CDISC Def-XML Controlled Terminology

CDISC Def-XML Controlled Terminology, 2020-12-18
Legend:
CodeList
CodeListItem
NCI attributes
C165635ADaM Basic Data Structure Subclass
C165636ADaM Integrated Basic Data Structure Subclass
C176227ADaM Occurrence Data Structure Subclass
C117745Analysis Purpose
C117744Analysis Reason
C172331CDISC Controlled Terminology Standard Type
C66788Dictionary Name
C103329General Observation Class
C170448ODM Context
C170450Origin Source
C170449Origin Type
C170452Standard Name
C172332Standard Status
C170451Standard Type

Codelist Definitions

OIDName
(CDISC Submission Value)
DataType
Extensible
NCI CodeCDISC SynonymCDISC DefinitionPreferred Term
CDISC Submission Value [ODM:CodedValue]
CL.C165635.BDSSCADaM Basic Data Structure Subclass
(BDSSC)
text
Extensible: No
C165635ADaM Basic Data Structure SubclassTerminology relevant to the subclasses of the ADaM basic data structure.CDISC Define-XML ADaM Basic Data Structure Subclass Terminology
NON-COMPARTMENTAL ANALYSISC172452NCAA dataset containing data that is used for non-compartmental analyses.Non-Compartmental Analysis Dataset
TIME-TO-EVENTC165637TTEA dataset containing data that is used for Time-to-Event analyses.Time-to-Event Dataset
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CL.C165636.BDSISCADaM Integrated Basic Data Structure Subclass
(BDSISC)
text
Extensible: No
C165636ADaM Integrated Basic Data Structure SubclassTerminology relevant to the subclasses of the ADaM integrated basic data structure.CDISC Define-XML ADaM Integrated Basic Data Structure Subclass Terminology
TIME-TO-EVENTC165637TTEA dataset containing data that is used for Time-to-Event analyses.Time-to-Event Dataset
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CL.C176227.OCCSCADaM Occurrence Data Structure Subclass
(OCCSC)
text
Extensible: No
C176227ADaM Occurrence Data Structure SubclassTerminology relevant to the subclasses of the ADaM occurrence data structure.CDISC Define-XML ADaM Occurrence Data Structure Subclass Terminology
ADVERSE EVENTC176265A dataset containing data that is used for adverse event analyses.Adverse Event Dataset
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CL.C117745.ANLPURPAnalysis Purpose
(ANLPURP)
text
Extensible: Yes
C117745Analysis PurposePurpose of a specific analysis result described in Define-XML analysis results metadata.CDISC Define-XML Analysis Purpose Terminology
EXPLORATORY OUTCOME MEASUREC98724Exploratory Outcome MeasureThe outcome measure(s) that is part of a pre-specified analysis plan used to evaluate the exploratory endpoint(s) associated with exploratory study objective(s) and/or any other measures, excluding post-hoc measures, that are a focus of the study. (After clinicaltrials.gov)Exploratory Outcome Measure
PRIMARY OUTCOME MEASUREC98772Primary Outcome MeasureThe outcome measure(s) of greatest importance specified in the protocol, usually the one(s) used in the power calculation, to evaluate the primary endpoint(s) associated with the primary study objective(s). (After Clinicaltrials.gov)Primary Outcome Measure
SECONDARY OUTCOME MEASUREC98781Secondary Outcome MeasureThe outcome measure(s) that is part of a pre-specified analysis plan used to evaluate the secondary endpoint(s) associated with secondary study objective(s) and/or used to evaluate any measure(s) ancillary to the primary or secondary endpoint(s). (After Clinicaltrials.gov).Secondary Outcome Measure
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CL.C117744.ANLREASAnalysis Reason
(ANLREAS)
text
Extensible: Yes
C117744Analysis ReasonReason for reporting a specific analysis result described in Define-XML analysis results metadata.CDISC Define-XML Analysis Reason Terminology
DATA DRIVENC117750The analysis was triggered by findings in the data.Data Driven Analysis
REQUESTED BY REGULATORY AGENCYC117751The analysis has been requested by a regulatory agency.Analysis Requested by Regulatory Agency
SPECIFIED IN PROTOCOLC117752The analysis is specified in a protocol.Analysis Specified in Protocol
SPECIFIED IN SAPC117753The analysis is specified in a statistical analysis plan.Analysis Specified in Statistical Analysis Plan
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CL.C172331.CTSTDTYPCDISC Controlled Terminology Standard Type
(CTSTDTYP)
text
Extensible: Yes
C172331CDISC Controlled Terminology Standard TypeTerminology relevant to the classification of the CDISC controlled terminology standard described in the Define-XML document.CDISC Define-XML CDISC Controlled Terminology Standard Type Terminology
ADaMC81222The terminology subset that includes terms pertaining to the Clinical Data Interchange Standards Consortium (CDISC) Analysis Data Model (ADaM).CDISC ADaM Terminology
CDASHC77527The terminology subset that includes terms relevant to the Clinical Data Interchange Standards Consortium (CDISC) Clinical Data Acquisition Standards Harmonization (CDASH) group.CDISC CDASH Terminology
DEFINE-XMLC165634The terminology subset that includes terms relevant to the Clinical Data Interchange Standards Consortium (CDISC) Define-XML standard.CDISC Define-XML Terminology
SDTMC66830The terminology subset that includes terms pertaining to the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM).CDISC SDTM Terminology
SENDC77526The terminology subset that includes terms relevant to the Clinical Data Interchange Standards Consortium (CDISC) Standard for Exchange of Non-clinical Data (SEND) group.CDISC SEND Terminology
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CL.C66788.DICTNAMDictionary Name
(DICTNAM)
text
Extensible: Yes
C66788Dictionary NameA name given to a reference source that lists words and gives their meaning. (NCI)CDISC Dictionary Name Terminology
CDISC CTC163415CDISC Controlled Terminology;Clinical Data Interchange Standards Consortium Controlled TerminologyA standard terminology developed and maintained by Clinical Data Interchange Standards Consortium (CDISC) and the National Cancer Institute Enterprise Vocabulary Services (NCI-EVS) to support CDISC models, domains and specifications for data representation in regulated research.Clinical Data Interchange Standards Consortium Controlled Terminology
COSTARTC49471Coding Symbols for a Thesaurus of Adverse Reaction TermsA terminology developed and used by the Food and Drug Administration (FDA) for the coding, filing and retrieving of post marketing adverse reaction reports. (NCI)Thesaurus of Adverse Reaction Term Coding Symbols
CTCAEC49704Common Terminology Criteria for Adverse EventsA standard terminology developed and maintained by the National Cancer Institute to report adverse events occurring in clinical trials. The CTCAE contains a grading scale for each adverse event term representing the severity of the event.Common Terminology Criteria for Adverse Events
D-U-N-S NUMBERC134003DUNS Numbers;Data Universal Number SystemA proprietary system developed and regulated by Dun & Bradstreet that assigns a unique nine digit numeric identifier to a single business entity location.Data Universal Numbering System
ICDC49474International Classification of DiseasesA system of categories to which morbid entries are assigned according to established criteria. Included is the entire range of conditions in a manageable number of categories, grouped to facilitate mortality reporting. It is produced by the World Health Organization (from ICD-10, p1). The Clinical Modifications, produced by the United States Dept. of Health and Human Services, are larger extensions used for morbidity and general epidemiological purposes, primarily in the U.S. (MSH2005_2004_10_12)International Classification of Diseases
LOINCC49476Logical Observation Identifiers Names and CodesPublished by The Regenstrief Institute, the Logical Observation Identifiers Names and Codes covers clinical and clinical laboratory terminology. (NCI)Logical Observation Identifiers Names and Codes
MED-RTC163416Medication Reference Terminology;NDF-RTA standard terminology developed and maintained by the Veterans Health Administration (VHA) that includes terminology to support the mechanism of action, physiologic effect, and asserted pharmacologic classification relationships of medications. MED-RT incorporates terminology from RxNORM, MeSH, and SNOMED CT.Medication Reference Terminology
MedDRAC43820Medical Dictionary for Regulatory ActivitiesMedDRA is an international medical terminology designed to support the classification, retrieval, presentation, and communication of medical information throughout the medical product regulatory cycle. MedDRA was developed under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The MedDRA Maintenance and Support Services Organization (MSSO) holds a contract with the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) to maintain and support the implementation of the terminology. (NCI)MedDRA
SNOMEDC53489Systematized Nomenclature of MedicineA multiaxial, hierarchical classification system for diseases in man developed by the College of American Pathologists. (NCI)Systematized Nomenclature of Medicine
UNIIC163417SRS-UNII;Substance Registration System-Unique Ingredient IdentifierA standard terminology developed and maintained by the Department of Veterans Affairs/Veterans Health Administration designated federal collaborative Structured Product Labeling Interagency Expert Panel (SPLIEP). It contains terminology to support the mechanism of action, physiologic effect, and asserted pharmacologic classification relationships of drug ingredients and food allergens.Substance Registration System-Unique Ingredient Identifier
WHO ATC CLASSIFICATION SYSTEMC154331Anatomical Therapeutic Chemical Classification SystemA World Health Organization (WHO) classification system, developed and maintained by the WHO Collaborating Centre for Drug Statistics Methodology, for medicinal substances where active substances are divided into different groups according to the organ or system on which they act and their therapeutic, pharmacological, and chemical properties.Anatomical Therapeutic Chemical Classification System
WHOARTC49468World Health Organization Adverse Reaction TermsA terminology implemented by the World Health Organization to describe adverse reactions to a prescribed medication or treatment regimen. (NCI)World Health Organization Adverse Reaction Terminology
WHODDC49475WHODrug Global;World Health Organization Drug DictionaryA reference source of drugs and drug associated information maintained by the World Health Organization. (NCI)World Health Organization Drug Dictionary
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CL.C103329.GNRLOBSCGeneral Observation Class
(GNRLOBSC)
text
Extensible: No
C103329General Observation ClassTerminology related to the classification of a CDISC domain.CDISC Define-XML General Observation Class Terminology
ADAM OTHERC103375An analysis dataset that doesn't conform to a pre-defined ADaM dataset structure (e.g. ADSL, BDS or OCCDS).CDISC Other ADaM Dataset
BASIC DATA STRUCTUREC103371BDSAn ADaM BDS dataset contains one or more records per subject, per analysis parameter, per analysis time point. Variables include the value being analyzed (e.g., AVAL) and the description of the value being analyzed (e.g., PARAM). Other variables in the dataset provide more information about the value being analyzed (e.g., the subject identification) or describe and trace the derivation of it (e.g., DTYPE) or support the analysis of it (e.g., treatment variables, covariates).CDISC Basic Data Structure Dataset
EVENTSC103372This SDTM class captures planned protocol milestones such as randomization and study completion, and occurrences, conditions, or incidents independent of planned study evaluations occurring during the trial (e.g., adverse events) or prior to the trial (e.g., medical history).CDISC Events Class
FINDINGSC103373This SDTM class captures the observations resulting from planned evaluations to address specific tests or questions such as laboratory tests, ECG testing, and questions listed on questionnaires.CDISC Findings Class
FINDINGS ABOUTC135396This SDTM class is a specialization of the findings general observation class. It is intended, as its name implies, to be used when collected data represent findings about an event or intervention that cannot be represented within an event or intervention record or as a supplemental qualifier to such a record.CDISC Findings About Class
INTEGRATED BASIC DATA STRUCTUREC132357IBDSThe Integrated Basic Data Structure is the ADaM data structure including POOL as defined in the integrated SAP. If the IBDS class is needed then IADSL is required. See the study-level BDS class for further details.CDISC Integrated Basic Data Structure Dataset
INTEGRATED OCCURRENCE DATA STRUCTUREC132358IOCCDSThe Integrated Occurrence Data Strucutre is the ADaM data structure including POOL as defined in the integrated SAP. If the IOCCDS class is needed then IADSL is required. See the study-level OCCDS class for further details.CDISC Integrated Occurrence Data Structure Dataset
INTEGRATED SUBJECT LEVELC132359IADSLThe Integrated Subject-Level Analysis Dataset is one record per subject per pool as defined in the integrated SAP and allows multiple records per subject. The integrated ADSL dataset, similar to the study-level ADSL dataset, contains variables that describe subject demographic characteristics and group the subjects for analysis, and is the primary source for subject-level variables included in other analysis datasets such as population flags and treatment variables.CDISC Integrated Subject Level Dataset
INTERVENTIONSC103374This SDTM class captures investigational, therapeutic and other treatments that are administered to the subject (with some actual or expected physiological effect) either as specified by the study protocol (e.g., exposure to study drug), coincident with the study assessment period (e.g., concomitant medications), or self-administered by the subject (such as use of alcohol, tobacco, or caffeine).CDISC Interventions Class
OCCURRENCE DATA STRUCTUREC123454OCCDSThe Occurrence Data Structure (OCCDS) is the ADaM data structure for occurrence analysis. Occurrence analysis is the counting of subjects with a record or term, and often includes a structured hierarchy of dictionary coding categories.CDISC Occurrence Data Structure
RELATIONSHIPC103376This SDTM class provides a means to link related records between datasets. It includes the RELREC and SUPPQUAL datasets.CDISC Relationship Class
SPECIAL PURPOSEC103377SPECIAL-PURPOSEThis SDTM class contains a set of domains which do not conform to the Findings, Events or Interventions observation classes. The domains included are DM, CO, SE and SV.CDISC Special Purpose Class
STUDY REFERENCEC147271This special purpose SDTM class contains further descriptions of study-specific identifiers that will be used in subject based domains.CDISC Study Reference Class
SUBJECT LEVEL ANALYSIS DATASETC103378ADSLThe Subject-Level Analysis Dataset (ADSL) is a one-record-per-subject dataset which contains variables that describe subject demographic characteristics and group the subjects for analysis. ADSL is the primary source for subject-level variables included in other analysis datasets such as population flags and treatment variables.CDISC Subject Level Analysis Dataset
TRIAL DESIGNC103379This SDTM class describes the plan for the procedures to be followed in a clinical trial, including planned and actual timing of events, control group, method of allocating treatments, blinding methods, assignment of epochs that subjects pass through in the course of a trial.CDISC Trial Design Class
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CL.C170448.ODMCNTXODM Context
(ODMCNTX)
text
Extensible: No
C170448ODM ContextTerminology relevant to the context in which the Define-XML document is used.CDISC Define-XML ODM Context Terminology
OtherC17649OtherDifferent than the one(s) previously specified or mentioned. (NCI)Other
SubmissionC70885An assembly of one or more regulatory submission units supporting a specific regulatory purpose or decision. In most cases, the compilation of the submission units is utilized in the assessment of a regulated medical product quality, safety and/or effectiveness.Regulatory Submission
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CL.C170450.ORIGINSOrigin Source
(ORIGINS)
text
Extensible: No
C170450Origin SourceTerminology relevant to the origin source for datasets in the Define-XML document.CDISC Define-XML Origin Source Terminology
InvestigatorC25936A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at the trial site, the investigator is the responsible leader of the team and may be called the principle investigator.Investigator
SponsorC70793Clinical Study Sponsor;Sponsor;Study SponsorAn entity that is responsible for the initiation, management, and/or financing of a clinical study.Clinical Study Sponsor
SubjectC41189An individual who is observed, analyzed, examined, investigated, experimented upon, or/and treated in the course of a particular study.Study Subject
VendorC68608A person or agency that promotes or exchanges goods or services for money. (NCI)Vendor
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CL.C170449.ORIGINTOrigin Type
(ORIGINT)
text
Extensible: No
C170449Origin TypeTerminology relevant to the origin type for datasets in the Define-XML document.CDISC Define-XML Origin Type Terminology
AssignedC170547A value that is derived through designation, such as values from a look up table or a label on a CRF.Assigned Value
CollectedC170548A value that is actually observed and recorded by a person or obtained by an instrument.Collected Value
DerivedC170549A value that is calculated by an algorithm or reproducible rule, and which is dependent upon other data values.Derived Value
Not AvailableC126101A value that is not discoverable or accessible.Not Available
PredecessorC170550A value that is copied from a variable in another dataset.Copied Value
ProtocolC170551A value that is included as part of the study protocol.Protocol Value
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CL.C170452.STDNAMStandard Name
(STDNAM)
text
Extensible: Yes
C170452Standard NameTerminology relevant to the name of the standard described in the Define-XML document.CDISC Define-XML Standard Name Terminology
ADaMIGC170552The implementation guide for the Clinical Data Interchange Standards Consortium (CDISC) Analysis Data Model standard.ADaM Implementation Guide
CDISC/NCIC163415CDISC Controlled Terminology;Clinical Data Interchange Standards Consortium Controlled TerminologyA standard terminology developed and maintained by Clinical Data Interchange Standards Consortium (CDISC) and the National Cancer Institute Enterprise Vocabulary Services (NCI-EVS) to support CDISC models, domains and specifications for data representation in regulated research.Clinical Data Interchange Standards Consortium Controlled Terminology
SDTMIGC170455The implementation guide for the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model standard.SDTM Implementation Guide
SDTMIG-APC170553The implementation guide for the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model Associated Persons standard.SDTM Implementation Guide-Associated Persons
SDTMIG-MDC170554The implementation guide for the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model Medical Devices standard.SDTM Implementation Guide-Medical Devices
SDTMIG-PGxC170555The implementation guide for the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model Pharmacogenomics/Genetics standard.SDTM Implementation Guide-Pharmacogenomics/Genetics
SENDIGC170456The implementation guide for the Clinical Data Interchange Standards Consortium (CDISC) Standard for the Exchange of Nonclinical Data standard.SEND Implementation Guide
SENDIG-DARTC170556The implementation guide for the Clinical Data Interchange Standards Consortium (CDISC) Standard for the Exchange of Nonclinical Data Developmental and Reproductive Toxicology standard.SEND Implementation Guide-Developmental and Reproductive Toxicology
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CL.C172332.STDSTATStandard Status
(STDSTAT)
text
Extensible: Yes
C172332Standard StatusTerminology relevant to the development or publication status of the standard.CDISC Define-XML Standard Status Terminology
DRAFTC172453A preliminary version of a CDISC standard that has not yet completed the CDISC standards development process. (NCI)CDISC Draft Standard
FINALC172455A final version of a CDISC standard that has completed the CDISC standards development process. (NCI)CDISC Final Standard
PROVISIONALC172454A version of a CDISC standard whose conclusiveness is dependent upon the fulfillment of some contingency or final alteration. (NCI)CDISC Provisional Standard
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CL.C170451.STDTYPStandard Type
(STDTYP)
text
Extensible: Yes
C170451Standard TypeTerminology relevant to the classification of the standard described in the Define-XML document.CDISC Define-XML Standard Type Terminology
CTC163415CDISC Controlled Terminology;Clinical Data Interchange Standards Consortium Controlled TerminologyA standard terminology developed and maintained by Clinical Data Interchange Standards Consortium (CDISC) and the National Cancer Institute Enterprise Vocabulary Services (NCI-EVS) to support CDISC models, domains and specifications for data representation in regulated research.Clinical Data Interchange Standards Consortium Controlled Terminology
IGC170454CDISC Implementation GuideA standard document developed and maintained by Clinical Data Interchange Standards Consortium (CDISC) that contains instructions and requirements for the organization, structure, and format of standard clinical and non-clinical trial tabulation and analysis datasets.CDISC Implementation Guide
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