Althea Draper Mar 9, 2022:

@Neil The links here are from the Pan American Health Organisation on Good Pharmacovigilance Practices for the Americas, 2011. There are translations for each of the two source pieces you have quoted in them.
"Causality (see also “Imputability”). Causality categories can be based on the results of imputability analysis and individual evaluation of the relationship between administration of a medicine and the onset of an adverse reaction. "

"Imputability (see also Causality). This is a case-by-case analysis of the causal relationship between medicine administration and the onset of an adverse reaction. It is an individual analysis used for reporting purposes, as it does not seek to study the potential risk of the medicine overall or the importance of the risk associated with the medicine in the population. Imputability methods used are to harmonize and standardize the imputation process and to allow for reproducibility by different evaluators"
https://www.paho.org/en/documents/good-pharmacovigilance-pra...
https://www.paho.org/en/file/58204/download?token=L4jmCy92 (pages 41 & 44)

Neil Forrest (asker) Mar 9, 2022:

Additional context Imputabilidad: el análisis, caso por caso, de la relación de causalidad entre la administración de un medicamento y la aparición de una reacción adversa. Se trata de un análisis individual para una notificación dada, que no pretende estudiar el potencial de riesgo del medicamento en forma global o la importancia del riesgo inducido por el medicamento en la población. Los métodos de imputabilidad sirven para armonizar o uniformar el proceso de imputación y para permitir la reproducibilidad de en evaluador a otro