Education and Training

All investigators and key research personnel engaged in human research (proposals involving drugs, devices, interventional or behavioral treatments) must submit documentation of Good Clinical Practice (GCP) training prior to IRB submission of a proposal where he/she will participate in the conduct of human research.

Key research personnel is defined as the Principal Investigator, Sub-Investigator(s) and any other research staff who are directly involved in the conduct of research with study participants or who are directly involved with the clinical trial and/or handling of private information related to study participants during the course of the research project. Key research personnel also includes individuals (students, faculty sponsors, program directors, physician mentors) who provide direct oversight of the human research.

At Trinity Health Office of Research & Innovation – West Michigan, GCP training is provided through a partnership with the Collaborative Institutional Training Initiative (CITI). Successful completion of these web-based training modules will result in certification in Human Subject Protection and meet the requirements for institutional GCP training. For more information, please visit the IRB's Human Subjects Protection Training Requirements.

After completing this training, research personnel will have a comprehensive understanding of FDA Good Clinical Practices and will be expected to apply those practices to the conduct of clinical research at Trinity Health Michigan.