Radioactive Drug Research Committee (RDRC)
The Radioactive Drug Research Committee approves, reviews and advises protocols that conduct research involving radioactive drugs in humans. The RDRC approves protocols under the purview of the Food and Drug Administration in accordance with FDA regulation 21 CFR 361.1.
The Committee meets quarterly and is made up of at least five individuals as follows:
- A physician recognized as a specialist in nuclear medicine [§ 361.1(c)(1)].
- A person qualified by training and experience to formulate radioactive drugs [§ 361.1(c)(1)].
- A person with special competence in radiation safety and radiation dosimetry [§ 361.1(c)(1)].
- Individuals qualified in various disciplines pertinent to the field of nuclear medicine (e.g., radiology, internal medicine, clinical pathology, hematology, endocrinology, radiation therapy, radiation physics, radiation biophysics, and radiopharmacy) [§ 361.1(c)(1)].
Approved qualified investigators require both RDRC approval and the approval of the IRB before the study may begin. To receive a RDRC protocol approval, you will need to fill out a Radioactive Materials Authorization Application for Human Use. Go to the Radiation Safety Forms page to access the application.
If you have any questions please contact the main office at 303-724-0345 or send an email to Riad.Safadi@ucdenver.edu.