Start a new Sponsored Study
Use our web form to easily submit your study documents package to the COMP Translational Research Office for review.

The University of Arizona College of Medicine – Phoenix strives to establish strong collaborations with industry and sponsors. By creating partnerships that result in positive clinical trial opportunities for investigators, participants and sponsors, we bring novel therapies and products directly to our patients for the best in care and innovation.

More information on the timeline for start up for Sponsored Trials can be located here.

Please reach out to PBC-TREO-CR@arizona.edu with any questions.

 

Contracts, Budgets, & Billing

Sponsors can upload all study agreement requests, draft budgets, protocols and other essential documents securely to the Translational Research Office Sponsored Study Intake Portal for initial intake and review. All contract and budget process begins once the upload is complete. To decrease contracting timelines, we recommend Sponsors consider using an Accelerated Clinical Trial Agreement (ACTA). More information pertaining to this type of agreement can be located here.

Contracts & Budgets
The University of Arizona Health Sciences Research Administration is utilized for budget and contract review and negotiations. Contract and budget review begins once the study has received Banner’s approval. These documents can be negotiated concurrently, however, the contract will need to be finalized prior to IRB submission. Site is unable to provide regulatory documents for initial Sponsor review until the budget has been finalized. Our agreements are 3-party agreements between the University of Arizona, Banner Health, and Sponsor.

Committee Reviews

The following committee’s reviews are required prior to submission to the UA IRB:

  • Banner Feasibility Review (prior to contract/budget negotiations)
  • Informed Consent Congruency Review (following execution of the study budget)
  • Conflict of Interest Committee
  • Radiation Safety Committee (if applicable)

Clinical Trial Billing
TReO uses OnCore for comprehensive, streamlined management of clinical trials billing and workflow.

Frequently Asked Questions

  • Is site able to use Central IRB?
    • Yes, site can use many central IRB’s (WIRB, Advarra, etc.) but must submit to the University of Arizona IRB for deferral approval first.
  • What is the submission deadline to UA IRB prior to review for deferred studies?
    • Deferrals are reviewed by a single chair on a regular basis and do not need to wait for a convened full committee meeting.
  • Is the EMR and electronic source system 21 CFR Part 11 compliant?  
    • Yes, both the electronic medical records system (Cerner Powerchart) and our source database (REDCap) are Part 11 compliant.
  • Does site allow on and off site monitoring?
    • Yes, site allows on/off site monitoring (off site preferred).
  • Will site need a finalized protocol prior to beginning start-up activities?
    • Yes, a finalized protocol is required to begin study start-up activities
  • What equipment does site have to conduct a clinical trial?
    • Please visit our Resources Page for a full listing of services and resources available to conduct clinical trials.

Electronic Source Documentation

REDCap   

TReO's Clinical Data Team utilizes REDCap to create a secure, paperless source for study teams. REDCap maintains compliance with all study related documentation requirements. Our dedicated team is trained in all compliance measures necessary to satisfy University and Hospital Department/Divisions, College/University, and State/Federal reporting requirements.

Cerner EMS

TReO's affiliate Banner - University Medical Center Phoenix uses CERNER as their electronic health record. All research staff are trained and approved to obtain access.