Regulations for Good Clinical Practice Article 52
The sponsor should utilize appropriately qualified individual to design the protocol, produce case report forms (CRFs), plan the analysis, and prepare interim and final clinical trial reports.
中文原文 藥品優良臨床試驗作業準則第52條
試驗委託者應任用合格適當之人員設計試驗計畫書之內容，製作個案報告、規劃分析、期中報告及臨床試驗報告。