Certificate of Translation for Foreign Site Documents in Clinical Trials Under an IND
(10/31/2007)

Question 1:

I have come upon a question that I would like to clarify. When submitting site registration documents (1572, IRB consent form, investigator CV) from ex-US countries, does FDA have any consensus/guidance on whether these documents must be translated a “certified translator,” and/or if an official certificate of translation is required?

Answer 1:

The guidance on acceptability of translated documents is pretty limited--this is an excerpt from the Information Sheet Guidance on Informed Consent:

Non-English Speaking Subjects

To meet the requirements of 21 CFR 50.20, the informed consent document should be in language understandable to the subject (or authorized representative). When the consent interview is conducted in English, the consent document should be in English. When the study subject population includes non-English speaking people or the clinical investigator or the IRB anticipates that the consent interviews will be conducted in a language other than English, the IRB should require a translated consent document to be prepared and assure that the translation is accurate. As required by 21 CFR 50.27, a copy of the consent document must be given to each subject. In the case of non-English speaking subjects, this would be the translated document. While a translator may be helpful in facilitating conversation with a non-English speaking subject, routine ad hoc translation of the consent document should not be substituted for a written translation.

If a non-English speaking subject is unexpectedly encountered, investigators will not have a written translation of the consent document and must rely on oral translation. Investigators should carefully consider the ethical/legal ramifications of enrolling subjects when a language barrier exists. If the subject does not clearly understand the information presented, the subject's consent will not truly be informed and may not be legally effective. If investigators enroll subjects without an IRB approved written translation, a "short form" written consent document, in a language the subject understands, should be used to document that the elements of informed consent required by 21 CFR 50.25 were presented orally. The required signatures on a short form are stated in 21 CFR 50.27(b)(2).

How the IRB assures "that the translation is accurate" is really up to the IRB. In other words, the IRB is free to establish its own requirements for translations and the acceptability of translated documents, for example by requiring "certified translators," or an official certificate. However, the particulars of doing so are really up to them, since we do not have any specific regulations about this.

Question 2:

[none]

Answer 2:

PS--I re-read your question and realized that I didn't address your concerns about CVs, 1572s, and other documents.

The regs are also silent with respect to translating other trial related documents. At the very least, the documents would have to be translated for FDA staff, if they are being submitted to us, so the sponsor would want to ensure that any translations are accurate. In any case, it would be up to the sponsor to decide on the method that would make the documents acceptable (e.g., certified translator, use of a specific translation service, submission of an official certificate).


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