Clinical Trial Regulation
/ˈklɪnɪkəl traɪəl ˌrɛɡjʊˈleɪʃən/
Definitions
- (n.) A legal framework governing the authorization, conduct, and oversight of clinical trials involving human subjects to ensure safety, ethical standards, and data reliability.
The European Clinical Trial Regulation harmonizes procedures for clinical trial approvals across member states.
Forms
- clinical trial regulation
- clinical trial regulations
Related terms
See also
Commentary
Often abbreviated as CTR in EU law, it streamlines processes and replaces prior directives to enhance trial transparency and participant safety.
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.