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- This document does not replace or supersede the foundational CDISC standards or their implementation guides, and should not be used as a substitute for any other CDISC standard.
- This document generally does not repeat content already published in another CDISC standard.
- This document is not and does not try to be an exhaustive documentation of every possible kind of data that could be collected in relation to rare diseases.
- As this document ages, parts of it may become outdated. Please bear in mind the release date when contrasting advice and/or modeling in this guide against that in other CDISC standards.
- The examples in this document use CDISC Controlled Terminology where possible, but some values that seem to be controlled terminology may still be under development at the time of publication, or even especially plausible "best-guess" placeholder values. Do not rely on any source other than the CDISC value set in the National Cancer Institute Thesaurus for controlled terminology (available at http://www.cancer.gov/research/resources/terminology/cdisc).
- Links to other CDISC implementation guides were configured to take readers directly to the applicable sections of the IG. Readers need to be logged in to the CDISC website to be able to use this page-link feature.
All general caveats for therapeutic area (TA) standards given in the Introduction to Therapeutic Area Standards apply to this document.
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