Study Data Tabulation Model (SDTM)

SDTM Public Review

New Draft Content SDTMIG v3.3 Batch 3 Now Available for Public Review – Comments Due 21 October 2016.

 

The CDISC draft SDTMIG v3.3 Batch 3 package of content is now available for public comment. 

Please refer to the following page to see the contents of the package SDTMIG v3.3 Batch 3.

 

CDISC Wiki is a different login than www.cdisc.org. You will need to log in or register for the CDISC Wiki to review the Read Me and provide comments.  

 

SDTM provides a standard for organizing and formatting data to streamline processes in collection, management, analysis and reporting. Implementing SDTM supports data aggregation and warehousing; fosters mining and reuse; facilitates sharing; helps perform due diligence and other important data review activities; and improves the regulatory review and approval process. SDTM is also used in non-clinical data (SEND), medical devices and pharmacogenomics/genetics studies.

 

SDTM is one of the required standards that sponsors must use as specified in the FDA’s Data Standards Catalog (see section II.C) for NDA, ANDA, and certain BLA submissions effective December 2016. For more information, please visit the Guidance on Standardized Data.

 

CDISC Study Data Tabulation Model (SDTM) v1.4, Study Data Tabulation Model Implementation Guide (SDTMIG) v3.2 and Associated Persons Implementation Guide (SDTMIG-AP) v1.0 Final Documents 

 

Download the complete document package as a zip file.

 

SDTM v1.4 – Adds variables to the general observation classes for clinical and non-clinical trials.

 

Download SDTM v1.4

 

SDTMIG v3.2 – Includes eleven additional domains: EC, PR, HO, DD, IS, MI, MO, RP, SR, SS, and TD. Re-designed as a PDF Portfolio instead of the traditional single PDF file**. Note: All previous annotations in SDTMIG 3.1.3, originally published in 2012, have been incorporated in SDTMIG v3.2. Learn more about the enhancements to SDTMIG v3.2

 

Download the SDTMIG v3.2 as a single file 

 

Download SDTMIG v3.2 (Portfolio)

 

IMPORTANT: Please first read the PDF document “PDF Portfolios at a Glance” inside the SDTMIG, which provides information on the SDTMIG v3.2 in its new format and how to navigate. 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. 

 

SDTMIG-AP v1.0 – 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.

 

Download SDTMIG-AP v1.0 

 

SDTMIG for Medical Devices v1.0 - Defines recommended standards for submitting data from clinical trials when medical devices are used. The document includes seven additional domains, developed by a team composed of medical device experts, CDISC specialists, and the FDA (CDRH and CBER).

 

Download SDTMIG for Medical Devices v1.0

 

SDTM v1.3 and SDTMIG v3.1.3 include:

  • Additional variables to the general observation classes for clinical and non-clinical trials
  • Content previously published in the SDTM Amendment 1
  • Changes to the trial design section
  • Document formatting updates
  • TU/TR/RS Oncology domains developed as the Oncology Disease-specific Therapeutic Area Supplement.

Note: 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 Members Only Area.

 

Download SDTM v1.3 and SDTMIG v3.1.3

 

IMPORTANT: Please first read the PDF document “How to Use SDTMIG 3.1.3”, which provides information of the SDTMIG 3.1.3 documentation package.

 

Previous versions of SDTM and SDTMIG

SDTM v1.2 & SDTM IG v3.1.2

SDTM v1.1 & SDTM IG v3.1.1

 

Metadata Submission Guideline (MSG) for SDTMIG

CDISC has released the final version 1.0 of the MSG Package, which was originally released for public comment from 2010-05-14 to 2010-06-07. During that review period, over 570 comments were received, which needed to be resolved before this final package could be released. An appendix to SDTM 3.1.2 is included with the package to familiarize users with the SDTM submission components. Additionally, a sample electronic submission is included, which contains 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.


Download MSG for SDTMIG

 

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