Regulations for Good Clinical Practice Article 45
The sponsor should designate appropriately qualified medical personnel who will be readily available to advise on trial related medical questions or problems. If necessary, outside consultant(s) may be appointed for this purpose.
中文原文 藥品優良臨床試驗作業準則第45條
試驗委託者應任用合格、適當，以及能對試驗相關醫療問題提供意見之醫療人員。
必要時，亦可指派外部顧問擔任上述工作。
必要時，亦可指派外部顧問擔任上述工作。