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Live Webinar on
What is a Serious Adverse Events and how do I handle these Date: Thursday, May 15, 2014 Duration:
60 Minutes
Time: 10:00 AM PDT | 01:00 PM EDT Location: Online
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Instructor: Sarah Fowler-Dixon
Overview: When conducting clinical trials it is important to understand and be able to identify serious adverse events (SAE). These are events that are serious, likely related to the study drug, device, treatment or procedure, and increase risks to participants or others.
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ICH guidelines and Good Clinical Practice (GCP)
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Department of Health and Human Services (DHHS) guidance Food and Drug Administration (FDA) guidance
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Definitions Potential effects on consent and the protocol Examples Links to useful resources
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Human Subjects Research Healthcare interested in exploring the field of Clinical Research New Clinical Research Coordinator Positions (1-2 years) New Principal Investigator Positions Administration in charge of Clinical Research Regulatory Compliance
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About Speaker Sarah Fowler-Dixon Education Specialist and instructor , Washington University Sarah Fowler-Dixon PhD, CIP is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program.... more
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