For any study approved by the RDRC under the authority of 21 CFR 261.1 that involved the study of more than 30 adult subjects or of subjects under 18 years of age, the RDRC must submit an FDA Form 2915 to the FDA at the time of approval as a Special Summary.
Additionally, submission of a Special Summary also is required for approved studies meeting the above criteria if there is a substantial modification to the protocol (including a further increase in subject number beyond 30).
The RDRC provides guidance to investigators in the preparation of both Annual Reports and Special Summaries.