Office of Clinical Trials

A woman standing in front of model skeletons.

What We Do

The UNLV Office of Clinical Trials is a vital resource in supporting interventional, observational, and epidemiological research in relation to human subjects. Our office assists with review, analysis, preparation, and execution of:

  • Industry-sponsored
  • Investigator-initiated clinical research
  • Federally funded clinical research (with OSP)

The office also supports:

  • Study feasibility
  • Policies and procedures
  • Logistical considerations
  • Central data management
  • Budgetary review and negotiation, financial management
  • Contractual obligations

Affiliated Research Service Sites

In support of cross-collaboration and maintaining the feasibility of research studies, Office of Clinical Trials has established partnerships within the community that support the research and assessments necessary to meet protocol requirements.

  • University Medical Center of Southern Nevada
  • Sunrise Hospital and Medical Center
  • Desert Radiology
  • Quest Diagnostics
  • Exam One (a Quest Diagnostic Company)
  • CPL Laboratories
  • LMC Pathology

School of Medicine Resources

The Kirk Kerkorian School of Medicine at UNLV has experienced clinical research coordinators that liaise with industry sponsors and provide the following service support to researchers:

  • Preparation and submission of materials for internal committee reviews and initial, continuing, and amendment preparations for the internal review board (IRB).
  • Site selection/qualification visits and site initiation visits.
  • Protocol review and training.
  • Meeting with, preparing with, and analyzing between collaborating departments/service sites.
  • Investigator meetings, source documentation development, electronic data capture training, and updating the university’s clinical trials management system.
  • Assisting study data monitors for site visits, audits, and subject data review.

Master Confidentiality Disclosure Agreements

To help expedite the review of protocols for interested potential investigators, the Office of Clinical Trials is currently working with sponsors/CROs to finalize general or master Confidentiality Disclosure Agreements.

Protocol Activation Process

  1. Investigator Identifies a Protocol
  2. A CDA is sent to the Clinical Trials Office at UNLV
  3. A Sponsor Feasibility Questionnaire is sent to the Investigator
  4. Protocol reviewed for feasibility by departments supporting schedule of assessments
  5. Scientific Merit Review Committee Review/Approval
    1. Budgets and Contracts
  6. Informed Consent Form(s) drafted
  7. Submit SMFRC approval letter, Initial IRB Application Packet to ORI and IRB of Record
  8. IRB review and Approval
  9. Protocol Training/Site Initiation Visit
  10. Protocol Opens to Accrual
    1. Budgets and Contracts

Investigator Initiated Protocol Assistance/Support

Office of Clinical Trials is HAPPY to help with any of the following:

  • IND/IDE Application
  • Phase
  • Subject Population
  • Schedule of Assessments required
  • Protocol
    • Protocol Templates based on funding source, phase, intervention, IND/IDE application, subject population, specifications and requirements of sponsor.
  • Funding Source
  • Industry – will work with Sponsors to obtain proper funding and contracts.
  • Grants – will work with OSP to verify protocol meets all requirements.

Contact Us

Clinical Research Coordinator Support

Amrita Patel
702-671-5093
amrita.patel@unlv.edu

UNLV Office of Clinical Trials

Michelle Tomasino
Manager, UNLV Office of Clinical Trials
702-895-4923
michelle.tomasino@unlv.edu
cto@unlv.edu

Availability

Tuesdays
UNLV Clinic (1707 Building)
2nd Floor Conference Room
Call to schedule a time.