This adverse event reporting Webinar/training will discuss the clinical trial regulations requirements with respect to adverse event and explain how to assess and report AEs and SAEs.
Areas Covered in the seminar:
- The CFR definitions of Adverse Events, Serious Adverse Events, Unanticipated Adverse Device Effects and many more.
- How to know what an Adverse Event is and when to report it or them.
- Understanding laboratory AEs and the "Reference Range" concept.
- Type A and Type B Adverse Reactions.
- Common Mistakes in AE / SAE Reporting.
- Reporting of Adverse Events - when and to whom and the use of Adverse Event.
- Terminology systems.
- The Role of Data safety Monitoring in Protecting Human Volunteers.
- How to record Adverse Events and assess causality - the algorithm.
Who will benefit:
This webinar will provide invaluable assistance to investigators and their staff in the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product (Drug or device) research involving human subjects. Those benefiting the most would be:
- Principal Investigators / Sub-investigators.
- Clinical Research Scientists (PKs, Biostatisticians).
- Safety Nurses.
- Clinical Research Associates (CRAs) and Coordinators (CRCs).
- QA / QC auditors and staff.
- Clinical Research Data managers
