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Short courses

CREDE Safety and Adverse Event Course


Content
  • Section 1: Introduction & regulations
  • Welcome
  • Introduction
  • Regulations
  • Section 2: Components, roles and scope
  • Components of Safety
  • Role Players Introduction
  • Roles in Safety Management
  • DSMB
  • Roles Quiz
  • Scope of Practice introduction
  • Scope and delegation
  • Scope of practice case scenario
  • What is an AE?
  • Introduction Adverse Events
  • Components of AEs
  • AE log
  • What is an adverse event?
  • What is an AE?
  • Case Scenario: what is an AE 1
  • Case scenario: is this an AE 2?
  • Components of Adverse Events
  • Components of AEs
  • Reminder component of AEs
  • More on components
  • Medical Term
  • Term case scenario 1
  • Severity introduction
  • Severity: meaning
  • Severity: grading
  • Severity: tox tables
  • Severity: example with tox table
  • Severity: riddles
  • Severity case scenario
  • Duration intro
  • Duration
  • Duration AE case scenario
  • Causality intro
  • Causality
  • Causality case scenario
  • Expectedness intro
  • Expectedness
  • Status intro
  • Status
  • Adverse reaction vs adverse event
  • Serious Adverse Events
  • SAE intro
  • SAE
  • SAE rationale
  • IREs
  • SAE case scenario
  • Common audit findings & Conclusion
  • Findings introduction
  • Audit findings
  • Summary
  • Conclusion
Completion rules
  • All units must be completed
  • Leads to a certificate with a duration: 3 years
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