Clinical Trial Protocol
/ˈklɪnɪkəl traɪəl ˈproʊtəˌkɔl/
Definitions
- (n.) A detailed document outlining the objectives, design, methodology, statistical considerations, and organization of a clinical trial, serving as a legal and procedural framework for conducting the trial.
The clinical trial protocol must be approved by the institutional review board before the study can commence.
Forms
- clinical trial protocol
- clinical trial protocols
Related terms
See also
Commentary
The clinical trial protocol is a foundational legal document in clinical research ensuring regulatory adherence and participant safety; clear drafting is essential to avoid ambiguities in trial conduct and data integrity.
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.