|
課程名稱 |
醫療器材臨床試驗
Medical Device Clinical Trials |
|
開課學期 |
113-1 |
|
授課對象 |
醫學院 醫療器材與醫學影像研究所 |
|
授課教師 |
蕭輔仁 |
|
課號 |
MDI8032 |
|
課程識別碼 |
458ED0810 |
|
班次 |
|
|
學分 |
2.0 |
|
全/半年 |
半年 |
|
必/選修 |
選修 |
|
上課時間 |
星期一6,7(13:20~15:10) |
|
上課地點 |
基醫1222 |
|
備註 |
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）
限學士班四年級以上
總人數上限：15人
外系人數限制：5人 |
|
|
|
|
課程簡介影片 |
|
|
核心能力關聯 |
核心能力與課程規劃關聯圖 |
|
課程大綱
|
|
為確保您我的權利,請尊重智慧財產權及不得非法影印
|
|
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 Hours |
另約時間 |
|
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
(僅供參考) |
|
No. |
項目 |
百分比 |
說明 |
|
1. |
Attendance |
50% |
Presentation and discussion |
2. |
Final report |
50% |
|
- 本校建議 A+ 比例上限為 20% ，非強制規定，授課教師可依課程要求調整，建議必修課程參考。
- 本校採用等第制評定成績，學生成績評量辦法中的百分制分數區間與單科成績對照表僅供參考，授課教師可依等第定義調整分數區間。詳見學習評量專區 (連結)。
|
|
針對學生困難提供學生調整方式 |
|
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 |
|
考試形式 |
|
|
其他 |
由師生雙方議定 |
|
|
週次 |
日期 |
單元主題 |
|
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 |
|