IMPStudy object

IMP - Definition

The investigational medicinal product is the study drug and the comparator including the placebo or active drug. The background treatment is also considered an investigational medicinal product if collecting information on it is one of the objectives of the study.

IMP Study - Definition

The definition of a clinical trial on Medicinal Products ("essai clinique d'un ou plusieurs médicaments") is provided in Article R. 1121-1 du CSP (according to Art2 of Directive 2001/20/CE)

Additional Information

Further definitions (e.g. Biomedical research, Interventional Studies, Observational Studies) are provided in "Annexe 1- Définitons", provided on the ANSM website in section: Activités > Médicaments et produits biologiques > Avis aux promoteurs - Formulaires.