ACRP 2018 Meeting & Expo

312 - Identifying and Documenting Adverse Events: A Decision Making Process

Apr 30, 2018 8:15am ‐ Apr 30, 2018 9:15am


Credits: None available.

Members: $25.00
Standard: $75.00

Description

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.

Learning Objectives:

  • 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

Speaker(s):

Credits Available


Identifying and Documenting Adverse Events: A Decision Making Process

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