http://www.cdisc.org/sdtm - 02/06/16 22:15:15 - 04/06/11 04:47:30
The SDTM product family has been supported by the CDISC Submission Data Standards (SDS) team since 1999. SDTM is also used for non-clinical data (SEND) and Medical Devices.
The addition of variables to the general observation classes for both human clinical trials and SEND.
A completely re-designed SDTMIG as a PDF Portfolio instead of Eleven New Domains: EC, PR, HO, DD, IS, MI, MO, RP, SR, SS, and TD
An IG which describes how to represent collected data about persons other than the subject under study, who could be associated with the study itself, a particular study subject, or a device used in the study.
Note that all of previous annotations in SDTMIG 3.1.3, originally
The Study Data Tabulation Model Guide for Medical Devices (SDTMIG-MD) v.1.0 defines recommended standards for the submission of data from clinical trials in which medical devices are used. The document includes seven new domains, developed by a team composed of medical device experts, CDISC experts, and the FDA (CDRH and CBER), and represents years of work by the members of the CDISC Medical Device team. Training on these seven new domains has been incorporated into the standard SDTM training available through CDISC.
- Comments due 29 January 2016
The CDISC SDS Team is pleased to announce the release of SDTM v1.4,