Glossary

adverse event

as defined by “E6 Good Clinical Practice: Consolidated Guidance,” “any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.” See also E6.

Analysis Dataset Model (ADaM)

as defined by CDISC, “a set of guidelines and examples for analysis datasets used to generate the statistical results for submission to a regulatory authority ...

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