What is a Serious Adverse Events and how do I handle these?

Summary: MentorHealth, a leading provider of online training for the healthcare industry, is organizing a webinar on May 15 on the topic, "What is a Serious Adverse Events and how do I handle these?" It will be presented by Sarah Fowler-Dixon, an Education Specialist and instructor with Washington University School of Medicine.

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Description:

Serious Adverse Events (SAE) are a very important aspect of a clinical trial. Since they are usually related to the study drug, device, treatment or procedure, and have the potential to increase risks to participants or others; it is important to understand and be able to identify these events.

The FDA has a clear-cut definition of an SAE; yet, there are many areas that need to be understood with greater clarity, if the trial has to be seen as being compliant. So, the important questions the staff conducting the trial should ask and address are: What do we at the trial consider as an adverse experience? Are an adverse experience and an adverse drug experience the same as each other, or do they differ? How can a more severe form be identified, if it has occurred? Is death the SAE itself, or is SAE the cause of death? Who is the initial reporter?

The answers to questions like these will be found in this webinar. It will help sort out all these issues and lead participants to a better understanding of what needs to be reported to whom.

It will cover the following areas:

• ICH guidelines and Good Clinical Practice (GCP)
• Department of Health and Human Services (DHHS) guidance
• Food and Drug Administration (FDA) guidance
• Definitions
• Potential effects on consent and the protocol
• Examples
• Links to useful resources
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When: May 15, 10:00 AM PDT | 01:00 PM EDT

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By whom:

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. She has initiated the planning, development, authorship and implementation of many human subjects’ research policies, practices, guidelines, and submission and reviewer forms often working with state and federal authorities.

She has provided consultation regarding ethical, federal, state, and institutional requirements for faculty and staff both in the design and execution of their projects and teaches research ethics and regulatory affairs and the fundamentals of research management to graduate and undergraduate students. More recently, she led a task force in the development of the Community Engaged Research Program at Washington University.

Dr. Fowler-Dixon has simultaneously served as an Independent Consultant, providing expertise and creating supplemental educational materials, including a copyrighted workbook.

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For whom:

The webinar will benefit those in:

• 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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Duration: 60 minutes

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To enroll for this webinar, contact

webinars@mentorhealth.com

Ph: 800-385-1607

Fax: 302-288-6884

http://bit.ly/1s5Uz0t

MentorHealth is a comprehensive training source for healthcare professionals. Our trainings are high on value, but not on cost. MentorHealth is the right training solution for healthcare professionals.