Beginning October 1, 2020, all clinical research teams will begin reporting accrual data in uTRAC, which serves as the University of Utah Health Sciences’ clinical trials management system. This new requirement will apply to all IRB approved projects that meet the NIH definition of a clinical trial regardless of funding source (please click HERE for the NIH Definition of a clinical trial.) Study teams from Pediatrics and Internal Medicine have successfully piloted this system over the last year, and will now be expanded to the rest of the Health Science Campus. Early adoption is encouraged.
Accrual reporting takes approximately five minutes per study to complete, and will be required on a quarterly basis beginning in October 2020. Notification emails will be sent from uTRAC to investigators and to their designated study coordinators when the previous quarter’s accrual data entry is due and will contain a list of the investigator’s studies for review to determine those applicable for reporting accrual data. The required entry will include information such as:
- Projected recruitment end dates (one time)
- Expected number of participants (one time)
- Participant accrual activity to date (i.e. patients screened, approached, consented, and randomized) (each quarter)
- Number of research participant dropouts, withdrawals or patients lost to follow-up (each quarter).
The University of Utah Center for Clinical and Translation Science (CCTS) will use Institution-wide data from the accrual tracker to report an aggregated accrual ratio metric to National Center for Advancing Translational Sciences (NCATS) and provide to University leadership. Data may be used to assess availability of recruitment resources that can help a study meet targets; identify trials with superior recruitment and retention; to mitigate enrollment-related issues; and proactively identify studies that may be at risk of not meeting enrollment goals.
The “Clinical Trials Accrual Tip Sheet” can be found HERE. To request a uTRAC Account, please contact your department Account Requestor, or contact uTRAC Support. All other questions can regarding this process can be directed to Trent Matheson.
Thank you for your participation in this important initiative!