The sponsor or applicant is required by 21 CFR 312.120(b)(6) to provide only the name and address of the IEC that reviewed the study and a statement that the IEC meets the definition of an IEC in 21 CFR 312.3(b). However, as provided in 21 CFR 312.120(b)(6), the sponsor or applicant must maintain records supporting the statement, including the names and qualifications (e.g., occupation, training, and experience) of all IEC members, and must make these records available for Agency review upon request. If that is not possible because of governing law relating to privacy concerns, FDA recommends that sponsors and applicants clearly document the attempts made to obtain IEC member names along with an explanation as to why the IEC member names cannot be obtained or disclosed. Such information can then be submitted to FDA in a waiver request, as described below in Section III.C.
