The Clinical Trials Office offers a full range of services to support the development, execution, and oversight of clinical trials and research studies at the University of Utah. Our team works collaboratively with Principal Investigators (PIs) and study teams to ensure adherence to all relevant regulations and provides dedicated care and support for patients participating in clinical trials.

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Clinical Trial Finance Team

The Clinical Trial Finance team manages the entire financial scope of pre-award and post-award financial oversight.

The team is responsible for:

  • Budget development and negotiation

  • Clinical research billing compliance

  • Study account reconciliation and monitoring

  • Financial reporting for Principal Investigators and administrators

  • Account close-out procedures

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Contracts Team

The Office of Sponsored Projects (OSP) supports University of Utah faculty through effective management of extramural sponsored proposals and awards funded by federal and state agencies, foundations, and other public and private sources.

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OSP is primarily responsible for: 

  • Interpreting and ensuring compliance with

    • University policy, proposal and award terms and conditions

    • Applicable federal and state laws and regulations

  • Proposal review and submission on behalf of the University of Utah

  • Sponsored agreements and subaward drafting, negotiation and execution

Quality Assurance Team

The Quality Assurance (QA) team routinely monitors all active studies for both industry-sponsored and investigator-initiated clinical trials and research studies.

The QA team ensures clinical trials adhere to:

  • Study protocols

  • Applicable federal and state regulations 

  • ICH Good Clinical Practice (GCP) guidelines

  • Institutional policies and procedures

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Regulatory Team

The regulatory team manages all regulatory aspects of the protocols for both industry-sponsored and investigator-initiated clinical trials and research studies.

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The team provides fee-for-service activities including:

  • Regulatory submissions (initial IRB application, continuing reviews, amendments, safety report forms, FDA IND/IDE submissions and reports)

  • Developing study forms, such as Informed Consent (ICF), Assent, Parental Permission (PPF)

  • Creating and maintaining regulatory documents to meet sponsor and federal requirements

  • Ensuring compliance with ICH GCP E6 (R2), federal and state regulations, and institutional policies

Study Coordination Team

The study coordinator team supports the management and coordination of clinical research studies. They perform PI-delegated study protocol activities for both industry-sponsored and investigator-initiated clinical trials and research studies.

The team provides fee-for-service activities, such as:

  • Participant screening

  • Obtaining informed consent

  • Reporting and tracking adverse events, serious adverse events, and protocol deviations

  • Completing case report forms and data entry

  • Sample collection, processing, and shipping

  • Coordinating sponsor monitor visits 

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Study Start-up

The study start-up coordinator serves as the first point of contact for incoming clinical trials.

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Responsibilities include:

  • Initial contact with sponsors, PIs, and study teams

  • Study feasibility

  • Site selection

  • Internal Study Review (ISR)

    •       An ISR is a meeting with site staff to discuss protocol logistics

Request Services

The Clinical Trials Office (CTO) offers multiple clinical research services ranging from minimal support to full study support. We look forward to partnering with you.

Today's Discovery. Tomorrow's Hope.

Contact Us:

Email: ClinicalTrialsOffice@hsc.utah.edu

Phone: 801-587-7514