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

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

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• Instructor Profile
• Dr.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.

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• Description
• The topic covers the serious
  adverse events along with adverse events,
  anticipated events, unanticipated events and
  unanticipated problems are often confused and
  misunderstood and so this session will make a
  distinction between nomenclatures and discuss the
  reporting requirements to the FDA and Office for
  Human Research Protections (OHRP).
• 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.

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• Objectives of the Presentation
• The objectives of the presentation
  are to be spoken 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

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• Who can be Benefited
• 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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• Live Session - How it works?
• Username and Password will be sent to you 24
  hours prior to the webinar
• Presentation handouts in pdf format will be
  mailed to you
• Login to the session using the username and
  password provided to you
• Get answer to your queries through interactive
  QA sessions via chat
• Get certification of attendance.
• Recorded Session - How it works?
• A link will be provided to you upon purchase of
  the recorded session
• Please click on the link to access the session
• Presentation handouts in pdf format will be
  mailed to you
• Get certification of attendance.

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• Get Connected With Us

www.onlinecompliancepanel.com
www.onlinecompliancepanel.com 510-857-5896
customersupport_at_onlinecompliancepanel.com