Criteria Changes to Research Studies Requiring RDRC/SHUR Review
The RDRC and or SHUR Committees need to review an amendment to a previously approved research project if any of the following changes have been made:
- Change to PI
- Change in Radiopharmaceutical/ tracer use in the Protocol
- Change or addition of radiopharmaceutical
- Change in dose of/exposure to radiopharmaceutical
- Increase in the number of subjects to be studied
- RDRC approved studies must submit FDA Form 2915 "Special Summary" to the RDRC when requesting approval to study more than 30 subjects
- Be sure to check the FDA website for most current version of this form (expired versions will not be accepted by FDA)
- AE involving the radiopharmaceutical
- ORIO involving the radiopharmaceutical
- Study has ended enrollment and is now open only for data analysis
- RDRC Studies must submit a "Termination" FDA Form 2915 to the RDRC when the study ends enrollment and is only open for data analysis.
If the study team/ PI/ Study Coordinator notice that the RDRC or SHUR don’t respond when any of the above items are amended in the previously approved research project, they are encouraged to post a correspondence within eResearch to either RDRC or SHUR ancillary committee so that the amendment can be reviewed. eResearch is a work in progress and does not as of yet consistently send notifications for all of these amendments to the RDRC/SHUR for review.