Category:Data Standards & Governance

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The structure and semantics of clinical data has become subject of regulated standardisation, being mainly defined by various CDISC data standards and the respective documentation requirements. Many of these particular standards are integrated into super ordinated frameworks, like BRIDG, SHARE, RDF. Effective implementation and governance of standards becomes vital for the acquisition, exchange, analyses, archival and submission of clinical data and metadata.

This stream focuses on the foundational aspects of existing, as well as future clinical data standards covering topics like the underlying concepts; descriptions; explanations; interpretations; processes to support the implementation, governance and compliance.

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