Translation of Non-English Good Laboratory Practice (GLP) Study Reports (DRAFT)
This guidance provides recommendations for translating Good Laboratory Practice (GLP) study reports from non-English languages into English. It applies to nonclinical toxicology studies, safety pharmacology studies, and device safety studies submitted to FDA that were conducted in compliance with GLP regulations (21 CFR part 58).
This is a draft guidance. Not for implementation.
What You Need to Know? 👇
What qualifications should translators of GLP study reports have?
Translators should have education, training, or experience in both English and the original language. They must be familiar with translating medical and scientific documents into English, with qualifications clearly described in written procedures.
Should translated GLP study reports include original signatures from study personnel?
No, translated GLP study reports should not be signed. They should include typed names of study director, quality assurance auditor, and facility management with signature dates from the original report only.
What documentation is required when translating GLP study reports for FDA submission?
A signed translation statement must be included with translator name/affiliation, qualifications, translation dates, and attestation that the document is a clear, truthful, accurate, and complete representation of the original report.
Are written procedures required for GLP study report translation processes?
Yes, sponsors or testing facilities must have written procedures covering translator qualifications, documentation requirements, verification of translation accuracy, and completeness checks. These procedures must be available to and followed by translators.
Should GLP study report amendments be translated separately from the main report?
Yes, each amendment to the original final study report should be translated as a separate document. The final study report and all amendment versions must be kept as individual documents.
What review process is recommended for translated GLP study reports?
A second person (not the translator) should review the complete translated report for format, tabular content, and figures completeness. If issues are found, the report returns to the translator for revision and re-review.
What You Need to Do 👇
Recommended Actions
- Establish written procedures for GLP study report translation including translator qualifications and verification processes
- Ensure translators meet required qualifications in terms of language skills and medical/scientific expertise
- Implement a translation statement/certificate process that includes all required elements
- Set up a review process with a second person checking completeness of translations
- Create a document retention system for both original and translated reports
- Develop a process for handling amendments as separate translated documents
- Establish a quality control process to ensure translated tables and appendixes maintain the same format and content
- Create a documentation system for all translation-related communications
- Train relevant staff on the translation procedures and requirements
- Implement a verification process to ensure all parts of the original report are included in the translation
Key Considerations
Non-clinical testing
- The entire GLP study report must be translated, including all tables, appendixes, contributing scientist reports, protocol and amendments
- Data tables should maintain the same format and content as the original report
- Each amendment should be translated as a separate document
Other considerations
- Translators must have education, training, experience in English and the original language
- Translators should be familiar with medical and scientific document translation
- A signed and dated translation statement/certificate must be included
- Written procedures for translation must be in place
- The translated report must be reviewed by a second person for completeness
- Original and translated reports must be retained along with related communications
- The translated report should not be signed but include typed names and original signature dates
Relevant Guidances 🔗
Related references and norms 📂
- 21 CFR part 58: Good Laboratory Practice for Nonclinical Laboratory Studies
- 21 CFR 312.23(c): IND Application - Foreign language submissions
- 21 CFR 514.1(a): New Animal Drug Applications - Foreign language submissions