流水號
24601
課號
MDI8032
課程識別碼
458 D0810
無分班
- 2 學分
選修
醫療器材與醫學影像研究所 / 精準健康碩士學位學程 / 精準健康博士學位學程
醫療器材與醫學影像研究所
精準健康碩士學位學程
精準健康博士學位學程
選修- 蕭輔仁
- 搜尋教師開設的課程
醫學院 醫療器材與醫學影像研究所
- 一 6, 7
基醫1222
2 類加選
修課總人數 15 人
本校 15 人
無領域專長
- 英文授課
- NTU COOL
- 核心能力與課程規劃關聯圖
- 備註醫材影像所 本課程以英語授課。乙群組應用鍊結領域：醫療器材商品化、醫療器材臨床試驗、轉譯與橋接醫學專題討論（三科目至少選一門） 精準健康博士, 精準健康碩士 本課程以英語授課。乙群組(產業鏈結領域):醫療器材臨床試驗/醫療器材商品化(2科目中必選1科目)。
- 修課限制
限學士班四年級以上
本校選課狀況
載入中- 課程概述A clinical trial is a systematic assessment of the device’s safety and/or efficacy that uses human participants. This course will initially guide students to know the guidance and regulation of clinical trials especially in the field of medical device.
- 課程目標Guiding students to know the regulation of medical device clinical trials, understand how to plan and execute a clinical research by themselves.
- 課程要求Course discussions Oral presentations Final report
- 預期每週課後學習時數
- Office Hour
*此 Office Hour 需要提前預約 - 指定閱讀Abdel-aleem, Salah M. The design and management of medical device clinical trials: strategies and challenges. John Wiley & Sons, 2011. Abdel-Aleem, Salah M. Design, execution, and management of medical device clinical trials. John Wiley & Sons, 2009. Glenn Cohen, Timo Minssen, W. Nicholson Price II, Christopher Robertson, Carmel Shachar, The future of medical device regulation : innovation and protection I, 2022. Tong, Raymond (Raymond Kai-yu), Wong Jack. Medical Regulatory Affairs : An International Handbook for Medical Devices and Healthcare Products, 2022.
- 參考書目
- 評量方式
50% Attendance
Presentation and discussion
50% Final report
- 針對學生困難提供學生調整方式
調整方式 說明 上課形式 提供學生彈性出席課程方式
作業繳交方式 學生與授課老師協議改以其他形式呈現
其他 由師生雙方議定
- 課程進度
第 1 週 Course Introduction 第 2 週 Clinical Research Tasks 第 3 週 Essential Documents for Clinical Trials 第 4 週 Responsibilities of Investigators Conducting Research Involving Human Participants 第 5 週 Adverse Event Identification and Reporting 第 6 週 Statistical Methods in Medical Device Clinical Trials 第 7 週 Clinical Study Report 第 8 週 Medical Device Regulations, Combination Products, Research Committees 第 9 週 Design Issues in Medical Device Research 第 10 週 Investigator-Initiated Studies 第 11 週 Ethics in Clinical Research 第 12 週 Choice of Control Group and Related Issues in Clinical Trials 第 13 週 Regulatory Challenges for Medical Device 第 14 週 Challenging FDA PMA Cases 第 15 週 Clinical Validation of AI Software in Medical Imaging 第 16 週 Final Report