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In a few moments you will have an opportunity to download the SDTM
documentation set.
Let’s learn how to locate the documentation on the CDISC web site.
You will navigate to the CDISC web site by entering the CDISC web site address:
www.cdisc.org. Doing so brings you to the CDISC web site home page shown here.
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To access SDTM standard documents,
<ANIM1> hover over the “Standards” tab from the CDISC-dot-org homepage. From
the drop down menu that appears, look under the “Foundational” column,
<ANIM2> you will notice links to both the SDTM model and the SDTM
Implementation Guide, or SDTMIG.
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As we discussed in the first chapter,
<ANIM1> the SDTM model provides a standard template for organizing and
formatting data for human and animal studies.
<ANIM2> The SDTMIG is intended to guide the organization, structure, and format of
standard clinical trial tabulation datasets.
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Once you access the SDTMIG page from the CDISC homepage dropdown menu,
<ANIM1> you’ll notice that there are both HTML and PDF versions of the
Implementation Guide.
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In addition to SDTM documentation, it is also important to access CDISC Controlled
Terminology, or CT.
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To access CT documents,
<ANIM1> hover over the “Standards” tab from the CDISC-dot-org homepage. In the
menu appears, look under the “Terminology” column,
<ANIM2> you will then be able to access a link to the Controlled Terminology page.
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Controlled Terminology is the set of codelists and valid values used with data items
within CDISC-defined datasets, including SDTM.
CDISC, in collaboration with the National Cancer Institute's Enterprise Vocabulary
Services (NCI-EVS), supports the Controlled Terminology needs of CDISC Foundational
and Therapeutic Area Standards.
<ANIM1>You can access the Controlled Terminology documents on the NCI-EVS site,
by selecting the link on the right side of the page. <ANIM2>
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On the National Cancer Institute Controlled Terminology Page,
<ANIM1> you’ll notice links to controlled terminology documents for several CDISC
standards, including SDTM.
<ANIM2> Selecting the SDTM link…,
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….will take you to the SDTM Controlled Terminology section of the page.
<ANIM1> Controlled Terminology is available in several formats—both online
versions and those available via download.
<ANIM2> You can access the web-based version by selecting the “CDISC SDTM
Directory“ link…,
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…which will bring you to the CDISC SDTM directory on the NCI File Transfer Protocol,
or FTP, site.
<ANIM1> Select the file labeled “SDTM terminology-dot-HTML”…,
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…to view the HTML version of CDISC SDTM Controlled Terminology.
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SDTM-related content is also available in CDISC Therapeutic Area, or TA, User Guides.
<ANIM1> Several User Guides are available on the CDISC website, including HIV.
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In individual TA User Guides, you’ll find disease-specific metadata, examples and
guidance on implementing CDISC standards—including newly-modeled SDTM
domains related to the specific therapeutic area.
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