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?
A. Sites should submit the amended protocol and all the amended site-specific ICF(s) to their IRBs/ECs and other applicable REs 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.
Related Questions
- What is the time period of an Institutional Review Board (IRB) or Independent Ethics Committee (IEC) registration, and how quickly does the information on file with OHRP need to be updated?
- Does Institutional Review Board (IRB) approval need to be approved at the time of proposal submission or can it just be submitted?
- What are the requirements for Institutional Review Board (IRB) or Independent Ethics Committee (IEC) membership?
