臨床試驗資訊學
Clinical Trial Informatics
學期
107-1
學分
2
學分
當期課號
B384
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 a clinical trial |
| 第 2 週 | IBIS: from CDE to data repository for discovery research |
| 第 3 週 | Practical guide to create form structure and e-form in IBIS(use stroke registry as and example) at 圖資401電腦室 |
| 第 4 週 | 9/29 CIMS workshop(6 hrs)at 圖資401電腦教室 |
| 第 5 週 | User interview :collect needs and discuss the form design issues at 圖資401電腦教室User interview:collect needs and discuss the form design issues at 圖資401電腦教室 |
| 第 6 週 | CSIS management :access right management, form design, study plan setup at 圖資401電腦教室CSIS management:access right management, form design,study plan setup at 圖資401電腦教室 |
| 第 7 週 | CDISC form design at 圖資401電腦教室CDISC form desing at 圖資401電腦教室 |
| 第 8 週 | Collecting data using eCRF |
| 第 9 週 | Midterm examination |
| 第 10 週 | Preparing submission package to FDA |
| 第 11 週 | Quality assurance and quality control of clinical data:data validation plan and daily checking |
| 第 12 週 | Skills for delivering CSIS training |
| 第 13 週 | No class (class is moved to Sep 29) |
| 第 14 週 | CDISC standards -CDASH and SDTM |
| 第 15 週 | GCP and ECRIN standards |
| 第 16 週 | Controlled vocabulary - MedDRA |
| 第 17 週 | No class (class is moved to Sep 29) |
| 第 18 週 | Final examination |