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University of Colorado Denver


Clinical Research Support Center

Office of Regulatory Compliance

Welcome to the Clinical Research Support Center at the University of Colorado Denver’s Anschutz Medical Campus.

We offer guidance for clinical research professionals at CU-AMC and its affiliates at no cost. Our team consists of senior clinical research specialists whose role is to assist and guide you through the various regulatory requirements for research involving human subjects. 

Our goal is to provide appropriate guidance in a very responsive way and help you develop a strategy to get your study up and running.

Services include:

  • FDA submission assistance guidance
  • Clinical Trials Budgeting guidance
  • Education and training
  • Review of IRB documents before submission
    • Application for Protocol Review
    • Consent
    • Additional Documents
  • Site initiation visits
  • Compliance advice
  • Assistance with submissions and maintenance


“Being educated about the requirements and how to satisfy them will help research professionals get their trials open as quickly and efficiently as possible.”
Alison Lakin, R.N., L.L.B., L.L.M., Ph.D, Assistant Vice Chancellor for Regulatory Compliance

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