IMPStudy object

Yes

Definition of IMP is provided in Art 2 (1.d) of Legislative Decree 211/2003.
The investigational medicinal product is the study drug and the comparator including the placebo or active drug. The drugs which are not the direct subject of the experimental design, but their use is considered in the protocol, are also considered investigational medicinal products:
1. Drugs with market authorisation, used according to the indications, included in the protocol as needed to the success of the trial, such as drugs to prevent or treat side effects of the investigational medicinal product.
2. Drugs with market authorisation, used outside the approved indication.
3. Drugs without market authorisation, but with market authorisation in other countries of the EC, used within or without the approved indication.
4. Challenge agents, i.e., drugs that are used to induce physiological reactions needed to evaluate the effect of the investigational medicinal product. The rescue drug, and background treatments are not investigational medicinal products.