Submission Guidelines

Initial Submissions 

• Review the RDRC Training Manual
• Complete the RDRC Application

Note: Upload the completed application materials (including the study protocol) to myResearch RDRC.

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. 
  • RDRC Adverse Event Reporting Form
• Notify the RDRC of any changes to the protocol or to study personnel using theRDRC Amendment Form
• On or before January 5th of each year, RDRC requires a submission of an FDA 2915, completed for each study This form requires that you include details of all subjects scanned during the prior calendar year.