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Study Data Tabulation Model
CDISC Study Data Tabulation Model (SDTM) v1.3 released for Public Review and Comment
The CDISC SDS Team is releasing SDTM v1.3 for a two week public review. This updated SDTM incorporates changes to the model that support a new Study Data Tabulation Model Implementation Guide (SDTMIG) v3.1.3 to be published at the end of May. The changes 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; and, contains document formatting updates.
The review package also includes the Oncology Disease-specific Therapeutic Area Supplement to the SDTM-IG in order to help provide context for some of the new variables. The oncology domains will be published later as part of the SDTM-IG v3.1.3 package. The Oncology Supplement has undergone a previous public comment period and so we are not looking for additional comments on that document at this time.
Follow this link for full details.
PUBLIC REVIEW COMMENTS WILL BE ACCEPTED UNTIL MONDAY, 7 MAY 2012.
Please send comment spreadsheet to cdiscreviewcomments@cdisc.org
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.
Release of Revised SDTMIG Trial Summary Dataset, Including Null Flavor Enumeration
CDISC is pleased to announce the availability of an Updated Trial Summary Dataset, which includes a new null flavor enumeration method. This updated version is an advance release of revised and supplemental material that is planned for incorporation in the forthcoming SDTM v1.3 and SDTMIG v3.1.3.
This updated version, which underwent a public review for comment period in August 2011, includes new variables to represent the code, coding system and version for trial summary responses using controlled terminology, and a new variable to represent null flavors in cases when a value is not provided for a particular parameter code. The revised model also includes significant changes to the assumptions and examples, and a new section explaining the purpose and use of the new null flavor representation.
As always, users are advised to check available FDA guidance or contact the FDA directly (edata@fda.hhs.gov for CDER questions or CBER.CDISC@fda.hhs.gov for CBER) to determine which version of trial summary to use in a specific submission.
Please access the Revised Trial Summary Dataset at the bottom of this page.
SDTM Amendment 1 Now Available!
CDISC is pleased to announce the posting of 'Amendment 1 to the Study Data Tabulation Model (SDTM) v1.2 and the SDTM Implementation Guide: Human Clinical Trials V3.1.2.' Amendment 1 contains new variables for certain domains as well as instructions and clarifications. This was a collaborative effort between CDISC and FDA and is a companion document to the 'CDER Common Data Standards Issues Document Version 1.1.'
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