ICH E3说明了Clinical Study Reports(CSR)的结构和内容,是我们统计师工作的指导文件之一。 Trial Design Model Datasets,简写为TDM,即试验设计数据集,我们明确一下其基本内容及包括的Domain。 试验计划:试验设计计划及详细的治疗信息 Trial ...
Although, R has been used in exploratory analysis in Pharma/Biotech industry for a long time, it has not been used for creating and analyzing clinical trial datasets (SDTM/ADaM). Traditionally, SAS(R) has been used to generate clinical trial datasets. In this paper we will explore the ...