Radioactive Drug Metabolism Research

 

NEW -  Important Information for Investigators with International Collaborations

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.
  • Please contact Dr. Suman Grewal, by email at Suman.Grewal@stonybrookmedicine.edu or by phone at 631-638-2056, for an RDRC application submission consultation.  Once you are ready for submission, submit all documents, including the study protocol, by email to Dr. Grewal for QA and administrative pre-review.  Please allow for a one week turn-around time in order to allow Dr. Grewal adequate time to conduct her review.
  • Dr. Grewal will be in contact with you, if necessary, to finalize the submission. Once it is ready for submission to RDRC, she will send the documents back to you.
  • Submit the completed application materials, including the study protocol, to Emily Capak at emily.capak@stonybrook.edu

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.
RDRC Meeting Date 2020 Deadline for applications 2020
January 6th December 23rd
February 3rd January 20th
March 2nd   February 17th
April 6th March 23rd
May 4th April 20th
June 1st May 18th
July 6th June 22nd
August 3rd July 20th
September 14th August 31st
October 5th September 21st
November 2nd October 19th
December 7th November 23rd

 

 

Website updated on 11/11/19

Research Compliance
Phone: 631-632-9036
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