CDISC DDF Controlled Terminology

CDISC DDF Controlled Terminology, 2025-09-26

C215479	Administrable Product Property Type Value Set Terminology
C215483	Administrable Product Sourcing Value Set Terminology
C215456	DDF Abbreviation Attribute Terminology
C188714	DDF Activity Attribute Terminology
C201253	DDF Address Attribute Terminology
C215459	DDF Administrable Product Attribute Terminology
C215460	DDF Administrable Product Identifier Attribute Terminology
C215461	DDF Administrable Product Property Attribute Terminology
C207421	DDF Administration Attribute terminology
C215451	DDF Alias Code Attribute Terminology
C188720	DDF Analysis Population Attribute Terminology
C215465	DDF Assigned Person Attribute Terminology
C201254	DDF Biomedical Concept Attribute Terminology
C201255	DDF Biomedical Concept Category Attribute Terminology
C201256	DDF Biomedical Concept Property Attribute Terminology
C201257	DDF Biomedical Concept Surrogate Attribute Terminology
C215475	DDF Biospecimen Retention Attribute Terminology
C207422	DDF Characteristic Attribute Terminology
C188699	DDF Clinical Study Attribute Terminology
C188722	DDF Code Attribute Terminology
C215452	DDF Comment Annotation Attribute Terminology
C207425	DDF Condition Assignment Attribute Terminology
C207424	DDF Condition Attribute Terminology
C215468	DDF Document Content Reference Attribute Terminology
C216966	DDF Duration Attribute Terminology
C207427	DDF Eligibility Criteria Attribute Terminology
C215476	DDF Eligibility Criterion Item Attribute Terminology
C188713	DDF Encounter Attribute Terminology
C188708	DDF Endpoint Attribute Terminology
C188698	DDF Entity Terminology
C188719	DDF Estimand Attribute Terminology
C207428	DDF Geographic Scope Attribute Terminology
C207429	DDF Governance Date Attribute Terminology
C215458	DDF Identifier Attribute Terminology
C188705	DDF Indication Attribute Terminology
C215464	DDF Ingredient Attribute Terminology
C188721	DDF Intercurrent Event Attribute Terminology
C215473	DDF Interventional Study Design Attribute Terminology
C207430	DDF Masking Attribute Terminology
C215470	DDF Medical Device Attribute Terminology
C215471	DDF Medical Device Identifier Attribute Terminology
C207426	DDF Narrative Content Attribute Terminology
C215453	DDF Narrative Content Item Attribute Terminology
C188707	DDF Objective Attribute Terminology
C215474	DDF Observational Study Design Attribute Terminology
C188702	DDF Organization Attribute Terminology
C207431	DDF Parameter Map Attribute Terminology
C216965	DDF Person Name Terminology
C207432	DDF Population Definition Attribute Terminology
C188716	DDF Procedure Attribute Terminology
C215472	DDF Product Organization Role Attribute Terminology
C207433	DDF Quantity Attribute Terminology
C207434	DDF Range Attribute Terminology
C215457	DDF Reference Identifier Attribute Terminology
C201258	DDF Response Code Attribute Terminology
C201259	DDF Schedule Timeline Attribute Terminology
C207436	DDF Scheduled Activity Instance Attribute Terminology
C201260	DDF Scheduled Decision Instance Attribute Terminology
C201261	DDF Scheduled Instance Attribute Terminology
C215463	DDF Strength Attribute Terminology
C207437	DDF Study Amendment Attribute Terminology
C215469	DDF Study Amendment Impact Attribute Terminology
C207438	DDF Study Amendment Reason Attribute Terminology
C188709	DDF Study Arm Attribute Terminology
C215467	DDF Study Change Attribute Terminology
C207439	DDF Study Cohort Attribute Terminology
C215454	DDF Study Definition Document Attribute Terminology
C215455	DDF Study Definition Document Version Attribute Terminology
C188703	DDF Study Design Attribute Terminology
C188706	DDF Study Design Population Attribute Terminology
C188711	DDF Study Element Attribute Terminology
C188710	DDF Study Epoch Attribute Terminology
C188701	DDF Study Identifier Attribute Terminology
C188704	DDF Study Intervention Attribute Terminology
C215466	DDF Study Role Attribute Terminology
C207441	DDF Study Site Attribute Terminology
C207442	DDF Study Title Attribute Terminology
C207443	DDF Study Version Attribute Terminology
C207444	DDF Subject Enrollment Attribute Terminology
C215462	DDF Substance Attribute Terminology
C207445	DDF Syntax Template Attribute Terminology
C207446	DDF Syntax Template Dictionary Attribute Terminology
C201262	DDF Timing Attribute Terminology
C188712	DDF Transition Rule Attribute Terminology
C188728	Encounter Type Value Set Terminology
C188726	Endpoint Level Value Set Terminology
C207412	Geographic Scope Type Value Set Terminology
C207413	Governance Date Type Value Set Terminology
C215484	Medical Device Identifier Type Value Set Terminology
C215482	Medical Device Sourcing Value Set Terminology
C188725	Objective Level Value Set Terminology
C215486	Observational Study Design Subtype Value Set Terminology
C188724	Organization Type Value Set Terminology
C207418	Product Designation Value Set Terminology
C215485	Product Organization Role Code Value Set Terminology
C215478	Reference Identifier Type Value Set Terminology
C215481	Study Amendment Impact Type Value Set Terminology
C207415	Study Amendment Reason Code Value Set Terminology
C188727	Study Arm Data Origin Type Value Set Terminology
C215477	Study Definition Document Type Value Set Terminology
C188723	Study Definition Document Version Value Set Terminology
C207416	Study Design Characteristics Value Set Terminology
C207417	Study Intervention Role Value Set Terminology
C215480	Study Role Code Value Set Terminology
C207419	Study Title Type Value Set Terminology
C201265	Timing Relative To From Value Set Terminology
C201264	Timing Type Value Set Terminology

Codelist Definitions

OID	Name (CDISC Submission Value)	DataType Extensible	NCI Code	CDISC Synonym	CDISC Definition	Preferred Term
	CDISC Submission Value [ODM:CodedValue]
CL.C215479.Administrable Product Property Type Value Set Terminology	Administrable Product Property Type Value Set Terminology (Administrable Product Property Type Value Set Terminology)	text Extensible: Yes	C215479	Administrable Product Property Type Value Set Terminology	The terminology relevant to the administrable product property type value set.	CDISC DDF Administrable Product Property Type Value Set Terminology
	pH		C45997	pH	The negative logarithm (base 10) of the concentration of hydronium ions, which is used as a measure of the acidity or alkalinity of a fluid.	pH
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CL.C215483.Administrable Product Sourcing Value Set Terminology	Administrable Product Sourcing Value Set Terminology (Administrable Product Sourcing Value Set Terminology)	text Extensible: Yes	C215483	Administrable Product Sourcing Value Set Terminology	The terminology relevant to the administrable product sourcing value set.	CDISC DDF Administrable Product Sourcing Value Set Terminology
	Centrally Sourced		C215659		An indication that the entity is obtained from a central source.	Centrally Sourced Indicator
	Locally Sourced		C215660		An indication that the entity is obtained from a local source.	Locally Sourced Indicator
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CL.C215456.DDF Abbreviation Attribute Terminology	DDF Abbreviation Attribute Terminology (DDF Abbreviation Attribute Terminology)	text Extensible: No	C215456	DDF Abbreviation Attribute Terminology	A terminology value set relevant to the attributes of the abbreviation.	CDISC DDF Abbreviation Attribute Terminology
	Abbreviation Long Name		C215569		The full literal representation of the abbreviation.	Abbreviation Long Name
	Abbreviation Notes		C215570		A brief written record relevant to the abbreviation.	Abbreviation Note
	Text Abbreviation Value		C215487		The literal value of an instance of unstructured text that is used as the abbreviation.	Text Abbreviation Value
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CL.C188714.DDF Activity Attribute Terminology	DDF Activity Attribute Terminology (DDF Activity Attribute Terminology)	text Extensible: No	C188714	DDF Activity Attribute Terminology	A terminology value set relevant to the attributes of the activity.	CDISC DDF Activity Attribute Terminology
	Activity Notes		C215519		A brief written record relevant to the activity.	Activity Note
	Study Activity Description		C70960		The textual representation of the study activity.	Clinical Study Activity Description
	Study Activity Label		C207458		The short descriptive designation for the study activity.	Study Activity Label
	Study Activity Name		C188842		The literal identifier (i.e., distinctive designation) of the study activity.	Clinical Study Activity Name
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CL.C201253.DDF Address Attribute Terminology	DDF Address Attribute Terminology (DDF Address Attribute Terminology)	text Extensible: No	C201253	DDF Address Attribute Terminology	A terminology value set relevant to the attributes of the address.	CDISC DDF Address Attribute Terminology
	Address Full Text		C201311		A standardized representation of the complete set of components denoting the physical address of the person, business, building, or organization.	Address Full Text
	Address Line		C25690		The street name and number, building number, apartment or unit number, or post office box number where an entity is physically located.	Street Address
	City		C25160		A relatively large and/or densely populated area of human habitation with administrative or legal status that may be specified as a component of a postal address.	City
	Country		C25464		A sovereign nation occupying a distinct territory and ruled by an autonomous government.	Country
	District		C176229		An administrative or territorial division of a city, town, county, parish, state, country, or other locality based on a shared characteristic.	District
	Postal Code		C25621		An alphanumeric code assigned to a mail delivery area.	Postal Code
	State		C87194		A sub-division of a country that forms part of a federal union. States are usually, but not always, more autonomous than provinces and may have different laws from the central government.	State
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CL.C215459.DDF Administrable Product Attribute Terminology	DDF Administrable Product Attribute Terminology (DDF Administrable Product Attribute Terminology)	text Extensible: No	C215459	DDF Administrable Product Attribute Terminology	A terminology value set relevant to the attributes of the administrable product.	CDISC DDF Administrable Product Attribute Terminology
	Administrable Product Definition Description		C215574		A narrative representation of the administrable product.	Administrable Product Definition Description
	Administrable Product Definition Label		C215575		The short descriptive designation for the administrable product.	Administrable Product Definition Label
	Administrable Product Definition Name		C215573		The literal identifier (i.e., distinctive designation) of the administrable product.	Administrable Product Definition Name
	Administrable Product Dose Form		C215576		The physical form in which formulated ingredient(s) are presented in the administrable product.	Administrable Product Dose Form
	Administrable Product Notes		C215580		A brief written record relevant to the administrable product.	Administrable Product Note
	Administrable Product Pharmacologic Class		C215577		The pharmacological class of the administrable product.	Administrable Product Pharmacologic Class
	Administrable Product Product Designation		C215579		An indication as to whether the administrable product is an investigational medicinal product or an auxiliary medicinal product.	Administrable Product Designation Indicator
	Administrable Product Sourcing		C215578		An indication as to whether the administrable product is obtained from a local or central source.	Administrable Product Sourcing Indicator
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CL.C215460.DDF Administrable Product Identifier Attribute Terminology	DDF Administrable Product Identifier Attribute Terminology (DDF Administrable Product Identifier Attribute Terminology)	text Extensible: No	C215460	DDF Administrable Product Identifier Attribute Terminology	A terminology value set relevant to the attributes of the administrable product identifier.	CDISC DDF Administrable Product Identifier Attribute Terminology
	Administrable Product Identifier Text		C215581		An instance of structured text that represents the administrable product.	Administrable Product Identifier Text
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CL.C215461.DDF Administrable Product Property Attribute Terminology	DDF Administrable Product Property Attribute Terminology (DDF Administrable Product Property Attribute Terminology)	text Extensible: No	C215461	DDF Administrable Product Property Attribute Terminology	A terminology value set relevant to the attributes of the administrable product property.	CDISC DDF Administrable Product Property Attribute Terminology
	Administrable Product Property Name		C215582		The literal identifier (i.e., distinctive designation) of the administrable product property.	Administrable Product Property Name
	Administrable Product Property Quantity Value		C215584		The numeric value associated with an administrable product property.	Administrable Product Property Quantity Value
	Administrable Product Property Text		C215583		An instance of structured text that represents the administrable product property.	Administrable Product Property Text
	Administrable Product Property Type		C215585		A characterization or classification of the administrable product property.	Administrable Product Property Type
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CL.C207421.DDF Administration Attribute terminology	DDF Administration Attribute terminology (DDF Administration Attribute terminology)	text Extensible: No	C207421	DDF Administration Attribute terminology	A terminology value set relevant to the attributes of the agent administration.	CDISC DDF Agent Administration Attribute Terminology
	Administration Description		C207463		A narrative representation for the administration of a product, agent, or therapy.	Agent Administration Description
	Administration Dose		C167190		The value representing the amount of an agent given to an individual at one time.	Dose Administered
	Administration Duration		C69282		The amount of time elapsed during the administration of an agent.	Duration of Administration
	Administration Label		C207464		The short descriptive designation for the administration of a product, agent, or therapy.	Agent Administration Label
	Administration Name		C207465		The literal identifier (i.e., distinctive designation) for the administration of a product, agent, or therapy.	Agent Administration Name
	Administration Notes		C215544		A brief written record relevant to the administration of the product, agent, or therapy.	Agent Administration Note
	Dosing Frequency		C89081	Dosing Frequency	The number of doses administered per a specific interval.	Dose Frequency
	Route of Administration		C38114	Route of Administration	The way in which a pharmaceutical product is taken into, or makes contact with, the body. (CDISC Glossary)	Route of Administration
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CL.C215451.DDF Alias Code Attribute Terminology	DDF Alias Code Attribute Terminology (DDF Alias Code Attribute Terminology)	text Extensible: No	C215451	DDF Alias Code Attribute Terminology	A terminology value set relevant to the attributes of the alias code.	CDISC DDF Alias Code Attribute Terminology
	Standard Code Aliases		C215529		Alternative combinations of symbols used to represent aliases or alternatives to the standard code.	Standard Code Alias
	Standard Code		C215528		A combination of symbols that is used to represent the standard code.	Standard Code
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CL.C188720.DDF Analysis Population Attribute Terminology	DDF Analysis Population Attribute Terminology (DDF Analysis Population Attribute Terminology)	text Extensible: No	C188720	DDF Analysis Population Attribute Terminology	A terminology value set relevant to the attributes of the analysis population.	CDISC DDF Analysis Population Attribute Terminology
	Analysis Population Description		C188854		A narrative representation of the analysis population.	Analysis Population Description
	Analysis Population Label		C207466		The short descriptive designation for the analysis population.	Analysis Population Label
	Analysis Population Name		C207467		The literal identifier (i.e., distinctive designation) of the analysis population.	Analysis Population Name
	Analysis Population Notes		C215525		A brief written record relevant to the analysis population.	Analysis Population Note
	Analysis Population Text		C207468		An instance of unstructured text that represents the analysis population.	Analysis Population Text
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CL.C215465.DDF Assigned Person Attribute Terminology	DDF Assigned Person Attribute Terminology (DDF Assigned Person Attribute Terminology)	text Extensible: No	C215465	DDF Assigned Person Attribute Terminology	A terminology value set relevant to the attributes of the assigned person.	CDISC DDF Assigned Person Attribute Terminology
	Assigned Person Description		C215597		A narrative representation of the assigned person.	Assigned Person Description
	Assigned Person Job Title		C215599		An identifying designation related to the assigned person's occupation.	Assigned Person Job Title
	Assigned Person Label		C215598		The short descriptive designation for the assigned person.	Assigned Person Label
	Assigned Person Name		C215596		The literal identifier (i.e., distinctive designation) of the assigned person.	Assigned Person Name
	Assigned Person Person Name		C216993	Assigned Person Human Name	A word or group of words indicating the identity of an assigned person usually consisting of a first (personal) name and a last (family) name with an optional middle name. In some cultural traditions the family name comes first.	Assigned Person Person Name
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CL.C201254.DDF Biomedical Concept Attribute Terminology	DDF Biomedical Concept Attribute Terminology (DDF Biomedical Concept Attribute Terminology)	text Extensible: No	C201254	DDF Biomedical Concept Attribute Terminology	A terminology value set relevant to the attributes of the biomedical concept.	CDISC DDF Biomedical Concept Attribute Terminology
	Biomedical Concept Concept Code		C207469		A concept unique identifier assigned to a biomedical concept that points to the meaning of that biomedical concept.	Biomedical Concept Code
	Biomedical Concept Label		C207470		The short descriptive designation for the biomedical concept.	Biomedical Concept Label
	Biomedical Concept Name		C201312		The literal identifier (i.e., distinctive designation) of the biomedical concept.	Biomedical Concept Name
	Biomedical Concept Notes		C215530		A brief written record relevant to the biomedical concept.	Biomedical Concept Note
	Biomedical Concept Reference		C201313		A citation to an authoritative source for a biomedical concept.	Biomedical Concept Reference
	Biomedical Concept Synonym		C201314		A word or an expression that serves as a figurative, symbolic, or exact substitute for a biomedical concept, and which has the same meaning.	Biomedical Concept Synonym
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CL.C201255.DDF Biomedical Concept Category Attribute Terminology	DDF Biomedical Concept Category Attribute Terminology (DDF Biomedical Concept Category Attribute Terminology)	text Extensible: No	C201255	DDF Biomedical Concept Category Attribute Terminology	A terminology value set relevant to the attributes of the biomedical concept category.	CDISC DDF Biomedical Concept Category Attribute Terminology
	Biomedical Concept Category Code		C201315		A symbol or combination of symbols which is assigned to the biomedical concept category.	Biomedical Concept Category Code
	Biomedical Concept Category Description		C201316		A narrative representation of the biomedical concept category.	Biomedical Concept Category Description
	Biomedical Concept Category Label		C207471		The short descriptive designation for the biomedical concept category.	Biomedical Concept Category Label
	Biomedical Concept Category Name		C201317		The literal identifier (i.e., distinctive designation) of the biomedical concept category.	Biomedical Concept Category Name
	Biomedical Concept Category Notes		C215533		A brief written record relevant to the biomedical concept category.	Biomedical Concept Category Note
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CL.C201256.DDF Biomedical Concept Property Attribute Terminology	DDF Biomedical Concept Property Attribute Terminology (DDF Biomedical Concept Property Attribute Terminology)	text Extensible: No	C201256	DDF Biomedical Concept Property Attribute Terminology	A terminology value set relevant to the attributes of the biomedical concept property.	CDISC DDF Biomedical Concept Property Attribute Terminology
	Biomedical Concept Property Concept Code		C201318		A concept unique identifier assigned to a biomedical concept property that points to the meaning of that biomedical concept property.	Biomedical Concept Property Concept Code
	Biomedical Concept Property Enabled Indicator		C202496		An indication as to whether the biomedical concept property is activated for use within a given usage context for a biomedical concept.	Biomedical Concept Property Enabled Indicator
	Biomedical Concept Property Label		C207472		The short descriptive designation for the biomedical concept property.	Biomedical Concept Property Label
	Biomedical Concept Property Name		C202494		The literal identifier (i.e., distinctive designation) of the biomedical concept property.	Biomedical Concept Property Name
	Biomedical Concept Property Notes		C215531		A brief written record relevant to the biomedical concept property.	Biomedical Concept Property Note
	Biomedical Concept Property Required Indicator		C202495		An indication as to whether the biomedical concept property is required.	Biomedical Concept Property Required Indicator
	Biomedical Concept Property Response Data Type		C201319		The structural format of the biomedical concept property response value. The datatype is carried in the attribute and influences the set of allowable values the attribute may assume. (After HL7)	Biomedical Concept Property Response Data Type
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CL.C201257.DDF Biomedical Concept Surrogate Attribute Terminology	DDF Biomedical Concept Surrogate Attribute Terminology (DDF Biomedical Concept Surrogate Attribute Terminology)	text Extensible: No	C201257	DDF Biomedical Concept Surrogate Attribute Terminology	A terminology value set relevant to the attributes of the biomedical concept surrogate.	CDISC DDF Biomedical Concept Surrogate Attribute Terminology
	Biomedical Concept Surrogate Description		C201320		A narrative representation of the biomedical concept surrogate.	Biomedical Concept Surrogate Description
	Biomedical Concept Surrogate Label		C207473		The short descriptive designation for the biomedical concept surrogate.	Biomedical Concept Surrogate Label
	Biomedical Concept Surrogate Name		C207474		The literal identifier (i.e., distinctive designation) of the biomedical concept surrogate.	Biomedical Concept Surrogate Name
	Biomedical Concept Surrogate Notes		C215532		A brief written record relevant to the biomedical concept surrogate.	Biomedical Concept Surrogate Note
	Biomedical Concept Surrogate Reference		C201321		A citation to an authoritative source for a biomedical concept surrogate.	Biomedical Concept Surrogate Reference
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CL.C215475.DDF Biospecimen Retention Attribute Terminology	DDF Biospecimen Retention Attribute Terminology (DDF Biospecimen Retention Attribute Terminology)	text Extensible: No	C215475	DDF Biospecimen Retention Attribute Terminology	A terminology value set relevant to the attributes of the biospecimen retention.	CDISC DDF Biospecimen Retention Attribute Terminology
	Biospecimen Retention Description		C181231	Biospecimen Retention	A narrative representation of the biospecimen retention.	Biological Sample Retention Description
	Biospecimen Retention Includes DNA Indicator		C127777	Biospecimen Retention Contains DNA Ind	An indication as to whether retained biospecimens contain DNA.	Retained Biospecimen Contains DNA Indicator
	Biospecimen Retention Indicator		C164620	Biospecimen Retention Indicator	An indication as to whether biospecimens were retained.	Biospecimen Retention Indicator
	Biospecimen Retention Label		C215646		The short descriptive designation for the biospecimen retention.	Biospecimen Retention Label
	Biospecimen Retention Name		C215645		The literal identifier (i.e., distinctive designation) of the biospecimen retention.	Biospecimen Retention Name
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CL.C207422.DDF Characteristic Attribute Terminology	DDF Characteristic Attribute Terminology (DDF Characteristic Attribute Terminology)	text Extensible: No	C207422	DDF Characteristic Attribute Terminology	A terminology value set relevant to the attributes of the characteristic.	CDISC DDF Characteristic Attribute Terminology
	Characteristic Description		C207475		A narrative representation of the characteristic.	Characteristic Description
	Characteristic Label		C207476		The short descriptive designation for the characteristic.	Characteristic Label
	Characteristic Name		C207477		The literal identifier (i.e., distinctive designation) of the characteristic.	Characteristic Name
	Characteristic Notes		C215548		A brief written record relevant to the characteristic.	Characteristic Note
	Characteristic Text		C207478		An instance of structured text that represents the characteristic.	Characteristic Text
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CL.C188699.DDF Clinical Study Attribute Terminology	DDF Clinical Study Attribute Terminology (DDF Clinical Study Attribute Terminology)	text Extensible: No	C188699	DDF Clinical Study Attribute Terminology	A terminology value set relevant to the attributes of the clinical study.	CDISC DDF Clinical Study Attribute Terminology
	Clinical Study Description		C142704		A narrative representation of the clinical study.	Study Description
	Clinical Study Label		C207479		The short descriptive designation for the clinical study.	Clinical Study Label
	Clinical Study Name		C68631		The literal identifier (i.e., distinctive designation) of the clinical study.	Study Name
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CL.C188722.DDF Code Attribute Terminology	DDF Code Attribute Terminology (DDF Code Attribute Terminology)	text Extensible: No	C188722	DDF Code Attribute Terminology	A terminology value set relevant to the attributes of the code.	CDISC DDF Code Attribute Terminology
	Code System Name		C188859		The literal identifier (i.e., distinctive designation) of the system used to assign and/or manage codes.	Code System Name
	Code System Version		C188868		The version of the code system.	Coding System Version
	Code Value		C188858		The literal value of a code.	Code Value
	Decode		C188861		Standardized or dictionary-derived human readable text associated with a code.	Decode Text
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CL.C215452.DDF Comment Annotation Attribute Terminology	DDF Comment Annotation Attribute Terminology (DDF Comment Annotation Attribute Terminology)	text Extensible: No	C215452	DDF Comment Annotation Attribute Terminology	A terminology value set relevant to the attributes of the comment annotation.	CDISC DDF Comment Annotation Attribute Terminology
	Comment Annotation Code		C215556		A symbol or combination of symbols which is assigned to the comment annotation.	Comment Annotation Code
	Comment Annotation Text		C215555		An instance of unstructured text that represents the comment annotation.	Comment Annotation Text
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CL.C207425.DDF Condition Assignment Attribute Terminology	DDF Condition Assignment Attribute Terminology (DDF Condition Assignment Attribute Terminology)	text Extensible: No	C207425	DDF Condition Assignment Attribute Terminology	A terminology value set relevant to the attributes of the condition assignment.	CDISC DDF Condition Assignment Attribute Terminology
	Logical Condition		C47953		An assumption on which rests the validity or effect of something else.	Logical Condition
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CL.C207424.DDF Condition Attribute Terminology	DDF Condition Attribute Terminology (DDF Condition Attribute Terminology)	text Extensible: No	C207424	DDF Condition Attribute Terminology	A terminology value set relevant to the attributes of the condition.	CDISC DDF Condition Attribute Terminology
	Condition Description		C207481		A narrative representation of the condition.	Condition Description
	Condition Label		C207482		The short descriptive designation for the condition.	Condition Label
	Condition Name		C207483		The literal identifier (i.e., distinctive designation) of the condition.	Condition Name
	Condition Notes		C215552		A brief written record relevant to the condition.	Condition Note
	Condition Text		C207484		An instance of structured text that represents the condition.	Condition Text
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CL.C215468.DDF Document Content Reference Attribute Terminology	DDF Document Content Reference Attribute Terminology (DDF Document Content Reference Attribute Terminology)	text Extensible: No	C215468	DDF Document Content Reference Attribute Terminology	A terminology value set relevant to the attributes of the document content reference.	CDISC DDF Document Content Reference Attribute Terminology
	Document Content Reference Section Number		C215609		The numeric identifier of a particular section for the document content reference.	Document Content Reference Section Number
	Document Content Reference Section Title		C215610		An identifying designation for a particular section for the document content reference.	Document Content Reference Section Title
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CL.C216966.DDF Duration Terminology	DDF Duration Attribute Terminology (DDF Duration Terminology)	text Extensible: No	C216966	DDF Duration Attribute Terminology	A terminology value set relevant to the attributes of the event duration.	CDISC DDF Duration Attribute Terminology
	Duration Quantity Value		C217011		The value representing the amount of time over which the event occurs.	Duration Quantity Value
	Duration Text		C217008		An instance of unstructured text that represents the event duration.	Duration Text
	Duration Will Vary Indicator		C217009		An indication as to whether the event duration is planned to vary within and/or across subjects.	Duration Will Vary Indicator
	Reason Duration Will Vary		C217010		The explanation for why the event duration will vary within and/or across subjects.	Reason Duration Will Vary
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CL.C207427.DDF Eligibility Criteria Attribute Terminology	DDF Eligibility Criteria Attribute Terminology (DDF Eligibility Criteria Attribute Terminology)	text Extensible: No	C207427	DDF Eligibility Criteria Attribute Terminology	A terminology value set relevant to the attributes of the eligibility criteria.	CDISC DDF Eligibility Criteria Attribute Terminology
	Eligibility Criterion Notes		C215537		A brief written record relevant to the eligibility criterion.	Eligibility Criterion Note
	Study Eligibility Criterion Category		C83016	Study Eligibility Criteria Category	A classification of the inclusion exclusion criterion.	Inclusion Exclusion Criterion Category
	Study Eligibility Criterion Description		C207486	Study Eligibility Criteria Description	A narrative representation of the study eligibility criterion.	Study Eligibility Criteria Description
	Study Eligibility Criterion Identifier		C207489		A sequence of characters used to identify, name, or characterize the inclusion or exclusion criterion.	Study Eligibility Criterion Identifier
	Study Eligibility Criterion Label		C207487	Study Eligibility Criteria Label	The short descriptive designation for the study eligibility criterion.	Study Eligibility Criteria Label
	Study Eligibility Criterion Name		C207488	Study Eligibility Criteria Description	The literal identifier (i.e., distinctive designation) of the study eligibility criterion.	Study Eligibility Criteria Name
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CL.C215476.DDF Eligibility Criterion Item Attribute Terminology	DDF Eligibility Criterion Item Attribute Terminology (DDF Eligibility Criterion Item Attribute Terminology)	text Extensible: No	C215476	DDF Eligibility Criterion Item Attribute Terminology	A terminology value set relevant to the attributes of the eligibility criterion item.	CDISC DDF Eligibility Criterion Item Attribute Terminology
	Eligibility Criterion Item Description		C215649		A narrative representation of the eligibility criterion item.	Eligibility Criterion Item Description
	Eligibility Criterion Item Label		C215650		The short descriptive designation for the eligibility criterion item.	Eligibility Criterion Item Label
	Eligibility Criterion Item Name		C215647		The literal identifier (i.e., distinctive designation) of the eligibility criterion item.	Eligibility Criterion Item Name
	Eligibility Criterion Item Notes		C215651		A brief written record relevant to the eligibility criterion item.	Eligibility Criterion Item Note
	Eligibility Criterion Item Text		C215648		An instance of structured text that represents the eligibility criterion item.	Eligibility Criterion Item Text
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CL.C188713.DDF Encounter Attribute Terminology	DDF Encounter Attribute Terminology (DDF Encounter Attribute Terminology)	text Extensible: No	C188713	DDF Encounter Attribute Terminology	A terminology value set relevant to the attributes of the encounter.	CDISC DDF Encounter Attribute Terminology
	Contact Mode		C188841		The means by which an interaction occurs between the subject/participant and person or entity (e.g., a device).	Contact Mode
	Encounter Notes		C215518		A brief written record relevant to the study encounter.	Study Encounter Note
	Environmental Setting		C188840		The environment/setting where the event, intervention, or finding occurred.	Environmental Setting
	Study Encounter Description		C188836		A narrative representation of the protocol-defined study encounter.	Clinical Encounter Description
	Study Encounter Label		C207490		The short descriptive designation for the study encounter.	Study Encounter Label
	Study Encounter Name		C171010		The literal identifier (i.e., distinctive designation) for a protocol-defined study encounter.	Clinical Encounter Name
	Study Encounter Type		C188839		A characterization or classification of the study encounter.	Clinical Encounter Type
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CL.C188708.DDF Endpoint Attribute Terminology	DDF Endpoint Attribute Terminology (DDF Endpoint Attribute Terminology)	text Extensible: No	C188708	DDF Endpoint Attribute Terminology	A terminology value set relevant to the attributes of the endpoint.	CDISC DDF Endpoint Attribute Terminology
	Endpoint Notes		C215514		A brief written record relevant to the study endpoint.	Study Endpoint Note
	Study Endpoint Description		C188824		A narrative representation of the study endpoint.	Study Endpoint Description
	Study Endpoint Label		C207491		The short descriptive designation for the study endpoint.	Study Endpoint Label
	Study Endpoint Level		C188826		A characterization or classification of the study endpoint that determines its category of importance relative to other study endpoints.	Study Endpoint Level
	Study Endpoint Name		C207492		The literal identifier (i.e., distinctive designation) of the study endpoint.	Study Endpoint Name
	Study Endpoint Purpose		C188825		The reason or intention for the study endpoint.	Study Endpoint Purpose
	Study Endpoint Text		C207493		An instance of structured text that represents the study endpoint.	Study Endpoint Text
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CL.C188698.DDF Entity Terminology	DDF Entity Terminology (DDF Entity Terminology)	text Extensible: No	C188698	DDF Entity Terminology	A terminology value set relevant to the entities within the CDISC digital data flow (DDF) model.	CDISC DDF Entities Terminology
	Abbreviation		C42610		A set of letters that are drawn from a word or from a sequence of words and that are used for brevity in place of the full word or phrase. (CDISC Glossary)	Abbreviation
	Address		C25407		A standardized representation of the location of a person, business, building, or organization. (NCI)	Address
	Administrable Product Identifier		C215493		A sequence of characters used to identify, name, or characterize the administrable product.	Administrable Study Product Identifier
	Administrable Product Property		C215494		A characteristic from a set of characteristics used to define an administrable product.	Administrable Study Product Property
	Administrable Product		C215492		Any study product that is formulated and presented in the form that is suitable for administration to a study participant.	Administrable Study Product
	Administration		C25409		The act of dispensing, applying, or tendering a product, agent, or therapy.	Administration
	Alias Code		C201344		An alternative symbol or combination of symbols which is assigned to the members of a collection.	Alias Code
	Analysis Population		C188814	Study Target Population for Analysis;Target Study Population for Analysis	A target study population on which an analysis is performed. These may be represented by the entire study population, a subgroup defined by a particular characteristic measured at baseline, or a principal stratum defined by the occurrence (or non-occurrence, depending on context) of a specific intercurrent event. (ICH E9 R1 Addendum)	Target Study Population for Analysis
	Assigned Person		C215496		An individual person who is allotted or appointed to a particular role, function, or other entity.	Assigned Person
	Biomedical Concept Category		C201346		A grouping of biomedical concepts based on some commonality or by user defined characteristics.	Biomedical Concept Category
	Biomedical Concept Property		C202493		A characteristic from a set of characteristics used to define a biomedical concept.	Biomedical Concept Property
	Biomedical Concept Surrogate		C207590		A concept that substitutes for a standard biomedical concept from the designated source.	Biomedical Concept Surrogate
	Biomedical Concept		C201345		A unit of biomedical knowledge created from a unique combination of characteristics that include implementation details like variables and terminologies, used as building blocks for standardized, hierarchically structured clinical research information.	Biomedical Concept
	Biospecimen Retention		C215505		The continued possession, cataloging, and storage of collected biological specimens beyond their initial use.	Biospecimen Retention
	Characteristic		C25447		The distinguishing qualities or prominent aspects of an entity.	Characteristic
	Clinical Study		C15206		A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. (CDISC Glossary)	Clinical Study
	Code		C25162		A symbol or combination of symbols which is assigned to the members of a collection.	Code
	Comment Annotation		C44272		An explanatory or critical comment, or other in-context information (e.g., pattern, motif, link), that has been associated with data or other types of information.	Annotation
	Condition Assignments		C201335		An allotting or appointment to a set of conditions that are to be met in order to make a logical decision.	Condition Assignment
	Condition		C25457		A state of being.	Condition
	Disease/Condition Indication		C41184		The disease or condition the intervention is intended to diagnose, treat, prevent, cure, or mitigate.	Indication
	Document Content Reference		C215499		A citation pointing to the location of specific content within a document.	Document Content Reference
	Duration		C25330	Duration;Time;Time Duration	The length of time during which something continues.	Duration
	Eligibility Criterion Item		C215506		An individual item within the container that holds an instance of an eligibility criterion.	Eligibility Criterion Item
	Estimand		C188813		A precise description of the treatment effect reflecting the clinical question posed by a given clinical trial objective. It summarises at a population level what the outcomes would be in the same patients under different treatment conditions being compared. (ICH E9 R1 Addendum)	Estimand
	Geographic Scope		C207591		The extent or range related to the physical location of an entity.	Geographic Scope
	Identifier		C25364		One or more characters used to identify, name, or characterize the nature, properties, or contents of a thing.	Identifier
	Ingredient		C51981		Any component that constitutes a part of a compound or mixture.	Ingredient
	Intercurrent Event		C188815		An event(s) occurring after treatment initiation that affects either the interpretation or the existence of the measurements associated with the clinical question of interest. (ICH E9 Addendum on Estimands)	Intercurrent Event
	Interventional Study Design		C215503		The strategy that specifies the structure of an interventional trial in terms of the planned activities (including timing) and statistical analysis approach intended to meet the objectives of the study.	Interventional Study Design
	Masking		C191278		The mechanism used to obscure the distinctive characteristics of the study intervention or procedure to make it indistinguishable from the comparator. NOTE: Blinding refers to study participants while masking refers to the study intervention. (CDISC Glossary)	Masking
	Medical Device Identifier		C215501		A sequence of characters used to identify, name, or characterize the medical device.	Medical Device Identifier
	Medical Device		C16830	Medical Device	Any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination for, one or more specific medical purpose(s). [After REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices]	Medical Device
	Narrative Content Item		C215489		An individual item within the container that holds an instance of unstructured text and which may include objects such as tables, figures, and images.	Narrative Content Item
	Narrative Content		C207592		The container that holds an instance of unstructured text and which may include objects such as tables, figures, and images.	Narrative Content
	Observational Study Design		C215504		The strategy that specifies the structure of an observational study in terms of the planned activities (including timing) and statistical analysis approach intended to meet the objectives of the study.	Observational Study Design
	Organization		C19711		A formalized group of persons or other organizations collected together for a common purpose (such as administrative, legal, political) and the infrastructure to carry out that purpose. (BRIDG)	Professional Organization or Group
	Parameter Map		C207456		The paired name and value for a given parameter.	Parameter Map
	Person Name		C25191	Human Name;Individual's Name;Name	A word or group of words indicating the identity of a person usually consisting of a first (personal) name and a last (family) name with an optional middle name. In some cultural traditions the family name comes first.	Person Name
	Population Definition		C207593		A concise explanation of the meaning of a population.	Population Definition
	Procedure		C98769	Medical Procedure	Any activity performed by manual and/or instrumental means for the purpose of diagnosis, assessment, therapy, prevention, or palliative care.	Physical Medical Procedure
	Product Organization Role		C215502		A designation that identifies the function of an organization within the context of the product.	Product Organization Role
	Quantity or Range		C217000		The total amount (number), or the limits (minimum and maximum) of a variation.	Quantity or Range
	Quantity		C25256		How much there is of something that can be measured; the total amount or number.	Quantity
	Range		C38013		An expression that defines the lower and upper limits of a variation.	Range
	Reference Identifier		C82531		A sequence of characters used to identify, name, or characterize the reference.	Reference ID
	Response Code		C201347		A symbol or combination of symbols representing the response to the question.	Response Code
	Schedule Timeline Exit		C201349		To go out of or leave the schedule timeline.	Schedule Timeline Exit
	Schedule Timeline		C201348		A chronological schedule of planned temporal events.	Schedule Timeline
	Scheduled Activity Instance		C201350		A scheduled occurrence of an activity event.	Scheduled Activity Instance
	Scheduled Decision Instance		C201351		A scheduled occurrence of a decision event.	Scheduled Decision Instance
	Scheduled Instance		C201299		A scheduled occurrence of a temporal event.	Scheduled Instance
	Study Activity		C71473		An action, undertaking, or event, which is anticipated to be performed or observed, or was performed or observed, according to the study protocol during the execution of the study.	Study Activity
	Study Amendment Impact		C215500		The effect or consequence of an amendment on some aspect of the study.	Study Amendment Impact
	Study Amendment Reason		C207457	Reason(s) for Amendment	The rationale for the change(s) to, or formal clarification of, a protocol.	Study Amendment Reason
	Study Amendment		C207594		A written description of a change(s) to, or formal clarification of, a study.	Study Amendment
	Study Arm		C174447	Arm	A planned pathway assigned to the subject as they progress through the study, usually referred to by a name that reflects one or more treatments, exposures, and/or controls included in the path.	Study Arm
	Study Change		C215498		The act of alteration or modification to a study.	Study Change
	Study Cohort		C61512		A group of individuals who share a set of characteristics (e.g., exposures, experiences, attributes), which logically defines a population under study.	Cohort
	Study Definition Document Version		C215491		A representation of a particular edition or snapshot of the study definition document as it exists at a particular point in time.	Study Definition Document Version
	Study Definition Document		C215490		Any physical or electronic document that is related to defining a study or part of a study.	Study Definition Document
	Study Design Cell		C188810		A partitioning of a study arm into individual pieces, which are associated with an epoch and any number of sequential elements within that epoch.	Study Design Cell
	Study Design Element		C142735		A basic building block for time within a clinical study comprising the following characteristics: a description of what happens to the subject during the element; a definition of the start of the element; a rule for ending the element.	Trial Design Element
	Study Design Population		C142728	Target Population	The group of people in the general population to which the study results can be generalized.	Target Study Population
	Study Design		C15320		A strategy that specifies the structure of a study in terms of the planned activities (including timing) and statistical analysis approach intended to meet the objectives of the study.	Study Design
	Study Eligibility Criterion		C16112	Study Eligibility Criteria;Trial Eligibility Criteria;Trial Eligibility Criterion	Characteristics which are necessary to allow a subject to participate in a clinical study, as outlined in the study protocol. The concept covers inclusion and exclusion criteria.	Clinical Trial Eligibility Criteria
	Study Encounter		C215488		Any physical or virtual contact between two or more parties involved in a study, at which an assessment or activity takes place.	Study Encounter
	Study Endpoint		C25212		A defined variable intended to reflect an outcome of interest that is statistically analyzed to address a particular research question. NOTE: A precise definition of an endpoint typically specifies the type of assessments made, the timing of those assessments, the assessment tools used, and possibly other details, as applicable, such as how multiple assessments within an individual are to be combined. [After BEST Resource] (CDISC Glossary)	End Point
	Study Epoch		C71738		A named time period defined in the protocol, wherein a study activity is specified and unchanging throughout the interval, to support a study-specific purpose.	Clinical Trial Epoch
	Study Governance Date		C207595		Any of the dates associated with event milestones within a clinical study's oversight and management framework.	Study Governance Date
	Study Identifier		C83082		A sequence of characters used to identify, name, or characterize the study.	Study Identifier
	Study Intervention		C207649	Investigational Trial Intervention	Any agent, device, or procedure being tested or used as a reference or comparator in the conduct of a clinical trial.	Trial Intervention
	Study Objective		C142450		The reason for performing a study in terms of the scientific questions to be answered by the analysis of data collected during the study.	Clinical Trial Objective
	Study Role		C215497		A designation that identifies the function of study personnel or an organization within the context of the study.	Study Role
	Study Site		C80403		The location at which a study investigator conducts study activities.	Study Site
	Study Title		C49802	Official Study Title;Study Title;Trial Title	The sponsor-defined name of the clinical study.	Trial Title
	Study Version		C188816		A plan at a particular point in time for a study.	Study Version
	Subject Enrollment		C37948		The act of enrolling subjects into a study. The subject will have met the inclusion/exclusion criteria to participate in the trial and will have signed an informed consent form. (CDISC Glossary)	Enrollment
	Substance Strength		C215495		The content of a substance expressed quantitatively per dosage unit, per unit of volume, or per unit of weight, according to the pharmaceutical dose form of the product.	Substance Strength
	Substance		C45306		Any matter of defined composition that has discrete existence, whose origin may be biological, mineral or chemical.	Substance
	Syntax Template Dictionary		C207597		A reference source that provides a listing of valid parameter names and values used in syntax template text strings.	Syntax Template Dictionary
	Syntax Template		C207596		A standardized pattern used for the arrangement of words and phrases to create well-formed, structured sentences.	Syntax Template
	Timing		C80484		The chronological relationship between temporal events.	Timing
	Transition Rule		C82567		A guide that governs the allocation of subjects to operational options at a discrete decision point or branch (e.g., assignment to a particular arm, discontinuation) within a clinical trial plan.	Transition Rule
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CL.C188719.DDF Estimand Attribute Terminology	DDF Estimand Attribute Terminology (DDF Estimand Attribute Terminology)	text Extensible: No	C188719	DDF Estimand Attribute Terminology	A terminology value set relevant to the attributes of the estimand.	CDISC DDF Estimand Attribute Terminology
	Estimand Description		C215523		A narrative representation of the estimand.	Estimand Description
	Estimand Label		C215524		The short descriptive designation for the estimand.	Estimand Label
	Estimand Name		C215522		The literal identifier (i.e., distinctive designation) of the estimand.	Estimand Name
	Estimand Notes		C215521		A brief written record relevant to the study estimand.	Estimand Note
	Population-Level Summary		C188853		A synopsis of the clinical endpoint of interest within the analysis target study population.	Population-Level Summary
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CL.C207428.DDF Geographic Scope Attribute Terminology	DDF Geographic Scope Attribute Terminology (DDF Geographic Scope Attribute Terminology)	text Extensible: No	C207428	DDF Geographic Scope Attribute Terminology	A terminology value set relevant to the attributes of the geographic scope.	CDISC DDF Geographic Scope Attribute Terminology
	Geographic Scope Code		C207494		A symbol or combination of symbols which is assigned to the geographic scope.	Geographic Scope Code
	Geographic Scope Type		C207495		A characterization or classification of the geographic scope.	Geographic Scope Type
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CL.C207429.DDF Governance Date Attribute Terminology	DDF Governance Date Attribute Terminology (DDF Governance Date Attribute Terminology)	text Extensible: No	C207429	DDF Governance Date Attribute Terminology	A terminology value set relevant to the attributes of the governance date.	CDISC DDF Governance Date Attribute Terminology
	Study Governance Date Description		C207497		A narrative representation of the study governance date.	Study Governance Date Description
	Study Governance Date Label		C207498		The short descriptive designation for the study governance date.	Study Governance Date Label
	Study Governance Date Name		C207499		The literal identifier (i.e., distinctive designation) of the study governance date	Study Governance Date Name
	Study Governance Date Type		C207496		A characterization or classification of the study governance date	Study Governance Date Type
	Study Governance Date Value		C207500		The information contained in the date field.	Study Governance Date Value
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CL.C215458.DDF Identifier Attribute Terminology	DDF Identifier Attribute Terminology (DDF Identifier Attribute Terminology)	text Extensible: No	C215458	DDF Identifier Attribute Terminology	A terminology value set relevant to the attributes of the identifier.	CDISC DDF Identifier Attribute Terminology
	Identifier Text		C215450		An instance of structured text that represents the identifier.	Identifier Text
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CL.C188705.DDF Indication Attribute Terminology	DDF Indication Attribute Terminology (DDF Indication Attribute Terminology)	text Extensible: No	C188705	DDF Indication Attribute Terminology	A terminology value set relevant to the attributes of the disease indication.	CDISC DDF Indication Attribute Terminology
	Disease/Condition Indication Code		C188822		A short sequence of characters that represents the disease indication.	Disease Indication Code
	Disease/Condition Indication Description		C112038	Indication for Use;Trial Disease/Condition Indication;Trial Disease/Condition Indication Description	A narrative representation of the condition, disease or disorder that the clinical trial is intended to investigate or address.	Trial Indication
	Disease/Condition Indication Is Rare Disease Indicator		C207501		An indication as to whether the disease/condition indication under study is considered a rare disease.	Disease Indication Is Rare Disease Indicator
	Disease/Condition Indication Label		C207502		The short descriptive designation for the disease/condition indication.	Disease Indication Label
	Disease/Condition Indication Name		C207503		The literal identifier (i.e., distinctive designation) of the disease/condition indication.	Disease Indication Name
	Indication Notes		C215509		A brief written record relevant to the disease/condition indication.	Disease Or Condition Indication Note
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CL.C215464.DDF Ingredient Attribute Terminology	DDF Ingredient Attribute Terminology (DDF Ingredient Attribute Terminology)	text Extensible: No	C215464	DDF Ingredient Attribute Terminology	A terminology value set relevant to the attributes of the ingredient.	CDISC DDF Ingredient Attribute Terminology
	Ingredient Role		C215595		The intended use of the ingredient within the context of the compounded substance or mixture.	Ingredient Role
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CL.C188721.DDF Intercurrent Event Attribute Terminology	DDF Intercurrent Event Attribute Terminology (DDF Intercurrent Event Attribute Terminology)	text Extensible: No	C188721	DDF Intercurrent Event Attribute Terminology	A terminology value set relevant to the attributes of the intercurrent event.	CDISC DDF Intercurrent Event Attribute Terminology
	Intercurrent Event Description		C188856		A narrative representation of the intercurrent event.	Intercurrent Event Description
	Intercurrent Event Label		C207504		The short descriptive designation for the intercurrent event.	Intercurrent Event Label
	Intercurrent Event Name		C188855		The literal identifier (i.e., distinctive designation) of the intercurrent event.	Intercurrent Event Name
	Intercurrent Event Notes		C215527		A brief written record relevant to the intercurrent event.	Intercurrent Event Note
	Intercurrent Event Strategy		C188857		A textual description of the planned strategy to manage and/or mitigate intercurrent events.	Intercurrent Event Strategy
	Intercurrent Event Text		C215526		An instance of structured text that represents the intercurrent event.	Intercurrent Event Text
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CL.C215473.DDF Interventional Study Design Attribute Terminology	DDF Interventional Study Design Attribute Terminology (DDF Interventional Study Design Attribute Terminology)	text Extensible: No	C215473	DDF Interventional Study Design Attribute Terminology	A terminology value set relevant to the attributes of the interventional study design.	CDISC DDF Interventional Study Design Attribute Terminology
	Intervention Model Type		C98746	Intervention Model	The general design of the strategy for assigning interventions to participants in a clinical study. (clinicaltrials.gov)	Intervention Model
	Interventional Study Design Characteristics		C215632		The distinguishing qualities or prominent aspects of an interventional study design.	Interventional Study Design Characteristic
	Interventional Study Design Description		C215627		A narrative representation of the interventional study design.	Interventional Study Design Description
	Interventional Study Design Label		C215628		The short descriptive designation for the interventional study design.	Interventional Study Design Label
	Interventional Study Design Name		C215626		The literal identifier (i.e., distinctive designation) of the interventional study design.	Interventional Study Design Name
	Interventional Study Design Notes		C215634		A brief written record relevant to the interventional study design.	Interventional Study Design Note
	Interventional Study Design Rationale		C215629		Reason(s) for choosing the interventional study design. This may include reasons for the choice of control or comparator, as well as the scientific rationale for the study design.	Interventional Study Design Rationale
	Interventional Study Design Study Phase		C215630		The study phase associated with the interventional study design.	Interventional Study Design Study Phase
	Interventional Study Design Study Type		C215631		The study type associated with the interventional study design.	Interventional Study Design Study Type
	Interventional Study Design Therapeutic Areas		C215633		A categorization of a disease, disorder, or other condition based on common characteristics and often associated with a medical specialty focusing on research and development of specific therapeutic interventions for the purpose of treatment and prevention, which is associated with the interventional study design.	Interventional Study Design Therapeutic Areas
	Trial Blinding Schema		C49658	Study Blinding Design;Study Blinding Schema;Study Masking Design;Trial Blinding Design;Trial Blinding Schema;Trial Masking Design	The type of experimental design used to describe the level of awareness of the study subjects and/ or study personnel as it relates to the respective intervention(s) or assessments being observed, received or administered.	Trial Blinding Schema
	Trial Intent Type		C49652	Trial Intent Type	The planned purpose of the therapy, device, or agent under study in the clinical trial.	Clinical Study by Intent
	Trial Type		C49660	Trial Scope;Trial Type	The nature of the interventional study for which information is being collected.	Trial Type
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CL.C207430.DDF Masking Attribute Terminology	DDF Masking Attribute Terminology (DDF Masking Attribute Terminology)	text Extensible: No	C207430	DDF Masking Attribute Terminology	A terminology value set relevant to the attributes of the masking.	CDISC DDF Masking Attribute Terminology
	Masked Indicator		C215554		An indication as to whether the study role is masked.	Study Role Masked Indicator
	Masking Text		C215553		An instance of unstructured text that represents how the masking is performed and maintained.	Masking Text
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CL.C215470.DDF Medical Device Attribute Terminology	DDF Medical Device Attribute Terminology (DDF Medical Device Attribute Terminology)	text Extensible: No	C215470	DDF Medical Device Attribute Terminology	A terminology value set relevant to the attributes of the medical device.	CDISC DDF Medical Device Attribute Terminology
	Hardware Version		C215617		A form or variant of hardware; one of a sequence of copies of the physical components from which a computer is constructed, each incorporating new modifications.	Hardware Version
	Medical Device Description		C215615		A narrative representation of the medical device.	Medical Device Description
	Medical Device Label		C215616		The short descriptive designation for the medical device.	Medical Device Label
	Medical Device Name		C215614		The literal identifier (i.e., distinctive designation) of the medical device.	Medical Device Name
	Medical Device Notes		C215618		A brief written record relevant to the medical device.	Medical Device Note
	Medical Device Sourcing		C215619		An indication as to whether the medical device is obtained from a local or central source.	Medical Device Sourcing Indicator
	Software Version		C111093	Software Version	A form or variant of software; one of a sequence of copies of a software program, each incorporating new modifications. (NCI)	Software Version
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CL.C215471.DDF Medical Device Identifier Attribute Terminology	DDF Medical Device Identifier Attribute Terminology (DDF Medical Device Identifier Attribute Terminology)	text Extensible: No	C215471	DDF Medical Device Identifier Attribute Terminology	A terminology value set relevant to the attributes of the medical device identifier.	CDISC DDF Medical Device Identifier Attribute Terminology
	Medical Device Identifier Text		C215620		An instance of structured text that represents the medical device identifier.	Medical Device Identifier Text
	Medical Device Identifier Type		C215621		A characterization or classification of the medical device identifier.	Medical Device Identifier Type
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CL.C207426.DDF Narrative Content Attribute Terminology	DDF Narrative Content Attribute Terminology (DDF Narrative Content Attribute Terminology)	text Extensible: No	C207426	DDF Narrative Content Attribute Terminology	A terminology value set relevant to the attributes of the narrative content.	CDISC DDF Narrative Content Attribute Terminology
	Narrative Content Name		C207507		The literal identifier (i.e., distinctive designation) of the narrative content.	Narrative Content Name
	Narrative Content Section Number Display Indicator		C215535		An indication as to whether the section number is to be displayed in the document containing narrative content.	Narrative Content Section Number Display Indicator
	Narrative Content Section Number		C207509		The numeric identifier assigned to a particular document section containing narrative content.	Narrative Content Section Number
	Narrative Content Section Title Display Indicator		C215534		An indication as to whether the section title is to be displayed in the document containing narrative content.	Narrative Content Section Title Display Indicator
	Narrative Content Section Title		C207510		An identifying designation for the document section containing narrative content.	Narrative Content Section Title
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CL.C215453.DDF Narrative Content Item Attribute Terminology	DDF Narrative Content Item Attribute Terminology (DDF Narrative Content Item Attribute Terminology)	text Extensible: No	C215453	DDF Narrative Content Item Attribute Terminology	A terminology value set relevant to the attributes of the narrative content item.	CDISC DDF Narrative Content Item Attribute Terminology
	Narrative Content Item Name		C215557		The literal identifier (i.e., distinctive designation) of the narrative content item.	Narrative Content Item Name
	Narrative Content Item Text		C215558		An instance of unstructured text that represents the narrative content item.	Narrative Content Item Text
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CL.C188707.DDF Objective Attribute Terminology	DDF Objective Attribute Terminology (DDF Objective Attribute Terminology)	text Extensible: No	C188707	DDF Objective Attribute Terminology	A terminology value set relevant to the attributes of the objective.	CDISC DDF Objective Attribute Terminology
	Objective Notes		C215513		A brief written record relevant to the study objective.	Study Objective Note
	Study Objective Description		C94090		A narrative representation of the study objective.	Study Objective Description
	Study Objective Label		C207511		The short descriptive designation for the study objective.	Study Objective Label
	Study Objective Level		C188823		A characterization or classification of the study objective that determines its category of importance relative to other study objectives.	Study Objective Level
	Study Objective Name		C207512		The literal identifier (i.e., distinctive designation) of the study objective.	Study Objective Name
	Study Objective Text		C207513		An instance of structured text that represents the study objective.	Study Objective Text
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CL.C215474.DDF Observational Study Design Attribute Terminology	DDF Observational Study Design Attribute Terminology (DDF Observational Study Design Attribute Terminology)	text Extensible: No	C215474	DDF Observational Study Design Attribute Terminology	A terminology value set relevant to the attributes of the observational study design.	CDISC DDF Observational Study Design Attribute Terminology
	Observation Study Design Model Type		C147138	Observation Model	The general design of the strategy for identifying and following up with participants during observational studies. (clinicaltrials.gov)	Observational Study Model
	Observational Study Design Characteristics		C215642		The distinguishing qualities or prominent aspects of an observational study design.	Observational Study Design Characteristics
	Observational Study Design Description		C215637		A narrative representation of the observational study design.	Observational Study Design Description
	Observational Study Design Label		C215638		The short descriptive designation for the observational study design.	Observational Study Design Label
	Observational Study Design Name		C215636		The literal identifier (i.e., distinctive designation) of the observational study design.	Observational Study Design Name
	Observational Study Design Notes		C215644		A brief written record relevant to the observational study design.	Observational Study Design Note
	Observational Study Design Rationale		C215639		Reason(s) for choosing the observational study design. This may include reasons for the choice of control or comparator, as well as the scientific rationale for the study design.	Observational Study Design Rationale
	Observational Study Design Study Phase		C215640		The study phase associated with the observational study design.	Observational Study Design Study Phase
	Observational Study Design Study Type		C215641		The study type associated with the observational study design.	Observational Study Design Study Type
	Observational Study Design Therapeutic Areas		C215643		A categorization of a disease, disorder, or other condition based on common characteristics and often associated with a medical specialty focusing on research and development of specific therapeutic interventions for the purpose of treatment and prevention, which is associated with the observational study design.	Observational Study Design Therapeutic Area
	Observational Study Sampling Method		C126067	Observational Study Sampling Method	The sampling method used to assign study participants into groups or cohorts within an observational study.	Observational Study Sampling Method
	Observational Study Type		C215635		The nature of the observational study for which information is being collected.	Observational Study Type
	Observational Time Perspective		C126065	Observational Time Perspective	The temporal relationship between the observation period and time of subject enrollment. (ClinicalTrials.gov)	Observational Time Perspective of Study
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CL.C188702.DDF Organization Attribute Terminology	DDF Organization Attribute Terminology (DDF Organization Attribute Terminology)	text Extensible: No	C188702	DDF Organization Attribute Terminology	A terminology value set relevant to the attributes of the organization.	CDISC DDF Organization Attribute Terminology
	Identifier Provider Organization Name		C188819		The name of the organization that provides the identifier for the entity.	Identifier Provider Organization Name
	Organization Identifier		C93401		A unique symbol that establishes identity of the organization. (BRIDG)	Organization Identifier
	Organization Label		C207514		The short descriptive designation for the organization.	Organization Label
	Organization Name		C93874		A non-unique textual identifier for the organization. (BRIDG)	Organization Name
	Organization Type		C188820		A characterization or classification of the formalized group of persons or other organizations collected together for a common purpose (such as administrative, legal, political) and the infrastructure to carry out that purpose.	Organization Type
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CL.C207431.DDF Parameter Map Attribute Terminology	DDF Parameter Map Attribute Terminology (DDF Parameter Map Attribute Terminology)	text Extensible: No	C207431	DDF Parameter Map Attribute Terminology	A terminology value set relevant to the attributes of the parameter map.	CDISC DDF Parameter Map Attribute Terminology
	Programming Tag Reference		C207516		The reference for a tag used in programming languages, such as a markup language (e.g., HTML, XML), to store attributes and elements.	Programming Tag Reference
	Programming Tag		C207515		Character strings bounded by angle brackets that act as containers for programming language elements.	Programming Tag
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CL.C216965.DDF Person Name Attribute Terminology	DDF Person Name Terminology (DDF Person Name Attribute Terminology)	text Extensible: No	C216965	DDF Person Name Terminology	A terminology value set relevant to the attributes of the person name.	CDISC DDF Person Name Attribute Terminology
	Person Family Name		C40975	Person Surname	A word or group of words indicating a person's last (family) name.	Last Name
	Person Given Name		C40974		A word or group of words indicating a person's first (personal or given) name; the name that precedes the surname.	First Name
	Person Name Prefix		C217002		An affix occurring at the start of the person name string, usually denoting a title or honorific.	Person Name Prefix
	Person Name Suffix		C217003		An affix occurring at the end of the person name, usually denoting educational or professional degrees and certifications, and/or filial rank.	Person Name Suffix
	Person Name Text		C217001	Human Name Text	An instance of structured text that represents the person's full name.	Person Name Text
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CL.C207432.DDF Population Definition Attribute Terminology	DDF Population Definition Attribute Terminology (DDF Population Definition Attribute Terminology)	text Extensible: No	C207432	DDF Population Definition Attribute Terminology	A terminology value set relevant to the attributes of the population definition.	CDISC DDF Population Definition Attribute Terminology
	Population Definition Description		C207517		A narrative representation of the population definition.	Population Definition Description
	Population Definition Includes Healthy Subjects Indicator		C207518		An indication as to whether the population definition includes healthy subjects, that is, subjects without the disease or condition under study.	Population Definition Includes Healthy Subjects Indicator
	Population Definition Label		C207519		The short descriptive designation for the population definition.	Population Definition Label
	Population Definition Name		C207520		The literal identifier (i.e., distinctive designation) of the population definition.	Population Definition Name
	Population Definition Notes		C215551		A brief written record relevant to the population definition.	Population Definition Note
	Population Definition Planned Age		C207701		The anticipated age of subjects within the population definition.	Population Definition Planned Age
	Population Definition Planned Completion Number		C207521		The value representing the planned number of subjects that must complete the study in order to meet the objectives and endpoints of the study, within the population definition.	Population Definition Planned Completion Number
	Population Definition Planned Enrollment Number		C207522		The value representing the planned number of subjects to be entered in a clinical trial, within the population definition.	Population Definition Planned Enrollment Number
	Population Definition Planned Sex		C207523		The protocol-defined sex within the population definition.	Population Definition Planned Sex
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CL.C188716.DDF Procedure Attribute Terminology	DDF Procedure Attribute Terminology (DDF Procedure Attribute Terminology)	text Extensible: No	C188716	DDF Procedure Attribute Terminology	A terminology value set relevant to the attributes of the procedure.	CDISC DDF Procedure Attribute Terminology
	Procedure Code		C154626		A symbol or combination of symbols which is assigned to medical procedure.	Procedure Code
	Procedure Description		C201324		A narrative representation of the procedure.	Procedure Description
	Procedure Label		C207524		The short descriptive designation for the procedure.	Procedure Label
	Procedure Name		C201325		The literal identifier (i.e., distinctive designation) of the procedure.	Procedure Name
	Procedure Notes		C215520		A brief written record relevant to the procedure.	Procedure Note
	Procedure Type		C188848		A characterization or classification of the study procedure.	Study Procedure Type
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CL.C215472.DDF Product Organization Role Attribute Terminology	DDF Product Organization Role Attribute Terminology (DDF Product Organization Role Attribute Terminology)	text Extensible: No	C215472	DDF Product Organization Role Attribute Terminology	A terminology value set relevant to the attributes of the product organization role.	CDISC DDF Product Organization Role Attribute Terminology
	Product Organization Role Code		C215625		A symbol or combination of symbols which is assigned to the product organization role.	Product Organization Role Code
	Product Organization Role Description		C215623		A narrative representation of the product organization role.	Product Organization Role Description
	Product Organization Role Label		C215624		The short descriptive designation for the product organization role.	Product Organization Role Label
	Product Organization Role Name		C215622		The literal identifier (i.e., distinctive designation) of the product organization role.	Product Organization Role Name
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CL.C207433.DDF Quantity Attribute Terminology	DDF Quantity Attribute Terminology (DDF Quantity Attribute Terminology)	text Extensible: No	C207433	DDF Quantity Attribute Terminology	A terminology value set relevant to the attributes of the quantity.	CDISC DDF Quantity Attribute Terminology
	Quantity Unit		C44258		The type of unit of measure being used to express a quantity.	Unit of Quantity
	Quantity Value		C25712		A numerical quantity measured or assigned or computed.	Value
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CL.C207434.DDF Range Attribute Terminology	DDF Range Attribute Terminology (DDF Range Attribute Terminology)	text Extensible: No	C207434	DDF Range Attribute Terminology	A terminology value set relevant to the attributes of the range.	CDISC DDF Range Attribute Terminology
	Maximum Value		C25564		The largest value in quantity or degree in a set of values.	Maximum
	Minimum Value		C25570		The smallest value in quantity or degree in a set of values.	Minimum
	Value Range is Approximate Indicator		C207525		An indication as to whether the value range is almost, but not quite, exact.	Value Range is Approximate Indicator
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CL.C215457.DDF Reference Identifier Attribute Terminology	DDF Reference Identifier Attribute Terminology (DDF Reference Identifier Attribute Terminology)	text Extensible: No	C215457	DDF Reference Identifier Attribute Terminology	A terminology value set relevant to the attributes of the reference identifier.	CDISC DDF Reference Identifier Attribute Terminology
	Reference Identifier Text		C215572		An instance of structured text that represents the reference identifier.	Reference Identifier Text
	Reference Identifier Type		C215571		A characterization or classification of the reference identifier.	Reference Identifier Type
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CL.C201258.DDF Response Code Attribute Terminology	DDF Response Code Attribute Terminology (DDF Response Code Attribute Terminology)	text Extensible: No	C201258	DDF Response Code Attribute Terminology	A terminology value set relevant to the attributes of the response code.	CDISC DDF Response Code Attribute Terminology
	Response Code Enabled Indicator		C201330		An indication as to whether the response code is activated for use within a given usage context.	Response Code Enabled Indicator
	Response Code Label		C216999		The short descriptive designation for the response code.	Response Code Label
	Response Code Name		C216998		The literal identifier (i.e., distinctive designation) of the response code.	Response Code Name
	Response Code Value		C217013		The literal value of a response code.	Response Code Value
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CL.C201259.DDF Schedule Timeline Attribute Terminology	DDF Schedule Timeline Attribute Terminology (DDF Schedule Timeline Attribute Terminology)	text Extensible: No	C201259	DDF Schedule Timeline Attribute Terminology	A terminology value set relevant to the attributes of the schedule timeline.	CDISC DDF Schedule Timeline Attribute Terminology
	Main Timeline Indicator		C201331		An indication as to whether the timeline or timeline component is part of the central or principal timeline.	Main Timeline Indicator
	Schedule Timeline Description		C201332		A narrative representation of the schedule timeline.	Schedule Timeline Description
	Schedule Timeline Entry Condition		C201333		A logical evaluation on which rests the validity of entry into a schedule timeline.	Schedule Timeline Entry Condition
	Schedule Timeline Label		C207530		The short descriptive designation for the schedule timeline.	Schedule Timeline Label
	Schedule Timeline Name		C201334		The literal identifier (i.e., distinctive designation) of the schedule timeline.	Schedule Timeline Name
	Scheduled Timeline Planned Duration		C217012		The period of time over which the scheduled timeline is intended to take place.	Schedule Timeline Planned Duration
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CL.C207436.DDF Scheduled Activity Instance Attribute Terminology	DDF Scheduled Activity Instance Attribute Terminology (DDF Scheduled Activity Instance Attribute Terminology)	text Extensible: No	C207436	DDF Scheduled Activity Instance Attribute Terminology	A terminology value set relevant to the attributes of the scheduled activity instance.	CDISC DDF Scheduled Activity Instance Attribute Terminology
	Scheduled Activity Instance Description		C207531		A narrative representation of the scheduled activity instance.	Scheduled Activity Instance Description
	Scheduled Activity Instance Label		C207532		The short descriptive designation for the scheduled activity instance.	Scheduled Activity Instance Label
	Scheduled Activity Instance Name		C207533		The literal identifier (i.e., distinctive designation) of the scheduled activity instance.	Scheduled Activity Instance Name
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CL.C201260.DDF Scheduled Decision Instance Attribute Terminology	DDF Scheduled Decision Instance Attribute Terminology (DDF Scheduled Decision Instance Attribute Terminology)	text Extensible: No	C201260	DDF Scheduled Decision Instance Attribute Terminology	A terminology value set relevant to the attributes of the scheduled decision instance.	CDISC DDF Scheduled Decision Instance Attribute Terminology
	Scheduled Decision Instance Description		C207534		A narrative representation of the scheduled Decision instance.	Scheduled Decision Instance Description
	Scheduled Decision Instance Label		C207535		The short descriptive designation for the scheduled Decision instance.	Scheduled Decision Instance Label
	Scheduled Decision Instance Name		C207536		The literal identifier (i.e., distinctive designation) of the scheduled Decision instance.	Scheduled Decision Instance Name
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CL.C201261.DDF Scheduled Instance Attribute Terminology	DDF Scheduled Instance Attribute Terminology (DDF Scheduled Instance Attribute Terminology)	text Extensible: No	C201261	DDF Scheduled Instance Attribute Terminology	A terminology value set relevant to the attributes of the scheduled instance.	CDISC DDF Scheduled Instance Attribute Terminology
	Scheduled Instance Description		C207453		A narrative representation of the scheduled instance.	Scheduled Instance Description
	Scheduled Instance Label		C207454		The short descriptive designation for the scheduled instance.	Scheduled Instance Label
	Scheduled Instance Name		C207455		The literal identifier (i.e., distinctive designation) of the scheduled instance.	Scheduled Instance Name
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CL.C215463.DDF Strength Attribute Terminology	DDF Strength Attribute Terminology (DDF Strength Attribute Terminology)	text Extensible: No	C215463	DDF Strength Attribute Terminology	A terminology value set relevant to the attributes of the strength.	CDISC DDF Strength Attribute Terminology
	Denominator		C80489		The divisor of a fraction.	Denominator
	Numerator		C80490		The dividend of a fraction.	Numerator
	Substance Strength Description		C215591		A narrative representation of the substance strength.	Substance Strength Description
	Substance Strength Label		C215592		The short descriptive designation for the substance strength.	Substance Strength Label
	Substance Strength Name		C215590		The literal identifier (i.e., distinctive designation) of the substance strength.	Substance Strength Name
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CL.C207437.DDF Study Amendment Attribute Terminology	DDF Study Amendment Attribute Terminology (DDF Study Amendment Attribute Terminology)	text Extensible: No	C207437	DDF Study Amendment Attribute Terminology	A terminology value set relevant to the attributes of the study amendment.	CDISC DDF Study Amendment Attribute Terminology
	Study Amendment Description		C216996		A narrative representation of the study amendment.	Study Amendment Description
	Study Amendment Label		C216997		The short descriptive designation for the study amendment.	Study Amendment Label
	Study Amendment Name		C216995		The literal identifier (i.e., distinctive designation) of the study amendment.	Study Amendment Name
	Study Amendment Notes		C215538		A brief written record relevant to the study amendment.	Study Amendment Note
	Study Amendment Number		C207537	Amendment Identifier	A string of numerals that uniquely identifies a protocol amendment.	Study Amendment Number
	Study Amendment Summary		C115627		A short narrative representation describing the changes introduced in the current version of the protocol.	Clinical Trial Protocol Amendment Summary
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CL.C215469.DDF Study Amendment Impact Attribute Terminology	DDF Study Amendment Impact Attribute Terminology (DDF Study Amendment Impact Attribute Terminology)	text Extensible: No	C215469	DDF Study Amendment Impact Attribute Terminology	A terminology value set relevant to the attributes of the study amendment impact.	CDISC DDF Study Amendment Impact Attribute Terminology
	Study Amendment Impact Notes		C215613		A brief written record relevant to the study amendment impact.	Study Amendment Impact Note
	Study Amendment Impact Substantial Indicator		C207538		An indication as to whether the study amendment's impact on the study is substantial.	Study Amendment Substantial Impact Indicator
	Study Amendment Impact Text		C215611		An instance of unstructured text that represents the study amendment impact.	Study Amendment Impact Text
	Study Amendment Impact Type		C215612		A characterization or classification of the study amendment impact.	Study Amendment Impact Type
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CL.C207438.DDF Study Amendment Reason Attribute Terminology	DDF Study Amendment Reason Attribute Terminology (DDF Study Amendment Reason Attribute Terminology)	text Extensible: No	C207438	DDF Study Amendment Reason Attribute Terminology	A terminology value set relevant to the attributes of the study amendment reason.	CDISC DDF Study Amendment Reason Attribute Terminology
	Other Reason for Study Amendment		C207539		The rationale for the change(s) to, or formal clarification of, a protocol that is not otherwise specified.	Other Reason for Study Amendment
	Study Amendment Reason Code		C207540	Study Amendment Reason Code	A symbol or combination of symbols which is assigned to the study amendment reason.	Study Amendment Reason Code
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CL.C188709.DDF Study Arm Attribute Terminology	DDF Study Arm Attribute Terminology (DDF Study Arm Attribute Terminology)	text Extensible: No	C188709	DDF Study Arm Attribute Terminology	A terminology value set relevant to the attributes of the study Arm.	CDISC DDF Study Arm Attribute Terminology
	Study Arm Data Origin Description		C188828		The textual representation of the study arm data origin.	Study Arm Data Origin Description
	Study Arm Data Origin Type		C188829		A characterization or classification of the study arm with respect to where the study arm data originates.	Study Arm Data Origin Type
	Study Arm Description		C93728	Arm Description	A narrative representation of the study arm.	Arm Description
	Study Arm Label		C172456	Arm Label	The short descriptive designation for the study arm.	Study Arm Label
	Study Arm Name		C170984		The literal identifier (i.e., distinctive designation) of the study arm.	Planned Study Arm Name
	Study Arm Notes		C215515		A brief written record relevant to the study arm.	Study Arm Note
	Study Arm Type		C172457	Arm Type	A characterization or classification of the study arm.	Study Arm Type
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CL.C215467.DDF Study Change Attribute Terminology	DDF Study Change Attribute Terminology (DDF Study Change Attribute Terminology)	text Extensible: No	C215467	DDF Study Change Attribute Terminology	A terminology value set relevant to the attributes of the study change.	CDISC DDF Study Change Attribute Terminology
	Study Change Description		C215605		A narrative representation of the study change.	Study Change Description
	Study Change Label		C215606		The short descriptive designation for the study change.	Study Change Label
	Study Change Name		C215604		The literal identifier (i.e., distinctive designation) of the study change.	Study Change Name
	Study Change Rationale		C215608		An explanation as to the logical reasons for why a study change has occurred.	Study Change Rationale
	Study Change Summary		C215607		A short narrative representation describing the changes introduced in the current version of the study.	Study Change Summary
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CL.C207439.DDF Study Cohort Attribute Terminology	DDF Study Cohort Attribute Terminology (DDF Study Cohort Attribute Terminology)	text Extensible: No	C207439	DDF Study Cohort Attribute Terminology	A terminology value set relevant to the attributes of the study cohort.	CDISC DDF Study Cohort Attribute Terminology
	Study Cohort Description		C207542		A narrative representation of the study cohort.	Study Cohort Description
	Study Cohort Includes Healthy Subjects Indicator		C207480		An indication as to whether the study cohort includes healthy subjects, that is, subjects without the disease or condition under study.	Study Cohort Includes Healthy Subjects Indicator
	Study Cohort Label		C207543		The short descriptive designation for the study cohort.	Study Cohort Label
	Study Cohort Name		C207544		The literal identifier (i.e., distinctive designation) of the study cohort.	Study Cohort Name
	Study Cohort Notes		C215547		A brief written record relevant to the study cohort.	Study Cohort Note
	Study Cohort Planned Age		C207545		The anticipated age of subjects within the study cohort.	Study Cohort Planned Age
	Study Cohort Planned Completion Number		C207546		The value representing the planned number of subjects that must complete the study in order to meet the objectives and endpoints of the study, within the study cohort.	Study Cohort Planned Completion Number
	Study Cohort Planned Enrollment Number		C207702		The value representing the planned number of subjects to be entered in a clinical trial, within the study cohort.	Study Cohort Planned Enrollment Number
	Study Cohort Planned Sex		C207541		The protocol-defined sex within the study cohort.	Planned Sex of Study Cohort Participants
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CL.C215454.DDF Study Definition Document Attribute Terminology	DDF Study Definition Document Attribute Terminology (DDF Study Definition Document Attribute Terminology)	text Extensible: No	C215454	DDF Study Definition Document Attribute Terminology	A terminology value set relevant to the attributes of the study definition document.	CDISC DDF Study Definition Document Attribute Terminology
	Study Definition Document Description		C215560		A narrative representation of the study definition document.	Study Definition Document Description
	Study Definition Document Label		C215561		The short descriptive designation for the study definition document.	Study Definition Document Label
	Study Definition Document Language		C215563		The language in which the study definition document is written.	Study Definition Document Language
	Study Definition Document Name		C215559		The literal identifier (i.e., distinctive designation) of the study definition document.	Study Definition Document Name
	Study Definition Document Notes		C215565		A brief written record relevant to the study definition document.	Study Definition Document Note
	Study Definition Document Template Name		C215562		The literal identifier (i.e., distinctive designation) of the study definition document template.	Study Definition Document Template Name
	Study Definition Document Type		C215564		A characterization or classification of the study definition document.	Study Definition Document Type
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CL.C215455.DDF Study Definition Document Version Attribute Terminology	DDF Study Definition Document Version Attribute Terminology (DDF Study Definition Document Version Attribute Terminology)	text Extensible: No	C215455	DDF Study Definition Document Version Attribute Terminology	A terminology value set relevant to the attributes of the study definition document version.	CDISC DDF Study Definition Document Version Attribute Terminology
	Study Definition Document Status		C215567		A condition of the study definition document at a point in time with respect to its state of readiness for implementation.	Study Definition Document Status
	Study Definition Document Version Identifier		C215566		A sequence of characters used to identify the version of the study definition document.	Study Definition Document Version Identifier
	Study Definition Document Version Notes		C215568		A brief written record relevant to the study definition document version.	Study Definition Document Version Note
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CL.C188703.DDF Study Design Attribute Terminology	DDF Study Design Attribute Terminology (DDF Study Design Attribute Terminology)	text Extensible: No	C188703	DDF Study Design Attribute Terminology	A terminology value set relevant to the attributes of the study design.	CDISC DDF Study Design Attribute Terminology
	Study Design Characteristic		C207547		The distinguishing qualities or prominent aspect of a study design.	Study Design Characteristic
	Study Design Description		C147139	Overall Design;Study Design Description;Study Design Overview;Summary of Study Design	A narrative representation of the study design.	Study Design Description
	Study Design Label		C207548		The short descriptive designation for the study design.	Study Design Label
	Study Design Name		C201338		The literal identifier (i.e., distinctive designation) of the study design.	Study Design Name
	Study Design Notes		C215508		A brief written record relevant to the study design.	Study Design Note
	Study Design Rationale		C142705		Reason(s) for choosing the study design. This may include reasons for the choice of control or comparator, as well as the scientific rationale for the study design.	Study Design Rationale
	Study Type		C142175	Study Type;Study Type Classification	The nature of the investigation for which study information is being collected. (After clinicaltrials.gov)	Study Type
	Therapeutic Areas		C101302	Therapeutic Area	A categorization of a disease, disorder, or other condition based on common characteristics and often associated with a medical specialty focusing on research and development of specific therapeutic interventions for the purpose of treatment and prevention.	Therapeutic Area
	Trial Phase		C48281	Trial Phase;Trial Phase Classification	A step in the clinical research and development of a therapy from initial clinical trials to post-approval studies. NOTE: Clinical trials are generally categorized into four (sometimes five) phases. A therapeutic intervention may be evaluated in two or more phases simultaneously in different trials, and some trials may overlap two different phases. [21 CFR section 312.21; After ICH Topic E8 NOTE FOR GUIDANCE ON GENERAL CONSIDERATIONS FOR CLINICAL TRIALS, CPMP/ICH/291/95 March 1998]	Trial Phase
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CL.C188706.DDF Study Design Population Attribute Terminology	DDF Study Design Population Attribute Terminology (DDF Study Design Population Attribute Terminology)	text Extensible: No	C188706	DDF Study Design Population Attribute Terminology	A terminology value set relevant to the attributes of the study design population.	CDISC DDF Study Design Population Attribute Terminology
	Study Design Population Description		C70834		A narrative representation of the study design population.	Study Population Description
	Study Design Population Includes Healthy Subjects Indicator		C207549		An indication as to whether the study design population includes healthy subjects, that is, subjects without the disease or condition under study.	Study Design Population Includes Healthy Subjects Indicator
	Study Design Population Label		C207550		The short descriptive designation for the study design population.	Study Design Population Label
	Study Design Population Name		C207553		The literal identifier (i.e., distinctive designation) of the study design population.	Study Design Population Name
	Study Design Population Notes		C215512		A brief written record relevant to the study design population.	Study Design Population Note
	Study Design Population Planned Age		C207450		The anticipated age of subjects within the study design population.	Study Design Population Planned Age
	Study Design Population Planned Completion Number		C207451		The value representing the planned number of subjects that must complete the study in order to meet the objectives and endpoints of the study, within the study design population.	Study Design Population Planned Completion Number
	Study Design Population Planned Enrollment Number		C207452		The value representing the planned number of subjects to be entered in a clinical trial, within the study design population.	Study Design Population Planned Enrollment Number
	Study Design Population Planned Sex		C207551		The protocol-defined sex within the study design population.	Study Design Population Planned Sex
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CL.C188711.DDF Study Element Attribute Terminology	DDF Study Element Attribute Terminology (DDF Study Element Attribute Terminology)	text Extensible: No	C188711	DDF Study Element Attribute Terminology	A terminology value set relevant to the attributes of the study element.	CDISC DDF Study Element Attribute Terminology
	Study Design Element Description		C188834		A narrative representation of the study design element.	Study Design Element Description
	Study Design Element Label		C207554		The short descriptive designation for the study design element.	Study Design Element Label
	Study Design Element Name		C188833		The literal identifier (i.e., distinctive designation) of the study design element.	Study Design Element Name
	Study Element Notes		C215517		A brief written record relevant to the study element.	Study Element Note
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CL.C188710.DDF Study Epoch Attribute Terminology	DDF Study Epoch Attribute Terminology (DDF Study Epoch Attribute Terminology)	text Extensible: No	C188710	DDF Study Epoch Attribute Terminology	A terminology value set relevant to the attributes of the study epoch.	CDISC DDF Study Epoch Attribute Terminology
	Study Epoch Description		C93824		A narrative representation of the study epoch.	Epoch Description
	Study Epoch Label		C207555		The short descriptive designation for the study epoch.	Study Epoch Label
	Study Epoch Name		C93825		The literal identifier (i.e., distinctive designation) of the study epoch, i.e., the named time period defined in the protocol, wherein a study activity is specified and unchanging throughout the interval, to support a study-specific purpose.	Epoch Name
	Study Epoch Notes		C215516		A brief written record relevant to the study epoch.	Study Epoch Note
	Study Epoch Type		C188830		A characterization or classification of the study epoch, i.e., the named time period defined in the protocol, wherein a study activity is specified and unchanging throughout the interval, to support a study-specific purpose.	Study Epoch Type
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CL.C188701.DDF Study Identifier Attribute Terminology	DDF Study Identifier Attribute Terminology (DDF Study Identifier Attribute Terminology)	text Extensible: No	C188701	DDF Study Identifier Attribute Terminology	A terminology value set relevant to the attributes of the study identifier.	CDISC DDF Study Identifier Attribute Terminology
	Study Identifier Text		C215507		An instance of structured text that represents the study identifier.	Study Identifier Text
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CL.C188704.DDF Study Intervention Attribute Terminology	DDF Study Intervention Attribute Terminology (DDF Study Intervention Attribute Terminology)	text Extensible: No	C188704	DDF Study Intervention Attribute Terminology	A terminology value set relevant to the attributes of the study interventions.	CDISC DDF Study Intervention Attribute Terminology
	Study Intervention Code		C207648		A symbol or combination of symbols which is assigned to the study intervention.	Study Intervention Code
	Study Intervention Description		C207647		A narrative representation of the study intervention.	Study Intervention Description
	Study Intervention Label		C207556		The short descriptive designation for the study intervention.	Study Intervention Label
	Study Intervention Minimum Response Duration		C207557		The value representing the minimum amount of time required to meet the criteria for response to study intervention.	Study Intervention Minimum Response Duration
	Study Intervention Name		C207558		The literal identifier (i.e., distinctive designation) of the study intervention.	Study Intervention Name
	Study Intervention Notes		C215543		A brief written record relevant to the study intervention.	Study Intervention Note
	Study Intervention Role		C207560	Study Intervention Use	The intended use of the trial intervention within the context of the study design.	Study Intervention Role
	Study Intervention Type		C98747	Intervention Type	The kind of product or procedure studied in a trial.	Intervention Type
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CL.C215466.DDF Study Role Attribute Terminology	DDF Study Role Attribute Terminology (DDF Study Role Attribute Terminology)	text Extensible: No	C215466	DDF Study Role Attribute Terminology	A terminology value set relevant to the attributes of the study role.	CDISC DDF Study Role Attribute Terminology
	Study Role Code		C215603		A symbol or combination of symbols which is assigned to the study role.	Study Role Code
	Study Role Description		C215601		A narrative representation of the study role.	Study Role Description
	Study Role Label		C215602		The short descriptive designation for the study role.	Study Role Label
	Study Role Name		C215600		The literal identifier (i.e., distinctive designation) of the study role.	Study Role Name
	Study Role Notes		C216994		A brief written record relevant to the study role.	Study Role Notes
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CL.C207441.DDF Study Site Attribute Terminology	DDF Study Site Attribute Terminology (DDF Study Site Attribute Terminology)	text Extensible: No	C207441	DDF Study Site Attribute Terminology	A terminology value set relevant to the attributes of the study site.	CDISC DDF Study Site Attribute Terminology
	Country of Study Site		C170990		The country in which the study site is located.	Country of Investigational Site
	Study Site Description		C207564		A narrative representation of the study site.	Study Site Description
	Study Site Label		C207565		The short descriptive designation for the study site.	Study Site Label
	Study Site Name		C207566		The literal identifier (i.e., distinctive designation) of the study site.	Study Site Name
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CL.C207442.DDF Study Title Attribute Terminology	DDF Study Title Attribute Terminology (DDF Study Title Attribute Terminology)	text Extensible: No	C207442	DDF Study Title Attribute Terminology	A terminology value set relevant to the attributes of the study title.	CDISC DDF Study Title Attribute Terminology
	Study Title Text		C207567		An instance of unstructured text that represents the study title.	Study Title Text
	Study Title Type		C207568		A characterization or classification of the study title.	Study Title Type
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CL.C207443.DDF Study Version Attribute Terminology	DDF Study Version Attribute Terminology (DDF Study Version Attribute Terminology)	text Extensible: No	C207443	DDF Study Version Attribute Terminology	A terminology value set relevant to the attributes of the study version.	CDISC DDF Study Version Attribute Terminology
	Business Therapeutic Areas		C201322		A therapeutic area classification based on the structure and operations of the business unit.	Business Therapeutic Area
	Study Rationale		C94122	Study Purpose	A statement describing the overall rationale of the study. This field describes the contribution of this study to product development, i.e., what knowledge is being contributed from the conduct of this study.	Study Protocol Version Purpose Statement
	Study Version Identifier		C207570		A sequence of characters used to identify, name, or characterize the study version.	Study Version Identifier
	Study Version Notes		C215539		A brief written record relevant to the study version.	Study Version Note
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CL.C207444.DDF Subject Enrollment Attribute Terminology	DDF Subject Enrollment Attribute Terminology (DDF Subject Enrollment Attribute Terminology)	text Extensible: No	C207444	DDF Subject Enrollment Attribute Terminology	A terminology value set relevant to the attributes of the subject enrollment.	CDISC DDF Subject Enrollment Attribute Terminology
	Subject Enrollment Description		C215541		A narrative representation of the subject enrollment.	Subject Enrollment Description
	Subject Enrollment Label		C215542		The short descriptive designation for the subject enrollment.	Subject Enrollment Label
	Subject Enrollment Name		C215540		The literal identifier (i.e., distinctive designation) of the subject enrollment.	Subject Enrollment Name
	Subject Enrollment Quantity Value		C207573		The value representing the number of individuals enrolled in a study.	Subject Enrollment Quantity Value
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CL.C215462.DDF Substance Attribute Terminology	DDF Substance Attribute Terminology (DDF Substance Attribute Terminology)	text Extensible: No	C215462	DDF Substance Attribute Terminology	A terminology value set relevant to the attributes of the substance.	CDISC DDF Substance Attribute Terminology
	Substance Code		C215589		A symbol or combination of symbols which is assigned to the substance.	Substance Code
	Substance Description		C215587		A narrative representation of the substance.	Substance Description
	Substance Label		C215588		The short descriptive designation for the substance.	Substance Label
	Substance Name		C215586		The literal identifier (i.e., distinctive designation) of the substance.	Substance Name
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CL.C207445.DDF Syntax Template Attribute Terminology	DDF Syntax Template Attribute Terminology (DDF Syntax Template Attribute Terminology)	text Extensible: No	C207445	DDF Syntax Template Attribute Terminology	A terminology value set relevant to the attributes of the syntax template.	CDISC DDF Syntax Template Attribute Terminology
	Syntax Template Description		C207575		A narrative representation of the syntax template.	Syntax Template Description
	Syntax Template Label		C207576		The short descriptive designation for the syntax template.	Syntax Template Label
	Syntax Template Name		C207577		The literal identifier (i.e., distinctive designation) of the syntax template.	Syntax Template Name
	Syntax Template Notes		C215536		A brief written record relevant to the syntax template.	Syntax Template Note
	Syntax Template Text		C207578		A structured text string containing prescribed text interspersed with user-defined parameter values.	Syntax Template Text
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CL.C207446.DDF Syntax Template Dictionary Attribute Terminology	DDF Syntax Template Dictionary Attribute Terminology (DDF Syntax Template Dictionary Attribute Terminology)	text Extensible: No	C207446	DDF Syntax Template Dictionary Attribute Terminology	A terminology value set relevant to the attributes of the syntax template dictionary.	CDISC DDF Syntax Template Dictionary Attribute Terminology
	Syntax Template Dictionary Description		C207579		A narrative representation of the syntax template dictionary.	Syntax Template Dictionary Description
	Syntax Template Dictionary Label		C207580		The short descriptive designation for the syntax template dictionary.	Syntax Template Dictionary Label
	Syntax Template Dictionary Name		C207581		The literal identifier (i.e., distinctive designation) of the syntax template dictionary.	Syntax Template Dictionary Name
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CL.C201262.DDF Timing Attribute Terminology	DDF Timing Attribute Terminology (DDF Timing Attribute Terminology)	text Extensible: No	C201262	DDF Timing Attribute Terminology	A terminology value set relevant to the attributes of the timing.	CDISC DDF Timing Attribute Terminology
	Timing Description		C164648		A narrative representation of the biomedical concept category.	Timing Description
	Timing Label		C207583		The short descriptive designation for the timing.	Timing Label
	Timing Name		C207584		The literal identifier (i.e., distinctive designation) of the timing.	Timing Name
	Timing Relative To From		C201297		The name of the reference event used to define the temporal relationship with another event.	Timing Relative To From Name
	Timing Type		C201298		A characterization or classification of the chronological relationship between temporal events.	Timing Type
	Timing Value Label		C207585		The short descriptive designation for the timing value.	Timing Value Label
	Timing Value		C201341		The temporal value of the chronological relationship between temporal events.	Timing Value
	Timing Window Label		C207586		The short descriptive designation for a time period, or other type of interval, during which a temporal event may be achieved, obtained, or observed.	Timing Window Label
	Timing Window, Lower		C201342		The earliest chronological value of an allowable period of time during which a temporal event takes place.	Lower Timing Window
	Timing Window, Upper		C201343		The latest chronological value of an allowable period of time during which a temporal event takes place.	Upper Timing Window
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CL.C188712.DDF Transition Rule Attribute Terminology	DDF Transition Rule Attribute Terminology (DDF Transition Rule Attribute Terminology)	text Extensible: No	C188712	DDF Transition Rule Attribute Terminology	A terminology value set relevant to the attributes of the transition rule.	CDISC DDF Transition Rule Attribute Terminology
	Transition Rule Description		C188835		A narrative representation of the transition rule.	Transition Rule Description
	Transition Rule Label		C207587		The short descriptive designation for the transition rule.	Transition Rule Label
	Transition Rule Name		C207588		The literal identifier (i.e., distinctive designation) of the transition rule.	Transition Rule Name
	Transition Rule Text		C207589		An instance of unstructured text that represents the transition rule.	Transition Rule Text
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CL.C188728.Encounter Type Value Set Terminology	Encounter Type Value Set Terminology (Encounter Type Value Set Terminology)	text Extensible: Yes	C188728	Encounter Type Value Set Terminology	The terminology relevant to the encounter type.	CDISC DDF Encounter Type Value Set Terminology
	Visit		C25716		The act of going to see some person or place or thing; it can cover a short or long period but refers to a non-permanent arrangement.	Visit
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CL.C188726.Endpoint Level Value Set Terminology	Endpoint Level Value Set Terminology (Endpoint Level Value Set Terminology)	text Extensible: No	C188726	Endpoint Level Value Set Terminology	The terminology relevant to the endpoint level.	CDISC DDF Endpoint Level Value Set Terminology
	Exploratory Endpoint		C170559		Endpoint(s) that may include clinically important events that are expected to occur too infrequently to show a treatment effect or endpoints that for other reasons are thought to be less likely to show an effect but are included to explore new hypotheses. (After FDA-NIH Protocol Template)	Exploratory Endpoint
	Primary Endpoint		C94496		Endpoint(s) of greatest importance that is the basis for concluding whether the study met its objective(s) and provides a clinically relevant, valid, and reliable measure of the primary objective(s). (After FDA-NIH Protocol Template)	Primary Endpoint
	Secondary Endpoint		C139173		Endpoint(s) that may provide supportive information about the effect of the study intervention(s) on the primary endpoint or demonstrate additional effects on the disease or condition. (After FDA-NIH Protocol Template)	Secondary Endpoint
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CL.C207412.Geographic Scope Type Value Set Terminology	Geographic Scope Type Value Set Terminology (Geographic Scope Type Value Set Terminology)	text Extensible: No	C207412	Geographic Scope Type Value Set Terminology	The terminology relevant to the geographic scope type value set.	CDISC DDF Geographic Scope Type Value Set Terminology
	Country		C25464		A sovereign nation occupying a distinct territory and ruled by an autonomous government.	Country
	Global		C68846		Covering or affecting the whole of a system.	Global
	Region		C41129		An area or portion of something with more or less definite boundaries designed or specified according to some established criteria.	Region
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CL.C207413.Governance Date Type Value Set Terminology	Governance Date Type Value Set Terminology (Governance Date Type Value Set Terminology)	text Extensible: Yes	C207413	Governance Date Type Value Set Terminology	The terminology relevant to the governance date type value set.	CDISC DDF Governance Date Type Value Set Terminology
	Approval Date		C71476		The date on which the entity receives official approbation, recognition, or acceptance as satisfactory.	Approval Date
	Effective Date		C215663		The date on which the entity becomes active, goes into effect, or is slated to begin use.	Effective Date
	Issued Date		C215664		The date on which the entity is officially released, made available, or delivered to its intended recipient.	Issued Date
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CL.C215484.Medical Device Identifier Type Value Set Terminology	Medical Device Identifier Type Value Set Terminology (Medical Device Identifier Type Value Set Terminology)	text Extensible: Yes	C215484	Medical Device Identifier Type Value Set Terminology	The terminology relevant to the medical device identifier type value set.	CDISC DDF Medical Device Identifier Type Value Set Terminology
	Batch Number		C104504	Batch Identifier;Batch Number	A distinctive alpha-numeric identification code assigned by the manufacturer or distributor to a specific quantity of manufactured material or product that is produced in a manner that is expected to render it homogeneous.	Batch Number
	FDA Unique Device Identification		C112279	FDA Unique Device Identification	A UDI is a unique numeric or alphanumeric code that includes a device identifier, which is specific to a device model, and a production identifier, which includes the current production information for that specific device, such as the lot or batch number, the serial number and/or expiration date. (FDA)	FDA Unique Device Identifier
	Lot Number		C70848	Lot Identifier;Lot Number	A distinctive alpha-numeric identification code assigned by the manufacturer or distributor to a specific quantity of manufactured material or product within a batch.	Lot Number
	Model Number		C99285	Model Identifier;Model Number	The identifier assigned to a particular design of a device, usually an alphanumeric text string.	Model Number
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CL.C215482.Medical Device Sourcing Value Set Terminology	Medical Device Sourcing Value Set Terminology (Medical Device Sourcing Value Set Terminology)	text Extensible: Yes	C215482	Medical Device Sourcing Value Set Terminology	The terminology relevant to the medical device sourcing value set.	CDISC DDF Medical Device Sourcing Value Set Terminology
	Centrally Sourced		C215659		An indication that the entity is obtained from a central source.	Centrally Sourced Indicator
	Locally Sourced		C215660		An indication that the entity is obtained from a local source.	Locally Sourced Indicator
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CL.C188725.Objective Level Value Set Terminology	Objective Level Value Set Terminology (Objective Level Value Set Terminology)	text Extensible: No	C188725	Objective Level Value Set Terminology	The terminology relevant to the objective level.	CDISC DDF Objective Level Value Set Terminology
	Exploratory Objective		C163559	Study Exploratory Objective;Trial Exploratory Objective	Additional scientific question(s) within the study that enable further discovery research, beyond the primary and secondary objectives.	Trial Exploratory Objective
	Study Primary Objective		C85826	Study Primary Objective;Trial Primary Objective	The main scientific question(s) the study is designed to answer. (CDISC Glossary)	Trial Primary Objective
	Study Secondary Objective		C85827	Study Secondary Objective;Trial Secondary Objective	The supportive or ancillary scientific question(s) the study is designed to answer. (CDISC Glossary)	Trial Secondary Objective
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CL.C215486.Observational Study Design Subtype Value Set Terminology	Observational Study Design Subtype Value Set Terminology (Observational Study Design Subtype Value Set Terminology)	text Extensible: Yes	C215486	Observational Study Design Subtype Value Set Terminology	The terminology relevant to the observational study design subtype value set.	CDISC DDF Observational Study Design Subtype Value Set Terminology
	Clinical Education		C215657		A study that assesses the effectiveness of health information on reducing ill health and enhancing good health by influencing beliefs, attitudes, and behavior of individuals and communities.	Clinical Education Study
	Disease Determinants		C215654		A study that assesses the variables that influence the occurrence frequency and/or population distribution of a given disease, condition, or injury	Disease Determinants Study
	Disease Etiology		C215658		A study that assesses the causative factors associated with a disease, condition, or injury.	Disease Etiology Study
	Disease Incidence		C215653		A study that assesses the occurrence of new cases of disease, condition, or injury in a defined population over a specified period of time.	Disease Incidence Study
	Disease Prevalence		C215675		A study that assesses the proportion of persons in a population who have a particular disease, condition, or injury at a specified point in time or over a specified period of time. (CDC)	Disease Prevalence Study
	Disease Prognosis		C215655		A study that assesses the prediction of the probable course and outcome of a disease, condition, or injury.	Disease Prognosis Study
	Drug Utilization		C215656		A study that assesses drug usage patterns for prophylaxis or treatment of health problems, or promoting maintenance of health and well-being.	Drug Utilization Study
	Safety		C49667		A study that assesses the medical risks to a subject. Safety is usually assessed by examining a wide range of clinical parameters, including adverse events, vital signs, physical exam, laboratory tests.	Safety Study
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CL.C188724.Organization Type Value Set Terminology	Organization Type Value Set Terminology (Organization Type Value Set Terminology)	text Extensible: Yes	C188724	Organization Type Value Set Terminology	The terminology relevant to the organization type.	CDISC DDF Organization Type Value Set Terminology
	Academic Institution		C18240		An organization, such as a college or university, established for the purpose of scholastic pursuit, education, granting degrees, and research.	Academia
	Clinical Study Registry		C93453		An organization (typically a government agency) that administers the registration of studies. (BRIDG)	Study Registry
	Contract Research Organization		C54148		A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions. [ICH E6 Glossary]	Contract Research Organization
	Government Institute		C199144		An organization established, funded, and overseen by a government, which has a specific purpose or intent.	Governmental Agency or Group
	Healthcare Facility		C21541		The buildings and organizations where healthcare services are provided.	Healthcare Facility
	Laboratory		C37984		An organization with the capability and competency to perform scientific research, experiments, and measurements. (BRIDG)	Laboratory
	Medical Device Company		C215661		A company licensed to discover, develop, market, and/or distribute medical devices.	Medical Device Company
	Pharmaceutical Company		C54149		A company licensed to discover, develop, market, and/or distribute drugs.	Drug Company
	Regulatory Agency		C188863	Regulator;Regulatory Body	An organization (typically a government agency) that is responsible for implementing and enforcing laws, licensing and regulating products and services, promoting the use of standards, and ensuring safety and consumer protections.	Regulatory Agency
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CL.C207418.Product Designation Value Set Terminology	Product Designation Value Set Terminology (Product Designation Value Set Terminology)	text Extensible: No	C207418	Product Designation Value Set Terminology	The terminology relevant to the product designation value set.	CDISC DDF Product Designation Value Set Terminology
	IMP		C202579		A medicinal product which is being tested or used as a reference, including as a placebo, in a clinical trial. (Regulation (EU) No 536/2014 Article 2 (5))	Investigational Medicinal Product
	NIMP		C156473	AxIMP	A medicinal product that is related to the specific needs of the clinical trial as described in the protocol, but not as an investigational medicinal product. NOTE: Auxiliary medicinal products may be authorised for marketing in a country or region or non-authorised. (CDISC Glossary)	Auxiliary Medicinal Product
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CL.C215485.Product Organization Role Code Value Set Terminology	Product Organization Role Code Value Set Terminology (Product Organization Role Code Value Set Terminology)	text Extensible: Yes	C215485	Product Organization Role Code Value Set Terminology	The terminology relevant to the product organization role code value set.	CDISC DDF Product Organization Role Code Value Set Terminology
	Manufacturer		C25392	Manufacturer	The organization defined as being responsible for creating the product as stated on the package in which the product is supplied. (BRIDG)	Manufacturer
	Supplier		C43530		An individual or organization whose business is to supply a particular service or commodity.	Supplier
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CL.C215478.Reference Identifier Type Value Set Terminology	Reference Identifier Type Value Set Terminology (Reference Identifier Type Value Set Terminology)	text Extensible: Yes	C215478	Reference Identifier Type Value Set Terminology	The terminology relevant to the reference identifier type value set.	CDISC DDF Reference Identifier Type Value Set Terminology
	Clinical Development Plan		C142424	CDP	A document that describes the collection of clinical studies that are to be performed in sequence, or in parallel, with a particular active substance, device, procedure, or treatment strategy, typically with the intention of submitting them as part of an application for a marketing authorization. (CDISC Glossary)	Clinical Development Plan
	Pediatric Investigation Plan		C215674	PIP	A development plan aimed at ensuring that the necessary data are obtained to support the authorisation of a medicine for children, through studies in children. (EMA)	Pediatric Investigation Clinical Development Plan
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CL.C215481.Study Amendment Impact Type Value Set Terminology	Study Amendment Impact Type Value Set Terminology (Study Amendment Impact Type Value Set Terminology)	text Extensible: Yes	C215481	Study Amendment Impact Type Value Set Terminology	The terminology relevant to the study amendment impact type value set.	CDISC DDF Study Amendment Impact Type Value Set Terminology
	Study Data Reliability		C215667		The completeness and accuracy of data as a measure of how well it can be counted on to be consistent and free from errors across time and sources. (IBM)	Study Data Reliability
	Study Data Robustness		C215668		The data's ability to remain accurate and relevant despite changes or disruptions to the data environment.	Study Data Robustness
	Study Subject Rights		C215666	Participant Rights	A study subject's moral, ethical, and legal entitlements before, during, and after the study.	Study Subject Rights
	Study Subject Safety		C215665	Participant Safety	The condition in which a study subject is free from harmful effects which may arise as a result of study participation.	Study Subject Safety
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CL.C207415.Study Amendment Reason Code Value Set Terminology	Study Amendment Reason Code Value Set Terminology (Study Amendment Reason Code Value Set Terminology)	text Extensible: Yes	C207415	Study Amendment Reason Code Value Set Terminology	The terminology relevant to the study amendment reason code value set.	CDISC DDF Study Amendment Reason Code Value Set Terminology
	Change In Standard Of Care		C207600		A change in the standard of care necessitates a change(s) to, or formal clarification of, the protocol. (ICH M11)	Change In Standard Of Care
	Change In Strategy		C207601		A change in the study purpose or intent of the scientific plan necessitates a change(s) to, or formal clarification of, the protocol. (ICH M11)	Change In Strategy
	IMP Addition		C207602		The addition of an investigational medicinal product to a clinical trial design necessitates a change(s) to, or formal clarification of, the protocol. (ICH M11)	IMP Addition
	Inconsistency And/or Error In The Protocol		C207603		An error or inconsistency in the protocol necessitates a change(s) to, or formal clarification of, the protocol. (ICH M11)	Inconsistency and/or Error In The Protocol
	Investigator/Site Feedback		C207604		Feedback from the investigator or study site necessitates a change(s) to, or formal clarification of, the protocol. (ICH M11)	Investigator/Site Feedback
	IRB/IEC Feedback		C207605		Feedback from the institutional review board or independent ethics committee necessitates a change(s) to, or formal clarification of, the protocol. (ICH M11)	IRB/IEC Feedback
	Manufacturing Change		C207606		A change to manufacturing processes of the study agents necessitates a change(s) to, or formal clarification of, the protocol. (ICH M11)	Manufacturing Change
	New Data Available (Other Than Safety Data)		C207607		Previously unavailable data (other than safety data) becomes available, which necessitates a change(s) to, or formal clarification of, the protocol. (ICH M11)	New Data Available (Other Than Safety Data)
	New Regulatory Guidance		C207608		A regulatory agency has published a guidance document that necessitates a change(s) to, or formal clarification of, the protocol. (ICH M11)	New Regulatory Guidance
	New Safety Information Available		C207609		Previously unavailable safety data becomes available, which necessitates a change(s) to, or formal clarification of, the protocol. (ICH M11)	New Safety Information Available
	NOT APPLICABLE		C48660	NA;Not Applicable	Determination of a value is not relevant in the current context. (NCI)	Not Applicable
	OTHER		C17649	Other	Different than the one(s) previously specified or mentioned. (NCI)	Other
	Protocol Design Error		C207610		A protocol design error necessitates a change(s) to, or formal clarification of, a document. (ICH M11)	Protocol Design Error
	Recruitment Difficulty		C207611		Challenges with participant recruitment necessitates a change(s) to, or formal clarification of, the protocol. (ICH M11)	Recruitment Difficulty
	Regulatory Agency Request To Amend		C207612		A regulatory agency has expressed a need for a change(s) to, or formal clarification of, the protocol. (ICH M11)	Regulatory Agency Request To Amend
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CL.C188727.Study Arm Data Origin Type Value Set Terminology	Study Arm Data Origin Type Value Set Terminology (Study Arm Data Origin Type Value Set Terminology)	text Extensible: Yes	C188727	Study Arm Data Origin Type Value Set Terminology	The terminology relevant to the study arm data origin type.	CDISC DDF Study Arm Data Origin Type Value Set Terminology
	Data Generated Within Study		C188866		Data that are generated from within the current study.	Data Generated Within Study
	Historical Data		C188864		Data from studies that have occurred in the past.	Historical Data
	Real World Data		C165830		Data relating to patient health status and/or the delivery of health care routinely collected from sources other than traditional clinical trials. NOTE: Examples of sources include data derived from electronic health records (EHRs); medical claims and billing data; data from product and disease registries; patient-generated data, including from in-home-use settings; and data gathered from other sources that can inform on health status, such as mobile devices. [After 21 U.S.C. 355g(b)).5 and Framework for FDA's Real-World Evidence Program December 2018] See also Real-World Evidence (RWE)	Real-world Data
	Synthetic Data		C176263		Data that are artificially created rather than being generated by actual events. NOTE: Data are often created with the help of algorithms and used for a wide range of activities, including as test data for new products and tools, for model validation, and in AI optimization. [After The Ultimate Guide to Synthetic Data in 2020, August 29, 2020]. See also artificial intelligence.	Synthetic Data
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CL.C215477.Study Definition Document Type Value Set Terminology	Study Definition Document Type Value Set Terminology (Study Definition Document Type Value Set Terminology)	text Extensible: Yes	C215477	Study Definition Document Type Value Set Terminology	The terminology relevant to the study definition document type value set.	CDISC DDF Study Definition Document Type Value Set Terminology
	Protocol		C70817		The formal plan of an experiment or research activity, including the objective, rationale, design, materials and methods for the conduct of the study, intervention description, and method of data analysis.	Study Protocol
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CL.C188723.Study Definition Document Version Value Set Terminology	Study Definition Document Version Value Set Terminology (Study Definition Document Version Value Set Terminology)	text Extensible: No	C188723	Study Definition Document Version Value Set Terminology	The terminology relevant to the study definition document version status.	CDISC DDF Study Definition Document Version Value Set Terminology
	Approved		C25425		Acceptance as satisfactory by an authoritative body; established by authority; given authoritative approval.	Approval
	Draft		C85255		A preliminary version of a written work, design, or picture.	Draft
	Final		C25508		Conclusive in a process or progression.	Final
	Obsolete		C63553		No longer in use or valid; old.	Obsolete
	Pending Review		C188862	Draft Pending Review	A preliminary version of a written work, design, or picture that is awaiting review.	Pending Review
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CL.C207416.Study Design Characteristics Value Set Terminology	Study Design Characteristics Value Set Terminology (Study Design Characteristics Value Set Terminology)	text Extensible: Yes	C207416	Study Design Characteristics Value Set Terminology	The terminology relevant to the study design characteristics value set.	CDISC DDF Study Design Characteristics Value Set Terminology
	Adaptive		C98704		A study design that allows for prospectively planned modifications to one or more aspects of the design based on accumulating data from subjects in the trial. (FDA)	Adaptive Design
	Extension		C207613	Roll-over Study	A study design in which subjects enrolled in one study are subsequently continued into a related study for longer term safety, tolerability, and/or effectiveness monitoring.	Extension Study Design
	Multicentre		C217005		A clinical study conducted according to a single protocol but at more than one study site.	Multicenter Study
	Multiple Countries		C217007		Of, or pertaining to, an occurrence in more than one country.	Multiple Countries
	Randomized		C46079		A study design in which interventions are assigned to subjects according to randomization principles.	Randomized Controlled Clinical Trial
	Single Country		C217006		Of, or pertaining to, an occurrence in one country.	Single Country
	Single-Centre		C217004		A clinical study that is conducted at a single study site.	Single-Center Study
	Stratification		C25689		Grouping defined by important prognostic factors measured at baseline. (ICH E9)	Stratification
	Stratified Randomisation		C147145		A type of block randomization in which participants are stratified into groups based on prognostic variables and then randomized into balanced treatment groups.	Stratified Randomization
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CL.C207417.Study Intervention Role Value Set Terminology	Study Intervention Role Value Set Terminology (Study Intervention Role Value Set Terminology)	text Extensible: No	C207417	Study Intervention Role Value Set Terminology	The terminology relevant to the study intervention role value set.	CDISC DDF Study Intervention Role Value Set Terminology
	Active Comparator		C68609	Active Control	A type of control, which has a demonstrated effect, administered as a comparator to subjects in a clinical trial. [From ICH E10]	Active Comparator
	Additional Required Treatment		C207614		A medicinal product that must be administered along with the experimental treatment (e.g., drug studies wherein opioid blockers are administered to prevent overdose).	Additional Required Medicinal Product
	Background Treatment		C165822		Medicinal products that are administered to each clinical trial subject, regardless of randomization group, a) to treat the indication which is the object of the study, or b) required in the protocol as part of standard care for a condition that is not the indication under investigation, and is relevant for the clinical trial design. [After Recommendations from the expert group on clinical trials for the implementation of Regulation (EU) No 536/2014' dd 28 June 2017]	Background Treatment
	Challenge Agent		C158128		A non-investigational medicinal product (NIMP) given to trial subjects to produce a physiological response that is necessary before the pharmacological action of the investigational medicinal product can be assessed. [After Recommendations from the expert group on clinical trials for the implementation of Regulation (EU) No 536/2014' dd 28 June 2017]	Challenge Agent
	Diagnostic		C18020		Any procedure or test used to diagnose a disease or disorder.	Diagnostic Procedure
	Experimental Intervention		C41161	Investigational Interventional;Investigational Therapy or Treatment	The drug, device, therapy, procedure, or process under investigation in a clinical study that is believed to have an effect on outcomes of interest in a study (e.g., health-related quality of life, efficacy, safety, pharmacoeconomics). [After https://grants.nih.gov/grants/policy/faq_clinical_trial_definition.htm#5224; https://grants.nih.gov/policy/clinical-trials/protocol-template.htm] See also test articles, devices, drug product, combination product, treatment, diagnosis. Contrast with investigational medicinal product.	Protocol Agent
	Placebo		C753		A pharmaceutical preparation that does not contain the investigational agent and is generally prepared to be physically indistinguishable from the preparation containing the investigational product.	Placebo
	Rescue Medicine		C165835		Medicinal products identified in the protocol as those that may be administered to subjects when the efficacy of the investigational medicinal product (IMP) is not satisfactory, the effect of the IMP is too great and is likely to cause a hazard to the patient, or to manage an emergency situation. [After EU-CTR Recommendations from the expert group on clinical trials for the implementation of Regulation (EU) No 536/2014' dd 28 June 2017]	Rescue Medications
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CL.C215480.Study Role Code Value Set Terminology	Study Role Code Value Set Terminology (Study Role Code Value Set Terminology)	text Extensible: Yes	C215480	Study Role Code Value Set Terminology	The terminology relevant to the study role code terminology value set.	CDISC DDF Study Role Code Value Set Terminology
	Adjudication Committee		C78726		An external committee whose purpose is to evaluate study data and decide whether a study endpoint or other criterion has been met. (NCI)	Adjudication Committee
	Care Provider		C17445	Caregiver;Carer;Caretaker	The primary person in charge of the care of a patient, usually a family member or a designated health care professional. (NCI)	Caregiver
	Clinical Trial Physician		C215672	Study Doctor	Any physician that is associated with clinical trial.	Clinical Trial Physician
	Co-Sponsor		C215669		An individual, company, institution, or organization that is designated by the study sponsor as a vested partner in the study.	Study Co-Sponsor
	Contract Research		C215662		Research that is conducted by an individual or organization on behalf of another organization through a contracting mechanism.	Contract Research
	Data Safety Monitoring Board		C142489	Data and Safety Monitoring Board;Data and Safety Monitoring Committee DSMB;Data Monitoring and Oversight Committee;DMC;DMOC;DSMC;IDMC;Independent Data Monitoring Committee	A group of independent experts who are appointed to monitor the safety and scientific integrity of a research intervention, protect the confidentiality of participant data, and to make recommendations to the sponsor regarding the stopping of the trial for safety, efficacy, or for futility. (After clinicaltrials.gov; Committee for Medicinal Products for Human Use (CHMP), 2005, EMA; FDA Establishment and Operation of Clinical Trial Data Monitoring Committees. March 2006)	Data Monitoring Committee
	Dose Escalation Committee		C215671		A committee established to assess whether a dose adjustment is appropriate and to determine whether the maximum-tolerated dose had been attained, based on a review of available safety and efficacy data at specified time points.	Dose Escalation Committee
	Independent Data Monitoring Committee		C142578		A committee established by the sponsor to assess at intervals the progress of a clinical trial, safety data, and critical efficacy variables and recommend to the sponsor whether to continue, modify, or terminate the trial. [ICH E9] (CDISC Glossary)	Independent Data Monitoring Committee
	Investigator		C25936		A person responsible for the conduct of the study, ensuring adherence to the protocol and good clinical practices. (CDISC Glossary)	Investigator
	Laboratory		C37984		An organization with the capability and competency to perform scientific research, experiments, and measurements. (BRIDG)	Laboratory
	Local Sponsor		C215670		The sponsor's legal representative at a geographical region within which the sponsor has no legal presence. (ICH M11)	Local Legal Sponsor
	Manufacturer		C25392	Manufacturer	The organization defined as being responsible for creating the product as stated on the package in which the product is supplied. (BRIDG)	Manufacturer
	Medical Expert		C51876		A physician or health care provider selected by the sponsor to be readily available to advise clinical trial officials on trial related medical questions or problems.	Sponsor Medical Expert
	Outcomes Assessor		C207599		The individual who evaluates the outcome(s) of interest. (Clinicaltrials.gov)	Outcomes Assessor
	Pharmacovigilance		C215673		A group that is responsible for monitoring the safety of medicines and taking action to reduce their risks and increase their benefits.	Pharmacovigilance Group
	Principal investigator		C19924		The study investigator who has the primary responsibility for the conduct of a study and for the study-related personnel at the participating site(s).	Principal Investigator
	Project Manager		C51851	Project Coordinator	A staff member who is responsible for the overall integration and interaction of different people and different components of subject matter associated with a specific project.	Project Coordinator
	Regulatory Agency		C188863	Regulator;Regulatory Body	An organization (typically a government agency) that is responsible for implementing and enforcing laws, licensing and regulating products and services, promoting the use of standards, and ensuring safety and consumer protections.	Regulatory Agency
	Sponsor		C70793	Clinical Study Sponsor;Sponsor;Study Sponsor	An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical study. [After ICH E6, WHO, 21 CFR 50.3 (e), and after IDMP]	Clinical Study Sponsor
	Statistician		C51877		A professional who specializes in applying statistical principles to experimental design and data analysis.	Statistician
	Study Site		C80403		The location at which a study investigator conducts study activities.	Study Site
	Study Subject		C41189		An individual who is observed, analyzed, examined, investigated, experimented upon, or/and treated in the course of a particular study.	Study Subject
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CL.C207419.Study Title Type Value Set Terminology	Study Title Type Value Set Terminology (Study Title Type Value Set Terminology)	text Extensible: No	C207419	Study Title Type Value Set Terminology	The terminology relevant to the study title type value set.	CDISC DDF Study Title Type Value Set Terminology
	Brief Study Title		C207615	Abbreviated Protocol Title	The short descriptive name for the study.	Brief Study Title
	Official Study Title		C207616		The formal descriptive name for the study.	Official Study Title
	Public Study Title		C207617		The descriptive name of the study that is intended for the lay public, written in easily understood language.	Public Study Title
	Scientific Study Title		C207618		A more extensive descriptive name of the study that is intended for medical professionals, written using medical and scientific language.	Scientific Study Title
	Study Acronym		C207646	Trial Acronym	A word or words formed from the beginning letters or a combination of syllables and letters of a compound term, which identifies a clinical study.	Study Acronym
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CL.C201265.Timing Relative To From Value Set Terminology	Timing Relative To From Value Set Terminology (Timing Relative To From Value Set Terminology)	text Extensible: No	C201265	Timing Relative To From Value Set Terminology	The terminology relevant to the timing relative to from value set.	CDISC DDF Timing Relative To From Value Set Terminology
	End to End		C201352		A timing relationship defined as the end of one event to the end of another event.	End to End
	End to Start		C201353		A timing relationship defined as the end of one event to the start of another event.	End to Start
	Start to End		C201354		A timing relationship defined as the start of one event to the end of another event.	Start to End
	Start to Start		C201355		A timing relationship defined as the start of one event to the start of another event.	Start to Start
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CL.C201264.Timing Type Value Set Terminology	Timing Type Value Set Terminology (Timing Type Value Set Terminology)	text Extensible: No	C201264	Timing Type Value Set Terminology	The terminology relevant to the timing type value set.	CDISC DDF Timing Type Value Set Terminology
	After		C201356		A type of time point relationship that follows a point or period of time within a timeline.	After Timing Type
	Before		C201357		A type of time point relationship that comes before a point or period of time within a timeline.	Before Timing Type
	Fixed Reference		C201358		A type of time point relationship that is fixed with respect to a timeline.	Fixed Reference Timing Type
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