IMPStudy object

Yes

IMP (Definition pursuant to Section 1 of 95th Act of 2005):
'investigational medicinal product' shall mean a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products that already have a marketing authorization but are used or assembled (formulated or packaged) in clinical trials in a way different from the authorized form, or when used for an unauthorized indication, or when used to gain further information about the authorized form of the medicinal product in question;'

Yes

Clinical trial (Definition pursuant to Section 1 of 95th Act of 2005):
'shall mean any investigation in human subjects conducted at a single site or according to a single protocol but at more than one site:
a) intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more investigational medicinal product(s), and/or,
b) to identify any adverse reactions to one or more investigational medicinal product(s) and/or,
c) to study absorption, distribution, metabolism and excretion of one or more investigational medicinal product(s) with the object of ascertaining its (their) safety and/or efficacy, and the risk-benefit balance,
not including non-interventional trials;'

Definition of a 'non-interventional trial' is provided in Section 1 of 95th Act of 2005.