Radioactive Drug Metabolism Research

The Office(s) of the Vice President for Research will be CLOSED as follows during this holiday season:
Thursday and Friday, November 23 and 24 - Thanksgiving Holiday
Monday and Tuesday, December 24 and 25 - Christmas Holiday
Monday and Tuesday, December 31 - January 01, 2019

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.

Review

Apply to the RDRC

  • Download and complete the RDRC Application.
    •  For FEPPA the maximum injected dose in subjects is 5 mCi/3.2 ug.
  • Once you believe your submission is complete, submit all documents, including the study protocol, 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 suman.grewal@stonybrookmedicine.edu
  •  

RDRC Meeting Date, 2018

Deadline for applications, 2018

February 5

January 22

March 5

February 19

April 2

March 19

May 7

April 23

June 4

May 21

July 2

June 18

August 6

July 23

September 10

August 27

October 1

September 17

November 5

October 22

December 3

November 19

Understand your reporting responsibilities, post-RDRC approval

  • Each protocol approved by the RDRC is also required to have IRB approval in compliance with 45 CFR 46 (OHRP) and 21 CFR 50 and 56 (FDA) prior to initiation.  
  • Within 5 working days, all adverse events associated the use of the radioactive drug in the research study must be reported to the IRB and the RDRC.  All adverse events 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. 
  • 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.

 

Website updated on 7/3/2018

Research Compliance
Phone: 631-632-9036
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