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