Clinical Trials Office
Conducting clinical research at University Medical Center of Southern Nevada (UMC) is an essential part of achieving the mission, vision and values of the institution. To achieve these, the UMC Clinical Trials Office was established to ensure the compliant conduct of clinical research while verifying UMC costs are covered and research billing compliance is adhered to.
Mission
The mission of the University Medical Center of Southern Nevada (UMC) Clinical Trials Office (CTO) is to ensure research billing compliance and ensure costs associated with clinical research at UMC are covered.
The actions of the UMC CTO conform to all other applicable Federal, State and local laws and regulations including CMS Clinical Trial Policy, False Claims Act, Stark Law, Anti-Kickback, Sunshine Act and Fair-Market Value
Goals
To accomplish the mission, the CTO reviews clinical research submission applications, analyzes protocol documentation, and develops a plan for the proposed research through:
- Prospectively determine research costs versus routine care cost
- Determine the clinical trial is deemed “Qualifying”
- Negotiate, review and approve study budgets
- Assure all UMC costs are covered in the conduct of research
- Track clinical research patients and adjudicate research charges
- Ensure regulatory and research billing compliance
- Issue institutional approval
SUBMIT A NEW APPLICATION
NEW STUDY SUBMISSION REQUIREMENTS, FORMS & DOCUMENTS
Documents Required for All New Study Initial Reviews
- Clinical Trials Office Research Application (Required for all submissions)
- CTO Required Review Worksheet
- Study Protocol
- Informed Consent (if applicable)
- Clinical Trial Agreement (if applicable)
- Budget (if applicable)
Patient Enrollment, Study Visit and Off-Study
All human subjects research conducted at UMC must:
- Request and be granted IRB approval as well as institutional approval from the CTO.
- Follow the Medical Billing Compliance in Clinical Research Trials policy and procedures outlined by the CTO.
For interventional studies that have billable items and services, the CTO Patient On-Study/Study Visit form and appropriate research must be submitted to the CTO within 24 hours of patient consent and/or study visits.
The UMC Clinical Trials Office provides the following 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 Startup
- 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
Policies & Procedures
UMC CTO Policies & Procedures
UMC CTO Standard Operating Procedures
Federal Regulations and Guidance
Office of Management and Budget Circulars
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