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:

  1. Change to PI
  2. Change in Radiopharmaceutical/ tracer use in the Protocol
  3. Change or addition of radiopharmaceutical
  4. Change in dose of/exposure to radiopharmaceutical
  5. Increase in the number of subjects to be studied
    1. RDRC approved studies must submit FDA Form 2915 "Special Summary" to the RDRC when requesting approval to study more than 30 subjects
    2. Be sure to check the FDA website for most current version of this form (expired versions will not be accepted by FDA)
  6. AE involving the radiopharmaceutical
  7. ORIO involving the radiopharmaceutical
  8. Study has ended enrollment and is now open only for data analysis
    1. 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.