Radioactive Drug Research Committee

The Radioactive Drug Research Committee (RDRC) reviews research studies that involve the use of radioactive material in or on human subjects regardless of the amount of radioactivity. The RDRC only reviews and approves basic research studies, and does not review and approve studies intended to determine the safety and effectiveness of the drug in humans for such purposes as carrying out a clinical trial, for example.

When the research involves radioactive materials, documentation of RDRC review, including RDRC comments and approval before the IRB can grant approval.  Alternatively, documentation of an IND from the FDA is required before final IRB approval.  Sufficient documentation of an IND include IND letter from FDA or IND number on Sponsor’s Master Protocol, if externally sponsored.

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