Welcome to EVS | Enterprise Vocabulary Services



|The controlled terminology in this spreadsheet is contained in Appendix A of the Clinical Data Acquisition Standards Harmonization Standard Version 1.0 (CDASH |

|V1.0). Appendix A includes subsets of SDTM controlled terminology codelists for selected CDASH data collection fields. The purpose of the commonly used CDISC |

|Controlled Terminology appendix A of the CDASH STDv1.0 is to provide frequently used terms from the CDISC SDTM controlled terminology codelists for a number of|

|data collection fields, as an aid for CDASH implementers. Commonly used terms are available for the following domains: CM, DA, EG, EX, VS. However, the full |

|SDTM controlled terminology codelists are also available for CDASH usage. |

|Column |Description |

|Code (Column A) |A C-code with a leading character C followed by a sequence of digits used for uniquely identifying each |

| |concept in NCI Thesaurus (NCIt), including all CDISC concepts. |

|Codelist Code (Column B) |An NCIt C-code assigned to the parent codelist name. This code is repeated for each concept (aka |

| |permissible value) belonging to a codelist. **NOTE - light blue highlighting is used to identify the |

| |beginning of a new codelist and its applicable term set. |

|Codelist Extensible (Yes/No) (Column C) |Defines if controlled terms may be added to the codelist. New terms may be added to existing codelist |

| |values when the codelist has "Yes" in Column C as long as the terms are not duplicates or synonyms of |

| |existing terms. The expectation is that sponsors will use the published controlled terminology as a |

| |standard baseline and codelists defined as “extensible” (or "Yes") may have terms added by the sponsor |

| |internally. For codelists with "No" in Column C sponsor organizations may not add to the published |

| |lists. Suggestions for new terms may be requested through the New Term Request Page. |

|Codelist Name (Column D) |Contains the descriptive name of the codelist which is also referred to as the codelist label in the |

| |implementation guide. As with the Codelist Code, the Codelist Name is repeated for each controlled term |

| |belonging to a codelist. |

|CDISC Submission Value (Column E) |IMPORTANT COLUMN: This is the specific value expected for submissions. Each value corresponding to a |

| |Codelist Name is indicated by light blue shading. |

|CDISC Synonym(s) (Column F) |This identifies the applicable synonyms for the CDISC Submission Value in Column E. These terms should |

| |not be submitted, but are included for collection and mapping purposes.**NOTE - this is especially |

| |important in instances where a Test name or Parameter Test name contains a corresponding Test Code or |

| |Parameter Test Code. |

|CDISC Definition (Column G) |This identifies the value of an ALT_DEFINITION property of a CDISC source for a particular concept. In |

| |many cases an existing NCI definition has been used. The source for a definition is noted in parentheses|

| |(e.g. NCI, CDISC glossary). |

|NCI Preferred Term (Column H) |This identifies the value of a PREFERRED_NAME property for a concept in NCIt. **NOTE - This column |

| |designates the human readable, fully specified preferred term corresponding to the NCI C-code, and is |

| |especially helpful for searching NCIt to get the entire concept with links to all instances of the term.|

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