Module 12 2019

Reviewer’s Guides

➢ Define.XML does not adequately document SDTM & SEND mapping decisions, sponsor-defined domains, sponsor-defined controlled terminology, and sponsor extensions to CDISC controlled terminology.

➢ Standardized Data Guides help to address this documentation gap

➢ The Study Data Reviewer's Guide (SDRG) is recommended as a component of the eCTD's Module 4 (nonclinical) and 5 (clinical) SEND & SDTM dataset documentation.

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