Definicija: In this Directive: a study where the medicinal product(s) is (are) prescribed in the usual manner in accordance with the terms of the marketing authorisation. The assignment of the patient to a particular therapeutic strategy is not decided in advance by a trial protocol but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study.

Definicija: V tej direktivi: raziskava, pri kateri se zdravilo (zdravila) predpiše(jo) na običajen način skladno s pogoji, navedenimi v dovoljenju za promet z zdravilom. O dodelitvi bolnika določenemu načinu zdravljenja se ne odloči vnaprej s protokolom preskušanja, ampak sodi v ustaljeno prakso, predpisovanje zdravila pa je jasno ločeno od odločitve, da se bolnik vključi v raziskavo.