CDISC DDF Controlled Terminology

CDISC DDF Controlled Terminology, 2022-12-16
Legend:
CodeList
CodeListItem
NCI attributes
C188714DDF Activity Attribute Terminology
C188720DDF Analysis Population 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
C188709DDF Study Arm Attribute Terminology
C188715DDF Study Data 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
C188712DDF Transition Rule Attribute Terminology
C188717DDF Workflow Attribute Terminology
C188718DDF Workflow Item 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
C188727Study Arm Data Origin Type Value Set Terminology
C99077Study Type 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
Next Activity IdentifierC188844A system identifier assigned to a study activity that occurs immediately after the current study activity.Next Activity Identifier
Previous Activity IdentifierC188843A system identifier assigned to a study activity that occurs immediately prior to the current study activity.Previous Activity Identifier
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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.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
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
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 Study DataC188811Data collected in the course of a clinical study.Clinical Study Data
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
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
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
InterventionC25218The 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]Intervention or Procedure
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
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
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
Trial Disease/Condition Indication DescriptionC112038Trial 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
Workflow Item DescriptionC188812The textual representation of the workflow item.Workflow Item Description
WorkflowC42753The operational aspect of a work procedure: how tasks are structured, who performs them, what their relative order is, how they are synchronized, how information flows to support the tasks and how tasks are being tracked.Workflow
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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
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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 DescriptionC112038Trial 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 endpoint 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 TypeC188848A characterization or classification of the study procedure.Study Procedure 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 Type NameC188827The literal identifier (i.e., distinctive designation) of the study arm type.Study Arm Type Name
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CL.C188715.DDF Study Data Attribute TerminologyDDF Study Data Attribute Terminology
(DDF Study Data Attribute Terminology)
text
Extensible:
C188715DDF Study Data Attribute TerminologyA terminology value set relevant to the attributes of the study data.CDISC DDF Study Data Attribute Terminology
Clinical Study Data DescriptionC188846The textual representation of the study data.Clinical Study Data Description
Clinical Study Data NameC188845The literal identifier (i.e., distinctive designation) for the study data.Clinical Study Data Name
Electronic Case Report Form LinkC188847The uniform resource locator used to access the digital case report form.Electronic Case Report Form Uniform Resource Locator
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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
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
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
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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.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.C188717.DDF Workflow Attribute TerminologyDDF Workflow Attribute Terminology
(DDF Workflow Attribute Terminology)
text
Extensible:
C188717DDF Workflow Attribute TerminologyA terminology value set relevant to the attributes of the workflow.CDISC DDF Workflow Attribute Terminology
Workflow DescriptionC188849The textual representation of the workflow.Workflow Description
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CL.C188718.DDF Workflow Item Attribute TerminologyDDF Workflow Item Attribute Terminology
(DDF Workflow Item Attribute Terminology)
text
Extensible:
C188718DDF Workflow Item Attribute TerminologyA terminology value set relevant to the attributes of the workflow item.CDISC DDF Workflow Item Attribute Terminology
Next Workflow Item IdentifierC188852A system identifier assigned to a workflow item that occurs immediately after the current workflow item.Next Workflow Item Identifier
Previous Workflow Item IdentifierC188851A system identifier assigned to a workflow item that occurs immediately prior to the current workflow item.Previous Workflow Item Identifier
Workflow Item DescriptionC188812The textual representation of the workflow item.Workflow Item 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-UPC99158A period in a clinical study during which information about the health status of an individual is obtained after study interventions have concluded.Clinical Study Follow-up
INDUCTION TREATMENTC123453Induction Phase;Intensive PhaseA period in a clinical study during which subjects receive induction treatment.Induction Therapy Epoch
LONG-TERM FOLLOW-UPC16032A 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
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
RUN-INC98779A period in a clinical study that occurs before the commencement of the primary clinical study investigation, during which subjects may be assessed for suitability in the clinical study, withdrawn from existing therapy, trained in study methodology or evaluated for any other protocol-specified reason.Run-in Period
SCREENINGC48262A period in a clinical study during which subjects are evaluated for participation in the study.Trial Screening
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
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
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
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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.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.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.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 II TRIALC156012;Trial Phase 2Phase 2. Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug. NOTE: Phase 2 studies are typically well controlled, closely monitored, and conducted in a relatively small number of patients, usually involving no more than several hundred subjects. [After FDA CDER Handbook, ICH E8] (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 2AA clinical research protocol generally referred to as a pilot or feasibility trial that aims to prove the concept of the new intervention in question. (NCI)Phase IIa Trial
PHASE IIB TRIALC496882B;Trial Phase 2BA clinical research protocol generally referred to as a well-controlled and pivotal trial that aims to prove the mechanism of action of the new intervention in question. A pivotal study will generally be well-controlled, randomized, of adequate size, and whenever possible, double-blind. (NCI)Phase IIb Trial
PHASE III TRIALC156023;Trial Phase 3Phase 3. Studies are expanded controlled and uncontrolled trials. They are performed after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather the additional information about effectiveness and safety that is needed to confirm efficacy and evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling. NOTE: Phase 3 studies usually include from several hundred to several thousand subjects. [After FDA CDER Handbook, ICH E8] (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 3BA subcategory of Phase III trials done near the time of approval to elicit additional findings. NOTE: Dossier review may continue while associated Phase IIIB trials are conducted. These trials may be required as a condition of regulatory authority approval.Phase IIIb Trial
PHASE IV TRIALC156034;Trial Phase 4Phase 4. Postmarketing (Phase 4) 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: These 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] (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
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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