Regulations for Good Clinical Practice Article 112
If the trial is suspended or terminated, the investigator and the institution shall promptly inform the trial subjects, should assure appropriate therapy and follow-up for the subjects.Under the circumstances referred to in the preceding paragraph, the investigator and the institution shall inform the Competent Authority of the reasons for suspension or termination of the trial in writing.
中文原文 藥品優良臨床試驗作業準則第112條
試驗中止或終止時，試驗主持人及試驗機構應立即通知受試者，並確保受試者有適當之治療及追蹤。
前項情形，試驗主持人及試驗機構應將試驗中止或終止之事由，以書面通知主管機關。
前項情形，試驗主持人及試驗機構應將試驗中止或終止之事由，以書面通知主管機關。