The Study Data Tabulation Model (SDTM) provides a general framework for describing the organization of information collected during human and animal studies. The SDTM is built around the concept of observations collected about subjects who participated in a clinical study.
http://www.cdisc.org/sdtm - May 22, 2013 2:08:24 PM - Apr 6, 2011 4:47:30 AM
- The incorporation of the content previously published in the SDTM Amendment 1;
- Changes to the Trial design section;