IMI Code of Practice: Any investigation in human subjects intended to discover or verify the effect of one or more investigational health interventions (e.g., drugs, diagnostics, devices, therapy protocols) that generate safety and efficacy data before making the health intervention available in health care[34]. [34] Adapted from its definition in Directive 2001/20/EC of 4 April 2001 (on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use). This includes clinical trials carried out in either one or multiple sites, whether in one or several countries.