|
Conference Directory
Clinical Trial Regulations and GCP Compliance as they relate to Adverse Events
|
Venue Name: Online Webinar
Country: United States of America
City: Palo Alto
Number of Attendees: Unknown
Webinar or Virtual Event: Yes
Keywords: 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
Start Date of Conference:: 12-02-2009
End Date of Conference: 12-02-2009
Description of Conference: 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.
Website
|
|
|
|
|
|
|
|
