causality assessment

causality assessment

An evaluation performed by a medical professional regarding the likelihood that a therapy or product being assessed in a clinical trial caused or contributed to an adverse event.
References in periodicals archive ?
The expert panel used the World Health Organization's algorithm for causality assessment of adverse events following immunization, a systematic, scientifically sound and universally accepted proof of assessing causality of events following any vaccination, she said.
Aguilar said they used the World Health Organization (WHO) Algorithm for Causality Assessment of Adverse Events Following Immunizations (AEFI).
The Roussel Uclaf Causality Assessment Method score was 9, which was consistent with highly probable DILI.
The causality assessment pointed toward a probable/likely association as per the Naranjo algorithm and the WHO--UMC scale.
All suspected ADRs were initially assessed by the Consultant Incharge--Diabetes Clinic and subsequently the information was collected and analyzed by the pharmacologists for causality assessment.
The causality assessment was done using the WHO scale [10] by a special committee with two experts from pharmacology and clinician.
The causality and severity analysis of the adverse drug reactions were done by using WHO causality assessment scale.
Causality assessment of an adverse event following immunization (AEFI), user manual for the revised WHO classification.
We also utilized a simplified Roussel Uclaf Causality Assessment Method (RUCAM) score for probable causality assessment between drugs and liver injury.
The Roussel Uclaf Causality Assessment Method (RUCAM)(15)used by the authors is also inaccurate given the fact that Formula 1 has no established history of liver-related incidence and relevant etiologies were not ruled out (both considerations would significantly impact RUCAM scoring).
In the late 1980s, meetings sponsored by the pharmacovigilance division of Roussel Uclaf (Paris, France) in conjunction with the Council for International Organizations of Medical Sciences (Geneva, Switzerland) led to the creation of the Council for International Organizations of Medical Sciences/Roussel Uclaf Causality Assessment Method (CIOMS/RUCAM).