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Regulatory Knowledge & Support

Training & Education


Federal requirements for education in the protection of human research participants are met according to Colorado Multiple Institutional Review Board (COMIRB) policy for all affiliated/local principal investigators, co-investigators, and research coordinators listed on human research protocols by successfully completing the CITI course in human subject protections AND the Conflict of Interest (COI) prior to submitting a protocol.

Optional Clinical Research Training

Office of Regulatory Compliance Training Calendar

Clinical Trials Training for Investigators and Coordinators is provided for study coordinators and investigators conducting clinical research and covers:

  • Clinical trial core training
  • Submitting to COMIRB and unanticipated problems
  • Submitting to Institutional Bio-Safety Committee (IBC)
  • Budgeting for a clinical trial
  • Informed consent for clinical trials
  • Recruitment for clinical trials
  • FDA audits

The CITI Good Clinical Practice Course is designed specifically for clinical researchers participating in human subjects research to have knowledge of:

  • Federal regulations
  • International Conference on Harmonisation (ICH)
  • Regulations and good clinical practice guidelines

Resources

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