Overview: When conducting clinical trials it is important to understand and to 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.
Serious adverse events are defined by the FDA as "Any adverse experience that places the patient, in the view of the initial reporter, at immediate risk of death from the adverse experience as it occurred, i.e., it does not include an adverse drug experience that, had it occurred in a more severe form, might have caused death." Although this definition seems clear, there are words within the definition itself that have to be understood in order to ensure compliance. Who is the initial reporter? What is an adverse experience? Is an adverse experience different or the same as an adverse drug experience? How do you know if a more severe form as occurred? Is death the SAE or is the cause of death the SAE?
This webinar will help sort out all these issues and get you to a better understanding of what needs to be reported to who.
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.
Areas Covered in the Session:
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 Will 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
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.
Serious adverse events are defined by the FDA as "Any adverse experience that places the patient, in the view of the initial reporter, at immediate risk of death from the adverse experience as it occurred, i.e., it does not include an adverse drug experience that, had it occurred in a more severe form, might have caused death." Although this definition seems clear, there are words within the definition itself that have to be understood in order to ensure compliance. Who is the initial reporter? What is an adverse experience? Is an adverse experience different or the same as an adverse drug experience? How do you know if a more severe form as occurred? Is death the SAE or is the cause of death the SAE?
This webinar will help sort out all these issues and get you to a better understanding of what needs to be reported to who.
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.
Areas Covered in the Session:
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 Will 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
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.
