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Services of the Clinical Research Administration Division for Clinical Trials

For Our Sponsors

KUMC-RI strives to establish and maintain mutually productive relationships with cooperative research groups, and federal and industry sponsors. Our centralized financial and regulatory services facilitate the timely start-up of clinical trials conducted at KUMCClinical Areas of Research at KUMC.

  • Interventional Cardiology
  • Electrophysiology
  • Cardiovascular Surgery
  • Oncology
  • Orthopedic Surgery
  • Trauma Surgery
  • Neurology
  • Emergency Medicine
  • Pulmonary Medicine
  • Anesthesia
  • Pain Management
  • Genetics
  • Pediatrics
  • Clinical Pharmacology
  • Endocrinology
  • Nursing Research
  • Dietetics and Nutrition


  • Attend, if requested by study staff, site evaluation visits to answer institutional questions study processing and activation time
  • Serve as centralized contact between sponsors and the study staff for all clinical trial, regulatory, administrative, and budget and contract work at the University of Kansas Medical Center
  • Provide protocol development support for investigators
  • Prepare consent form for investigator's review
  • Secure Human Subjects Committee approval of protocol and consent form
  • File regulatory documents required by FDA and sponsor
  • Prepare and negotiate trial budgets
  • Request pricing for hospital and clinical services
  • Review and negotiate clinical trial and data use agreements
  • Notify investigator and sponsor of final HSC approval
  • Prepare and submit initial IND documents, amendment and annual progress reports for IND


  • Secure HSC approval of protocol revisions and revised consent forms
  • Obtain HSC approval for print or media advertising
  • Process internal adverse events and IND safety reports for HSC submission and approval
  • Provide status reports of each investigator's trials as requested
  • Submit reports to HSC for annual re-certification of trials
  • Coordinate ongoing communication between sponsor and investigator
  • Revise and negotiate budget and clinical trial agreements


  • Process study closure for trial termination
  • Complete reconcilliation documents for trial account closure


  • In conjunction with the Office of Compliance, conduct quality improvement visits [QIV]


  • Host and organize Clinical Trial Education Lecture (CTEL) series on a monthly basis
  • Provide training workshops (CTEC) for investigators and study coordinators
  • Meet with physicians and study coordinators to review Research Institute services
  • Provide new study coordinator/research nurse orientation
  • Facilitate coordinator certification, networking and educational opportunities

Last modified: Jun 10, 2019