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University of Colorado Cancer Center

University of Colorado Cancer Center, A National Cancer Institute-designated Comprehensive Cancer Center
 

Clinical Investigations

The Clinical Investigations Shared Resource (CISR) provides support to clinical investigators on all activities related to the successful conduct of clinical trial research. This is the cornerstone to translate basic science knowledge of the cancer process into clinically useful treatment for patients.

Mission & Objectives:

The mission of the CISR is to support the "develop" portion of the broader CU Cancer Center mission to discover, develop and deliver breakthroughs in diagnosis, treatment and prevention that improve cancer care.

  • Support all aspects of clinical investigations including protocol development, patient recruitment and treatment, coordination of care with other clinical services
  • Perform all aspects of regulatory compliance and quality assurance
  • Facilitate CU Cancer Center investigator-initiated cancer clinical trials
  • Provide clinical trials education to investigators, research staff and clinic personnel
  • Provide fiscal and operational excellence leading to cost effectiveness
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    Services:

  • Regulatory submission and monitoring
  • Protocol Development
  • Budget development and contract negotiation
  • Enrollment of eligible patients
  • Data collection and monitoring
  • Specimen procurement and processing
  • Adverse event reporting
  • Coordination of patient treatment
  • Training and education of clinical and regulatory staff
  • Training of Phase I oncology fellows
  • General Good Clinical Practice Training
  • Maintenance of the CU Cancer Center Clinical Trials Database
  • Quality Assurance
  • Protocol Review and Monitoring
  • PQASC-audit schedule & Data Safety Management Plan