At the end of each calendar year, the RDRC must submit an annual report to the FDA for each “F” protocol regulated under 21 CFR 361.1. The process of working with the responsible physicians and their coordinators on these reports starts in early November.
For each protocol that was active during the calendar year (including protocols closed during the calendar year), an FDA Form 2915 Annual Report, along with the radioactive drug administrations and dosimetry for each subject studied in the calendar year, must be submitted to the RDRC. These reports are reviewed by the RDRC and then submitted to the FDA. The FDA deadline for receipt of the RDRC’s annual report (including all of the individual study reposts)is January 31 of each year.