CDISC DDF Controlled Terminology

CDISC DDF Controlled Terminology, 2024-03-29
Legend:
CodeList
CodeListItem
NCI attributes
C188714DDF Activity Attribute Terminology
C201253DDF Address 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
C188699DDF Clinical Study Attribute Terminology
C188722DDF Code Attribute Terminology
C188713DDF Encounter Attribute Terminology
C188708DDF Endpoint Attribute Terminology
C188698DDF Entity Terminology
C188719DDF Estimand Attribute Terminology
C188705DDF Indication Attribute Terminology
C188721DDF Intercurrent Event Attribute Terminology
C188704DDF Investigational Interventions Attribute Terminology
C188707DDF Objective Attribute Terminology
C188702DDF Organization Attribute Terminology
C188716DDF Procedure Attribute Terminology
C201258DDF Response Code Attribute Terminology
C201259DDF Schedule Timeline Attribute Terminology
C201260DDF Scheduled Decision Instance Attribute Terminology
C201261DDF Scheduled Instance Attribute Terminology
C188709DDF Study Arm 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
C188700DDF Study Protocol Version Attribute Terminology
C201262DDF Timing Attribute Terminology
C188712DDF Transition Rule Attribute Terminology
C188728Encounter Type Value Set Terminology
C188726Endpoint Level Value Set Terminology
C127262Environmental Setting
C99079Epoch
C99076Intervention Model Response
C171445Mode of Subject Contact
C188725Objective Level Value Set Terminology
C188724Organization Type Value Set Terminology
C188723Protocol Status Value Set Terminology
C66732Sex of Participants Response
C188727Study Arm Data Origin Type Value Set Terminology
C174222Study Arm Type Value Set Terminology
C99077Study Type Response
C201265Timing Relative To From Value Set Terminology
C201264Timing Type Value Set Terminology
C66735Trial Blinding Schema Response
C66736Trial Intent Type Response
C66737Trial Phase Response
C66739Trial Type Response

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:
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 NameC188842The literal identifier (i.e., distinctive designation) of the clinical study activity.Clinical Study Activity Name
Study Activity is Conditional ReasonC201308The explanation for why the study activity is subject to or dependent upon something else.Study Activity is Conditional Reason
Study Activity is ConditionalC201307An indication as to whether the study activity is subject to or dependent upon something else.Study Activity is Conditional Indicator
Study Activity is Optional ReasonC201310The explanation for why the study activity is available to be performed but is not obligatory.Study Activity is Optional Reason
Study Activity is OptionalC201309An indication as to whether the study activity is available to be performed but is not obligatory.Study Activity is Optional Indicator
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CL.C201253.DDF Address Attribute TerminologyDDF Address Attribute Terminology
(DDF Address Attribute Terminology)
text
Extensible:
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.C188720.DDF Analysis Population Attribute TerminologyDDF Analysis Population Attribute Terminology
(DDF Analysis Population Attribute Terminology)
text
Extensible:
C188720DDF Analysis Population Attribute TerminologyA terminology value set relevant to the attributes of the analysis population.CDISC DDF Analysis Population Attribute Terminology
Target Study Population for Analysis DescriptionC188854The textual representation of the study population for analysis.Target Study Population for Analysis Description
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CL.C201254.DDF Biomedical Concept Attribute TerminologyDDF Biomedical Concept Attribute Terminology
(DDF Biomedical Concept Attribute Terminology)
text
Extensible:
C201254DDF Biomedical Concept Attribute TerminologyA terminology value set relevant to the attributes of the biomedical concept.CDISC DDF Biomedical Concept Attribute Terminology
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:
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 DescriptionC201316The textual representation of the biomedical concept category.Biomedical Concept Category Description
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:
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 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:
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 DescriptionC201320The textual representation of the biomedical concept surrogate.Biomedical Concept Surrogate Description
Biomedical Concept Surrogate ReferenceC201321A citation to an authoritative source for a biomedical concept surrogate.Biomedical Concept Surrogate Reference
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CL.C188699.DDF Clinical Study Attribute TerminologyDDF Clinical Study Attribute Terminology
(DDF Clinical Study Attribute Terminology)
text
Extensible:
C188699DDF Clinical Study Attribute TerminologyA terminology value set relevant to the attributes of the clinical study.CDISC DDF Clinical Study Attribute Terminology
Business Therapeutic AreasC201322A therapeutic area classification based on the structure and operations of the business unit.Business Therapeutic Areas
Study AcronymC94108Trial 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 Protocol Version Acronym
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 TitleC49802Official Study Title;Study Title;Trial TitleThe sponsor-defined name of the clinical study.Trial Title
Study Type ClassificationC142175Study Type;Study Type ClassificationThe nature of the investigation for which study information is being collected. (After clinicaltrials.gov)Study Type
Study VersionC188816A plan at a particular point in time for a study.Study Version
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.C188722.DDF Code Attribute TerminologyDDF Code Attribute Terminology
(DDF Code Attribute Terminology)
text
Extensible:
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.C188713.DDF Encounter Attribute TerminologyDDF Encounter Attribute Terminology
(DDF Encounter Attribute Terminology)
text
Extensible:
C188713DDF Encounter Attribute TerminologyA terminology value set relevant to the attributes of the encounter.CDISC DDF Encounter Attribute Terminology
Clinical Encounter DescriptionC188836The textual 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
Next Encounter IdentifierC188838A system identifier assigned to a clinical encounter that occurs immediately after the current clinical encounter.Next Clinical Encounter Identifier
Previous Encounter IdentifierC188837A system identifier assigned to a clinical encounter that occurs immediately prior to the current clinical encounter.Previous Clinical Encounter Identifier
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CL.C188708.DDF Endpoint Attribute TerminologyDDF Endpoint Attribute Terminology
(DDF Endpoint Attribute Terminology)
text
Extensible:
C188708DDF Endpoint Attribute TerminologyA terminology value set relevant to the attributes of the endpoint.CDISC DDF Endpoint Attribute Terminology
Study Endpoint DescriptionC188824The textual representation of the study endpoint.Study Endpoint Description
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 Purpose DescriptionC188825The textual representation of the study endpoint purpose.Study Endpoint Purpose Description
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CL.C188698.DDF Entity TerminologyDDF Entity Terminology
(DDF Entity Terminology)
text
Extensible:
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
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 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
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
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
Experimental InterventionC41161Investigational Interventional;Investigational Therapy or TreatmentThe drug, device, therapy, 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]Protocol Agent
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
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
ProcedureC98769Medical ProcedureAny activity performed by manual and/or instrumental means for the purpose of diagnosis, assessment, therapy, prevention, or palliative care.Physical Medical Procedure
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 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 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 plan detailing how a study will be performed in order to represent the phenomenon under examination, to answer the research questions that have been asked, and informing the statistical approach.Study Design
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 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 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
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 population within the general population for 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:
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
Variable of InterestC201323The variable identified as the focus for developing the estimand.Variable of Interest for the Estimand
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CL.C188705.DDF Indication Attribute TerminologyDDF Indication Attribute Terminology
(DDF Indication Attribute Terminology)
text
Extensible:
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
Trial Disease/Condition Indication DescriptionC112038Indication for Use;Trial Disease/Condition Indication;Trial Disease/Condition Indication DescriptionThe textual representation of the condition, disease or disorder that the clinical trial is intended to investigate or address.Trial Indication
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CL.C188721.DDF Intercurrent Event Attribute TerminologyDDF Intercurrent Event Attribute Terminology
(DDF Intercurrent Event Attribute Terminology)
text
Extensible:
C188721DDF Intercurrent Event Attribute TerminologyA terminology value set relevant to the attributes of the intercurrent event.CDISC DDF Intercurrent Event Attribute Terminology
Intercurrent Event DescriptionC188856The textual representation of the intercurrent event.Intercurrent Event Description
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.C188704.DDF Investigational Interventions Attribute TerminologyDDF Investigational Interventions Attribute Terminology
(DDF Investigational Interventions Attribute Terminology)
text
Extensible:
C188704DDF Investigational Interventions Attribute TerminologyA terminology value set relevant to the attributes of the investigational interventions.CDISC DDF Investigational Interventions Attribute Terminology
Intervention DescriptionC177931The textual representation of the study intervention.Intervention Description
Investigational Intervention CodeC188821A short sequence of characters that represents the investigational intervention.Investigational Intervention Code
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CL.C188707.DDF Objective Attribute TerminologyDDF Objective Attribute Terminology
(DDF Objective Attribute Terminology)
text
Extensible:
C188707DDF Objective Attribute TerminologyA terminology value set relevant to the attributes of the objective.CDISC DDF Objective Attribute Terminology
Study Objective DescriptionC94090The textual representation of the study objective. (BRIDG)Study Objective Description
Study Objective LevelC188823A characterization or classification of the study objective that determines its category of importance relative to other study objectives.Study Objective Level
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CL.C188702.DDF Organization Attribute TerminologyDDF Organization Attribute Terminology
(DDF Organization Attribute Terminology)
text
Extensible:
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 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.C188716.DDF Procedure Attribute TerminologyDDF Procedure Attribute Terminology
(DDF Procedure Attribute Terminology)
text
Extensible:
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 DescriptionC201324The textual representation of the procedure.Procedure Description
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
Study Procedure is Conditional ReasonC201327The explanation for why the study procedure is subject to or dependent upon something else.Study Procedure is Conditional Reason
Study Procedure is ConditionalC201326An indication as to whether the study procedure is subject to or dependent upon something else.Study Procedure is Conditional Indicator
Study Procedure is Optional ReasonC201329The explanation for why the study procedure is available to be performed but is not obligatory.Study Procedure is Optional Reason
Study Procedure is OptionalC201328An indication as to whether the study procedure is available to be performed but is not obligatory.Study Procedure is Optional Indicator
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CL.C201258.DDF Response Code Attribute TerminologyDDF Response Code Attribute Terminology
(DDF Response Code Attribute Terminology)
text
Extensible:
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:
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 DescriptionC201332The textual 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 NameC201334The literal identifier (i.e., distinctive designation) of the schedule timeline.Schedule Timeline 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:
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
Condition AssignmentsC201335An allotting or appointment to a set of conditions that are to be met in order to make a logical decision.Condition Assignments
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CL.C201261.DDF Scheduled Instance Attribute TerminologyDDF Scheduled Instance Attribute Terminology
(DDF Scheduled Instance Attribute Terminology)
text
Extensible:
C201261DDF Scheduled Instance Attribute TerminologyA terminology value set relevant to the attributes of the scheduled instance.CDISC DDF Scheduled Instance Attribute Terminology
Schedule Sequence NumberC201336A numeral or string of numerals expressing a relative sequence of scheduled temporal events.Schedule Sequence Number
Scheduled Instance TypeC201337A characterization or classification of the scheduled instance.Scheduled Instance Type
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CL.C188709.DDF Study Arm Attribute TerminologyDDF Study Arm Attribute Terminology
(DDF Study Arm Attribute Terminology)
text
Extensible:
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 DescriptionThe textual representation of the arm for the study.Arm Description
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.C188703.DDF Study Design Attribute TerminologyDDF Study Design Attribute Terminology
(DDF Study Design Attribute Terminology)
text
Extensible:
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 DescriptionC147139Overall Design;Study Design Description;Study Design Overview;Summary of Study DesignSummary description of the overall study plan and design, should include treatments studied, population studied, level and method of blinding/unmasking, kind of controls, method of assignment to treatment, sequence and duration of study periods, any safety, data monitoring or special steering or evaluation committees, and interim analyses. (ICH E3)Study Design Description
Study Design NameC201338The literal identifier (i.e., distinctive designation) of the study design.Study Design Name
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:
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
Planned Maximum Age of SubjectsC49694Planned Maximum Age of SubjectsThe anticipated maximum age of the subjects to be entered in a clinical trial. (NCI)Planned Maximum Age of Subjects
Planned Minimum Age of SubjectsC49693Planned Minimum Age of SubjectsThe anticipated minimum age of the subjects to be entered in a clinical trial. (NCI)Planned Minimum Age of Subjects
Planned Number of ParticipantsC49692Anticipated Enrollment;Planned Enrollment;Planned Number of Subjects;Target EnrollmentThe planned number of subjects to be entered in a clinical trial. (NCI)Planned Subject Number
Sex of ParticipantsC49696Sex of ParticipantsThe specific sex, either male, female, or mixed of the subject group being studied. (NCI)Sex of Study Group
Target Study Population DescriptionC70834The textual representation of the study population.Study Population Description
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CL.C188711.DDF Study Element Attribute TerminologyDDF Study Element Attribute Terminology
(DDF Study Element Attribute Terminology)
text
Extensible:
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 DescriptionC188834The textual representation of the study design element.Study Design Element Description
Study Design Element NameC188833The literal identifier (i.e., distinctive designation) of the study design element.Study Design Element Name
Transition End RuleC201339A criterion that establishes the end of a subject transition within a study workflow.Transition End Rule
Transition Start RuleC201340A criterion that establishes the beginning of a subject transition within a study workflow.Transition Start Rule
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CL.C188710.DDF Study Epoch Attribute TerminologyDDF Study Epoch Attribute Terminology
(DDF Study Epoch Attribute Terminology)
text
Extensible:
C188710DDF Study Epoch Attribute TerminologyA terminology value set relevant to the attributes of the study epoch.CDISC DDF Study Epoch Attribute Terminology
Next Epoch IdentifierC188832A system identifier assigned to the epoch that occurs immediately after the current epoch.Next Epoch Identifier
Previous Epoch IdentifierC188831A system identifier assigned to the epoch that occurs immediately prior to the current epoch.Previous Epoch Identifier
Study Epoch DescriptionC93824The textual representation of the study epoch.Epoch Description
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:
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.C188700.DDF Study Protocol Version Attribute TerminologyDDF Study Protocol Version Attribute Terminology
(DDF Study Protocol Version Attribute Terminology)
text
Extensible:
C188700DDF Study Protocol Version Attribute TerminologyA terminology value set relevant to the attributes of the study protocol version.CDISC DDF Study Protocol Version Attribute Terminology
Brief Protocol TitleC132345Abbreviated Protocol TitleThe short descriptive name for the protocol.Brief Protocol Title
Official Protocol TitleC132346The formal descriptive name for the protocol.Official Protocol Title
Protocol StatusC188818A condition of the protocol at a point in time with respect to its state of readiness for implementation.Study Protocol Status
Public Protocol TitleC94105The descriptive name of the protocol that is intended for the lay public, written in easily understood language.Study Protocol Document Version Public Title
Scientific Protocol TitleC132350A more extensive descriptive name of the protocol that is intended for medical professionals, written using medical and scientific language.Scientific Protocol Title
Study Protocol Amendment Effective DateC188817The date and time specifying when the protocol amendment takes effect or becomes operative.Study Protocol Amendment Effective Date
Study Protocol AmendmentC132347A written description of a change(s) to, or formal clarification of, a protocol. (ICH E6)Protocol Amendment
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
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CL.C201262.DDF Timing Attribute TerminologyDDF Timing Attribute Terminology
(DDF Timing Attribute Terminology)
text
Extensible:
C201262DDF Timing Attribute TerminologyA terminology value set relevant to the attributes of the timing.CDISC DDF Timing Attribute Terminology
Timing DescriptionC164648The textual representation of the chronological relationship between temporal events.Timing Description
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 ValueC201341The temporal value of the chronological relationship between temporal events.Timing Value
Timing WindowC48921A time period, or other type of interval, during which a temporal event may be achieved, obtained, or observed.Window
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:
C188712DDF Transition Rule Attribute TerminologyA terminology value set relevant to the attributes of the transition rule.CDISC DDF Transition Rule Attribute Terminology
Transition Rule DescriptionC188835The textual representation of the transition rule.Transition Rule Description
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CL.C188728.Encounter Type Value Set TerminologyEncounter Type Value Set Terminology
(Encounter Type Value Set Terminology)
text
Extensible:
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:
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.C127262.SETTINGEnvironmental Setting
(SETTING)
text
Extensible: Yes
C127262Environmental SettingTerminology relevant to the surroundings or environment.CDISC SDTM Environmental Setting Terminology
CHILD CARE CENTERC127785An establishment that provides care for infants and children.Childcare Center
CLINICC51282A health care facility where subjects or patients may receive assessments, procedures, or treatments that are provided by physicians and other healthcare providers.Clinic
FARMC48953A tract of land cultivated for the purpose of agricultural production or devoted to the raising and breeding of domestic animals.Farm
FIELDC102650A setting outside the clinic or a comparable health care facility, e.g. a doctor's office, the subject's home or workplace, a school, a public park, or a restaurant.In the Field
HEALTH FACILITYC21541The buildings and organizations where healthcare services are provided.Healthcare Facility
HOMEC18002A person's place of residence.Home
HOSPITALC16696An institution that provides medical, surgical, or psychiatric care and treatment for the sick or the injured.Hospital
HOUSEHOLD ENVIRONMENTC102647The area in which an individual lives.Household Environment
INSTITUTIONC41206An established society, corporation, foundation or other organization founded and united for a specific purpose, e.g. for health-related research; also used to refer to a building or buildings occupied or used by such organization.Institution
MOTOR VEHICLEC181529A motorized conveyance for people and goods.Motor Vehicle
NON-HOUSEHOLD ENVIRONMENTC102679An area outside of that in which an individual lives.Non-household Environment
NOT IN CLINICC181530Any environmental setting outside of a clinic.Not In Clinic
OUTPATIENT CLINICC16281A medical care center that provides healthcare services on an outpatient basis.Ambulatory Care Facility
PRISONC85862An institution where persons are confined for punishment and to protect the public.Correctional Institution
SCHOOLC17118An educational institution.School
SHELTERC85863Temporary housing for displaced or at-risk persons.Shelter
SOCIAL SETTINGC102712The surroundings or environment in which social activities occur.Social Setting
WORKSITEC17556Place or physical location of work or employment.Worksite
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CL.C99079.EPOCHEpoch
(EPOCH)
text
Extensible: Yes
C99079EpochThe name of the EPOCH.CDISC SDTM Epoch Terminology
BASELINEC125938A period in a clinical study after eligibility has been met and before the start of treatment, at which baseline measurements are collected.Baseline Epoch
BLINDED TREATMENTC102255A period in a clinical study during which subjects receive blinded therapeutic treatment.Blinded Treatment Epoch
CONTINUATION TREATMENTC123452Continuation PhaseA period in a clinical study during which subjects receive continuation treatment.Continuation Therapy Epoch
FOLLOW-UPC202578A period in a clinical study during which information about the health status of an individual is obtained after study interventions have concluded.Follow-Up Epoch
INDUCTION TREATMENTC123453Induction Phase;Intensive PhaseA period in a clinical study during which subjects receive induction treatment.Induction Therapy Epoch
LONG-TERM FOLLOW-UPC202577A period in a clinical study during which information about the health status of an individual is obtained long after study interventions have concluded.Long-term Follow-up Epoch
OBSERVATIONC165873A period in a clinical study during which subjects are observed, without any planned intervention.Observation Study Epoch
OPEN LABEL TREATMENTC102256A period in a clinical study during which subjects receive open label therapeutic treatment.Open Label Treatment Epoch
PRE-SCREENINGC199844A period in a clinical study during which subjects are evaluated prior to entering the full screening period.Pre-Screening Epoch
RUN-INC98779A period in a clinical study that occurs after screening and before randomization, during which the subject is further evaluated and/or prepared for the commencement of the clinical study investigation.Run-in Period
SCREENINGC202487A period in a clinical study during which subjects are evaluated for participation in the study.Screening Epoch
TREATMENTC101526A period in a study during which subjects are receiving investigational therapy or treatment.Treatment Epoch
WASHOUTC42872A period of time during a study when a subject is taken off of the investigational therapy or treatment in order to reduce the amount of investigational product within the body.Washout Period
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CL.C99076.INTMODELIntervention Model Response
(INTMODEL)
text
Extensible: Yes
C99076Intervention Model ResponseA terminology codelist relevant to the trial design developed to compare treatment groups.CDISC SDTM Intervention Model Terminology
CROSS-OVERC82637Participants receive one of two or more alternative intervention(s) during the initial epoch of the study and receive other intervention(s) during the subsequent epoch(s) of the study.Crossover Study
FACTORIALC82638Two or more interventions, each alone or in combination, are evaluated in parallel against a control group. This study design allows for the comparison of active drug to placebo, presence of drug-drug interactions, and comparison of active drugs against each other.Factorial Study
PARALLELC82639Participants are assigned to one of two or more treatment groups in parallel for the duration of the study.Parallel Study
SEQUENTIALC142568Groups of participants are assigned to receive interventions based on prior milestones being reached in the study. (clinicaltrials.gov)Group Sequential Design
SINGLE GROUPC82640All trial participants are assigned to a single treatment group for the duration of the study.Single Group Study
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CL.C171445.CNTMODEMode of Subject Contact
(CNTMODE)
text
Extensible: Yes
C171445Mode of Subject ContactTerminology relevant to the means by which interaction occurs between the subject and person or entity.CDISC SDTM Mode of Subject Contact Terminology
E-MAILC25170Electronic MailComposing, sending, and receiving messages over electronic communication systems.E-mail
IN PERSONC175574In-PersonAn interaction that takes place in the physical presence of someone else.In Person
IVRSC177933Interactive Voice Response SystemA type of automated system in which individuals can access information menus containing pre-recorded or dynamically generated information with voice prompts, without the need for an agent or operator.Interactive Voice Response System
LETTERC70805A written message addressed to a person or organization.Letter
REMOTE AUDIO VIDEOC171525A form of remote communication by audio video technology.Audio-Videoconferencing
REMOTE AUDIOC171524A form of remote communication by audio technology.Audioconferencing
SHIPMENT CONFIRMED BY SIGNATUREC171533Receipt of shipped material was confirmed by signature.Shipment Confirmed by Signature
TELEPHONE CALLC171537Communication by way of telephone.Telephone Call
TEXT MESSAGEC157352A short electronic communication, usually sent and received by a mobile phone.Text Message
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CL.C188725.Objective Level Value Set TerminologyObjective Level Value Set Terminology
(Objective Level Value Set Terminology)
text
Extensible:
C188725Objective Level Value Set TerminologyThe terminology relevant to the objective level.CDISC DDF Objective Level Value Set Terminology
Study Primary ObjectiveC85826Study Primary Objective;Trial Primary ObjectiveA principle objective of the study.Trial Primary Objective
Study Secondary ObjectiveC85827Study Secondary Objective;Trial Secondary ObjectiveAn auxiliary objective of the study.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:
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:
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.C66732.SEXPOPSex of Participants Response
(SEXPOP)
text
Extensible: No
C66732Sex of Participants ResponseA terminology codelist relevant to the specific sex, either male, female, or mixed of the subject group being studied.CDISC SDTM Sex of Study Group Terminology
BOTHC49636One and the other; relating to or being two in conjunction. (NCI)Both
FC16576FemaleA person who belongs to the sex that normally produces ova. The term is used to indicate biological sex distinctions, or cultural gender role distinctions, or both. (NCI)Female
MC20197MaleA person who belongs to the sex that normally produces sperm. The term is used to indicate biological sex distinctions, cultural gender role distinctions, or both. (NCI)Male
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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:
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.C174222.Study Arm Type Value Set TerminologyStudy Arm Type Value Set Terminology
(Study Arm Type Value Set Terminology)
text
Extensible:
C174222Study Arm Type Value Set TerminologyThe terminology relevant to the identification of the kind of arm.CDISC Protocol Study Arm Type Value Set Terminology
Active Comparator ArmC174267An arm describing the active comparator.Active Comparator Arm
Control ArmC174226An arm describing the intervention or treatment plan for a group of participants in the study receiving a control. The control may comprise a non-investigational product (active control) or regimen, placebo, or no treatment.Control Arm
Experimental ArmC174266Investigational ArmAn arm describing the intervention or treatment plan for a group of participants in the study receiving test product(s).Investigational Arm
No Intervention ArmC174270A study arm without an intervention or treatment.No Intervention Arm
Placebo Comparator ArmC174268Placebo Control ArmAn arm describing the placebo comparator.Placebo Control Arm
Sham Comparator ArmC174269Sham Intervention ArmAn arm describing the sham comparator.Sham Comparator Arm
Treatment ArmC15538An arm describing the intervention or treatment plan for a group of participants in the study. Treatment may consist of either experimental or control products under investigation.Protocol Treatment Arm
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CL.C99077.STYPEStudy Type Response
(STYPE)
text
Extensible: No
C99077Study Type ResponseA terminology codelist relevant to the role the study plays in determining the interventions a subject receives.CDISC SDTM Study Type Terminology
EXPANDED ACCESSC98722Compassionate UseStudies that provide a means for obtaining an experimental drug or device for patients who are not adequately treated by existing therapy, who do not meet the eligibility criteria for enrollment, or who are otherwise unable to participate in another clinical study.Expanded Access Study
INTERVENTIONALC98388Studies in which individuals are assigned by an investigator based on a protocol to receive specific interventions. Subjects may receive diagnostic, therapeutic or other types of interventions. The assignment of the intervention may or may not be random. The individuals are then followed and biomedical and/or health outcomes are assessed.Interventional Study
OBSERVATIONALC16084Studies in which biomedical and/or health outcomes are assessed in pre-defined groups of individuals. Subjects in the study may receive diagnostic, therapeutic, or other interventions, but the investigator does not assign specific interventions to the subjects of the study.Observational Study
PATIENT REGISTRYC129000Observational studies which include an organized system that uses observational methods to collect uniform data (clinical and other) prospectively for a population defined by a particular disorder/disease, condition (including susceptibility to a disorder), or exposure (including products, health care services, and/or procedures) and that serves a predetermined scientific, clinical, or policy purpose. Patient registries may be single purpose or on-going data collection programs that address one or more questions. (AHRQ)Patient Registry Study
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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:
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:
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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CL.C66735.TBLINDTrial Blinding Schema Response
(TBLIND)
text
Extensible: Yes
C66735Trial Blinding Schema ResponseA terminology codelist relevant to the type of blinding for the trial.CDISC SDTM Trial Blinding Schema Terminology
DOUBLE BLINDC15228Double Masked;Double-MaskedA study in which neither the subject nor the study personnel interacting with the subject or data during the study knows what intervention a subject is receiving.Double Blind Study
OBSERVER BLINDC187674A study in which the study personnel who measure, record, or assess the subject do not know which intervention the subject is receiving or, in the context of observational studies, do not know the external factors to which a subject has been exposed.Observer Blind Study
OPEN LABEL TO TREATMENT AND DOUBLE BLIND TO IMP DOSEC156592A study in which the therapeutic treatment is open label but the dosing information of the investigational medicinal product (IMP) is double-blinded.Open Label for Treatment And Double Blind to Dose
OPEN LABELC49659A study in which subjects and study personnel know which intervention each subject is receiving.Open Label Study
SINGLE BLINDC28233Single Masked;Single-MaskedA study in which one party, either the subject or study personnel, does not know which intervention is administered to the subject.Single Blind Study
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CL.C66736.TINDTPTrial Intent Type Response
(TINDTP)
text
Extensible: Yes
C66736Trial Intent Type ResponseA terminology codelist relevant to the responses for the planned purpose of the therapy, device, or agent under study in the clinical trial.CDISC SDTM Trial Indication Type Terminology
BASIC SCIENCEC15714Basic ResearchA type of study designed to examine the basic mechanism of action (e.g., physiology, biomechanics) of an intervention. (ClinicalTrials.gov)Basic Research
CUREC49654A type of study designed to evaluate intervention(s) aimed to cure a disease or condition.Cure Study
DEVICE FEASIBILITYC139174An intervention of a device product is being evaluated to determine the feasibility of the product or to test a prototype device and not health outcomes. Such studies are conducted to confirm the design and operating specifications of a device before beginning a full clinical trial. (ClinicalTrials.gov)Device Feasibility Study
DIAGNOSISC49653A type of study designed to evaluate intervention(s) aimed at identifying a disease or condition.Diagnosis Study
DISEASE MODIFYINGC170629A type of study designed to evaluate the effects of treatment(s) intended to cause a change in disease, syndrome, or condition beyond the point of treatment administration.Disease Modifying Treatment Study
HEALTH SERVICES RESEARCHC15245A type of study designed to evaluate the delivery, processes, management, organization or financing of health care. (ClinicalTrials.gov)Health Services Research
MITIGATIONC49655A type of study designed to identify actions necessary to eliminate or reduce the risk to human life or well-being as a result of a particular medication or treatment regimen. (NCI)Adverse Effect Mitigation Study
PREVENTIONC49657Prophylaxis StudyA type of study designed to identify actions necessary to permanently eliminate or reduce the long-term risk to human life as a result of a particular medication or treatment regimen.Prevention Study
SCREENINGC71485A type of study designed to assess or examine methods of identifying a condition (or risk factors for a condition) in people who are not yet known to have the condition (or risk factor). (Clinicaltrials.gov)Screening Study
SUPPORTIVE CAREC71486A type of study designed to evaluate one or more interventions where the primary intent is to maximize comfort, minimize side effects or mitigate against a decline in the subject's health or function. In general, supportive care interventions are not intended to cure a disease. (ClinicalTrials.gov)Supportive Care Study
TREATMENTC49656Therapy TrialA type of study designed to evaluate intervention(s) for treatment of disease, syndrome or condition.Treatment Study
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CL.C66737.TPHASETrial Phase Response
(TPHASE)
text
Extensible: Yes
C66737Trial Phase ResponseA terminology codelist relevant to the phase, or stage, of the clinical trial.CDISC SDTM Trial Phase Terminology
NOT APPLICABLEC48660NA;Not ApplicableDetermination of a value is not relevant in the current context. (NCI)Not Applicable
PHASE 0 TRIALC547210;Pre-clinical Trial;Trial Phase 0First-in-human trials, in a small number of subjects, that are conducted before Phase 1 trials and are intended to assess new candidate therapeutic and imaging agents. The study agent is administered at a low dose for a limited time, and there is no therapeutic or diagnostic intent. NOTE: FDA Guidance for Industry, Investigators, and Reviewers: Exploratory IND Studies, January 2006 classifies such studies as Phase 1. NOTE: A Phase 0 study might not include any drug delivery but may be an exploration of human material from a study (e.g., tissue samples or biomarker determinations). [Improving the Quality of Cancer Clinical Trials: Workshop summary-Proceedings of the National Cancer Policy Forum Workshop, improving the Quality of Cancer Clinical Trials (Washington, DC, Oct 2007)] (CDISC glossary)Phase 0 Trial
PHASE I TRIALC156001;Trial Phase 1The initial introduction of an investigational new drug into humans. Phase 1 studies are typically closely monitored and may be conducted in patients or normal volunteer subjects. NOTE: These studies are designed to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. During Phase 1, sufficient information about the drug's pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid, Phase 2 studies. The total number of subjects and patients included in Phase I studies varies with the drug, but is generally in the range of 20 to 80. Phase 1 studies also include studies of drug metabolism, structure-activity relationships, and mechanism of action in humans, as well as studies in which investigational drugs are used as research tools to explore biological phenomena or disease processes. [After FDA CDER Handbook, ICH E8] (CDISC glossary)Phase I Trial
PHASE I/II TRIALC156931-2;Trial Phase 1-2A class of clinical study that combines elements characteristic of traditional Phase I and Phase II trials. See also Phase I, Phase II.Phase I/II Trial
PHASE I/II/III TRIALC1983661/2/3;Trial Phase 1/2/3A study that begins as a Phase I study and transitions into Phases II and III based upon successful completion of each previous portion.Phase I/II/III Trial
PHASE I/III TRIALC1983671/3;Trial Phase 1/3A study that begins as a Phase I study and transitions into a Phase III study upon successful completion of the Phase I portion.Phase I/III Trial
PHASE IA TRIALC1999901A;Trial Phase 1AA type of phase 1 trial with a single ascending dose (dose escalation) in a smaller group of patients (in comparison to a Phase 1B).Phase Ia Trial
PHASE IB TRIALC1999891B;Trial Phase 1BA type of phase 1 trial with multiple ascending doses (dose expansion) in a larger group of patients (in comparison to a Phase 1A).Phase Ib Trial
PHASE II TRIALC156012;Trial Phase 2Phase that includes the controlled clinical trials conducted to evaluate the safety and efficacy of the drug in a limited number of patients with the disease or condition under study. Objectives can be dose-ranging (dose-response, frequency of dosing), type of patients, or numerous other characteristics of safety and efficacy. [After 21 CRF Part 312.21 Phases of an investigation] See also phase, phase 2a, phase 2b. (CDISC Glossary)Phase II Trial
PHASE II/III TRIALC156942-3;Trial Phase 2-3A class of clinical study that combines elements characteristic of traditional Phase II and Phase III trials.Phase II/III Trial
PHASE IIA TRIALC496862A;Trial Phase 2AEarly Phase 2 trials that focus on a proof-of-concept assessment of efficacy and safety in a small number of patients. [After FDA Guidance for industry end of Phase 2a meetings, September 2009] (CDISC Glossary)Phase IIa Trial
PHASE IIB TRIALC496882B;Trial Phase 2BLater Phase 2 trials, in transition to Phase 3, where the study populations more closely reflect the population, dosage, and condition for intended use. [Clarification of FDA Guidance for industry end of Phase 2a meetings, September 2009; Discussion in Peter B. Gilbert. SOME DESIGN ISSUES IN PHASE 2B VERSUS PHASE 3 PREVENTION TRIALS FOR TESTING EFFICACY OF PRODUCTS OR CONCEPTS. Stat Med. 2010 May 10; 29(10): 1061-1071.]Phase IIb Trial
PHASE III TRIALC156023;Trial Phase 3Phase that includes the controlled clinical trials intended to confirm safety and effectiveness, evaluate the overall benefit-risk relationship, and to provide substantial evidence for regulatory approval and labeling. NOTE: Phase 3 studies usually include from several hundred to several thousand subjects. [After ICH E8; Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products Draft Guidance for Industry. December 2019] See also phase, phase 3b. (CDISC Glossary)Phase III Trial
PHASE IIIA TRIALC496873A;Trial Phase 3AA classification typically assigned retrospectively to a Phase III trial upon determination by regulatory authorities of a need for a Phase III B trial. (NCI)Phase IIIa Trial
PHASE IIIB TRIALC496893B;Trial Phase 3BLater Phase 3 trial done near the time of approval to elicit additional findings. NOTE: Dossier review may continue while associated Phase 3b trials are conducted. These trials may be required as a condition of regulatory authority approval. Phase 3a is in common usage but not reflected in regulatory guidance. (CDISC Glossary)Phase IIIb Trial
PHASE IV TRIALC156034;Trial Phase 4Post-approval studies to delineate additional information about the drug's risks, benefits, and optimal use that may be requested by regulatory authorities in conjunction with marketing approval. NOTE: Phase 4 studies could include, but would not be limited to, studying different doses or schedules of administration than were used in Phase 2 studies, use of the drug in other patient populations or other stages of the disease, or use of the drug over a longer period of time. [after FDA CDER handbook, ICH E8] See also phase. (CDISC Glossary)Phase IV Trial
PHASE V TRIALC478655;Trial Phase 5Postmarketing surveillance is sometimes referred to as Phase V.Phase V Trial
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CL.C66739.TTYPETrial Type Response
(TTYPE)
text
Extensible: Yes
C66739Trial Type ResponseA terminology codelist relevant to the type of primary outcome or endpoint that the protocol is designed to evaluate.CDISC SDTM Trial Type Terminology
ADHESION PERFORMANCEC158283A type of study designed to evaluate the strength of the bond between an adhesive and the application surface.Adhesion Performance Study
ALCOHOL EFFECTC158284A type of study designed to evaluate the effects of alcohol on investigational product safety and/or efficacy.Alcohol Effect Study
BIO-AVAILABILITYC49664A study of the degree to which or rate at which a drug or other substance is absorbed or becomes available at the site of physiological activity after administration. (NCI)Bioavailability Study
BIO-EQUIVALENCEC49665A study most often used to compare the efficacy of different formulations to treat a given disease. It is the testing of an old versus a new formulation in healthy volunteers or subjects with the disease under study and usually in one dose. (NCI)Therapeutic Equivalency Study
BIOSIMILARITYC158288A type of study designed to evaluate whether a biologic test article is highly similar in function and effect to an existing biologic that has already been clinically tested and approved for use.Biosimilarity Study
DEVICE-DRUG INTERACTIONC158285A type of study designed to evaluate the interaction between a device and a drug, where the use of one may affect the disposition, function, efficacy, or safety of the other.Device-Drug Interaction Study
DIAGNOSISC49653A type of study designed to evaluate intervention(s) aimed at identifying a disease or condition.Diagnosis Study
DOSE FINDINGC158289An early phase clinical study with the objective of determining the optimal dose of an investigational product.Dose Finding Study
DOSE PROPORTIONALITYC158290A type of study designed to evaluate the relationship between dose and resulting exposure.Dose Proportionality Study
DOSE RESPONSEC127803A study of the effect of dose changes on the efficacy of a drug in order to determine the dose-response relationship and optimal dose of a therapy.Dose Response Study
DRUG-DRUG INTERACTIONC158286A type of study designed to evaluate the interaction between drugs, where the use of one may affect the disposition, efficacy, or safety of the other.Drug-Drug Interaction Study
ECGC178057Electrocardiographic StudyA study that evaluates the effect of a treatment on cardiac electrical activity, as assessed by electrocardiography.Electrocardiographic Study
EFFICACYC49666A study of the relative therapeutic efficacy of treatment of a disease. Usually this is a Phase II or III study. (NCI)Efficacy Study
FOOD EFFECTC98729Studies that are conducted to assess the effect of food on the rate and extent of absorption of a drug, either compared to a fasted state or to a reference drug.Food Effect Study
IMMUNOGENICITYC120842A study that assesses an agent's ability to provoke an immune response.Immunogenicity Study
MASS BALANCEC201484A type of study designed to evaluate the overall pathways of metabolism and excretion of a drug, and to identify and/or quantify metabolites in plasma and excreta.Mass Balance Study
PHARMACODYNAMICC49662A study of the biochemical and physiological effect of a drug and the mechanism of drug action and the relationship between drug concentration and effect. (NCI)Pharmacodynamic Study
PHARMACOECONOMICC39493A study that assesses the value associated with a given drug in therapeutic and economic terms. This type of study is multidisciplinary in nature and takes into consideration the social and economic costs (resource utilization costs including direct, indirect, and intangible costs) of drug therapy in addition to its direct therapeutic benefits. Analyses relate the difference in therapeutic benefits to the difference in costs between treatment alternatives. (NCI)Pharmacoeconomic Study
PHARMACOGENETICC129001A study that assesses variation in DNA sequence, usually within a single gene, and its effect on drug response.Pharmacogenetic Study
PHARMACOGENOMICC49661A study that identifies or assesses variations within the entire genome, including DNA, RNA, or transcriptional elements, and its effects on drug response.Pharmacogenomic Study
PHARMACOKINETICC49663A study of the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. (NCI)Pharmacokinetic Study
POSITION EFFECTC161477A type of study designed to evaluate the effect of body position during and/or after administration of the investigational product.Position Effect Trial
PREVENTIONC49657Prophylaxis StudyA type of study designed to identify actions necessary to permanently eliminate or reduce the long-term risk to human life as a result of a particular medication or treatment regimen.Prevention Study
REACTOGENICITYC174366A type of study designed to evaluate the expected, acute types of immunological responses, sometimes considered excessive, following agent administration.Reactogenicity Study
SAFETYC49667A 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
SWALLOWING FUNCTIONC161478A type of study designed to evaluate the effect of the investigational product on the physiologic act of swallowing.Swallowing Function Trial
THOROUGH QTC158287TQT StudyA type of study designed to evaluate the ability of an investigational product and/or approved drug to delay cardiac ventricular repolarization as detected by QT prolongation and other ECG parameters.Thorough QT Study
TOLERABILITYC98791A type of safety study that assesses the degree to which overt adverse effects can be tolerated by the subject.Tolerability Study
TREATMENTC49656Therapy TrialA type of study designed to evaluate intervention(s) for treatment of disease, syndrome or condition.Treatment Study
USABILITY TESTINGC161479A type of study designed to evaluate the user experience with a product.Usability Testing Study
WATER EFFECTC161480A type of study designed to evaluate the effects of water on investigational product safety and/or efficacy.Water Effect Trial
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