noun
clinical trial protocol; trial implementation plan
A formal document detailing the design, methodology, and procedures for a clinical trial. Used in medical and pharmaceutical contexts.
治験実施計画書は倫理審査委員会の承認を得なければならない。
The clinical trial protocol must be approved by the ethics review committee.
Compound of 治験 (clinical trial) + 実施 (implementation) + 計画書 (plan document). A modern technical term.