What are Serious Adverse Events and how do I handle these?

Duration: 60 Minutes
Serious adverse events along with adverse events, anticipated events, unanticipated events and unanticipated problems are often confused and misunderstood. This session will make a distinction between nomenclatures and discuss the reporting requirements to the FDA and Office for Human Research Protections (OHRP).
Adverse Events Reporting
Instructor: Sarah Fowler Dixon
Product ID: 500659

Why Should you Attend:
Regulations and guidance can be overwhelming and seem conflicting when it comes to handling serious adverse events, it is important to know when and what needs to be submitted, reviewed, and approved by an Institutional Review Board (IRB) and what can be handled by the investigator as non-reporting of events that are considered reportable can lead to issues related to non-compliance.

Objectives of the Presentation:
The objectives of the presentation are to talk in detail about:
  • 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
Who can Benefit:
  • 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
$300
Recorded Session for one participant
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
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  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Sarah Fowler-Dixon, PhD, CIP is an 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, 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.

Prior to joining Washington University, Dr. Fowler-Dixon was the Educational Development and Learning Specialist for Saint Louis University serving on various committees to improve research, procedures, community outreach, and retention.
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