What We Do

The strength of the University of Washington Clinical Trials Office (UW CTO) is generated by dedicated individuals working together to achieve excellence in clinical research. Understanding team functions can be a valuable resource to co-workers, Principal Investigators, and Study Teams when navigating the complexities of a study lifecycle.

• Administration
  • Administrative Team

    The team oversees CTO operations and enables stable resourcing and creative environment to drive the evolution of service offerings, process improvements, and compliance maintenance.

    Our staff ensures consistent and uninterrupted service and links study teams and investigators to resources they need to be successful in their research.

• Clinical Research Contracts
  • Contracts Team

    Our Contracts staff ensure timely and effective negotiation and execution of in-scope agreements and contracts that propel clinical research forward.

    They serve as contract liaisons between sponsors and contract research organizations (CROs) on one side and UW investigators and departments on the other.

    CTO Contracts scope:

    •  Confidentiality/Non-disclosure Agreements (CDA/NDA) for all Oncology and Hematology related trials
    •  Service agreements with external clients

     

    UW Office of Sponsored Programs (OSP) continues to negotiate all Clinical Trial Agreements (CTA) and Confidentiality agreements outside of Oncology and Hematology therapeutic areas (https://www.washington.edu/research/osp/) 

• Study Coordination
  • Research Coordination Center (RCC) Team

    Our dedicated central team of study coordinators support principal investigators and their trials across the institution in many therapeutic areas. Our team is comprised of experienced start-up, regulatory, and implementation coordinators covering the full cycle of a clinical trial.

    Our senior staff offer advanced regulatory and internal monitoring support.

• Research Nursing
  • Translational Research Unit (TRU) Team

    Our Translational Research Unit is a dedicated, fee-for-service clinical research space with patient beds and experienced research nurses and medical assistants to facilitate research patient visits.

    Our dedicated TRU staff are experienced in clinical research operations, adhere to study protocols and follow Good Clinical Practice while conducting both outpatient and inpatient research visits. 

    Our research nurses also work with our investigators and research teams, attending research subjects in all of our hospitals and clinics as part of the mobile program.

• Pre-Award Financial Operations
  • Clinical Research Budgeting Team

    The budgeting team has a dual role of providing clinical research financial services and ensuring that billing compliance requirements are met.

    The team performs and facilitates the Coverage Analysis for each new and amended clinical trial or research study. The final product of this work is the CMS audit-ready Billing Grid document that justifies how study-related services should be billed – to study participant or their insurance, or to study budget. This function is required for all clinical research studies with expected hospital and professional tests, items and services performed at UWMC, HMC or FHCC hospitals and billed through Epic EMR.

    The team also offers clinical trial budget development service and sponsor negotiation. Our staff are experienced and trained to create and negotiate appropriate budgets that cover the costs of conducting the trial. This service is offered at principal investigator’s request, based on existing capacity.

    As part of institutional compliance responsibility, the team is tasked to provide institutional approval to start up clinical trials after review of applicable trial documents to ensure their consistency with federal policy and alignment of billing and payment terms.

  • Coding Analysis and Chargemaster Team

    Our team of experienced professional coders allocates appropriate codes to procedures in a study protocol and references the chargemaster to ensure research procedures are appropriately priced in preparation for clinical trial budget development and negotiation.

    The team is the liaison with multiple clinical areas that bill research studies (e.g., Radiology, Investigational Pharmacy, Lab Services, etc.) and make sure the research chargemaster remains accurate and up-to-date.

• Post-Award Financial Operations
  • Clinical Research Billing Team

    The Billing Team is responsible for timely and accurate billing of research-related UWMC and HMC hospital procedures, items, and services to study budgets. 

    The team is also responsible for timely and accurate billing of research funded clinical services furnished by UW providers through UW Physicians faculty practice plan, regardless of the site of practice.

    The team’s general scope is as follows:

    •  Activate an Epic EMR research account for clinical research studies
    •  Review hospital and professional charges for patients enrolled in clinical research
    •  Direct the charges appropriately to either patient/patient’s insurance or research study budget
    •  Create invoices for research-funded hospital and professional studies and send them to study teams for review and payment
    •  Address any charge disputes from study teams or study participants
    •  Provide hands-on training and training materials to study teams on how to properly perform their billing-related responsibilities in Epic EMR
    •  Close Epic EMR research accounts
• Research Data Support
  • Analytical Support Team

    Our Data Analytics team is instrumental in creating new and supporting existing tools, dashboards, and ways to organize operating data for metrics reporting and operational decision-making.