Phase 2: SDTM v2.0, SDTMIG v3.4 and Conformance Rules v2.0

Comments Due By

CDISC invites you to submit comments on Phase 2 of the SDTM v2.0, SDTMIG v3.4, and SDTM and SDTMIG Conformance Rules v2.0 during Public Review. New content has been added to these publications since the Phase 1 Public Review was carried out. Please visit the Instructions for Reviewers for each document for information regarding changes and additions.

To Provide Comments

SDTM v2.0

Changes to SDTM v2.0 since previous Public Review include: responses to Public Review comments, addition of the RELSPEC domain, addition of several new variables, and the addition of a new section to announce proposed future changes.

SDTMIG v3.4

The Subject Visits (SV) domain has been moved from Special Purpose to Events. All the original variables are present, and many additional variables have been added. In the transition period between this forthcoming version of the SDTMIG and the next version, the standard will allow Subject Visits data, which includes only variables described in the Special Purpose Subject Visits domain.

Question for Reviewers : What are the impacts on the implementation of retaining the SV domain abbreviation versus using a different domain abbreviation (e.g., VE) for the events domain for subject visits (i.e., what specific impacts would the domain abbreviation (SV or VE) have on implementation)?

SDTM and SDTMIG Conformance Rules v2.0

The SDTM and SDTMIG Conformance Rules v2.0 comprise all rules for the SDTM through version 2.0 and the SDTMIG through version 3.4. Changes that occurred from the first phase of these rules include 208 rules for which either the cited guidance had been modified or the location of the guidance in the document had been moved. The Conformance Rules include 19 new rules and notice of the retirement of 37 rules.

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Public review is a key quality step in our Standards Development Process. Thank you for contributing your time and expertise. 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.