http://www.cdisc.org/sdtm - Jul 29, 2014 2:55:08 PM - Apr 6, 2011 4:47:30 AM
Study Data Tabulation Model (SDTM)
The Study Data Tabulation Model (SDTM) product family has been supported by the CDISC Submission Data Standards (SDS) team since 1999. The SDTM is also used for non-clinical data (SEND) and Medical Devices.
CDISC Study Data Tabulation Model (SDTM) v1.4, Study Data TabulationModel Implementation Guide (SDTMIG) v3.2 and Associated Persons Implementation Guide (SDTMIG-AP) v1.0 Final Documents
The CDISC SDS Team is pleased to announce the release of SDTM v1.4, SDTMIG v3.2, and SDTMIG-AP v1.0. These include:
The addition of new variables to the general observation classes for both human clinical trials and SEND;
A completely re-designed SDTMIG as a PDF Portfolio instead of the traditional single PDF file**. 11 New Domains: EC, PR, HO, DD, IS, MI, MO, RP, SR, SS, and TD
A brand new IG to describe 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
Inside the SDTMIG please read the PDF document “PDF Portfolios at a Glance” first, which provides information on the SDTMIG v3.2 in its new format and how to navigate through it.
Note that all of previous annotations in SDTMIG 3.1.3, originally published in 2012, have been incorporated in SDTMIG v3.2.
**Some browsers may have difficulty viewing PDF portfolios, which require Adobe Flash. If you cannot view the portfolio, you can download this document as a single PDF here, though you will not be able to capitalize on the portfolio's advanced navigation features**
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 comprised 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.
CDISC Study Data Tabulation Model (SDTM) v1.3 and Study Data Tabulation Model Implementation Guide (SDTMIG) v3.1.3
SDTM v1.3 and SDTMIG v3.1.3 include:
IMPORTANT: Please read the PDF document “How to Use SDTMIG 3.1.3” first. This document provides information of the SDTMIG 3.1.3 documentation package and, as the title implies, how to use it.
Note that all of Amendment 1 to the SDTM v1.2 and SDTMIG v3.1.2, originally published in 2011, has been incorporated in SDTMIG v3.1.3. The original posted version of Amendment 1 can be accessed for reference purposes in the Member's Only section.
Older versions of SDTM and SDTMIG:
FDA announcements on acceptance of CDISC SDTM
FDA announced on 6 November 2009 that they will accept SDTMIG v3.1.2 submissions in the Study Data Specifications
Please note the following taken directly from the Study Data Specifications: Sponsors "should discuss with the review division the datasets that should be provided, the data elements that should be included in each dataset, and the organization of the data within the file. Additionally, not all FDA centers have adopted all aspects of these specifications; sponsors are advised to discuss with the reviewing division data needs prior to preparing data for submission."