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Message from CCTS: uTRAC Clinical Research Accrual Tracking Module

Below is an important message from the Center for Clinical & Translational Science:

 

Hello –

Beginning October 1, 2020, all clinical research teams will begin reporting accrual data in uTRAC. uTRAC is 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 (see weblink further below to determine if your study is applicable). Study teams from Pediatrics and Internal Medicine have successfully piloted this system over the last year. This is now expanding 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.

Thank you for your participation in this important initiative! Please feel free to contact me at trent.matheson@hsc.utah.edu with any questions regarding this process.

 

Thanks,

 

Trent Matheson, MPP | Director of Tracking & Evaluation

Center for Clinical & Translational Science (CCTS)