IMPStudy object
IMP - Definition available in national law
Yes
IMP - Definition
Definition according to Art 3 (3) GCP-V (English translation):
"a pharmaceutical form of active pharmaceutical substances and placebos that is tested in a clinical trial on humans or used as a comparator or that is applied to induce specific reactions in humans. This includes EU authorised drugs if they are investigated within a clinical trial, EU authorised drugs if they will be used as comparator, and EU non-authorised drugs"