Clinical Research Support Office (CRSO)

Welcome to

The Clinical Research Support Office

CRSO

The Clinical Research Support Office serves as a central resource to support investigators and research teams that conduct clinical research across campus. The CRSO aims to provide exceptional service, reduce administrative burdens, enhance compliance, and remove barriers to enable efficiency, collaboration, cost recovery, and growth of clinical trials at the university.

The CRSO offers a variety of services including:

OnCore Training & Support
eReg Training & Support
Participant Payments Training & Support
Monitoring & Quality Assurance

IND/IDE Support
Adobe Sign
MyChart Recruitment

Services and support are made available to all investigators and coordinators to promote smooth, efficient conduct of their research at the University of Utah.

OnCore

OnCore CTMS (along with its imbedded modules: Insights, eReg, Payments, and EDC) will provide a centralized electronic infrastructure to support the management of budgets, study participants, financial processes, and regulatory documentation. In addition, it will enhance research billing capabilities, transparency and planning opportunities.

OnCore Quick Links

Additional Resources

IND/IDE Support

Provides high-level expertise, guidance, and support to investigators, reviewing, developing, and submitting applications to the FDA to support sponsor-investigator INDs and IDEs.

Monitoring and QA

Provides independent monitoring support & guidance to for investigators and study teams, and to ensure studies are conducted in compliance with the protocol, ICH-GCP guidelines, and applicable Federal, State, and University policies and procedures.

Design Studios

The CTSI’s Design Studios are a venue for clinical research investigators to solicit expert recommendations for developing or optimizing their research project, clinical research protocol, grant application, and/or other opportunities. The goal is to increase the quality and efficiency of clinical research on campus through expert design and leveraging of resources. The studios will connect investigators with expert recommendations and jumpstart consultations with appropriate research services.

Design Studios

Adobe Sign

We are pleased to announce that Adobe Sign is now validated to be compliant with 21 CFR Part 11 when used with the approved procedures. This validation enables UU researchers and study teams to obtain electronic signatures on all research records required for FDA-regulated research, including written consent signatures from research participants.

CRSO News & Updates

The Clinical Research Support Office is aware of escalating fraudulent activity impacting participant debit cards and the significant burden this could place on your participants to submit fraud claims to the Hyperwallet Visa team. It is unacceptable that some participants are receiving cards with depleted funds due to this activity. We understand that replacement cards issued by departments have also been compromised.

Immediate Action Required:

Effective immediately, all study teams must temporarily cease distributing debit cards to participants. The current cycle of issuing and reissuing compromised cards is unsustainable and unapproved.

Alternative Payment Methods: Please utilize direct deposit or one of the other approved forms of compensation: gift cards, or ePR, as outlined in the "Payments to Human Research Participant" guidelines. This temporary measure will remain in effect until a secure replacement for debit cards is identified.

If you have any questions, feel free to contact the CRSO Payments Support Teams Channel, Marlyn Galindo at marlyn.galindo@hsc.utah.edu or Jaci Skidmore at jaci.skidmore@hsc.utah.edu.