When conducting clinical trials it is important to understand and 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:
Who Will Benefit:
- ICH guidelines and Good Clinical Practice (GCP)
- Department of Health and Human Services (DHHS) guidance
- Food and Drug Administration (FDA) guidance
- Potential effects on consent and the protocol
- Links to useful resources
CME Credit Statement
- 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
This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of Colorado Foundation for Medical Care (CFMC) and MentorHealth. CFMC is accredited by the ACCME to provide continuing medical education for physicians.
Colorado Foundation for Medical Care designates this educational activity for a maximum of 1 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity.
Other Healthcare Professionals Credit Statement
This educational activity has been planned and implemented following the administrative and educational design criteria required for certification of health care professions continuing education credits. Registrants attending this activity may submit their certificate along with a copy of the course content to their professional organizations or state licensing agencies for recognition for 1 hour.
It is the policy of Colorado Foundation for Medical Care (CFMC) and MentorHealth that the faculty discloses real or apparent conflicts of interest relating to the topics of the educational activity.
All members of the faculty and planning team have nothing to disclose nor do they have any vested interests or affiliations.
Continuing Education Credit
Colorado Foundation for Medical Care (CFMC) hosts an online activity evaluation system, certificate and outcomes measurement process. Following the activity, you must link to CFMC’s online site (link below) to complete the evaluation form in order to receive your certificate of credit. Once the evaluation form is complete and submitted, you will be automatically sent a copy of your certificate via email. Please note, participants must attend the entire activity to receive all types of credit. Continuing Education evaluation and request for certificates will be accepted up to 60 days post activity date. CFMC will keep a record of attendance on file for 6 years.