Pharmacovigilance data assessment

Causality assessment in individual case reports

This course aims to introduce causality assessment in individual case safety reports, demonstrate its multifaceted nature, and highlight the importance of using structured, systematic approaches. 
To enrol in this course, you must meet the following requirements:

      • Length: 2 hours
      • Target audience: WHO PIDM staff
      • Language: English
      • Award: Yes
      • Course level: Introductory
      • Course type: Self-paced

What you will learn

By the end of this course, you will be able to:
  • Explain the necessity of a logical process for causality assessment 
  • List and describe all WHO-UMC causality categories 
  • Apply logical reasoning to typical individual case safety reports submitted to pharmacovigilance authorities 
  • Clarify the capabilities and limitations of the WHO-UMC categories for individual case causality assessment 
  • Identify the categories that WHO-UMC system, Naranjo Method and Modified Karch and Lasagna Algorithm, have in common. 
  • Compare the results of the Naranjo Algorithm with the WHO-UMC system 
  • Compare the results of the Modified Karch and Lasagna algorithm with the WHO-UMC system 
  • Identify the main challenges and limitations during individual case causality assessment 
  • Recognise the need for high-quality reports to accurately establish the likelihood of causality in an individual case report 

Questions and answers

How long does it take to complete the course?

The course takes 2 hours to complete.

Do I receive an award?

Learners that successfully complete the course receive a confirmation of completion.

Will this course give me academic credit?

No, UMC is not an academic institution.

Where do I reach out if I face any issues or have further questions?

Please contact us here

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