About
The Clinical Research Unit (CRU) is a dedicated research facility designed to provide medical scientists with the resources and conditions necessary to conduct clinical research in an effective and efficient manner. The CRU supports over 150 studies, including investigator-initiated and industry studies, representing all phases of clinical research, including Phase I (first in human) clinical trials. The CRU supports both outpatient and overnight stays for studies in adult subject populations ages 18 and over and is located on D6/6 in University Hospital in downtown Madison.
Process for Study Activation on CRU:
Please refer to the full CRU Process for Study Activation for additional details. Supporting documents are below in tools and resources.
- Submit a CRU Consult Request to formally request CRU staff review study protocol and initiate a feasibility review.
- CRU will schedule and facilitate a consult meeting.
- Study team is responsible to develop a study budget based on the study protocol and lab manual.
- Submit CRU Application.
- Continue collaborating with the CRU protocol team lead to facilitate operationalization of the protocol on CRU.
- Once all CRU procedures have been clarified, CRU documents and provider orders approved, staff training (if needed) has been completed, IRB approval and study registration / SMPH signoff is complete, the CRU Reservation form will be released and you can begin scheduling participant visits on the CRU.
- Please refer to CRU Guidance for Study Implementation for an outline of study team and CRU responsibilities.
Principal Investigator Responsibilities:
While CRU staff provide expertise in data gathering and high-quality patient/participant care, investigators are responsible for the following items:
- Study coordination of their protocols and visit scheduling.
- Maintaining UW Health privileges for study providers (e.g., MD, PA, NP).
- Obtaining provider coverage for their CRU patient participant, as well as daily rounding by a provider for overnight stays.
- Securing access to UW Health’s electronic medical records (i.e., Health Link) as appropriate for members of their team.
- Generating a budget and study registration through OnCore software.
