Data Standard

CDISC-Gloss – Defined rules, conventions, guidelines, characteristics, methods, formats, and terminologies that provide structure and consistency for exchange and utilization of data. NOTE: Data standards may describe the elements and relationships necessary to achieve the unambiguous exchange of data between disparate information systems. [After https://www.fda.gov/media/124694/download Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research Guidance for Industry MARCH2019, NCI Thesaurus]. See also interoperability, standard, CDISC standards, Study Data Standardization Plan, and Standards Development Organization.