According to the ICH Guidelines for Clinical Safety Data Management, an adverse event is defined as “any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment”.
This standardised procedure describes a method for identifying, assessing, reporting, and following adverse events occurring in study patients enrolled in an antimalarial drug efficacy trial.
This procedure is intended for use in clinical trials where patients are attending a clinic for antimalarial treatment. It is designed to be modified to reflect the needs of specific study sites.
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