Clinical Trial Activation Pathway

• The study team follows department and school processes to determine study feasibility and gathers required documents.
  • Protocol
  • Informed Consent
  • Budget
  • Contract
  • Manuals
• The study team submits the Clinical Research Activation Form.
• The OCTA Portfolio Manager reviews the Clinical Research Activation Form and schedules a kickoff meeting with the study team, to include KUMC and UKHS staff who support study activation.
• The study team follows up as indicated in the responses to the Clinical Research Activation Form. For clinical trials occurring on the Kansas City campus, this includes (where applicable) the Clinical and Translational Science Unit, Hoglund Imaging Center, Investigational Drug Services and other areas of the University of Kansas Health System.
• The Portfolio Manager supports timely and efficient activation by assisting to coordinate and harmonize start up activities across the clinical research enterprise. Editorial assistance with informed consents and other documents is available when needed.
• Parallel study start-up activities proceed, for example:
  • IRB submission and approval
  • Ancillary committee submissions and approval (where applicable)
  • Coverage Analysis and development of Billing Matrix (where applicable)
  • Contract review and negotiation
  • Budget development and negotiation
  • Greenfire Clincard participant payment set up
  • Research Systems (CRIS, Complion, myResearch) implementation
• The Portfolio Manager provides written Notice of Activation Approval after confirming completion of required tasks.

Locate your assigned Portfolio Manager and Budget Analysts.