Are annual IRB reviews required when all studies are reviewed by the IRB each quarter?
The IRB records for each study’s initial and continuing review should note the frequency (not to exceed one year) for the next continuing review in either months or other conditions, such as after a particular number of subjects are enrolled. An IRB may decide, to review all studies on a quarterly basis. If every quarterly report contains sufficient information for an adequate continuing review and is reviewed by the IRB under procedures that meet FDA requirements for continuing review, FDA would not require an additional “annual” review. 32. 21 CFR 56.115(a)(1) requires that the IRB maintain copies of “research proposals reviewed.” Is the “research proposal” the same as the formal study protocol that the investigator receives from the sponsor of the research? Yes. The IRB should receive and review all research activities [21 CFR 56.109(a)]. The documents reviewed should include the complete documents received from the clinical investigator, such as the protocol, the investigator’s bro
