Updates

Studies requesting credentialed UCHealth clinical care providers (who are not listed as study personnel) to administer study medications require an oversight plan addressing the phase of the study, experience of the investigator, patient population, known risk of the study medication, and how oversight will be provided and documented, in accordance with FDA regulations. Please use this link to submit your proposed oversight plan.

New SOP can be found here: Managing Administration of Non-Oncology Study Medications in UCHealth Inpatient Units, Outpatient Locations, and with Pre-hospital Care Providers Involving Non-Research Staff

Of note:

CTRC staff education will be completed by the team and documented in the delegation of authority for the study.  If CTRC staff are administering the study medication, an oversight plan is not required as they are on the delegation of authority and part of the study team. 

Oncology Infusion RNs: An oversight plan is not required for studies involving oncology infusion RNs.  Oncology infusion RNs will not routinely be delegated, but are permitted to administer study medications as the administration and monitoring the participant clinically is within their scope of practice.