Frequently Asked Questions

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Translation Requirements FAQs

Will time requirements for documentation submitted to the Institutional Review Board (IRB)/ Ethics Committee (EC) also apply for consents that must be translated into other languages as well?

Sites should submit the amended protocol and all the amended site-specific ICF(s) to their IRBs/ECs and other applicable REs/Approving Entity(ies) for review and approval as soon as possible. Per the DAIDS Protocol Registration policy, submission to the local IRB/EC must take place within 45 calendar days for U.S. sites and 75 calendar days for non-U.S. sites of the date the amendment was approved by DAIDS and distributed to the sites.
At our site we will enroll English- and French-speaking subjects. Do we need to submit a back translation of the French ICFs?

No, if you have an IRB/EC-approved English site-specific ICF, you are not required by DAIDS to submit a back translation of the French site-specific ICF. However, some networks require back translations for all local language site-specific ICFs.
What if my network requires a back translation even though we have an IRB/EC approved English site-specific ICF and DAIDS does not require a back translation?

You should comply with your network’s requirements regarding back translation.
My site only consents participants in languages other than English. Is a back translation for each language required?

Yes, if there is no IRB/EC approved English site-specific ICF then a back translation is required for all other languages (with the exception of Spanish).
I have already been approved for my English site-specific ICF and the IRB/EC just approved my local language site-specific ICF. Do I need to receive protocol registration notification for additional languages?

Yes, all site-specific ICFs in all languages are required to be submitted to the DAIDS PRO and a registration notification must be received prior to utilizing the ICF.
Is a back translation for Spanish site-specific ICFs required?

No. However, if your network requires a back translation you should comply with your network’s requirements. A Translation Confirmation Document is NOT required for all Spanish site-specific ICFs.

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Home | Website User Feedback | Accessibility | Privacy Policy | Disclaimer
Copyright © DAIDS RSC. All rights reserved.
This project has been funded in whole or in part with Federal funds from the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under contract No. HHSN272201700014C, entitled NIAID DAIDS Regulatory Support Center (RSC).

Frequently Asked Questions

Translation Requirements FAQs