Metadata Submission Guidelines, Appendix to SDTM IG V3.1.1

Metadata Submission Guidelines, Appendix to SDTM IG V3.1.1

The CDISC Submission Data Standards (SDS) Metadata Team has released a draft version of the Metadata Submission Guidelines, Appendix to the Study Data Tabulation Model Implementation Guide 3.1.1 for review. Included with the IG Appendix is a sample electronic submission that contains examples of CRF annotations, metadata associated with the submission domains, SDTM domains, and an example of a define.xml. The Appendix describes the sample submission and the steps that need to be taken to prepare the data for submission.

Please note that this Appendix refers to the SDTMIG version 3.1.1.  The Appendix will be published as final and updated to incorporate the review comments and reflect the features of the SDTMIG 3.1.2 after the comment period for both documents.