Regulations for Good Clinical Practice Article 79
The monitoring report should comply with the following requirements:1.The monitor should submit a written report to the sponsor after each trial-site visit or trial-related communication.2.Reports should include the date, site, name of the monitor, and name of the investigator or other individual(s) contacted.3.Reports should include a summary of what the monitor reviewed and the monitor's statements concerning the significant findings/facts, deviations and deficiencies, conclusions, actions taken or to be taken and actions recommended to secure compliance.4.The sponsor should designate representatives to record, review and follow-up of the monitoring report.
中文原文 藥品優良臨床試驗作業準則第79條
監測報告應符合下列規定：
一、監測者應於每次試驗場所之訪視或試驗相關之溝通後，向試驗委託者提出書面報告。
二、報告應包含日期、地點、監測者姓名、及試驗主持人或其他聯絡人之姓名。
三、報告應摘要描述監測者檢閱之部分、重大發現、偏離及缺失、結論、採取或將採取之措施，及為確保遵守試驗而建議之措施。
四、試驗委託者應指定代表記錄、檢閱及追蹤監測報告。
一、監測者應於每次試驗場所之訪視或試驗相關之溝通後，向試驗委託者提出書面報告。
二、報告應包含日期、地點、監測者姓名、及試驗主持人或其他聯絡人之姓名。
三、報告應摘要描述監測者檢閱之部分、重大發現、偏離及缺失、結論、採取或將採取之措施，及為確保遵守試驗而建議之措施。
四、試驗委託者應指定代表記錄、檢閱及追蹤監測報告。