Regulations for Good Clinical Practice Article 89
The investigator and the institution should conduct the trial in compliance with the protocol agreed to by the sponsor, by the Ethics Committee and by the Competent Authority. The investigator, the institution and the sponsor should sign the protocol, or an alternative contract, to confirm agreement.
中文原文 藥品優良臨床試驗作業準則第89條
試驗主持人及試驗機構應依經試驗委託者、人體試驗委員會及主管機關同意之試驗計畫書執行臨床試驗。
試驗主持人及試驗機構應與試驗委託者共同簽署試驗計畫書或另行簽訂書面契約，以確認雙方之同意。
試驗主持人及試驗機構應與試驗委託者共同簽署試驗計畫書或另行簽訂書面契約，以確認雙方之同意。