Clinical Investigation
/ˈklɪnɪkəl ɪnˌvɛstəˈɡeɪʃən/
Definitions
- (n.) A legally regulated process of testing a medical treatment, drug, or device in human subjects to determine its safety and efficacy.
The clinical investigation must comply with regulatory standards to ensure patient safety.
Forms
- clinical investigation
- clinical investigations
Related terms
See also
Commentary
Clinical investigation is a term often used interchangeably with clinical trial in regulatory contexts, but may emphasize the investigational nature of the study as distinct from established therapy.
This glossary is for general informational and educational purposes only. Definitions are jurisdiction-agnostic but reflect terminology and concepts primarily drawn from English and American legal traditions. Nothing herein constitutes legal advice or creates a lawyer-client relationship. Users should consult qualified counsel for advice on specific matters or jurisdictions.