臨床試驗資訊學
Clinical Trial Informatics
學期
109-1
學分
2
學分
當期課號
B418
永久課號
B0777
開課單位
生物醫學資訊研究所
授課教師
楊永正
校區
陽明
類別
選修
上課時間表
| 節 | 週四 |
|---|---|
5 13:20–14:10 | 臨床試驗資訊學 YR103 2 節連堂 |
6 14:20–15:10 |
* 根據陽明交大上課時間表所列
週次計畫
| 週次 | 主題 |
|---|---|
| 第 1 週 | Introduction of clinical trials and data management |
| 第 2 週 | Major components of a clinical trial protocol |
| 第 3 週 | No class(中秋節放假) |
| 第 4 週 | The clinical study information system (CSIS) (I) |
| 第 5 週 | The clinical study information system (CSIS) (II) |
| 第 6 週 | Practical aspects of CRF design |
| 第 7 週 | User interview: collect needs and discuss the form design issues |
| 第 8 週 | Basic features of eCRF design (import forms, formatting, skip rules, etc.) |
| 第 9 週 | Midterm examination |
| 第 10 週 | Advanced features of eCRF design (Question lib, etc.) |
| 第 11 週 | eCRF design and trial setup: access right, study plan |
| 第 12 週 | eCRF completion guide and skills for delivering CSIS training |
| 第 13 週 | Data validation plan and rule design (I) |
| 第 14 週 | Data validation plan and rule design (II) |
| 第 15 週 | CRA and quality assurance |
| 第 16 週 | Final examination |
| 第 17 週 | Supplemental lecture: Data management (video) |
| 第 18 週 | Supplemental lecture: Controlled vocabulary - MedDRA (video) |