Study Data Tabulation Model

Medical Device Supplement to the Study Data Tabulation Model v.1.0 – Now Available

The Medical Device Supplement to the Study Data Tabulation Model (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:

• The addition of new variables to the general observation classes for both human clinical trials and SEND;
• The incorporation of the content previously published in the SDTM Amendment 1; • Changes to the Trial design section;
• Document formatting updates;
• Inclusion of the domains developed as the Oncology Disease-specific Therapeutic Area Supplement.

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.

Follow the link to download the zip file containing the Documentation package.

A spreadsheet including all metadata tables from SDTM v1.3 and SDTMIG v3.1.3 is now available in the Member's Only area.

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.

The FDA can now accept SDTM V3.1.2.

FDA announced on 6 November 2009 that they will accept SDTM V3.1.2 submissions. Please read the latest version of the Study Data Specifications (1.5.1) here.

In addition, other documents related to the Study Data Standards Resources can be found here.

Please note the following taken directly from the document: 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."