6 November, 2006 Wednesday
0900-1000 Overview of clinical data management
Data management plan
Dr. Charcrin Na-Bangchang, TU-CDMC, Thailand
1000-1030 Statistical Analysis Plan (SAP)
Data: primary & secondary data
Dr. Rui Wang, SMMC-CDMC, China
1030-1100 Tea break
1100-1230 Data capture , development of database
Dr. Arunachalam Rajagopal, CMC-CDMC, India
1230-1330 Lunch
1330-1400 Data entry, data verification, data validation, audit trail
Data clarification process
Data query and resolution
Dr. Jose Fernando Florez Arango, CMC-CDMC, Colombia
1400-1500 Data transform process
・Adverse Event Dictionary
・Drug Dictionary
Dr. Sangkae Chamnanvanakij, TU-CDMC, Thailand
1500-1530 Tea break
1530-1700 Statistical analysis
Dr. Rui Wang, SMMC-CDMC, China
1700-1800 Quality Control & Assurance (QC & QA)
Standard Operating Procedures (SOPs)
Dr. Jose Fernando Florez Arango, CMC-CDMC, Colombia