Define-XML 2.1.10 define-enumerations schema as developed by the CDISC Data Exchange Standards Team based on CDISC/NCI DefineXML Controlled Terminology Package 60 (version 2025-09-26)
Schema version: 2.1.10
| Name | Description [NCI Code] | Type | Extensible | Permitted Values [NCI Code] |
|---|---|---|---|---|
| DefineVersion | Version of Define-XML that the file conforms to. | Pattern | No (odm:text) | 2.1.(0|([1-9][0-9]*)) |
| ExternalCodeListDictionary | Terminology relevant to the names given to a reference source that lists words and gives their meaning. [C66788] | Enumeration | Yes (odm:text) | 'CDISC CT' [C163415] 'ClinicalTrials.gov' [C124233] 'COSTART' [C49471] 'CTCAE' [C49704] 'CTIS' [C221530] 'D-U-N-S NUMBER' [C134003] 'EudraCT' [C132782] 'EUDRAVIGILANCE' [C221532] 'GENC' [C221529] 'ICD' [C49474] 'ICD-O' [C37978] 'ISO 21090' [C81895] 'ISO 3166' [C209537] 'jRCT' [C221531] 'LOINC' [C49476] 'MED-RT' [C163416] 'MedDRA' [C43820] 'MeSH' [C82845] 'PubMed' [C42881] 'SNOMED' [C53489] 'UNII' [C163417] 'WHO ATC CLASSIFICATION SYSTEM' [C154331] 'WHOART' [C49468] 'WHODD' [C49475] |
| ItemGroupClass | Terminology related to the classification of a CDISC domain. [C103329] | Enumeration | No | 'ADAM OTHER' [C103375] 'BASIC DATA STRUCTURE' [C103371] 'DEVICE LEVEL ANALYSIS DATASET' [C177921] 'EVENTS' [C103372] 'FINDINGS' [C103373] 'FINDINGS ABOUT' [C135396] 'INTERVENTIONS' [C103374] 'MEDICAL DEVICE BASIC DATA STRUCTURE' [C177922] 'MEDICAL DEVICE OCCURRENCE DATA STRUCTURE' [C177923] 'OCCURRENCE DATA STRUCTURE' [C123454] 'REFERENCE DATA STRUCTURE' [C204611] 'RELATIONSHIP' [C103376] 'SPECIAL PURPOSE' [C103377] 'STUDY REFERENCE' [C147271] 'SUBJECT LEVEL ANALYSIS DATASET' [C103378] 'TRIAL DESIGN' [C103379] |
| ItemGroupSubClass | Sub class of a general observation class. | Enumeration | No | 'ADVERSE EVENT' [C176265] 'MEDICAL DEVICE TIME-TO-EVENT' [C177920] 'NON-COMPARTMENTAL ANALYSIS' [C172452] 'POPULATION PHARMACOKINETIC ANALYSIS' [C189348] 'TIME-TO-EVENT' [C165637] |
| ItemGroupClassSubClass | Sub class of a general observation class. Union of ItemGroupClass and ItemGroupSubClass | Enumeration | No | def:ItemGroupClass def:ItemGroupSubClass |
| ODMContext | Terminology relevant to the context in which the Define-XML document is used. [C170448] | Enumeration | No | 'Other' [C17649] 'Submission' [C70885] |
| OriginSource | Terminology relevant to the origin source for datasets in the Define-XML document. [C170450] | Enumeration | No | 'Investigator' [C25936] 'Sponsor' [C70793] 'Subject' [C41189] 'Vendor' [C68608] |
| OriginType | Terminology relevant to the origin type for datasets in the Define-XML document. [C170449] | Enumeration | No | 'Assigned' [C170547] 'Collected' [C170548] 'Derived' [C170549] 'Not Available' [C126101] 'Other' [C17649] 'Predecessor' [C170550] 'Protocol' [C170551] |
| PDFPageType | Type of PDF reference (Physical reference or named destination). | Enumeration | No | 'NamedDestination' 'PhysicalRef' |
| StandardName | Terminology relevant to the name of the standard described in the Define-XML document. [C170452] | Enumeration | No | 'ADaM-OCCDSIG' [C214535] 'ADaMIG' [C170552] 'ADaMIG-MD' [C214532] 'ADaMIG-NCA' [C214533] 'ADaMIG-popPK' [C214534] 'BIMO' [C191213] 'CDISC/NCI' [C163415] 'SDTMIG' [C170455] 'SDTMIG-AP' [C170553] 'SDTMIG-MD' [C170554] 'SENDIG' [C170456] 'SENDIG-AR' [C181230] 'SENDIG-DART' [C170556] 'SENDIG-GENETOX' [C199687] |
| StandardPublishingSet | Terminology relevant to the classification of the CDISC controlled terminology standard described in the Define-XML document. [C172331] | Enumeration | No | 'ADaM' [C180548] 'CDASH' [C180549] 'DEFINE-XML' [C180550] 'SDTM' [C180551] 'SEND' [C180552] |
| StandardStatus | Terminology relevant to the development or publication status of the standard. [C172332] | Enumeration | Yes (odm:text) | 'Draft' [C172453] 'Final' [C172455] 'Provisional' [C172454] |
| StandardType | Terminology relevant to the classification of the standard described in the Define-XML document. [C170451] | Enumeration | No | 'CT' [C163415] 'IG' [C170454] |
| YesOnly | Yes Response. | Enumeration | No | 'Yes' |
| SdtmigVersionResponse | A terminology codelist relevant to the version of the CDISC Study Data Tabulation Model implementation guide that is being used in the study submission. [C160924] | Enumeration | Yes (odm:text) | '3.1.1' [C161432] '3.1.2' [C161433] '3.1.3' [C161435] '3.2' [C161436] '3.3' [C161437] '3.4' [C161438] 'Version 3.1.2 Amendment 1' [C161434] |