IMPStudy object

Yes

Definition according to section 51(2c) Act No. 378/2007 Coll., on Pharmaceuticals:
a pharmaceutical form of an active substance or product obtained through technological processing of mere excipients (a placebo) which are being tested or used for comparison in a clinical trial; an investigational
medicinal product may also be a product already with a marketing authorisation but used or assembled (including changes to composition of the pharmaceutical form or packaging) in a way different from the authorised form of the medicinal product or when used out of the authorised indication(s) or for the purposes to gain further information about the authorized presentation of the medicinal product.

Yes

Definition according to section 51(2) Act No. 378/2007 Coll., on Pharmaceuticals:
"A clinical trial shall mean any systematic testing conducted on trial subjects intended to:
1. discover or verify the clinical, pharmacological or other pharmacodynamic effects,
2. identify any adverse reactions,
3. study absorption, distribution, metabolism or excretion of one or more investigational
medicinal product(s) with the objective of ascertaining its (their) safety or efficacy, including
clinical trials conducted at one or more trial sites in the Czech Republic or in the Member
States, where applicable