New research protocols under RDRC
For new protocol submissions requiring RDRC approval, faculty researchers should use the paper application. At this time, completed applications should be submitted to the Yale RDRC (RDRC@yale.edu) as a PDF file for initial review and pre-approval prior to submission of the protocol to the IRB (HIC). However, final Yale RDRC approval cannot be granted, and PI’s cannot commence human subject research without official approval by the IRB.
Existing approved research protocols
Faculty researchers are not required to re-submit approved protocols to the Yale RDRC using the new application at this time. However, if there is an amendment to a currently approved research protocol the faculty researcher is required to submit the amendment using the paper forms. The completed amendment forms should be sent to Yale RDRC (RDRC@yale.edu) as a PDF file.
Adverse reactions associated with use of radioactive drugs in an RDRC approved research study
The Investigator must immediately, but no later than 7 calendar days, report to the RDRC all adverse effects associated with the use of the radioactive drug in the research study. Please email the PET Center Adverse Event Report to the RDRC (RDRC@yale.edu and copied to Dr. Sinusas at firstname.lastname@example.org).