University-wide Clinical Research Standard Operating Procedures (SOP) have been established. By standardizing these SOPs, we are aligning our clinical research activities across campus with the 1U4U vision.
Beginning in January 2020, clinical research teams will begin reporting accrual data in uTRAC. This will apply to all IRB approved projects that meet the NIH definition of a clinical trial, regardless of funding source.
The Clinical Research Compliance and Education (CRCE) Office is a core team within Compliance Services at the University of Utah. The CRCE team facilitates processes, provides training and education, and engages in oversight activities designed to ensure that clinical services associated with human subjects research are charged to the correct party, that claims submitted to government health care programs comply with the requirements of the applicable program, and that human subjects research complies with expectations imposed by the federal Food and Drug Administration. The Clinical Research Compliance and Education team manages the University Tracking of Clinical Research (uTRAC) system, our clinical trial management system which play a crucial role in efforts to meet clinical research compliance obligations.