|
週次 |
日期 |
單元主題 |
|
第1週 |
3/02 |
Introduction and course overview |
|
第2週 |
3/09 |
History of clinical trials |
|
第3週 |
3/16 |
Randomization and sample size estimation |
|
第4週 |
3/23 |
Comparison group(s) |
|
第5週 |
3/30 |
Special topic –Phase I trials |
|
第6週 |
4/06 |
溫書假 |
|
第7週 |
4/13 |
End point considerations |
|
第8週 |
4/20 |
Efficient trial designs |
|
第9週 |
4/27 |
Interim analysis and adaptive design, DSMB |
|
第10週 |
5/04 |
Case Report Form and Data Management
Quality control and quality assurance |
|
第11週 |
5/11 |
Investigator Initiated Trials |
|
第12週 |
5/18 |
Data analysis and interpretation (I), CONSORT |
|
第13週 |
5/25 |
Data analysis and interpretation (II) |
|
第14週 |
6/01 |
Human Subject Protection and Research Integrity |
|
第15週 |
6/08 |
Development of Medical Products, Real World Evidence |
|
第16週 |
6/15 |
Safety reporting, 課程總結 |