Regulations for Good Clinical Practice Article 19
The language used in the oral and written information about the trial, including the informed consent form, should be as non-technical as practical and should be understandable to the subject or the subject's legally acceptable representative and the impartial witness, where applicable.
中文原文 藥品優良臨床試驗作業準則第19條
有關試驗計畫之口頭及書面資料，包括受試者同意書，皆應使用口語化及非技術性之語言，且為受試者、法定代理人或有同意權之人所能理解者。