Implementing, Managing, and Validating a Clinical Standard Using SAS Clinical Standards Toolkit 1.3 ®

Content Provider	Semantic Scholar
Author	Lightfoot, Gene
Copyright Year	2010
Abstract	Many pharmaceutical companies are starting to implement the various CDISC models that are now available for download. Unquestionably the most popular standard is the Submission Data Tabulation Model version 3.1.2, most commonly referred to as SDTM 3.1.2. It is the primary model for data submitted to the Federal Drug Administration (FDA). There are many ways to implement, manage, and validate standards and this paper will discuss this process using SDTM 3.1.2 as the example standard.
File Format	PDF HTM / HTML
Alternate Webpage(s)	https://www.lexjansen.com/phuse/2010/cd/CD14.pdf
Language	English
Access Restriction	Open
Content Type	Text
Resource Type	Article