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Published on 25/12/2025

Site Data Submission Formatting and Translation QA SOP

Department	Clinical Research
SOP No.	CS/PMDA-DATA/172/2025
Supersedes	N.A.
Page No.	1 of 22
Issue Date	28/08/2025
Effective Date	05/09/2025
Review Date	05/09/2027

Purpose

This SOP defines the standardized process for site data submission formatting and translation quality assurance (QA) for clinical trials conducted under the oversight of the Pharmaceuticals and Medical Devices Agency (PMDA). It ensures that site-level documents and datasets submitted in Japanese or translated from English are accurate, compliant with J-GCP, and ready for regulatory inspection.

Scope

This SOP applies to all site-level data submissions including Case Report Forms (CRFs), essential documents (ICFs, IBs, safety updates), monitoring visit reports, and trial notifications that require submission to PMDA or REBs. It covers formatting standards, translation workflows, back-translation, QA verification, and archival processes for both English and Japanese versions.

Responsibilities

• Principal Investigator (PI): Ensures accuracy and completeness of site data submissions and reviews translations of subject-facing materials.
• Clinical Research Coordinator (CRC): Prepares and formats CRFs, manages bilingual documentation, and supports submission processes.
• Regulatory Affairs (RA): Reviews site data submissions for compliance with PMDA formatting requirements and files them in TMF.
• Translation Vendors: Provide certified translations and perform back-translations for critical documents.
• Quality Assurance (QA): Conducts quality audits of formatted data and verifies translation integrity.

Accountability

The Sponsor’s Head of Clinical Research is accountable for ensuring compliance with site data submission and translation standards. The PI is accountable for confirming subject-facing translations are accurate and comprehensible to participants.

Procedure

1. Identification of Data Requiring Formatting and Translation

1. List all documents requiring Japanese versions, including CRFs, ICFs, patient diaries, monitoring visit reports, and REB submissions.
2. Record them in the Site Data Translation Requirement Log.

2. Formatting Standards

1. Follow PMDA formatting guidelines (e.g., font, margins, numbering, electronic file naming).
2. Ensure version control, with dates, version numbers, and author initials on all documents.
3. Prepare electronic files in eCTD-compatible formats where applicable.

3. Translation Process

1. Engage certified translators with clinical research expertise.
2. Translate documents into Japanese for regulatory and subject use.
3. Perform back-translation of critical documents (ICFs, safety reports, narratives).

4. Translation QA

1. QA reviews forward and back translations for consistency, accuracy, and regulatory compliance.
2. Resolve discrepancies using the Translation Discrepancy Resolution Log.
3. File Certificates of Translation Accuracy in TMF.

5. Submission Workflow

1. Submit formatted bilingual documents through PMDA electronic gateway or via REB submission portals.
2. Ensure site staff have access to final approved versions for subject use.

6. Documentation and Archiving

1. Maintain Translation Requirement Logs, Discrepancy Resolution Logs, and Certificates of Accuracy.
2. Archive all bilingual versions for 15 years or as per PMDA retention requirements.

Abbreviations

• CRF: Case Report Form
• ICF: Informed Consent Form
• REB: Research Ethics Board
• RA: Regulatory Affairs
• QA: Quality Assurance
• TMF: Trial Master File
• eCTD: Electronic Common Technical Document

Documents

1. Site Data Translation Requirement Log (Annexure-1)
2. Translation Discrepancy Resolution Log (Annexure-2)
3. Certificate of Translation Accuracy (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: Site Data Translation Requirement Log

Date	Document	Language	Translator	Status
05/08/2025	ICF v1.0	Japanese	Tokyo MedTrans	Completed

Annexure-2: Translation Discrepancy Resolution Log

Date	Document	Discrepancy	Resolution	QA Reviewer
08/08/2025	ICF v1.0	Term “adverse event” mistranslated	Corrected to “有害事象”	Sunita Reddy

Annexure-3: Certificate of Translation Accuracy

Document	Translator	Date	Reviewer
ICF v1.0	Naoko Tanaka	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 site data submission formatting and translation QA.	New SOP created for J-GCP compliance and PMDA requirements.	Head of Clinical Research

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