CDISC invites you to submit comments during Public Review for SDTMIG v3.4, SDTM 2.0, and Conformance Rules v1.2.
Used together, the SDTMIG v3.4 and SDTM v2.0 are intended for organizations and individuals involved in the collection, preparation, and analysis of clinical data. The Conformance Rules v1.2 allow users to evaluate conformance of the data structure to the standard.
SDTMIG v3.4 provides specific domain models, assumptions, business rules, and examples for preparing standard tabulation datasets that are based on the SDTM. Specifically, SDTMIG v3.4 includes major changes to the Immunogenicity Specimen Assessments (IS) domain and fifteen new variables, most of which have do to with the IS and LB domains, and allow implementers to more completely specify tests.
Version 3.4 supersedes all prior versions of the SDTMIG. A detailed list of changes is included in the Reviewers' Roadmap to the Revised Pages.
SDTM v2.0 defines a standard structure for study data tabulations and represents changes to the organization of the document to clarify the relationship between special purpose domains and the general observation classes. Layout of the tables of metadata was updated to improve consistency between tables and to provide more detailed metadata including newly approved variable definitions.
Version 2.0 supersedes all prior versions of the SDTM.
Conformance Rules v1.2
The Conformance Rules v1.2 comprise all rules in which there has been a change since SDTMIG v3.3 and SDTM v1.7, including 202 rules for which the cited guidance has been modified, or for which the location of the guidance in the document has moved. The Conformance Rules v1.2 also include 45 new rules and notice of the retirement of 42 rules.
When released, the final Conformance Rules v1.2 will represent a cumulative package of current and previously published Conformance Rules.
Reviewer Instructions - Instructions for Reviewers are located at each of the below links.
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Public review is a key quality step in our Standards Development Process. CDISC relies on your input to ensure neutral, consensus-based data standards are developed and adopted by a diverse global community interested in improving research processes and quality for the benefit of all.
Thank you for contributing your time and expertise by reviewing and commenting on this draft standard.