IMPStudy object

Yes

“A pharmaceutical form or an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorisation but used or assembled (formulated or packaged) in a way different form the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form” (pursuant to Section 2 of Regulation 2/2012)

Yes

Definitions pursuant to Section 2 of Regulation 2/2012:

• Clinical trial:
'An interventional clinical trial conducted with human subjects in order to discover the effects of medicinal products in human subjects (effectiveness or safety, i.e. pharmacodynamics) or their pharmacokinetics in the human organism (absorption, distribution, metabolism or excretion), or both.

• Interventional clinical trial:
'A trial which intervenes with the inviolability of the trial subject for the purpose of the investigation. For example, the administration of an investigational medical product to the trial subject or use of some extra means of intervention (i.e. samples, tests or questionnaires) that would not otherwise be used.'

• Non-interventional clinical trial:
'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 wholly independent of the decision to include the patient in the study. No additional diagnostic or monitoring procedures shall be applied to the patients and epidemiological methods shall be used for the analysis of the data.'