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User guides do not replace the foundational CDISC standards or their implementation guides. Users should read those standards and implementation guides before applying the advice in user guides.
CDISC data standards are living documents. Due differing update cycles, some of the modeling approaches and controlled terminology presented in the examples in a document may become outdated before the next version of the document is released.
When a particular type of data has existing CDISC standards that can be used without additional development or customization, it is not covered in special detail in subsequent standards.
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A TA standard describes common kinds of data needed for area studies, so that those handling the data (e.g., data managers, statisticians, programmers) understand the data and can apply standards appropriately. These descriptions include the clinical situations from which the data arise, and the reasons these data are relevant for area.
A TA standard strives to define biomedical concepts unambiguously, so that consistent terminology can be used in area studies to enable aggregation and comparison of data across studies and drug programs, and so that metadata for these biomedical concepts can be likewise defined.
References
Clinical guidelines, articles, and other works consulted by the team during the creation of a document are referenced where appropriate. Documents that cite or rely on a large number of references include the full list of references in an appendix labeled "References".
Controlled Terminology
Although the examples in CDISC data standards try to appear plausible, including using controlled terminology where available, they should not be regarded as a definitive source for controlled terminology. Some codelists and/or values applicable to biomedical concepts and data elements in a document may still be in development at the time of publication. Some examples may use values that appear to be controlled terminology, but which are actually generic or "best guess" placeholders. Readers should consult the current CDISC Controlled Terminology (available at the link above) as the ultimate authority for correct controlled terminology codelists and values.
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