Japanese–English glossary
Clinical trial protocol
治験実施計画chiken jisshi keikaku
Also written 治験プロトコル
The document that defines a clinical trial's objectives, design, methods, statistical analysis and conditions of conduct, and against which the trial is run. Japanese documents usually name the document itself with a suffix meaning 'written document' (治験実施計画書), or simply call it the protocol. Do not confuse it with the clinical trial plan notification (治験計画届), which the sponsor files with the authorities before the trial; the two Japanese names differ by only a few characters. For manufacturing and supply, the protocol fixes what the investigational product must support, such as dose levels, blinding and the number of subjects.