Regulations for Good Clinical Practice Article 29
The Ethics Committee should retain written procedures, membership lists, lists of occupations/affiliations of members, submitted documents, minutes of meetings, correspondence and any other relevant records for a period of at least 3 years after completion of the trial and make them available upon request from the Competent Authority.The Ethics Committee may be asked by investigators, sponsors or regulatory authorities to provide its written procedures and membership lists. Upon requests, the Ethics Committee shall not reject.
中文原文 藥品優良臨床試驗作業準則第29條
人體試驗委員會應保存書面作業程序、委員名單、委員職業及聯繫名單、送審文件、會議紀錄、信件、及其他臨床試驗相關資料至試驗結束後三年，且可供主管機關隨時調閱。
試驗主持人、試驗委託者或主管機關得向人體試驗委員會索取書面作業程序及全體委員名單，人體試驗委員會不得拒絕。
試驗主持人、試驗委託者或主管機關得向人體試驗委員會索取書面作業程序及全體委員名單，人體試驗委員會不得拒絕。