主 题: Clinical Data Safety Review Using SAS
报告人: Dr. Jim Sattler (President, SATMARI Software Systems, Inc.)
时 间: 2011-02-25 14:00-16:00
地 点: 理科一号楼1114
1) Introduction: The need for analysis data in decision-making
2) A pharmaceutical business scenario
Is an experimental drug safe?
The safety review determines the fate of the experimental new drug
Converting raw clinical trials data into analysis data
Generating reports to facilitate decision-making
3) Preparing analytical data for safety review
a. Data management techniques using SAS(R)
b. Creating derived variables such as
i. Change from baseline
ii. Time to event
4) Preparing customized reports and graphs for safety review
a. Complex, highly customized reporting techniques using SAS(R)
b. Statistical graphic reporting
5) Expertise required for clinical trials data processing
