Protocol Registration Translation Requirements Frequently Asked Questions
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.