臨床試驗概論與實務
Fundamentals and Practice of Clinical Research
| 節 | 週三 |
|---|---|
7 15:30–16:20 | 臨床試驗概論與實務 YL403 3 節連堂 |
8 16:30–17:20 | |
9 17:30–18:20 |
* 根據陽明交大上課時間表所列
課程內容介紹優良臨床實務基本要素、可行性評估、試驗之起動與過程監控、試驗終止、數據管理等不同階段臨床試驗所需知識與技能，並包含百瑞精鼎公司之職場場域見習。Contents, in addition to 6 hours of clerkship training, including introduction of Fundamentals of Good Clinical Practice, Feasibility and Study Start Up, Site Initiation Visit/Monitoring Visit/Termination Visit, Data management at different stages of clinical trial
本課程聘請國內著名CRO公司之業界講師授課，藉由講堂介紹與實務見習教學，讓學生深入認識藥物開發之臨床試驗相關知識與技能，提升學生欲申請CRA職位時之就業競爭力。This course consists of both lectures, given by teachers from CRO company, and clerkship practice, and provides the essential knowledge and skills for students interested in clinical trials of drug development.
整體學習表現(出席率、學習態度、上課發問)100% Overall learning performance (attendance, attitude, Q&A) 100%
| 週次 | 主題 |
|---|---|
| 第 1 週 | |
| 第 2 週 | |
| 第 3 週 | Fundamentals of Good Clinical Practice 百瑞精鼎講師 Tina Lin |
| 第 4 週 | CRO industry Overview 百瑞精鼎講師 Carolin Chao |
| 第 5 週 | Key Essential Documents 百瑞精鼎講師 Sharon Huang |
| 第 6 週 | |
| 第 7 週 | Feasibility (Country and Site Selection) 百瑞精鼎講師 Jerry Chou |
| 第 8 週 | Study Start-up (I): RA Submission and Approval 百瑞精鼎講師Lydia Yang |
| 第 9 週 | |
| 第 10 週 | Study Start-up (II): IRB Submission and Approval 百瑞精鼎講師 |
| 第 11 週 | Data Management 百瑞精鼎講師 |
| 第 12 週 | Site Management / Monitoring 百瑞精鼎講師: Jay Chen |
| 第 13 週 | |
| 第 14 週 | |
| 第 15 週 | 百瑞精鼎參訪 (下午) Course Feedback |
| 第 16 週 |
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