My study sponsor wants a copy of the IRB membership list. Why does the IRB want us to provide them with a standard letter instead?
The sponsor needs to make sure an investigator is using an IRB that complies with the requirements from 21 CFR 56 [see 21 CFR 312.23(a)(1)(iv)]. The sponsor views a membership list as one marker of compliance. The FDA information sheets (see “Sponsor-Investigator-IRB relationship” in the 1998 update) state: FDA regulations [21 CFR 312.23(a)(1)(iv)] require that a sponsor assure the FDA that a study will be conducted in compliance with the informed consent and IRB regulations [21 CFR parts 50 and 56]. This requirement has been misinterpreted to mean that it is a sponsor’s obligation to determine IRB compliance with the regulations. This is not the case. Sponsors should rely on the clinical investigator, who assures the sponsor on form FDA-1572 for drugs and biologics or the investigator agreement for devices that the study will be reviewed by an IRB. Because clinical investigators work directly with IRBs, it is appropriate that they assure the sponsor that the IRB is functioning in comp
Related Questions
- The studys sponsor has sent me an Investigators Brochure (IB) that I need the IRB to acknowledge. What do I need to include when I send it to the IRB office?
- My study sponsor wants a copy of the IRB membership list. Why does the IRB want us to provide them with a standard letter instead?
- If the study is approved, will Schulman provide the sponsor/CRO with an approval letter?
