- First, read the CDASH Implementation Guide (CDASHIG); the SDTM and the SDTM Implementation Guide for Human Clinical Trials (SDTMIG); and the SDTM Implementation Guide for Pharmacogenomics/Genetics (SDTMIG-PGx) NUT-49 - Getting issue details... STATUS v1.0 to gain some familiarity with the models and their general implementation in human clinical trials. These standards are available from: http://www.cdisc.org/cdash, http://www.cdisc.org/sdtm, and https://www.cdisc.org/standards/foundational/pgx, respectively.
- Next, read Introduction to Therapeutic Area Standards to be sure to know what to expect from a TAUG.
- Read this guide in its entirety, without skipping any sections, at least once.
- Finally, revisit any sections of particular interest.
Draft standards of interest to this document are listed at: https://wiki.cdisc.org/x/w42zAg.
Some things to bear in mind while reading this document:
- 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 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 nutritional research.
- The advice and examples presented in this document are influenced by ongoing internal standards development at CDISC. If a modeling approach seems inconsistent with a published standard, it may be a genuine error, but it also could be a reflection of potential or upcoming changes to the standard.
- The examples in this document use CDISC Controlled Terminology where possible, although 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 NCI Terminology Resources (available at http://www.cancer.gov/research/resources/terminology/cdisc) for controlled terminology.