Code Codelist Code Codelist Extensible (Yes/No) Codelist Name CDISC Submission Value CDISC Synonym(s) CDISC Definition NCI Preferred Term 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 C70960 C188714 DDF Activity Attribute Terminology Clinical Study Activity Description The textual representation of the study activity. Clinical Study Activity Description C207458 C188714 DDF Activity Attribute Terminology Clinical Study Activity Label The short descriptive designation for the study activity. Study Activity Label C188842 C188714 DDF Activity Attribute Terminology Clinical Study Activity Name The literal identifier (i.e., distinctive designation) of the clinical 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 C207420 No DDF Administration Duration Attribute Terminology DDF Administration Duration Attribute Terminology DDF Administration Duration Attribute Terminology A terminology value set relevant to the attributes of the administration duration. CDISC DDF Administration Duration Attribute Terminology C207459 C207420 DDF Administration Duration Attribute Terminology Administration Duration Description A narrative representation of the agent administration duration. Administration Duration Description C207460 C207420 DDF Administration Duration Attribute Terminology Administration Duration Quantity Value The value representing the amount of time over which the administration of an agent occurs. Administration Duration Quantity Value C207462 C207420 DDF Administration Duration Attribute Terminology Administration Duration Reason Duration Will Vary Reason Administration Duration Will Vary The explanation for why the agent administration duration will vary within and/or across subjects. Reason Administration Duration Will Vary C207461 C207420 DDF Administration Duration Attribute Terminology Administration Duration Will Vary Indicator An indication as to whether the agent administration duration is planned to vary within and/or across subjects. Administration Duration Will Vary Indicator C207421 No DDF Agent Administration Attribute Terminology DDF Agent Administration Attribute Terminology DDF Agent Administration Attribute Terminology A terminology value set relevant to the attributes of the agent administration. CDISC DDF Agent Administration Attribute Terminology C207463 C207421 DDF Agent Administration Attribute Terminology Agent Administration Description A narrative representation of the agent administration. Agent Administration Description C167190 C207421 DDF Agent Administration Attribute Terminology Agent Administration Dose The value representing the amount of an agent given to an individual at one time. Dose Administered C207464 C207421 DDF Agent Administration Attribute Terminology Agent Administration Label The short descriptive designation for the agent administration. Agent Administration Label C207465 C207421 DDF Agent Administration Attribute Terminology Agent Administration Name The literal identifier (i.e., distinctive designation) of the agent administration. Agent Administration Name C89081 C207421 DDF Agent Administration Attribute Terminology Dosing Frequency Dosing Frequency The number of doses administered per a specific interval. Dose Frequency C38114 C207421 DDF Agent 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 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 The textual representation of the study population for analysis. 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 C207468 C188720 DDF Analysis Population Attribute Terminology Analysis Population Text An instance of unstructured text that represents the analysis population. Analysis Population Text 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 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 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 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 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 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 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 C207479 C188699 DDF Clinical Study Attribute Terminology Clinical Study Label The short descriptive designation for the clinical study. Clinical Study Label C142704 C188699 DDF Clinical Study Attribute Terminology Study Description A narrative representation of the study. Study Description C68631 C188699 DDF Clinical Study Attribute Terminology Study Name The literal identifier (i.e., distinctive designation) of the 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 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 C207484 C207424 DDF Condition Attribute Terminology Condition Text An instance of structured text that represents the condition. Condition Text 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 C83016 C207427 DDF Eligibility Criteria Attribute Terminology 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 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 The short descriptive designation for the study eligibility criterion. Study Eligibility Criteria Label C207488 C207427 DDF Eligibility Criteria Attribute Terminology Study Eligibility Criterion Name The literal identifier (i.e., distinctive designation) of the study eligibility criterion. Study Eligibility Criteria Name C207485 C207427 DDF Eligibility Criteria Attribute Terminology Study Eligibility Criterion Text An instance of structured text that represents the study eligibility criterion. Study Eligibility Criteria 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 C188836 C188713 DDF Encounter Attribute Terminology Clinical Encounter Description A narrative representation of the protocol-defined clinical encounter. Clinical Encounter Description C171010 C188713 DDF Encounter Attribute Terminology Clinical Encounter Name The literal identifier (i.e., distinctive designation) for a protocol-defined clinical encounter. Clinical Encounter Name C188839 C188713 DDF Encounter Attribute Terminology Clinical Encounter Type A characterization or classification of contact between subject/patient and healthcare practitioner/researcher, during which an assessment or activity is performed. Clinical Encounter Type 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 C188840 C188713 DDF Encounter Attribute Terminology Environmental Setting The environment/setting where the event, intervention, or finding occurred. Environmental Setting C207490 C188713 DDF Encounter Attribute Terminology Study Encounter Label The short descriptive designation for the study encounter. Study Encounter Label 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 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 C25407 C188698 DDF Entity Terminology Address A standardized representation of the location of a person, business, building, or organization. (NCI) Address C69282 C188698 DDF Entity Terminology Administration Duration The amount of time elapsed during the administration of an agent. Duration of Administration C70962 C188698 DDF Entity Terminology Agent Administration The act of the dispensing, applying, or tendering a medical product or other agent. Agent 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 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 C25447 C188698 DDF Entity Terminology Characteristic The distinguishing qualities or prominent aspects of an entity. Characteristic C142427 C188698 DDF Entity Terminology Clinical Encounter Contact between subject/patient and healthcare practitioner/researcher, during which an assessment or activity is performed. Contact may be physical or virtual. Clinical Encounter 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. [ClinicalTrials.gov] See also clinical trial. (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 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 A health problem or disease that is identified as likely to be benefited by a therapy being studied in clinical trials. Indication 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 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 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 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 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 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 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 The difference between the lowest and highest numerical values; the limits or scale of variation. Range C93448 C188698 DDF Entity Terminology Research Organization An organization that undertakes systematic investigation within a field of study in order to discover facts, establish or revise a theory, test a hypothesis, or develop a plan of action based on the facts discovered. Research Organization 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 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 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 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 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 Criteria Trial Eligibility Criteria 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 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 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 C93381 C188698 DDF Entity Terminology Study Protocol Document A representation of the study protocol (that persists over time) in document form. Study Protocol Document C93490 C188698 DDF Entity Terminology Study Protocol Version A plan at a particular point in time for a formal investigation to assess the utility, impact, pharmacological, physiological, and/or psychological effects of a particular treatment, procedure, drug, device, biologic, food product, cosmetic, care plan, or subject characteristic. (BRIDG) Study Protocol Version 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 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 C188814 C188698 DDF Entity Terminology 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 C142728 C188698 DDF Entity Terminology Target Study Population Target Population The group of people in the general population to which the study results can be generalized. Target Study Population 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 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 C207496 C207429 DDF Governance Date Attribute Terminology Protocol Approval Date Type A characterization or classification of the protocol approval date. Protocol Approval Date Type 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 C207500 C207429 DDF Governance Date Attribute Terminology Study Governance Date Value The information contained in the date field. Study Governance Date Value 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 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 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 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 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 C207505 C207430 DDF Masking Attribute Terminology Masking Description A narrative representation of the study masking strategy, based on a person's role within the study. Study Masking Description C207506 C207430 DDF Masking Attribute Terminology Masking Role Blinded Roles; Blinding Roles An identifying designation assigned to a masked individual within a study that corresponds with their function. Study Masking Role 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 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 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 C207508 C207426 DDF Narrative Content Attribute Terminology Narrative Content Text A textual representation of the narrative content. Narrative Content 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 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 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 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 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 C188848 C188716 DDF Procedure Attribute Terminology Procedure Type A characterization or classification of the study procedure. Study Procedure Type 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 C25709 C207434 DDF Range Attribute Terminology Unit of Measure A named quantity in terms of which other quantities are measured or specified, used as a standard measurement of like kinds. Unit of Measure 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 C207435 No DDF Research Organization Attribute Terminology DDF Research Organization Attribute Terminology DDF Research Organization Attribute Terminology A terminology value set relevant to the attributes of the research organization. CDISC DDF Research Organization Attribute Terminology C207526 C207435 DDF Research Organization Attribute Terminology Identifier Provider Research Organization Name The name of the research organization that provides the identifier for the entity. Identifier Provider Research Organization Name C188820 C207435 DDF Research 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 C207527 C207435 DDF Research Organization Attribute Terminology Research Organization Identifier A sequence of characters used to identify, name, or characterize the research organization. Research Organization Identifier C207528 C207435 DDF Research Organization Attribute Terminology Research Organization Label The short descriptive designation for the research organization. Research Organization Label C207529 C207435 DDF Research Organization Attribute Terminology Research Organization Name The literal identifier (i.e., distinctive designation) of the research organization. Research Organization Name 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 C25162 C201258 DDF Response Code Attribute Terminology Code A symbol or combination of symbols which is assigned to the members of a collection. Code 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 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 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 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 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 C207538 C207437 DDF Study Amendment Attribute Terminology Study Amendment Substantial Impact Indicator An indication as to whether the amendment is likely to have a substantial impact on the safety or rights of study subjects/participants. Study Amendment Substantial Impact Indicator 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 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 C172457 C188709 DDF Study Arm Attribute Terminology Study Arm Type Arm Type A characterization or classification of the study arm. Study Arm Type 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 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 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 C98746 C188703 DDF 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 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 C70834 C188703 DDF Study Design Attribute Terminology Study Design Population Description A narrative representation of the study design population. Study Population Description 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 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 C49658 C188703 DDF 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 C188703 DDF 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 C188703 DDF Study Design Attribute Terminology Trial Type Trial Scope; Trial Type The nature of the interventional study for which information is being collected. Trial Type 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 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 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 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 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 C83082 C188701 DDF Study Identifier Attribute Terminology Study Identifier A sequence of characters used to identify, name, or characterize the study. Study Identifier 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 C98768 C188704 DDF Study Intervention Attribute Terminology Pharmacologic Class Pharmacologic Class The pharmacological class of the investigational product. Pharmacological Class of Investigational Therapy 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 C207559 C188704 DDF Study Intervention Attribute Terminology Study Intervention Product Designation An indication as to whether the investigational intervention is an investigational medicinal product or an auxiliary medicinal product. Study Intervention Product Type 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 C207440 No DDF Study Protocol Document Attribute Terminology DDF Study Protocol Document Attribute Terminology DDF Study Protocol Document Attribute Terminology A terminology value set relevant to the attributes of the study protocol document. CDISC DDF Study Protocol Document Attribute Terminology C207561 C207440 DDF Study Protocol Document Attribute Terminology Study Protocol Document Description A narrative representation of the study protocol document. Study Protocol Document Description C207562 C207440 DDF Study Protocol Document Attribute Terminology Study Protocol Document Label The short descriptive designation for the study protocol document. Study Protocol Document Label C207563 C207440 DDF Study Protocol Document Attribute Terminology Study Protocol Document Name The literal identifier (i.e., distinctive designation) of the study protocol document. Study Protocol Document Name 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 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 C142175 C207443 DDF Study Version Attribute Terminology Study Type Classification Study Type; Study Type Classification The nature of the investigation for which study information is being collected. (After clinicaltrials.gov) Study Type 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 C48281 C207443 DDF Study Version 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 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 C207571 C207444 DDF Subject Enrollment Attribute Terminology Subject Enrollment Code A symbol or combination of symbols which is assigned to the subject enrollment. Subject Enrollment Code 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 C207574 C207444 DDF Subject Enrollment Attribute Terminology Subject Enrollment Type A characterization or classification of the subject enrollment. Subject Enrollment Type 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 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 C207598 C207413 Governance Date Type Value Set Terminology Protocol Effective Date The date and time specifying when the protocol takes effect or becomes operative. Protocol Effective Date C132352 C207413 Governance Date Type Value Set Terminology Sponsor Approval Date Protocol Amendment Approval by Sponsor Date; Study Protocol Version Approval Date The date on which a version of the protocol was finalized or approved by the sponsor. Protocol Approval by Sponsor Date C207414 Yes Masking Role Value Set Terminology Masking Role Value Set Terminology Masking Role Value Set Terminology The terminology relevant to the masking role value set. CDISC DDF Masking Role Value Set Terminology C17445 C207414 Masking Role 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 C25936 C207414 Masking Role 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 C207599 C207414 Masking Role Value Set Terminology Outcomes Assessor The individual who evaluates the outcome(s) of interest. (Clinicaltrials.gov) Outcomes Assessor C70793 C207414 Masking Role 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 C41189 C207414 Masking Role 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 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 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 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 C70793 C188724 Organization Type Value Set Terminology Clinical Study 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 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 C188723 No Protocol Status Value Set Terminology Protocol Status Value Set Terminology Protocol Status Value Set Terminology The terminology relevant to the protocol status. CDISC DDF Protocol Status Value Set Terminology C25425 C188723 Protocol Status Value Set Terminology Approved Acceptance as satisfactory by an authoritative body; established by authority; given authoritative approval. Approval C85255 C188723 Protocol Status Value Set Terminology Draft A preliminary version of a written work, design, or picture. Draft C25508 C188723 Protocol Status Value Set Terminology Final Conclusive in a process or progression. Final C63553 C188723 Protocol Status Value Set Terminology Obsolete No longer in use or valid; old. Obsolete C188862 C188723 Protocol Status Value Set Terminology Pending Review Draft Pending Review A preliminary version of a written work, design, or picture that is awaiting review. Pending Review C207415 No 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 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 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 C188865 C188727 Study Arm Data Origin Type Value Set Terminology Virtual Data Data that are generated from virtual encounters between investigators and subjects. Virtual Data 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 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 C207418 No Study Intervention Product Designation Value Set Terminology Study Intervention Product Designation Value Set Terminology Study Intervention Product Designation Value Set Terminology The terminology relevant to the study intervention product designation value set. CDISC DDF Study Intervention Product Designation Value Set Terminology C202579 C207418 Study Intervention 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 Study Intervention Product Designation Value Set Terminology NIMP (AxMP) 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 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 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 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