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What are Serious Adverse Events and How do I Handle These?
This webinar will make a distinction between nomenclatures (serious adverse events, adverse events, anticipated events, unanticipated events and unanticipated problems) 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.
Serious adverse events along with their cousins, 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).
Areas Covered in the Webinar:
- ICH guidelines and Good Clinical Practice (GCP).
- Department of Health and Human Services (DHHS) guidance.
- Food and Drug Administration (FDA) guidance.
- Definitions of serious adverse events, adverse events, anticipated events, unanticipated events and unanticipated problems.
- Potential effects on consent and the protocol.
- Examples of events that are considered reportable.
- Links to useful resources.
Who Will Benefit:
This webinar will provide valuable assistance to all personnel in:
- Human Subjects Research
- Healthcare professionals 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
Dr. 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, 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 lead 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.
ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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Sarah Fowler Dixon
Deviations: What are they? Do you need to report? New Part 11 Guidance for Clinical Trials: What This Means for You Institutional Review Boards (IRBs): The Changing Landscape and the Effect on the Conduct of Clinical Research Achieving Research Compliance Through Risk Assessment