Radioactive Drug Metabolism Research

Radioactive Drug Metabolism Research in Human Subjects

The Radioactive Drug Research Committee (RDRC) reviews human research protocols involving radioactive drugs that are without a New Drug Application (NDA) filed with the FDA, or an approved Investigational New Drug (IND) application. Such protocols are intended to obtain basic information regarding the metabolism of radioactive drugs including kinetics, distribution, dosimetry, and localization or obtain basic information regarding human physiology, pathophysiology, and biochemistry of radioactive drugs.

Once a protocol is approved by the RDRC, it must then be reviewed and approved by the Institutional Review Board (IRB; ‘CORIHS’), in compliance with 45 CFR 46 (OHRP) and 21 CFR 50 and 56 (FDA).   Any revisions or modifications required by the IRB must be sent to RDRC for review and approval of the modified protocol.

Review

Apply to the RDRC

  • Download and complete the RDRC Application.
  • Once you believe your submission is complete, submit all documents by email to Dr. Mark Slifstein (email address: Mark.Slifstein@stonybrookmedicine.edu) for QA review. Please allow for a two week turn-around time in order to allow Dr. Slifstein adequate time to conduct his review.
  • Dr. Slifstein will be in contact with you, if necessary, to finalize the submission. Once it is ready for submission to RDRC, he will send the documents back to you.
  • Submit the completed application materials, including the study protocol, to judy.matuk@stonybrook.edu
You may submit your IRB materials to the IRB concurrently with submission to RDRC, however, the study will not be placed on an IRB meeting agenda until final approval has been granted by the RDRC.

Understand your reporting responsibilities, post-RDRC approval

As an RDRC-approved principal investigator, you must report to the RDRC:

  • Within 5 working days, all adverse effects associated with the use of the radioactive drug in the research study. All adverse reactions probably attributable to the use of the radioactive drug in the research study will, in turn be immediately reported by the RDRC to the FDA. & Submit FDA 2915's to RDRC as follows: Each research subject in your study should have his/her scan information contained in one (1) FDA 2915. If the subject is scanned on multiple occasions, then after each scan the relevant information should be added to that one form and the form should be submitted to the RDRC for review within 10 working days of the scan.
  • On or before January 5th of each year, RDRC requires a submission of an FDA 2915, completed for each study that provides the details of all subjects scanned during the prior calendar year.

Research Compliance
Phone: 631-632-9036
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