Yesterday, FDA published its first official list of validation rules for CDISC SDTM. These long awaited rules cover both conformance and quality requirements, as described in the FDA Study Data Technical Conformance Guide. Conformance validation rules …
Tag: FDA
Github for Clinical/Statistical Programmers
PhUSE-FDA Working Group 5 (Development of Standard Scripts for Analysis and Programming) just adopted Google Code as collaborative programming platform. Google Code is one of the most popular and respected open source software hosting sites in the world and it is definitely a good choice for PhUSE-FDA WG5. But after viewing one of WG5’s working […]