IMPStudy object

Yes

Investigational Medicinal Products (IMP) pursuant to Chapter 1, Section 1(5) Regulation 2009:
„A pharmaceutical form of an active substance or placebo which is being tested or used as a reference in a clinical trial. Medicinal products with marketing authorisation are also regarded as investigational medicinal products if they are used, formulated or packaged in a manner other than the approved form, or used for a non-approved indication, or to procure further information about the authoirised form“

Yes

Clinical trial of Medicines pursuant to Chapter 1, Section 1(5) Regulation 2009:
“Any systematic study of medicinal products for human use for the purpose of acquiring or verifying knowledge of the effects or influence of the products on physiological function, interactions, adverse reactions, absorption, distribution, metabolism and secretion, or to study their therapeutic value”

Definition: Non-interventional trial (pursuant to Chapter 1, Section 1(5) Regulation 2009):
“A study where one or more medicinal product(s) is (are) prescribed in the usual manner in accordance with the terms of the marketing authorisation. A therapeutic strategy for each individual patient is not decided in advance by a trial protocol, but falls within current practice, and the prescription of the medicinal products is clearly separated from the decision to include the patient in the study. Additional diagnostic or monitoring procedures for patients shall not be necessary and epidemiological methods shall be used to analyse the collected data