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Understanding CDISC Standards Across Studies: Truths and Myths

This article explores the nuanced understanding of CDISC standards at the study level, evaluating popular misconceptions such as the idea that all standards are strictly defined at this level. It investigates the current state of discussions surrounding these standards, highlights the lack of offered solutions from providers, and prompts readers to seek their own answers. It also delves into the necessity of libraries that contain comprehensive items, variables, and mapping details, as well as the importance of enforcement rules and the definition of submission XML documents.

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Understanding CDISC Standards Across Studies: Truths and Myths

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Presentation Transcript

  1. 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

  2. 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

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