Services of the Clinical Research Administration Division for Clinical Trials

PRE-INITIATION

  • 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

POST-INITIATION

  • 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

STUDY CLOSURE

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

QUALITY IMPROVEMENT FOR CLINICAL RESEARCH

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

EDUCATION OPPORTUNITIES

  • 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: Mar 03, 2015
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