CDISC Therapeutic Area (TA) Standard

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A Clinical Data Interchange Standards Consortium Therapeutic Area (CDISC-TA) Standard is a CDISC Standard that extends the CDISC Foundational Standards to represent data that pertains to specific disease area.



References

2022a

2022b

2018

Except for Protocol, the foundational standards and their implementation guides are organized into classes of related categories of information. Within SDTM for example, each class is subdivided into domains, and each domain is comprised of variables. Semantics include CDISC Controlled Terminologies, developed in collaboration with NCI EVS, and the Biomedical Research Integrated Domains Group (BRIDG) domain information model. TA User Guides provide indication-specific “slices” of foundational standards and their terminologies, with examples of how to use these standards for a given TA. Transport Standards support submissions, data interchange, study archival, and automated study setup[1].