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“headline”: “SOP for Korean Language Consent and Document Localization”,
“name”: “SOP for Korean Language Consent and Document Localization”,
“description”: “Comprehensive SOP describing sponsor and investigator responsibilities for preparing Korean-language informed consent forms and ensuring accurate localization of essential trial documents in compliance with MFDS and Korean GCP.”,
“keywords”: “Korean consent SOP, SOP for document localization Korea, SOP for clinical trial translations Korea, SOP for informed consent Korean language, SOP for essential documents Korea, SOP for ICF Korean translation SOP, SOP for subject-facing documents Korea, SOP for translation vendor SOP Korea, SOP for patient safety documents Korea, SOP for ethics submissions Korea, SOP for BASEC equivalent Korea, SOP for Korean trial governance, SOP for investigator responsibilities Korean documentation, SOP for sponsor translation oversight Korea, SOP for regulatory submissions Korea, SOP for eConsent Korean requirements, SOP for cultural adaptation of trial materials Korea, SOP for patient comprehension SOP Korea, SOP for bilingual documentation Korea, SOP
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Published on 24/12/2025
Korean Language Consent and Document Localization SOP
| Department | Clinical Research |
|---|---|
| SOP No. | CS/MFDS-DOC/197/2025 |
| Supersedes | N.A. |
| Page No. | 1 of 23 |
| Issue Date | 28/08/2025 |
| Effective Date | 05/09/2025 |
| Review Date | 05/09/2027 |
Purpose
This SOP defines requirements for preparing informed consent forms (ICFs) and essential documents in the Korean language, ensuring cultural, linguistic, and regulatory compliance. It ensures participant comprehension, ethical compliance, and alignment with MFDS and Korean GCP standards.
Scope
This SOP applies to all clinical trials conducted in South Korea where subject-facing documents and essential regulatory documents require Korean language localization. It covers translation, back-translation, certification, cultural adaptation, ethics submissions, and archiving of localized records.
Responsibilities
- Sponsor: Ensures availability of ICFs and subject-facing materials in Korean, oversees translation processes, and verifies certification.
- Principal Investigator (PI): Ensures participants understand the content of the ICF and maintains localized versions in the ISF.
- Regulatory Affairs (RA): Submits localized documents to MFDS and ethics committees.
- Translation Vendor: Provides certified translations and back-translations of documents.
- Quality Assurance (QA): Audits translation and localization processes to ensure compliance with KGCP.
Accountability
The Sponsor’s Head of Clinical Operations is accountable for ensuring localized document availability. The PI is accountable for confirming comprehension during the consent process.
Procedure
1. Identification of Documents Requiring Localization
- Prepare a list of documents needing translation (ICFs, PIS, subject leaflets, safety reports).
- Document requirements in Translation Tracker (Annexure-1).
2. Translation and Back-Translation
- Engage certified medical translators for Korean translation.
- Perform back-translation into English to verify accuracy.
- Retain Certificate of Translation Accuracy in TMF.
3. Ethics Submission
- Submit localized ICFs and patient materials to ethics committees and MFDS.
- Maintain acknowledgment letters in Submission Log (Annexure-2).
4. Consent Process
- Ensure that PIs or delegated staff explain the consent form to participants in Korean.
- Confirm comprehension by asking subjects to summarize key points.
5. Archiving
- Maintain localized documents in ISF and TMF for at least 10 years post-study.
- Ensure availability for inspections and audits.
Abbreviations
- MFDS: Ministry of Food and Drug Safety
- KGCP: Korean Good Clinical Practice
- ICF: Informed Consent Form
- PIS: Patient Information Sheet
- ISF: Investigator Site File
- TMF: Trial Master File
- RA: Regulatory Affairs
- QA: Quality Assurance
- PI: Principal Investigator
Documents
- Translation Tracker (Annexure-1)
- Submission Log (Annexure-2)
- Certificate of Translation Accuracy (Annexure-3)
References
- MFDS — Ministry of Food and Drug Safety
- ICH E6(R2) Good Clinical Practice
- WHO Clinical Trials 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 Tracker
| Document | Language | Translator | Date | Status |
|---|---|---|---|---|
| ICF v1.0 | Korean | Lee Min-Jung | 05/08/2025 | Certified |
Annexure-2: Submission Log
| Date | Protocol No. | Document | Submitted To | Status |
|---|---|---|---|---|
| 12/08/2025 | KR-2025-03 | Korean ICF | MFDS | Approved |
Annexure-3: Certificate of Translation Accuracy
| Document | Translator | Reviewer | Date |
|---|---|---|---|
| PIS v1.0 | Kim Jae-Hyun | Sunita Reddy | 06/08/2025 |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 28/08/2025 | 1.0 | Initial SOP for Korean language consent and document localization. | New SOP created for MFDS compliance. | Head of Clinical Research |
For more SOPs visit: Pharma SOP.