CDISC DDF Controlled Terminology

CDISC DDF Controlled Terminology, 2024-09-27
Legend:
CodeList
CodeListItem
NCI attributes
C188714DDF Activity Attribute Terminology
C201253DDF Address Attribute Terminology
C207420DDF Administration Duration Attribute Terminology
C207421DDF Agent Administration Attribute Terminology
C188720DDF Analysis Population Attribute Terminology
C201254DDF Biomedical Concept Attribute Terminology
C201255DDF Biomedical Concept Category Attribute Terminology
C201256DDF Biomedical Concept Property Attribute Terminology
C201257DDF Biomedical Concept Surrogate Attribute Terminology
C207422DDF Characteristic Attribute Terminology
C188699DDF Clinical Study Attribute Terminology
C188722DDF Code Attribute Terminology
C207425DDF Condition Assignment Attribute Terminology
C207424DDF Condition Attribute Terminology
C207427DDF Eligibility Criteria Attribute Terminology
C188713DDF Encounter Attribute Terminology
C188708DDF Endpoint Attribute Terminology
C188698DDF Entity Terminology
C188719DDF Estimand Attribute Terminology
C207428DDF Geographic Scope Attribute Terminology
C207429DDF Governance Date Attribute Terminology
C188705DDF Indication Attribute Terminology
C188721DDF Intercurrent Event Attribute Terminology
C207430DDF Masking Attribute Terminology
C207426DDF Narrative Content Attribute Terminology
C188707DDF Objective Attribute Terminology
C188702DDF Organization Attribute Terminology
C207431DDF Parameter Map Attribute Terminology
C207432DDF Population Definition Attribute Terminology
C188716DDF Procedure Attribute Terminology
C207433DDF Quantity Attribute Terminology
C207434DDF Range Attribute Terminology
C207435DDF Research Organization Attribute Terminology
C201258DDF Response Code Attribute Terminology
C201259DDF Schedule Timeline Attribute Terminology
C207436DDF Scheduled Activity Instance Attribute Terminology
C201260DDF Scheduled Decision Instance Attribute Terminology
C201261DDF Scheduled Instance Attribute Terminology
C207437DDF Study Amendment Attribute Terminology
C207438DDF Study Amendment Reason Attribute Terminology
C188709DDF Study Arm Attribute Terminology
C207439DDF Study Cohort Attribute Terminology
C188703DDF Study Design Attribute Terminology
C188706DDF Study Design Population Attribute Terminology
C188711DDF Study Element Attribute Terminology
C188710DDF Study Epoch Attribute Terminology
C188701DDF Study Identifier Attribute Terminology
C188704DDF Study Intervention Attribute Terminology
C207440DDF Study Protocol Document Attribute Terminology
C207441DDF Study Site Attribute Terminology
C207442DDF Study Title Attribute Terminology
C207443DDF Study Version Attribute Terminology
C207444DDF Subject Enrollment Attribute Terminology
C207445DDF Syntax Template Attribute Terminology
C207446DDF Syntax Template Dictionary Attribute Terminology
C201262DDF Timing Attribute Terminology
C188712DDF Transition Rule Attribute Terminology
C188728Encounter Type Value Set Terminology
C188726Endpoint Level Value Set Terminology
C207412Geographic Scope Type Value Set Terminology
C207413Governance Date Type Value Set Terminology
C207414Masking Role Value Set Terminology
C188725Objective Level Value Set Terminology
C188724Organization Type Value Set Terminology
C188723Protocol Status Value Set Terminology
C207415Study Amendment Reason Code Value Set Terminology
C188727Study Arm Data Origin Type Value Set Terminology
C207416Study Design Characteristics Value Set Terminology
C207418Study Intervention Product Designation Value Set Terminology
C207417Study Intervention Role Value Set Terminology
C207419Study Title Type Value Set Terminology
C201265Timing Relative To From Value Set Terminology
C201264Timing Type Value Set Terminology

Codelist Definitions

OIDName
(CDISC Submission Value)
DataType
Extensible
NCI CodeCDISC SynonymCDISC DefinitionPreferred Term
CDISC Submission Value [ODM:CodedValue]
CL.C188714.DDF Activity Attribute TerminologyDDF Activity Attribute Terminology
(DDF Activity Attribute Terminology)
text
Extensible: No
C188714DDF Activity Attribute TerminologyA terminology value set relevant to the attributes of the activity.CDISC DDF Activity Attribute Terminology
Clinical Study Activity DescriptionC70960The textual representation of the study activity.Clinical Study Activity Description
Clinical Study Activity LabelC207458The short descriptive designation for the study activity.Study Activity Label
Clinical Study Activity NameC188842The literal identifier (i.e., distinctive designation) of the clinical study activity.Clinical Study Activity Name
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CL.C201253.DDF Address Attribute TerminologyDDF Address Attribute Terminology
(DDF Address Attribute Terminology)
text
Extensible: No
C201253DDF Address Attribute TerminologyA terminology value set relevant to the attributes of the address.CDISC DDF Address Attribute Terminology
Address Full TextC201311A standardized representation of the complete set of components denoting the physical address of the person, business, building, or organization.Address Full Text
Address LineC25690The street name and number, building number, apartment or unit number, or post office box number where an entity is physically located.Street Address
CityC25160A 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
CountryC25464A sovereign nation occupying a distinct territory and ruled by an autonomous government.Country
DistrictC176229An administrative or territorial division of a city, town, county, parish, state, country, or other locality based on a shared characteristic.District
Postal CodeC25621An alphanumeric code assigned to a mail delivery area.Postal Code
StateC87194A 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.C207420.DDF Administration Duration Attribute TerminologyDDF Administration Duration Attribute Terminology
(DDF Administration Duration Attribute Terminology)
text
Extensible: No
C207420DDF Administration Duration Attribute TerminologyA terminology value set relevant to the attributes of the administration duration.CDISC DDF Administration Duration Attribute Terminology
Administration Duration DescriptionC207459A narrative representation of the agent administration duration.Administration Duration Description
Administration Duration Quantity ValueC207460The value representing the amount of time over which the administration of an agent occurs.Administration Duration Quantity Value
Administration Duration Reason Duration Will VaryC207462Reason Administration Duration Will VaryThe explanation for why the agent administration duration will vary within and/or across subjects.Reason Administration Duration Will Vary
Administration Duration Will Vary IndicatorC207461An indication as to whether the agent administration duration is planned to vary within and/or across subjects.Administration Duration Will Vary Indicator
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CL.C207421.DDF Agent Administration Attribute TerminologyDDF Agent Administration Attribute Terminology
(DDF Agent Administration Attribute Terminology)
text
Extensible: No
C207421DDF Agent Administration Attribute TerminologyA terminology value set relevant to the attributes of the agent administration.CDISC DDF Agent Administration Attribute Terminology
Agent Administration DescriptionC207463A narrative representation of the agent administration.Agent Administration Description
Agent Administration DoseC167190The value representing the amount of an agent given to an individual at one time.Dose Administered
Agent Administration LabelC207464The short descriptive designation for the agent administration.Agent Administration Label
Agent Administration NameC207465The literal identifier (i.e., distinctive designation) of the agent administration.Agent Administration Name
Dosing FrequencyC89081Dosing FrequencyThe number of doses administered per a specific interval.Dose Frequency
Route of AdministrationC38114Route of AdministrationThe 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.C188720.DDF Analysis Population Attribute TerminologyDDF Analysis Population Attribute Terminology
(DDF Analysis Population Attribute Terminology)
text
Extensible: No
C188720DDF Analysis Population Attribute TerminologyA terminology value set relevant to the attributes of the analysis population.CDISC DDF Analysis Population Attribute Terminology
Analysis Population DescriptionC188854The textual representation of the study population for analysis.Analysis Population Description
Analysis Population LabelC207466The short descriptive designation for the analysis population.Analysis Population Label
Analysis Population NameC207467The literal identifier (i.e., distinctive designation) of the analysis population.Analysis Population Name
Analysis Population TextC207468An instance of unstructured text that represents the analysis population.Analysis Population Text
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CL.C201254.DDF Biomedical Concept Attribute TerminologyDDF Biomedical Concept Attribute Terminology
(DDF Biomedical Concept Attribute Terminology)
text
Extensible: No
C201254DDF Biomedical Concept Attribute TerminologyA terminology value set relevant to the attributes of the biomedical concept.CDISC DDF Biomedical Concept Attribute Terminology
Biomedical Concept Concept CodeC207469A concept unique identifier assigned to a biomedical concept that points to the meaning of that biomedical concept.Biomedical Concept Code
Biomedical Concept LabelC207470The short descriptive designation for the biomedical concept.Biomedical Concept Label
Biomedical Concept NameC201312The literal identifier (i.e., distinctive designation) of the biomedical concept.Biomedical Concept Name
Biomedical Concept ReferenceC201313A citation to an authoritative source for a biomedical concept.Biomedical Concept Reference
Biomedical Concept SynonymC201314A 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 TerminologyDDF Biomedical Concept Category Attribute Terminology
(DDF Biomedical Concept Category Attribute Terminology)
text
Extensible: No
C201255DDF Biomedical Concept Category Attribute TerminologyA terminology value set relevant to the attributes of the biomedical concept category.CDISC DDF Biomedical Concept Category Attribute Terminology
Biomedical Concept Category CodeC201315A symbol or combination of symbols which is assigned to the biomedical concept category.Biomedical Concept Category Code
Biomedical Concept Category DescriptionC201316A narrative representation of the biomedical concept category.Biomedical Concept Category Description
Biomedical Concept Category LabelC207471The short descriptive designation for the biomedical concept category.Biomedical Concept Category Label
Biomedical Concept Category NameC201317The literal identifier (i.e., distinctive designation) of the biomedical concept category.Biomedical Concept Category Name
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CL.C201256.DDF Biomedical Concept Property Attribute TerminologyDDF Biomedical Concept Property Attribute Terminology
(DDF Biomedical Concept Property Attribute Terminology)
text
Extensible: No
C201256DDF Biomedical Concept Property Attribute TerminologyA terminology value set relevant to the attributes of the biomedical concept property.CDISC DDF Biomedical Concept Property Attribute Terminology
Biomedical Concept Property Concept CodeC201318A 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 IndicatorC202496An 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 LabelC207472The short descriptive designation for the biomedical concept property.Biomedical Concept Property Label
Biomedical Concept Property NameC202494The literal identifier (i.e., distinctive designation) of the biomedical concept property.Biomedical Concept Property Name
Biomedical Concept Property Required IndicatorC202495An indication as to whether the biomedical concept property is required.Biomedical Concept Property Required Indicator
Biomedical Concept Property Response Data TypeC201319The 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 TerminologyDDF Biomedical Concept Surrogate Attribute Terminology
(DDF Biomedical Concept Surrogate Attribute Terminology)
text
Extensible: No
C201257DDF Biomedical Concept Surrogate Attribute TerminologyA terminology value set relevant to the attributes of the biomedical concept surrogate.CDISC DDF Biomedical Concept Surrogate Attribute Terminology
Biomedical Concept Surrogate DescriptionC201320A narrative representation of the biomedical concept surrogate.Biomedical Concept Surrogate Description
Biomedical Concept Surrogate LabelC207473The short descriptive designation for the biomedical concept surrogate.Biomedical Concept Surrogate Label
Biomedical Concept Surrogate NameC207474The literal identifier (i.e., distinctive designation) of the biomedical concept surrogate.Biomedical Concept Surrogate Name
Biomedical Concept Surrogate ReferenceC201321A citation to an authoritative source for a biomedical concept surrogate.Biomedical Concept Surrogate Reference
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CL.C207422.DDF Characteristic Attribute TerminologyDDF Characteristic Attribute Terminology
(DDF Characteristic Attribute Terminology)
text
Extensible: No
C207422DDF Characteristic Attribute TerminologyA terminology value set relevant to the attributes of the characteristic.CDISC DDF Characteristic Attribute Terminology
Characteristic DescriptionC207475A narrative representation of the characteristic.Characteristic Description
Characteristic LabelC207476The short descriptive designation for the characteristic.Characteristic Label
Characteristic NameC207477The literal identifier (i.e., distinctive designation) of the characteristic.Characteristic Name
Characteristic TextC207478An instance of structured text that represents the characteristic.Characteristic Text
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CL.C188699.DDF Clinical Study Attribute TerminologyDDF Clinical Study Attribute Terminology
(DDF Clinical Study Attribute Terminology)
text
Extensible: No
C188699DDF Clinical Study Attribute TerminologyA terminology value set relevant to the attributes of the clinical study.CDISC DDF Clinical Study Attribute Terminology
Clinical Study LabelC207479The short descriptive designation for the clinical study.Clinical Study Label
Study DescriptionC142704A narrative representation of the study.Study Description
Study NameC68631The literal identifier (i.e., distinctive designation) of the study.Study Name
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CL.C188722.DDF Code Attribute TerminologyDDF Code Attribute Terminology
(DDF Code Attribute Terminology)
text
Extensible: No
C188722DDF Code Attribute TerminologyA terminology value set relevant to the attributes of the code.CDISC DDF Code Attribute Terminology
Code System NameC188859The literal identifier (i.e., distinctive designation) of the system used to assign and/or manage codes.Code System Name
Code System VersionC188868The version of the code system.Coding System Version
Code ValueC188858The literal value of a code.Code Value
DecodeC188861Standardized or dictionary-derived human readable text associated with a code.Decode Text
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CL.C207425.DDF Condition Assignment Attribute TerminologyDDF Condition Assignment Attribute Terminology
(DDF Condition Assignment Attribute Terminology)
text
Extensible: No
C207425DDF Condition Assignment Attribute TerminologyA terminology value set relevant to the attributes of the condition assignment.CDISC DDF Condition Assignment Attribute Terminology
Logical ConditionC47953An assumption on which rests the validity or effect of something else.Logical Condition
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CL.C207424.DDF Condition Attribute TerminologyDDF Condition Attribute Terminology
(DDF Condition Attribute Terminology)
text
Extensible: No
C207424DDF Condition Attribute TerminologyA terminology value set relevant to the attributes of the condition.CDISC DDF Condition Attribute Terminology
Condition DescriptionC207481A narrative representation of the condition.Condition Description
Condition LabelC207482The short descriptive designation for the condition.Condition Label
Condition NameC207483The literal identifier (i.e., distinctive designation) of the condition.Condition Name
Condition TextC207484An instance of structured text that represents the condition.Condition Text
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CL.C207427.DDF Eligibility Criteria Attribute TerminologyDDF Eligibility Criteria Attribute Terminology
(DDF Eligibility Criteria Attribute Terminology)
text
Extensible: No
C207427DDF Eligibility Criteria Attribute TerminologyA terminology value set relevant to the attributes of the eligibility criteria.CDISC DDF Eligibility Criteria Attribute Terminology
Study Eligibility Criteria CategoryC83016A classification of the inclusion exclusion criterion.Inclusion Exclusion Criterion Category
Study Eligibility Criterion DescriptionC207486A narrative representation of the study eligibility criterion.Study Eligibility Criteria Description
Study Eligibility Criterion IdentifierC207489A sequence of characters used to identify, name, or characterize the inclusion or exclusion criterion.Study Eligibility Criterion Identifier
Study Eligibility Criterion LabelC207487The short descriptive designation for the study eligibility criterion.Study Eligibility Criteria Label
Study Eligibility Criterion NameC207488The literal identifier (i.e., distinctive designation) of the study eligibility criterion.Study Eligibility Criteria Name
Study Eligibility Criterion TextC207485An instance of structured text that represents the study eligibility criterion.Study Eligibility Criteria Text
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CL.C188713.DDF Encounter Attribute TerminologyDDF Encounter Attribute Terminology
(DDF Encounter Attribute Terminology)
text
Extensible: No
C188713DDF Encounter Attribute TerminologyA terminology value set relevant to the attributes of the encounter.CDISC DDF Encounter Attribute Terminology
Clinical Encounter DescriptionC188836A narrative representation of the protocol-defined clinical encounter.Clinical Encounter Description
Clinical Encounter NameC171010The literal identifier (i.e., distinctive designation) for a protocol-defined clinical encounter.Clinical Encounter Name
Clinical Encounter TypeC188839A characterization or classification of contact between subject/patient and healthcare practitioner/researcher, during which an assessment or activity is performed.Clinical Encounter Type
Contact ModeC188841The means by which an interaction occurs between the subject/participant and person or entity (e.g., a device).Contact Mode
Environmental SettingC188840The environment/setting where the event, intervention, or finding occurred.Environmental Setting
Study Encounter LabelC207490The short descriptive designation for the study encounter.Study Encounter Label
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CL.C188708.DDF Endpoint Attribute TerminologyDDF Endpoint Attribute Terminology
(DDF Endpoint Attribute Terminology)
text
Extensible: No
C188708DDF Endpoint Attribute TerminologyA terminology value set relevant to the attributes of the endpoint.CDISC DDF Endpoint Attribute Terminology
Study Endpoint DescriptionC188824A narrative representation of the study endpoint.Study Endpoint Description
Study Endpoint LabelC207491The short descriptive designation for the study endpoint.Study Endpoint Label
Study Endpoint LevelC188826A characterization or classification of the study endpoint that determines its category of importance relative to other study endpoints.Study Endpoint Level
Study Endpoint NameC207492The literal identifier (i.e., distinctive designation) of the study endpoint.Study Endpoint Name
Study Endpoint PurposeC188825The reason or intention for the study endpoint.Study Endpoint Purpose
Study Endpoint TextC207493An instance of structured text that represents the study endpoint.Study Endpoint Text
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CL.C188698.DDF Entity TerminologyDDF Entity Terminology
(DDF Entity Terminology)
text
Extensible: No
C188698DDF Entity TerminologyA terminology value set relevant to the entities within the CDISC digital data flow (DDF) model.CDISC DDF Entities Terminology
AddressC25407A standardized representation of the location of a person, business, building, or organization. (NCI)Address
Administration DurationC69282The amount of time elapsed during the administration of an agent.Duration of Administration
Agent AdministrationC70962The act of the dispensing, applying, or tendering a medical product or other agent.Agent Administration
Alias CodeC201344An alternative symbol or combination of symbols which is assigned to the members of a collection.Alias Code
Biomedical Concept CategoryC201346A grouping of biomedical concepts based on some commonality or by user defined characteristics.Biomedical Concept Category
Biomedical Concept PropertyC202493A characteristic from a set of characteristics used to define a biomedical concept.Biomedical Concept Property
Biomedical Concept SurrogateC207590A concept that substitutes for a standard biomedical concept from the designated source.Biomedical Concept Surrogate
Biomedical ConceptC201345A 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
CharacteristicC25447The distinguishing qualities or prominent aspects of an entity.Characteristic
Clinical EncounterC142427Contact between subject/patient and healthcare practitioner/researcher, during which an assessment or activity is performed. Contact may be physical or virtual.Clinical Encounter
Clinical StudyC15206A 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. [ClinicalTrials.gov] See also clinical trial. (CDISC Glossary)Clinical Study
CodeC25162A symbol or combination of symbols which is assigned to the members of a collection.Code
Condition AssignmentsC201335An allotting or appointment to a set of conditions that are to be met in order to make a logical decision.Condition Assignment
ConditionC25457A state of being.Condition
Disease/Condition IndicationC41184A health problem or disease that is identified as likely to be benefited by a therapy being studied in clinical trials.Indication
EstimandC188813A 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 ScopeC207591The extent or range related to the physical location of an entity.Geographic Scope
Intercurrent EventC188815An 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
MaskingC191278The 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
Narrative ContentC207592The container that holds an instance of unstructured text and which may include objects such as tables, figures, and images.Narrative Content
OrganizationC19711A 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 MapC207456The paired name and value for a given parameter.Parameter Map
Population DefinitionC207593A concise explanation of the meaning of a population.Population Definition
ProcedureC98769Medical ProcedureAny activity performed by manual and/or instrumental means for the purpose of diagnosis, assessment, therapy, prevention, or palliative care.Physical Medical Procedure
QuantityC25256How much there is of something that can be measured; the total amount or number.Quantity
RangeC38013The difference between the lowest and highest numerical values; the limits or scale of variation.Range
Research OrganizationC93448An organization that undertakes systematic investigation within a field of study in order to discover facts, establish or revise a theory, test a hypothesis, or develop a plan of action based on the facts discovered.Research Organization
Response CodeC201347A symbol or combination of symbols representing the response to the question.Response Code
Schedule Timeline ExitC201349To go out of or leave the schedule timeline.Schedule Timeline Exit
Schedule TimelineC201348A chronological schedule of planned temporal events.Schedule Timeline
Scheduled Activity InstanceC201350A scheduled occurrence of an activity event.Scheduled Activity Instance
Scheduled Decision InstanceC201351A scheduled occurrence of a decision event.Scheduled Decision Instance
Scheduled InstanceC201299A scheduled occurrence of a temporal event.Scheduled Instance
Study ActivityC71473An 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 ReasonC207457Reason(s) for AmendmentThe rationale for the change(s) to, or formal clarification of, a protocol.Study Amendment Reason
Study AmendmentC207594A written description of a change(s) to, or formal clarification of, a study.Study Amendment
Study ArmC174447ArmA 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 CohortC61512A group of individuals who share a set of characteristics (e.g., exposures, experiences, attributes), which logically defines a population under study.Cohort
Study Design CellC188810A 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 ElementC142735A 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 DesignC15320A 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 CriteriaC16112Trial Eligibility CriteriaCharacteristics 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 EndpointC25212A 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 EpochC71738A 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 DateC207595Any of the dates associated with event milestones within a clinical study's oversight and management framework.Study Governance Date
Study IdentifierC83082A sequence of characters used to identify, name, or characterize the study.Study Identifier
Study ObjectiveC142450The 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 Protocol DocumentC93381A representation of the study protocol (that persists over time) in document form.Study Protocol Document
Study Protocol VersionC93490A plan at a particular point in time for a formal investigation to assess the utility, impact, pharmacological, physiological, and/or psychological effects of a particular treatment, procedure, drug, device, biologic, food product, cosmetic, care plan, or subject characteristic. (BRIDG)Study Protocol Version
Study SiteC80403The location at which a study investigator conducts study activities.Study Site
Study TitleC49802Official Study Title;Study Title;Trial TitleThe sponsor-defined name of the clinical study.Trial Title
Study VersionC188816A plan at a particular point in time for a study.Study Version
Subject EnrollmentC37948The 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
Syntax Template DictionaryC207597A reference source that provides a listing of valid parameter names and values used in syntax template text strings.Syntax Template Dictionary
Syntax TemplateC207596A standardized pattern used for the arrangement of words and phrases to create well-formed, structured sentences.Syntax Template
Target Study Population for AnalysisC188814A 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
Target Study PopulationC142728Target PopulationThe group of people in the general population to which the study results can be generalized.Target Study Population
TimingC80484The chronological relationship between temporal events.Timing
Transition RuleC82567A 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 TerminologyDDF Estimand Attribute Terminology
(DDF Estimand Attribute Terminology)
text
Extensible: No
C188719DDF Estimand Attribute TerminologyA terminology value set relevant to the attributes of the estimand.CDISC DDF Estimand Attribute Terminology
Population-Level SummaryC188853A 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 TerminologyDDF Geographic Scope Attribute Terminology
(DDF Geographic Scope Attribute Terminology)
text
Extensible: No
C207428DDF Geographic Scope Attribute TerminologyA terminology value set relevant to the attributes of the geographic scope.CDISC DDF Geographic Scope Attribute Terminology
Geographic Scope CodeC207494A symbol or combination of symbols which is assigned to the geographic scope.Geographic Scope Code
Geographic Scope TypeC207495A characterization or classification of the geographic scope.Geographic Scope Type
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CL.C207429.DDF Governance Date Attribute TerminologyDDF Governance Date Attribute Terminology
(DDF Governance Date Attribute Terminology)
text
Extensible: No
C207429DDF Governance Date Attribute TerminologyA terminology value set relevant to the attributes of the governance date.CDISC DDF Governance Date Attribute Terminology
Protocol Approval Date TypeC207496A characterization or classification of the protocol approval date.Protocol Approval Date Type
Study Governance Date DescriptionC207497A narrative representation of the study governance date.Study Governance Date Description
Study Governance Date LabelC207498The short descriptive designation for the study governance date.Study Governance Date Label
Study Governance Date NameC207499The literal identifier (i.e., distinctive designation) of the study governance dateStudy Governance Date Name
Study Governance Date ValueC207500The information contained in the date field.Study Governance Date Value
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CL.C188705.DDF Indication Attribute TerminologyDDF Indication Attribute Terminology
(DDF Indication Attribute Terminology)
text
Extensible: No
C188705DDF Indication Attribute TerminologyA terminology value set relevant to the attributes of the disease indication.CDISC DDF Indication Attribute Terminology
Disease Indication CodeC188822A short sequence of characters that represents the disease indication.Disease Indication Code
Disease/Condition Indication DescriptionC112038Indication for Use;Trial Disease/Condition Indication;Trial Disease/Condition Indication DescriptionA 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 IndicatorC207501An indication as to whether the disease/condition indication under study is considered a rare disease.Disease Indication Is Rare Disease Indicator
Disease/Condition Indication LabelC207502The short descriptive designation for the disease/condition indication.Disease Indication Label
Disease/Condition Indication NameC207503The literal identifier (i.e., distinctive designation) of the disease/condition indication.Disease Indication Name
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CL.C188721.DDF Intercurrent Event Attribute TerminologyDDF Intercurrent Event Attribute Terminology
(DDF Intercurrent Event Attribute Terminology)
text
Extensible: No
C188721DDF Intercurrent Event Attribute TerminologyA terminology value set relevant to the attributes of the intercurrent event.CDISC DDF Intercurrent Event Attribute Terminology
Intercurrent Event DescriptionC188856A narrative representation of the intercurrent event.Intercurrent Event Description
Intercurrent Event LabelC207504The short descriptive designation for the intercurrent event.Intercurrent Event Label
Intercurrent Event NameC188855The literal identifier (i.e., distinctive designation) of the intercurrent event.Intercurrent Event Name
Intercurrent Event StrategyC188857A textual description of the planned strategy to manage and/or mitigate intercurrent events.Intercurrent Event Strategy
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CL.C207430.DDF Masking Attribute TerminologyDDF Masking Attribute Terminology
(DDF Masking Attribute Terminology)
text
Extensible: No
C207430DDF Masking Attribute TerminologyA terminology value set relevant to the attributes of the masking.CDISC DDF Masking Attribute Terminology
Masking DescriptionC207505A narrative representation of the study masking strategy, based on a person's role within the study.Study Masking Description
Masking RoleC207506Blinded Roles;Blinding RolesAn identifying designation assigned to a masked individual within a study that corresponds with their function.Study Masking Role
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CL.C207426.DDF Narrative Content Attribute TerminologyDDF Narrative Content Attribute Terminology
(DDF Narrative Content Attribute Terminology)
text
Extensible: No
C207426DDF Narrative Content Attribute TerminologyA terminology value set relevant to the attributes of the narrative content.CDISC DDF Narrative Content Attribute Terminology
Narrative Content NameC207507The literal identifier (i.e., distinctive designation) of the narrative content.Narrative Content Name
Narrative Content Section NumberC207509The numeric identifier assigned to a particular document section containing narrative content.Narrative Content Section Number
Narrative Content Section TitleC207510An identifying designation for the document section containing narrative content.Narrative Content Section Title
Narrative Content TextC207508A textual representation of the narrative content.Narrative Content Text
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CL.C188707.DDF Objective Attribute TerminologyDDF Objective Attribute Terminology
(DDF Objective Attribute Terminology)
text
Extensible: No
C188707DDF Objective Attribute TerminologyA terminology value set relevant to the attributes of the objective.CDISC DDF Objective Attribute Terminology
Study Objective DescriptionC94090A narrative representation of the study objective.Study Objective Description
Study Objective LabelC207511The short descriptive designation for the study objective.Study Objective Label
Study Objective LevelC188823A characterization or classification of the study objective that determines its category of importance relative to other study objectives.Study Objective Level
Study Objective NameC207512The literal identifier (i.e., distinctive designation) of the study objective.Study Objective Name
Study Objective TextC207513An instance of structured text that represents the study objective.Study Objective Text
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CL.C188702.DDF Organization Attribute TerminologyDDF Organization Attribute Terminology
(DDF Organization Attribute Terminology)
text
Extensible: No
C188702DDF Organization Attribute TerminologyA terminology value set relevant to the attributes of the organization.CDISC DDF Organization Attribute Terminology
Identifier Provider Organization NameC188819The name of the organization that provides the identifier for the entity.Identifier Provider Organization Name
Organization IdentifierC93401A unique symbol that establishes identity of the organization. (BRIDG)Organization Identifier
Organization LabelC207514The short descriptive designation for the organization.Organization Label
Organization NameC93874A non-unique textual identifier for the organization. (BRIDG)Organization Name
Organization TypeC188820A 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 TerminologyDDF Parameter Map Attribute Terminology
(DDF Parameter Map Attribute Terminology)
text
Extensible: No
C207431DDF Parameter Map Attribute TerminologyA terminology value set relevant to the attributes of the parameter map.CDISC DDF Parameter Map Attribute Terminology
Programming Tag ReferenceC207516The 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 TagC207515Character strings bounded by angle brackets that act as containers for programming language elements.Programming Tag
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CL.C207432.DDF Population Definition Attribute TerminologyDDF Population Definition Attribute Terminology
(DDF Population Definition Attribute Terminology)
text
Extensible: No
C207432DDF Population Definition Attribute TerminologyA terminology value set relevant to the attributes of the population definition.CDISC DDF Population Definition Attribute Terminology
Population Definition DescriptionC207517A narrative representation of the population definition.Population Definition Description
Population Definition Includes Healthy Subjects IndicatorC207518An 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 LabelC207519The short descriptive designation for the population definition.Population Definition Label
Population Definition NameC207520The literal identifier (i.e., distinctive designation) of the population definition.Population Definition Name
Population Definition Planned AgeC207701The anticipated age of subjects within the population definition.Population Definition Planned Age
Population Definition Planned Completion NumberC207521The 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 NumberC207522The 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 SexC207523The protocol-defined sex within the population definition.Population Definition Planned Sex
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CL.C188716.DDF Procedure Attribute TerminologyDDF Procedure Attribute Terminology
(DDF Procedure Attribute Terminology)
text
Extensible: No
C188716DDF Procedure Attribute TerminologyA terminology value set relevant to the attributes of the procedure.CDISC DDF Procedure Attribute Terminology
Procedure CodeC154626A symbol or combination of symbols which is assigned to medical procedure.Procedure Code
Procedure DescriptionC201324A narrative representation of the procedure.Procedure Description
Procedure LabelC207524The short descriptive designation for the procedure.Procedure Label
Procedure NameC201325The literal identifier (i.e., distinctive designation) of the procedure.Procedure Name
Procedure TypeC188848A characterization or classification of the study procedure.Study Procedure Type
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CL.C207433.DDF Quantity Attribute TerminologyDDF Quantity Attribute Terminology
(DDF Quantity Attribute Terminology)
text
Extensible: No
C207433DDF Quantity Attribute TerminologyA terminology value set relevant to the attributes of the quantity.CDISC DDF Quantity Attribute Terminology
Quantity UnitC44258The type of unit of measure being used to express a quantity.Unit of Quantity
Quantity ValueC25712A numerical quantity measured or assigned or computed.Value
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CL.C207434.DDF Range Attribute TerminologyDDF Range Attribute Terminology
(DDF Range Attribute Terminology)
text
Extensible: No
C207434DDF Range Attribute TerminologyA terminology value set relevant to the attributes of the range.CDISC DDF Range Attribute Terminology
Maximum ValueC25564The largest value in quantity or degree in a set of values.Maximum
Minimum ValueC25570The smallest value in quantity or degree in a set of values.Minimum
Unit of MeasureC25709A named quantity in terms of which other quantities are measured or specified, used as a standard measurement of like kinds.Unit of Measure
Value Range is Approximate IndicatorC207525An indication as to whether the value range is almost, but not quite, exact.Value Range is Approximate Indicator
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CL.C207435.DDF Research Organization Attribute TerminologyDDF Research Organization Attribute Terminology
(DDF Research Organization Attribute Terminology)
text
Extensible: No
C207435DDF Research Organization Attribute TerminologyA terminology value set relevant to the attributes of the research organization.CDISC DDF Research Organization Attribute Terminology
Identifier Provider Research Organization NameC207526The name of the research organization that provides the identifier for the entity.Identifier Provider Research Organization Name
Organization TypeC188820A 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
Research Organization IdentifierC207527A sequence of characters used to identify, name, or characterize the research organization.Research Organization Identifier
Research Organization LabelC207528The short descriptive designation for the research organization.Research Organization Label
Research Organization NameC207529The literal identifier (i.e., distinctive designation) of the research organization.Research Organization Name
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CL.C201258.DDF Response Code Attribute TerminologyDDF Response Code Attribute Terminology
(DDF Response Code Attribute Terminology)
text
Extensible: No
C201258DDF Response Code Attribute TerminologyA terminology value set relevant to the attributes of the response code.CDISC DDF Response Code Attribute Terminology
CodeC25162A symbol or combination of symbols which is assigned to the members of a collection.Code
Response Code Enabled IndicatorC201330An indication as to whether the response code is activated for use within a given usage context.Response Code Enabled Indicator
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CL.C201259.DDF Schedule Timeline Attribute TerminologyDDF Schedule Timeline Attribute Terminology
(DDF Schedule Timeline Attribute Terminology)
text
Extensible: No
C201259DDF Schedule Timeline Attribute TerminologyA terminology value set relevant to the attributes of the schedule timeline.CDISC DDF Schedule Timeline Attribute Terminology
Main Timeline IndicatorC201331An indication as to whether the timeline or timeline component is part of the central or principal timeline.Main Timeline Indicator
Schedule Timeline DescriptionC201332A narrative representation of the schedule timeline.Schedule Timeline Description
Schedule Timeline Entry ConditionC201333A logical evaluation on which rests the validity of entry into a schedule timeline.Schedule Timeline Entry Condition
Schedule Timeline LabelC207530The short descriptive designation for the schedule timeline.Schedule Timeline Label
Schedule Timeline NameC201334The literal identifier (i.e., distinctive designation) of the schedule timeline.Schedule Timeline Name
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CL.C207436.DDF Scheduled Activity Instance Attribute TerminologyDDF Scheduled Activity Instance Attribute Terminology
(DDF Scheduled Activity Instance Attribute Terminology)
text
Extensible: No
C207436DDF Scheduled Activity Instance Attribute TerminologyA terminology value set relevant to the attributes of the scheduled activity instance.CDISC DDF Scheduled Activity Instance Attribute Terminology
Scheduled Activity Instance DescriptionC207531A narrative representation of the scheduled activity instance.Scheduled Activity Instance Description
Scheduled Activity Instance LabelC207532The short descriptive designation for the scheduled activity instance.Scheduled Activity Instance Label
Scheduled Activity Instance NameC207533The 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 TerminologyDDF Scheduled Decision Instance Attribute Terminology
(DDF Scheduled Decision Instance Attribute Terminology)
text
Extensible: No
C201260DDF Scheduled Decision Instance Attribute TerminologyA terminology value set relevant to the attributes of the scheduled decision instance.CDISC DDF Scheduled Decision Instance Attribute Terminology
Scheduled Decision Instance DescriptionC207534A narrative representation of the scheduled Decision instance.Scheduled Decision Instance Description
Scheduled Decision Instance LabelC207535The short descriptive designation for the scheduled Decision instance.Scheduled Decision Instance Label
Scheduled Decision Instance NameC207536The 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 TerminologyDDF Scheduled Instance Attribute Terminology
(DDF Scheduled Instance Attribute Terminology)
text
Extensible: No
C201261DDF Scheduled Instance Attribute TerminologyA terminology value set relevant to the attributes of the scheduled instance.CDISC DDF Scheduled Instance Attribute Terminology
Scheduled Instance DescriptionC207453A narrative representation of the scheduled instance.Scheduled Instance Description
Scheduled Instance LabelC207454The short descriptive designation for the scheduled instance.Scheduled Instance Label
Scheduled Instance NameC207455The literal identifier (i.e., distinctive designation) of the scheduled instance.Scheduled Instance Name
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CL.C207437.DDF Study Amendment Attribute TerminologyDDF Study Amendment Attribute Terminology
(DDF Study Amendment Attribute Terminology)
text
Extensible: No
C207437DDF Study Amendment Attribute TerminologyA terminology value set relevant to the attributes of the study amendment.CDISC DDF Study Amendment Attribute Terminology
Study Amendment NumberC207537Amendment IdentifierA string of numerals that uniquely identifies a protocol amendment.Study Amendment Number
Study Amendment Substantial Impact IndicatorC207538An indication as to whether the amendment is likely to have a substantial impact on the safety or rights of study subjects/participants.Study Amendment Substantial Impact Indicator
Study Amendment SummaryC115627A short narrative representation describing the changes introduced in the current version of the protocol.Clinical Trial Protocol Amendment Summary
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CL.C207438.DDF Study Amendment Reason Attribute TerminologyDDF Study Amendment Reason Attribute Terminology
(DDF Study Amendment Reason Attribute Terminology)
text
Extensible: No
C207438DDF Study Amendment Reason Attribute TerminologyA terminology value set relevant to the attributes of the study amendment reason.CDISC DDF Study Amendment Reason Attribute Terminology
Other Reason for Study AmendmentC207539The 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 CodeC207540Study Amendment Reason CodeA 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 TerminologyDDF Study Arm Attribute Terminology
(DDF Study Arm Attribute Terminology)
text
Extensible: No
C188709DDF Study Arm Attribute TerminologyA terminology value set relevant to the attributes of the study Arm.CDISC DDF Study Arm Attribute Terminology
Study Arm Data Origin DescriptionC188828The textual representation of the study arm data origin.Study Arm Data Origin Description
Study Arm Data Origin TypeC188829A characterization or classification of the study arm with respect to where the study arm data originates.Study Arm Data Origin Type
Study Arm DescriptionC93728Arm DescriptionA narrative representation of the study arm.Arm Description
Study Arm LabelC172456Arm LabelThe short descriptive designation for the study arm.Study Arm Label
Study Arm NameC170984The literal identifier (i.e., distinctive designation) of the study arm.Planned Study Arm Name
Study Arm TypeC172457Arm TypeA characterization or classification of the study arm.Study Arm Type
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CL.C207439.DDF Study Cohort Attribute TerminologyDDF Study Cohort Attribute Terminology
(DDF Study Cohort Attribute Terminology)
text
Extensible: No
C207439DDF Study Cohort Attribute TerminologyA terminology value set relevant to the attributes of the study cohort.CDISC DDF Study Cohort Attribute Terminology
Study Cohort DescriptionC207542A narrative representation of the study cohort.Study Cohort Description
Study Cohort Includes Healthy Subjects IndicatorC207480An 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 LabelC207543The short descriptive designation for the study cohort.Study Cohort Label
Study Cohort NameC207544The literal identifier (i.e., distinctive designation) of the study cohort.Study Cohort Name
Study Cohort Planned AgeC207545The anticipated age of subjects within the study cohort.Study Cohort Planned Age
Study Cohort Planned Completion NumberC207546The 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 NumberC207702The 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 SexC207541The protocol-defined sex within the study cohort.Planned Sex of Study Cohort Participants
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CL.C188703.DDF Study Design Attribute TerminologyDDF Study Design Attribute Terminology
(DDF Study Design Attribute Terminology)
text
Extensible: No
C188703DDF Study Design Attribute TerminologyA terminology value set relevant to the attributes of the study design.CDISC DDF Study Design Attribute Terminology
Intervention Model TypeC98746Intervention ModelThe general design of the strategy for assigning interventions to participants in a clinical study. (clinicaltrials.gov)Intervention Model
Study Design CharacteristicC207547The distinguishing qualities or prominent aspect of a study design.Study Design Characteristic
Study Design DescriptionC147139Overall Design;Study Design Description;Study Design Overview;Summary of Study DesignA narrative representation of the study design.Study Design Description
Study Design LabelC207548The short descriptive designation for the study design.Study Design Label
Study Design NameC201338The literal identifier (i.e., distinctive designation) of the study design.Study Design Name
Study Design Population DescriptionC70834A narrative representation of the study design population.Study Population Description
Study Design RationaleC142705Reason(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
Therapeutic AreasC101302Therapeutic AreaA 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 Blinding SchemaC49658Study Blinding Design;Study Blinding Schema;Study Masking Design;Trial Blinding Design;Trial Blinding Schema;Trial Masking DesignThe 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 TypeC49652Trial Intent TypeThe planned purpose of the therapy, device, or agent under study in the clinical trial.Clinical Study by Intent
Trial TypeC49660Trial Scope;Trial TypeThe nature of the interventional study for which information is being collected.Trial Type
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CL.C188706.DDF Study Design Population Attribute TerminologyDDF Study Design Population Attribute Terminology
(DDF Study Design Population Attribute Terminology)
text
Extensible: No
C188706DDF Study Design Population Attribute TerminologyA terminology value set relevant to the attributes of the study design population.CDISC DDF Study Design Population Attribute Terminology
Study Design Population Includes Healthy Subjects IndicatorC207549An 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 LabelC207550The short descriptive designation for the study design population.Study Design Population Label
Study Design Population NameC207553The literal identifier (i.e., distinctive designation) of the study design population.Study Design Population Name
Study Design Population Planned AgeC207450The anticipated age of subjects within the study design population.Study Design Population Planned Age
Study Design Population Planned Completion NumberC207451The 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 NumberC207452The 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 SexC207551The protocol-defined sex within the study design population.Study Design Population Planned Sex
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CL.C188711.DDF Study Element Attribute TerminologyDDF Study Element Attribute Terminology
(DDF Study Element Attribute Terminology)
text
Extensible: No
C188711DDF Study Element Attribute TerminologyA terminology value set relevant to the attributes of the study element.CDISC DDF Study Element Attribute Terminology
Study Design Element DescriptionC188834A narrative representation of the study design element.Study Design Element Description
Study Design Element LabelC207554The short descriptive designation for the study design element.Study Design Element Label
Study Design Element NameC188833The literal identifier (i.e., distinctive designation) of the study design element.Study Design Element Name
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CL.C188710.DDF Study Epoch Attribute TerminologyDDF Study Epoch Attribute Terminology
(DDF Study Epoch Attribute Terminology)
text
Extensible: No
C188710DDF Study Epoch Attribute TerminologyA terminology value set relevant to the attributes of the study epoch.CDISC DDF Study Epoch Attribute Terminology
Study Epoch DescriptionC93824A narrative representation of the study epoch.Epoch Description
Study Epoch LabelC207555The short descriptive designation for the study epoch.Study Epoch Label
Study Epoch NameC93825The 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 TypeC188830A 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 TerminologyDDF Study Identifier Attribute Terminology
(DDF Study Identifier Attribute Terminology)
text
Extensible: No
C188701DDF Study Identifier Attribute TerminologyA terminology value set relevant to the attributes of the study identifier.CDISC DDF Study Identifier Attribute Terminology
Study IdentifierC83082A sequence of characters used to identify, name, or characterize the study.Study Identifier
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CL.C188704.DDF Study Intervention Attribute TerminologyDDF Study Intervention Attribute Terminology
(DDF Study Intervention Attribute Terminology)
text
Extensible: No
C188704DDF Study Intervention Attribute TerminologyA terminology value set relevant to the attributes of the study interventions.CDISC DDF Study Intervention Attribute Terminology
Pharmacologic ClassC98768Pharmacologic ClassThe pharmacological class of the investigational product.Pharmacological Class of Investigational Therapy
Study Intervention CodeC207648A symbol or combination of symbols which is assigned to the study intervention.Study Intervention Code
Study Intervention DescriptionC207647A narrative representation of the study intervention.Study Intervention Description
Study Intervention LabelC207556The short descriptive designation for the study intervention.Study Intervention Label
Study Intervention Minimum Response DurationC207557The value representing the minimum amount of time required to meet the criteria for response to study intervention.Study Intervention Minimum Response Duration
Study Intervention NameC207558The literal identifier (i.e., distinctive designation) of the study intervention.Study Intervention Name
Study Intervention Product DesignationC207559An indication as to whether the investigational intervention is an investigational medicinal product or an auxiliary medicinal product.Study Intervention Product Type
Study Intervention RoleC207560Study Intervention UseThe intended use of the trial intervention within the context of the study design.Study Intervention Role
Study Intervention TypeC98747Intervention TypeThe kind of product or procedure studied in a trial.Intervention Type
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CL.C207440.DDF Study Protocol Document Attribute TerminologyDDF Study Protocol Document Attribute Terminology
(DDF Study Protocol Document Attribute Terminology)
text
Extensible: No
C207440DDF Study Protocol Document Attribute TerminologyA terminology value set relevant to the attributes of the study protocol document.CDISC DDF Study Protocol Document Attribute Terminology
Study Protocol Document DescriptionC207561A narrative representation of the study protocol document.Study Protocol Document Description
Study Protocol Document LabelC207562The short descriptive designation for the study protocol document.Study Protocol Document Label
Study Protocol Document NameC207563The literal identifier (i.e., distinctive designation) of the study protocol document.Study Protocol Document Name
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CL.C207441.DDF Study Site Attribute TerminologyDDF Study Site Attribute Terminology
(DDF Study Site Attribute Terminology)
text
Extensible: No
C207441DDF Study Site Attribute TerminologyA terminology value set relevant to the attributes of the study site.CDISC DDF Study Site Attribute Terminology
Study Site DescriptionC207564A narrative representation of the study site.Study Site Description
Study Site LabelC207565The short descriptive designation for the study site.Study Site Label
Study Site NameC207566The literal identifier (i.e., distinctive designation) of the study site.Study Site Name
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CL.C207442.DDF Study Title Attribute TerminologyDDF Study Title Attribute Terminology
(DDF Study Title Attribute Terminology)
text
Extensible: No
C207442DDF Study Title Attribute TerminologyA terminology value set relevant to the attributes of the study title.CDISC DDF Study Title Attribute Terminology
Study Title TextC207567An instance of unstructured text that represents the study title.Study Title Text
Study Title TypeC207568A characterization or classification of the study title.Study Title Type
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CL.C207443.DDF Study Version Attribute TerminologyDDF Study Version Attribute Terminology
(DDF Study Version Attribute Terminology)
text
Extensible: No
C207443DDF Study Version Attribute TerminologyA terminology value set relevant to the attributes of the study version.CDISC DDF Study Version Attribute Terminology
Business Therapeutic AreasC201322A therapeutic area classification based on the structure and operations of the business unit.Business Therapeutic Area
Study RationaleC94122Study PurposeA 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 Type ClassificationC142175Study Type;Study Type ClassificationThe nature of the investigation for which study information is being collected. (After clinicaltrials.gov)Study Type
Study Version IdentifierC207570A sequence of characters used to identify, name, or characterize the study version.Study Version Identifier
Trial PhaseC48281Trial Phase;Trial Phase ClassificationA 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.C207444.DDF Subject Enrollment Attribute TerminologyDDF Subject Enrollment Attribute Terminology
(DDF Subject Enrollment Attribute Terminology)
text
Extensible: No
C207444DDF Subject Enrollment Attribute TerminologyA terminology value set relevant to the attributes of the subject enrollment.CDISC DDF Subject Enrollment Attribute Terminology
Subject Enrollment CodeC207571A symbol or combination of symbols which is assigned to the subject enrollment.Subject Enrollment Code
Subject Enrollment Quantity ValueC207573The value representing the number of individuals enrolled in a study.Subject Enrollment Quantity Value
Subject Enrollment TypeC207574A characterization or classification of the subject enrollment.Subject Enrollment Type
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CL.C207445.DDF Syntax Template Attribute TerminologyDDF Syntax Template Attribute Terminology
(DDF Syntax Template Attribute Terminology)
text
Extensible: No
C207445DDF Syntax Template Attribute TerminologyA terminology value set relevant to the attributes of the syntax template.CDISC DDF Syntax Template Attribute Terminology
Syntax Template DescriptionC207575A narrative representation of the syntax template.Syntax Template Description
Syntax Template LabelC207576The short descriptive designation for the syntax template.Syntax Template Label
Syntax Template NameC207577The literal identifier (i.e., distinctive designation) of the syntax template.Syntax Template Name
Syntax Template TextC207578A 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 TerminologyDDF Syntax Template Dictionary Attribute Terminology
(DDF Syntax Template Dictionary Attribute Terminology)
text
Extensible: No
C207446DDF Syntax Template Dictionary Attribute TerminologyA terminology value set relevant to the attributes of the syntax template dictionary.CDISC DDF Syntax Template Dictionary Attribute Terminology
Syntax Template Dictionary DescriptionC207579A narrative representation of the syntax template dictionary.Syntax Template Dictionary Description
Syntax Template Dictionary LabelC207580The short descriptive designation for the syntax template dictionary.Syntax Template Dictionary Label
Syntax Template Dictionary NameC207581The literal identifier (i.e., distinctive designation) of the syntax template dictionary.Syntax Template Dictionary Name
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CL.C201262.DDF Timing Attribute TerminologyDDF Timing Attribute Terminology
(DDF Timing Attribute Terminology)
text
Extensible: No
C201262DDF Timing Attribute TerminologyA terminology value set relevant to the attributes of the timing.CDISC DDF Timing Attribute Terminology
Timing DescriptionC164648A narrative representation of the biomedical concept category.Timing Description
Timing LabelC207583The short descriptive designation for the timing.Timing Label
Timing NameC207584The literal identifier (i.e., distinctive designation) of the timing.Timing Name
Timing Relative To FromC201297The name of the reference event used to define the temporal relationship with another event.Timing Relative To From Name
Timing TypeC201298A characterization or classification of the chronological relationship between temporal events.Timing Type
Timing Value LabelC207585The short descriptive designation for the timing value.Timing Value Label
Timing ValueC201341The temporal value of the chronological relationship between temporal events.Timing Value
Timing Window LabelC207586The 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, LowerC201342The earliest chronological value of an allowable period of time during which a temporal event takes place.Lower Timing Window
Timing Window, UpperC201343The 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 TerminologyDDF Transition Rule Attribute Terminology
(DDF Transition Rule Attribute Terminology)
text
Extensible: No
C188712DDF Transition Rule Attribute TerminologyA terminology value set relevant to the attributes of the transition rule.CDISC DDF Transition Rule Attribute Terminology
Transition Rule DescriptionC188835A narrative representation of the transition rule.Transition Rule Description
Transition Rule LabelC207587The short descriptive designation for the transition rule.Transition Rule Label
Transition Rule NameC207588The literal identifier (i.e., distinctive designation) of the transition rule.Transition Rule Name
Transition Rule TextC207589An instance of unstructured text that represents the transition rule.Transition Rule Text
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CL.C188728.Encounter Type Value Set TerminologyEncounter Type Value Set Terminology
(Encounter Type Value Set Terminology)
text
Extensible: Yes
C188728Encounter Type Value Set TerminologyThe terminology relevant to the encounter type.CDISC DDF Encounter Type Value Set Terminology
VisitC25716The 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 TerminologyEndpoint Level Value Set Terminology
(Endpoint Level Value Set Terminology)
text
Extensible: No
C188726Endpoint Level Value Set TerminologyThe terminology relevant to the endpoint level.CDISC DDF Endpoint Level Value Set Terminology
Exploratory EndpointC170559Endpoint(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 EndpointC94496Endpoint(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 EndpointC139173Endpoint(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 TerminologyGeographic Scope Type Value Set Terminology
(Geographic Scope Type Value Set Terminology)
text
Extensible: No
C207412Geographic Scope Type Value Set TerminologyThe terminology relevant to the geographic scope type value set.CDISC DDF Geographic Scope Type Value Set Terminology
CountryC25464A sovereign nation occupying a distinct territory and ruled by an autonomous government.Country
GlobalC68846Covering or affecting the whole of a system.Global
RegionC41129An 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 TerminologyGovernance Date Type Value Set Terminology
(Governance Date Type Value Set Terminology)
text
Extensible: Yes
C207413Governance Date Type Value Set TerminologyThe terminology relevant to the governance date type value set.CDISC DDF Governance Date Type Value Set Terminology
Protocol Effective DateC207598The date and time specifying when the protocol takes effect or becomes operative.Protocol Effective Date
Sponsor Approval DateC132352Protocol Amendment Approval by Sponsor Date;Study Protocol Version Approval DateThe date on which a version of the protocol was finalized or approved by the sponsor.Protocol Approval by Sponsor Date
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CL.C207414.Masking Role Value Set TerminologyMasking Role Value Set Terminology
(Masking Role Value Set Terminology)
text
Extensible: Yes
C207414Masking Role Value Set TerminologyThe terminology relevant to the masking role value set.CDISC DDF Masking Role Value Set Terminology
Care ProviderC17445Caregiver;Carer;CaretakerThe primary person in charge of the care of a patient, usually a family member or a designated health care professional. (NCI)Caregiver
InvestigatorC25936A person responsible for the conduct of the study, ensuring adherence to the protocol and good clinical practices. (CDISC Glossary)Investigator
Outcomes AssessorC207599The individual who evaluates the outcome(s) of interest. (Clinicaltrials.gov)Outcomes Assessor
SponsorC70793Clinical Study Sponsor;Sponsor;Study SponsorAn 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
Study SubjectC41189An 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.C188725.Objective Level Value Set TerminologyObjective Level Value Set Terminology
(Objective Level Value Set Terminology)
text
Extensible: No
C188725Objective Level Value Set TerminologyThe terminology relevant to the objective level.CDISC DDF Objective Level Value Set Terminology
Exploratory ObjectiveC163559Study Exploratory Objective;Trial Exploratory ObjectiveAdditional scientific question(s) within the study that enable further discovery research, beyond the primary and secondary objectives.Trial Exploratory Objective
Study Primary ObjectiveC85826Study Primary Objective;Trial Primary ObjectiveThe main scientific question(s) the study is designed to answer. (CDISC Glossary)Trial Primary Objective
Study Secondary ObjectiveC85827Study Secondary Objective;Trial Secondary ObjectiveThe supportive or ancillary scientific question(s) the study is designed to answer. (CDISC Glossary)Trial Secondary Objective
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CL.C188724.Organization Type Value Set TerminologyOrganization Type Value Set Terminology
(Organization Type Value Set Terminology)
text
Extensible: Yes
C188724Organization Type Value Set TerminologyThe terminology relevant to the organization type.CDISC DDF Organization Type Value Set Terminology
Clinical Study RegistryC93453An organization (typically a government agency) that administers the registration of studies. (BRIDG)Study Registry
Clinical Study SponsorC70793Clinical Study Sponsor;Sponsor;Study SponsorAn 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
Regulatory AgencyC188863Regulator;Regulatory BodyAn 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.C188723.Protocol Status Value Set TerminologyProtocol Status Value Set Terminology
(Protocol Status Value Set Terminology)
text
Extensible: No
C188723Protocol Status Value Set TerminologyThe terminology relevant to the protocol status.CDISC DDF Protocol Status Value Set Terminology
ApprovedC25425Acceptance as satisfactory by an authoritative body; established by authority; given authoritative approval.Approval
DraftC85255A preliminary version of a written work, design, or picture.Draft
FinalC25508Conclusive in a process or progression.Final
ObsoleteC63553No longer in use or valid; old.Obsolete
Pending ReviewC188862Draft Pending ReviewA preliminary version of a written work, design, or picture that is awaiting review.Pending Review
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CL.C207415.Study Amendment Reason Code Value Set TerminologyStudy Amendment Reason Code Value Set Terminology
(Study Amendment Reason Code Value Set Terminology)
text
Extensible: No
C207415Study Amendment Reason Code Value Set TerminologyThe terminology relevant to the study amendment reason code value set.CDISC DDF Study Amendment Reason Code Value Set Terminology
Change In Standard Of CareC207600A 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 StrategyC207601A 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 AdditionC207602The 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 ProtocolC207603An 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 FeedbackC207604Feedback from the investigator or study site necessitates a change(s) to, or formal clarification of, the protocol. (ICH M11)Investigator/Site Feedback
IRB/IEC FeedbackC207605Feedback 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 ChangeC207606A 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)C207607Previously 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 GuidanceC207608A 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 AvailableC207609Previously unavailable safety data becomes available, which necessitates a change(s) to, or formal clarification of, the protocol. (ICH M11)New Safety Information Available
Protocol Design ErrorC207610A protocol design error necessitates a change(s) to, or formal clarification of, a document. (ICH M11)Protocol Design Error
Recruitment DifficultyC207611Challenges with participant recruitment necessitates a change(s) to, or formal clarification of, the protocol. (ICH M11)Recruitment Difficulty
Regulatory Agency Request To AmendC207612A 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 TerminologyStudy Arm Data Origin Type Value Set Terminology
(Study Arm Data Origin Type Value Set Terminology)
text
Extensible: Yes
C188727Study Arm Data Origin Type Value Set TerminologyThe terminology relevant to the study arm data origin type.CDISC DDF Study Arm Data Origin Type Value Set Terminology
Data Generated Within StudyC188866Data that are generated from the current study.Data Generated Within Study
Historical DataC188864Data from studies that have occurred in the past.Historical Data
Real World DataC165830Data 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 DataC176263Data 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
Virtual DataC188865Data that are generated from virtual encounters between investigators and subjects.Virtual Data
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CL.C207416.Study Design Characteristics Value Set TerminologyStudy Design Characteristics Value Set Terminology
(Study Design Characteristics Value Set Terminology)
text
Extensible: Yes
C207416Study Design Characteristics Value Set TerminologyThe terminology relevant to the study design characteristics value set.CDISC DDF Study Design Characteristics Value Set Terminology
AdaptiveC98704A 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
ExtensionC207613Roll-over StudyA 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
RandomizedC46079A study design in which interventions are assigned to subjects according to randomization principles.Randomized Controlled Clinical Trial
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CL.C207418.Study Intervention Product Designation Value Set TerminologyStudy Intervention Product Designation Value Set Terminology
(Study Intervention Product Designation Value Set Terminology)
text
Extensible: No
C207418Study Intervention Product Designation Value Set TerminologyThe terminology relevant to the study intervention product designation value set.CDISC DDF Study Intervention Product Designation Value Set Terminology
IMPC202579A 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 (AxMP)C156473A 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.C207417.Study Intervention Role Value Set TerminologyStudy Intervention Role Value Set Terminology
(Study Intervention Role Value Set Terminology)
text
Extensible: No
C207417Study Intervention Role Value Set TerminologyThe terminology relevant to the study intervention role value set.CDISC DDF Study Intervention Role Value Set Terminology
Additional Required TreatmentC207614A 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 TreatmentC165822Medicinal 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 AgentC158128A 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
DiagnosticC18020Any procedure or test used to diagnose a disease or disorder.Diagnostic Procedure
Experimental InterventionC41161Investigational Interventional;Investigational Therapy or TreatmentThe 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
PlaceboC753A 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 MedicineC165835Medicinal 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.C207419.Study Title Type Value Set TerminologyStudy Title Type Value Set Terminology
(Study Title Type Value Set Terminology)
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Extensible: No
C207419Study Title Type Value Set TerminologyThe terminology relevant to the study title type value set.CDISC DDF Study Title Type Value Set Terminology
Brief Study TitleC207615Abbreviated Protocol TitleThe short descriptive name for the study.Brief Study Title
Official Study TitleC207616The formal descriptive name for the study.Official Study Title
Public Study TitleC207617The descriptive name of the study that is intended for the lay public, written in easily understood language.Public Study Title
Scientific Study TitleC207618A more extensive descriptive name of the study that is intended for medical professionals, written using medical and scientific language.Scientific Study Title
Study AcronymC207646Trial AcronymA 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 TerminologyTiming Relative To From Value Set Terminology
(Timing Relative To From Value Set Terminology)
text
Extensible: No
C201265Timing Relative To From Value Set TerminologyThe terminology relevant to the timing relative to from value set.CDISC DDF Timing Relative To From Value Set Terminology
End to EndC201352A timing relationship defined as the end of one event to the end of another event.End to End
End to StartC201353A timing relationship defined as the end of one event to the start of another event.End to Start
Start to EndC201354A timing relationship defined as the start of one event to the end of another event.Start to End
Start to StartC201355A 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 TerminologyTiming Type Value Set Terminology
(Timing Type Value Set Terminology)
text
Extensible: No
C201264Timing Type Value Set TerminologyThe terminology relevant to the timing type value set.CDISC DDF Timing Type Value Set Terminology
AfterC201356A type of time point relationship that follows a point or period of time within a timeline.After Timing Type
BeforeC201357A type of time point relationship that comes before a point or period of time within a timeline.Before Timing Type
Fixed ReferenceC201358A type of time point relationship that is fixed with respect to a timeline.Fixed Reference Timing Type
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