University Of Utah Health Campus With Mountains

Investigator Resources

Resources, service models, and guidance for successful clinical trial management.

The University of Utah, Department of Pediatrics, Clinical Trials Office (CTO) offers multiple service models ranging from minimal support to full study support.

I- Recharge Center Services Model

The PI is billed only for services used, with all financial management handled by their Division/Department.

II- Start-up Services Model

The CTO handles all contract and budget negotiations. If Recharge Center services are needed, the Mixed Services Model is recommended instead.

III- Mixed Services Model

Combination of I and II

The CTO manages start-up and negotiates its fee with the sponsor directly, while the PI pays only for Recharge Center services used and their Division/Department handles post-award account management.

IV- Shared Risk Model

Industry sponsored trials only (excludes Pediatrics)

The CTO handles all study operations and finances, the PI is responsible for oversight and recruitment, and any financial risk is split 50/50 with the PI's Division/Department.

Need Help Choosing a Service Model?

Our team can help identify the best support approach for your study and research goals.

.

Contact the Clinical Trials Office

Details and pricing information are available in PULSE.

Service Models and Pricing

GENERAL RESEARCH RESOURCES

Collaborative Institutional Training Initiative (CITI)

is a nationally and internationally recognized expert in research ethics, compliance and research education. The CITI program provides training courses for colleges and universities, healthcare institutions, technology and research organizations, and governmental agencies.

CITI training is required for Human Subjects Research.

Required CITI Trainings:

1) Group 1: Biomedical Research Investigators and Key Personnel

2) Good Clinical Practice Course (US FDA focus)

CITI

Form FDA 1572

is a document required for FDA-regulated clinical trials that establishes the investigator's agreement to uphold legal requirements for human subject protection and data integrity.

By signing the Form FDA 1572, the investigator agrees to:

Conduct the study according to the protocol and regulations.
Inform subjects the drug is investigational.
Report adverse experiences to the sponsor.
Maintain accurate records and make them available for inspection.
Ensure Institutional Review Board (IRB) oversight.

Form 1572

Office for Human Research Protections (OHRP)

The Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and wellbeing of human subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS). OHRP is part of the Office of the Assistant Secretary for Health in the Office of the Secretary of HHS.

OHRP

National Institutes of Health (NIH)

The National Institutes of Health (NIH) is the primary Federal agency responsible for biomedical and public health research.

NIH

UNIVERSITY RESOURCES

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 offers:

OnCore Training and Support
eReg Training and Support
Participant Payments Training and Support
Monitoring & Quality Assurance
IND/IDE Support
AdobeSign
MyChart Recruitment

CRSO

Institutional Review Board (IRB)

The IRB conducts ethics review for research that includes human participants.

They protect the rights and welfare of human research participants by ensuring compliance with state and federal laws, and the ethical standards set forth in University policy.
Provide guidance to researchers and staff across the University
Manage single IRB process

IRB

Radioactive Drug Research Committee (RDRC)

The RDRC evaluates and approves or disapproves of applications involving investigational or non-routine clinical uses of radioactive drugs without New Drug Applications (NDA) filed with the FDA or without Investigational New Drug (IND) numbers issued by the FDA.

The RDRC reports directly to the United States Federal Drug Agency (FDA) and must ensure compliance with 21 CFR 631.1.

RDRC

Office of the Vice President for Research

The Office of the Vice President for Research (VPR) handles research infrastructure, policies and compliance at the University of Utah. The VPR office oversees the following research administration units:

Conflict of Interest
Environmental Health and Safety
Institutional BioSafety Committee
Office of Quality Compliance
Office of Research Information Systems
Office of Sponsored Projects
Pre-Award Office
Research Education (REd)
Research Integrity & Compliance
Research Participant Advocacy
Research Security Office

VPR

Utah Data Coordinating Center (DCC)

The University of Utah Data Coordinating Center (DCC) is a full-service Academic Research Organization (ARO) that operates a comprehensive Clinical and Data Coordinating Center.

DCC

Clinical Research Standard Operating Procedures (SOPs)

The University of Utah Clinical Research Standard Operating Procedures have been established to ensure consistency and compliance with Federal & State Regulations, institutional policies, and Good Clinical Practice guidelines that are common in all types of research.

SOPs

Clinical and Translational Science Institute (CTSI)

The Utah CTSI accelerates the delivery of impactful health solutions from bench to bedside to populations. Our experts design new research methods and train the next generation to tackle complex biomedical problems. We look forward to providing comprehensive services and education for you and all members of our Mountain West research community.

CTSI

Technology Licensing Office (TLO)

The Technology Licensing Office (TLO) brings together diverse expertise and experience, combining knowledge of intellectual property, business development, licensing and industry engagement. We are here to guide you through the technology transfer process and help transform your innovative ideas into tangible, impactful solutions.

TLO

Investigational Drug Services (HCI)

The Investigational Drug Service (IDS) is a licensed pharmacy that provides support and guidance for the safe and efficient conduct of clinical drug trials.

HCI IDS