Regulations for Good Clinical Practice Article 111
Upon the trial is completed or prematurely terminated, the investigator and the institution shall provide the sponsor and the Competent Authority with any reports required, and provide the Ethics Committee with a summary of the trial’s outcome.Under the circumstances referred to in the preceding paragraph, the sponsor shall provide the Competent Authority with a complete and detailed clinical trial report.The format of the clinical trial reports referred to in the preceding paragraph is announced by the Competent Authority.
中文原文 藥品優良臨床試驗作業準則第111條
試驗完成或提早終止時，試驗主持人及試驗機構應提供試驗委託者及主管機關其所要求之任何報告，並提供人體試驗委員會試驗結果摘要。
前項情形，試驗委託者應向主管機關提出完整詳盡之臨床試驗報告。
前項報告之格式由主管機關公告。
前項情形，試驗委託者應向主管機關提出完整詳盡之臨床試驗報告。
前項報告之格式由主管機關公告。