Regulations for Good Clinical Practice Article 103
The monitor, auditor, the Ethics Committee, or the Competent Authority, can request for direct access to all trial-related records. However, prior to access to the subject’s personal identity information, confirmation of the subject’s written consent is required.
中文原文 藥品優良臨床試驗作業準則第103條
監測者、稽核者、人體試驗委員會或主管機關得要求檢視任何與試驗相關之資料。
但檢視受試者個人之身分資料前，應先確認已取得受試者書面同意。
但檢視受試者個人之身分資料前，應先確認已取得受試者書面同意。