Exact(1)
Adverse event surveillance during clinical trials involves the detection, reporting to the appropriate body (Sponsor or regulatory authorities) within acceptable time limits depending on the seriousness of the event and the investigation of adverse events to determine a causality relationship with the substance being investigated.
Similar(59)
In our prediction model we could not determine a strong causality between the included factors of personality, disability and physical activity level in the onset of MOH, however, we are not able to reject it either.
First, it is not possible to determine a direct causality between the HIV program and the increase in the volume of other health services, since this is a retrospective study based on routinely collated health center data.
The small sample size of this preliminary study certainly represented a limitation and did not allow us to determine a specific causality relation between some psychological features and endometriosis onset or pain perception or to exactly identify specific risk factors.
A structured ADE assessment was used to determine the causality between a drug and an adverse event, preventability and severity of an ADE, recognition of ADEs by medical teams, and, when applicable, type of underlying medication error.
This study aimed to determine causality using a mouse model of maternal diet induced obesity.
Hill proposed one way to determine causality in a biological system, on the basis of nine criteria: strength of association, consistency, specificity, temporality, biological gradient, plausibility, coherence, experiment and analogy.
Project personnel reviewed all incoming forms to determine the causality and when unclear, a trial clinical monitor assisted in reviewing the forms.
Even though the cross-sectional design adopted in this research prohibits us to determine causality, it provides however that a causal link exists between EBM utilization and social collaborative relationships.
Firstly, it has a cross-sectional design, so it is difficult to determine the causality of any relationship.
There is a need to further investigate this obtained association in longitudinal studies, to determine potential causality between caregiving status and health.
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