| AdministrableProductProperty |
A characteristic from a set of characteristics used to define an administrable product. |
no |
| Characteristic |
The distinguishing qualities or prominent aspects of an entity. |
no |
| ScheduledActivityInstance |
A scheduled occurrence of an activity event. |
no |
| Substance |
Any matter of defined composition that has discrete existence, whose origin may be biological, mineral or chemical. |
no |
| ScheduledDecisionInstance |
A scheduled occurrence of a decision event. |
no |
| StudyRole |
A designation that identifies the function of study personnel or an organization within the context of the study. |
no |
| StudyCohort |
A group of individuals who share a set of characteristics (e.g., exposures, experiences, attributes), which logically defines a population under study. |
no |
| Organization |
A formalized group of persons or other organizations collected together for a common purpose (such as administrative, legal, political) and the infrastructure to carry out that purpose. (BRIDG) |
no |
| SyntaxTemplate |
A standardized pattern used for the arrangement of words and phrases to create well-formed, structured sentences. |
no |
| StudyEpoch |
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. |
no |
| Condition |
A state of being. |
no |
| Timing |
The chronological relationship between temporal events. |
no |
| StudyDesign |
A plan detailing how a study will be performed in order to represent the phenomenon under examination, to answer the research questions that have been asked, and informing the statistical approach. |
no |
| EligibilityCriterion |
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. |
no |
| StudyDesignPopulation |
The population within the general population to which the study results can be generalized. |
no |
| AssignedPerson |
An individual person who is allotted or appointed to a particular role, function, or other entity. |
no |
| BiomedicalConceptProperty |
A characteristic from a set of characteristics used to define a biomedical concept. |
no |
| StudyDefinitionDocument |
Any physical or electronic document that is related to defining a study or part of a study. |
no |
| ScheduleTimeline |
A chronological schedule of planned temporal events. |
no |
| BiomedicalConceptCategory |
A grouping of biomedical concepts based on some commonality or by user defined characteristics. |
no |
| Activity |
An action, undertaking, or event, which is anticipated to be performed or observed, or was performed or observed, according to the study protocol during the execution of the study. |
no |
| ObservationalStudyDesign |
The strategy that specifies the structure of an observational study in terms of the planned activities (including timing) and statistical analysis approach intended to meet the objectives of the study. |
no |
| Strength |
The content of an substance expressed quantitatively per dosage unit, per unit of volume, or per unit of weight, according to the pharmaceutical dose form of the product. |
no |
| BiomedicalConceptSurrogate |
A concept that substitutes for a standard biomedical concept from the designated source. |
no |
| BiospecimenRetention |
The continued possession, cataloging, and storage of collected biological specimens beyond their initial use. |
no |
| GovernanceDate |
Any of the dates associated with event milestones within a clinical study's oversight and management framework. |
no |
| MedicalDevice |
Any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination for, one or more specific medical purpose(s). [After REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices] |
no |
| StudyAmendment |
A written description of a change(s) to, or formal clarification of, a study. |
no |
| Objective |
The reason for performing a study in terms of the scientific questions to be answered by the analysis of data collected during the study. |
no |
| InterventionalStudyDesign |
The strategy that specifies the structure of an interventional trial in terms of the planned activities (including timing) and statistical analysis approach intended to meet the objectives of the study. |
no |
| StudyChange |
The act of alteration or modification to a study. |
no |
| StudySite |
The location at which a study investigator conducts study activities. |
no |
| Study |
A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. (CDISC Glossary) |
no |
| Administration |
The act of dispensing, applying, or tendering a product, agent, or therapy. |
no |
| ScheduledInstance |
A scheduled occurrence of a temporal event. |
no |
| AnalysisPopulation |
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) |
no |
| PopulationDefinition |
A concise explanation of the meaning of a population. |
no |
| BiomedicalConcept |
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. |
no |
| Indication |
The disease or condition the intervention will diagnose, treat, prevent, cure, or mitigate. |
no |
| Procedure |
Any activity performed by manual and/or instrumental means for the purpose of diagnosis, assessment, therapy, prevention, or palliative care. |
no |
| StudyIntervention |
Any agent, device, or procedure being tested or used as a reference or comparator in the conduct of a clinical trial. |
no |
| SyntaxTemplateDictionary |
A reference source that provides a listing of valid parameter names and values used in syntax template text strings. |
no |
| AdministrableProduct |
Any study product that is formulated and presented in the form that is suitable for administration to a study participant. |
no |
| NarrativeContent |
The container that holds an instance of unstructured text and which may include objects such as tables, figures, and images. |
no |
| EligibilityCriterionItem |
An individual item within the container that holds an instance of an eligibility criterion. |
no |
| SubjectEnrollment |
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) |
no |
| StudyElement |
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. |
no |
| Estimand |
A precise description of the treatment effect reflecting the clinical question posed by a given clinical trial objective. It summarises at a population level what the outcomes would be in the same patients under different treatment conditions being compared. (ICH E9 R1 Addendum) |
no |
| IntercurrentEvent |
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) |
no |
| NarrativeContentItem |
An individual item within the container that holds an instance of unstructured text and which may include objects such as tables, figures, and images. |
no |
| StudyArm |
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. |
no |
| ResponseCode |
A symbol or combination of symbols representing the response to the question. |
no |
| ProductOrganizationRole |
A designation that identifies the function of an organization within the context of the product. |
no |
| Endpoint |
A defined variable intended to reflect an outcome of interest that is statistically analyzed to address a particular research question. NOTE: A precise definition of an endpoint typically specifies the type of assessments made, the timing of those assessments, the assessment tools used, and possibly other details, as applicable, such as how multiple assessments within an individual are to be combined. [After BEST Resource] (CDISC Glossary) |
no |
| Encounter |
Any physical or virtual contact between two or more parties involved in a study, at which an assessment or activity takes place. |
no |
| TransitionRule |
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. |
no |