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SDTM Across Studies. True or false? All CDISC standards defined on study level All CDISC discussions on study level No solutions offered so far by providers Help yourself. Who has a Solution?. To be planned, implemented and maintained:
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SDTM Across Studies • True or false? • All CDISC standards defined on study level • All CDISC discussions on study level • No solutions offered so far by providers • Help yourself
Who has a Solution? • To be planned, implemented and maintained: • Libraries containing supersets of items (ODM), variables (SDTM), value level metadata, etc. • Libraries containing mapping details • Define_submission.xml? • Enforcement rules