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.
New Draft Standard Study Data Tabulation Model Implementation Guide:
Pharmacogenomics/Genetics Version 1.0 - Now Available for Public Review - Comments due December 2, 2014
The CDISC Draft Study Data Tabulation Model Implementation Guide: Pharmacogenomics/Genetics (SDTM-PGx) v1.0 is now available for a 45-day public review. The aim of this new proposed standard is to guide the representation in SDTM format of gene-related data (including data relevant to biospecimen handling, genetic variation, gene expression and biomarkers) submitted to regulatory authorities as part of a product application.
Use this link to register/login to the Tracker so you can access the review package.
Please submit your comments using the CDISC Public Comment Tracker on the CDISC Portal for this review.
Click here for directions on how to access and use the Public Comment Tracker Tool.
Detailed information on using the tracker can also be found via “Help” after clicking on Public Comment Tracker.
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
IMPORTANT: 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.
Learn more about the rationale for SDTMIG v3.2 in its new Portfolio format and version number.
**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**
Download the SDTMIG v3.2 as a single file
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.
SDTM v1.3 and SDTMIG v3.1.3 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 TU/TR/RS Oncology 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.
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.
A spreadsheet including all metadata tables from SDTM v1.3 and SDTMIG v3.1.3 is available in the Member's Only area.
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.
Metadata Submission Guideline (MSG) Package
FDA announcements on acceptance of CDISC SDTM
CBER/CDER Study Data Standards for Regulatory Submissions Position Statement (September 2013)
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."
Other documents related to the FDA Study Data Standards Resources.