Module 6: Clinical Data Management
31 October, 2007 Wednesday
0900-1000 Overview of clinical data management
Data
management plan
Dr. Sangkae Chamnanvanakij,
TU-CDMC, Thailand
1000-1030 Protocol and CRF
Dr.
Sangkae Chamnanvanakij, TU-CDMC, Thailand
1000-1030 Protocol and CRF
1030-1100 Tea break
1100-1230 Practical session on Protocol and CRF
Prof. Dr.
Kesara Na-Bangchang,
1230-1330 Lunch
1330-1430 Statistical Analysis Plan (SAP)
Data: primary & secondary data
Prof. Dr. Jia He, SMMC-CDMC, China
1430-1445 Tea Break
1445-1700 Data capture , development of database
Data entry, data verification, data validation, audit trail
Data clarification process
Data query and resolution
1 November,
2007 Thursday
900-1200 Practical session on data entry, verification,
validation
1200-1300 Lunch
1300-1400 Data transform process (demonstration)
・Adverse Event Dictionary
・Drug
Dictionary
Dr. Sangkae Chamnanvanakij, TU-CDMC, Thailand
1400-1530 Quality Control & Assurance (QC & QA)
Prof. Dr. Jia He, SMMC-CDMC, China
1530-1545 Tea Break
1545-1700 Standard Operating Procedures (SOPs)
Dr. Sangkae Chamnanvanakij, TU-CDMC, Thailand