May 5th, 2016

Effective 5/1/2016, the Radioactive Drug Research Committee and Human Use Subcommittee (RDRC-HUS) will now review all amendments related to radiation use within the ERICA system. This includes any increases or decreases in human exposure to radioisotopes and ionizing radiation.

The process for amending and reviewing the changes to radiation use are as follows:

1. Investigators must submit an amendment application in ERICA to initiate review by both the RDRC-HUS and the IRB.
2. On the Amendment Introduction page, question 2, investigators must select the box for “Changes to the exposure to radioisotopes or ionizing radiation.”
3. Investigators must update the existing application (using the Update Study button) with the changes proposed in the amendment application.  This includes the existing application for the IRB as well as RDRC-HUS.
4. Once the changes are made, investigators must submit the amendment application in ERICA.  The application will be routed to RDRC-HUS for review prior to receiving IRB review.  Investigators should take into account this additional time for review when submitting amendment applications.

For questions about the RDRC-HUS amendment review process, please call 801-581-6141.