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Guidance Snapshot

Translation of Good Laboratory Practices 

Study Reports: Questions and Answers

Draft Guidance for Industry

What is Covered

in This Guidance?

This question-and-answer 

document is intended to clarify FDA’s 

recommendations concerning the 

translation of study reports from a non-English 

language into English for studies conducted in 

compliance with good laboratory practice (GLP) 

regulations (21 CFR part 58). GLP studies include, 

but are not limited to nonclinical toxicology studies, 

safety pharmacology studies, and device safety studies 

received by different FDA Centers.

Why is This Guidance 

Important?

A large number of nonclinical 

toxicology studies are conducted 

by testing facilities located outside 

of the United States. In instances where the GLP 

study report is generated in a language other than 

English, the study report is translated into English 

for FDA submission. This guidance provides FDA’s 

expectations and requirements that the translated 

study report be an accurate, truthful, and complete 

representation of the original report. This is important 

to ensure reliable study data are submitted to FDA 

for review.

Do the Guidance Recommendations Apply 

to the Translation of Other Study Reports 

Submitted to FDA?

This draft guidance does not address the translation of 

other study reports. FDA may issue guidance regarding 

questions & answers for the translation of other study 

reports submitted to FDA in support of marketing 

authorizations as appropriate..

Guidance Snapshots are a communication tool and are not a substitute for the guidance 

document. To learn more about the translation of nonclinical toxicology study reports, 

read the guidance.
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Guidance Snapshots are a communication tool and are not a substitute for the guidance 

document. To learn more about the translation of nonclinical toxicology study reports, 

read the guidance.

What Translation Details are Discussed in This Guidance?

Translator Qualification 

English translation should be performed by a translator with education, training, experience, 

or combination thereof, in English and in the native language. The translator should be familiar 

with translating medical and scientific documents into English.

Translation Statement

The translator should generate a signed and dated translation statement, separate from the 

translated nonclinical study report, stating the translated document is a truthful, accurate 

and complete representation of the original GLP study report. The statement should be placed 

immediately in front of the translated study report cover page.

Translation SOP 

Procedures for GLP study report translation should be established. The procedures should 

include translator qualifications and requirements for the translation, such as documentation, 

and completeness checks.

Translation of Amended Study Report

Each amendment to the original GLP final study report should be translated as a 

separate document. The final study report and any report amendments should be kept as 

separate documents.

Translation of Tables 

The entire GLP study report, inclusive of all tables, appendixes, and contributing scientist 

reports, should be accurately and completely translated into English in the translated study 

report. Data tables should include the same tabular data, with the same format and 

translated text.

Signatures in Translated Study Reports

The translated GLP study report should not be signed. The translated study report should 

include the typed name of the study director and the date the original final study report was 

signed. The translated study report should also include the names of contributing scientists, 

quality assurance auditor, and testing facility management.
Continue the Conversation

Share your thoughts on the 

draft guidance

Click here to provide 

official comments to 

the FDA Docket

Guidance Recap Podcast

Hear highlights from FDA staff

Speaker(s): Rick Wasko, Biologist in the Center for Drug Evaluation and 

Research’s Office of Study Integrity and Surveillance

Click here to listen Click here to 

read transcript

Guidance Snapshots are a communication tool and are not a substitute for the guidance 

document. To learn more about translation of nonclinical study reports, read the guidance. 

To see additional guidance Snapshots, check out the pilot program.

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Completeness Check

This check should be performed by a second person on the final version of the translated GLP study 

report to verify the report format, tabular content, and figures (graphical representation of data) for 

completeness. All translations should be accurate, complete, truthful, and follow written processes and 

procedures to consistently ensure the quality of the study data.

Drug Development Timeline

When to Apply the Guidance Recommendations

BASIC 

RESEARCH

PROTOTYPE 

DESIGN OR 

DISCOVERY

PRECLINICAL 

DEVELOPMENT

CLINICAL 

DEVELOPMENT

PHASE 1 PHASE 2 PHASE 3

FDA 

FILING & 

APPROVAL

POSTMARKET OR 

POSTAPPROVAL 

STUDIES

During Preclinical and Clinical Development: This guidance provides the Agency’s expectations 

to sponsors and nonclinical laboratories regarding the translation of study reports for studies 

conducted in compliance with GLP regulations.