Non-interventional study definition

Non-interventional study means a clinical study other than a clinical trial;
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Non-interventional study means post-authorised non-interventional clinical investigations in humans where the assignment of a subject to a therapeutic strategy is not decided in advance by a protocol and the medicinal product is prescribed in the usual manner in accordance with the terms of the marketing authorisation.
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Non-interventional study means the investigation as defined in the cadre on page 1 of this Agreement, (also) to be conducted at the Study Site in accordance with the Protocol as mentioned below;
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Examples of Non-interventional study in a sentence

  • Non-Interventional Study (NIS) refers, in general terms, to a study where the assignment of the Patient to a particular therapeutic strategy is not decided in advance by a study protocol but falls within the HCP’s current practice, and the prescription of the Company Product is clearly separated from the decision to include the Patient in the study.

Related to Non-interventional study

  • Intervention means any action intended to reduce or avert exposure or the likelihood of exposure to sources which are not part of a controlled practice or which are out of control as a consequence of an accident;