Regulations for Good Clinical Practice Article 51
Agreements, made by the sponsor with the investigator, the institution and any other parties involved with the clinical trial, should be in writing, as part of the protocol or in a separate agreement.
中文原文 藥品優良臨床試驗作業準則第51條
試驗委託者與試驗主持人、試驗機構或任何其他參與此臨床試驗之人員所訂定之協議，皆應以書面為之，並得作為試驗計畫書之一部分。