

2. Translation Process

1. Engage certified translators with subject-matter expertise.
2. Ensure forward translation of documents into Japanese.
3. Perform back-translation for subject-facing materials (ICFs, safety narratives) to verify accuracy.

3. Quality Review

1. Translation QA team reviews discrepancies between forward and back translations.
2. Document resolution of discrepancies in Translation Verification Log.
3. Maintain certificates of translation accuracy in TMF.

4. Submissions

1. Include Japanese versions of essential documents in CTA submissions and amendments to PMDA.
2. Ensure REB submissions include both Japanese and English ICFs.

5. Site Implementation

1. Provide Japanese ICFs to participants during the consent process.
2. Document comprehension checks using bilingual comprehension checklists.
3. File approved bilingual documents in ISF and TMF.

6. Archiving

1. Archive all bilingual versions in TMF and ISF for at least 15 years or as per PMDA requirements.

Abbreviations

• ICF: Informed Consent Form
• IB: Investigator’s Brochure
• REB: Research Ethics Board
• CTA: Clinical Trial Application
• TMF: Trial Master File
• ISF: Investigator Site File
• QA: Quality Assurance

Documents

1. Translation Requirement Log (Annexure-1)
2. Translation Verification Log (Annexure-2)
3. Bilingual Comprehension Checklist (Annexure-3)

References

• PMDA — Pharmaceuticals and Medical Devices Agency
• ICH E6(R2) Good Clinical Practice
• Ministry of Health, Labour and Welfare (MHLW)
• 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	Translator	Status
05/08/2025	ICF v1.0	Japanese	Tokyo MedTranslate	Completed

Annexure-2: Translation Verification Log

Date	Document	Forward Translator	Back Translator	QA Reviewer	Status
06/08/2025	ICF v1.0	Naoko Tanaka	Kenji Sato	Sunita Reddy	Approved

Annexure-3: Bilingual Comprehension Checklist

Subject ID	ICF Version	Language Provided	Comprehension Confirmed By	Date
SUB-201	v1.0	Japanese	PI – Dr. Yamamoto	12/08/2025

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
28/08/2025	1.0	Initial SOP for Japanese language consent and essential document localization.	New SOP developed for J-GCP compliance.	Head of Clinical Research

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