According to GCP, an institutional review board (IRB), also called independent ethics committee (IEC) must review and approve all required documents on a regular basis. The aim of such a committee is to protect the rights, safety and well-being of subjects participating in a study.

The IRB may question the rationale behind the protocol and request all pertinent documents related to the trial such as protocols, consent forms (ICF), investigator credentials and information on the test product(s). This committee also has the power to reject a study, request amendments to protocol, supervise the progress of a trial and/or stop a trial if necessary.