Services Offered

The Clinical Trials Office (CTO) of the University of Vermont Cancer Center supports clinical and translational investigators in all operational aspects of clinical cancer research. We support all trial types including investigator-initiated, National Clinical Trial Network cooperative group, and industry-sponsored cancer-focused trials for adults. The staff in the UVM Cancer Center CTO provide a broad spectrum of support for investigator-initiated, industry-sponsored, and NCI-funded clinical research from study start-up through project close-out.  Our extensive services span 3 functional areas and reflect a comprehensive approach to clinical research management.

Operational and Financial Support

The UVMCC CTO staff can assist investigators in navigating an increasingly complex research landscape to ensure efficient protocol management and sound financial conduct.

  • Protocol feasibility and site selection process management
  • Clinical research pre-award services, including budget development and review of research billing plans
  • Clinical research post-award services, including management of patient stipends, sponsor invoicing, account management, and overall study account reconciliation
  • Liaison with the sponsor, Office of Clinical Trials Research, UVM Medical Center billing teams and billing compliance office
  • Support and facilitate the Protocol Review and Monitoring Committee and Data Safety Monitoring Committee

Study Coordination and Clinical Support

With the help of the UVMCC CTO research coordinators and nurses, Investigators can be assured that eligible patients are identified for study participation, enrolled patients are managed in accordance with the protocol and Good Clinical Practice guidelines, and study data is thoroughly captured.

  • Patient screening
  • Eligibility determination
  • Participant visit coordination
  • Adherence to protocol specific criteria for enrollment, treatment and follow up
  • Translational specimen coordination, including collection and processing
  • Data management services, including data capture, data submission and query resolution
  • Adverse event management, including reporting of Serious Adverse Events
  • Liaison with pharmacy, radiology, pathology and other ancillary departments

Regulatory and Compliance Support

The UVMCC CTO Regulatory team promotes regulatory compliance by ensuring appropriate submission and management of required documentation for the lifecycle of the study from inception to study closeout.

  • Submissions to PRMC, IRB, and other review committees as required. See the Study Start-Up for an overview.
  • Development and maintenance of regulatory documents (1572, Financial Disclosure Forms, Delegation of Duty logs, protocol training records, etc.)
  • Development and modifications to Informed Consent forms
  • Liaison with review committees, sponsor, and clinical team
  • Management of internal and external audits, including preparation, audit conduct, and required follow-up steps

Other Services

  • Quality assurance review and monitoring
  • Database development
  • Protocol development
  • Affiliate network and multi-center trial operations
  • IND/IDE submissions