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

Session dates/times: Classes are held the 4th Friday of each month (10:00 a.m. - 11:30 a.m.)

 Previous Seminars

• “The JHM Monitoring Program: New IRB Guideline Changes and Converting to eIRB - Suggestions for Maintaining Compliance” - Fall 2010
• "Audit Preparation Suggestions and Strategies" - Spring 2006
• "Projects That Do Not Involve FDA Regulated Products: Investigator Responsibilities and Compliance" - Fall 2006
• "Common Informed Consent Problems and Solutions" - Spring 2007
• "Protocol Deviations: Identification, Responses and Solutions" - Fall 2008