- Complete the RDRC Application
Note: Submit the completed application materials, including the study protocol, to Emily Capak at email@example.com
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.
- Notify the RDRC of any changes to the protocol or the study personnel RDRC 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 .