Reporting Adverse Events, Serious Adverse Events , and Unanticipated Problems (CR Seminar,1 hour)

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Presenter
Eric Devine, PhD, Director, Clinical Studies Unit, Department of Psychiatry, and Vice-Chair, BMC/BUMC IRB

Objectives:

  1. "Define Adverse Events (AE), Serious Adverse Events (SAE), and Unanticipated Problems (UP).

  2. Understand how to assess, grade, and document AEs, SAEs, and UPs.

  3. Understand reporting obligations and reporting deadlines.

  4. Practice determinations using case examples."

Clinical Research Seminars,  BMC/BUMC Clinical Research Resources Office

Register in advance through the Clinical Research Seminars webpage

Duration: 1 hour