PTDCDISC的博客

做SDTM算AEDY, LBDY, MHDY等等--DY变量时，可参考以下一看就明白的方法。计算方法：If --DTC>=SDTM.DM.RFSTDTC then --DY=(date portion of --DTC) - (date portion of DM.RFSTDTC) + 1; else --DY=(date portion of --DTC) - (date portion of DM.RFSTDTC)Notes: --DTC can be used...

2 Fundamentals of the SDTM SDTM基础2.1 Observations and Variables 观测（数据）和变量The V3.x Submission Data Standards are based on the SDTM’s general framework for organizing clinical trials information that is to be submitted to the FDA. The SDTM is built around

**1 Introduction【重点1.4节】**1.1 Purpose目的This document comprises the CDISC Version 3.2 (V3.2) Study DataTabulation Model Implementation Guide for Human Clinical Trials (SDTMIG), which has been prepared by the Submissions Data Standards (SDS) team of the