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?
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