Clinical Trial Regulations and GCP Compliance as they relate to Adverse Events - How to Assess and report AEs and SAEs
29 Oct 2010
Webinar
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
Past Events
Clinical Trial Regulations and GCP Compliance as they relate to Adverse Events - How to Assess and report AEs and SAEs - 29 Oct 2010, Webinar (8656)
Clinical Trial Regulations and GCP Compliance as they relate to Adverse Events - How to Assess and report AEs and SAEs 2026
Important
Please, check "Clinical Trial Regulations and GCP Compliance as they relate to Adverse Events - How to Assess and report AEs and SAEs" official website for possible changes, before making any traveling arrangements
