Clinical Research Services

The Department of Neurosurgery Office of Clinical Research Services is available to support faculty, residents and staff navigate the complexities of regulatory and institutional requirements to initiate and conduct research involving human subjects and clinical trials at UF. Support is available beginning with protocol development and feasibility assessments through agreement processing, obtaining UF-required regulatory approvals, and life-cycle support including closure and clinicaltrials.gov results reporting.

Research Services include:

Clinical Trial and Research-related Agreements

  • Confidentiality, Non-disclosure Agreements
  • Data Use/Material Transfer Agreements
  • Clinical Trial Agreements

Financial Management

  • Feasibility assessments
  • Budget development and negotiation
  • Study invoicing and financial management

Billing Compliance Management

  • Medicare Coverage determination
  • Charge tracking and routing
  • Payment for sponsor-funded services

Regulatory Management

  • IRB submissions, meeting representation, liaison activities
  • FDA IND submissions and life-cycle support
  • NIH OBA RAC submissions and life-cycle support
  • Institutional Submissions:
    HURRC
    PRMC
    DSMB
    IBC
    Human subjects protection and HIPAA Training
  • ClinicalTrials.gov registration and management
  • NCI/CTEP Registration
  • Study Sponsor
    • E-binder management and liaison

Biostatistics

Study Management and Coordination

 

FOR QUESTIONS OR ASSISTANCE STARTING A NEW RESEARCH PROJECT, CONTACT THE NEUROSURGERY OFFICE OF CLINICAL RESEARCH SERVICES, 352-273-9000