Yale RDRC – Yale University Radioactive Drug Research Committee

The Yale University Radioactive Drug Research Program (Yale RDRC) program operates under federal regulation 21 CFR 361.1, which permits review and monitoring of basic research using radioactive drugs in humans without an IND when the drug is administered under specific conditions. These specific conditions are outlined in detail on the Food & Drug Administration (FDA) website.

For more information regarding the U.S. Food & Drug Administration (FDA) Radioactive Drug Research Communittee (RDRC) Program, please refer to the following information located on the FDA website.

For questions regarding the application process, approvals and/or future committee meeting dates and deadlines, please contact Donna McMahon at RDRC_admin@yale.edu.

Radioactive Drug Research Committee (YU-RDRC) Policies & Procedures

Radioactive Drug Research Committee (YU-RDRC)

940 GD.1 Research Using Radiation

Yale RDRC Quarterly Report Form

Overview

New research protocols under RDRC

For new protocol submissions requiring RDRC approval, faculty researchers should use the paper application. At this time, completed applications should be submitted to the Yale RDRC (RDRC@yale.edu) as a PDF file for initial review and pre-approval prior to submission of the protocol to the IRB (HIC). However, final Yale RDRC approval cannot be granted, and PI’s cannot commence human subject research without official approval by the IRB.

Existing approved research protocols

Faculty researchers are not required to re-submit approved protocols to the Yale RDRC using the new application at this time. However, if there is an amendment to a currently approved research protocol the faculty researcher is required to submit the amendment using the paper forms. The completed amendment forms should be sent to Yale RDRC (RDRC@yale.edu) as a PDF file.

Adverse reactions associated with use of radioactive drugs in an RDRC approved research study

The Investigator must immediately, but no later than 7 calendar days, report to the RDRC all adverse effects associated with the use of the radioactive drug in the research study.  Please email the PET Center Adverse Event Report to the RDRC (RDRC@yale.edu and copied to Dr. Sinusas at albert.sinusas@yale.edu).