Adverse events gathering information

Additional examples of variability in data collection (which, in turn, affects data interpretation) include questionnaires and physical exam forms. Questionnaires often utilize open-ended questions that allow great variability in the type and extent of adverse event information gathered. Physical exam forms—even when designed in a checklist format—may elicit variable collection of adverse event data what is a serious event to one clinician may not be serious to another. 

Studied. Some of the information gathered on spontaneous adverse event reporting (ADRs) was made available to the ICH EC Working Party by Dr M. Papaluca. 

It is important in the beginning of an investigation to gather the information immediately or soon after the adverse event occurs or is discovered because ... 

An essential part of regulation of veterinary products is pharmacovigilance, that is the gathering of information on adverse reactions to veterinary products post-marketing. This is done in most developed countries and data are collected both on human adverse reactions and adverse events in animals. ... 

The full appreciation of the overriding importance of metal speciation in evaluating the transport and effects of metals in an environment is a relatively recent event. As more information is gathered on the forms in which metals exist and are transported through various environmental compartments, it will become possible to predict more accurately the response of the biological communities exposed to the metals and hopefully avert or mitigate the adverse effects. 

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