Initial Assessment

The main purpose of the initial assessment is to make a decision regarding whether or not the possible hazard requires further investigation. The key principles of the initial assessment are to review the strength of the evidence which indicates a possible drug-related hazard, consider how that evidence can be extended (e.g. by further analyses) and to consider the other evidence that is immediately available which may help to support or refute the hypothesis. There are four key issues that will determine whether or not a signal should be investigated further, as signified by the acronym "SNIP":

1. the strength of the signal;

2. whether or not the issue or some aspect of it is new;

3. the clinical importance as judged by the seriousness of the reaction and severity of the cases; and

4. the potential for preventive measures.

The main factors influencing the assessment vary depending on the source of the signal and, in particular, whether it derives from spontaneous reporting or from a formal study.

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