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
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
已選上0/15外系已選上0/5剩餘名額0已登記0- 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
- 預期每週課前或/與課後學習時數
- 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 A3 提供學生彈性出席課程方式
Provide students with flexible ways of attending courses
B6 學生與授課老師協議改以其他形式呈現
Mutual agreement to present in other ways between students and instructors
D1 由師生雙方議定
Negotiated by both teachers and students
- 補課資訊
- 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