Mandatory elements in the definition of an adverse event (AE) include Untoward medical occurrence only. Thus, the correct option is A.
An adverse event may be defined as any negative and obligatory sign symptoms, or disease temporally associated with the service of medicinal products.
Use of pharmaceuticals products or a study intervention, patient or clinical investigation subject involvement, and causal relationship with the pharmaceutical product do not involve any consequences of adverse events in the field of medicinal healthcare.
Therefore, the correct option for this question is A.
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