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?
At our site we will enroll English- and French-speaking subjects. Do we need to submit a back translation of the French 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?
My site only consents participants in languages other than English. Is a back translation for each language required?
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?
Is a back translation for Spanish site-specific ICFs required?
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. HHSN272201000013C, entitled NIAID DAIDS Regulatory Support Center (RSC).