SDTM Implementation Guide for Medical Devices – Now Available
The Study Data Tabulation Model Guide for Medical Devices (SDTMIG-MD) v.1.0 is now available. This standard 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. Follow the link.
CDISC Study Data Tabulation Model (SDTM) v1.3 and Study Data Tabulation Model Implementation Guide (SDTMIG) v3.1.3 final documents released
The CDISC SDS Team is pleased to announce the release SDTM v1.3 and SDTMIG v3.1.3. The updates to these documents 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.
Standards in Production
Metadata Submission Guideline (MSG) Package Preface
The CDISC Submission Data Standards (SDS) Metadata Team has released the final version 1.0 of the Metadata Submission Guidelines (MSG) Package. The package was originally released for public comment from 2010-05-14 to 2010-06-07. During that review period, over 570 comments were received, all of which needed to be resolved before this final package could be released. Included with the package is the Metadata Submission Guidelines (MSG), an appendix to the Study Data Tabulation Model Implementation Guide 3.1.2, which will enable users to become familiar with the SDTM submission components. Included in this posting is a sample electronic submission which includes an annotated CRF, submission datasets compliant with the SDTM-IG 3.1.2, a define.xml file describing the structure and content of the submitted datasets, a stylesheet for visualizing the define.xml in a user-friendly way, and an optional Reviewers’ Guide.
Please access the folder through the link located at the bottom of this page.