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Human Subjects Protection Training

Required

Information pertaining to Human SubjectsSubject Protection Training

All research personnel planning to conduct human subject research are required to complete Web-based training on human subject protection and good clinical practice (GCP) on the Collaborative Institutional Training Initiative (CITI) website.

Instructions and registration for the CITI Training Program are also available through the UNMCResearch, Institutional Review BoardBoard, (IRB)and websitethe onOffice theirof CITIRegulatory pages.Affairs is no longer updated in this handbook.

Additional training in clinical research is available for trainees, faculty, health providers, and research personnel at the annual Clinical Research Symposium coordinated by the Clinical Research Center (CRC). View the schedule and registration details on the CRC's website.

Training for Clinical Coordinators

Required training

  • CITI Training: Good Clinical Practice Course available through the UNMC Institutional Review Board (IRB) web site at unmc.edu/irb/resources/citi.
  • Clinical Trials Master Matrix (CTMM)/billing grid training is required for access to the secure drive where centralized Clinical Trials folders are stored. Training is provided upon request by contacting the Senior Research Billing Associate at 402-559-4939.
  • Coverage Analysis instruction is required for clinical coordinators. Schedule training through the Clinical Research Manager at 402-552-6601 or the Senior Clinical Trials Analyst at 402-552-7817.
  • One Chart Electronic Health Record training is required for all clinical coordinators to have access to One Chart in order to perform duties such as chart review, order entry, patient enrollments, and study visit/orders linking. Access requests may be completed in the IT Service Requests portal. Coordinators may sign up for training in Apollo or reach out to OneChartTrainingRequests@NebraskaMed.com for assistance.
  • The Clinical Research Coordinator’s Workshop is available on the CCTR website. Recommended for all new clinical coordinators. A live training program is scheduled annually as well. For information and access to the workshop materials, contact the Research Subject Advocate Office, 402-559-6941.
  • Clinical Coordinator Orientation is available on request from UNeHealth. Coordinators receive an overview of the contract and negotiation process and learn best practices to speed study start-up.
  • IRB Orientation is available upon request by contacting the IRB Office at 402-559-6463. The session is tailored to the needs of the attendee based on the type of research conducted and their role in studies. The session includes specific information on the IRB submission process, post-approval submission requirements, informed consent training, and orientation to the electronic IRB application submission system.
  • The IRB Education Series offers educational sessions for new and experienced clinical personnel. Topics range from an orientation level to research subject compensation, tips for a trouble-free IRB review, and more. For a schedule, visitVisit the IRB Education Series webpageGuidebook or contactfor the IRBmost Educationup-to-date Coordinatorinformation.

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can be found within the Training section of the guidebook.

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