Metadata Submission Guidelines Appendix to the Study Data ...

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Metadata Subteam Page 1 Metadata Submission Guidelines Appendix to the Study data tabulation model Implementation Guide Prepared by the CDISC SDS Metadata Team Notes to Readers This is Version of the Metadata submissions Guidelines , posted for comment by the CDISC submissions data Standards Metadata sub team. Revision History Date Version Summary of Changes 2007-07-25 Original draft for comment SDS submissions Guidelines Version Metadata Subteam Draft Page 2 07/25/2007 Metadata Submission 1 1 5 5 REFERENCES AND 5 ORGANIZATION OF THIS 5 2 GENERAL SPECIFICATIONS FOR SUBMITTING 7 Submission 7 data tabulation 7 ANNOTATED 7 3 data DEFINITION FILE ( Metadata ).............................. ........................................ ....................................... 8 8 Metadata FOR DOMAIN 8 8 8 Metadata FOR DOMAIN 10 11 CONTROLLED 12 CDISC CONTROLLED 12 EXTERNAL CONTROLLED 12 12 ITEMREF ATTRIBUTE MANDATORY.

Data Tabulation Model (SDTM). This Appendix, which is comprised of this document in conjunction with study-related files, identifies and describes the components highly …

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