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Clinical Trials Office

NEW STUDY SUBMISSION REQUIREMENTS

Documents Required for All New Study Initial Reviews

All human subjects research conducted at UMC must request and be granted IRB approval as well as institutional approval from the CTO.

For interventional studies that have billable items and services, the CTO Patient On-Study/Study Visit form must be submitted to the CTO within 24 hours of patient consent and/or study visits.

The UMC Clinical Trials Office provides the follow services to all physicians conducting clinical trials at University Medical Center of Southern Nevada:

Pre-Award Process

  • Identify Clinical Trial Opportunities
  • Site Information Form
  • Confidentiality Disclosure Agreement
  • Protocol Review
  • Site Selection
  • IRB Submission/Approval
  • CTO Application Submission/Approval
    • Qualifying Clinical Trial Determination
    • Medicare Coverage Analysis
    • Budget Development/Negotiation/Approval
  • CAR Application and Routing
  • Clinical Trial Agreement Execution
  • Memorandum of Understanding

Post-Award Process

  • Provide Clinical Research Coordinator support
  • Site Initiation Visit
  • Restricted and Designated Funds Account
  • Study Start Up
    • Patients Consented and Enrolled
    • On-Study Notification
    • Visit Notification
  • Review and Adjudication of Research Related Charges
  • Invoicing and Restricted Study Account Management
  • Study Close-Out
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