What is the relationship of RAC review to review by the IRB, the IBC, and the FDA?
Unlike the RAC, these other entities will be reviewing your protocol as part of a formal approval process, either for conduct at your institution (in the case of local review bodies) or for authorizing your Investigational New Drug (IND) application (in the case of the FDA). A benefit of the RAC process is that it informs the discussions that these other bodies will undertake in making certain determinations about your protocol.
Related Questions
- What is the relationship between HIPAA and the human subjects protection regulations of the Common Rule for which IRB review was established?
- Is the sponsor required to review the consent form approved by the IRB to make sure all FDA requirements are met?
- What is the relationship of RAC review to review by the IRB, the IBC, and the FDA?
