ࡱ> ?A>{ IbjbjBrBr ..  I TL0hhhhhCCC$|.bCCCCChhChhChO=F0L CCCCCCCCCCLCCCCCCCCCCCCC : The controlled terminology in this spreadsheet is contained in Appendix A of the Clinical Data Acquisition Standards Harmonization Standard Version 1.0 (CDASH STDv1.0). 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.ColumnDescriptionCode (Column A)Unique numeric code generated by NCI Thesaurus (NCIt) and assigned to individual CDISC controlled terms.Codelist Code (Column B)Unique numeric code assigned to the CDASH parent codelist subset names. This code is repeated for each controlled term (aka preferred term) belonging to a codelist. **NOTE - light blue highlighting is used to identify the beginning of a new CDASH codelist subset 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 as long as they 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. Codelist Name (Column D)Contains the descriptive name of the CDASH parent codelist subset. 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 CDISC preferred name for a term as identified in the NCIt environment and to which numeric codes (Column A) are assigned. Currently (as per SDTMIG 3.1.2) this is the specific value expected for submissions.CDISC Synonym(s) (Column F)The CDASH synonyms column contains standard medical abbreviations that are commonly used in medical records (source documents) and on paper case report forms (CRFs). These correspond to CDASH abbreviations in Appendix A of the CDASH STD v1.0. When commonly used medical abbreviations are not available, this is indicated by dashes (- - -) in the CDASH synonyms column. These are 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.CDISC Definition (Column G) This identifies the CDISC definition for a particular term. The source for a definition is noted in parentheses (e.g. NCI, CDISC glossary, FDA).NCI Preferred Term (Column H)This identifies the NCI preferred name for a term as identified 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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