Practical exercises in individual case causality assessment
Course
The aim of this course is that you apply the theoretical concepts for individual case causality assessment using examples.
Our estimate is that it can take approximately 3 h to complete this course. But the completion time can be shorter or longer depending on your knowledge about the drugs used in the examples, previous experience and detail level when you do the assessments.
Before taking this course you need to complete the introductory Causality assessment of single case safety reports course. It will provide you with the basics of causality assessment and the WHO-UMC assessment method used in this course.
Course syllabus
Assessment of several suspect drug - ADR combinations.
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After completion of this course you will be able to:
- define important pieces of information in an individual case safety report (ICSR) relevant for causality assessment
- examine a potential relationship between a suspected drug and an ADR according to the assessment criteria of the WHO-UMC method
- choose a WHO-UMC method category for an ICSR
Here is the course outline:
General Introduction- Introduction to the course - Course setup - Course instructors |
Individual case causality assessment- Learning objectives - Individual case causality assessment |
Case AA case report with tocilizumab and intestinal perforation |
Case BA case report with cariprazine and pathological gambling |
Additional cases- Additional cases C, D and E - Key points of individual case causality assessment - Evaluation of the course |
Completion
The following certificates are awarded when the course is completed:
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Certificate of completion ENG 3 hour |