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Compliance Monitoring Program Educational Seminars
The following presentations are from the informational sessions that have been presented by the OHSR Compliance Monitors. To date, these presentations have highlighted organization and conduct issues observed from site visits. Also included in these presentations are practical recommendations to implement strategies to increase regulatory and subject compliance, as well as helping with the preparation for monitoring and audit visits
Dates for Upcoming Seminars:
Training Sessions: Good Clinical Practice (GCP) Fundamentals: Understanding and Applying GCP to Human Subjects Research (JHM IRB)
Good Clinical Practice or ‘GCP’ training for investigators and study-team members is increasing becoming required by institutions, sponsors, and the NIH. This 90 minute course will explain the elements of the International Conference for Harmonization’s (ICH) principles and specific guidelines for Good Clinical Practice. Attendees will be introduced to the GCP Principles, and will explore investigator responsibilities in human subject research, focusing on the areas of trial conduct (experience, resources, and physician duties); performance (communication with the IRB, protocol compliance, and investigational product management); ethical research (safety oversight and informed consent); and recording/reporting (data acquisition, progress summaries, and safety-event reporting).. Please register via this link: http://lms14.learnshare.com/l.aspx?CID=89&A=2&T=339728
Classes are held the 4th Friday of each month (10:00 a.m. - 11:30 a.m.)