CDISC DDF Controlled Terminology CDISC DDF Controlled Terminology, 2026-03-27 CDISC DDF Controlled Terminology The terminology relevant to the administrable product property type value set. pH The negative logarithm (base 10) of the concentration of hydronium ions, which is used as a measure of the acidity or alkalinity of a fluid. pH Administrable Product Property Type Value Set Terminology Administrable Product Property Type Value Set Terminology CDISC DDF Administrable Product Property Type Value Set Terminology The terminology relevant to the administrable product sourcing value set. An indication that the entity is obtained from a central source. Centrally Sourced Indicator An indication that the entity is obtained from a local source. Locally Sourced Indicator Administrable Product Sourcing Value Set Terminology Administrable Product Sourcing Value Set Terminology CDISC DDF Administrable Product Sourcing Value Set Terminology A terminology value set relevant to the attributes of the abbreviation. The full literal representation of the abbreviation. Abbreviation Long Name A brief written record relevant to the abbreviation. Abbreviation Note The literal value of an instance of unstructured text that is used as the abbreviation. Text Abbreviation Value DDF Abbreviation Attribute Terminology DDF Abbreviation Attribute Terminology CDISC DDF Abbreviation Attribute Terminology A terminology value set relevant to the attributes of the activity. A brief written record relevant to the activity. Activity Note The textual representation of the study activity. Clinical Study Activity Description The short descriptive designation for the study activity. Study Activity Label The literal identifier (i.e., distinctive designation) of the study activity. Clinical Study Activity Name DDF Activity Attribute Terminology DDF Activity Attribute Terminology CDISC DDF Activity Attribute Terminology A terminology value set relevant to the attributes of the address. A standardized representation of the complete set of components denoting the physical address of the person, business, building, or organization. Address Full Text The street name and number, building number, apartment or unit number, or post office box number where an entity is physically located. Street Address 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 A sovereign nation occupying a distinct territory and ruled by an autonomous government. Country An administrative or territorial division of a city, town, county, parish, state, country, or other locality based on a shared characteristic. District An alphanumeric code assigned to a mail delivery area. Postal Code 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 DDF Address Attribute Terminology DDF Address Attribute Terminology CDISC DDF Address Attribute Terminology A terminology value set relevant to the attributes of the administrable product. A narrative representation of the administrable product. Administrable Product Definition Description The short descriptive designation for the administrable product. Administrable Product Definition Label The literal identifier (i.e., distinctive designation) of the administrable product. Administrable Product Definition Name The physical form in which formulated ingredient(s) are presented in the administrable product. Administrable Product Dose Form A brief written record relevant to the administrable product. Administrable Product Note The pharmacological class of the administrable product. Administrable Product Pharmacologic Class An indication as to whether the administrable product is an investigational medicinal product or an auxiliary medicinal product. Administrable Product Designation Indicator An indication as to whether the administrable product is obtained from a local or central source. Administrable Product Sourcing Indicator DDF Administrable Product Attribute Terminology DDF Administrable Product Attribute Terminology CDISC DDF Administrable Product Attribute Terminology A terminology value set relevant to the attributes of the administrable product identifier. An instance of structured text that represents the administrable product. Administrable Product Identifier Text DDF Administrable Product Identifier Attribute Terminology DDF Administrable Product Identifier Attribute Terminology CDISC DDF Administrable Product Identifier Attribute Terminology A terminology value set relevant to the attributes of the administrable product property. The literal identifier (i.e., distinctive designation) of the administrable product property. Administrable Product Property Name The numeric value associated with an administrable product property. Administrable Product Property Quantity Value An instance of structured text that represents the administrable product property. Administrable Product Property Text A characterization or classification of the administrable product property. Administrable Product Property Type DDF Administrable Product Property Attribute Terminology DDF Administrable Product Property Attribute Terminology CDISC DDF Administrable Product Property Attribute Terminology A terminology value set relevant to the attributes of the agent administration. A narrative representation for the administration of a product, agent, or therapy. Agent Administration Description The value representing the amount of an agent given to an individual at one time. Dose Administered The amount of time elapsed during the administration of an agent. Duration of Administration The short descriptive designation for the administration of a product, agent, or therapy. Agent Administration Label The literal identifier (i.e., distinctive designation) for the administration of a product, agent, or therapy. Agent Administration Name A brief written record relevant to the administration of the product, agent, or therapy. Agent Administration Note Dosing Frequency The number of doses administered per a specific interval. Dose Frequency Route of Administration The way in which an agent is introduced into, or onto, the body. Route of Administration DDF Administration Attribute terminology DDF Administration Attribute terminology CDISC DDF Agent Administration Attribute Terminology A terminology value set relevant to the attributes of the alias code. Alternative combinations of symbols used to represent aliases or alternatives to the standard code. Standard Code Alias A combination of symbols that is used to represent the standard code. Standard Code DDF Alias Code Attribute Terminology DDF Alias Code Attribute Terminology CDISC DDF Alias Code Attribute Terminology A terminology value set relevant to the attributes of the analysis population. A narrative representation of the analysis population. Analysis Population Description The short descriptive designation for the analysis population. Analysis Population Label The literal identifier (i.e., distinctive designation) of the analysis population. Analysis Population Name A brief written record relevant to the analysis population. Analysis Population Note An instance of unstructured text that represents the analysis population. Analysis Population Text DDF Analysis Population Attribute Terminology DDF Analysis Population Attribute Terminology CDISC DDF Analysis Population Attribute Terminology A terminology value set relevant to the attributes of the assigned person. A narrative representation of the assigned person. Assigned Person Description An identifying designation related to the assigned person's occupation. Assigned Person Job Title The short descriptive designation for the assigned person. Assigned Person Label The literal identifier (i.e., distinctive designation) of the assigned person. Assigned Person Name Assigned Person Human Name A word or group of words indicating the identity of an assigned person usually consisting of a first (personal) name and a last (family) name with an optional middle name. In some cultural traditions the family name comes first. Assigned Person Person Name DDF Assigned Person Attribute Terminology DDF Assigned Person Attribute Terminology CDISC DDF Assigned Person Attribute Terminology A terminology value set relevant to the attributes of the biomedical concept. A concept unique identifier assigned to a biomedical concept that points to the meaning of that biomedical concept. Biomedical Concept Code The short descriptive designation for the biomedical concept. Biomedical Concept Label The literal identifier (i.e., distinctive designation) of the biomedical concept. Biomedical Concept Name A brief written record relevant to the biomedical concept. Biomedical Concept Note A citation to an authoritative source for a biomedical concept. Biomedical Concept Reference 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 DDF Biomedical Concept Attribute Terminology DDF Biomedical Concept Attribute Terminology CDISC DDF Biomedical Concept Attribute Terminology A terminology value set relevant to the attributes of the biomedical concept category. A symbol or combination of symbols which is assigned to the biomedical concept category. Biomedical Concept Category Code A narrative representation of the biomedical concept category. Biomedical Concept Category Description The short descriptive designation for the biomedical concept category. Biomedical Concept Category Label The literal identifier (i.e., distinctive designation) of the biomedical concept category. Biomedical Concept Category Name A brief written record relevant to the biomedical concept category. Biomedical Concept Category Note DDF Biomedical Concept Category Attribute Terminology DDF Biomedical Concept Category Attribute Terminology CDISC DDF Biomedical Concept Category Attribute Terminology A terminology value set relevant to the attributes of the biomedical concept property. 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 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 The short descriptive designation for the biomedical concept property. Biomedical Concept Property Label The literal identifier (i.e., distinctive designation) of the biomedical concept property. Biomedical Concept Property Name A brief written record relevant to the biomedical concept property. Biomedical Concept Property Note An indication as to whether the biomedical concept property is required. Biomedical Concept Property Required Indicator 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 DDF Biomedical Concept Property Attribute Terminology DDF Biomedical Concept Property Attribute Terminology CDISC DDF Biomedical Concept Property Attribute Terminology A terminology value set relevant to the attributes of the biomedical concept surrogate. A narrative representation of the biomedical concept surrogate. Biomedical Concept Surrogate Description The short descriptive designation for the biomedical concept surrogate. Biomedical Concept Surrogate Label The literal identifier (i.e., distinctive designation) of the biomedical concept surrogate. Biomedical Concept Surrogate Name A brief written record relevant to the biomedical concept surrogate. Biomedical Concept Surrogate Note A citation to an authoritative source for a biomedical concept surrogate. Biomedical Concept Surrogate Reference DDF Biomedical Concept Surrogate Attribute Terminology DDF Biomedical Concept Surrogate Attribute Terminology CDISC DDF Biomedical Concept Surrogate Attribute Terminology A terminology value set relevant to the attributes of the biospecimen retention. Biospecimen Retention A narrative representation of the biospecimen retention. Biological Sample Retention Description Biospecimen Retention Contains DNA Ind An indication as to whether retained biospecimens contain DNA. Retained Biospecimen Contains DNA Indicator Biospecimen Retention Indicator An indication as to whether biospecimens were retained. Biospecimen Retention Indicator The short descriptive designation for the biospecimen retention. Biospecimen Retention Label The literal identifier (i.e., distinctive designation) of the biospecimen retention. Biospecimen Retention Name DDF Biospecimen Retention Attribute Terminology DDF Biospecimen Retention Attribute Terminology CDISC DDF Biospecimen Retention Attribute Terminology A terminology value set relevant to the attributes of the characteristic. A narrative representation of the characteristic. Characteristic Description The short descriptive designation for the characteristic. Characteristic Label The literal identifier (i.e., distinctive designation) of the characteristic. Characteristic Name A brief written record relevant to the characteristic. Characteristic Note An instance of structured text that represents the characteristic. Characteristic Text DDF Characteristic Attribute Terminology DDF Characteristic Attribute Terminology CDISC DDF Characteristic Attribute Terminology A terminology value set relevant to the attributes of the clinical study. A narrative representation of the clinical study. Study Description The short descriptive designation for the clinical study. Clinical Study Label The literal identifier (i.e., distinctive designation) of the clinical study. Study Name DDF Clinical Study Attribute Terminology DDF Clinical Study Attribute Terminology CDISC DDF Clinical Study Attribute Terminology A terminology value set relevant to the attributes of the code. The literal identifier (i.e., distinctive designation) of the system used to assign and/or manage codes. Code System Name The version of the code system. Coding System Version The literal value of a code. Code Value Standardized or dictionary-derived human readable text associated with a code. Decode Text DDF Code Attribute Terminology DDF Code Attribute Terminology CDISC DDF Code Attribute Terminology A terminology value set relevant to the attributes of the comment annotation. A symbol or combination of symbols which is assigned to the comment annotation. Comment Annotation Code An instance of unstructured text that represents the comment annotation. Comment Annotation Text DDF Comment Annotation Attribute Terminology DDF Comment Annotation Attribute Terminology CDISC DDF Comment Annotation Attribute Terminology A terminology value set relevant to the attributes of the condition assignment. An assumption on which rests the validity or effect of something else. Logical Condition DDF Condition Assignment Attribute Terminology DDF Condition Assignment Attribute Terminology CDISC DDF Condition Assignment Attribute Terminology A terminology value set relevant to the attributes of the condition. A narrative representation of the condition. Condition Description The short descriptive designation for the condition. Condition Label The literal identifier (i.e., distinctive designation) of the condition. Condition Name A brief written record relevant to the condition. Condition Note An instance of structured text that represents the condition. Condition Text DDF Condition Attribute Terminology DDF Condition Attribute Terminology CDISC DDF Condition Attribute Terminology A terminology value set relevant to the attributes of the document content reference. The numeric identifier of a particular section for the document content reference. Document Content Reference Section Number An identifying designation for a particular section for the document content reference. Document Content Reference Section Title DDF Document Content Reference Attribute Terminology DDF Document Content Reference Attribute Terminology CDISC DDF Document Content Reference Attribute Terminology A terminology value set relevant to the attributes of the event duration. The value representing the amount of time over which the event occurs. Duration Quantity Value An instance of unstructured text that represents the event duration. Duration Text An indication as to whether the event duration is planned to vary within and/or across subjects. Duration Will Vary Indicator The explanation for why the event duration will vary within and/or across subjects. Reason Duration Will Vary DDF Duration Terminology DDF Duration Attribute Terminology CDISC DDF Duration Attribute Terminology A terminology value set relevant to the attributes of the eligibility criteria. A brief written record relevant to the eligibility criterion. Eligibility Criterion Note Study Eligibility Criteria Category A classification of the inclusion exclusion criterion. Inclusion Exclusion Criterion Category Study Eligibility Criteria Description A narrative representation of the study eligibility criterion. Study Eligibility Criteria Description A sequence of characters used to identify, name, or characterize the inclusion or exclusion criterion. Study Eligibility Criterion Identifier Study Eligibility Criteria Label The short descriptive designation for the study eligibility criterion. Study Eligibility Criteria Label Study Eligibility Criteria Description The literal identifier (i.e., distinctive designation) of the study eligibility criterion. Study Eligibility Criteria Name DDF Eligibility Criteria Attribute Terminology DDF Eligibility Criteria Attribute Terminology CDISC DDF Eligibility Criteria Attribute Terminology A terminology value set relevant to the attributes of the eligibility criterion item. A narrative representation of the eligibility criterion item. Eligibility Criterion Item Description The short descriptive designation for the eligibility criterion item. Eligibility Criterion Item Label The literal identifier (i.e., distinctive designation) of the eligibility criterion item. Eligibility Criterion Item Name A brief written record relevant to the eligibility criterion item. Eligibility Criterion Item Note An instance of structured text that represents the eligibility criterion item. Eligibility Criterion Item Text DDF Eligibility Criterion Item Attribute Terminology DDF Eligibility Criterion Item Attribute Terminology CDISC DDF Eligibility Criterion Item Attribute Terminology A terminology value set relevant to the attributes of the encounter. The means by which an interaction occurs between the subject/participant and person or entity (e.g., a device). Contact Mode A brief written record relevant to the study encounter. Study Encounter Note The environment/setting where the event, intervention, or finding occurred. Environmental Setting A narrative representation of the protocol-defined study encounter. Clinical Encounter Description The short descriptive designation for the study encounter. Study Encounter Label The literal identifier (i.e., distinctive designation) for a protocol-defined study encounter. Clinical Encounter Name A characterization or classification of the study encounter. Clinical Encounter Type DDF Encounter Attribute Terminology DDF Encounter Attribute Terminology CDISC DDF Encounter Attribute Terminology A terminology value set relevant to the attributes of the endpoint. A brief written record relevant to the study endpoint. Study Endpoint Note A narrative representation of the study endpoint. Study Endpoint Description The short descriptive designation for the study endpoint. Study Endpoint Label A characterization or classification of the study endpoint that determines its category of importance relative to other study endpoints. Study Endpoint Level The literal identifier (i.e., distinctive designation) of the study endpoint. Study Endpoint Name The reason or intention for the study endpoint. Study Endpoint Purpose An instance of structured text that represents the study endpoint. Study Endpoint Text DDF Endpoint Attribute Terminology DDF Endpoint Attribute Terminology CDISC DDF Endpoint Attribute Terminology A terminology value set relevant to the entities within the CDISC digital data flow (DDF) model. A set of letters that are drawn from a word or from a sequence of words and that are used for brevity in place of the full word or phrase. (CDISC Glossary) Abbreviation A standardized representation of the location of a person, business, building, or organization. (NCI) Address A sequence of characters used to identify, name, or characterize the administrable product. Administrable Study Product Identifier A characteristic from a set of characteristics used to define an administrable product. Administrable Study Product Property Any study product that is formulated and presented in the form that is suitable for administration to a study participant. Administrable Study Product The act of dispensing, applying, or tendering a product, agent, or therapy. Administration An alternative symbol or combination of symbols which is assigned to the members of a collection. Alias Code Study Target Population for Analysis Target Study Population for Analysis A target study population on which an analysis is performed. These may be represented by the entire study population, a subgroup defined by a particular characteristic measured at baseline, or a principal stratum defined by the occurrence (or non-occurrence, depending on context) of a specific intercurrent event. (ICH E9 R1 Addendum) Target Study Population for Analysis An individual person who is allotted or appointed to a particular role, function, or other entity. Assigned Person A grouping of biomedical concepts based on some commonality or by user defined characteristics. Biomedical Concept Category A characteristic from a set of characteristics used to define a biomedical concept. Biomedical Concept Property A concept that substitutes for a standard biomedical concept from the designated source. Biomedical Concept Surrogate 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 The continued possession, cataloging, and storage of collected biological specimens beyond their initial use. Biospecimen Retention The distinguishing qualities or prominent aspects of an entity. Characteristic A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. (CDISC Glossary) Clinical Study A symbol or combination of symbols which is assigned to the members of a collection. Code An explanatory or critical comment, or other in-context information (e.g., pattern, motif, link), that has been associated with data or other types of information. Annotation An allotting or appointment to a set of conditions that are to be met in order to make a logical decision. Condition Assignment A state of being. Condition The disease or condition the intervention is intended to diagnose, treat, prevent, cure, or mitigate. Indication A citation pointing to the location of specific content within a document. Document Content Reference Duration Time Time Duration The length of time during which something continues. Duration An individual item within the container that holds an instance of an eligibility criterion. Eligibility Criterion Item 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 The extent or range related to the physical location of an entity. Geographic Scope One or more characters used to identify, name, or characterize the nature, properties, or contents of a thing. Identifier Any component that constitutes a part of a compound or mixture. Ingredient 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 The strategy that specifies the structure of an interventional trial in terms of the planned activities (including timing) and statistical analysis approach intended to meet the objectives of the study. Interventional Study Design 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 A sequence of characters used to identify, name, or characterize the medical device. Medical Device Identifier Medical Device Any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination for, one or more specific medical purpose(s). [After REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices] Medical Device An individual item within the container that holds an instance of unstructured text and which may include objects such as tables, figures, and images. Narrative Content Item The container that holds an instance of unstructured text and which may include objects such as tables, figures, and images. Narrative Content The strategy that specifies the structure of an observational study in terms of the planned activities (including timing) and statistical analysis approach intended to meet the objectives of the study. Observational Study Design 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 The paired name and value for a given parameter. Parameter Map Human Name Individual's Name Name A word or group of words indicating the identity of a person usually consisting of a first (personal) name and a last (family) name with an optional middle name. In some cultural traditions the family name comes first. Person Name A concise explanation of the meaning of a population. Population Definition 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 A designation that identifies the function of an organization within the context of the product. Product Organization Role The total amount (number), or the limits (minimum and maximum) of a variation. Quantity or Range How much there is of something that can be measured; the total amount or number. Quantity An expression that defines the lower and upper limits of a variation. Range A sequence of characters used to identify, name, or characterize the reference. Reference ID A symbol or combination of symbols representing the response to the question. Response Code To go out of or leave the schedule timeline. Schedule Timeline Exit A chronological schedule of planned temporal events. Schedule Timeline A scheduled occurrence of an activity event. Scheduled Activity Instance A scheduled occurrence of a decision event. Scheduled Decision Instance A scheduled occurrence of a temporal event. Scheduled Instance 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 The effect or consequence of an amendment on some aspect of the study. Study Amendment Impact Reason(s) for Amendment The rationale for the change(s) to, or formal clarification of, a protocol. Study Amendment Reason A written description of a change(s) to, or formal clarification of, a study. Study Amendment 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 The act of alteration or modification to a study. Study Change A group of individuals who share a set of characteristics (e.g., exposures, experiences, attributes), which logically defines a population under study. Cohort A representation of a particular edition or snapshot of the study definition document as it exists at a particular point in time. Study Definition Document Version Any physical or electronic document that is related to defining a study or part of a study. Study Definition Document 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 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 Target Population The group of people in the general population to which the study results can be generalized. Target Study Population 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 Study Eligibility Criteria Trial Eligibility Criteria Trial Eligibility Criterion Characteristics which are necessary to allow a subject to participate in a clinical study, as outlined in the study protocol. The concept covers inclusion and exclusion criteria. Clinical Trial Eligibility Criteria Any physical or virtual contact between two or more parties involved in a study, at which an assessment or activity takes place. Study Encounter 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 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 Any of the dates associated with event milestones within a clinical study's oversight and management framework. Study Governance Date A sequence of characters used to identify, name, or characterize the study. Study Identifier Investigational Trial Intervention Any agent, device, or procedure being tested or used as a reference or comparator in the conduct of a clinical trial. Trial Intervention 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 A designation that identifies the function of study personnel or an organization within the context of the study. Study Role The location at which a study investigator conducts study activities. Study Site Official Study Title Study Title Trial Title The sponsor-defined name of the clinical study. Trial Title A plan at a particular point in time for a study. Study Version 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 The content of a substance expressed quantitatively per dosage unit, per unit of volume, or per unit of weight, according to the pharmaceutical dose form of the product. Substance Strength Any matter of defined composition that has discrete existence, whose origin may be biological, mineral or chemical. Substance A reference source that provides a listing of valid parameter names and values used in syntax template text strings. Syntax Template Dictionary A standardized pattern used for the arrangement of words and phrases to create well-formed, structured sentences. Syntax Template The chronological relationship between temporal events. Timing 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 DDF Entity Terminology DDF Entity Terminology CDISC DDF Entities Terminology A terminology value set relevant to the attributes of the estimand. A narrative representation of the estimand. Estimand Description The short descriptive designation for the estimand. Estimand Label The literal identifier (i.e., distinctive designation) of the estimand. Estimand Name A brief written record relevant to the study estimand. Estimand Note A synopsis of the clinical endpoint of interest within the analysis target study population. Population-Level Summary DDF Estimand Attribute Terminology DDF Estimand Attribute Terminology CDISC DDF Estimand Attribute Terminology A terminology value set relevant to the attributes of the geographic scope. A symbol or combination of symbols which is assigned to the geographic scope. Geographic Scope Code A characterization or classification of the geographic scope. Geographic Scope Type DDF Geographic Scope Attribute Terminology DDF Geographic Scope Attribute Terminology CDISC DDF Geographic Scope Attribute Terminology A terminology value set relevant to the attributes of the governance date. A narrative representation of the study governance date. Study Governance Date Description The short descriptive designation for the study governance date. Study Governance Date Label The literal identifier (i.e., distinctive designation) of the study governance date Study Governance Date Name A characterization or classification of the study governance date Study Governance Date Type The information contained in the date field. Study Governance Date Value DDF Governance Date Attribute Terminology DDF Governance Date Attribute Terminology CDISC DDF Governance Date Attribute Terminology A terminology value set relevant to the attributes of the identifier. An instance of structured text that represents the identifier. Identifier Text DDF Identifier Attribute Terminology DDF Identifier Attribute Terminology CDISC DDF Identifier Attribute Terminology A terminology value set relevant to the attributes of the disease indication. A short sequence of characters that represents the disease indication. Disease Indication Code 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 An indication as to whether the disease/condition indication under study is considered a rare disease. Disease Indication Is Rare Disease Indicator The short descriptive designation for the disease/condition indication. Disease Indication Label The literal identifier (i.e., distinctive designation) of the disease/condition indication. Disease Indication Name A brief written record relevant to the disease/condition indication. Disease Or Condition Indication Note DDF Indication Attribute Terminology DDF Indication Attribute Terminology CDISC DDF Indication Attribute Terminology A terminology value set relevant to the attributes of the ingredient. The intended use of the ingredient within the context of the compounded substance or mixture. Ingredient Role DDF Ingredient Attribute Terminology DDF Ingredient Attribute Terminology CDISC DDF Ingredient Attribute Terminology A terminology value set relevant to the attributes of the intercurrent event. A narrative representation of the intercurrent event. Intercurrent Event Description The short descriptive designation for the intercurrent event. Intercurrent Event Label The literal identifier (i.e., distinctive designation) of the intercurrent event. Intercurrent Event Name A brief written record relevant to the intercurrent event. Intercurrent Event Note A textual description of the planned strategy to manage and/or mitigate intercurrent events. Intercurrent Event Strategy An instance of structured text that represents the intercurrent event. Intercurrent Event Text DDF Intercurrent Event Attribute Terminology DDF Intercurrent Event Attribute Terminology CDISC DDF Intercurrent Event Attribute Terminology A terminology value set relevant to the attributes of the interventional study design. Intervention Model The general design of the strategy for assigning interventions to participants in a clinical study. (clinicaltrials.gov) Intervention Model The distinguishing qualities or prominent aspects of an interventional study design. Interventional Study Design Characteristic A narrative representation of the interventional study design. Interventional Study Design Description The short descriptive designation for the interventional study design. Interventional Study Design Label The literal identifier (i.e., distinctive designation) of the interventional study design. Interventional Study Design Name A brief written record relevant to the interventional study design. Interventional Study Design Note Reason(s) for choosing the interventional study design. This may include reasons for the choice of control or comparator, as well as the scientific rationale for the study design. Interventional Study Design Rationale The study phase associated with the interventional study design. Interventional Study Design Study Phase The study type associated with the interventional study design. Interventional Study Design Study Type A categorization of a disease, disorder, or other condition based on common characteristics and often associated with a medical specialty focusing on research and development of specific therapeutic interventions for the purpose of treatment and prevention, which is associated with the interventional study design. Interventional Study Design Therapeutic Areas 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 Trial Intent Type The planned purpose of the therapy, device, or agent under study in the clinical trial. Clinical Study by Intent Trial Scope Trial Type The nature of the interventional study for which information is being collected. Trial Type DDF Interventional Study Design Attribute Terminology DDF Interventional Study Design Attribute Terminology CDISC DDF Interventional Study Design Attribute Terminology A terminology value set relevant to the attributes of the masking. An indication as to whether the study role is masked. Study Role Masked Indicator An instance of unstructured text that represents how the masking is performed and maintained. Masking Text DDF Masking Attribute Terminology DDF Masking Attribute Terminology CDISC DDF Masking Attribute Terminology A terminology value set relevant to the attributes of the medical device. A form or variant of hardware; one of a sequence of copies of the physical components from which a computer is constructed, each incorporating new modifications. Hardware Version A narrative representation of the medical device. Medical Device Description The short descriptive designation for the medical device. Medical Device Label The literal identifier (i.e., distinctive designation) of the medical device. Medical Device Name A brief written record relevant to the medical device. Medical Device Note An indication as to whether the medical device is obtained from a local or central source. Medical Device Sourcing Indicator Software Version A form or variant of software; one of a sequence of copies of a software program, each incorporating new modifications. (NCI) Software Version DDF Medical Device Attribute Terminology DDF Medical Device Attribute Terminology CDISC DDF Medical Device Attribute Terminology A terminology value set relevant to the attributes of the medical device identifier. An instance of structured text that represents the medical device identifier. Medical Device Identifier Text A characterization or classification of the medical device identifier. Medical Device Identifier Type DDF Medical Device Identifier Attribute Terminology DDF Medical Device Identifier Attribute Terminology CDISC DDF Medical Device Identifier Attribute Terminology A terminology value set relevant to the attributes of the narrative content. The literal identifier (i.e., distinctive designation) of the narrative content. Narrative Content Name An indication as to whether the section number is to be displayed in the document containing narrative content. Narrative Content Section Number Display Indicator The numeric identifier assigned to a particular document section containing narrative content. Narrative Content Section Number An indication as to whether the section title is to be displayed in the document containing narrative content. Narrative Content Section Title Display Indicator An identifying designation for the document section containing narrative content. Narrative Content Section Title DDF Narrative Content Attribute Terminology DDF Narrative Content Attribute Terminology CDISC DDF Narrative Content Attribute Terminology A terminology value set relevant to the attributes of the narrative content item. The literal identifier (i.e., distinctive designation) of the narrative content item. Narrative Content Item Name An instance of unstructured text that represents the narrative content item. Narrative Content Item Text DDF Narrative Content Item Attribute Terminology DDF Narrative Content Item Attribute Terminology CDISC DDF Narrative Content Item Attribute Terminology A terminology value set relevant to the attributes of the objective. A brief written record relevant to the study objective. Study Objective Note A narrative representation of the study objective. Study Objective Description The short descriptive designation for the study objective. Study Objective Label A characterization or classification of the study objective that determines its category of importance relative to other study objectives. Study Objective Level The literal identifier (i.e., distinctive designation) of the study objective. Study Objective Name An instance of structured text that represents the study objective. Study Objective Text DDF Objective Attribute Terminology DDF Objective Attribute Terminology CDISC DDF Objective Attribute Terminology A terminology value set relevant to the attributes of the observational study design. Observation Model The general design of the strategy for identifying and following up with participants during observational studies. (clinicaltrials.gov) Observational Study Model The distinguishing qualities or prominent aspects of an observational study design. Observational Study Design Characteristics A narrative representation of the observational study design. Observational Study Design Description The short descriptive designation for the observational study design. Observational Study Design Label The literal identifier (i.e., distinctive designation) of the observational study design. Observational Study Design Name A brief written record relevant to the observational study design. Observational Study Design Note Reason(s) for choosing the observational study design. This may include reasons for the choice of control or comparator, as well as the scientific rationale for the study design. Observational Study Design Rationale The study phase associated with the observational study design. Observational Study Design Study Phase The study type associated with the observational study design. Observational Study Design Study Type A categorization of a disease, disorder, or other condition based on common characteristics and often associated with a medical specialty focusing on research and development of specific therapeutic interventions for the purpose of treatment and prevention, which is associated with the observational study design. Observational Study Design Therapeutic Area Observational Study Sampling Method The sampling method used to assign study participants into groups or cohorts within an observational study. Observational Study Sampling Method The nature of the observational study for which information is being collected. Observational Study Type Observational Time Perspective The temporal relationship between the observation period and time of subject enrollment. (ClinicalTrials.gov) Observational Time Perspective of Study DDF Observational Study Design Attribute Terminology DDF Observational Study Design Attribute Terminology CDISC DDF Observational Study Design Attribute Terminology A terminology value set relevant to the attributes of the organization. The name of the organization that provides the identifier for the entity. Identifier Provider Organization Name A unique symbol that establishes identity of the organization. (BRIDG) Organization Identifier The short descriptive designation for the organization. Organization Label A non-unique textual identifier for the organization. (BRIDG) Organization Name 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 DDF Organization Attribute Terminology DDF Organization Attribute Terminology CDISC DDF Organization Attribute Terminology A terminology value set relevant to the attributes of the parameter map. 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 Character strings bounded by angle brackets that act as containers for programming language elements. Programming Tag DDF Parameter Map Attribute Terminology DDF Parameter Map Attribute Terminology CDISC DDF Parameter Map Attribute Terminology A terminology value set relevant to the attributes of the person name. Person Surname A word or group of words indicating a person's last (family) name. Last Name A word or group of words indicating a person's first (personal or given) name; the name that precedes the surname. First Name An affix occurring at the start of the person name string, usually denoting a title or honorific. Person Name Prefix An affix occurring at the end of the person name, usually denoting educational or professional degrees and certifications, and/or filial rank. Person Name Suffix Human Name Text An instance of structured text that represents the person's full name. Person Name Text DDF Person Name Attribute Terminology DDF Person Name Terminology CDISC DDF Person Name Attribute Terminology A terminology value set relevant to the attributes of the population definition. A narrative representation of the population definition. Population Definition Description 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 The short descriptive designation for the population definition. Population Definition Label The literal identifier (i.e., distinctive designation) of the population definition. Population Definition Name A brief written record relevant to the population definition. Population Definition Note The anticipated age of subjects within the population definition. Population Definition Planned Age 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 The value representing the planned number of subjects to be entered in a clinical trial, within the population definition. Population Definition Planned Enrollment Number The protocol-defined sex within the population definition. Population Definition Planned Sex DDF Population Definition Attribute Terminology DDF Population Definition Attribute Terminology CDISC DDF Population Definition Attribute Terminology A terminology value set relevant to the attributes of the procedure. A symbol or combination of symbols which is assigned to medical procedure. Procedure Code A narrative representation of the procedure. Procedure Description The short descriptive designation for the procedure. Procedure Label The literal identifier (i.e., distinctive designation) of the procedure. Procedure Name A brief written record relevant to the procedure. Procedure Note A characterization or classification of the study procedure. Study Procedure Type DDF Procedure Attribute Terminology DDF Procedure Attribute Terminology CDISC DDF Procedure Attribute Terminology A terminology value set relevant to the attributes of the product organization role. A symbol or combination of symbols which is assigned to the product organization role. Product Organization Role Code A narrative representation of the product organization role. Product Organization Role Description The short descriptive designation for the product organization role. Product Organization Role Label The literal identifier (i.e., distinctive designation) of the product organization role. Product Organization Role Name DDF Product Organization Role Attribute Terminology DDF Product Organization Role Attribute Terminology CDISC DDF Product Organization Role Attribute Terminology A terminology value set relevant to the attributes of the quantity. The type of unit of measure being used to express a quantity. Unit of Quantity A numerical quantity measured or assigned or computed. Value DDF Quantity Attribute Terminology DDF Quantity Attribute Terminology CDISC DDF Quantity Attribute Terminology A terminology value set relevant to the attributes of the range. The largest value in quantity or degree in a set of values. Maximum The smallest value in quantity or degree in a set of values. Minimum An indication as to whether the value range is almost, but not quite, exact. Value Range is Approximate Indicator DDF Range Attribute Terminology DDF Range Attribute Terminology CDISC DDF Range Attribute Terminology A terminology value set relevant to the attributes of the reference identifier. An instance of structured text that represents the reference identifier. Reference Identifier Text A characterization or classification of the reference identifier. Reference Identifier Type DDF Reference Identifier Attribute Terminology DDF Reference Identifier Attribute Terminology CDISC DDF Reference Identifier Attribute Terminology A terminology value set relevant to the attributes of the response code. An indication as to whether the response code is activated for use within a given usage context. Response Code Enabled Indicator The short descriptive designation for the response code. Response Code Label The literal identifier (i.e., distinctive designation) of the response code. Response Code Name The literal value of a response code. Response Code Value DDF Response Code Attribute Terminology DDF Response Code Attribute Terminology CDISC DDF Response Code Attribute Terminology A terminology value set relevant to the attributes of the schedule timeline. An indication as to whether the timeline or timeline component is part of the central or principal timeline. Main Timeline Indicator A narrative representation of the schedule timeline. Schedule Timeline Description A logical evaluation on which rests the validity of entry into a schedule timeline. Schedule Timeline Entry Condition The short descriptive designation for the schedule timeline. Schedule Timeline Label The literal identifier (i.e., distinctive designation) of the schedule timeline. Schedule Timeline Name The period of time over which the scheduled timeline is intended to take place. Schedule Timeline Planned Duration DDF Schedule Timeline Attribute Terminology DDF Schedule Timeline Attribute Terminology CDISC DDF Schedule Timeline Attribute Terminology A terminology value set relevant to the attributes of the scheduled activity instance. A narrative representation of the scheduled activity instance. Scheduled Activity Instance Description The short descriptive designation for the scheduled activity instance. Scheduled Activity Instance Label The literal identifier (i.e., distinctive designation) of the scheduled activity instance. Scheduled Activity Instance Name DDF Scheduled Activity Instance Attribute Terminology DDF Scheduled Activity Instance Attribute Terminology CDISC DDF Scheduled Activity Instance Attribute Terminology A terminology value set relevant to the attributes of the scheduled decision instance. A narrative representation of the scheduled Decision instance. Scheduled Decision Instance Description The short descriptive designation for the scheduled Decision instance. Scheduled Decision Instance Label The literal identifier (i.e., distinctive designation) of the scheduled Decision instance. Scheduled Decision Instance Name DDF Scheduled Decision Instance Attribute Terminology DDF Scheduled Decision Instance Attribute Terminology CDISC DDF Scheduled Decision Instance Attribute Terminology A terminology value set relevant to the attributes of the scheduled instance. A narrative representation of the scheduled instance. Scheduled Instance Description The short descriptive designation for the scheduled instance. Scheduled Instance Label The literal identifier (i.e., distinctive designation) of the scheduled instance. Scheduled Instance Name DDF Scheduled Instance Attribute Terminology DDF Scheduled Instance Attribute Terminology CDISC DDF Scheduled Instance Attribute Terminology A terminology value set relevant to the attributes of the strength. The divisor of a fraction. Denominator The dividend of a fraction. Numerator A narrative representation of the substance strength. Substance Strength Description The short descriptive designation for the substance strength. Substance Strength Label The literal identifier (i.e., distinctive designation) of the substance strength. Substance Strength Name DDF Strength Attribute Terminology DDF Strength Attribute Terminology CDISC DDF Strength Attribute Terminology A terminology value set relevant to the attributes of the study amendment. A narrative representation of the study amendment. Study Amendment Description The short descriptive designation for the study amendment. Study Amendment Label The literal identifier (i.e., distinctive designation) of the study amendment. Study Amendment Name A brief written record relevant to the study amendment. Study Amendment Note Amendment Identifier A string of numerals that uniquely identifies a protocol amendment. Study Amendment Number A short narrative representation describing the changes introduced in the current version of the protocol. Clinical Trial Protocol Amendment Summary DDF Study Amendment Attribute Terminology DDF Study Amendment Attribute Terminology CDISC DDF Study Amendment Attribute Terminology A terminology value set relevant to the attributes of the study amendment impact. A brief written record relevant to the study amendment impact. Study Amendment Impact Note An indication as to whether the study amendment's impact on the study is substantial. Study Amendment Substantial Impact Indicator An instance of unstructured text that represents the study amendment impact. Study Amendment Impact Text A characterization or classification of the study amendment impact. Study Amendment Impact Type DDF Study Amendment Impact Attribute Terminology DDF Study Amendment Impact Attribute Terminology CDISC DDF Study Amendment Impact Attribute Terminology A terminology value set relevant to the attributes of the study amendment reason. The rationale for the change(s) to, or formal clarification of, a protocol that is not otherwise specified. Other Reason for Study Amendment Study Amendment Reason Code A symbol or combination of symbols which is assigned to the study amendment reason. Study Amendment Reason Code DDF Study Amendment Reason Attribute Terminology DDF Study Amendment Reason Attribute Terminology CDISC DDF Study Amendment Reason Attribute Terminology A terminology value set relevant to the attributes of the study Arm. The textual representation of the study arm data origin. Study Arm Data Origin Description A characterization or classification of the study arm with respect to where the study arm data originates. Study Arm Data Origin Type Arm Description A narrative representation of the study arm. Arm Description Arm Label The short descriptive designation for the study arm. Study Arm Label The literal identifier (i.e., distinctive designation) of the study arm. Planned Study Arm Name A brief written record relevant to the study arm. Study Arm Note Arm Type A characterization or classification of the study arm. Study Arm Type DDF Study Arm Attribute Terminology DDF Study Arm Attribute Terminology CDISC DDF Study Arm Attribute Terminology A terminology value set relevant to the attributes of the study change. A narrative representation of the study change. Study Change Description The short descriptive designation for the study change. Study Change Label The literal identifier (i.e., distinctive designation) of the study change. Study Change Name An explanation as to the logical reasons for why a study change has occurred. Study Change Rationale A short narrative representation describing the changes introduced in the current version of the study. Study Change Summary DDF Study Change Attribute Terminology DDF Study Change Attribute Terminology CDISC DDF Study Change Attribute Terminology A terminology value set relevant to the attributes of the study cohort. A narrative representation of the study cohort. Study Cohort Description 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 The short descriptive designation for the study cohort. Study Cohort Label The literal identifier (i.e., distinctive designation) of the study cohort. Study Cohort Name A brief written record relevant to the study cohort. Study Cohort Note The anticipated age of subjects within the study cohort. Study Cohort Planned Age 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 The value representing the planned number of subjects to be entered in a clinical trial, within the study cohort. Study Cohort Planned Enrollment Number The protocol-defined sex within the study cohort. Planned Sex of Study Cohort Participants DDF Study Cohort Attribute Terminology DDF Study Cohort Attribute Terminology CDISC DDF Study Cohort Attribute Terminology A terminology value set relevant to the attributes of the study definition document. A narrative representation of the study definition document. Study Definition Document Description The short descriptive designation for the study definition document. Study Definition Document Label The language in which the study definition document is written. Study Definition Document Language The literal identifier (i.e., distinctive designation) of the study definition document. Study Definition Document Name A brief written record relevant to the study definition document. Study Definition Document Note The literal identifier (i.e., distinctive designation) of the study definition document template. Study Definition Document Template Name A characterization or classification of the study definition document. Study Definition Document Type DDF Study Definition Document Attribute Terminology DDF Study Definition Document Attribute Terminology CDISC DDF Study Definition Document Attribute Terminology A terminology value set relevant to the attributes of the study definition document version. A condition of the study definition document at a point in time with respect to its state of readiness for implementation. Study Definition Document Status A sequence of characters used to identify the version of the study definition document. Study Definition Document Version Identifier A brief written record relevant to the study definition document version. Study Definition Document Version Note DDF Study Definition Document Version Attribute Terminology DDF Study Definition Document Version Attribute Terminology CDISC DDF Study Definition Document Version Attribute Terminology A terminology value set relevant to the attributes of the study design. The distinguishing qualities or prominent aspect of a study design. Study Design Characteristic Overall Design Study Design Description Study Design Overview Summary of Study Design A narrative representation of the study design. Study Design Description The short descriptive designation for the study design. Study Design Label The literal identifier (i.e., distinctive designation) of the study design. Study Design Name A brief written record relevant to the study design. Study Design Note 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 Study Type Study Type Classification The nature of the investigation for which study information is being collected. (After clinicaltrials.gov) Study Type 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 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 DDF Study Design Attribute Terminology DDF Study Design Attribute Terminology CDISC DDF Study Design Attribute Terminology A terminology value set relevant to the attributes of the study design population. A narrative representation of the study design population. Study Population Description 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 The short descriptive designation for the study design population. Study Design Population Label The literal identifier (i.e., distinctive designation) of the study design population. Study Design Population Name A brief written record relevant to the study design population. Study Design Population Note The anticipated age of subjects within the study design population. Study Design Population Planned Age 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 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 The protocol-defined sex within the study design population. Study Design Population Planned Sex DDF Study Design Population Attribute Terminology DDF Study Design Population Attribute Terminology CDISC DDF Study Design Population Attribute Terminology A terminology value set relevant to the attributes of the study element. A narrative representation of the study design element. Study Design Element Description The short descriptive designation for the study design element. Study Design Element Label The literal identifier (i.e., distinctive designation) of the study design element. Study Design Element Name A brief written record relevant to the study element. Study Element Note DDF Study Element Attribute Terminology DDF Study Element Attribute Terminology CDISC DDF Study Element Attribute Terminology A terminology value set relevant to the attributes of the study epoch. A narrative representation of the study epoch. Epoch Description The short descriptive designation for the study epoch. Study Epoch Label 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 A brief written record relevant to the study epoch. Study Epoch Note 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 DDF Study Epoch Attribute Terminology DDF Study Epoch Attribute Terminology CDISC DDF Study Epoch Attribute Terminology A terminology value set relevant to the attributes of the study identifier. An instance of structured text that represents the study identifier. Study Identifier Text DDF Study Identifier Attribute Terminology DDF Study Identifier Attribute Terminology CDISC DDF Study Identifier Attribute Terminology A terminology value set relevant to the attributes of the study interventions. A symbol or combination of symbols which is assigned to the study intervention. Study Intervention Code A narrative representation of the study intervention. Study Intervention Description The short descriptive designation for the study intervention. Study Intervention Label The value representing the minimum amount of time required to meet the criteria for response to study intervention. Study Intervention Minimum Response Duration The literal identifier (i.e., distinctive designation) of the study intervention. Study Intervention Name A brief written record relevant to the study intervention. Study Intervention Note Study Intervention Use The intended use of the trial intervention within the context of the study design. Study Intervention Role Intervention Type The kind of product or procedure studied in a trial. Intervention Type DDF Study Intervention Attribute Terminology DDF Study Intervention Attribute Terminology CDISC DDF Study Intervention Attribute Terminology A terminology value set relevant to the attributes of the study role. A symbol or combination of symbols which is assigned to the study role. Study Role Code A narrative representation of the study role. Study Role Description The short descriptive designation for the study role. Study Role Label The literal identifier (i.e., distinctive designation) of the study role. Study Role Name A brief written record relevant to the study role. Study Role Notes DDF Study Role Attribute Terminology DDF Study Role Attribute Terminology CDISC DDF Study Role Attribute Terminology A terminology value set relevant to the attributes of the study site. The country in which the study site is located. Country of Investigational Site A narrative representation of the study site. Study Site Description The short descriptive designation for the study site. Study Site Label The literal identifier (i.e., distinctive designation) of the study site. Study Site Name DDF Study Site Attribute Terminology DDF Study Site Attribute Terminology CDISC DDF Study Site Attribute Terminology A terminology value set relevant to the attributes of the study title. An instance of unstructured text that represents the study title. Study Title Text A characterization or classification of the study title. Study Title Type DDF Study Title Attribute Terminology DDF Study Title Attribute Terminology CDISC DDF Study Title Attribute Terminology A terminology value set relevant to the attributes of the study version. A therapeutic area classification based on the structure and operations of the business unit. Business Therapeutic Area 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 A sequence of characters used to identify, name, or characterize the study version. Study Version Identifier A brief written record relevant to the study version. Study Version Note DDF Study Version Attribute Terminology DDF Study Version Attribute Terminology CDISC DDF Study Version Attribute Terminology A terminology value set relevant to the attributes of the subject enrollment. A narrative representation of the subject enrollment. Subject Enrollment Description The short descriptive designation for the subject enrollment. Subject Enrollment Label The literal identifier (i.e., distinctive designation) of the subject enrollment. Subject Enrollment Name The value representing the number of individuals enrolled in a study. Subject Enrollment Quantity Value DDF Subject Enrollment Attribute Terminology DDF Subject Enrollment Attribute Terminology CDISC DDF Subject Enrollment Attribute Terminology A terminology value set relevant to the attributes of the substance. A symbol or combination of symbols which is assigned to the substance. Substance Code A narrative representation of the substance. Substance Description The short descriptive designation for the substance. Substance Label The literal identifier (i.e., distinctive designation) of the substance. Substance Name DDF Substance Attribute Terminology DDF Substance Attribute Terminology CDISC DDF Substance Attribute Terminology A terminology value set relevant to the attributes of the syntax template. A narrative representation of the syntax template. Syntax Template Description The short descriptive designation for the syntax template. Syntax Template Label The literal identifier (i.e., distinctive designation) of the syntax template. Syntax Template Name A brief written record relevant to the syntax template. Syntax Template Note A structured text string containing prescribed text interspersed with user-defined parameter values. Syntax Template Text DDF Syntax Template Attribute Terminology DDF Syntax Template Attribute Terminology CDISC DDF Syntax Template Attribute Terminology A terminology value set relevant to the attributes of the syntax template dictionary. A narrative representation of the syntax template dictionary. Syntax Template Dictionary Description The short descriptive designation for the syntax template dictionary. Syntax Template Dictionary Label The literal identifier (i.e., distinctive designation) of the syntax template dictionary. Syntax Template Dictionary Name DDF Syntax Template Dictionary Attribute Terminology DDF Syntax Template Dictionary Attribute Terminology CDISC DDF Syntax Template Dictionary Attribute Terminology A terminology value set relevant to the attributes of the timing. A narrative representation of the biomedical concept category. Timing Description The short descriptive designation for the timing. Timing Label The literal identifier (i.e., distinctive designation) of the timing. Timing Name The name of the reference event used to define the temporal relationship with another event. Timing Relative To From Name A characterization or classification of the chronological relationship between temporal events. Timing Type The short descriptive designation for the timing value. Timing Value Label The temporal value of the chronological relationship between temporal events. Timing Value 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 The earliest chronological value of an allowable period of time during which a temporal event takes place. Lower Timing Window The latest chronological value of an allowable period of time during which a temporal event takes place. Upper Timing Window DDF Timing Attribute Terminology DDF Timing Attribute Terminology CDISC DDF Timing Attribute Terminology A terminology value set relevant to the attributes of the transition rule. A narrative representation of the transition rule. Transition Rule Description The short descriptive designation for the transition rule. Transition Rule Label The literal identifier (i.e., distinctive designation) of the transition rule. Transition Rule Name An instance of unstructured text that represents the transition rule. Transition Rule Text DDF Transition Rule Attribute Terminology DDF Transition Rule Attribute Terminology CDISC DDF Transition Rule Attribute Terminology The terminology relevant to the encounter type. 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 Encounter Type Value Set Terminology Encounter Type Value Set Terminology CDISC DDF Encounter Type Value Set Terminology The terminology relevant to the endpoint level. 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 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 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 Endpoint Level Value Set Terminology Endpoint Level Value Set Terminology CDISC DDF Endpoint Level Value Set Terminology The terminology relevant to the geographic scope type value set. A sovereign nation occupying a distinct territory and ruled by an autonomous government. Country Covering or affecting the whole of a system. Global An area or portion of something with more or less definite boundaries designed or specified according to some established criteria. Region Geographic Scope Type Value Set Terminology Geographic Scope Type Value Set Terminology CDISC DDF Geographic Scope Type Value Set Terminology The terminology relevant to the governance date type value set. The date on which the entity receives official approbation, recognition, or acceptance as satisfactory. Approval Date The date on which the entity becomes active, goes into effect, or is slated to begin use. Effective Date The date on which the entity is officially released, made available, or delivered to its intended recipient. Issued Date Governance Date Type Value Set Terminology Governance Date Type Value Set Terminology CDISC DDF Governance Date Type Value Set Terminology The terminology relevant to the medical device identifier type value set. Batch Identifier Batch Number A distinctive alpha-numeric identification code assigned by the manufacturer or distributor to a specific quantity of manufactured material or product that is produced in a manner that is expected to render it homogeneous. Batch Number FDA Unique Device Identification A UDI is a unique numeric or alphanumeric code that includes a device identifier, which is specific to a device model, and a production identifier, which includes the current production information for that specific device, such as the lot or batch number, the serial number and/or expiration date. (FDA) FDA Unique Device Identifier Lot Identifier Lot Number A short sequence of characters assigned by the manufacturer or distributor to a specific quantity of manufactured material or product. Lot Number Model Identifier Model Number The identifier assigned to a particular design of a device, usually an alphanumeric text string. Model Number Medical Device Identifier Type Value Set Terminology Medical Device Identifier Type Value Set Terminology CDISC DDF Medical Device Identifier Type Value Set Terminology The terminology relevant to the medical device sourcing value set. An indication that the entity is obtained from a central source. Centrally Sourced Indicator An indication that the entity is obtained from a local source. Locally Sourced Indicator Medical Device Sourcing Value Set Terminology Medical Device Sourcing Value Set Terminology CDISC DDF Medical Device Sourcing Value Set Terminology The terminology relevant to the objective level. 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 Study Primary Objective Trial Primary Objective The main scientific question(s) the study is designed to answer. (CDISC Glossary) Trial Primary 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 Objective Level Value Set Terminology Objective Level Value Set Terminology CDISC DDF Objective Level Value Set Terminology The terminology relevant to the observational study design subtype value set. A study that assesses the effectiveness of health information on reducing ill health and enhancing good health by influencing beliefs, attitudes, and behavior of individuals and communities. Clinical Education Study A study that assesses the variables that influence the occurrence frequency and/or population distribution of a given disease, condition, or injury Disease Determinants Study A study that assesses the causative factors associated with a disease, condition, or injury. Disease Etiology Study A study that assesses the occurrence of new cases of disease, condition, or injury in a defined population over a specified period of time. Disease Incidence Study A study that assesses the proportion of persons in a population who have a particular disease, condition, or injury at a specified point in time or over a specified period of time. (CDC) Disease Prevalence Study A study that assesses the prediction of the probable course and outcome of a disease, condition, or injury. Disease Prognosis Study A study that assesses drug usage patterns for prophylaxis or treatment of health problems, or promoting maintenance of health and well-being. Drug Utilization Study A study that assesses the medical risks to a subject. Safety is usually assessed by examining a wide range of clinical parameters, including adverse events, vital signs, physical exam, laboratory tests. Safety Study Observational Study Design Subtype Value Set Terminology Observational Study Design Subtype Value Set Terminology CDISC DDF Observational Study Design Subtype Value Set Terminology The terminology relevant to the organization type. An organization, such as a college or university, established for the purpose of scholastic pursuit, education, granting degrees, and research. Academia An organization (typically a government agency) that administers the registration of studies. (BRIDG) Study Registry A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions. [ICH E6 Glossary] Contract Research Organization An organization established, funded, and overseen by a government, which has a specific purpose or intent. Governmental Agency or Group The buildings and organizations where healthcare services are provided. Healthcare Facility An organization with the capability and competency to perform scientific research, experiments, and measurements. (BRIDG) Laboratory A company licensed to discover, develop, market, and/or distribute medical devices. Medical Device Company A company licensed to discover, develop, market, and/or distribute drugs. Drug Company 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 Organization Type Value Set Terminology Organization Type Value Set Terminology CDISC DDF Organization Type Value Set Terminology The terminology relevant to the product designation value set. 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 AxIMP A medicinal product that is related to the specific needs of the clinical trial as described in the protocol, but not as an investigational medicinal product. NOTE: Auxiliary medicinal products may be authorised for marketing in a country or region or non-authorised. (CDISC Glossary) Auxiliary Medicinal Product Product Designation Value Set Terminology Product Designation Value Set Terminology CDISC DDF Product Designation Value Set Terminology The terminology relevant to the product organization role code value set. Manufacturer The organization defined as being responsible for creating the product as stated on the package in which the product is supplied. (BRIDG) Manufacturer An individual or organization whose business is to supply a particular service or commodity. Supplier Product Organization Role Code Value Set Terminology Product Organization Role Code Value Set Terminology CDISC DDF Product Organization Role Code Value Set Terminology The terminology relevant to the reference identifier type value set. CDP A document that describes the collection of clinical studies that are to be performed in sequence, or in parallel, with a particular active substance, device, procedure, or treatment strategy, typically with the intention of submitting them as part of an application for a marketing authorization. (CDISC Glossary) Clinical Development Plan PIP A development plan aimed at ensuring that the necessary data are obtained to support the authorisation of a medicine for children, through studies in children. (EMA) Pediatric Investigation Clinical Development Plan Reference Identifier Type Value Set Terminology Reference Identifier Type Value Set Terminology CDISC DDF Reference Identifier Type Value Set Terminology The terminology relevant to the study amendment impact type value set. The completeness and accuracy of data as a measure of how well it can be counted on to be consistent and free from errors across time and sources. (IBM) Study Data Reliability The data's ability to remain accurate and relevant despite changes or disruptions to the data environment. Study Data Robustness Participant Rights A study subject's moral, ethical, and legal entitlements before, during, and after the study. Study Subject Rights Participant Safety The condition in which a study subject is free from harmful effects which may arise as a result of study participation. Study Subject Safety Study Amendment Impact Type Value Set Terminology Study Amendment Impact Type Value Set Terminology CDISC DDF Study Amendment Impact Type Value Set Terminology The terminology relevant to the study amendment reason code value set. 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 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 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 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 Feedback from the investigator or study site necessitates a change(s) to, or formal clarification of, the protocol. (ICH M11) Investigator/Site 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 A change to manufacturing processes of the study agents necessitates a change(s) to, or formal clarification of, the protocol. (ICH M11) Manufacturing Change 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) 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 Previously unavailable safety data becomes available, which necessitates a change(s) to, or formal clarification of, the protocol. (ICH M11) New Safety Information Available NA Not Applicable Determination of a value is not relevant in the current context. (NCI) Not Applicable Other Different than the one(s) previously specified or mentioned. (NCI) Other A protocol design error necessitates a change(s) to, or formal clarification of, a document. (ICH M11) Protocol Design Error Challenges with participant recruitment necessitates a change(s) to, or formal clarification of, the protocol. (ICH M11) Recruitment Difficulty 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 Study Amendment Reason Code Value Set Terminology Study Amendment Reason Code Value Set Terminology CDISC DDF Study Amendment Reason Code Value Set Terminology The terminology relevant to the study arm data origin type. Data that are generated from within the current study. Data Generated Within Study Data from studies that have occurred in the past. Historical 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 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 Study Arm Data Origin Type Value Set Terminology Study Arm Data Origin Type Value Set Terminology CDISC DDF Study Arm Data Origin Type Value Set Terminology The terminology relevant to the study arm type value set. An arm describing the active comparator. Active Comparator Arm An arm describing the intervention or treatment plan for a group of participants in the study receiving a control. The control may comprise a non-investigational product (active control) or regimen, placebo, or no treatment. Control Arm Investigational Arm An arm describing the intervention or treatment plan for a group of participants in the study receiving test product(s). Investigational Arm A study arm without an intervention or treatment. No Intervention Arm Placebo Control Arm An arm describing the placebo comparator. Placebo Control Arm Sham Intervention Arm An arm describing the sham comparator. Sham Comparator Arm A planned pathway through the study to which subjects are assigned, and that describes treatments, exposures, controls, and/or observations. Protocol Treatment Arm Study Arm Type Value Set Terminology Study Arm Type Value Set Terminology CDISC DDF Study Arm Type Value Set Terminology The terminology relevant to the study definition document type value set. The formal plan of an experiment or research activity, including the objective, rationale, design, materials and methods for the conduct of the study, intervention description, and method of data analysis. Study Protocol Study Definition Document Type Value Set Terminology Study Definition Document Type Value Set Terminology CDISC DDF Study Definition Document Type Value Set Terminology The terminology relevant to the study definition document version status. Acceptance as satisfactory by an authoritative body; established by authority; given authoritative approval. Approval A preliminary version of a written work, design, or picture. Draft Conclusive in a process or progression. Final No longer in use or valid; old. Obsolete Draft Pending Review A preliminary version of a written work, design, or picture that is awaiting review. Pending Review Study Definition Document Version Value Set Terminology Study Definition Document Version Value Set Terminology CDISC DDF Study Definition Document Version Value Set Terminology The terminology relevant to the study design characteristics value set. 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 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 A clinical study conducted according to a single protocol but at more than one study site. Multicenter Study Of, or pertaining to, an occurrence in more than one country. Multiple Countries A study design in which interventions are assigned to subjects according to randomization principles. Randomized Controlled Clinical Trial Of, or pertaining to, an occurrence in one country. Single Country A clinical study that is conducted at a single study site. Single-Center Study Grouping defined by important prognostic factors measured at baseline. (ICH E9) Stratification A type of block randomization in which participants are stratified into groups based on prognostic variables and then randomized into balanced treatment groups. Stratified Randomization Study Design Characteristics Value Set Terminology Study Design Characteristics Value Set Terminology CDISC DDF Study Design Characteristics Value Set Terminology The terminology relevant to the study intervention role value set. Active Control A type of control, which has a demonstrated effect, administered as a comparator to subjects in a clinical trial. [From ICH E10] Active Comparator 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 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 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 Any procedure or test used to diagnose a disease or disorder. Diagnostic Procedure 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 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 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 Study Intervention Role Value Set Terminology Study Intervention Role Value Set Terminology CDISC DDF Study Intervention Role Value Set Terminology The terminology relevant to the study role code terminology value set. An external committee whose purpose is to evaluate study data and decide whether a study endpoint or other criterion has been met. (NCI) Adjudication Committee 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 Study Doctor Any physician that is associated with clinical trial. Clinical Trial Physician An individual, company, institution, or organization that is designated by the study sponsor as a vested partner in the study. Study Co-Sponsor Research that is conducted by an individual or organization on behalf of another organization through a contracting mechanism. Contract Research Data and Safety Monitoring Board Data and Safety Monitoring Committee DSMB Data Monitoring and Oversight Committee DMC DMOC DSMC IDMC Independent Data Monitoring Committee A group of independent experts who are appointed to monitor the safety and scientific integrity of a research intervention, protect the confidentiality of participant data, and to make recommendations to the sponsor regarding the stopping of the trial for safety, efficacy, or for futility. (After clinicaltrials.gov; Committee for Medicinal Products for Human Use (CHMP), 2005, EMA; FDA Establishment and Operation of Clinical Trial Data Monitoring Committees. March 2006) Data Monitoring Committee A committee established to assess whether a dose adjustment is appropriate and to determine whether the maximum-tolerated dose had been attained, based on a review of available safety and efficacy data at specified time points. Dose Escalation Committee A committee established by the sponsor to assess at intervals the progress of a clinical trial, safety data, and critical efficacy variables and recommend to the sponsor whether to continue, modify, or terminate the trial. [ICH E9] (CDISC Glossary) Independent Data Monitoring Committee A person responsible for the conduct of the study, ensuring adherence to the protocol and good clinical practices. (CDISC Glossary) Investigator An organization with the capability and competency to perform scientific research, experiments, and measurements. (BRIDG) Laboratory The sponsor's legal representative at a geographical region within which the sponsor has no legal presence. (ICH M11) Local Legal Sponsor Manufacturer The organization defined as being responsible for creating the product as stated on the package in which the product is supplied. (BRIDG) Manufacturer A physician or health care provider selected by the sponsor to be readily available to advise clinical trial officials on trial related medical questions or problems. Sponsor Medical Expert The individual who evaluates the outcome(s) of interest. Outcomes Assessor A group that is responsible for monitoring the safety of medicines and taking action to reduce their risks and increase their benefits. Pharmacovigilance Group The study investigator who has the primary responsibility for the conduct of a study and for the study-related personnel at the participating site(s). Principal Investigator Project Coordinator A staff member who is responsible for the overall integration and interaction of different people and different components of subject matter associated with a specific project. Project Coordinator 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 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 A professional who specializes in applying statistical principles to experimental design and data analysis. Statistician The location at which a study investigator conducts study activities. Study Site An individual who is observed, analyzed, examined, investigated, experimented upon, or/and treated in the course of a particular study. Study Subject Study Role Code Value Set Terminology Study Role Code Value Set Terminology CDISC DDF Study Role Code Value Set Terminology The terminology relevant to the study title type value set. Abbreviated Protocol Title The short descriptive name for the study. Brief Study Title The formal descriptive name for the study. Official Study Title The descriptive name of the study that is intended for the lay public, written in easily understood language. Public 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 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 Study Title Type Value Set Terminology Study Title Type Value Set Terminology CDISC DDF Study Title Type Value Set Terminology The terminology relevant to the timing relative to from value set. A timing relationship defined as the end of one event to the end of another event. End to End A timing relationship defined as the end of one event to the start of another event. End to Start A timing relationship defined as the start of one event to the end of another event. Start to End A timing relationship defined as the start of one event to the start of another event. Start to Start Timing Relative To From Value Set Terminology Timing Relative To From Value Set Terminology CDISC DDF Timing Relative To From Value Set Terminology The terminology relevant to the timing type value set. A type of time point relationship that follows a point or period of time within a timeline. After Timing Type A type of time point relationship that comes before a point or period of time within a timeline. Before Timing Type A type of time point relationship that is fixed with respect to a timeline. Fixed Reference Timing Type Timing Type Value Set Terminology Timing Type Value Set Terminology CDISC DDF Timing Type Value Set Terminology