CodeList |
CodeListItem |
NCI attributes |
OID | Name
(CDISC Submission Value) | DataType
Extensible | NCI Code | CDISC Synonym | CDISC Definition | Preferred Term |
---|---|---|---|---|---|---|
CDISC Submission Value [ODM:CodedValue] | ||||||
CL.C188714.DDF Activity Attribute Terminology | DDF Activity Attribute Terminology
(DDF Activity Attribute Terminology) | text
Extensible: No | C188714 | DDF Activity Attribute Terminology | A terminology value set relevant to the attributes of the activity. | CDISC DDF Activity Attribute Terminology |
Clinical Study Activity Description | C70960 | The textual representation of the study activity. | Clinical Study Activity Description | |||
Clinical Study Activity Label | C207458 | The short descriptive designation for the study activity. | Study Activity Label | |||
Clinical Study Activity Name | C188842 | The literal identifier (i.e., distinctive designation) of the clinical study activity. | Clinical Study Activity Name | |||
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CL.C201253.DDF Address Attribute Terminology | DDF Address Attribute Terminology
(DDF Address Attribute Terminology) | text
Extensible: No | C201253 | DDF Address Attribute Terminology | A terminology value set relevant to the attributes of the address. | CDISC DDF Address Attribute Terminology |
Address Full Text | C201311 | A standardized representation of the complete set of components denoting the physical address of the person, business, building, or organization. | Address Full Text | |||
Address Line | C25690 | The street name and number, building number, apartment or unit number, or post office box number where an entity is physically located. | Street Address | |||
City | C25160 | 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 | |||
Country | C25464 | A sovereign nation occupying a distinct territory and ruled by an autonomous government. | Country | |||
District | C176229 | An administrative or territorial division of a city, town, county, parish, state, country, or other locality based on a shared characteristic. | District | |||
Postal Code | C25621 | An alphanumeric code assigned to a mail delivery area. | Postal Code | |||
State | C87194 | 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 | |||
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CL.C207420.DDF Administration Duration Attribute Terminology | DDF Administration Duration Attribute Terminology
(DDF Administration Duration Attribute Terminology) | text
Extensible: No | C207420 | DDF Administration Duration Attribute Terminology | A terminology value set relevant to the attributes of the administration duration. | CDISC DDF Administration Duration Attribute Terminology |
Administration Duration Description | C207459 | A narrative representation of the agent administration duration. | Administration Duration Description | |||
Administration Duration Quantity Value | C207460 | The value representing the amount of time over which the administration of an agent occurs. | Administration Duration Quantity Value | |||
Administration Duration Reason Duration Will Vary | C207462 | Reason Administration Duration Will Vary | The explanation for why the agent administration duration will vary within and/or across subjects. | Reason Administration Duration Will Vary | ||
Administration Duration Will Vary Indicator | C207461 | An indication as to whether the agent administration duration is planned to vary within and/or across subjects. | Administration Duration Will Vary Indicator | |||
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CL.C207421.DDF Agent Administration Attribute Terminology | DDF Agent Administration Attribute Terminology
(DDF Agent Administration Attribute Terminology) | text
Extensible: No | C207421 | DDF Agent Administration Attribute Terminology | A terminology value set relevant to the attributes of the agent administration. | CDISC DDF Agent Administration Attribute Terminology |
Agent Administration Description | C207463 | A narrative representation of the agent administration. | Agent Administration Description | |||
Agent Administration Dose | C167190 | The value representing the amount of an agent given to an individual at one time. | Dose Administered | |||
Agent Administration Label | C207464 | The short descriptive designation for the agent administration. | Agent Administration Label | |||
Agent Administration Name | C207465 | The literal identifier (i.e., distinctive designation) of the agent administration. | Agent Administration Name | |||
Dosing Frequency | C89081 | Dosing Frequency | The number of doses administered per a specific interval. | Dose Frequency | ||
Route of Administration | C38114 | Route of Administration | The way in which a pharmaceutical product is taken into, or makes contact with, the body. (CDISC Glossary) | Route of Administration | ||
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CL.C188720.DDF Analysis Population Attribute Terminology | DDF Analysis Population Attribute Terminology
(DDF Analysis Population Attribute Terminology) | text
Extensible: No | C188720 | DDF Analysis Population Attribute Terminology | A terminology value set relevant to the attributes of the analysis population. | CDISC DDF Analysis Population Attribute Terminology |
Analysis Population Description | C188854 | The textual representation of the study population for analysis. | Analysis Population Description | |||
Analysis Population Label | C207466 | The short descriptive designation for the analysis population. | Analysis Population Label | |||
Analysis Population Name | C207467 | The literal identifier (i.e., distinctive designation) of the analysis population. | Analysis Population Name | |||
Analysis Population Text | C207468 | An instance of unstructured text that represents the analysis population. | Analysis Population Text | |||
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CL.C201254.DDF Biomedical Concept Attribute Terminology | DDF Biomedical Concept Attribute Terminology
(DDF Biomedical Concept Attribute Terminology) | text
Extensible: No | C201254 | DDF Biomedical Concept Attribute Terminology | A terminology value set relevant to the attributes of the biomedical concept. | CDISC DDF Biomedical Concept Attribute Terminology |
Biomedical Concept Concept Code | C207469 | A concept unique identifier assigned to a biomedical concept that points to the meaning of that biomedical concept. | Biomedical Concept Code | |||
Biomedical Concept Label | C207470 | The short descriptive designation for the biomedical concept. | Biomedical Concept Label | |||
Biomedical Concept Name | C201312 | The literal identifier (i.e., distinctive designation) of the biomedical concept. | Biomedical Concept Name | |||
Biomedical Concept Reference | C201313 | A citation to an authoritative source for a biomedical concept. | Biomedical Concept Reference | |||
Biomedical Concept Synonym | C201314 | 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 | |||
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CL.C201255.DDF Biomedical Concept Category Attribute Terminology | DDF Biomedical Concept Category Attribute Terminology
(DDF Biomedical Concept Category Attribute Terminology) | text
Extensible: No | C201255 | DDF Biomedical Concept Category Attribute Terminology | A terminology value set relevant to the attributes of the biomedical concept category. | CDISC DDF Biomedical Concept Category Attribute Terminology |
Biomedical Concept Category Code | C201315 | A symbol or combination of symbols which is assigned to the biomedical concept category. | Biomedical Concept Category Code | |||
Biomedical Concept Category Description | C201316 | A narrative representation of the biomedical concept category. | Biomedical Concept Category Description | |||
Biomedical Concept Category Label | C207471 | The short descriptive designation for the biomedical concept category. | Biomedical Concept Category Label | |||
Biomedical Concept Category Name | C201317 | The literal identifier (i.e., distinctive designation) of the biomedical concept category. | Biomedical Concept Category Name | |||
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CL.C201256.DDF Biomedical Concept Property Attribute Terminology | DDF Biomedical Concept Property Attribute Terminology
(DDF Biomedical Concept Property Attribute Terminology) | text
Extensible: No | C201256 | DDF Biomedical Concept Property Attribute Terminology | A terminology value set relevant to the attributes of the biomedical concept property. | CDISC DDF Biomedical Concept Property Attribute Terminology |
Biomedical Concept Property Concept Code | C201318 | 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 | |||
Biomedical Concept Property Enabled Indicator | C202496 | 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 | |||
Biomedical Concept Property Label | C207472 | The short descriptive designation for the biomedical concept property. | Biomedical Concept Property Label | |||
Biomedical Concept Property Name | C202494 | The literal identifier (i.e., distinctive designation) of the biomedical concept property. | Biomedical Concept Property Name | |||
Biomedical Concept Property Required Indicator | C202495 | An indication as to whether the biomedical concept property is required. | Biomedical Concept Property Required Indicator | |||
Biomedical Concept Property Response Data Type | C201319 | 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 | |||
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CL.C201257.DDF Biomedical Concept Surrogate Attribute Terminology | DDF Biomedical Concept Surrogate Attribute Terminology
(DDF Biomedical Concept Surrogate Attribute Terminology) | text
Extensible: No | C201257 | DDF Biomedical Concept Surrogate Attribute Terminology | A terminology value set relevant to the attributes of the biomedical concept surrogate. | CDISC DDF Biomedical Concept Surrogate Attribute Terminology |
Biomedical Concept Surrogate Description | C201320 | A narrative representation of the biomedical concept surrogate. | Biomedical Concept Surrogate Description | |||
Biomedical Concept Surrogate Label | C207473 | The short descriptive designation for the biomedical concept surrogate. | Biomedical Concept Surrogate Label | |||
Biomedical Concept Surrogate Name | C207474 | The literal identifier (i.e., distinctive designation) of the biomedical concept surrogate. | Biomedical Concept Surrogate Name | |||
Biomedical Concept Surrogate Reference | C201321 | A citation to an authoritative source for a biomedical concept surrogate. | Biomedical Concept Surrogate Reference | |||
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CL.C207422.DDF Characteristic Attribute Terminology | DDF Characteristic Attribute Terminology
(DDF Characteristic Attribute Terminology) | text
Extensible: No | C207422 | DDF Characteristic Attribute Terminology | A terminology value set relevant to the attributes of the characteristic. | CDISC DDF Characteristic Attribute Terminology |
Characteristic Description | C207475 | A narrative representation of the characteristic. | Characteristic Description | |||
Characteristic Label | C207476 | The short descriptive designation for the characteristic. | Characteristic Label | |||
Characteristic Name | C207477 | The literal identifier (i.e., distinctive designation) of the characteristic. | Characteristic Name | |||
Characteristic Text | C207478 | An instance of structured text that represents the characteristic. | Characteristic Text | |||
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CL.C188699.DDF Clinical Study Attribute Terminology | DDF Clinical Study Attribute Terminology
(DDF Clinical Study Attribute Terminology) | text
Extensible: No | C188699 | DDF Clinical Study Attribute Terminology | A terminology value set relevant to the attributes of the clinical study. | CDISC DDF Clinical Study Attribute Terminology |
Clinical Study Label | C207479 | The short descriptive designation for the clinical study. | Clinical Study Label | |||
Study Description | C142704 | A narrative representation of the study. | Study Description | |||
Study Name | C68631 | The literal identifier (i.e., distinctive designation) of the study. | Study Name | |||
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CL.C188722.DDF Code Attribute Terminology | DDF Code Attribute Terminology
(DDF Code Attribute Terminology) | text
Extensible: No | C188722 | DDF Code Attribute Terminology | A terminology value set relevant to the attributes of the code. | CDISC DDF Code Attribute Terminology |
Code System Name | C188859 | The literal identifier (i.e., distinctive designation) of the system used to assign and/or manage codes. | Code System Name | |||
Code System Version | C188868 | The version of the code system. | Coding System Version | |||
Code Value | C188858 | The literal value of a code. | Code Value | |||
Decode | C188861 | Standardized or dictionary-derived human readable text associated with a code. | Decode Text | |||
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CL.C207425.DDF Condition Assignment Attribute Terminology | DDF Condition Assignment Attribute Terminology
(DDF Condition Assignment Attribute Terminology) | text
Extensible: No | C207425 | DDF Condition Assignment Attribute Terminology | A terminology value set relevant to the attributes of the condition assignment. | CDISC DDF Condition Assignment Attribute Terminology |
Logical Condition | C47953 | An assumption on which rests the validity or effect of something else. | Logical Condition | |||
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CL.C207424.DDF Condition Attribute Terminology | DDF Condition Attribute Terminology
(DDF Condition Attribute Terminology) | text
Extensible: No | C207424 | DDF Condition Attribute Terminology | A terminology value set relevant to the attributes of the condition. | CDISC DDF Condition Attribute Terminology |
Condition Description | C207481 | A narrative representation of the condition. | Condition Description | |||
Condition Label | C207482 | The short descriptive designation for the condition. | Condition Label | |||
Condition Name | C207483 | The literal identifier (i.e., distinctive designation) of the condition. | Condition Name | |||
Condition Text | C207484 | An instance of structured text that represents the condition. | Condition Text | |||
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CL.C207427.DDF Eligibility Criteria Attribute Terminology | DDF Eligibility Criteria Attribute Terminology
(DDF Eligibility Criteria Attribute Terminology) | text
Extensible: No | C207427 | DDF Eligibility Criteria Attribute Terminology | A terminology value set relevant to the attributes of the eligibility criteria. | CDISC DDF Eligibility Criteria Attribute Terminology |
Study Eligibility Criteria Category | C83016 | A classification of the inclusion exclusion criterion. | Inclusion Exclusion Criterion Category | |||
Study Eligibility Criterion Description | C207486 | A narrative representation of the study eligibility criterion. | Study Eligibility Criteria Description | |||
Study Eligibility Criterion Identifier | C207489 | A sequence of characters used to identify, name, or characterize the inclusion or exclusion criterion. | Study Eligibility Criterion Identifier | |||
Study Eligibility Criterion Label | C207487 | The short descriptive designation for the study eligibility criterion. | Study Eligibility Criteria Label | |||
Study Eligibility Criterion Name | C207488 | The literal identifier (i.e., distinctive designation) of the study eligibility criterion. | Study Eligibility Criteria Name | |||
Study Eligibility Criterion Text | C207485 | An instance of structured text that represents the study eligibility criterion. | Study Eligibility Criteria Text | |||
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CL.C188713.DDF Encounter Attribute Terminology | DDF Encounter Attribute Terminology
(DDF Encounter Attribute Terminology) | text
Extensible: No | C188713 | DDF Encounter Attribute Terminology | A terminology value set relevant to the attributes of the encounter. | CDISC DDF Encounter Attribute Terminology |
Clinical Encounter Description | C188836 | A narrative representation of the protocol-defined clinical encounter. | Clinical Encounter Description | |||
Clinical Encounter Name | C171010 | The literal identifier (i.e., distinctive designation) for a protocol-defined clinical encounter. | Clinical Encounter Name | |||
Clinical Encounter Type | C188839 | A characterization or classification of contact between subject/patient and healthcare practitioner/researcher, during which an assessment or activity is performed. | Clinical Encounter Type | |||
Contact Mode | C188841 | The means by which an interaction occurs between the subject/participant and person or entity (e.g., a device). | Contact Mode | |||
Environmental Setting | C188840 | The environment/setting where the event, intervention, or finding occurred. | Environmental Setting | |||
Study Encounter Label | C207490 | The short descriptive designation for the study encounter. | Study Encounter Label | |||
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CL.C188708.DDF Endpoint Attribute Terminology | DDF Endpoint Attribute Terminology
(DDF Endpoint Attribute Terminology) | text
Extensible: No | C188708 | DDF Endpoint Attribute Terminology | A terminology value set relevant to the attributes of the endpoint. | CDISC DDF Endpoint Attribute Terminology |
Study Endpoint Description | C188824 | A narrative representation of the study endpoint. | Study Endpoint Description | |||
Study Endpoint Label | C207491 | The short descriptive designation for the study endpoint. | Study Endpoint Label | |||
Study Endpoint Level | C188826 | A characterization or classification of the study endpoint that determines its category of importance relative to other study endpoints. | Study Endpoint Level | |||
Study Endpoint Name | C207492 | The literal identifier (i.e., distinctive designation) of the study endpoint. | Study Endpoint Name | |||
Study Endpoint Purpose | C188825 | The reason or intention for the study endpoint. | Study Endpoint Purpose | |||
Study Endpoint Text | C207493 | An instance of structured text that represents the study endpoint. | Study Endpoint Text | |||
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CL.C188698.DDF Entity Terminology | DDF Entity Terminology
(DDF Entity Terminology) | text
Extensible: No | C188698 | DDF Entity Terminology | A terminology value set relevant to the entities within the CDISC digital data flow (DDF) model. | CDISC DDF Entities Terminology |
Address | C25407 | A standardized representation of the location of a person, business, building, or organization. (NCI) | Address | |||
Administration Duration | C69282 | The amount of time elapsed during the administration of an agent. | Duration of Administration | |||
Agent Administration | C70962 | The act of the dispensing, applying, or tendering a medical product or other agent. | Agent Administration | |||
Alias Code | C201344 | An alternative symbol or combination of symbols which is assigned to the members of a collection. | Alias Code | |||
Biomedical Concept Category | C201346 | A grouping of biomedical concepts based on some commonality or by user defined characteristics. | Biomedical Concept Category | |||
Biomedical Concept Property | C202493 | A characteristic from a set of characteristics used to define a biomedical concept. | Biomedical Concept Property | |||
Biomedical Concept Surrogate | C207590 | A concept that substitutes for a standard biomedical concept from the designated source. | Biomedical Concept Surrogate | |||
Biomedical Concept | C201345 | 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 | |||
Characteristic | C25447 | The distinguishing qualities or prominent aspects of an entity. | Characteristic | |||
Clinical Encounter | C142427 | Contact between subject/patient and healthcare practitioner/researcher, during which an assessment or activity is performed. Contact may be physical or virtual. | Clinical Encounter | |||
Clinical Study | C15206 | A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. [ClinicalTrials.gov] See also clinical trial. (CDISC Glossary) | Clinical Study | |||
Code | C25162 | A symbol or combination of symbols which is assigned to the members of a collection. | Code | |||
Condition Assignments | C201335 | An allotting or appointment to a set of conditions that are to be met in order to make a logical decision. | Condition Assignment | |||
Condition | C25457 | A state of being. | Condition | |||
Disease/Condition Indication | C41184 | A health problem or disease that is identified as likely to be benefited by a therapy being studied in clinical trials. | Indication | |||
Estimand | C188813 | 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 | |||
Geographic Scope | C207591 | The extent or range related to the physical location of an entity. | Geographic Scope | |||
Intercurrent Event | C188815 | 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 | |||
Masking | C191278 | 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 | |||
Narrative Content | C207592 | The container that holds an instance of unstructured text and which may include objects such as tables, figures, and images. | Narrative Content | |||
Organization | C19711 | 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 | |||
Parameter Map | C207456 | The paired name and value for a given parameter. | Parameter Map | |||
Population Definition | C207593 | A concise explanation of the meaning of a population. | Population Definition | |||
Procedure | C98769 | 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 | ||
Quantity | C25256 | How much there is of something that can be measured; the total amount or number. | Quantity | |||
Range | C38013 | The difference between the lowest and highest numerical values; the limits or scale of variation. | Range | |||
Research Organization | C93448 | An organization that undertakes systematic investigation within a field of study in order to discover facts, establish or revise a theory, test a hypothesis, or develop a plan of action based on the facts discovered. | Research Organization | |||
Response Code | C201347 | A symbol or combination of symbols representing the response to the question. | Response Code | |||
Schedule Timeline Exit | C201349 | To go out of or leave the schedule timeline. | Schedule Timeline Exit | |||
Schedule Timeline | C201348 | A chronological schedule of planned temporal events. | Schedule Timeline | |||
Scheduled Activity Instance | C201350 | A scheduled occurrence of an activity event. | Scheduled Activity Instance | |||
Scheduled Decision Instance | C201351 | A scheduled occurrence of a decision event. | Scheduled Decision Instance | |||
Scheduled Instance | C201299 | A scheduled occurrence of a temporal event. | Scheduled Instance | |||
Study Activity | C71473 | 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 | |||
Study Amendment Reason | C207457 | Reason(s) for Amendment | The rationale for the change(s) to, or formal clarification of, a protocol. | Study Amendment Reason | ||
Study Amendment | C207594 | A written description of a change(s) to, or formal clarification of, a study. | Study Amendment | |||
Study Arm | C174447 | 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 | ||
Study Cohort | C61512 | A group of individuals who share a set of characteristics (e.g., exposures, experiences, attributes), which logically defines a population under study. | Cohort | |||
Study Design Cell | C188810 | 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 | |||
Study Design Element | C142735 | 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 | |||
Study Design | C15320 | 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 | C16112 | Trial Eligibility Criteria | Characteristics which are necessary to allow a subject to participate in a clinical study, as outlined in the study protocol. The concept covers inclusion and exclusion criteria. | Clinical Trial Eligibility Criteria | ||
Study Endpoint | C25212 | 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 | |||
Study Epoch | C71738 | 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 | |||
Study Governance Date | C207595 | Any of the dates associated with event milestones within a clinical study's oversight and management framework. | Study Governance Date | |||
Study Identifier | C83082 | A sequence of characters used to identify, name, or characterize the study. | Study Identifier | |||
Study Objective | C142450 | 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 | |||
Study Protocol Document | C93381 | A representation of the study protocol (that persists over time) in document form. | Study Protocol Document | |||
Study Protocol Version | C93490 | A plan at a particular point in time for a formal investigation to assess the utility, impact, pharmacological, physiological, and/or psychological effects of a particular treatment, procedure, drug, device, biologic, food product, cosmetic, care plan, or subject characteristic. (BRIDG) | Study Protocol Version | |||
Study Site | C80403 | The location at which a study investigator conducts study activities. | Study Site | |||
Study Title | C49802 | Official Study Title;Study Title;Trial Title | The sponsor-defined name of the clinical study. | Trial Title | ||
Study Version | C188816 | A plan at a particular point in time for a study. | Study Version | |||
Subject Enrollment | C37948 | 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 | |||
Syntax Template Dictionary | C207597 | A reference source that provides a listing of valid parameter names and values used in syntax template text strings. | Syntax Template Dictionary | |||
Syntax Template | C207596 | A standardized pattern used for the arrangement of words and phrases to create well-formed, structured sentences. | Syntax Template | |||
Target Study Population for Analysis | C188814 | 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 | |||
Target Study Population | C142728 | Target Population | The group of people in the general population to which the study results can be generalized. | Target Study Population | ||
Timing | C80484 | The chronological relationship between temporal events. | Timing | |||
Transition Rule | C82567 | 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 | |||
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CL.C188719.DDF Estimand Attribute Terminology | DDF Estimand Attribute Terminology
(DDF Estimand Attribute Terminology) | text
Extensible: No | C188719 | DDF Estimand Attribute Terminology | A terminology value set relevant to the attributes of the estimand. | CDISC DDF Estimand Attribute Terminology |
Population-Level Summary | C188853 | A synopsis of the clinical endpoint of interest within the analysis target study population. | Population-Level Summary | |||
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CL.C207428.DDF Geographic Scope Attribute Terminology | DDF Geographic Scope Attribute Terminology
(DDF Geographic Scope Attribute Terminology) | text
Extensible: No | C207428 | DDF Geographic Scope Attribute Terminology | A terminology value set relevant to the attributes of the geographic scope. | CDISC DDF Geographic Scope Attribute Terminology |
Geographic Scope Code | C207494 | A symbol or combination of symbols which is assigned to the geographic scope. | Geographic Scope Code | |||
Geographic Scope Type | C207495 | A characterization or classification of the geographic scope. | Geographic Scope Type | |||
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CL.C207429.DDF Governance Date Attribute Terminology | DDF Governance Date Attribute Terminology
(DDF Governance Date Attribute Terminology) | text
Extensible: No | C207429 | DDF Governance Date Attribute Terminology | A terminology value set relevant to the attributes of the governance date. | CDISC DDF Governance Date Attribute Terminology |
Protocol Approval Date Type | C207496 | A characterization or classification of the protocol approval date. | Protocol Approval Date Type | |||
Study Governance Date Description | C207497 | A narrative representation of the study governance date. | Study Governance Date Description | |||
Study Governance Date Label | C207498 | The short descriptive designation for the study governance date. | Study Governance Date Label | |||
Study Governance Date Name | C207499 | The literal identifier (i.e., distinctive designation) of the study governance date | Study Governance Date Name | |||
Study Governance Date Value | C207500 | The information contained in the date field. | Study Governance Date Value | |||
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CL.C188705.DDF Indication Attribute Terminology | DDF Indication Attribute Terminology
(DDF Indication Attribute Terminology) | text
Extensible: No | C188705 | DDF Indication Attribute Terminology | A terminology value set relevant to the attributes of the disease indication. | CDISC DDF Indication Attribute Terminology |
Disease Indication Code | C188822 | A short sequence of characters that represents the disease indication. | Disease Indication Code | |||
Disease/Condition Indication Description | C112038 | 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 | ||
Disease/Condition Indication Is Rare Disease Indicator | C207501 | An indication as to whether the disease/condition indication under study is considered a rare disease. | Disease Indication Is Rare Disease Indicator | |||
Disease/Condition Indication Label | C207502 | The short descriptive designation for the disease/condition indication. | Disease Indication Label | |||
Disease/Condition Indication Name | C207503 | The literal identifier (i.e., distinctive designation) of the disease/condition indication. | Disease Indication Name | |||
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CL.C188721.DDF Intercurrent Event Attribute Terminology | DDF Intercurrent Event Attribute Terminology
(DDF Intercurrent Event Attribute Terminology) | text
Extensible: No | C188721 | DDF Intercurrent Event Attribute Terminology | A terminology value set relevant to the attributes of the intercurrent event. | CDISC DDF Intercurrent Event Attribute Terminology |
Intercurrent Event Description | C188856 | A narrative representation of the intercurrent event. | Intercurrent Event Description | |||
Intercurrent Event Label | C207504 | The short descriptive designation for the intercurrent event. | Intercurrent Event Label | |||
Intercurrent Event Name | C188855 | The literal identifier (i.e., distinctive designation) of the intercurrent event. | Intercurrent Event Name | |||
Intercurrent Event Strategy | C188857 | A textual description of the planned strategy to manage and/or mitigate intercurrent events. | Intercurrent Event Strategy | |||
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CL.C207430.DDF Masking Attribute Terminology | DDF Masking Attribute Terminology
(DDF Masking Attribute Terminology) | text
Extensible: No | C207430 | DDF Masking Attribute Terminology | A terminology value set relevant to the attributes of the masking. | CDISC DDF Masking Attribute Terminology |
Masking Description | C207505 | A narrative representation of the study masking strategy, based on a person's role within the study. | Study Masking Description | |||
Masking Role | C207506 | Blinded Roles;Blinding Roles | An identifying designation assigned to a masked individual within a study that corresponds with their function. | Study Masking Role | ||
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CL.C207426.DDF Narrative Content Attribute Terminology | DDF Narrative Content Attribute Terminology
(DDF Narrative Content Attribute Terminology) | text
Extensible: No | C207426 | DDF Narrative Content Attribute Terminology | A terminology value set relevant to the attributes of the narrative content. | CDISC DDF Narrative Content Attribute Terminology |
Narrative Content Name | C207507 | The literal identifier (i.e., distinctive designation) of the narrative content. | Narrative Content Name | |||
Narrative Content Section Number | C207509 | The numeric identifier assigned to a particular document section containing narrative content. | Narrative Content Section Number | |||
Narrative Content Section Title | C207510 | An identifying designation for the document section containing narrative content. | Narrative Content Section Title | |||
Narrative Content Text | C207508 | A textual representation of the narrative content. | Narrative Content Text | |||
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CL.C188707.DDF Objective Attribute Terminology | DDF Objective Attribute Terminology
(DDF Objective Attribute Terminology) | text
Extensible: No | C188707 | DDF Objective Attribute Terminology | A terminology value set relevant to the attributes of the objective. | CDISC DDF Objective Attribute Terminology |
Study Objective Description | C94090 | A narrative representation of the study objective. | Study Objective Description | |||
Study Objective Label | C207511 | The short descriptive designation for the study objective. | Study Objective Label | |||
Study Objective Level | C188823 | A characterization or classification of the study objective that determines its category of importance relative to other study objectives. | Study Objective Level | |||
Study Objective Name | C207512 | The literal identifier (i.e., distinctive designation) of the study objective. | Study Objective Name | |||
Study Objective Text | C207513 | An instance of structured text that represents the study objective. | Study Objective Text | |||
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CL.C188702.DDF Organization Attribute Terminology | DDF Organization Attribute Terminology
(DDF Organization Attribute Terminology) | text
Extensible: No | C188702 | DDF Organization Attribute Terminology | A terminology value set relevant to the attributes of the organization. | CDISC DDF Organization Attribute Terminology |
Identifier Provider Organization Name | C188819 | The name of the organization that provides the identifier for the entity. | Identifier Provider Organization Name | |||
Organization Identifier | C93401 | A unique symbol that establishes identity of the organization. (BRIDG) | Organization Identifier | |||
Organization Label | C207514 | The short descriptive designation for the organization. | Organization Label | |||
Organization Name | C93874 | A non-unique textual identifier for the organization. (BRIDG) | Organization Name | |||
Organization Type | C188820 | 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 | |||
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CL.C207431.DDF Parameter Map Attribute Terminology | DDF Parameter Map Attribute Terminology
(DDF Parameter Map Attribute Terminology) | text
Extensible: No | C207431 | DDF Parameter Map Attribute Terminology | A terminology value set relevant to the attributes of the parameter map. | CDISC DDF Parameter Map Attribute Terminology |
Programming Tag Reference | C207516 | 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 | |||
Programming Tag | C207515 | Character strings bounded by angle brackets that act as containers for programming language elements. | Programming Tag | |||
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CL.C207432.DDF Population Definition Attribute Terminology | DDF Population Definition Attribute Terminology
(DDF Population Definition Attribute Terminology) | text
Extensible: No | C207432 | DDF Population Definition Attribute Terminology | A terminology value set relevant to the attributes of the population definition. | CDISC DDF Population Definition Attribute Terminology |
Population Definition Description | C207517 | A narrative representation of the population definition. | Population Definition Description | |||
Population Definition Includes Healthy Subjects Indicator | C207518 | 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 | |||
Population Definition Label | C207519 | The short descriptive designation for the population definition. | Population Definition Label | |||
Population Definition Name | C207520 | The literal identifier (i.e., distinctive designation) of the population definition. | Population Definition Name | |||
Population Definition Planned Age | C207701 | The anticipated age of subjects within the population definition. | Population Definition Planned Age | |||
Population Definition Planned Completion Number | C207521 | 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 | |||
Population Definition Planned Enrollment Number | C207522 | The value representing the planned number of subjects to be entered in a clinical trial, within the population definition. | Population Definition Planned Enrollment Number | |||
Population Definition Planned Sex | C207523 | The protocol-defined sex within the population definition. | Population Definition Planned Sex | |||
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CL.C188716.DDF Procedure Attribute Terminology | DDF Procedure Attribute Terminology
(DDF Procedure Attribute Terminology) | text
Extensible: No | C188716 | DDF Procedure Attribute Terminology | A terminology value set relevant to the attributes of the procedure. | CDISC DDF Procedure Attribute Terminology |
Procedure Code | C154626 | A symbol or combination of symbols which is assigned to medical procedure. | Procedure Code | |||
Procedure Description | C201324 | A narrative representation of the procedure. | Procedure Description | |||
Procedure Label | C207524 | The short descriptive designation for the procedure. | Procedure Label | |||
Procedure Name | C201325 | The literal identifier (i.e., distinctive designation) of the procedure. | Procedure Name | |||
Procedure Type | C188848 | A characterization or classification of the study procedure. | Study Procedure Type | |||
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CL.C207433.DDF Quantity Attribute Terminology | DDF Quantity Attribute Terminology
(DDF Quantity Attribute Terminology) | text
Extensible: No | C207433 | DDF Quantity Attribute Terminology | A terminology value set relevant to the attributes of the quantity. | CDISC DDF Quantity Attribute Terminology |
Quantity Unit | C44258 | The type of unit of measure being used to express a quantity. | Unit of Quantity | |||
Quantity Value | C25712 | A numerical quantity measured or assigned or computed. | Value | |||
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CL.C207434.DDF Range Attribute Terminology | DDF Range Attribute Terminology
(DDF Range Attribute Terminology) | text
Extensible: No | C207434 | DDF Range Attribute Terminology | A terminology value set relevant to the attributes of the range. | CDISC DDF Range Attribute Terminology |
Maximum Value | C25564 | The largest value in quantity or degree in a set of values. | Maximum | |||
Minimum Value | C25570 | The smallest value in quantity or degree in a set of values. | Minimum | |||
Unit of Measure | C25709 | A named quantity in terms of which other quantities are measured or specified, used as a standard measurement of like kinds. | Unit of Measure | |||
Value Range is Approximate Indicator | C207525 | An indication as to whether the value range is almost, but not quite, exact. | Value Range is Approximate Indicator | |||
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CL.C207435.DDF Research Organization Attribute Terminology | DDF Research Organization Attribute Terminology
(DDF Research Organization Attribute Terminology) | text
Extensible: No | C207435 | DDF Research Organization Attribute Terminology | A terminology value set relevant to the attributes of the research organization. | CDISC DDF Research Organization Attribute Terminology |
Identifier Provider Research Organization Name | C207526 | The name of the research organization that provides the identifier for the entity. | Identifier Provider Research Organization Name | |||
Organization Type | C188820 | 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 | |||
Research Organization Identifier | C207527 | A sequence of characters used to identify, name, or characterize the research organization. | Research Organization Identifier | |||
Research Organization Label | C207528 | The short descriptive designation for the research organization. | Research Organization Label | |||
Research Organization Name | C207529 | The literal identifier (i.e., distinctive designation) of the research organization. | Research Organization Name | |||
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CL.C201258.DDF Response Code Attribute Terminology | DDF Response Code Attribute Terminology
(DDF Response Code Attribute Terminology) | text
Extensible: No | C201258 | DDF Response Code Attribute Terminology | A terminology value set relevant to the attributes of the response code. | CDISC DDF Response Code Attribute Terminology |
Code | C25162 | A symbol or combination of symbols which is assigned to the members of a collection. | Code | |||
Response Code Enabled Indicator | C201330 | An indication as to whether the response code is activated for use within a given usage context. | Response Code Enabled Indicator | |||
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CL.C201259.DDF Schedule Timeline Attribute Terminology | DDF Schedule Timeline Attribute Terminology
(DDF Schedule Timeline Attribute Terminology) | text
Extensible: No | C201259 | DDF Schedule Timeline Attribute Terminology | A terminology value set relevant to the attributes of the schedule timeline. | CDISC DDF Schedule Timeline Attribute Terminology |
Main Timeline Indicator | C201331 | An indication as to whether the timeline or timeline component is part of the central or principal timeline. | Main Timeline Indicator | |||
Schedule Timeline Description | C201332 | A narrative representation of the schedule timeline. | Schedule Timeline Description | |||
Schedule Timeline Entry Condition | C201333 | A logical evaluation on which rests the validity of entry into a schedule timeline. | Schedule Timeline Entry Condition | |||
Schedule Timeline Label | C207530 | The short descriptive designation for the schedule timeline. | Schedule Timeline Label | |||
Schedule Timeline Name | C201334 | The literal identifier (i.e., distinctive designation) of the schedule timeline. | Schedule Timeline Name | |||
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CL.C207436.DDF Scheduled Activity Instance Attribute Terminology | DDF Scheduled Activity Instance Attribute Terminology
(DDF Scheduled Activity Instance Attribute Terminology) | text
Extensible: No | C207436 | DDF Scheduled Activity Instance Attribute Terminology | A terminology value set relevant to the attributes of the scheduled activity instance. | CDISC DDF Scheduled Activity Instance Attribute Terminology |
Scheduled Activity Instance Description | C207531 | A narrative representation of the scheduled activity instance. | Scheduled Activity Instance Description | |||
Scheduled Activity Instance Label | C207532 | The short descriptive designation for the scheduled activity instance. | Scheduled Activity Instance Label | |||
Scheduled Activity Instance Name | C207533 | The literal identifier (i.e., distinctive designation) of the scheduled activity instance. | Scheduled Activity Instance Name | |||
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CL.C201260.DDF Scheduled Decision Instance Attribute Terminology | DDF Scheduled Decision Instance Attribute Terminology
(DDF Scheduled Decision Instance Attribute Terminology) | text
Extensible: No | C201260 | DDF Scheduled Decision Instance Attribute Terminology | A terminology value set relevant to the attributes of the scheduled decision instance. | CDISC DDF Scheduled Decision Instance Attribute Terminology |
Scheduled Decision Instance Description | C207534 | A narrative representation of the scheduled Decision instance. | Scheduled Decision Instance Description | |||
Scheduled Decision Instance Label | C207535 | The short descriptive designation for the scheduled Decision instance. | Scheduled Decision Instance Label | |||
Scheduled Decision Instance Name | C207536 | The literal identifier (i.e., distinctive designation) of the scheduled Decision instance. | Scheduled Decision Instance Name | |||
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CL.C201261.DDF Scheduled Instance Attribute Terminology | DDF Scheduled Instance Attribute Terminology
(DDF Scheduled Instance Attribute Terminology) | text
Extensible: No | C201261 | DDF Scheduled Instance Attribute Terminology | A terminology value set relevant to the attributes of the scheduled instance. | CDISC DDF Scheduled Instance Attribute Terminology |
Scheduled Instance Description | C207453 | A narrative representation of the scheduled instance. | Scheduled Instance Description | |||
Scheduled Instance Label | C207454 | The short descriptive designation for the scheduled instance. | Scheduled Instance Label | |||
Scheduled Instance Name | C207455 | The literal identifier (i.e., distinctive designation) of the scheduled instance. | Scheduled Instance Name | |||
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CL.C207437.DDF Study Amendment Attribute Terminology | DDF Study Amendment Attribute Terminology
(DDF Study Amendment Attribute Terminology) | text
Extensible: No | C207437 | DDF Study Amendment Attribute Terminology | A terminology value set relevant to the attributes of the study amendment. | CDISC DDF Study Amendment Attribute Terminology |
Study Amendment Number | C207537 | Amendment Identifier | A string of numerals that uniquely identifies a protocol amendment. | Study Amendment Number | ||
Study Amendment Substantial Impact Indicator | C207538 | An indication as to whether the amendment is likely to have a substantial impact on the safety or rights of study subjects/participants. | Study Amendment Substantial Impact Indicator | |||
Study Amendment Summary | C115627 | A short narrative representation describing the changes introduced in the current version of the protocol. | Clinical Trial Protocol Amendment Summary | |||
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CL.C207438.DDF Study Amendment Reason Attribute Terminology | DDF Study Amendment Reason Attribute Terminology
(DDF Study Amendment Reason Attribute Terminology) | text
Extensible: No | C207438 | DDF Study Amendment Reason Attribute Terminology | A terminology value set relevant to the attributes of the study amendment reason. | CDISC DDF Study Amendment Reason Attribute Terminology |
Other Reason for Study Amendment | C207539 | 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 | C207540 | Study Amendment Reason Code | A symbol or combination of symbols which is assigned to the study amendment reason. | Study Amendment Reason Code | ||
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CL.C188709.DDF Study Arm Attribute Terminology | DDF Study Arm Attribute Terminology
(DDF Study Arm Attribute Terminology) | text
Extensible: No | C188709 | DDF Study Arm Attribute Terminology | A terminology value set relevant to the attributes of the study Arm. | CDISC DDF Study Arm Attribute Terminology |
Study Arm Data Origin Description | C188828 | The textual representation of the study arm data origin. | Study Arm Data Origin Description | |||
Study Arm Data Origin Type | C188829 | A characterization or classification of the study arm with respect to where the study arm data originates. | Study Arm Data Origin Type | |||
Study Arm Description | C93728 | Arm Description | A narrative representation of the study arm. | Arm Description | ||
Study Arm Label | C172456 | Arm Label | The short descriptive designation for the study arm. | Study Arm Label | ||
Study Arm Name | C170984 | The literal identifier (i.e., distinctive designation) of the study arm. | Planned Study Arm Name | |||
Study Arm Type | C172457 | Arm Type | A characterization or classification of the study arm. | Study Arm Type | ||
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CL.C207439.DDF Study Cohort Attribute Terminology | DDF Study Cohort Attribute Terminology
(DDF Study Cohort Attribute Terminology) | text
Extensible: No | C207439 | DDF Study Cohort Attribute Terminology | A terminology value set relevant to the attributes of the study cohort. | CDISC DDF Study Cohort Attribute Terminology |
Study Cohort Description | C207542 | A narrative representation of the study cohort. | Study Cohort Description | |||
Study Cohort Includes Healthy Subjects Indicator | C207480 | 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 | |||
Study Cohort Label | C207543 | The short descriptive designation for the study cohort. | Study Cohort Label | |||
Study Cohort Name | C207544 | The literal identifier (i.e., distinctive designation) of the study cohort. | Study Cohort Name | |||
Study Cohort Planned Age | C207545 | The anticipated age of subjects within the study cohort. | Study Cohort Planned Age | |||
Study Cohort Planned Completion Number | C207546 | 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 | |||
Study Cohort Planned Enrollment Number | C207702 | The value representing the planned number of subjects to be entered in a clinical trial, within the study cohort. | Study Cohort Planned Enrollment Number | |||
Study Cohort Planned Sex | C207541 | The protocol-defined sex within the study cohort. | Planned Sex of Study Cohort Participants | |||
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CL.C188703.DDF Study Design Attribute Terminology | DDF Study Design Attribute Terminology
(DDF Study Design Attribute Terminology) | text
Extensible: No | C188703 | DDF Study Design Attribute Terminology | A terminology value set relevant to the attributes of the study design. | CDISC DDF Study Design Attribute Terminology |
Intervention Model Type | C98746 | Intervention Model | The general design of the strategy for assigning interventions to participants in a clinical study. (clinicaltrials.gov) | Intervention Model | ||
Study Design Characteristic | C207547 | The distinguishing qualities or prominent aspect of a study design. | Study Design Characteristic | |||
Study Design Description | C147139 | Overall Design;Study Design Description;Study Design Overview;Summary of Study Design | A narrative representation of the study design. | Study Design Description | ||
Study Design Label | C207548 | The short descriptive designation for the study design. | Study Design Label | |||
Study Design Name | C201338 | The literal identifier (i.e., distinctive designation) of the study design. | Study Design Name | |||
Study Design Population Description | C70834 | A narrative representation of the study design population. | Study Population Description | |||
Study Design Rationale | C142705 | 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 | |||
Therapeutic Areas | C101302 | 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 Blinding Schema | C49658 | 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 | C49652 | Trial Intent Type | The planned purpose of the therapy, device, or agent under study in the clinical trial. | Clinical Study by Intent | ||
Trial Type | C49660 | Trial Scope;Trial Type | The nature of the interventional study for which information is being collected. | Trial Type | ||
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CL.C188706.DDF Study Design Population Attribute Terminology | DDF Study Design Population Attribute Terminology
(DDF Study Design Population Attribute Terminology) | text
Extensible: No | C188706 | DDF Study Design Population Attribute Terminology | A terminology value set relevant to the attributes of the study design population. | CDISC DDF Study Design Population Attribute Terminology |
Study Design Population Includes Healthy Subjects Indicator | C207549 | 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 | |||
Study Design Population Label | C207550 | The short descriptive designation for the study design population. | Study Design Population Label | |||
Study Design Population Name | C207553 | The literal identifier (i.e., distinctive designation) of the study design population. | Study Design Population Name | |||
Study Design Population Planned Age | C207450 | The anticipated age of subjects within the study design population. | Study Design Population Planned Age | |||
Study Design Population Planned Completion Number | C207451 | 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 | |||
Study Design Population Planned Enrollment Number | C207452 | 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 | |||
Study Design Population Planned Sex | C207551 | The protocol-defined sex within the study design population. | Study Design Population Planned Sex | |||
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CL.C188711.DDF Study Element Attribute Terminology | DDF Study Element Attribute Terminology
(DDF Study Element Attribute Terminology) | text
Extensible: No | C188711 | DDF Study Element Attribute Terminology | A terminology value set relevant to the attributes of the study element. | CDISC DDF Study Element Attribute Terminology |
Study Design Element Description | C188834 | A narrative representation of the study design element. | Study Design Element Description | |||
Study Design Element Label | C207554 | The short descriptive designation for the study design element. | Study Design Element Label | |||
Study Design Element Name | C188833 | The literal identifier (i.e., distinctive designation) of the study design element. | Study Design Element Name | |||
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CL.C188710.DDF Study Epoch Attribute Terminology | DDF Study Epoch Attribute Terminology
(DDF Study Epoch Attribute Terminology) | text
Extensible: No | C188710 | DDF Study Epoch Attribute Terminology | A terminology value set relevant to the attributes of the study epoch. | CDISC DDF Study Epoch Attribute Terminology |
Study Epoch Description | C93824 | A narrative representation of the study epoch. | Epoch Description | |||
Study Epoch Label | C207555 | The short descriptive designation for the study epoch. | Study Epoch Label | |||
Study Epoch Name | C93825 | 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 | |||
Study Epoch Type | C188830 | 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 | |||
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CL.C188701.DDF Study Identifier Attribute Terminology | DDF Study Identifier Attribute Terminology
(DDF Study Identifier Attribute Terminology) | text
Extensible: No | C188701 | DDF Study Identifier Attribute Terminology | A terminology value set relevant to the attributes of the study identifier. | CDISC DDF Study Identifier Attribute Terminology |
Study Identifier | C83082 | A sequence of characters used to identify, name, or characterize the study. | Study Identifier | |||
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CL.C188704.DDF Study Intervention Attribute Terminology | DDF Study Intervention Attribute Terminology
(DDF Study Intervention Attribute Terminology) | text
Extensible: No | C188704 | DDF Study Intervention Attribute Terminology | A terminology value set relevant to the attributes of the study interventions. | CDISC DDF Study Intervention Attribute Terminology |
Pharmacologic Class | C98768 | Pharmacologic Class | The pharmacological class of the investigational product. | Pharmacological Class of Investigational Therapy | ||
Study Intervention Code | C207648 | A symbol or combination of symbols which is assigned to the study intervention. | Study Intervention Code | |||
Study Intervention Description | C207647 | A narrative representation of the study intervention. | Study Intervention Description | |||
Study Intervention Label | C207556 | The short descriptive designation for the study intervention. | Study Intervention Label | |||
Study Intervention Minimum Response Duration | C207557 | The value representing the minimum amount of time required to meet the criteria for response to study intervention. | Study Intervention Minimum Response Duration | |||
Study Intervention Name | C207558 | The literal identifier (i.e., distinctive designation) of the study intervention. | Study Intervention Name | |||
Study Intervention Product Designation | C207559 | An indication as to whether the investigational intervention is an investigational medicinal product or an auxiliary medicinal product. | Study Intervention Product Type | |||
Study Intervention Role | C207560 | Study Intervention Use | The intended use of the trial intervention within the context of the study design. | Study Intervention Role | ||
Study Intervention Type | C98747 | Intervention Type | The kind of product or procedure studied in a trial. | Intervention Type | ||
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CL.C207440.DDF Study Protocol Document Attribute Terminology | DDF Study Protocol Document Attribute Terminology
(DDF Study Protocol Document Attribute Terminology) | text
Extensible: No | C207440 | DDF Study Protocol Document Attribute Terminology | A terminology value set relevant to the attributes of the study protocol document. | CDISC DDF Study Protocol Document Attribute Terminology |
Study Protocol Document Description | C207561 | A narrative representation of the study protocol document. | Study Protocol Document Description | |||
Study Protocol Document Label | C207562 | The short descriptive designation for the study protocol document. | Study Protocol Document Label | |||
Study Protocol Document Name | C207563 | The literal identifier (i.e., distinctive designation) of the study protocol document. | Study Protocol Document Name | |||
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CL.C207441.DDF Study Site Attribute Terminology | DDF Study Site Attribute Terminology
(DDF Study Site Attribute Terminology) | text
Extensible: No | C207441 | DDF Study Site Attribute Terminology | A terminology value set relevant to the attributes of the study site. | CDISC DDF Study Site Attribute Terminology |
Study Site Description | C207564 | A narrative representation of the study site. | Study Site Description | |||
Study Site Label | C207565 | The short descriptive designation for the study site. | Study Site Label | |||
Study Site Name | C207566 | The literal identifier (i.e., distinctive designation) of the study site. | Study Site Name | |||
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CL.C207442.DDF Study Title Attribute Terminology | DDF Study Title Attribute Terminology
(DDF Study Title Attribute Terminology) | text
Extensible: No | C207442 | DDF Study Title Attribute Terminology | A terminology value set relevant to the attributes of the study title. | CDISC DDF Study Title Attribute Terminology |
Study Title Text | C207567 | An instance of unstructured text that represents the study title. | Study Title Text | |||
Study Title Type | C207568 | A characterization or classification of the study title. | Study Title Type | |||
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CL.C207443.DDF Study Version Attribute Terminology | DDF Study Version Attribute Terminology
(DDF Study Version Attribute Terminology) | text
Extensible: No | C207443 | DDF Study Version Attribute Terminology | A terminology value set relevant to the attributes of the study version. | CDISC DDF Study Version Attribute Terminology |
Business Therapeutic Areas | C201322 | A therapeutic area classification based on the structure and operations of the business unit. | Business Therapeutic Area | |||
Study Rationale | C94122 | 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 | ||
Study Type Classification | C142175 | Study Type;Study Type Classification | The nature of the investigation for which study information is being collected. (After clinicaltrials.gov) | Study Type | ||
Study Version Identifier | C207570 | A sequence of characters used to identify, name, or characterize the study version. | Study Version Identifier | |||
Trial Phase | C48281 | 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 | ||
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CL.C207444.DDF Subject Enrollment Attribute Terminology | DDF Subject Enrollment Attribute Terminology
(DDF Subject Enrollment Attribute Terminology) | text
Extensible: No | C207444 | DDF Subject Enrollment Attribute Terminology | A terminology value set relevant to the attributes of the subject enrollment. | CDISC DDF Subject Enrollment Attribute Terminology |
Subject Enrollment Code | C207571 | A symbol or combination of symbols which is assigned to the subject enrollment. | Subject Enrollment Code | |||
Subject Enrollment Quantity Value | C207573 | The value representing the number of individuals enrolled in a study. | Subject Enrollment Quantity Value | |||
Subject Enrollment Type | C207574 | A characterization or classification of the subject enrollment. | Subject Enrollment Type | |||
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CL.C207445.DDF Syntax Template Attribute Terminology | DDF Syntax Template Attribute Terminology
(DDF Syntax Template Attribute Terminology) | text
Extensible: No | C207445 | DDF Syntax Template Attribute Terminology | A terminology value set relevant to the attributes of the syntax template. | CDISC DDF Syntax Template Attribute Terminology |
Syntax Template Description | C207575 | A narrative representation of the syntax template. | Syntax Template Description | |||
Syntax Template Label | C207576 | The short descriptive designation for the syntax template. | Syntax Template Label | |||
Syntax Template Name | C207577 | The literal identifier (i.e., distinctive designation) of the syntax template. | Syntax Template Name | |||
Syntax Template Text | C207578 | A structured text string containing prescribed text interspersed with user-defined parameter values. | Syntax Template Text | |||
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CL.C207446.DDF Syntax Template Dictionary Attribute Terminology | DDF Syntax Template Dictionary Attribute Terminology
(DDF Syntax Template Dictionary Attribute Terminology) | text
Extensible: No | C207446 | DDF Syntax Template Dictionary Attribute Terminology | A terminology value set relevant to the attributes of the syntax template dictionary. | CDISC DDF Syntax Template Dictionary Attribute Terminology |
Syntax Template Dictionary Description | C207579 | A narrative representation of the syntax template dictionary. | Syntax Template Dictionary Description | |||
Syntax Template Dictionary Label | C207580 | The short descriptive designation for the syntax template dictionary. | Syntax Template Dictionary Label | |||
Syntax Template Dictionary Name | C207581 | The literal identifier (i.e., distinctive designation) of the syntax template dictionary. | Syntax Template Dictionary Name | |||
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CL.C201262.DDF Timing Attribute Terminology | DDF Timing Attribute Terminology
(DDF Timing Attribute Terminology) | text
Extensible: No | C201262 | DDF Timing Attribute Terminology | A terminology value set relevant to the attributes of the timing. | CDISC DDF Timing Attribute Terminology |
Timing Description | C164648 | A narrative representation of the biomedical concept category. | Timing Description | |||
Timing Label | C207583 | The short descriptive designation for the timing. | Timing Label | |||
Timing Name | C207584 | The literal identifier (i.e., distinctive designation) of the timing. | Timing Name | |||
Timing Relative To From | C201297 | The name of the reference event used to define the temporal relationship with another event. | Timing Relative To From Name | |||
Timing Type | C201298 | A characterization or classification of the chronological relationship between temporal events. | Timing Type | |||
Timing Value Label | C207585 | The short descriptive designation for the timing value. | Timing Value Label | |||
Timing Value | C201341 | The temporal value of the chronological relationship between temporal events. | Timing Value | |||
Timing Window Label | C207586 | 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 | |||
Timing Window, Lower | C201342 | The earliest chronological value of an allowable period of time during which a temporal event takes place. | Lower Timing Window | |||
Timing Window, Upper | C201343 | The latest chronological value of an allowable period of time during which a temporal event takes place. | Upper Timing Window | |||
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CL.C188712.DDF Transition Rule Attribute Terminology | DDF Transition Rule Attribute Terminology
(DDF Transition Rule Attribute Terminology) | text
Extensible: No | C188712 | DDF Transition Rule Attribute Terminology | A terminology value set relevant to the attributes of the transition rule. | CDISC DDF Transition Rule Attribute Terminology |
Transition Rule Description | C188835 | A narrative representation of the transition rule. | Transition Rule Description | |||
Transition Rule Label | C207587 | The short descriptive designation for the transition rule. | Transition Rule Label | |||
Transition Rule Name | C207588 | The literal identifier (i.e., distinctive designation) of the transition rule. | Transition Rule Name | |||
Transition Rule Text | C207589 | An instance of unstructured text that represents the transition rule. | Transition Rule Text | |||
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CL.C188728.Encounter Type Value Set Terminology | Encounter Type Value Set Terminology
(Encounter Type Value Set Terminology) | text
Extensible: Yes | C188728 | Encounter Type Value Set Terminology | The terminology relevant to the encounter type. | CDISC DDF Encounter Type Value Set Terminology |
Visit | C25716 | 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 | |||
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CL.C188726.Endpoint Level Value Set Terminology | Endpoint Level Value Set Terminology
(Endpoint Level Value Set Terminology) | text
Extensible: No | C188726 | Endpoint Level Value Set Terminology | The terminology relevant to the endpoint level. | CDISC DDF Endpoint Level Value Set Terminology |
Exploratory Endpoint | C170559 | 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 | |||
Primary Endpoint | C94496 | 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 | |||
Secondary Endpoint | C139173 | 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 | |||
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CL.C207412.Geographic Scope Type Value Set Terminology | Geographic Scope Type Value Set Terminology
(Geographic Scope Type Value Set Terminology) | text
Extensible: No | C207412 | Geographic Scope Type Value Set Terminology | The terminology relevant to the geographic scope type value set. | CDISC DDF Geographic Scope Type Value Set Terminology |
Country | C25464 | A sovereign nation occupying a distinct territory and ruled by an autonomous government. | Country | |||
Global | C68846 | Covering or affecting the whole of a system. | Global | |||
Region | C41129 | An area or portion of something with more or less definite boundaries designed or specified according to some established criteria. | Region | |||
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CL.C207413.Governance Date Type Value Set Terminology | Governance Date Type Value Set Terminology
(Governance Date Type Value Set Terminology) | text
Extensible: Yes | C207413 | Governance Date Type Value Set Terminology | The terminology relevant to the governance date type value set. | CDISC DDF Governance Date Type Value Set Terminology |
Protocol Effective Date | C207598 | The date and time specifying when the protocol takes effect or becomes operative. | Protocol Effective Date | |||
Sponsor Approval Date | C132352 | Protocol Amendment Approval by Sponsor Date;Study Protocol Version Approval Date | The date on which a version of the protocol was finalized or approved by the sponsor. | Protocol Approval by Sponsor Date | ||
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CL.C207414.Masking Role Value Set Terminology | Masking Role Value Set Terminology
(Masking Role Value Set Terminology) | text
Extensible: Yes | C207414 | Masking Role Value Set Terminology | The terminology relevant to the masking role value set. | CDISC DDF Masking Role Value Set Terminology |
Care Provider | C17445 | 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 | ||
Investigator | C25936 | A person responsible for the conduct of the study, ensuring adherence to the protocol and good clinical practices. (CDISC Glossary) | Investigator | |||
Outcomes Assessor | C207599 | The individual who evaluates the outcome(s) of interest. (Clinicaltrials.gov) | Outcomes Assessor | |||
Sponsor | C70793 | 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 | ||
Study Subject | C41189 | An individual who is observed, analyzed, examined, investigated, experimented upon, or/and treated in the course of a particular study. | Study Subject | |||
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CL.C188725.Objective Level Value Set Terminology | Objective Level Value Set Terminology
(Objective Level Value Set Terminology) | text
Extensible: No | C188725 | Objective Level Value Set Terminology | The terminology relevant to the objective level. | CDISC DDF Objective Level Value Set Terminology |
Exploratory Objective | C163559 | 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 | C85826 | 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 | C85827 | Study Secondary Objective;Trial Secondary Objective | The supportive or ancillary scientific question(s) the study is designed to answer. (CDISC Glossary) | Trial Secondary Objective | ||
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CL.C188724.Organization Type Value Set Terminology | Organization Type Value Set Terminology
(Organization Type Value Set Terminology) | text
Extensible: Yes | C188724 | Organization Type Value Set Terminology | The terminology relevant to the organization type. | CDISC DDF Organization Type Value Set Terminology |
Clinical Study Registry | C93453 | An organization (typically a government agency) that administers the registration of studies. (BRIDG) | Study Registry | |||
Clinical Study Sponsor | C70793 | 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 | ||
Regulatory Agency | C188863 | 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 | ||
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CL.C188723.Protocol Status Value Set Terminology | Protocol Status Value Set Terminology
(Protocol Status Value Set Terminology) | text
Extensible: No | C188723 | Protocol Status Value Set Terminology | The terminology relevant to the protocol status. | CDISC DDF Protocol Status Value Set Terminology |
Approved | C25425 | Acceptance as satisfactory by an authoritative body; established by authority; given authoritative approval. | Approval | |||
Draft | C85255 | A preliminary version of a written work, design, or picture. | Draft | |||
Final | C25508 | Conclusive in a process or progression. | Final | |||
Obsolete | C63553 | No longer in use or valid; old. | Obsolete | |||
Pending Review | C188862 | Draft Pending Review | A preliminary version of a written work, design, or picture that is awaiting review. | Pending Review | ||
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CL.C207415.Study Amendment Reason Code Value Set Terminology | Study Amendment Reason Code Value Set Terminology
(Study Amendment Reason Code Value Set Terminology) | text
Extensible: No | C207415 | Study Amendment Reason Code Value Set Terminology | The terminology relevant to the study amendment reason code value set. | CDISC DDF Study Amendment Reason Code Value Set Terminology |
Change In Standard Of Care | C207600 | 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 | |||
Change In Strategy | C207601 | 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 | |||
IMP Addition | C207602 | 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 | |||
Inconsistency And/or Error In The Protocol | C207603 | 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 | |||
Investigator/Site Feedback | C207604 | Feedback from the investigator or study site necessitates a change(s) to, or formal clarification of, the protocol. (ICH M11) | Investigator/Site Feedback | |||
IRB/IEC Feedback | C207605 | 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 | |||
Manufacturing Change | C207606 | A change to manufacturing processes of the study agents necessitates a change(s) to, or formal clarification of, the protocol. (ICH M11) | Manufacturing Change | |||
New Data Available (Other Than Safety Data) | C207607 | 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) | |||
New Regulatory Guidance | C207608 | 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 | |||
New Safety Information Available | C207609 | Previously unavailable safety data becomes available, which necessitates a change(s) to, or formal clarification of, the protocol. (ICH M11) | New Safety Information Available | |||
Protocol Design Error | C207610 | A protocol design error necessitates a change(s) to, or formal clarification of, a document. (ICH M11) | Protocol Design Error | |||
Recruitment Difficulty | C207611 | Challenges with participant recruitment necessitates a change(s) to, or formal clarification of, the protocol. (ICH M11) | Recruitment Difficulty | |||
Regulatory Agency Request To Amend | C207612 | 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 | |||
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CL.C188727.Study Arm Data Origin Type Value Set Terminology | Study Arm Data Origin Type Value Set Terminology
(Study Arm Data Origin Type Value Set Terminology) | text
Extensible: Yes | C188727 | Study Arm Data Origin Type Value Set Terminology | The terminology relevant to the study arm data origin type. | CDISC DDF Study Arm Data Origin Type Value Set Terminology |
Data Generated Within Study | C188866 | Data that are generated from the current study. | Data Generated Within Study | |||
Historical Data | C188864 | Data from studies that have occurred in the past. | Historical Data | |||
Real World Data | C165830 | 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 | |||
Synthetic Data | C176263 | 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 | |||
Virtual Data | C188865 | Data that are generated from virtual encounters between investigators and subjects. | Virtual Data | |||
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CL.C207416.Study Design Characteristics Value Set Terminology | Study Design Characteristics Value Set Terminology
(Study Design Characteristics Value Set Terminology) | text
Extensible: Yes | C207416 | Study Design Characteristics Value Set Terminology | The terminology relevant to the study design characteristics value set. | CDISC DDF Study Design Characteristics Value Set Terminology |
Adaptive | C98704 | 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 | |||
Extension | C207613 | 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 | ||
Randomized | C46079 | A study design in which interventions are assigned to subjects according to randomization principles. | Randomized Controlled Clinical Trial | |||
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CL.C207418.Study Intervention Product Designation Value Set Terminology | Study Intervention Product Designation Value Set Terminology
(Study Intervention Product Designation Value Set Terminology) | text
Extensible: No | C207418 | Study Intervention Product Designation Value Set Terminology | The terminology relevant to the study intervention product designation value set. | CDISC DDF Study Intervention Product Designation Value Set Terminology |
IMP | C202579 | 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 | |||
NIMP (AxMP) | C156473 | 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 | |||
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CL.C207417.Study Intervention Role Value Set Terminology | Study Intervention Role Value Set Terminology
(Study Intervention Role Value Set Terminology) | text
Extensible: No | C207417 | Study Intervention Role Value Set Terminology | The terminology relevant to the study intervention role value set. | CDISC DDF Study Intervention Role Value Set Terminology |
Additional Required Treatment | C207614 | 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 | |||
Background Treatment | C165822 | 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 | |||
Challenge Agent | C158128 | 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 | |||
Diagnostic | C18020 | Any procedure or test used to diagnose a disease or disorder. | Diagnostic Procedure | |||
Experimental Intervention | C41161 | 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 | ||
Placebo | C753 | 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 | |||
Rescue Medicine | C165835 | 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 | |||
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CL.C207419.Study Title Type Value Set Terminology | Study Title Type Value Set Terminology
(Study Title Type Value Set Terminology) | text
Extensible: No | C207419 | Study Title Type Value Set Terminology | The terminology relevant to the study title type value set. | CDISC DDF Study Title Type Value Set Terminology |
Brief Study Title | C207615 | Abbreviated Protocol Title | The short descriptive name for the study. | Brief Study Title | ||
Official Study Title | C207616 | The formal descriptive name for the study. | Official Study Title | |||
Public Study Title | C207617 | The descriptive name of the study that is intended for the lay public, written in easily understood language. | Public Study Title | |||
Scientific Study Title | C207618 | A more extensive descriptive name of the study that is intended for medical professionals, written using medical and scientific language. | Scientific Study Title | |||
Study Acronym | C207646 | 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 | ||
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CL.C201265.Timing Relative To From Value Set Terminology | Timing Relative To From Value Set Terminology
(Timing Relative To From Value Set Terminology) | text
Extensible: No | C201265 | Timing Relative To From Value Set Terminology | The terminology relevant to the timing relative to from value set. | CDISC DDF Timing Relative To From Value Set Terminology |
End to End | C201352 | A timing relationship defined as the end of one event to the end of another event. | End to End | |||
End to Start | C201353 | A timing relationship defined as the end of one event to the start of another event. | End to Start | |||
Start to End | C201354 | A timing relationship defined as the start of one event to the end of another event. | Start to End | |||
Start to Start | C201355 | A timing relationship defined as the start of one event to the start of another event. | Start to Start | |||
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CL.C201264.Timing Type Value Set Terminology | Timing Type Value Set Terminology
(Timing Type Value Set Terminology) | text
Extensible: No | C201264 | Timing Type Value Set Terminology | The terminology relevant to the timing type value set. | CDISC DDF Timing Type Value Set Terminology |
After | C201356 | A type of time point relationship that follows a point or period of time within a timeline. | After Timing Type | |||
Before | C201357 | A type of time point relationship that comes before a point or period of time within a timeline. | Before Timing Type | |||
Fixed Reference | C201358 | A type of time point relationship that is fixed with respect to a timeline. | Fixed Reference Timing Type | |||
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