Improve your understanding of adverse events (AEs) by working step-by-step through the definitions of the different types of AEs and reviewing the recording and reporting requirements of each. The speaker will provide a detailed review of AEs and requirements for assessment, documentation, recording, and reporting. Leave confident in your ability to effectively monitor AEs and ensure patient safety and data integrity.
Participants will be able to describe a decision-making framework that will facilitate correct adverse event recording and reporting
Participants will be able to describe Investigator, Clinical Research Coordinator (CRC) and Sponsor responsibilities with regards to identifying, documenting and reporting AEs
Participants will be able to discuss how the Common Terminology Criteria for Adverse Events (CTCAE) is used for assessing AEs