SV Domain

Comments Due By

CDISC invites you to provide comments solely on the Subject Visit (SV) Domain of the SDTM v2.0, SDTMIG v3.4, and SDTM and SDTMIG Conformance Rules v2.0. Review and consideration of comments received during the original Public Review initiated extensive revisions, leading to a second Public Review.

The SV domain has been reverted to a Special Purpose domain and additional variables have been included since the last Public Review was carried out.

This review is for the SV Domain only and is limited to 30 days.

Please visit the Instructions for Reviewers for each document for complete information for this review.

SDTM v2.0

SDTMIG v3.4

The SV domain has been moved from Events back to Special Purpose. All original variables from SDTMIG v3.3 are present, and some additional variables have been included. Links for the Subject Visits (SV) domain and instructions for review are:

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 previous public review of these rules include new rules CG0653 thru CG0658 for the SV domain.

You will need to log in or register for the CDISC Wiki to provide comments.

  • Register for the Wiki. If you already have an account on Wiki or JIRA, our issue-tracking system, simply log in to your account; Wiki and JIRA use the same login credentials. CDISC Wiki is a different login from www.cdisc.org.

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.

Thank you for contributing your time and expertise by reviewing and commenting on this domain.