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Integrating Quality into Investigator-Initiated Clinical Trials

There are many steps that must be taken to assess risk and integrate quality when developing, initiating and conducting a clinical trial. These steps are crucial for every type of clinical trial. This session will describe how to apply those principles to investigator-initiated clinical trials utilizing tips, tools and templates available to help along the way.


  • Tracy Ohrt, CCRC, CCRA, Administrative Director, FDA Regulated Research Oversight Program, University of Wisconsin-Madison, School of Medicine and Public Health