|
週次 |
日期 |
單元主題 |
|
第2週 |
3/03 |
Introduction and course overview |
|
第3週 |
3/10 |
History of clinical trials |
|
第4週 |
3/17 |
Randomization and sample size estimation |
|
第5週 |
3/24 |
Comparison group(s) |
|
第6週 |
03/31 |
End point considerations |
|
第7週 |
04/07 |
Special topic –Phase I trials |
|
第8週 |
4/14 |
Efficient trial design |
|
第9週 |
4/21 |
Interim analysis and adaptive design, DSMB |
|
第10週 |
4/28 |
Case Report Form and Data Management/
Investigator Initiated Trial (Example)
陳建煒/張詠森
|
|
第11週 |
5/5 |
Strategy and planning of clinical drug development - International biopharmaceuticals perspective
陳純誠 |
|
第12週 |
5/12 |
Ethics considerations for clinical trials |
|
第13週 |
5/19 |
Data analysis and interpretation (I), CONSORT |
|
第14週 |
5/26 |
Quality control & Quality assurance/
Monitor, Audit and Inspection
Investigator Initiated Trial (Example)
李日翔/盧彥伸
|
|
第16週 |
6/09 |
Data analysis and interpretation (II) |
|
第17週 |
6/16 |
Safety reporting and Research Integrity |