Radioactive Drug Research Committee (RDRC)
Basic research designed to study the metabolism of a radioactive drug or to gain information about human physiology, pathophysiology, or biochemistry requires review by the Radioactive Drug Research Committee which was formed under the authorization of the Food and Drug Administration (FDA) and the University.
The University of Kentucky's Radioactive Drug Research Committee (RDRC) is responsible for reviewing and approving all radioactive drug research projects that fall under the purview of the Food and Drug Administration (FDA) regulations as specified in 21 Code of Federal Regulations Part 361.1. Research projects which meet the criteria for review as outlined in the regulations must be submitted and approved by the RDRC prior to initiation of the study. Institutional Review Board approval is also required before initiation of the study. The RDRC operates in accord with 21 CFR Part 361. Committee members are appointed by the Vice President for Research. The RDRC is managed administratively by the Office of Research Integrity. TBN serves as the Chairperson. Copies of RDRC procedural guidelines may be obtained by contacting Suzanne Arnold at 859-257-0582. Questions regarding the federal requirements should be directed to Ada Sue Selwitz at 859-257-2978.
Links to FDA's Radioactive Drug Research Committee (RDRC) Program:
- What Information Does the RDRC Review? [HTML]
- RDRC Protocol Review Checklist [PDF]
- Guidance for Industry and Reviewers - Exploratory IND Studies (HHS/FDA) [PDF]
To apply for IRB approval for a study involving Radioactive Drug(s), use the Medical Full Review Application.