Documenting causality assessments

Casuality assessments can be documented using several different methods.

VigiFlow allows you to record causality assessment results using four different methods:

• WHO-UMC

• Naranjo

• French Method (Bégaud’s imputability method)

• WHO AEFI (for adverse events following immunisation)

If your organisation uses a different method, you can write it in the Comments field at the bottom of the section.

To register an assessment, go to the “Assessment” section of the report:

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You can add multiple assessments if needed. This is useful if the reporter or sender made their own causality assessment, but the national centre uses a different method or disagrees with the initial assessment.

Refer to the VigiFlow Intermediate Course: “ICSR processing and content” section → “Assessment”

Note: VigiFlow online courses are only available to VigiFlow users. Check with your national regulatory authority for access.