Regulations for Good Clinical Practice Article 75
Selection and qualifications of monitors should comply with:1.Monitors should be appointed by the sponsor.2.Monitors should be appropriately trained, and should have the scientific and clinical knowledge needed to monitor the trial adequately.3.A monitor’s qualifications should be documented.4.Monitors should be thoroughly familiar with the investigational product(s), the protocol, informed consent form and any other written information to be provided to subjects, the sponsor’s SOPs, this Regulations, and the applicable regulatory requirement(s).
中文原文 藥品優良臨床試驗作業準則第75條
監測者之選擇及其資格應符合下列規定：
一、監測者應由試驗委託者指派。
二、監測者應有適當之訓練，且應有足以適當監測試驗的科學及臨床知識。
三、監測者之資格應有書面證明。
四、監測者應熟知試驗藥品、試驗計畫書、受試者同意書及其他給與受試者之書面資料、試驗委託者之標準作業程序、本準則及相關法規之規定。
一、監測者應由試驗委託者指派。
二、監測者應有適當之訓練，且應有足以適當監測試驗的科學及臨床知識。
三、監測者之資格應有書面證明。
四、監測者應熟知試驗藥品、試驗計畫書、受試者同意書及其他給與受試者之書面資料、試驗委託者之標準作業程序、本準則及相關法規之規定。