Clinical Research Administration

The Research Institute’s Clinical Research Administration team manages and executes the administrative and regulatory elements for clinical trials at the University of Kansas Medical Center.

The CRA acts as the central liaison between funding agencies, institutional review boards, and researchers at the University of Kansas Medical Center. Our mission is to help researchers navigate and understand a rapidly-changing regulatory environment and to safeguard researchers from common risks experienced while conducting clinical trials.

Our team performs a wide range of services through every stage of clinical trial activity

Study Startup

  • Create initial study record in VELOS/CRIS
  • Serve as centralized sponsor contact point for the Medical Center
  • Create consent form(s)
  • Manage and set up Greenphire (ClinCard) account for subject payments
  • Manage IRB processes:
    • Secure Human Subjects Committee approval of protocol and consent form
    • Notify investigator and sponsor of final HSC approval
  • File regulatory documents required by FDA and sponsor
  • Prepare and negotiate trial budgets and contracts
  • Provide services for investigator initiated trials
    • Prepare and submit initial Investigational New Drug (IND) and Investigational Device Exemption (IDE) documents
    • Initiate registration
    • Provide protocol development services
    • Build proposal for funding sources for industry funded studies and assist with funding source identification
    • Create trial management tools including critical documents and study binders
  • Coordinate confidentiality agreement
  • Attend site evaluation visits to answer institutional questions about study processing and evaluation time (as needed/on request)

Ongoing Study Management

  • Manage IRB Process
    • Secure HSC approval of protocol revisions and revised consent forms
    • Obtain HSC approval for print or media advertising
    • Assist with processing internal adverse events and IND safety reports for HSC submission and approval
    • Submit reports to HSC for annual re-certification of trials
  • Monitor compliance with registrations
  • Manage all subsites for multi-site investigator initiated trials
  • Prepare amendments and annual progress reports for IND and IDE submissions
  • Coordinate ongoing communication between sponsor and investigator
  • Process study closure for trial termination
  • Process budget and contract amendments

Educational Opportunities

  • Host and organize Clinical Trial Education Lecture Series (CTELS)
  • Investigator/Study Team orientation
  • SoCRA hosted and organized

Last modified: Aug 07, 2015