Investigational Product

**Semantic type:** Conceptual Entity

**Definition:** A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use. NOTE: CDISC includes test articles in its definition of investigational products. (ICH)