CTO: Core Ontology of Clinical Trials
type: Ontology
contributor: Asiyah Yu Lin (CDRH, Food and Drug Administration)
contributor: Astghik Sargsyan (Fraunhofer SCAI)
contributor: Geena Mariya Jose (Causality Biomodels)
contributor: Leon Li (NIH)
contributor: Oliver He (University of Michigan)
contributor: Shounak Baksi (Causality Biomodels)
description: The core Ontology of Clinical Trials (CTO) will serve as a structured resource integrating basic terms and concepts in the context of clinical trials. Thereby covering clinicaltrails.gov. CoreCTO will serve as a basic ontology to generate extended versions for specific applications such as annotation of variables in study documents from clinical trials.
creator: Alpha Tom Kodamullil (Fraunhofer SCAI)
creator: Johannes Darms (Fraunhofer SCAI)
creator: Stephan Gebel (Fraunhofer SCAI)
creator: Sumit Madan (Fraunhofer SCAI)
license: http://creativecommons.org/licenses/by/4.0
version info: Version Release: 1.0.0

BFO OWL specification label
type: AnnotationProperty
editor preferred label: BFO OWL specification label
textual definition: Relates an entity in the ontology to the name of the variable that is used to represent it in the code that generates the BFO OWL file from the lispy specification.
curator note: Really of interest to developers only
sub property of: label

BFO CLIF specification label
type: AnnotationProperty
editor preferred label: BFO CLIF specification label
textual definition: Relates an entity in the ontology to the term that is used to represent it in the the CLIF specification of BFO2
definition source: Person:Alan Ruttenberg
curator note: Really of interest to developers only
sub property of: label

editor preferred label
type: AnnotationProperty
editor preferred label: editor preferred label
editor preferred label: editor preferred term
editor preferred label: editor preferred term~editor preferred label
has curation status: ready for release
textual definition: The concise, meaningful, and human-friendly name for a class or property preferred by the ontology developers. (US-English)
definition editor: PERSON:Daniel Schober
definition source: GROUP:OBI:<http://purl.obolibrary.org/obo/obi>
label: editor preferred term
label: editor preferred term~editor preferred label

example of usage
type: AnnotationProperty
editor preferred label: example
editor preferred label: example of usage
has curation status: ready for release
textual definition: A phrase describing how a class name should be used. May also include other kinds of examples that facilitate immediate understanding of a class semantics, such as widely known prototypical subclasses or instances of the class. Although essential for high level terms, examples for low level terms (e.g., Affymetrix HU133 array) are not
textual definition: A phrase describing how a term should be used and/or a citation to a work which uses it. May also include other kinds of examples that facilitate immediate understanding, such as widely know prototypes or instances of a class, or cases where a relation is said to hold.
definition editor: PERSON:Daniel Schober
definition source: GROUP:OBI:<http://purl.obolibrary.org/obo/obi>

has curation status
type: AnnotationProperty
editor preferred label: has curation status
definition editor: PERSON:Alan Ruttenberg
definition editor: PERSON:Bill Bug
definition editor: PERSON:Melanie Courtot
definition source: OBI_0000281

textual definition
type: AnnotationProperty
editor preferred label: definition
editor preferred label: textual definition
has curation status: ready for release
textual definition: A property representing the English language definitions of what NCI means by the concept. They may also include information about the definition's source and attribution in a form that can easily be interpreted by software.
textual definition: English language definitions of what NCI means by the concept. These are limited to 1024 characters. They may also include information about the definition's source and attribution in a form that can easily be interpreted by software.
textual definition: The official OBI definition, explaining the meaning of a class or property. Shall be Aristotelian, formalized and normalized. Can be augmented with colloquial definitions.
textual definition: The official definition, explaining the meaning of a class or property. Shall be Aristotelian, formalized and normalized. Can be augmented with colloquial definitions.
editor note: 2012-04-05: Barry Smith The official OBI definition, explaining the meaning of a class or property: 'Shall be Aristotelian, formalized and normalized. Can be augmented with colloquial definitions' is terrible. Can you fix to something like: A statement of necessary and sufficient conditions explaining the meaning of an expression referring to a class or property. Alan Ruttenberg Your proposed definition is a reasonable candidate, except that it is very common that necessary and sufficient conditions are not given. Mostly they are necessary, occasionally they are necessary and sufficient or just sufficient. Often they use terms that are not themselves defined and so they effectively can't be evaluated by those criteria. On the specifics of the proposed definition: We don't have definitions of 'meaning' or 'expression' or 'property'. For 'reference' in the intended sense I think we use the term 'denotation'. For 'expression', I think we you mean symbol, or identifier. For 'meaning' it differs for class and property. For class we want documentation that let's the intended reader determine whether an entity is instance of the class, or not. For property we want documentation that let's the intended reader determine, given a pair of potential relata, whether the assertion that the relation holds is true. The 'intended reader' part suggests that we also specify who, we expect, would be able to understand the definition, and also generalizes over human and computer reader to include textual and logical definition. Personally, I am more comfortable weakening definition to documentation, with instructions as to what is desirable. We also have the outstanding issue of how to aim different definitions to different audiences. A clinical audience reading chebi wants a different sort of definition documentation/definition from a chemistry trained audience, and similarly there is a need for a definition that is adequate for an ontologist to work with.
definition editor: PERSON:Daniel Schober
definition source: GROUP:OBI:<http://purl.obolibrary.org/obo/obi>
has exact synonym: DEFINITION
label: definition

editor note
type: AnnotationProperty
editor preferred label: editor note
has curation status: ready for release
textual definition: An administrative note intended for its editor. It may not be included in the publication version of the ontology, so it should contain nothing necessary for end users to understand the ontology.
definition editor: PERSON:Daniel Schober
definition source: GROUP:OBI:<http://purl.obfoundry.org/obo/obi>
database_cross_reference: IAO:0000116
has_obo_namespace: uberon
id: editor_note
is metadata tag: 1
shorthand: editor_note

definition editor
type: AnnotationProperty
editor preferred label: definition editor
editor preferred label: term editor
has curation status: ready for release
textual definition: Name of editor entering the definition in the file. The definition editor is a point of contact for information regarding the term. The definition editor may be, but is not always, the author of the definition, which may have been worked upon by several people
textual definition: Name of editor entering the term in the file. The term editor is a point of contact for information regarding the term. The term editor may be, but is not always, the author of the definition, which may have been worked upon by several people
editor note: 20110707, MC: label update to term editor and definition modified accordingly. See http://code.google.com/p/information-artifact-ontology/issues/detail?id=115.
editor note: 20110707, MC: label update to term editor and definition modified accordingly. See https://github.com/information-artifact-ontology/IAO/issues/115.
definition editor: PERSON:Daniel Schober
definition source: GROUP:OBI:<http://purl.obolibrary.org/obo/obi>
label: term editor

alternative term
type: AnnotationProperty
editor preferred label: alternative term
has curation status: pending final vetting
textual definition: An alternative name for a class or property which means the same thing as the preferred name (semantically equivalent)
definition editor: PERSON:Daniel Schober
definition source: GROUP:OBI:<http://purl.obolibrary.org/obo/obi>

definition source
type: AnnotationProperty
editor preferred label: definition source
has curation status: ready for release
textual definition: formal citation, e.g. identifier in external database to indicate / attribute source(s) for the definition. Free text indicate / attribute source(s) for the definition. EXAMPLE: Author Name, URI, MeSH Term C04, PUBMED ID, Wiki uri on 31.01.2007
definition editor: PERSON:Daniel Schober
definition source: Discussion on obo-discuss mailing-list, see http://bit.ly/hgm99w
definition source: GROUP:OBI:<http://purl.obolibrary.org/obo/obi>

curator note
type: AnnotationProperty
editor preferred label: curator note
has curation status: ready for release
textual definition: An administrative note of use for a curator but of no use for a user
definition editor: PERSON:Alan Ruttenberg
database_cross_reference: IAO:0000232
has_obo_namespace: uberon
id: curator_notes
is metadata tag: 1
shorthand: curator_notes
label: curator notes

term tracker item
type: AnnotationProperty
editor preferred label: term tracker item
example of usage: the URI for an OBI Terms ticket at sourceforge, such as https://sourceforge.net/p/obi/obi-terms/772/
has curation status: pending final vetting
textual definition: An IRI or similar locator for a request or discussion of an ontology term.
definition editor: Person: Jie Zheng, Chris Stoeckert, Alan Ruttenberg
definition source: Person: Jie Zheng, Chris Stoeckert, Alan Ruttenberg
comment: The 'tracker item' can associate a tracker with a specific ontology term.

imported from
type: AnnotationProperty
editor preferred label: imported from
has curation status: pending final vetting
textual definition: For external terms/classes, the ontology from which the term was imported
definition editor: PERSON:Alan Ruttenberg
definition editor: PERSON:Melanie Courtot
definition source: GROUP:OBI:<http://purl.obolibrary.org/obo/obi>

elucidation
type: AnnotationProperty
editor preferred label: elucidation
definition editor: person:Alan Ruttenberg
definition source: Person:Barry Smith
elucidation: Primitive terms in a highest-level ontology such as BFO are terms which are so basic to our understanding of reality that there is no way of defining them in a non-circular fashion. For these, therefore, we can provide only elucidations, supplemented by examples and by axioms

has associated axiom(nl)
type: AnnotationProperty
editor preferred label: has associated axiom(nl)
definition editor: Person:Alan Ruttenberg
definition source: Person:Alan Ruttenberg
elucidation: An axiom associated with a term expressed using natural language

has associated axiom(fol)
type: AnnotationProperty
editor preferred label: has associated axiom(fol)
definition editor: Person:Alan Ruttenberg
definition source: Person:Alan Ruttenberg
elucidation: An axiom expressed in first order logic using CLIF syntax

has axiom label
type: AnnotationProperty

Has_NICHD_Parent
type: AnnotationProperty
textual definition: A property created to allow the source NICHD to assign a parent to each concept with the intent of creating a hierarchy that includes only terms in which they are the contributing source.
textual definition: An association created to allow the source NICHD to assign a parent to each concept with the intent of creating a hierarchy that includes only terms in which they are a contributing source.
code: A11
Semantic_Type: Conceptual Entity
Preferred_Name: Has_NICHD_Parent
has exact synonym: Has_NICHD_Parent
range: anyURI

code
type: AnnotationProperty
read only: true
textual definition: A property representing a concept unique identifier within the NCI Enterprise Vocabulary Service's NCI Thesaurus.
code: NHC0
Preferred_Name: code
has exact synonym: code
range: string

Semantic_Type
type: AnnotationProperty
textual definition: A property that represents a description of the sort of thing or category to which a concept belongs in the context of the UMLS semantic network.
textual definition: The semantic type describes the sort of thing or category to which a concept belongs in the context of the UMLS semantic network.
code: P106
Semantic_Type: Conceptual Entity
Display_Name: Semantic Type
Preferred_Name: Semantic_Type
DesignNote: In general, applying semantic types aids in allowing users (or computer programs) to draw conclusions about concepts by virtue of the categories to which they have been assigned. We use a set of semantic types developed for the UMLS Metathesaurus. There are currently 134 semantic types in the UMLS.
has exact synonym: Semantic_Type
range: NCIT Semantic Type-enum

Display_Name
type: AnnotationProperty
textual definition: A property representing an alternative Preferred Name for use in some NCI systems.
textual definition: Provides an alternative Preferred Name for use in some NCI systems.
code: P107
Semantic_Type: Conceptual Entity
Display_Name: Display Name
Preferred_Name: Display_Name
has exact synonym: Display Name
has exact synonym: Display_Name
range: string

Preferred_Name
type: AnnotationProperty
textual definition: A property representing the word or phrase that NCI uses by preference to refer to the concept.
textual definition: The word or phrase that NCI uses by preference to refer to the concept.
code: P108
Semantic_Type: Conceptual Entity
Display_Name: Preferred Name
Preferred_Name: Preferred_Name
has exact synonym: Preferred Name
has exact synonym: Preferred Term
has exact synonym: Preferred_Name
range: string

UMLS_CUI
type: AnnotationProperty
textual definition: A property representing the concept unique identifier (CUI) assigned by the National Library of Medicine (NLM). If a concept in any NCI-maintained knowledgebase exists in the NLM Unified Medical Language System (UMLS), NCI includes the NLM CUI among the information we provide about the concept.
textual definition: Concept Unique Identifiers, or CUIs, are concept numbers assigned by the National Library of Medicine (NLM). If a concept in any NCI-maintained knowledgebase exists in the NLM Unified Medical Language System (UMLS), NCI includes the NLM CUI among the information we provide about the concept.
code: P207
Semantic_Type: Conceptual Entity
Display_Name: UMLS CUI
Preferred_Name: UMLS_CUI
has exact synonym: UMLS_CUI
range: string

NCI_META_CUI
type: AnnotationProperty
textual definition: A property representing the concept unique identifier (CUI) for those concepts that appear in NCI Metathesaurus but not in the National Library of Medicine Unified Medical Language System (NLM UMLS).
code: P208
Semantic_Type: Conceptual Entity
Display_Name: NCI Metathesaurus CUI
Preferred_Name: NCI_META_CUI
has exact synonym: NCI_META_CUI
range: string

Contributing_Source
type: AnnotationProperty
textual definition: A property is used to indicate when a non-EVS entity has contributed to, and has a stake in, a concept. This is used where such entities, within or outside NCI, have indicated the need to be able to track their own concepts. A single concept can have multiple instances of this property if multiple entities have such a defined stake.
textual definition: This property is used to indicate when a non-EVS entity has contributed to, and has a stake in, a concept. This is used where such entities, within or outside NCI, have indicated the need to be able to track their own concepts. A single concept can have multiple instances of this property if multiple entities have such a defined stake.
code: P322
Semantic_Type: Conceptual Entity
Display_Name: Contributing Source
Preferred_Name: Contributing_Source
has exact synonym: Contributing_Source
range: NCIT Contributing Source-enum

ALT_DEFINITION
type: AnnotationProperty
textual definition: A property representing the English language definition of a concept from a source other than NCI.
textual definition: English language definitions of what a source other than NCI means by the concept. These are limited to 1024 characters. They include information about the definition's source in a form that can easily be interpreted by software.
code: P325
Semantic_Type: Conceptual Entity
Display_Name: [source] Definition
Preferred_Name: ALT_DEFINITION
has exact synonym: ALT_DEFINITION
range: NCIT textArea

Legacy_Concept_Name
type: AnnotationProperty
read only: true
textual definition: A property representing a retired unique concept identifier created and stored as Concept Name by legacy EVS software. Use of these values was long discouraged, but continued as late as 2009 when creation of new values ceased and Concept Name was retired. Legacy values are intended solely to help resolve and update earlier coding.
textual definition: A retired unique concept identifier created and stored as Concept Name by legacy EVS software. Use of these values was long discouraged, but continued as late as 2009 when creation of new values ceased and Concept Name was retired. Legacy values are intended solely to help resolve and update earlier coding.
code: P366
Semantic_Type: Conceptual Entity
Preferred_Name: Legacy Concept Name
has exact synonym: Legacy Concept Name
range: string

NICHD_Hierarchy_Term
type: AnnotationProperty
textual definition: A property representing a term chosen by NICHD to be used in the representation of the NICHD hierarchy.
code: P371
Semantic_Type: Conceptual Entity
Preferred_Name: NICHD_Hierarchy_Term
Contributing_Source: NICHD
has exact synonym: NICHD_Hierarchy_Term
range: string

Maps_To
type: AnnotationProperty
textual definition: A property representing that a term in another terminology has been mapped to a term in NCIt and describes the relationship between the mapped terms.
code: P375
Semantic_Type: Conceptual Entity
Preferred_Name: Maps_To
has exact synonym: Maps_To
range: NCIT textArea

DesignNote
type: AnnotationProperty
textual definition: A property representing notations made by NCI vocabulary curators. They are intended to provide supplemental, unstructured information to the user or additional insight about the concept.
textual definition: Design notes are notations made by NCI vocabulary curators. They are intended to provide supplemental, unstructured information to the user or additional insight about the concept.
code: P98
Semantic_Type: Conceptual Entity
Display_Name: DesignNote
Preferred_Name: DesignNote
has exact synonym: DesignNote
range: string

ISA alternative term
type: AnnotationProperty
editor preferred label: ISA alternative term
has curation status: ready for release
textual definition: An alternative term used by the ISA tools project (http://isa-tools.org).
editor note: Requested by Alejandra Gonzalez-Beltran https://sourceforge.net/tracker/?func=detail&aid=3603413&group_id=177891&atid=886178
definition editor: Person: Alejandra Gonzalez-Beltran
definition editor: Person: Philippe Rocca-Serra
definition source: ISA tools project (http://isa-tools.org)
sub property of: alternative term

NIAID GSCID-BRC alternative term
type: AnnotationProperty
editor preferred label: NIAID GSCID-BRC alternative term
has curation status: ready for release
textual definition: An alternative term used by the National Institute of Allergy and Infectious Diseases (NIAID) Genomic Sequencing Centers for Infectious Diseases (GSCID) and Bioinformatics Resource Centers (BRC).
definition editor: PERSON: Chris Stoeckert, Jie Zheng
definition source: NIAID GSCID-BRC metadata working group
sub property of: alternative term

NCIT code
type: AnnotationProperty
textual definition: An annotation property that refers to a code defined by NCIT

has_rank
type: AnnotationProperty
textual definition: A metadata relation between a class and its taxonomic rank (eg species, family)
has_obo_namespace: ncbi_taxonomy

Description
type: AnnotationProperty
description: Description may include but is not limited to: an abstract, table of contents, reference to a graphical representation of content or a free-text account of the content.
comment: An account of the content of the resource.

Source
type: AnnotationProperty
description: The present resource may be derived from the Source resource in whole or in part. Recommended best practice is to reference the resource by means of a string or number conforming to a formal identification system.
comment: A reference to a resource from which the present resource is derived.

has_alternative_id
type: AnnotationProperty

database_cross_reference
type: AnnotationProperty

has exact synonym
type: AnnotationProperty
textual definition: A property representing a fully qualified synonym, contains the string, term type, source, and an optional source code if appropriate. Each subfield is deliniated to facilitate interpretation by software.
textual definition: Fully qualified synonym, contains the string, term type, source, and an optional source code if appropriate. Each subfield is deliniated to facilitate interpretation by software.
has exact synonym: FULL_SYN
has exact synonym: Synonym with Source Data
label: has_exact_synonym

has_narrow_synonym
type: AnnotationProperty

has_obo_namespace
type: AnnotationProperty

has_related_synonym
type: AnnotationProperty

in subset
type: AnnotationProperty
textual definition: An association that connects the concept defining a particular terminology subset with concepts that belong to this subset.
textual definition: Used to associate the concept defining a particular terminology subset with concepts that belong to this subset.
has exact synonym: Concept_In_Subset
label: in_subset

shorthand
type: AnnotationProperty

label
type: AnnotationProperty
editor preferred label: label

is about
type: ObjectProperty

has_specified_input
type: ObjectProperty

has participant
type: ObjectProperty

concretizes
type: ObjectProperty

has role
type: ObjectProperty

drug product
type: Class
textual definition: a material entity (1) containing at least one scattered molecular aggregate as part that is the bearer of an active ingredient role and (2) that is itself the bearer of a clinical drug role
definition editor: William Hogan
imported from: dron.owl
creator: William Hogan

research project
type: Class
subclass of: planned process
example of usage: A project to study the role of a specific protein in cell signaling.
has curation status: IAO_0000120
textual definition: A funded collection of investigations as described in a research proposal.
definition editor: PERSON: Melissa Haendel
definition source: PERSON: Melissa Haendel
imported from: ero.owl
comment: Maybe SameAs "Investigation" but is the subject of funding

human study
type: Class
subclass of: research project
editor preferred label: human study
example of usage: A clinical trial.
has curation status: IAO_0000120
textual definition: Research project that uses or collects measurements or assessments about humans.
definition editor: PERSON: Melissa Haendel
definition source: OCRe
imported from: ero.owl
comment: This should be imported from OCRE- but they currently have no generic human study type. Def is modified.

clinical trial
type: Class
subclass of: Interventional study
example of usage: A clinical trial to evaluate the efficacy of a new drug.
has curation status: IAO_0000120
textual definition: An interventional study that contains a set of procedures in medical research and drug development that are conducted to allow safety (or more specifically, information about adverse drug reactions and adverse effects of other treatments) and efficacy data to be collected for health interventions (e.g., drugs, diagnostics, devices, therapy protocols) that is performed over phases.
definition editor: PERSON: Nicole Vasilevsky
definition source: http://en.wikipedia.org/wiki/Clinical_trial
imported from: ero.owl

epidemiological study
type: Class
subclass of: human study
editor preferred label: epidemiological study
example of usage: A study of the populations and demographic of the avian flu.
has curation status: IAO_0000120
textual definition: A human study of diseases in populations of humans or other animals, specifically how, when and where they occur. Epidemiological studies can never prove causation, epidemiological evidence can only show that this risk factor is correlated with a higher incidence of disease in the population exposed to that risk factor. The higher the correlation the more certain the association, but it cannot prove the causation.
definition editor: PERSON: Karen Corday
definition source: http://pmep.cce.cornell.edu/profiles/extoxnet/TIB/epidemiology.html
imported from: ero.owl

case-only study
type: Class
subclass of: Observational study
editor preferred label: case-only study
has curation status: metadata incomplete
textual definition: Observational study whereby there is a single group of individuals with specific characteristics. This is a method that analyzes data from a case series and is used in case-crossover studies, in case-specular designs, and in molecular and genetic epidemiology to assess relationships between environmental exposures and genotypes.
textual definition: single group of individuals with specific characteristics.
definition editor: PERSON: Melissa Haendel
definition source: A Dictionary of Epidemiology, Fifth Edition, Edited by Miquel Porta. p. 33. ISBN:978-0-19-531449-6 http://prsinfo.clinicaltrials.gov/definitions.html
imported from: ero.owl

Axiom
annotated source: case-only study
annotated property: textual definition
annotated target: single group of individuals with specific characteristics.
definition source: https://prsinfo.clinicaltrials.gov/definitions.html

open blinded study
type: Class
subclass of: Blinded Clinical Study
editor preferred label: open blinded study
has curation status: metadata incomplete
textual definition: An interventional study in which the person collecting the data and the subject know whether the subjects are in the control or experimental groups.
definition editor: PERSON: Nicole Vasilevsky
alternative term: Open trial
alternative term: Open-label trial
definition source: http://medical-dictionary.thefreedictionary.com/single-blind+study
imported from: ero.owl

single blinded study
type: Class
subclass of: Blinded Clinical Study
editor preferred label: single blinded study
has curation status: metadata incomplete
textual definition: An interventional study in which the person collecting the data knows whether the subjects are in the control or experimental groups but the subjects do not.
definition editor: PERSON: Nicole Vasilevsky
definition source: http://medical-dictionary.thefreedictionary.com/single-blind+study
imported from: ero.owl

double blinded study
type: Class
subclass of: Blinded Clinical Study
editor preferred label: double blinded study
has curation status: metadata incomplete
textual definition: An interventional study in which neither the subjects of the experiment nor the persons administering the experiment know the critical aspects of the experiment; a double-blind procedure is used to guard against both experimenter bias and placebo effects.
definition editor: PERSON: Nicole Vasilevsky
definition source: http://www.thefreedictionary.com/double-blind+study
imported from: ero.owl

medical device
type: Class
example of usage: A blood pressure monitor is a medical device.
has curation status: IAO_0000120
textual definition: An instrument used in the diagnosis of disease or other conditions or for use in the care, treatment, or prevention of disease that does not achieve any of its primary intended purposes by chemical action or by being metabolized.
definition editor: PERSON: Nicole Vasilevsky
definition source: http://medical-dictionary.thefreedictionary.com/medical+device
imported from: ero.owl

feasibility study
type: Class
subclass of: human study
has curation status: metadata incomplete
textual definition: A preliminary study to determine the practicability of a proposed health program or procedure or of a larger study and to appraise the factors that may influence its practicability. A feasibility study aims to discover those things which may affect successful study conduct on a larger scale.
definition editor: PERSON: Melanie Wilson
definition source: Dictionary of Epidemiology, 5th edition.
imported from: ero.owl

registry
type: Class
subclass of: organization
has curation status: metadata incomplete
textual definition: An organization dedicated to the collection, storage and dissemination of a set of scientific or clinical data.
definition editor: PERSON: Nicole Vasilevsky
definition source: PERSON: Scott Hoffmann
imported from: ero.owl

objective specification
type: Class
subclass of: directive information entity
editor preferred label: objective specification
example of usage: In the protocol of a ChIP assay the objective specification says to identify protein and DNA interaction.
has curation status: ready for release
textual definition: a directive information entity that describes an intended process endpoint. When part of a plan specification the concretization is realized in a planned process in which the bearer tries to effect the world so that the process endpoint is achieved.
editor note: 2009-03-16: original definition when imported from OBI read: "objective is an non realizable information entity which can serve as that proper part of a plan towards which the realization of the plan is directed."
editor note: 2014-03-31: In the example of usage ("In the protocol of a ChIP assay the objective specification says to identify protein and DNA interaction") there is a protocol which is the ChIP assay protocol. In addition to being concretized on paper, the protocol can be concretized as a realizable entity, such as a plan that inheres in a person. The objective specification is the part that says that some protein and DNA interactions are identified. This is a specification of a process endpoint: the boundary in the process before which they are not identified and after which they are. During the realization of the plan, the goal is to get to the point of having the interactions, and participants in the realization of the plan try to do that.
editor note: Answers the question, why did you do this experiment?
definition editor: PERSON: Alan Ruttenberg
definition editor: PERSON: Barry Smith
definition editor: PERSON: Bjoern Peters
definition editor: PERSON: Jennifer Fostel
alternative term: goal specification
definition source: OBI Plan and Planned Process/Roles Branch
definition source: OBI_0000217
imported from: obi.owl
imported from: opmi.owl

action specification
type: Class
subclass of: directive information entity
example of usage: Pour the contents of flask 1 into flask 2
has curation status: ready for release
textual definition: a directive information entity that describes an action the bearer will take
definition editor: Alan Ruttenberg
definition source: OBI Plan and Planned Process branch
imported from: iao.owl

data item
type: Class
subclass of: information content entity
editor preferred label: data item
example of usage: Data items include counts of things, analyte concentrations, and statistical summaries.
has curation status: pending final vetting
textual definition: a data item is an information content entity that is intended to be a truthful statement about something (modulo, e.g., measurement precision or other systematic errors) and is constructed/acquired by a method which reliably tends to produce (approximately) truthful statements.
editor note: 2/2/2009 Alan and Bjoern discussing FACS run output data. This is a data item because it is about the cell population. Each element records an event and is typically further composed a set of measurment data items that record the fluorescent intensity stimulated by one of the lasers.
editor note: 2009-03-16: data item deliberatly ambiguous: we merged data set and datum to be one entity, not knowing how to define singular versus plural. So data item is more general than datum.
editor note: 2009-03-16: removed datum as alternative term as datum specifically refers to singular form, and is thus not an exact synonym.
editor note: 2014-03-31: See discussion at http://odontomachus.wordpress.com/2014/03/30/aboutness-objects-propositions/
editor note: JAR: datum -- well, this will be very tricky to define, but maybe some information-like stuff that might be put into a computer and that is meant, by someone, to denote and/or to be interpreted by some process... I would include lists, tables, sentences... I think I might defer to Barry, or to Brian Cantwell Smith JAR: A data item is an approximately justified approximately true approximate belief
definition editor: PERSON: Alan Ruttenberg
definition editor: PERSON: Chris Stoeckert
definition editor: PERSON: Jonathan Rees
alternative term: data
imported from: iao.owl
imported from: ogms.owl

information content entity
type: Class
editor preferred label: information content entity
example of usage: Examples of information content entites include journal articles, data, graphical layouts, and graphs.
has curation status: ready for release
textual definition: A generically dependent continuant that is about some thing.
textual definition: An information content entity is an entity that is generically dependent on some artifact and stands in relation of aboutness to some entity
editor note: 2014-03-10: The use of "thing" is intended to be general enough to include universals and configurations (see https://groups.google.com/d/msg/information-ontology/GBxvYZCk1oc/-L6B5fSBBTQJ).
editor note: information_content_entity 'is_encoded_in' some digital_entity in obi before split (040907). information_content_entity 'is_encoded_in' some physical_document in obi before split (040907). Previous. An information content entity is a non-realizable information entity that 'is encoded in' some digital or physical entity.
definition editor: PERSON: Chris Stoeckert
definition source: OBI_0000142
imported from: dron.owl
imported from: envo.owl
imported from: iao.owl
imported from: ico.owl
imported from: obi.owl
imported from: ogms.owl
imported from: The Ontology of Medically Related Social Entities
imported from: ontoneo.owl
imported from: opmi.owl
imported from: pdro.owl

directive information entity
type: Class
subclass of: information content entity
has curation status: ready for release
textual definition: An information content entity whose concretizations indicate to their bearer how to realize them in a process.
editor note: 2009-03-16: provenance: a term realizable information entity was proposed for OBI (OBI_0000337) , edited by the PlanAndPlannedProcess branch. Original definition was "is the specification of a process that can be concretized and realized by an actor" with alternative term "instruction".It has been subsequently moved to IAO where the objective for which the original term was defined was satisfied with the definitionof this, different, term.
editor note: 2013-05-30 Alan Ruttenberg: What differentiates a directive information entity from an information concretization is that it can have concretizations that are either qualities or realizable entities. The concretizations that are realizable entities are created when an individual chooses to take up the direction, i.e. has the intention to (try to) realize it.
editor note: 8/6/2009 Alan Ruttenberg: Changed label from "information entity about a realizable" after discussions at ICBO
editor note: Werner pushed back on calling it realizable information entity as it isn't realizable. However this name isn't right either. An example would be a recipe. The realizable entity would be a plan, but the information entity isn't about the plan, it, once concretized, *is* the plan. -Alan
definition editor: PERSON: Alan Ruttenberg
definition editor: PERSON: Bjoern Peters
imported from: iao.owl
imported from: obi.owl
imported from: opmi.owl

curation status specification
type: Class
subclass of: data about an ontology part
editor preferred label: curation status specification
has curation status: pending final vetting
textual definition: The curation status of the term. The allowed values come from an enumerated list of predefined terms. See the specification of these instances for more detailed definitions of each enumerated value.
editor note: Better to represent curation as a process with parts and then relate labels to that process (in IAO meeting)
definition editor: PERSON:Bill Bug
definition source: GROUP:OBI:<http://purl.obolibrary.org/obo/obi>
definition source: OBI_0000266
imported from: iao.owl

report
type: Class
subclass of: document
editor preferred label: report
example of usage: Examples of reports are gene lists and investigation reports. These are not published (journal) articles but may be included in a journal article.
has curation status: pending final vetting
textual definition: a document assembled by an author for the purpose of providing information for the audience. A report is the output of a documenting process and has the objective to be consumed by a specific audience. Topic of the report is on something that has completed. A report is not a single figure. Examples of reports are journal article, patent application, grant progress report, case report (not patient record)
editor note: 2009-03-16: comment from Darren Natale: I am slightly uneasy with the sentence "Topic of the report is on something that has completed." Should it be restricted to those things that are completed? For example, a progress report is (usually) about something that definitely has *not* been completed, or may include (only) projections. I think the definition would not suffer if the whole sentence is deleted.
editor note: 2009-03-16: this was report of results with definition: A report is a narrative object that is a formal statement of the results of an investigation, or of any matter on which definite information is required, made by some person or body instructed or required to do so.
editor note: 2009-03-16: work has been done on this term during during the OBI workshop winter 2009 and the current definition was considered acceptable for use in OBI. If there is a need to modify this definition please notify OBI.
editor note: 2009-08-10 Alan Ruttenberg: Larry Hunter suggests that this be obsoleted and replaced by 'document'. Alan restored as there are OBI dependencies and this merits further discussion
editor note: disagreement about where reports go. alan: only some gene lists are reports. Is a report all the content of some document? The example of usage suggests that a report may be part of some article. Term needs clarification
definition editor: PERSON: Alan Ruttenberg
definition editor: PERSON: Melanie Courtot
definition editor: PERSON:Chris Stoeckert
definition source: GROUP: OBI
definition source: OBI_0000099
imported from: iao.owl

data about an ontology part
type: Class
subclass of: data item
textual definition: data about an ontology part is a data item about a part of an ontology, for example a term
definition editor: Person:Alan Ruttenberg
imported from: iao.owl

plan specification
type: Class
subclass of: directive information entity
editor preferred label: plan specification
example of usage: PMID: 18323827.Nat Med. 2008 Mar;14(3):226.New plan proposed to help resolve conflicting medical advice.
has curation status: ready for release
textual definition: A directive information entity with action specifications and objective specifications as parts that, when concretized, is realized in a process in which the bearer tries to achieve the objectives by taking the actions specified.
editor note: 2009-03-16: provenance: a term a plan was proposed for OBI (OBI_0000344) , edited by the PlanAndPlannedProcess branch. Original definition was " a plan is a specification of a process that is realized by an actor to achieve the objective specified as part of the plan". It has been subsequently moved to IAO where the objective for which the original term was defined was satisfied with the definitionof this, different, term.
editor note: 2014-03-31: A plan specification can have other parts, such as conditional specifications.
editor note: Alternative previous definition: a plan is a set of instructions that specify how an objective should be achieved
definition editor: Alan Ruttenberg
definition source: OBI Plan and Planned Process branch
definition source: OBI_0000344
imported from: obi.owl
comment: 2/3/2009 Comment from OBI review. Action specification not well enough specified. Conditional specification not well enough specified. Question whether all plan specifications have objective specifications. Request that IAO either clarify these or change definitions not to use them

textual entity
type: Class
subclass of: information content entity
editor preferred label: textual entity
example of usage: Words, sentences, paragraphs, and the written (non-figure) parts of publications are all textual entities
has curation status: metadata incomplete
textual definition: A textual entity is a part of a manifestation (FRBR sense), a generically dependent continuant whose concretizations are patterns of glyphs intended to be interpreted as words, formulas, etc.
editor note: AR, (IAO call 2009-09-01): a document as a whole is not typically a textual entity, because it has pictures in it - rather there are parts of it that are textual entities. Examples: The title, paragraph 2 sentence 7, etc.
editor note: MC, 2009-09-14 (following IAO call 2009-09-01): textual entities live at the FRBR (http://en.wikipedia.org/wiki/Functional_Requirements_for_Bibliographic_Records) manifestation level. Everything is significant: line break, pdf and html versions of same document are different textual entities.
definition editor: PERSON: Lawrence Hunter
alternative term: text
imported from: iao.owl
imported from: obi.owl
imported from: opmi.owl

document
type: Class
subclass of: information content entity
editor preferred label: document
example of usage: A journal article, patent application, laboratory notebook, or a book
has curation status: IAO_0000120
textual definition: A collection of information content entities intended to be understood together as a whole
definition editor: PERSON: Lawrence Hunter
imported from: iao.owl

postal address
type: Class
subclass of: textual entity
has curation status: metadata incomplete
textual definition: A textual entity that is used as directive to deliver something to a person, or organization
editor note: 2010-05-24 Alan Ruttenberg. Use label for the string representation. See issue https://github.com/information-artifact-ontology/IAO/issues/59
imported from: obi.owl

email address
type: Class
subclass of: information content entity
editor preferred label: email address
has curation status: metadata incomplete
editor note: Alan Ruttenberg 1/3/2012 - Provisional id, see issue at https://github.com/information-artifact-ontology/IAO/issues/130&thanks=130&ts=1325636583
definition editor: Person:Alan Ruttenberg
definition editor: Person:Chris Stoeckart
imported from: obi.owl

CRID
type: Class
subclass of: information content entity
example of usage: Entries in a Column of which the header is "Pubmed ID"
example of usage: PMID:12345
example of usage: The following URL: "http://www.ncbi.nlm.nih.gov/pubmed/19918065"
example of usage: The following sentence contains a CRID: "The article with Pubmed ID: 19918065".
example of usage: The sentence "The article has Pubmed ID 12345." contains a CRID that has two parts: one part is the CRID symbol, which is '12345'; the other part denotes the CRID registry, which is Pubmed.
has curation status: IAO_0000120
textual definition: An information content entity that consists of a CRID symbol and additional information about the CRID registry to which it belongs.
textual definition: An information content entity that consists of a CRID symbol and additional information about which CRID registry it belongs.
editor note: 2014-05-05: In defining this term we take no position on what the CRID denotes. In particular do not assume it denotes a *record* in the CRID registry (since the registry might not have 'records').
editor note: Alan, IAO call 20101124: potentially the CRID denotes the instance it was associated with during creation.
editor note: Note, IAO call 20101124: URIs are not always CRID, as not centrally registered. We acknowledge that CRID is a subset of a larger identifier class, but this subset fulfills our current needs. OBI PURLs are CRID as they are registered with OCLC. UPCs (Universal Product Codes from AC Nielsen)are not CRID as they are not centrally registered.
definition editor: PERSON: Alan Ruttenberg
definition editor: PERSON: Bill Hogan
definition editor: PERSON: Bjoern Peters
definition editor: PERSON: Melanie Courtot
alternative term: CRID
alternative term: Centrally Registered IDentifier
definition source: Original proposal from Bjoern, discussions at IAO calls
imported from: iao.owl
imported from: The Ontology of Medically Related Social Entities
imported from: opmi.owl
has_narrow_synonym: Primary Registry and Trial Identifying Number
label: centrally registered identifier

Axiom
annotated source: CRID
annotated property: has_narrow_synonym
annotated target: Primary Registry and Trial Identifying Number

contact affiliation
type: Class
subclass of: textual entity
textual definition: Home institution of the contact person.
imported from: ms.owl
database_cross_reference: value-type:xsd:string
has_obo_namespace: MS
id: MS:1000590

root
type: Class
imported from: ncbitaxon.owl
database_cross_reference: GC_ID:1
has_obo_namespace: ncbi_taxonomy
has_related_synonym: all

cellular organisms
type: Class
subclass of: root
imported from: ncbitaxon.owl
database_cross_reference: GC_ID:1
has_obo_namespace: ncbi_taxonomy
has_related_synonym: biota

Eukaryota
type: Class
subclass of: cellular organisms
imported from: ncbitaxon.owl
has_rank: NCBITaxon superkingdom
database_cross_reference: GC_ID:1
database_cross_reference: PMID:23020233
database_cross_reference: PMID:30257078
has exact synonym: eucaryotes
has exact synonym: eukaryotes
has_obo_namespace: ncbi_taxonomy
has_related_synonym: Eucarya
has_related_synonym: Eucaryotae
has_related_synonym: Eukarya
has_related_synonym: Eukaryotae
has_related_synonym: eukaryotes

Mammalia
type: Class
subclass of: Vertebrata <vertebrates>
imported from: ncbitaxon.owl
has_rank: NCBITaxon class
database_cross_reference: GC_ID:1
has exact synonym: mammals
has_obo_namespace: ncbi_taxonomy
has_related_synonym: mammals

Vertebrata <vertebrates>
type: Class
subclass of: Eukaryota
imported from: ncbitaxon.owl
database_cross_reference: GC_ID:1
has exact synonym: Vertebrata
has exact synonym: vertebrates
has_obo_namespace: ncbi_taxonomy
has_related_synonym: vertebrates

Homo sapiens
type: Class
subclass of: Mammalia
editor preferred label: Homo sapiens
alternative term: human
alternative term: human being
alternative term: man
alternative term: person
imported from: envo.owl
imported from: ncbitaxon.owl
imported from: obi.owl
imported from: The Ontology of Medically Related Social Entities
imported from: opmi.owl
has_rank: NCBITaxon species
database_cross_reference: GC_ID:1
has exact synonym: human
has exact synonym: man
has_obo_namespace: ncbi_taxonomy
has_related_synonym: Home sapiens
has_related_synonym: Homo sampiens
has_related_synonym: Homo sapeins
has_related_synonym: Homo sapian
has_related_synonym: Homo sapians
has_related_synonym: Homo sapien
has_related_synonym: Homo sapience
has_related_synonym: Homo sapiense
has_related_synonym: Homo sapients
has_related_synonym: Homo sapines
has_related_synonym: Homo spaiens
has_related_synonym: Homo spiens
has_related_synonym: Humo sapiens
has_related_synonym: humans

Clinical Trial Final Report
type: Class
subclass of: report
textual definition: Records containing any interim or final results, as well as clinical and statistical descriptions, presentations, analyses and interpretations of any therapeutic, prophylactic, or diagnostic agent used in human subjects in a clinical trial.
imported from: ncit.owl
code: C115575
Semantic_Type: Intellectual Product
Preferred_Name: Clinical Trial Final Report
UMLS_CUI: C3889645
Contributing_Source: CDISC-GLOSS
Contributing_Source: CareLex
ALT_DEFINITION: A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report. [ICH E3]
ALT_DEFINITION: Subcategory name for the eTMF domain used to classify clinical study report documents.
has exact synonym: CTrial Fin Rept Subcat
has exact synonym: Central Trial Final Reports Subcategory
has exact synonym: Clinical Trial Final Report
has exact synonym: Reports
has exact synonym: final report
in subset: NCIT C114548
in subset: NCIT C61410
in subset: NCIT C67497

Patient Registry Study
type: Class
subclass of: Observational study
textual definition: An observational study that is also considered to be a Patient Registry. This type of study should only be registered once in the Protocol Registration and Results System (PRS), by the sponsor responsible for the primary data collection and analysis.
textual definition: Observational studies which include an organized system that uses observational methods to collect uniform data (clinical and other) prospectively for a population defined by a particular disorder/disease, condition (including susceptibility to a disorder), or exposure (including products, health care services, and/or procedures) and that serves a predetermined scientific, clinical, or policy purpose. Patient registries may be single purpose or on-going data collection programs that address one or more questions. (AHRQ)
imported from: ncit.owl
code: C129000
Semantic_Type: Research Activity
Preferred_Name: Patient Registry Study
UMLS_CUI: C0920631
Contributing_Source: CDISC
ALT_DEFINITION: Observational studies which include an organized system that uses observational methods to collect uniform data (clinical and other) prospectively for a population defined by a particular disorder/disease, condition (including susceptibility to a disorder), or exposure (including products, health care services, and/or procedures) and that serves a predetermined scientific, clinical, or policy purpose. Patient registries may be single purpose or on-going data collection programs that address one or more questions. (AHRQ)
has exact synonym: PATIENT REGISTRY
has exact synonym: Patient Registry Study
in subset: NCIT C132298
in subset: NCIT C61410
in subset: NCIT C66830
in subset: NCIT C99077

Axiom
annotated source: Patient Registry Study
annotated property: textual definition
annotated target: An observational study that is also considered to be a Patient Registry. This type of study should only be registered once in the Protocol Registration and Results System (PRS), by the sponsor responsible for the primary data collection and analysis.
definition source: https://prsinfo.clinicaltrials.gov/definitions.html

Study Type
type: Class
subclass of: human study
textual definition: The nature of the investigation or the investigational use for which clinical study is being done.
imported from: ncit.owl
code: C142175
Semantic_Type: Research Activity
Preferred_Name: Study Type
NCI_META_CUI: CL540168
Contributing_Source: CDISC
ALT_DEFINITION: Describes the role the study plays in determining the interventions a subject receives.
has exact synonym: STYPE
has exact synonym: Study Type
in subset: NCIT C132298
in subset: NCIT C142191
in subset: NCIT C61410
in subset: NCIT C66738
in subset: NCIT C66830
in subset: NCIT C67152

Random Allocation
type: Class
subclass of: Allocation
textual definition: Participants are assigned to intervention groups by chance
textual definition: The process of resource distribution that is done by chance.
imported from: ncit.owl
code: C142660
Semantic_Type: Activity
Preferred_Name: Random Allocation
NCI_META_CUI: CL540611
Contributing_Source: CDISC-GLOSS
ALT_DEFINITION: Assignment of subjects to treatment (or control) groups in an unpredictable way. NOTE: in a blinded study, assignment sequences are concealed, but available for disclosure in the event a subject has an adverse experience.
has exact synonym: Random Allocation
has exact synonym: random allocation
has exact synonym: randomized
in subset: NCIT C61410
in subset: NCIT C67497

Axiom
annotated source: Random Allocation
annotated property: textual definition
annotated target: Participants are assigned to intervention groups by chance
definition source: https://prsinfo.clinicaltrials.gov/definitions.html

Study Primary Purpose
type: Class
subclass of: plan specification
textual definition: The main objective of the intervention(s) being evaluated by the clinical trial.
textual definition: The principal reason or intention for the execution of an interventional or non-interventional clinical study.
imported from: ncit.owl
code: C147141
Semantic_Type: Idea or Concept
Preferred_Name: Study Primary Purpose
NCI_META_CUI: CL545057
Contributing_Source: CDISC
ALT_DEFINITION: The principal reason or intention for the execution of an interventional or non-interventional clinical study. (NCI)
has exact synonym: Study Primary Purpose
in subset: NCIT C132298
in subset: NCIT C147066
in subset: NCIT C61410

Axiom
annotated source: Study Primary Purpose
annotated property: textual definition
annotated target: The main objective of the intervention(s) being evaluated by the clinical trial.
definition source: https://prsinfo.clinicaltrials.gov/definitions.html

Gene Therapy
type: Class
subclass of: medical intervention
textual definition: Application of genetic material (usually DNA) into cells in order to permanently correct an inherited disease or acquired disease.
imported from: ncit.owl
code: C15238
Semantic_Type: Therapeutic or Preventive Procedure
Display_Name: Gene Therapy
Preferred_Name: Gene Therapy
UMLS_CUI: C0017296
Contributing_Source: CDISC
Contributing_Source: CTRP
ALT_DEFINITION: Application of genetic material into cells in order to correct an inherited or acquired disease.
ALT_DEFINITION: Treatment of human disease by gene transfer.
ALT_DEFINITION: Treatment that alters a gene. In studies of gene therapy for cancer, researchers are trying to improve the body's natural ability to fight the disease or to make the cancer cells more sensitive to other kinds of therapy.
Legacy_Concept_Name: Gene_Therapy
DesignNote: Gene therapy techniques attempt to replace a faulty or missing gene associated with a particular disease, mediate localized delivery of a protein producing specified therapeutic effects, or introduce new cellular functions.
has exact synonym: DNA Therapy
has exact synonym: GENETIC
has exact synonym: Gene Therapy
has exact synonym: Gene Transfer Procedure
has exact synonym: Gene transfer
has exact synonym: Genetic
has exact synonym: Intervention, Genetic
has exact synonym: Molecular Biology, Gene Therapy
has exact synonym: gene therapy
in subset: NCIT C116977
in subset: NCIT C118169
in subset: NCIT C61410
in subset: NCIT C66830
in subset: NCIT C99078

Axiom
annotated source: Gene Therapy
annotated property: has exact synonym
annotated target: Genetic

Health Services Research
type: Class
subclass of: Study Primary Purpose
textual definition: A multidisciplinary field of inquiry that examines the costs, quality, accessibility, delivery, organization, financing, and outcomes of health care services.
textual definition: One or more interventions for evaluating the delivery, processes, management, organization, or financing of healthcare.
imported from: ncit.owl
code: C15245
Semantic_Type: Research Activity
Preferred_Name: Health Services Research
UMLS_CUI: C0018757
Contributing_Source: CDISC
ALT_DEFINITION: A type of study designed to evaluate the delivery, processes, management, organization or financing of health care. (ClinicalTrials.gov)
Legacy_Concept_Name: Health_Services_Research
has exact synonym: HEALTH SERVICES RESEARCH
has exact synonym: Health Services Research
in subset: NCIT C132298
in subset: NCIT C147067
in subset: NCIT C61410
in subset: NCIT C66736
in subset: NCIT C66830

Axiom
annotated source: Health Services Research
annotated property: textual definition
annotated target: One or more interventions for evaluating the delivery, processes, management, organization, or financing of healthcare.
definition source: https://prsinfo.clinicaltrials.gov/definitions.html

Surgical Procedure
type: Class
subclass of: medical procedure
textual definition: A diagnostic or treatment procedure performed by manual and/or instrumental means, often involving an incision and the removal or replacement of a diseased organ or tissue; of or relating to or involving or used in surgery or requiring or amenable to treatment by surgery.
imported from: ncit.owl
Has_NICHD_Parent: NCIT C25218
code: C15329
Semantic_Type: Health Care Activity
Display_Name: Surgical Procedure
Preferred_Name: Surgical Procedure
UMLS_CUI: C0543467
Contributing_Source: CPTAC
Contributing_Source: CTRP
Contributing_Source: NICHD
ALT_DEFINITION: A procedure to remove or repair a part of the body or to find out whether disease is present. An operation.
Legacy_Concept_Name: Surgical_Procedure
NICHD_Hierarchy_Term: Surgical Procedure
Maps_To: Surgery
Maps_To: Surgically Treated
has exact synonym: Operation
has exact synonym: Surgery
has exact synonym: Surgical
has exact synonym: Surgical Interventions
has exact synonym: Surgical Procedure
has exact synonym: Surgical Procedures
has exact synonym: Surgically
has exact synonym: Type of Surgery
has exact synonym: surgery
in subset: NCIT C116977
in subset: NCIT C118169
in subset: NCIT C156952
in subset: NCIT C156953
in subset: NCIT C156954
in subset: NCIT C157524
in subset: NCIT C157526
in subset: NCIT C157527
in subset: NCIT C157528
in subset: NCIT C157529
in subset: NCIT C157530
in subset: NCIT C157532
in subset: NCIT C157533
in subset: NCIT C157534
in subset: NCIT C159412
in subset: NCIT C90259

Phase I Trial
type: Class
subclass of: clinical trial
textual definition: A clinical research protocol designed to test a new biomedical intervention in a small group of people for the first time. A Phase I trial can be to establish the toxicity of a new treatment with escalating intensity of the treatment administered and/or to determine the side effects of a new treatment for a particular indication in subjects.
textual definition: Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
imported from: ncit.owl
code: C15600
Semantic_Type: Research Activity
Preferred_Name: Phase I Trial
UMLS_CUI: C0920321
Contributing_Source: CDISC
Contributing_Source: CDISC-GLOSS
ALT_DEFINITION: The first step in testing a new treatment in humans. These studies test the best way to give a new treatment (for example, by mouth, intravenous infusion, or injection) and the best dose. The dose is usually increased a little at a time in order to find the highest dose that does not cause harmful side effects. Because little is known about the possible risks and benefits of the treatments being tested, phase I trials usually include only a small number of patients who have not been helped by other treatments.
ALT_DEFINITION: The initial introduction of an investigational new drug into humans. Phase 1 studies are typically closely monitored and may be conducted in patients or normal volunteer subjects. NOTE: These studies are designed to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. During Phase 1, sufficient information about the drug's pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid Phase 2 studies. The total number of subjects and patients included in Phase 1 studies varies with the drug, but is generally in the range of 20 to 80. Phase 1 studies also include studies of drug metabolism, structure-activity relationships, and mechanism of action in humans, as well as studies in which investigational drugs are used as research tools to explore biological phenomena or disease processes. [after FDA CDER handbook, ICH E8]
ALT_DEFINITION: The initial introduction of an investigational new drug into humans. Phase 1 studies are typically closely monitored and may be conducted in patients or normal volunteer subjects. NOTE: These studies are designed to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. During Phase 1, sufficient information about the drug's pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid, Phase 2 studies. The total number of subjects and patients included in Phase I studies varies with the drug, but is generally in the range of 20 to 80. Phase 1 studies also include studies of drug metabolism, structure-activity relationships, and mechanism of action in humans, as well as studies in which investigational drugs are used as research tools to explore biological phenomena or disease processes. [After FDA CDER Handbook, ICH E8] (CDISC glossary)
Legacy_Concept_Name: Phase_I_Trial
has exact synonym: 1
has exact synonym: Clinical Trials, Phase I
has exact synonym: Early-Stage Clinical Trials
has exact synonym: PHASE I TRIAL
has exact synonym: Phase 1 Study
has exact synonym: Phase I Clinical Trials
has exact synonym: Phase I Protocol
has exact synonym: Phase I Study
has exact synonym: Phase I Trial
has exact synonym: Trial Phase 1
has exact synonym: phase 1
has exact synonym: phase I trial
in subset: NCIT C132298
in subset: NCIT C61410
in subset: NCIT C66737
in subset: NCIT C66830
in subset: NCIT C67497

Axiom
annotated source: Phase I Trial
annotated property: textual definition
annotated target: Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
definition source: https://prsinfo.clinicaltrials.gov/definitions.html

Phase II Trial
type: Class
subclass of: clinical trial
textual definition: A clinical research protocol designed to study a biomedical or behavioral intervention in a larger group of people (several hundred), to evaluate the drug's effectiveness for a particular indication in patients with the disease or condition under study, and to determine the common short-term side effects and risks associated with the intervention.
textual definition: Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks.
imported from: ncit.owl
code: C15601
Semantic_Type: Research Activity
Preferred_Name: Phase II Trial
UMLS_CUI: C0282460
Contributing_Source: CDISC
Contributing_Source: CDISC-GLOSS
ALT_DEFINITION: A study to test whether a new treatment has an anticancer effect (for example, whether it shrinks a tumor or improves blood test results) and whether it works against a certain type of cancer.
ALT_DEFINITION: Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug. NOTE: Phase 2 studies are typically well controlled, closely monitored, and conducted in a relatively small number of patients, usually involving no more than several hundred subjects. [after FDA CDER handbook, ICH E8]
ALT_DEFINITION: Phase 2. Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug. NOTE: Phase 2 studies are typically well controlled, closely monitored, and conducted in a relatively small number of patients, usually involving no more than several hundred subjects. [After FDA CDER Handbook, ICH E8] (CDISC glossary)
Legacy_Concept_Name: Phase_II_Trial
has exact synonym: 2
has exact synonym: Clinical Trials, Phase II
has exact synonym: PHASE II TRIAL
has exact synonym: Phase 2 Study
has exact synonym: Phase II Clinical Trial
has exact synonym: Phase II Protocol
has exact synonym: Phase II Study
has exact synonym: Phase II Trial
has exact synonym: Trial Phase 2
has exact synonym: phase 2
has exact synonym: phase II trial
in subset: NCIT C132298
in subset: NCIT C61410
in subset: NCIT C66737
in subset: NCIT C66830
in subset: NCIT C67497

Axiom
annotated source: Phase II Trial
annotated property: textual definition
annotated target: Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks.
definition source: https://prsinfo.clinicaltrials.gov/definitions.html

Phase III Trial
type: Class
subclass of: clinical trial
textual definition: A clinical research protocol designed to investigate the efficacy of the biomedical or behavioral intervention in large groups of human subjects (from several hundred to several thousand), to confirm efficacy, to monitor adverse reactions to the new medication or treatment regimen with respect to long-term use and by comparing the intervention to other standard or experimental interventions as well as to a placebo.
textual definition: Includes trials conducted after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug.
imported from: ncit.owl
code: C15602
Semantic_Type: Research Activity
Preferred_Name: Phase III Trial
UMLS_CUI: C0282461
Contributing_Source: CDISC
Contributing_Source: CDISC-GLOSS
ALT_DEFINITION: A study to compare the results of people taking a new treatment with the results of people taking the standard treatment (for example, which group has better survival rates or fewer side effects). In most cases, studies move into phase III only after a treatment seems to work in phases I and II. Phase III trials may include hundreds of people.
ALT_DEFINITION: Phase 3. Studies are expanded controlled and uncontrolled trials. They are performed after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather the additional information about effectiveness and safety that is needed to confirm efficacy and evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling. NOTE: Phase 3 studies usually include from several hundred to several thousand subjects. [After FDA CDER Handbook, ICH E8] (CDISC glossary)
ALT_DEFINITION: Studies are expanded controlled and uncontrolled trials. They are performed after preliminary evidence suggesting effectiveness of the drug has been obtained and are intended to gather the additional information about effectiveness and safety that is needed to confirm efficacy and evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling. NOTE: Phase 3 studies usually include from several hundred to several thousand subjects. [after FDA CDER handbook, ICH E8]
Legacy_Concept_Name: Phase_III_Trial
has exact synonym: 3
has exact synonym: Clinical Trials, Phase III
has exact synonym: PHASE III TRIAL
has exact synonym: Phase 3 Study
has exact synonym: Phase III Clinical Trial
has exact synonym: Phase III Protocol
has exact synonym: Phase III Study
has exact synonym: Phase III Trial
has exact synonym: Phase III Trials
has exact synonym: Trial Phase 3
has exact synonym: phase 3
has exact synonym: phase III trial
in subset: NCIT C132298
in subset: NCIT C61410
in subset: NCIT C66737
in subset: NCIT C66830
in subset: NCIT C67497

Axiom
annotated source: Phase III Trial
annotated property: textual definition
annotated target: Includes trials conducted after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug.
comment: https://prsinfo.clinicaltrials.gov/definitions.html

Phase IV Trial
type: Class
subclass of: clinical trial
textual definition: A randomized, controlled trial that is designed to evaluate the long-term safety and efficacy of a drug for a given indication. Often they are designed to study side effects that may have become apparent after the phase III study was completed.
textual definition: Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use.
imported from: ncit.owl
code: C15603
Semantic_Type: Research Activity
Preferred_Name: Phase IV Trial
UMLS_CUI: C0282462
Contributing_Source: CDISC
Contributing_Source: CDISC-GLOSS
ALT_DEFINITION: After a treatment has been approved and is being marketed, it is studied in a phase IV trial to evaluate side effects that were not apparent in the phase III trial. Thousands of people are involved in a phase IV trial.
ALT_DEFINITION: Phase 4. Postmarketing (Phase 4) studies to delineate additional information about the drug's risks, benefits, and optimal use that may be requested by regulatory authorities in conjunction with marketing approval. NOTE: These studies could include, but would not be limited to, studying different doses or schedules of administration than were used in Phase 2 studies, use of the drug in other patient populations or other stages of the disease, or use of the drug over a longer period of time. [After FDA CDER Handbook, ICH E8] (CDISC glossary)
ALT_DEFINITION: Post approval studies to delineate additional information about the drug's risks, benefits, and optimal use that may be requested by regulatory authorities in conjunction with marketing approval. NOTE: These studies could include, but would not be limited to, studying different doses or schedules of administration than were used in Phase 2 studies, use of the drug in other patient populations or other stages of the disease, or use of the drug over a longer period of time. [after FDA CDER handbook, ICH E8]
Legacy_Concept_Name: Phase_IV_Trial
has exact synonym: 4
has exact synonym: Clinical Trials, Phase IV
has exact synonym: PHASE IV TRIAL
has exact synonym: Phase 4 Study
has exact synonym: Phase IV Clinical Trials
has exact synonym: Phase IV Study
has exact synonym: Phase IV Trial
has exact synonym: Trial Phase 4
has exact synonym: phase 4
has exact synonym: phase IV trial
in subset: NCIT C132298
in subset: NCIT C61410
in subset: NCIT C66737
in subset: NCIT C66830
in subset: NCIT C67497

Axiom
annotated source: Phase IV Trial
annotated property: textual definition
annotated target: Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use.
definition source: https://prsinfo.clinicaltrials.gov/definitions.html

Phase I/II Trial
type: Class
subclass of: clinical trial
textual definition: A clinical research protocol designed to study the safety, dosage levels and response to new treatment. Phase I/II trials combine a Phase I and a Phase II trial of the same treatment into a single protocol.
textual definition: Trials that are a combination of phases 1 and 2.
imported from: ncit.owl
code: C15693
Semantic_Type: Research Activity
Preferred_Name: Phase I/II Trial
UMLS_CUI: C1519043
Contributing_Source: CDISC
ALT_DEFINITION: A class of clinical study that combines elements characteristic of traditional Phase I and Phase II trials. See also Phase I, Phase II.
ALT_DEFINITION: A trial to study the safety, dosage levels, and response to a new treatment.
Legacy_Concept_Name: Phase_I_II_Trial
has exact synonym: 1-2
has exact synonym: PHASE I/II TRIAL
has exact synonym: Phase I/II Trial
has exact synonym: Phase I/II trial
has exact synonym: Trial Phase 1-2
has exact synonym: Trial Phase 1/2
in subset: NCIT C132298
in subset: NCIT C61410
in subset: NCIT C66737
in subset: NCIT C66830

Axiom
annotated source: Phase I/II Trial
annotated property: textual definition
annotated target: Trials that are a combination of phases 1 and 2.
definition source: https://prsinfo.clinicaltrials.gov/definitions.html

Phase II/III Trial
type: Class
subclass of: clinical trial
textual definition: A type of clinical study that combines elements characteristic of traditional Phase II and Phase III trials.
textual definition: Trials that are a combination of phases 2 and 3.
imported from: ncit.owl
code: C15694
Semantic_Type: Research Activity
Preferred_Name: Phase II/III Trial
UMLS_CUI: C1519042
Contributing_Source: CDISC
ALT_DEFINITION: A class of clinical study that combines elements characteristic of traditional Phase II and Phase III trials.
ALT_DEFINITION: A trial to study response to a new treatment and the effectiveness of the treatment compared with the standard treatment regimen.
Legacy_Concept_Name: Phase_II_III_Trial
has exact synonym: 2-3
has exact synonym: PHASE II/III TRIAL
has exact synonym: Phase II/III Trial
has exact synonym: Trial Phase 2-3
has exact synonym: Trial Phase 2/3
has exact synonym: phase II/III trial
in subset: NCIT C132298
in subset: NCIT C61410
in subset: NCIT C66737
in subset: NCIT C66830

Axiom
annotated source: Phase II/III Trial
annotated property: textual definition
annotated target: Trials that are a combination of phases 2 and 3.
definition source: https://prsinfo.clinicaltrials.gov/definitions.html

Basic Research
type: Class
subclass of: Study Primary Purpose
textual definition: Fundamental research designed to obtain or increase general scientific knowledge.
textual definition: One or more interventions for examining the basic mechanism of action (for example, physiology or biomechanics of an intervention).
imported from: ncit.owl
code: C15714
Semantic_Type: Research Activity
Preferred_Name: Basic Research
UMLS_CUI: C0681833
Contributing_Source: CDISC
ALT_DEFINITION: A type of study designed to examine the basic mechanism of action (e.g., physiology, biomechanics) of an intervention. (ClinicalTrials.gov)
Legacy_Concept_Name: Basic_Science
has exact synonym: BASIC SCIENCE
has exact synonym: Basic Research
has exact synonym: Basic Science
has exact synonym: Basic Science Research
in subset: NCIT C132298
in subset: NCIT C147067
in subset: NCIT C61410
in subset: NCIT C66736
in subset: NCIT C66830

Axiom
annotated source: Basic Research
annotated property: textual definition
annotated target: One or more interventions for examining the basic mechanism of action (for example, physiology or biomechanics of an intervention).
definition source: https://prsinfo.clinicaltrials.gov/definitions.html

Condition or Disease under Study
type: Class
subclass of: Study Condition
textual definition: Primary disease(s) or condition(s) being studied in the trial, or the focus of the study. (clinicaltrials.gov)
textual definition: The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
textual definition: The name(s) of the disease(s) or condition(s) studied in the clinical study, or the focus of the clinical study. Use, if available, appropriate descriptors from NLM's Medical Subject Headings (MeSH)-controlled vocabulary thesaurus or terms from another vocabulary, such as the Systematized Nomenclature of Medicine—Clinical Terms (SNOMED CT), that has been mapped to MeSH within the Unified Medical Language System (UMLS) Metathesaurus.
imported from: ncit.owl
code: C161319
Semantic_Type: Qualitative Concept
Preferred_Name: Condition or Disease under Study
Contributing_Source: CDISC
ALT_DEFINITION: Primary disease(s) or condition(s) being studied in the trial, or the focus of the study. (clinicaltrials.gov)
has exact synonym: Condition or Disease under Study
has exact synonym: Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
has exact synonym: health condition(s) or problem(s) studied
has exact synonym: target disease
has_narrow_synonym: condition
in subset: NCIT C132298
in subset: NCIT C160921
in subset: NCIT C61410

Axiom
annotated source: Condition or Disease under Study
annotated property: textual definition
annotated target: The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
definition source: https://clinicaltrials.gov/ct2/about-studies/glossary

Axiom
annotated source: Condition or Disease under Study
annotated property: textual definition
annotated target: The name(s) of the disease(s) or condition(s) studied in the clinical study, or the focus of the clinical study. Use, if available, appropriate descriptors from NLM's Medical Subject Headings (MeSH)-controlled vocabulary thesaurus or terms from another vocabulary, such as the Systematized Nomenclature of Medicine—Clinical Terms (SNOMED CT), that has been mapped to MeSH within the Unified Medical Language System (UMLS) Metathesaurus.
definition source: https://prsinfo.clinicaltrials.gov/definitions.html

Axiom
annotated source: Condition or Disease under Study
annotated property: has exact synonym
annotated target: health condition(s) or problem(s) studied

Personal Attribute
type: Class
subclass of: information content entity
textual definition: The distinguishing qualities or prominent aspects of an individual person.
imported from: ncit.owl
imported from: opmi.owl
code: C19332
Semantic_Type: Organism Attribute
Preferred_Name: Personal Attribute
UMLS_CUI: C0681884
Legacy_Concept_Name: Personal_Attribute
has exact synonym: Personal
has exact synonym: Personal Attribute
has exact synonym: Subject Characteristics

Age
type: Class
subclass of: Personal Attribute
textual definition: A type of eligibility criteria that indicates the age a person must be to participate in a clinical study.
textual definition: How long something has existed; elapsed time since birth.
imported from: ncit.owl
imported from: opmi.owl
Has_NICHD_Parent: NCIT C89335
code: C25150
Semantic_Type: Organism Attribute
Preferred_Name: Age
UMLS_CUI: C0001779
Contributing_Source: CDISC
Contributing_Source: FDA
Contributing_Source: NICHD
ALT_DEFINITION: How long something has existed; elapsed time since birth. (NCI)
ALT_DEFINITION: The time elapsed since birth.
Legacy_Concept_Name: Age
NICHD_Hierarchy_Term: Chronological Age
has exact synonym: AGE
has exact synonym: Age
has exact synonym: Aged
has exact synonym: Chronological Age
has exact synonym: Postnatal Age
has exact synonym: age
in subset: NCIT C118466
in subset: NCIT C19752
in subset: NCIT C54447
in subset: NCIT C61410
in subset: NCIT C77526
in subset: NCIT C83187
in subset: NCIT C83188
in subset: NCIT C90007
in subset: NCIT C90009
in subset: NCIT C90259

Axiom
annotated source: Age
annotated property: textual definition
annotated target: A type of eligibility criteria that indicates the age a person must be to participate in a clinical study.
definition source: https://clinicaltrials.gov/ct2/about-studies/glossary

Clinical Study Protocol
type: Class
subclass of: Study Protocol
textual definition: A formal document that describes a complete plan of research activity in the framework of a clinical study; specifically, the study objective(s), design, methodology, eligibility requests for prospective subjects and controls; intervention regimen(s), proposed methods of analysis of data; statistical considerations, and organization of the study. The protocol usually also provides the background and rationale for the trial, but these could be represented in other protocol referenced documents.
imported from: ncit.owl
code: C25320
Semantic_Type: Intellectual Product
Preferred_Name: Clinical Study Protocol
UMLS_CUI: C1507394
Contributing_Source: BRIDG
Contributing_Source: CDISC-GLOSS
Contributing_Source: CareLex
ALT_DEFINITION: A detailed plan of a scientific or medical experiment, treatment, or procedure. In clinical trials, it states what the study will do, how it will be done, and why it is being done. It explains how many people will be in the study, who is eligible to take part in it, what study drugs or other interventions will be given, what tests will be done and how often, and what information will be collected.
ALT_DEFINITION: A discrete, structured plan (that persists over time) of 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. NOTE(S): The term "protocol" is somewhat overloaded and must be qualified to provide semantic context. Therefore the term "study protocol" was chosen to disambiguate it from other protocols. In previous versions of BRIDG, there was one class for StudyProtocol. However this too represented multiple distinct aspects of the semantics of study protocol, each of which have now been split into separate classes:- The StudyProtocol class represents the content of the study protocol and can exist even before the information is put into document form. - The details of the structured plan for the study protocol are represented by the StudyProtocolVersion, so named because any aspect of the definition can change from version to version. These details include, but are not limited to, the characteristics, specifications, objective(s), background, the pre-study/study/post-study portions of the plan (including the design, methodology, statistical considerations, organization).- The protocol and its versions can each be represented in document form, respectively StudyProtocolDocument and StudyProtocolDocumentVersion. A StudyProtocolDocument groups the various document versions (StudyProtocolDocumentVersions).- The conduct of a study based on a study protocol definition is represented by the StudyExecution class.
ALT_DEFINITION: A formal document that describes a complete plan of research activity in the framework of a clinical study; specifically, the study objective(s), design, methodology, eligibility requests for prospective subjects and controls; intervention regimen(s), proposed methods of analysis of data; statistical considerations, and organization of the study. The protocol usually also provides the background and rationale for the trial, but these could be represented in other protocol referenced documents. [NCI]
ALT_DEFINITION: See protocol.
Legacy_Concept_Name: Protocol
has exact synonym: Clinical Study Protocol
has exact synonym: Clinical Trial Protocol
has exact synonym: Full Protocol
has exact synonym: Prot
has exact synonym: Protocol
has exact synonym: Protocol Amendment
has exact synonym: Study Protocol
has exact synonym: StudyProtocol
has exact synonym: Trial Protocol
has exact synonym: clinical protocol
has exact synonym: protocol
in subset: NCIT C114548
in subset: NCIT C159501
in subset: NCIT C159503
in subset: NCIT C61410
in subset: NCIT C67497

Sponsor
type: Class
subclass of: Homo sapiens
textual definition: A person or organization that supports or champions something.
imported from: ncit.owl
code: C48355
Semantic_Type: Human
Preferred_Name: Sponsor
UMLS_CUI: C1711305
Legacy_Concept_Name: Sponsor
has exact synonym: Applicant
has exact synonym: Sponsor

Diagnosis Study
type: Class
subclass of: Study Primary Purpose
textual definition: A type of study designed to evaluate method(s) aimed at identifying a disease or condition.
textual definition: One or more interventions are being evaluated for identifying a disease or health condition.
imported from: ncit.owl
code: C49653
Semantic_Type: Research Activity
Preferred_Name: Diagnosis Study
UMLS_CUI: C1704656
Contributing_Source: CDISC
ALT_DEFINITION: A type of study designed to evaluate intervention(s) aimed at identifying a disease or condition.
Legacy_Concept_Name: Diagnosis_Study
has exact synonym: DIAGNOSIS
has exact synonym: Diagnosis Study
has exact synonym: Diagnostic Study
in subset: NCIT C132298
in subset: NCIT C61410
in subset: NCIT C66736
in subset: NCIT C66739
in subset: NCIT C66830

Axiom
annotated source: Diagnosis Study
annotated property: textual definition
annotated target: One or more interventions are being evaluated for identifying a disease or health condition.
definition source: https://prsinfo.clinicaltrials.gov/definitions.html

Treatment Study
type: Class
subclass of: Study Primary Purpose
textual definition: A type of study protocol designed to evaluate intervention(s) for disease treatment.
textual definition: One or more interventions are being evaluated for treating a disease, syndrome, or condition.
imported from: ncit.owl
code: C49656
Semantic_Type: Research Activity
Preferred_Name: Treatment Study
UMLS_CUI: C3161471
Contributing_Source: CDISC
ALT_DEFINITION: A type of study designed to evaluate intervention(s) for treatment of disease, syndrome or condition.
Legacy_Concept_Name: Treatment_Study
has exact synonym: TREATMENT
has exact synonym: Therapy Trial
has exact synonym: Treatment Study
in subset: NCIT C132298
in subset: NCIT C61410
in subset: NCIT C66736
in subset: NCIT C66739
in subset: NCIT C66830

Axiom
annotated source: Treatment Study
annotated property: textual definition
annotated target: One or more interventions are being evaluated for treating a disease, syndrome, or condition.
definition source: https://prsinfo.clinicaltrials.gov/definitions.html

Prevention Study
type: Class
subclass of: Study Primary Purpose
textual definition: A type of study protocol designed to evaluate intervention(s) for disease prevention.
textual definition: One or more interventions are being assessed for preventing the development of a specific disease or health condition.
imported from: ncit.owl
code: C49657
Semantic_Type: Research Activity
Preferred_Name: Prevention Study
UMLS_CUI: C1706420
Contributing_Source: CDISC
ALT_DEFINITION: A type of study designed to identify actions necessary to permanently eliminate or reduce the long-term risk to human life as a result of a particular medication or treatment regimen.
Legacy_Concept_Name: Prevention_Study
has exact synonym: PREVENTION
has exact synonym: Prevention Study
has exact synonym: Preventive Clinical Trial
has exact synonym: Prophylaxis Study
in subset: NCIT C132298
in subset: NCIT C61410
in subset: NCIT C66736
in subset: NCIT C66739
in subset: NCIT C66830

Axiom
annotated source: Prevention Study
annotated property: textual definition
annotated target: One or more interventions are being assessed for preventing the development of a specific disease or health condition.
definition source: https://prsinfo.clinicaltrials.gov/definitions.html

Planned Subject Number
type: Class
subclass of: data item
textual definition: The number of subjects entered in a clinical trial.
imported from: ncit.owl
code: C49692
Semantic_Type: Group Attribute
Preferred_Name: Planned Subject Number
UMLS_CUI: C1709561
Contributing_Source: CDISC
Contributing_Source: CDISC-GLOSS
ALT_DEFINITION: The number of subjects in a class or group (including the total for the entire trial) intended to be enrolled in a trial to reach the planned sample size. Target enrollments are set so that statistical and scientific objectives of a trial will have a likelihood of being met as determined by agreement, algorithm, or other specified process.
ALT_DEFINITION: The planned number of subjects to be entered in a clinical trial. (NCI)
Legacy_Concept_Name: Planned_Subject_Number
has exact synonym: Anticipated Enrollment
has exact synonym: PLANSUB
has exact synonym: Planned Enrollment
has exact synonym: Planned Number of Subjects
has exact synonym: Planned Subject Number
has exact synonym: Target Enrollment
has exact synonym: target enrollment
has exact synonym: target number
has exact synonym: target size
in subset: NCIT C132298
in subset: NCIT C147066
in subset: NCIT C61410
in subset: NCIT C66738
in subset: NCIT C66830
in subset: NCIT C67152
in subset: NCIT C67497

Allocation
type: Class
subclass of: intervention design
textual definition: The distribution of resources over various time periods, products, operations, or investments.
textual definition: The method by which participants are assigned to arms in a clinical trial.
imported from: ncit.owl
code: C52580
Semantic_Type: Activity
Preferred_Name: Allocation
UMLS_CUI: C1706778
Contributing_Source: CDISC
ALT_DEFINITION: The process of assigning subjects to particular treatment groups or cohorts in a clinical study.
Legacy_Concept_Name: Allocation
has exact synonym: Allocation
has exact synonym: Subject Allocation
in subset: NCIT C132298
in subset: NCIT C147066
in subset: NCIT C61410

Axiom
annotated source: Allocation
annotated property: textual definition
annotated target: The method by which participants are assigned to arms in a clinical trial.
definition source: https://prsinfo.clinicaltrials.gov/definitions.html

Contact Information
type: Class
subclass of: textual entity
textual definition: Information regarding the means of contacting a person or group.
imported from: ncit.owl
code: C60776
Semantic_Type: Conceptual Entity
Preferred_Name: Contact Information
UMLS_CUI: C1880174
Legacy_Concept_Name: Contact_Information
has exact synonym: Contact Info
has exact synonym: Contact Information

Clinical Study Sponsor
type: Class
subclass of: Sponsor
textual definition: An entity such as an individual, company, institution, group, or organization which takes responsibility for the initiation, management, and/or financing of a clinical study. The sponsor does not actually conduct the investigation unless the sponsor is a sponsor-investigator. A person other than an individual (e.g., corporation or agency) that uses one or more of its own employees to conduct research it has initiated is considered to be a sponsor, and the employees are considered to be investigators. [21 CFR P.50.3(k)] [21 CFR P.50.102(j)] [21 CFR P.312.3]
imported from: ncit.owl
code: C70793
Semantic_Type: Health Care Related Organization
Preferred_Name: Clinical Study Sponsor
UMLS_CUI: C2347796
Contributing_Source: CDISC
Contributing_Source: CDISC-GLOSS
Contributing_Source: CareLex
ALT_DEFINITION: An entity that is responsible for the initiation, management, and/or financing of a clinical study.
ALT_DEFINITION: An entity that is responsible for the initiation, management, and/or financing of a clinical study.[NCI]
ALT_DEFINITION: An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial. NOTE: If there is also a secondary sponsor, the responsible entity would be considered the primary sponsor. A corporation or agency whose employees conduct the investigation is considered a sponsor and the employees are considered investigators. [After ICH E6, WHO, 21 CFR 50.3 (e), and after IDMP] See also secondary sponsor.
Legacy_Concept_Name: Clinical_Study_Sponsor
has exact synonym: CLINICAL STUDY SPONSOR
has exact synonym: Clinical Study Sponsor
has exact synonym: SPONSOR
has exact synonym: Sponsor
has exact synonym: Study Sponsor
has exact synonym: sponsor
in subset: NCIT C114548
in subset: NCIT C132298
in subset: NCIT C154681
in subset: NCIT C61410
in subset: NCIT C66738
in subset: NCIT C66830
in subset: NCIT C67152
in subset: NCIT C67497
in subset: NCIT C78735
in subset: NCIT C83187
in subset: NCIT C83188

Study Protocol
type: Class
subclass of: protocol
textual definition: The formal plan of an experiment or research activity, including the objective, rationale, design, materials and methods for the conduct of the study; intervention description, and method of data analysis.
textual definition: The written description of the clinical study, including objective(s), design, and methods. It may also include relevant scientific background and statistical considerations (if the protocol document includes the statistical analysis plan, use "Study Protocol with SAP and/or ICF" option). Note: All amendments approved by a human subjects protection review board (if applicable), before the time of submission and that apply to all clinical trial Facility Locations must be included.
imported from: ncit.owl
code: C70817
Semantic_Type: Intellectual Product
Preferred_Name: Study Protocol
UMLS_CUI: C2348563
Contributing_Source: CDISC
ALT_DEFINITION: The formal plan of an experiment or research activity, including the objective, rationale, design, materials and methods for the conduct of the study, intervention description, and method of data analysis.
Legacy_Concept_Name: Study_Protocol
has exact synonym: Protocol
has exact synonym: Study Protocol
in subset: NCIT C132298
in subset: NCIT C132310
in subset: NCIT C61410

Axiom
annotated source: Study Protocol
annotated property: textual definition
annotated target: The written description of the clinical study, including objective(s), design, and methods. It may also include relevant scientific background and statistical considerations (if the protocol document includes the statistical analysis plan, use "Study Protocol with SAP and/or ICF" option). Note: All amendments approved by a human subjects protection review board (if applicable), before the time of submission and that apply to all clinical trial Facility Locations must be included.
definition source: https://prsinfo.clinicaltrials.gov/results_definitions.html

Blinded Clinical Study
type: Class
subclass of: Interventional study
textual definition: A clinical study that is designed using a procedure in which one or more parties to the study [subject(s), investigator(s), monitor, or/and data analyst(s)] are kept unaware of the treatment assignment(s).
imported from: ncit.owl
code: C70840
Semantic_Type: Research Activity
Preferred_Name: Blinded Clinical Study
UMLS_CUI: C2347038
Contributing_Source: CDISC-GLOSS
ALT_DEFINITION: A study in which the subject, the investigator, or anyone assessing the outcome is unaware of the treatment assignment(s). NOTE: Blinding is used to reduce the potential for bias. [Modified ICH E6 Glossary] See also blinding/masking, double-blind study, single-blind study, triple-blind study; contrast with open-label or unblinded study.
ALT_DEFINITION: A type of study in which the patients (single-blinded) or the patients and their doctors (double-blinded) do not know which drug or treatment is being given. The opposite of a blinded study is an open label study.
Legacy_Concept_Name: Blinded_Clinical_Study
has exact synonym: Blind Clinical Study
has exact synonym: Blinded Clinical Study
has exact synonym: Blinded Clinical Trial
has exact synonym: Masked Clinical Study
has exact synonym: blinded study
in subset: NCIT C61410
in subset: NCIT C67497

Screening Study
type: Class
subclass of: Study Primary Purpose
textual definition: Clinical studies testing the efficacy of devices, techniques, procedures, or tests for the purpose of detecting the presence of disease, usually before there are any symptoms.
textual definition: One or more interventions are assessed or examined for identifying a condition, or risk factors for a condition, in people who are not yet known to have the condition or risk factor.
imported from: ncit.owl
code: C71485
Semantic_Type: Research Activity
Preferred_Name: Screening Study
UMLS_CUI: C2348164
Contributing_Source: CDISC
Contributing_Source: CDISC-GLOSS
ALT_DEFINITION: A type of study designed to assess or examine methods of identifying a condition (or risk factors for a condition) in people who are not yet known to have the condition (or risk factor). (Clinicaltrials.gov)
ALT_DEFINITION: Trials conducted to detect persons with early, mild, and asymptomatic disease.
Legacy_Concept_Name: Screening_Study
has exact synonym: SCREENING
has exact synonym: Screening Study
has exact synonym: Screening Trial
has exact synonym: screening trials
in subset: NCIT C132298
in subset: NCIT C61410
in subset: NCIT C66736
in subset: NCIT C66830
in subset: NCIT C67497

Axiom
annotated source: Screening Study
annotated property: textual definition
annotated target: One or more interventions are assessed or examined for identifying a condition, or risk factors for a condition, in people who are not yet known to have the condition or risk factor.
definition source: https://prsinfo.clinicaltrials.gov/definitions.html

Supportive Care Study
type: Class
subclass of: Study Primary Purpose
textual definition: Clinical studies intended to improve the comfort and quality of life for the patient using drugs, nutritional, dietary, behavioral or other interventions.
textual definition: One or more interventions are evaluated for maximizing comfort, minimizing side effects, or mitigating against a decline in the participant's health or function.
imported from: ncit.owl
code: C71486
Semantic_Type: Research Activity
Preferred_Name: Supportive Care Study
UMLS_CUI: C2348611
Contributing_Source: CDISC
ALT_DEFINITION: A type of study designed to evaluate one or more interventions where the primary intent is to maximize comfort, minimize side effects or mitigate against a decline in the subject's health or function. In general, supportive care interventions are not intended to cure a disease. (ClinicalTrials.gov)
Legacy_Concept_Name: Supportive_Care_Study
has exact synonym: SUPPORTIVE CARE
has exact synonym: Supportive Care Study
has exact synonym: Supportive Care Trial
in subset: NCIT C132298
in subset: NCIT C61410
in subset: NCIT C66736
in subset: NCIT C66830

Axiom
annotated source: Supportive Care Study
annotated property: textual definition
annotated target: One or more interventions are evaluated for maximizing comfort, minimizing side effects, or mitigating against a decline in the participant's health or function.
definition source: https://prsinfo.clinicaltrials.gov/definitions.html

Factorial Study
type: Class
subclass of: Interventional study
textual definition: A type of clinical study in which two or more treatments are given alone and in combination, such that all possible combinations are represented across the treatment arms, and are compared in parallel against the study control group.
textual definition: Two or more interventions, each alone and in combination, are evaluated in parallel against a control group
imported from: ncit.owl
code: C82638
Semantic_Type: Research Activity
Preferred_Name: Factorial Study
UMLS_CUI: C2826344
Contributing_Source: CDISC
ALT_DEFINITION: Two or more interventions, each alone or in combination, are evaluated in parallel against a control group. This study design allows for the comparison of active drug to placebo, presence of drug-drug interactions, and comparison of active drugs against each other.
Legacy_Concept_Name: Factorial_Study
has exact synonym: FACTORIAL
has exact synonym: Factorial Study
in subset: NCIT C132298
in subset: NCIT C61410
in subset: NCIT C66830
in subset: NCIT C77526
in subset: NCIT C89967
in subset: NCIT C99076

Axiom
annotated source: Factorial Study
annotated property: textual definition
annotated target: Two or more interventions, each alone and in combination, are evaluated in parallel against a control group
definition source: https://prsinfo.clinicaltrials.gov/definitions.html

Collaborator
type: Class
subclass of: Homo sapiens
textual definition: Any of two or more parties working jointly towards a common goal.
imported from: ncit.owl
code: C84336
Semantic_Type: Conceptual Entity
Preferred_Name: Collaborator
UMLS_CUI: C2827395
has exact synonym: Collaborator

Test Facility Country
type: Class
subclass of: Contact Information
textual definition: The country in which the test is conducted.
imported from: ncit.owl
code: C90467
Semantic_Type: Geographic Area
Preferred_Name: Test Facility Country
UMLS_CUI: C2983675
Contributing_Source: CDISC
ALT_DEFINITION: The country of the place in which a nonclinical laboratory study takes place, i.e., actually uses the test article in a test system. Testing facility includes any establishment required to register under section 510 of the act that conducts nonclinical laboratory studies and any consulting laboratory described in section 704 of the act that conducts such studies. Testing facility encompasses only those operational units that are being or have been used to conduct nonclinical laboratory studies. (FDA)
has exact synonym: TFCNTRY
has exact synonym: Test Facility Country
in subset: NCIT C61410
in subset: NCIT C77526
in subset: NCIT C90007
in subset: NCIT C90009

Test Facility Location
type: Class
subclass of: Contact Information
textual definition: The geographic area in which a test is conducted.
imported from: ncit.owl
code: C90468
Semantic_Type: Geographic Area
Preferred_Name: Test Facility Location
UMLS_CUI: C2983676
Contributing_Source: CDISC
ALT_DEFINITION: The geographic area of the place in which a nonclinical laboratory study takes place, i.e., actually uses the test article in a test system. Testing facility includes any establishment required to register under section 510 of the act that conducts nonclinical laboratory studies and any consulting laboratory described in section 704 of the act that conducts such studies. Testing facility encompasses only those operational units that are being or have been used to conduct nonclinical laboratory studies. (FDA)
has exact synonym: TSTFLOC
has exact synonym: Test Facility Location
in subset: NCIT C61410
in subset: NCIT C77526
in subset: NCIT C90007
in subset: NCIT C90009

Test Facility Name
type: Class
subclass of: Contact Information
textual definition: The name of the place in which a test is conducted.
imported from: ncit.owl
code: C90469
Semantic_Type: Intellectual Product
Preferred_Name: Test Facility Name
UMLS_CUI: C2983677
Contributing_Source: CDISC
ALT_DEFINITION: The name of the place in which a nonclinical laboratory study takes place, i.e., actually uses the test article in a test system. Testing facility includes any establishment required to register under section 510 of the act that conducts nonclinical laboratory studies and any consulting laboratory described in section 704 of the act that conducts such studies. Testing facility encompasses only those operational units that are being or have been used to conduct nonclinical laboratory studies. (FDA)
has exact synonym: TSTFNAM
has exact synonym: Test Facility Name
in subset: NCIT C61410
in subset: NCIT C77526
in subset: NCIT C90007
in subset: NCIT C90009

Study Condition
type: Class
subclass of: condition
textual definition: A condition that is a focus of the study.
imported from: ncit.owl
code: C93360
Semantic_Type: Qualitative Concept
Preferred_Name: Study Condition
UMLS_CUI: C2985574
Contributing_Source: BRIDG
ALT_DEFINITION: A condition that is a focus of the study.
has exact synonym: Study Condition
has exact synonym: StudyCondition
in subset: NCIT C159501
in subset: NCIT C159503

Clinical Trial Registry Identifier
type: Class
subclass of: CRID
textual definition: A sequence of letters, numbers, or other characters that uniquely identifies a clinical trial within a clinical trial registry.
imported from: ncit.owl
code: C98714
Semantic_Type: Intellectual Product
Preferred_Name: Clinical Trial Registry Identifier
UMLS_CUI: C3274381
Contributing_Source: CDISC
ALT_DEFINITION: Identification numbers assigned to the protocol by clinicaltrials.gov, EudraCT, or other registries.
has exact synonym: Clinical Trial Registry Identifier
has exact synonym: REGID
has exact synonym: Registry Identifier
has exact synonym: Trial Identifying Number
in subset: NCIT C61410
in subset: NCIT C66738
in subset: NCIT C66830
in subset: NCIT C67152

Expanded Access Study
type: Class
subclass of: human study
textual definition: An investigational drug product (including biological product) available through expanded access for patients who do not qualify for enrollment in a clinical trial. Expanded Access includes all expanded access types under section 561 of the Federal Food, Drug, and Cosmetic Act: (1) for individual patients, including emergency use; (2) for intermediate-size patient populations; and (3) under a treatment IND or treatment protocol.
textual definition: Studies that provide a means for obtaining an experimental drug or device for patients who are not adequately treated by existing therapy, who do not meet the eligibility criteria for enrollment, or who are otherwise unable to participate in another clinical study. Expanded Access studies include individual-patient IND, treatment IND, compassionate use, emergency use or continued access.
imported from: ncit.owl
code: C98722
Semantic_Type: Research Activity
Preferred_Name: Expanded Access Study
UMLS_CUI: C3274389
Contributing_Source: CDISC
ALT_DEFINITION: Studies that provide a means for obtaining an experimental drug or device for patients who are not adequately treated by existing therapy, who do not meet the eligibility criteria for enrollment, or who are otherwise unable to participate in another clinical study. Expanded Access studies include individual-patient IND, treatment IND, compassionate use, emergency use or continued access.
has exact synonym: EXPANDED ACCESS
has exact synonym: Expanded Access Study
in subset: NCIT C132298
in subset: NCIT C61410
in subset: NCIT C66830
in subset: NCIT C99077

Axiom
annotated source: Expanded Access Study
annotated property: textual definition
annotated target: An investigational drug product (including biological product) available through expanded access for patients who do not qualify for enrollment in a clinical trial. Expanded Access includes all expanded access types under section 561 of the Federal Food, Drug, and Cosmetic Act: (1) for individual patients, including emergency use; (2) for intermediate-size patient populations; and (3) under a treatment IND or treatment protocol.
definition source: https://prsinfo.clinicaltrials.gov/definitions.html

Intervention Type
type: Class
subclass of: planned process
textual definition: For each intervention studied in the clinical study, the general type of intervention.
textual definition: The kind of product or procedure studied in a trial.
imported from: ncit.owl
code: C98747
Semantic_Type: Functional Concept
Preferred_Name: Intervention Type
UMLS_CUI: C3274412
Contributing_Source: CDISC
ALT_DEFINITION: The kind of product or procedure studied in a trial.
has exact synonym: INTTYPE
has exact synonym: Intervention Type
has_narrow_synonym: intervention
in subset: NCIT C61410
in subset: NCIT C66738
in subset: NCIT C66830
in subset: NCIT C67152

Axiom
annotated source: Intervention Type
annotated property: textual definition
annotated target: For each intervention studied in the clinical study, the general type of intervention.
definition source: https://prsinfo.clinicaltrials.gov/definitions.html

Axiom
annotated source: Intervention Type
annotated property: has_narrow_synonym
annotated target: intervention

Primary Outcome Measure
type: Class
subclass of: data item
textual definition: The primary measurement(s) or observation(s) used to measure the effect of experimental variables in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment. These are the outcome measures used to assess the primary objective(s).
imported from: ncit.owl
code: C98772
Semantic_Type: Intellectual Product
Preferred_Name: Primary Outcome Measure
UMLS_CUI: C3274433
Contributing_Source: CDISC
ALT_DEFINITION: The primary measurement(s) or observation(s) used to measure the effect of experimental variables in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment. These are the outcome measures used to assess the primary objective(s).
has exact synonym: OUTMSPRI
has exact synonym: PRIMARY OUTCOME MEASURE
has exact synonym: Primary Outcome Measure
in subset: NCIT C117745
in subset: NCIT C61410
in subset: NCIT C66738
in subset: NCIT C66830
in subset: NCIT C67152
in subset: NCIT C81222

Secondary Outcome Measure
type: Class
subclass of: data item
textual definition: Other key measures that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study. These are the outcome measures used to assess the secondary objective(s).
imported from: ncit.owl
code: C98781
Semantic_Type: Intellectual Product
Preferred_Name: Secondary Outcome Measure
UMLS_CUI: C3274440
Contributing_Source: CDISC
ALT_DEFINITION: Secondary measures that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study. These are the outcome measures used to assess the secondary objective(s).
has exact synonym: OUTMSSEC
has exact synonym: SECONDARY OUTCOME MEASURE
has exact synonym: Secondary Outcome Measure
in subset: NCIT C117745
in subset: NCIT C61410
in subset: NCIT C66738
in subset: NCIT C66830
in subset: NCIT C67152
in subset: NCIT C81222

adverse event
type: Class
subclass of: pathological bodily process
textual definition: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant’s participation in the research, whether or not considered related to the participant’s participation in the research
textual definition: a pathological bodily process that occurs after a medical intervention. An adverse event is likely caused by the medical intervention; however, such a causal association is not required to be an adverse event.
editor note: Melanie Courtot and YH: More work is needed on how to restrict the scope of a term to be an 'adverse event', notably regarding temporal association. When is an appropirate time interval between a medical intervention and an adverse event observed? One week, one month, one year, or a lifetime? For some well-studied medical interventions (e.g., administration of many vaccines or drugs), we probably have a general idea. For many new interventions, we don't know much. In OAE, this issue is associated with defining the 'adverse event incubation time'.
editor note: YH: An adverse event is a process that has specified output of some adverse medical outcome (e.g., symptom, sign or accident) after a medical intervention (or process) (e.g., administration of drug or vaccine). The medical intervention can be an administration of a drug, a vaccine (i.e., vaccination), or a special nutritional product (for example, dietary supplement, infant formula, medical food), surgery, or usage of a medical device.
editor note: YH: An adverse event is possibly induced by the medical intervention. It can be caused by the medical intervention, or may not be caused by the medical intervention. One ultimate goal (or the goal in clinics) of study adverse events is to assess if the adverse event outcome is due to the medical intervention.
editor note: YH: In development of OAE, we initially use vaccine adverse event as our use case. A vaccine adverse event is associated with a vaccination (i.e. a medical intervention), regardless of whether it is considered vaccine-related, and includes any side effect, injury, toxicity, or sensitivity reaction or significant failure of immunization (i.e., a pharmacologic action). Ref: Baylor NW and Midthum K. Regulation and testing of vaccines. In: Vaccines (Editors: Plotkin S, Orenstein W, and Offit P). 2008. p1623.
editor note: YH: The current term 'adverse event' is different from the term definition shown in our paper: He Y, Xiang Z, Sarntivijai S, Toldo L, Ceusters W. OAE: a realism-based biomedical ontology for the representation of adverse events. Adverse Event Representation Workshop, International Conference on Biomedical Ontologies (ICBO), University at Buffalo, NY, July 26-30, 2011. Full lenghth conference proceeding paper. We made the name changing in order to make OAE cover the broader sense of the 'adverse event' which does not assume definite causal effect between an adverse event and a medical intervention. In current definition, the adverse event emphasizes the time association and assumes a likelihood of such a causal association. This term 'adverse event' is stil under the OGMS:pathological bodily process. The 'adverse event' defined in the above paper has now been changed to a new term: 'causal adverse event'. See more information in the new publication: Yongqun He Y, Sirarat Sarntivijai, Yu Lin, Zuoshuang Xiang, Abra Guo, Shelley Zhang, Desikan Jagannathan, Luca Toldo, Cui Tao and Barry Smith. OAE: The Ontology of Adverse Events. Journal of Biomedical Semantics. 2014, 5:29 doi:10.1186/2041-1480-5-29. PMID: 25093068.PMCID: PMC4120740.
editor note: YH: The main scope of OAE includes: (1) represent terms and relations in the area of adverse events, (2) assess possible associations between an adverse event and a medical intervention, particularly, identify any causal effect of a medical intervention to an adverse event; and (2) understand the mechanism (including molecular mechanisms) of causal adverse events.
editor note: YH: There has been discussion regarding whether the term 'side effect' is an alternative term for 'adverse event'. In AERO, the term 'AERO:adverse event' represents a subset of those adverse events for which causality has been established. In OAE, an adverse event for which causality has been established is called 'causal adverse event'.
definition editor: Yongqun He
alternative term: AE
alternative term: adverse reaction
definition source: WEB: http://en.wikipedia.org/wiki/Adverse_event
definition source: WEB: http://www.fda.gov/Safety/MedWatch/HowToReport/ucm053087.htm
definition source: WEB: http://www.ncbi.nlm.nih.gov/pubmed/25093068
imported from: oae.owl
comment: The OAE official website is: http://www.oae-ontology.org/.

Axiom
annotated source: adverse event
annotated property: textual definition
annotated target: Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant’s participation in the research, whether or not considered related to the participant’s participation in the research
definition source: https://prsinfo.clinicaltrials.gov/results_definitions.html

medical intervention
type: Class
subclass of: planned process
textual definition: A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
textual definition: medical intervention is a planned process that has the goal of diagnosing, preventing or relieving illness or injury.
editor note: The act of intervening, interfering or interceding with the intent of modifying the outcome. In medicine, an intervention is usually undertaken to help treat or cure a condition. For example, "Acupuncture as a therapeutic intervention is widely practiced in the United States," Reference: http://www.medterms.com/script/main/art.asp?articlekey=34214 . Some interventions can be used for diagnosis.
definition editor: YH
definition source: WEB: http://wiki.answers.com/Q/What_is_medical_intervention
imported from: oae.owl
imported from: The Ontology of Medically Related Social Entities
imported from: opmi.owl
has exact synonym: Intervention(s)

Axiom
annotated source: medical intervention
annotated property: textual definition
annotated target: A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
definition source: https://www.clinicaltrials.gov/ct2/about-studies/glossary

Axiom
annotated source: medical intervention
annotated property: has exact synonym
annotated target: Intervention(s)

drug administration
type: Class
subclass of: medical intervention
textual definition: a medical intervention where a patient is administered with a drug
definition editor: YH
imported from: oae.owl

therapeutic intervention
type: Class
subclass of: medical intervention
textual definition: a medical intervention that is used for therapeutic purpose
definition editor: YH
imported from: oae.owl

medical procedure
type: Class
subclass of: medical intervention
textual definition: a medical intervention that refers to any series of pre-defined steps that should be followed to achieve a desired result.
definition editor: YH, SS
definition source: WEB: http://www.wisegeekhealth.com/what-is-the-difference-between-a-surgery-and-a-procedure.htm
imported from: oae.owl

planned process
type: Class
editor preferred label: planned process
example of usage: Injecting mice with a vaccine in order to test its efficacy
has curation status: ready for release
textual definition: A processual entity that realizes a plan which is the concretization of a plan specification.
editor note: 'Plan' includes a future direction sense. That can be problematic if plans are changed during their execution. There are however implicit contingencies for protocols that an agent has in his mind that can be considered part of the plan, even if the agent didn't have them in mind before. Therefore, a planned process can diverge from what the agent would have said the plan was before executing it, by adjusting to problems encountered during execution (e.g. choosing another reagent with equivalent properties, if the originally planned one has run out.)
editor note: We are only considering successfully completed planned processes. A plan may be modified, and details added during execution. For a given planned process, the associated realized plan specification is the one encompassing all changes made during execution. This means that all processes in which an agent acts towards achieving some objectives is a planned process.
definition editor: Bjoern Peters
definition source: branch derived
curator note: 6/11/9: Edited at workshop. Used to include: is initiated by an agent
curator note: This class merges the previously separated objective driven process and planned process, as they the separation proved hard to maintain. (1/22/09, branch call)
imported from: ero.owl
imported from: oae.owl
imported from: obi.owl

responsible party role
type: Class
subclass of: investigation agent role
editor preferred label: responsible party role
example of usage: he THERAPIST has the ability to print a separate statement for the patient and each responsible party. http://www.beaverlog.com/therapist/ez_support/billing/responsible_party_statements.htm
has curation status: IAO_0000120
textual definition: a study personnel role played by a party who is accountable for the execution of a study component and can make decisions about the conduct of the study
definition editor: Person: Jennifer Fostel
alternative term: responsible party
definition source: OBI
imported from: obi.owl

intervention design
type: Class
subclass of: study design
editor preferred label: intervention design
example of usage: PMID: 18208636.Br J Nutr. 2008 Jan 22;:1-11.Effect of vitamin D supplementation on bone and vitamin D status among Pakistani immigrants in Denmark: a randomised double-blinded placebo-controlled intervention study.
has curation status: pending final vetting
textual definition: A description of the manner in which the clinical trial will be conducted.
textual definition: An intervention design is a study design in which a controlled process applied to the subjects (the intervention) serves as the independent variable manipulated by the experimentalist. The treatment (perturbation or intervention) defined can be defined as a combination of values taken by independent variable manipulated by the experimentalists are applied to the recruited subjects assigned (possibly by applying specific methods) to treatment groups. The specificity of intervention design is the fact that independent variables are being manipulated and a response of the biological system is evaluated via response variables as monitored by possibly a series of assays.
definition editor: Philppe Rocca-Serra
definition source: OBI branch derived
imported from: obi.owl
has exact synonym: Interventional Study Design
has exact synonym: intervention model

Axiom
annotated source: intervention design
annotated property: textual definition
annotated target: A description of the manner in which the clinical trial will be conducted.
definition source: https://prsinfo.clinicaltrials.gov/definitions.html

investigation agent role
type: Class
editor preferred label: investigation agent role
example of usage: The person perform microarray experiments and submit microarray results (including raw data, processed data) with experiment description to ArrayExpress.
has curation status: ready for release
textual definition: A role borne by an entity and that is realized in a process that is part of an investigation in which an objective is achieved. These processes include, among others: planning, overseeing, funding, reviewing.
editor note: Implementing a study means carrying out or performing the study and providing reagents or other materials used in the study and other tasks without which the study would not happen.
editor note: Philly2013: Historically, this role would have been borne only by humans or organizations. However, we now also want to enable representing investigations run by robot scientists such as ADAM (King et al, Science, 2009)
definition editor: GROUP: Role Branch
alternative term: investigator
definition source: OBI
curator note: Feb 10, 2009. changes after discussion at OBI Consortium Workshop Feb 2-6, 2009. accepted as core term.
imported from: obi.owl
imported from: opmi.owl
ISA alternative term: study person role
comment: Philly2013: Historically, this role would have been borne only by humans or organizations. However, we now also want to enable investigations run by robot scientists such as ADAM (King et al, Science, 2009)

sponsor role
type: Class
subclass of: responsible party role
editor preferred label: sponsor role
has curation status: IAO_0000120
textual definition: a responsible party role involved with any of the following activities: initiating, managing and funding a study
definition editor: Person: Jennifer Fostel
alternative term: sponsor
curator note: CDISC definition: sponsor. 1. An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial. 2. A corporation or agency whose employees conduct the investigation is considered a sponsor; employees are considered investigators
imported from: obi.owl
imported from: opmi.owl

organization
type: Class
editor preferred label: organization
example of usage: PMID: 16353909.AAPS J. 2005 Sep 22;7(2):E274-80. Review. The joint food and agriculture organization of the United Nations/World Health Organization Expert Committee on Food Additives and its role in the evaluation of the safety of veterinary drug residues in foods.
has curation status: ready for release
textual definition: An entity that can bear roles, has members, and has a set of organization rules. Members of organizations are either organizations themselves or individual people. Members can bear specific organization member roles that are determined in the organization rules. The organization rules also determine how decisions are made on behalf of the organization by the organization members.
editor note: BP: The definition summarizes long email discussions on the OBI developer, roles, biomaterial and denrie branches. It leaves open if an organization is a material entity or a dependent continuant, as no consensus was reached on that. The current placement as material is therefore temporary, in order to move forward with development. Here is the entire email summary, on which the definition is based: 1) there are organization_member_roles (president, treasurer, branch editor), with individual persons as bearers 2) there are organization_roles (employer, owner, vendor, patent holder) 3) an organization has a charter / rules / bylaws, which specify what roles there are, how they should be realized, and how to modify the charter/rules/bylaws themselves. It is debatable what the organization itself is (some kind of dependent continuant or an aggregate of people). This also determines who/what the bearer of organization_roles' are. My personal favorite is still to define organization as a kind of 'legal entity', but thinking it through leads to all kinds of questions that are clearly outside the scope of OBI. Interestingly enough, it does not seem to matter much where we place organization itself, as long as we can subclass it (University, Corporation, Government Agency, Hospital), instantiate it (Affymetrix, NCBI, NIH, ISO, W3C, University of Oklahoma), and have it play roles. This leads to my proposal: We define organization through the statements 1 - 3 above, but without an 'is a' statement for now. We can leave it in its current place in the is_a hierarchy (material entity) or move it up to 'continuant'. We leave further clarifications to BFO, and close this issue for now.
definition editor: PERSON: Alan Ruttenberg
definition editor: PERSON: Bjoern Peters
definition editor: PERSON: Philippe Rocca-Serra
definition editor: PERSON: Susanna Sansone
definition source: GROUP: OBI
imported from: obi.owl

protocol
type: Class
subclass of: plan specification
editor preferred label: protocol
example of usage: PCR protocol, has objective specification, amplify DNA fragment of interest, and has action specification describes the amounts of experimental reagents used (e..g. buffers, dNTPS, enzyme), and the temperature and cycle time settings for running the PCR.
has curation status: ready for release
textual definition: A plan specification which has sufficient level of detail and quantitative information to communicate it between investigation agents, so that different investigation agents will reliably be able to independently reproduce the process.
definition editor: PlanAndPlannedProcess Branch
definition source: OBI branch derived + wikipedia (http://en.wikipedia.org/wiki/Protocol_%28natural_sciences%29)
imported from: obi.owl
ISA alternative term: study protocol

informed consent process
type: Class
subclass of: planned process
subclass of: Restriction
  on property: has_specified_input
  some values from: Homo sapiens
subclass of: Restriction
  on property: has participant
  some values from: Restriction
    on property: has role
    some values from: investigation agent role
editor preferred label: informed consent process
has curation status: ready for release
textual definition: A planned process in which a person or their legal representative is informed about key facts about potential risks and benefits of a process and makes a documented decision as to whether the person in question will participate.
editor note: 09/28/2009 Alan Ruttenberg: This is made a subclass of the higher level processual entity in BFO because I don't want to take a stand on whether it is a process aggregate. Analogous to the situation with Material entity.
definition editor: Person:Alan Ruttenberg
definition source: http://clinicaltrials.gov/ct2/info/glossary#informed
curator note: 2009/09/28 Alan Ruttenberg. Fucoidan-use-case
imported from: obi.owl

device
type: Class
editor preferred label: device
example of usage: A voltmeter is a measurement device which is intended to perform some measure function.
example of usage: An autoclave is a device that sterlizes instruments or contaminated waste by applying high temperature and pressure.
has curation status: ready for release
textual definition: A material entity that is designed to perform a function in a scientific investigation, but is not a reagent.
editor note: 2012-12-17 JAO: In common lab usage, there is a distinction made between devices and reagents that is difficult to model. Therefore we have chosen to specifically exclude reagents from the definition of "device", and are enumerating the types of roles that a reagent can perform. 2013-6-5 MHB: The following clarifications are outcomes of the May 2013 Philly Workshop. Reagents are distinguished from devices that also participate in scientific techniques by the fact that reagents are chemical or biological in nature and necessarily participate in some chemical interaction or reaction during the realization of their experimental role. By contrast, devices do not participate in such chemical reactions/interactions. Note that there are cases where devices use reagent components during their operation, where the reagent-device distinction is less clear. For example: (1) An HPLC machine is considered a device, but has a column that holds a stationary phase resin as an operational component. This resin qualifies as a device if it participates purely in size exclusion, but bears a reagent role that is realized in the running of a column if it interacts electrostatically or chemically with the evaluant. The container the resin is in (“the column”) considered alone is a device. So the entire column as well as the entire HPLC machine are devices that have a reagent as an operating part. (2) A pH meter is a device, but its electrode component bears a reagent role in virtue of its interacting directly with the evaluant in execution of an assay. (3) A gel running box is a device that has a metallic lead as a component that participates in a chemical reaction with the running buffer when a charge is passed through it. This metallic lead is considered to have a reagent role as a component of this device realized in the running of a gel. In the examples above, a reagent is an operational component of a device, but the device itself does not realize a reagent role (as bearing a reagent…
definition editor: PERSON: Helen Parkinson
alternative term: instrument
definition source: OBI development call 2012-12-17.
imported from: obi.owl

country name
type: Class
subclass of: textual entity
editor preferred label: country name
has curation status: IAO_0000120
textual definition: A textual entity that denotes a geographic location that is a site or part of a site that is identified as a country in the political geography.
definition editor: Person: Chris Stoeckert, Jie Zheng
definition source: NIAID GSCID-BRC metadata working group
definition source: Website: http://en.wikipedia.org/wiki/Country
imported from: obi.owl
NIAID GSCID-BRC alternative term: Specimen Collection Location - Country
Source: NIAID GSCID-BRC

selection criterion
type: Class
subclass of: directive information entity
editor preferred label: selection criterion
example of usage: rats should be aged between 6 and 8 weeks and weight between 180-250grams
has curation status: ready for release
textual definition: A directive information entity which defines and states a principle of standard by which selection process may take place.
definition editor: Person: Philippe Rocca-Serra
alternative term: selection rule
definition source: OBI discussion summarized under the following tracker item : http://sourceforge.net/p/obi/obi-terms/678/
imported from: obi.owl

selection
type: Class
subclass of: planned process
editor preferred label: selection
example of usage: PMID: 24023800. In this study, a set of eleven genes (VATP16, 60 S, UQCC, SMD3, EF1α, UBQ, SAND, GAPDH, ACT, PsaB, PTB2) was evaluated to identify reference genes during the first hours of interaction (6, 12, 18 and 24 hpi) between two V. vinifera genotypes and P. viticola. Two analyses were used for the selection of reference genes: direct comparison of susceptible, Trincadeira, and resistant, Regent, V. vinifera cultivars at 0 h, 6, 12, 18 and 24 hours post inoculation with P. viticola (genotype effect); and comparison of each genotype with mock inoculated samples during inoculation time-course (biotic stress effect). Three statistical methods were used, GeNorm, NormFinder, and BestKeeper, allowing to identify UBQ, EF1α and GAPDH as the most stable genes for the genotype effect.
has curation status: ready for release
textual definition: A planned process which results in the creation of group of entity from a larger group by the application of predefined criteria.
editor note: this term refers to a planned process and therefore is distinct from the notion of 'natural selection', a process covering the operation of natural causes by which those individuals of a species that are best adapted to the environment tend to be preserved and to transmit their characters, while those less adapted die out, so that in the course of generations the degree of adaptation to the environment tends progressively to increase. (as defined by Oxford English Dictionary)
definition editor: Person: Philippe Rocca-Serra
alternative term: selection process
definition source: OBI
imported from: obi.owl

value specification
type: Class
subclass of: information content entity
editor preferred label: value specification
example of usage: The value of 'positive' in a classification scheme of "positive or negative"; the value of '20g' on the quantitative scale of mass.
has curation status: ready for release
textual definition: An information content entity that specifies a value within a classification scheme or on a quantitative scale.
editor note: This term is currently a descendant of 'information content entity', which requires that it 'is about' something. A value specification of '20g' for a measurement data item of the mass of a particular mouse 'is about' the mass of that mouse. However there are cases where a value specification is not clearly about any particular. In the future we may change 'value specification' to remove the 'is about' requirement.
definition editor: PERSON:Bjoern Peters
imported from: obi.owl

age group inclusion criterion
type: Class
subclass of: inclusion criterion
editor preferred label: age group inclusion criterion
example of usage: "18-33 years old"
has curation status: metadata incomplete
textual definition: A type of eligibility criteria that indicates the age a person must be to participate in a clinical study. This may be indicated by a specific age or the following age groups. The age groups are: Child (birth-17), Adult (18-64), Older Adult (65+).
textual definition: An inclusion criterion that defines and states an age bracket which, if met, makes an entity suitable for a given task or participation in a given process.
definition editor: Mathias Brochhausen
term tracker item: #839
imported from: obi.owl
has exact synonym: ages eligible for study

Axiom
annotated source: age group inclusion criterion
annotated property: textual definition
annotated target: A type of eligibility criteria that indicates the age a person must be to participate in a clinical study. This may be indicated by a specific age or the following age groups. The age groups are: Child (birth-17), Adult (18-64), Older Adult (65+).
definition source: https://clinicaltrials.gov/ct2/about-studies/glossary

minimum age value specification
type: Class
subclass of: value specification
editor preferred label: minimum age value specification
has curation status: metadata incomplete
textual definition: A value specifcation that specifies the youngest age when specifying an age range.
textual definition: The numerical value, if any, for the minimum age a potential participant must meet to be eligible for the clinical study.
definition editor: Mathias Brochhausen
imported from: obi.owl
has exact synonym: minimum age

Axiom
annotated source: minimum age value specification
annotated property: textual definition
annotated target: The numerical value, if any, for the minimum age a potential participant must meet to be eligible for the clinical study.
definition source: https://prsinfo.clinicaltrials.gov/definitions.html

maximum age value specification
type: Class
subclass of: value specification
editor preferred label: maximum age value specification
has curation status: metadata incomplete
textual definition: A value specifcation that specifies the oldest age when specifying an age range.
textual definition: The numerical value, if any, for the maximum age a potential participant can be to be eligible for the clinical study.
definition editor: Mathias Brochhausen
imported from: obi.owl
has exact synonym: maximum age

Axiom
annotated source: maximum age value specification
annotated property: textual definition
annotated target: The numerical value, if any, for the maximum age a potential participant can be to be eligible for the clinical study.
definition source: https://prsinfo.clinicaltrials.gov/definitions.html

sex inclusion criterion
type: Class
subclass of: inclusion criterion
editor preferred label: sex inclusion criterion
example of usage: "included males and females", "included male patients"
has curation status: metadata incomplete
textual definition: A type of eligibility criteria that indicates the sex of people who may participate in a clinical study (all, female, male). Sex is a person's classification as female or male based on biological distinctions. Sex is distinct from gender-based eligibility.
textual definition: An inclusion criterion that defines and states one or more sexes which, if met, makes an entity suitable for a given task or participation in a given process.
definition editor: Mathias Brochhausen
imported from: obi.owl
has exact synonym: sexes eligible for study

Axiom
annotated source: sex inclusion criterion
annotated property: textual definition
annotated target: A type of eligibility criteria that indicates the sex of people who may participate in a clinical study (all, female, male). Sex is a person's classification as female or male based on biological distinctions. Sex is distinct from gender-based eligibility.
definition source: https://clinicaltrials.gov/ct2/about-studies/glossary

observation design
type: Class
subclass of: study design
editor preferred label: observation design
example of usage: PMID: 12387964.Lancet. 2002 Oct 12;360(9340):1144-9.Deficiency of antibacterial peptides in patients with morbus Kostmann: an observation study.
has curation status: pending final vetting
textual definition: observation design is a study design in which subjects are monitored in the absence of any active intervention by experimentalists.
definition editor: Philippe Rocca-Serra
definition source: OBI branch derived
imported from: obi.owl

study design
type: Class
subclass of: plan specification
editor preferred label: study design
example of usage: a matched pairs study design describes criteria by which subjects are identified as pairs which then undergo the same protocols, and the data generated is analyzed by comparing the differences between the paired subjects, which constitute the results of the executed study design.
has curation status: ready for release
textual definition: A plan specification comprised of protocols (which may specify how and what kinds of data will be gathered) that are executed as part of an investigation and is realized during a study design execution.
editor note: Editor note: there is at least an implicit restriction on the kind of data transformations that can be done based on the measured data available.
definition editor: PERSON: Chris Stoeckert
alternative term: experimental design
curator note: rediscussed at length (MC/JF/BP). 12/9/08). The definition was clarified to differentiate it from protocol.
imported from: obi.owl

repeated measure design
type: Class
subclass of: intervention design
editor preferred label: repeated measure design
example of usage: PMID: 10959922.J Biopharm Stat. 2000 Aug;10(3):433-45.Equivalence in test assay method comparisons for the repeated-measure, matched-pair design in medical device studies: statistical considerations.
has curation status: IAO_0000120
textual definition: a study design which use the same individuals and exposure them to a set of conditions. The effect of order and practice can be confounding factor in such designs
definition editor: PlanAndPlannedProcess Branch
definition source: http://www.holah.karoo.net/experimentaldesigns.htm
imported from: obi.owl

cross over design
type: Class
subclass of: repeated measure design
editor preferred label: cross over design
example of usage: PMID: 17601993-Objective: HIV-infected patients with lipodystrophy (HIV-lipodystrophy) are insulin resistant and have elevated plasma free fatty acid (FFA) concentrations. We aimed to explore the mechanisms underlying FFA-induced insulin resistance in patients with HIV-lipodystrophy. Research Design and Methods: Using a randomized placebo-controlled cross-over design, we studied the effects of an overnight acipimox-induced suppression of FFA on glucose and FFA metabolism by using stable isotope labelled tracer techniques during basal conditions and a two-stage euglycemic, hyperinsulinemic clamp (20 mU insulin/m(2)/min; 50 mU insulin/m(2)/min) in nine patients with nondiabetic HIV-lipodystrophy. All patients received antiretroviral therapy. Biopsies from the vastus lateralis muscle were obtained during each stage of the clamp. Results: Acipimox treatment reduced basal FFA rate of appearance by 68.9% (52.6%-79.5%) and decreased plasma FFA concentration by 51.6 % (42.0%-58.9%), (both, P < 0.0001). Endogenous glucose production was not influenced by acipimox. During the clamp the increase in glucose-uptake was significantly greater after acipimox treatment compared to placebo (acipimox: 26.85 (18.09-39.86) vs placebo: 20.30 (13.67-30.13) mumol/kg/min; P < 0.01). Insulin increased phosphorylation of Akt (Thr(308)) and GSK-3beta (Ser(9)), decreased phosphorylation of glycogen synthase (GS) site 3a+b and increased GS-activity (I-form) in skeletal muscle (P < 0.01). Acipimox decreased phosphorylation of GS (site 3a+b) (P < 0.02) and increased GS-activity (P < 0.01) in muscle. Conclusion: The present study provides direct evidence that suppression of lipolysis in patients with HIV-lipodystrophy improves insulin-stimulated peripheral glucose-uptake. The increased glucose-uptake may in part be explained by increased dephosphorylation of GS (site 3a+b) resulting in increased GS activity.
has curation status: IAO_0000120
textual definition: a repeated measure design which ensures that experimental units receive, in sequence, the treatment (or the control), and then, after a specified time interval (aka *wash-out periods*), switch to the control (or treatment). In this design, subjects (patients in human context) serve as their own controls, and randomization may be used to determine the ordering which a subject receives the treatment and control
definition editor: Philippe Rocca-Serra
definition source: (source: http://www.sbu.se/Filer/Content0/publikationer/1/literaturesearching_1993/glossary.html)
imported from: obi.owl

n-to-1 design
type: Class
subclass of: cross over design
editor preferred label: n-to-1 design
has curation status: pending final vetting
textual definition: N-of-1 design is a cross-over design in which the same patient is repeatedly randomised to receive either the experimental treatment or its control (Senn, 1993).
definition editor: Philippe Rocca-Serra
definition source: Adapted from http://www.childrens-mercy.org/stats/definitions/crossover.htm and source:http://symptomresearch.nih.gov/chapter_6/sec1/csss1pg1.htm)
imported from: obi.owl

parallel group design
type: Class
subclass of: study design
editor preferred label: parallel group design
example of usage: PMID: 17408389-Purpose: Proliferative vitreoretinopathy (PVR) is the most important reason for blindness following retinal detachment. Presently, vitreous tamponades such as gas or silicone oil cannot contact the lower part of the retina. A heavier-than-water tamponade displaces the inflammatory and PVR-stimulating environment from the inferior area of the retina. The Heavy Silicone Oil versus Standard Silicone Oil Study (HSO Study) is designed to answer the question of whether a heavier-than-water tamponade improves the prognosis of eyes with PVR of the lower retina. Methods: The HSO Study is a multicentre, randomized, prospective controlled clinical trial comparing two endotamponades within a two-arm parallel group design. Patients with inferiorly and posteriorly located PVR are randomized to either heavy silicone oil or standard silicone oil as a tamponading agent. Three hundred and fifty consecutive patients are recruited per group. After intraoperative re-attachment, patients are randomized to either standard silicone oil (1000 cSt or 5000 cSt) or Densiron((R)) as a tamponading agent. The main endpoint criteria are complete retinal attachment at 12 months and change of visual acuity (VA) 12 months postoperatively compared with the preoperative VA. Secondary endpoints include complete retinal attachment before endotamponade removal, quality of life analysis and the number of retina affecting re-operation within 1 year of follow-up. Results: The design and early recruitment phase of the study are described. Conclusions: The results of this study will uncover whether or not heavy silicone oil improves the prognosis of eyes with PVR.
has curation status: pending final vetting
textual definition: A parallel group design or independent measure design is a study design which uses unique experimental unit each experimental group, in other word no two individuals are shared between experimental groups, hence also known as parallel group design. Subjects of a treatment group receive a unique combination of independent variable values making up a treatment
textual definition: Participants are assigned to one of two or more groups in parallel for the duration of the study
definition editor: Philippe Rocca-Serra
alternative term: independent measure design
definition source: http://www.holah.karoo.net/experimentaldesigns.htm
imported from: obi.owl

Axiom
annotated source: parallel group design
annotated property: textual definition
annotated target: Participants are assigned to one of two or more groups in parallel for the duration of the study
definition source: https://prsinfo.clinicaltrials.gov/definitions.html

factorial design
type: Class
subclass of: study design
editor preferred label: factorial design
example of usage: PMID: 17582121-Our objective was to examine the effects of dietary cation-anion difference (DCAD) with different concentrations of dietary crude protein (CP) on performance and acid-base status in early lactation cows. Six lactating Holstein cows averaging 44 d in milk were used in a 6 x 6 Latin square design with a 2 x 3 factorial arrangement of treatments: DCAD of -3, 22, or 47 milliequivalents (Na + K - Cl - S)/100 g of dry matter (DM), and 16 or 19% CP on a DM basis. Linear increases with DCAD occurred in DM intake, milk fat percentage, 4% fat-corrected milk production, milk true protein, milk lactose, and milk solids-not-fat. Milk production itself was unaffected by DCAD. Jugular venous blood pH, base excess and HCO3(-) concentration, and urine pH increased, but jugular venous blood Cl- concentration, urine titratable acidity, and net acid excretion decreased linearly with increasing DCAD. An elevated ratio of coccygeal venous plasma essential AA to nonessential AA with increasing DCAD indicated that N metabolism in the rumen was affected, probably resulting in more microbial protein flowing to the small intestine. Cows fed 16% CP had lower urea N in milk than cows fed 19% CP; the same was true for urea N in coccygeal venous plasma and urine. Dry matter intake, milk production, milk composition, and acid-base status did not differ between the 16 and 19% CP treatments. It was concluded that DCAD affected DM intake and performance of dairy cows in early lactation. Feeding 16% dietary CP to cows in early lactation, compared with 19% CP, maintained lactation performance while reducing urea N excretion in milk and urine.
has curation status: pending final vetting
textual definition: Two or more interventions, each alone and in combination, are evaluated in parallel against a control group
textual definition: factorial design is_a study design which is used to evaluate two or more factors simultaneously. The treatments are combinations of levels of the factors. The advantages of factorial designs over one-factor-at-a-time experiments is that they are more efficient and they allow interactions to be detected. In statistics, a factorial design experiment is an experiment whose design consists of two or more factors, each with discrete possible values or levels, and whose experimental units take on all possible combinations of these levels across all such factors. Such an experiment allows studying the effect of each factor on the response variable, as well as the effects of interactions between factors on the response variable.
definition editor: Philippe Rocca-Serra
definition source: http://www.stats.gla.ac.uk/steps/glossary/anova.html#facdes And from wikipedia (01/03/2007): http://en.wikipedia.org/wiki/Factorial_experiment)
imported from: obi.owl

Axiom
annotated source: factorial design
annotated property: textual definition
annotated target: Two or more interventions, each alone and in combination, are evaluated in parallel against a control group
definition source: https://prsinfo.clinicaltrials.gov/definitions.html

eligibility criterion
type: Class
subclass of: selection criterion
editor preferred label: eligibility criterion
example of usage: PMID: 17579629 -Eligibility criteria included: untreated ED-SCLC; age >/=70 and performance status 0-2, or age <70 and PS 3.
has curation status: ready for release
textual definition: A limited list of criteria for selection of participants in the clinical study, provided in terms of inclusion and exclusion criteria and suitable for assisting potential participants in identifying clinical studies of interest.
textual definition: The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex
textual definition: an eligibility criterion (rule) is_a selection criterion which defines and states the requirements (positive or negative) for an entity to be considered as suitable for a given task or participation in a process.
definition editor: Person: Philippe Rocca-Serra
alternative term: eligibility rule
definition source: Adapted from Clinical Research Glossary Version 4.0 CDICS glossary group
imported from: obi.owl

Axiom
annotated source: eligibility criterion
annotated property: textual definition
annotated target: A limited list of criteria for selection of participants in the clinical study, provided in terms of inclusion and exclusion criteria and suitable for assisting potential participants in identifying clinical studies of interest.
definition source: https://prsinfo.clinicaltrials.gov/definitions.html

Axiom
annotated source: eligibility criterion
annotated property: textual definition
annotated target: The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex
definition source: https://clinicaltrials.gov/ct2/about-studies/glossary

inclusion criterion
type: Class
subclass of: eligibility criterion
editor preferred label: inclusion criterion
example of usage: PMID: 23979341-The major inclusion criterion was patients in whom severe cerebral embolism was diagnosed at age 75 or younger (more than 9 in the NIHSS score on day 7 after the onset of stroke) .
has curation status: pending final vetting
textual definition: A type of eligibility criteria. These are the reasons that a person is allowed to participate in a clinical study.
textual definition: an inclusion criterion (rule) is_a *eligibility criterion* which defines and states a condition which, if met, makes an entity suitable for a given task or participation in a given process. For instance, in a study protocol, inclusion criteria indicate the conditions that prospective subjects MUST meet to be eligible for participation in a study.
definition editor: Person: Philippe Rocca-Serra
alternative term: inclusion condition
alternative term: inclusion rule
definition source: Adapted from Clinical Research Glossary Version 4.0 CDICS glossary group
imported from: obi.owl
has exact synonym: key inclusion criteria

Axiom
annotated source: inclusion criterion
annotated property: textual definition
annotated target: A type of eligibility criteria. These are the reasons that a person is allowed to participate in a clinical study.
definition source: https://clinicaltrials.gov/ct2/about-studies/glossary

Axiom
annotated source: inclusion criterion
annotated property: has exact synonym
annotated target: key inclusion criteria
definition source: http://www.icmje.org/recommendations/ https://www.who.int/ictrp/network/trds/en/

exclusion criterion
type: Class
subclass of: eligibility criterion
editor preferred label: exclusion rule
example of usage: PMID: 17600285-Exclusion criteria included the use of any topical ophthalmic or topical oral medication and/or history of ocular or oral surgery within the past six months.
has curation status: pending final vetting
textual definition: A type of eligibility criteria. These are reasons that a person is not allowed to participate in a clinical study.
textual definition: an exclusion criterion (rule) is_a *eligibility criterion* which defines and states a condition which, if met, makes an entity unsuitable for a given task or participation in a given process. For instance, in a study protocol, exclusion criteria indicate the conditions that prospective subjects SHOULD NOT meet to be eligible for participation in a study
definition editor: Person: Philippe Rocca-Serra
definition source: Adapted from Clinical Research Glossary Version 4.0 CDICS glossary group
imported from: obi.owl
has exact synonym: key exclusion criteria

Axiom
annotated source: exclusion criterion
annotated property: textual definition
annotated target: A type of eligibility criteria. These are reasons that a person is not allowed to participate in a clinical study.
definition source: https://clinicaltrials.gov/ct2/about-studies/glossary

Axiom
annotated source: exclusion criterion
annotated property: has exact synonym
annotated target: key exclusion criteria
definition source: http://www.icmje.org/recommendations/ https://www.who.int/ictrp/network/trds/en/

human subject enrollment
type: Class
subclass of: selection
editor preferred label: human subject enrollment
example of usage: enlisting familiy members of HIV patients into a study
has curation status: ready for release
textual definition: A planned process with the objective to obtain a population of human subjects to participate in an investigation by determining eligibility of subjects and obtaining informed consent.
editor note: As with group assignment, should the specified output here be an organism which bears a role
definition editor: Bjoern Peters
definition source: IEDB
curator note: criteria come from plan / clinical trial branch
imported from: obi.owl

clinical finding
type: Class
subclass of: data item
textual definition: A representation that is either the output of a clinical history taking or a physical examination or an image finding, or some combination thereof.
definition editor: Albert Goldfain
definition source: http://ontology.buffalo.edu/medo/Disease_and_Diagnosis.pdf
curator note: creation date: 2010-07-19T10:18:02Z
imported from: ogms.owl

clinical history
type: Class
subclass of: data item
textual definition: A series of statements representing health-relevant qualities of a patient and of a patient's family.
definition editor: Albert Goldfain
definition source: http://ontology.buffalo.edu/medo/Disease_and_Diagnosis.pdf
curator note: creation date: 2010-07-19T10:18:59Z
imported from: ogms.owl

preclinical finding
type: Class
subclass of: data item
textual definition: A representation of a quality of a patient that is (1) recorded by a clinician because the quality is hypothesized to be of clinical significance and (2) refers to qualities obtaining in the patient prior to their becoming detectable in a clinical history taking or physical examination.
definition editor: Albert Goldfain
definition source: http://ontology.buffalo.edu/medo/Disease_and_Diagnosis.pdf
curator note: creation date: 2009-06-23T10:22:44Z
imported from: ogms.owl

disease
type: Class
textual definition: A disposition (i) to undergo pathological processes that (ii) exists in an organism because of one or more disorders in that organism.
definition editor: Albert Goldfain
definition source: http://ontology.buffalo.edu/medo/Disease_and_Diagnosis.pdf
curator note: creation date: 2009-06-23T11:21:20Z
imported from: ogms.owl

bodily process
type: Class
definition editor: Albert Goldfain
curator note: creation date: 2009-06-23T11:53:49Z
imported from: oae.owl
imported from: ogms.owl

pathological bodily process
type: Class
subclass of: bodily process
textual definition: A bodily process that is clinically abnormal.
definition editor: Albert Goldfain
definition source: http://ontology.buffalo.edu/medo/Disease_and_Diagnosis.pdf
curator note: creation date: 2009-06-23T11:54:29Z
imported from: oae.owl
imported from: ogms.owl

diagnosis
type: Class
subclass of: data item
textual definition: 1. the determination of the nature of a case of disease. 2. the art of distinguishing one disease from another.
textual definition: The representation of a conclusion of a diagnostic process.
definition editor: Albert Goldfain
definition source: http://ontology.buffalo.edu/medo/Disease_and_Diagnosis.pdf
curator note: creation date: 2009-06-23T12:42:23Z
imported from: ogms.owl

Axiom
annotated source: diagnosis
annotated property: textual definition
annotated target: 1. the determination of the nature of a case of disease. 2. the art of distinguishing one disease from another.
definition source: https://www.clinicaltrialsregister.eu/doc/EU_Clinical_Trials_Register_Glossary.pdf

role in human social processes
type: Class
textual definition: A role inhering in an entity realized by social interactions in human society.
definition editor: Mathias Brochhausen
imported from: The Ontology of Medically Related Social Entities
comment: Previous definition: A role played by an entity in human social processes.

legal person role
type: Class
subclass of: role in human social processes
textual definition: A role borne by a human individual or by a collection of humans regarded as possessing rights and duties enforeable at law.
definition editor: Mathias Brochhausen
definition source: Malcolm N. Shaw: International Law. Cambridge University Press, Cambridge, 2008.
imported from: The Ontology of Medically Related Social Entities
comment: We are aware of the fact that Wikipedia's definition differs from ours by saying that "Legal personality (...) is the characteristic of a non-living entity regarded by law to have the status of personhood" (http://en.wikipedia.org/wiki/Legal_personality) However, Shaw explicates: "In any legal system, certain entities, whether they be individuals or companies, will be regarded as possessing rights and duties enforceable at law. Thus an individual may prosecute or be prosecuted for assault and a company can sue for breach of contract. They are able to do this because the law recognises them as 'legal persons' possessing the capacity to have and to maintain certain rights, and being subject to perform specific duties. (...) In municipal law individuals, limited companies and public corporations are recognized as each possessing a distinct legal personality, the terms of which are circumscribed by the relevant legislation" (Shaw MN: International Law. Sixth Edition. Cambridge University Press, Cambridge, 2008). We hold that Shaw's position is ontological more prolific since it not only allows to explain how groups of individuals become recognized as unities at law, but also how different individuals can hold different legal personality roles (always against the context of one legal system). The latter will proof useful when dealing with the representing comatous patients or minorsat law in ontologies.

telephone number
type: Class
subclass of: information content entity
textual definition: A telephone number is a sequence of digits assigned to a fixed-line telephone subscriber station connected to a telephone line or to a wireless electronic telephony device, such as a radio telephone or a mobile telephone, or to other devices for data transmission via the public switched telephone network (PSTN) or other public and private networks.
definition editor: Oliver He
alternative term: phone number
definition source: https://en.wikipedia.org/wiki/Telephone_number
imported from: opmi.owl

contact name
type: Class
subclass of: Contact Information
textual definition: The textual name of the contact person or organization
imported from: opmi.owl

USA National Clinical Trial identifier
type: Class
subclass of: Clinical Trial Registry Identifier
textual definition: A centrally registered identifier that is assigned for a specific clinical trial registered in the ClinicalTrials.gov. The format for the ClinicalTrials.gov registry number is “NCT” followed by an 8-digit number, e.g.: NCT00000419.
definition editor: Qingliang Leon Li, Asiyah Yu Lin, Oliver He
alternative term: NCT identifier
alternative term: NCT number
alternative term: National Clinical Trial identifier
definition source: https://clinicaltrials.gov/ct2/about-site/link-to
definition source: https://www.nlm.nih.gov/bsd/policy/clin_trials.html
imported from: opmi.owl

title of clinical trial
type: Class
subclass of: textual entity
textual definition: A textual entity that is the title of a clinical trial
definition source: https://prsinfo.clinicaltrials.gov/definitions.html
imported from: opmi.owl

official title of clinical trial
type: Class
subclass of: title of clinical trial
textual definition: A title of clinical trial that is recorded as official
definition source: https://prsinfo.clinicaltrials.gov/definitions.html
imported from: opmi.owl
has exact synonym: full title
has exact synonym: scientific title

lay title of clinical trial
type: Class
subclass of: title of clinical trial
textual definition: A title of clinical trial that is meant for lay people understanding
definition source: https://prsinfo.clinicaltrials.gov/definitions.html
imported from: opmi.owl
has exact synonym: brief title
has exact synonym: lay title
has exact synonym: public title

investigator
type: Class
subclass of: Homo sapiens
textual definition: A person who performs an investigation task and takes the role of an investigator role.
imported from: opmi.owl

clinical investigator
type: Class
subclass of: investigator
textual definition: An investigator who is involved in a clinical trial and is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs under investigation.
definition editor: Oliver He
definition source: https://en.wikipedia.org/wiki/Clinical_investigator
imported from: opmi.owl

study start date
type: Class
textual definition: The date on which a study starts
imported from: opmi.owl

clinical trial start date
type: Class
subclass of: study start date
textual definition: The (estimated) date on which the clinical study is open for recruitment of participants, or the actual date on which the first participant is enrolled.
definition source: https://prsinfo.clinicaltrials.gov/definitions.html
imported from: opmi.owl
has exact synonym: date of first enrollment
has exact synonym: study start

Axiom
annotated source: clinical trial start date
annotated property: has exact synonym
annotated target: date of first enrollment

study completion date
type: Class
textual definition: The date on which a study completes
textual definition: The date the final participant was examined or received an intervention for purposes of final collection of data for the primary and secondary outcome measures and adverse events (for example, last participant’s last visit), whether the clinical study concluded according to the pre-specified protocol or was terminated.
definition editor: Oliver He
imported from: opmi.owl
has exact synonym: Completion Date
has exact synonym: study completion

Axiom
annotated source: study completion date
annotated property: textual definition
annotated target: The date the final participant was examined or received an intervention for purposes of final collection of data for the primary and secondary outcome measures and adverse events (for example, last participant’s last visit), whether the clinical study concluded according to the pre-specified protocol or was terminated.
definition source: https://prsinfo.clinicaltrials.gov/definitions.html

Axiom
annotated source: study completion date
annotated property: has exact synonym
annotated target: Completion Date

clinical trial study completion date
type: Class
subclass of: study completion date
textual definition: The date the final participant was examined or received an intervention for purposes of final collection of data for the primary and secondary outcome measures and adverse events (for example, last participant’s last visit), whether the clinical study concluded according to the pre-specified protocol or was terminated.
definition source: https://prsinfo.clinicaltrials.gov/definitions.html
imported from: opmi.owl
has exact synonym: completion date

Axiom
annotated source: clinical trial study completion date
annotated property: has exact synonym
annotated target: completion date

clinical trial primary completion date
type: Class
subclass of: study completion date
textual definition: The date that the final participant was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical study concluded according to the pre-specified protocol or was terminated. In the case of clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all of the primary outcomes.
definition source: https://prsinfo.clinicaltrials.gov/definitions.html
imported from: opmi.owl
has exact synonym: primary completion

clinical trial primary purpose specification
type: Class
subclass of: objective specification
textual definition: The main objective of the intervention(s) being evaluated by the clinical trial.
alternative term: primary purpose of clinical trial
definition source: https://prsinfo.clinicaltrials.gov/definitions.html
imported from: opmi.owl

date of registration
type: Class
textual definition: The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
textual definition: a date when a registration occurs
imported from: opmi.owl
has exact synonym: First submitted
has exact synonym: date of registration in primary registry

Axiom
annotated source: date of registration
annotated property: textual definition
annotated target: The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
definition source: https://www.clinicaltrials.gov/ct2/about-studies/glossary

Axiom
annotated source: date of registration
annotated property: has exact synonym
annotated target: date of registration in primary registry

recruitment status
type: Class
subclass of: status
textual definition: The current stage of a clinical study and whether it is or will be open for enrollment
textual definition: The recruitment status for the clinical study as a whole, based upon the status of the individual sites. If at least one facility in a multi-site clinical study has an Individual Site Status of "Recruiting," then the Overall Recruitment Status for the study must be "Recruiting."
definition editor: Oliver He
definition source: https://clinicaltrials.gov/ct2/help/glossary/recruitment-status
imported from: opmi.owl

Axiom
annotated source: recruitment status
annotated property: textual definition
annotated target: The recruitment status for the clinical study as a whole, based upon the status of the individual sites. If at least one facility in a multi-site clinical study has an Individual Site Status of "Recruiting," then the Overall Recruitment Status for the study must be "Recruiting."
definition source: https://prsinfo.clinicaltrials.gov/definitions.html

status
type: Class
definition editor: Oliver He, Edison Ong
imported from: opmi.owl

study status
type: Class
subclass of: status
textual definition: The current stage of a clinical study and whether it is or will be open for enrollment
definition editor: Oliver He
definition source: https://clinicaltrials.gov/ct2/help/glossary/recruitment-status
imported from: opmi.owl

Japan clinical trial identifier
type: Class
subclass of: Clinical Trial Registry Identifier
definition editor: Qingliang Leon Li, Asiyah Yu Lin, Oliver He
definition source: https://pubchem.ncbi.nlm.nih.gov/source/NIPH%20Clinical%20Trials%20Search%20of%20Japan
definition source: https://rctportal.niph.go.jp/en/
imported from: opmi.owl

UMIN-CTR clinical trial identifier
type: Class
subclass of: Japan clinical trial identifier
textual definition: A Japan clinical trial identifier provided by the University Hospital Medical Information Network Center (UMIN-CTR)
definition editor: Qingliang Leon Li, Asiyah Yu Lin, Oliver He
alternative term: UMIN
definition source: https://rctportal.niph.go.jp/en/
imported from: opmi.owl

JAPIC clinical trial identifier
type: Class
subclass of: Japan clinical trial identifier
definition editor: Qingliang Leon Li, Asiyah Yu Lin, Oliver He
alternative term: JapicCTI
definition source: https://rctportal.niph.go.jp/en/
imported from: opmi.owl

JMACCT clinical trial identifier
type: Class
subclass of: Japan clinical trial identifier
textual definition: A centrally registered identifier that is assigned for a specific clinical trial registered in JMACCT. The format for the JMACCT registry number is “JMA-IIA” followed by a 5-digit number, e.g., JMA-IIA00391.
definition editor: Qingliang Leon Li, Asiyah Yu Lin, Oliver He
alternative term: JMACCT
definition source: https://rctportal.niph.go.jp/en/
imported from: opmi.owl

European clinical trial registry identifier
type: Class
subclass of: Clinical Trial Registry Identifier
example of usage: EudraCT Number: 2007-002422-29
definition editor: Qingliang Leon Li, Asiyah Yu Lin, Oliver He
alternative term: EudraCT identifier
definition source: https://en.wikipedia.org/wiki/EudraCT
definition source: https://www.clinicaltrialsregister.eu/ctr-search/search
imported from: opmi.owl

combinational intervention
type: Class
subclass of: medical intervention
textual definition: Combining a drug and device, a biological product and device; a drug and biological product; or a drug, biological product, and device
definition editor: Leon Li, Asiyah Lin, Oliver He
imported from: opmi.owl

Axiom
annotated source: combinational intervention
annotated property: textual definition
annotated target: Combining a drug and device, a biological product and device; a drug and biological product; or a drug, biological product, and device
definition source: https://prsinfo.clinicaltrials.gov/definitions.html

clinical trial phase
type: Class
subclass of: process quality
textual definition: The quality of a clinical trial that studies a drug or biological product. The phase is based on the study's objective, the number of participants, and other characteristics. According to USA FDA, there are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4.
definition editor: Leon Li, Asiyah Lin, Oliver He
alternative term: clinical trial stage
definition source: https://www.clinicaltrials.gov/ct2/help/glossary/phase
imported from: opmi.owl
has_narrow_synonym: phase

clinical trial phase 1
type: Class
subclass of: clinical trial phase
textual definition: A clinical trial phase that represents the first-in-man trial, which tests within a small group of people (typically 20-80) to evaluate safety, determine safe dosage ranges, and begin to identify side effects. A drug's side effects could be subtle or long term, or may only happen with a few people, so phase 1 trials are not expected to identify all side effects.
definition editor: Leon Li, Asiyah Lin, Oliver He
alternative term: Phase 1
alternative term: Phase I
definition source: Phase I Trial
definition source: https://en.wikipedia.org/wiki/Clinical_trial
imported from: opmi.owl
UMLS_CUI: C0920321
NCIT code: C15600

clinical trial phase 2
type: Class
subclass of: clinical trial phase
textual definition: A clinical trial phase that is designed to study a biomedical or behavioral intervention in a larger group of people (several hundred), to evaluate the drug's effectiveness for a particular indication in patients with the disease or condition under study, and to determine the common short-term side effects and risks associated with the intervention. [def-source: NCI]
definition editor: Leon Li, Asiyah Lin, Oliver He
alternative term: Phase II
definition source: Phase II Trial
definition source: https://en.wikipedia.org/wiki/Clinical_trial
imported from: opmi.owl
UMLS_CUI: C0282460
NCIT code: C15601

clinical trial phase 3
type: Class
subclass of: clinical trial phase
textual definition: A clinical trial phase that is designed to investigate the efficacy of the biomedical or behavioral intervention in large groups of human subjects (from several hundred to several thousand), to confirm efficacy, to monitor adverse reactions to the new medication or treatment regimen with respect to long-term use and by comparing the intervention to other standard or experimental interventions as well as to a placebo. [def-source: NCI]
definition editor: Leon Li, Asiyah Lin, Oliver He
alternative term: Phase III
definition source: Phase III Trial
definition source: https://en.wikipedia.org/wiki/Clinical_trial
imported from: opmi.owl
UMLS_CUI: C0282461
NCIT code: C15602

clinical trial phase 4
type: Class
subclass of: clinical trial phase
textual definition: A clinical trial phase that is designed for a randomized, controlled trial to evaluate the long-term safety and efficacy of a drug for a given indication. Often they are designed to study side effects that may have become apparent after the phase III study was completed. [def-source: NCI]
definition editor: Leon Li, Asiyah Lin, Oliver He
alternative term: Phase IV
definition source: https://en.wikipedia.org/wiki/Clinical_trial
imported from: opmi.owl
UMLS_CUI: C0282462
NCIT code: C15603

clinical trial early phase 1
type: Class
subclass of: clinical trial phase
textual definition: A clinical trial phase that is designed to use an investigational agent that is available only in very limited quantities and which has never previously given to humans or for which there is extremely limited human experience. Phase 0 clinical trials are intended to enable researchers to understand the path of the drug in the body and its efficacy. Adverse event reporting in Phase 0 trials is expedited. [def-source: NCI]
definition editor: Leon Li, Asiyah Lin, Oliver He
alternative term: Early Phase 1
alternative term: Pre-Clinical Phase
alternative term: clinical trial phase 0
definition source: http://purl.obolibrary.org/obo/NCIT_C54721
definition source: https://en.wikipedia.org/wiki/Clinical_trial
imported from: opmi.owl
UMLS_CUI: C1882358
NCIT code: C54721

behavioral intervention
type: Class
subclass of: medical intervention
textual definition: A medical intervention that involves a behavioral process to control, prevent, or treat a behavior problem.
definition editor: Leon Li, Asiyah Lin, Oliver He
definition source: https://www.understood.org/en/learning-attention-issues/treatments-approaches/educational-strategies/behavior-intervention-plans-what-you-need-to-know
imported from: opmi.owl
has exact synonym: behavioral

Axiom
annotated source: behavioral intervention
annotated property: has exact synonym
annotated target: behavioral

investigator role
type: Class
subclass of: investigation agent role
textual definition: An investigation agent role that is taken by a human individual
definition editor: Leon Li, Asiyah Lin, Oliver He
alternative term: human investigator role
imported from: opmi.owl

primary sponsor role
type: Class
subclass of: sponsor role
textual definition: A sponsor role taken by an individual, organization, group or other legal entity which takes responsibility for initiating, managing and/or financing a study. The Primary Sponsor is responsible for ensuring that the trial is properly registered. The Primary Sponsor may or may not be the main funder.
definition editor: Leon Li, Asiyah Lin, Oliver He
definition source: https://www.who.int/ictrp/network/trds/en/
imported from: opmi.owl

secondary sponsor role
type: Class
subclass of: sponsor role
textual definition: A sponsor role taken by an additional individual, organization or another legal person, if any, that has agreed with the primary sponsor to take on responsibilities of sponsorship.
definition editor: Leon Li, Asiyah Lin, Oliver He
alternative term: collaborator role
definition source: https://www.who.int/ictrp/network/trds/en/
imported from: opmi.owl
comment: A secondary sponsor may have agreed to: - take on all the responsibilities of sponsorship jointly with the primary sponsor; or - form a group with the Primary Sponsor in which the responsibilities of sponsorship are allocated among the members of the group; or - act as the Primary Sponsor’s legal representative in relation to some or all of the trial sites. by WHO (https://www.who.int/ictrp/network/trds/en/)
comment: In clinicaltrials.gov, the secondary sponsor role can be taken by a project collaborator (Reference: https://prsinfo.clinicaltrials.gov/trainTrainer/WHO-ICMJE-ClinTrialsgov-Cross-Ref.pdf). However, a secondary sponsor may serve as a collaborator role, but a collaborator may not serve as a secondary sponsor role.

principal investigator role
type: Class
subclass of: investigator role
textual definition: An investigator role taken by an individual who is designated as responsible party by the sponsor
definition editor: Leon Li, Asiyah Lin, Oliver He
definition source: https://prsinfo.clinicaltrials.gov/definitions.html
imported from: opmi.owl

sponsor investigator role
type: Class
subclass of: investigator role
textual definition: An investigator role taken by an individual who both initiates and conducts the study
definition editor: Leon Li, Asiyah Lin, Oliver He
definition source: https://prsinfo.clinicaltrials.gov/definitions.html
imported from: opmi.owl

Early Phase 1 clinical trial
type: Class
subclass of: clinical trial
textual definition: A clinical trial that is at Early Phase 1 or Phase 0
textual definition: A clinical trial that is at an Early Phase i or Phase 0, which is designed to use an investigational agent that is available only in very limited quantities and which has never previously given to humans or for which there is extremely limited human experience. Phase 0 clinical trials are intended to enable researchers to understand the path of the drug in the body and its efficacy. Adverse event reporting in Phase 0 trials is expedited. [def-source: NCI]
textual definition: Exploratory trials, involving very limited human exposure, with no therapeutic or diagnostic intent (e.g., screening studies, microdose studies). (Formerly listed as "Phase 0")
definition editor: Leon Li, Asiyah Lin, Oliver He
alternative term: Phase 0 clinical trial
alternative term: Phase 0 trial
alternative term: Pre-Clinical Trial
definition source: http://purl.obolibrary.org/obo/NCIT_C54721
definition source: https://en.wikipedia.org/wiki/Clinical_trial
imported from: opmi.owl

Axiom
annotated source: Early Phase 1 clinical trial
annotated property: textual definition
annotated target: Exploratory trials, involving very limited human exposure, with no therapeutic or diagnostic intent (e.g., screening studies, microdose studies). (Formerly listed as "Phase 0")
definition source: https://prsinfo.clinicaltrials.gov/definitions.html

biological sex
type: Class
subclass of: organismal quality
textual definition: An organismal quality inhering in a bearer by virtue of the bearer's ability to undergo sexual reproduction in order to differentiate the individuals or types involved.
imported from: pato.owl
has_obo_namespace: quality
id: PATO:0000047
in subset: attribute slim

female
type: Class
subclass of: phenotypic sex
textual definition: A biological sex quality inhering in an individual or a population that only produces gametes that can be fertilised by male gametes.
imported from: pato.owl
has_obo_namespace: quality
id: PATO:0000383
in subset: mpath slim
in subset: value slim

male
type: Class
subclass of: phenotypic sex
textual definition: A biological sex quality inhering in an individual or a population whose sex organs contain only male gametes.
imported from: pato.owl
has_obo_namespace: quality
id: PATO:0000384
in subset: mpath slim
in subset: value slim

process quality
type: Class
textual definition: A quality which inheres in an process.
imported from: oae.owl
imported from: opmi.owl
imported from: pato.owl
has_alternative_id: PATO:0001239
has_alternative_id: PATO:0001240
has exact synonym: quality of a process
has exact synonym: quality of occurrent
has exact synonym: quality of process
has exact synonym: relational quality of occurrent
has_obo_namespace: quality
id: PATO:0001236
comment: See comments of relational quality of a physical entity.

physical object quality
type: Class
textual definition: A quality which inheres in a continuant.
imported from: pato.owl
has_alternative_id: PATO:0001237
has_alternative_id: PATO:0001238
database_cross_reference: snap:Quality
has exact synonym: monadic quality of a continuant
has exact synonym: multiply inhering quality of a physical entity
has exact synonym: quality of a continuant
has exact synonym: quality of a single physical entity
has exact synonym: quality of an object
has exact synonym: quality of continuant
has_narrow_synonym: monadic quality of an object
has_narrow_synonym: monadic quality of continuant
has_obo_namespace: quality
id: PATO:0001241
comment: Relational qualities are qualities that hold between multiple entities. Normal (monadic) qualities such as the shape of a eyeball exist purely as a quality of that eyeball. A relational quality such as sensitivity to light is a quality of that eyeball (and connecting nervous system) as it relates to incoming light waves/particles.

phenotypic sex
type: Class
subclass of: biological sex
textual definition: An organismal quality inhering in a bearer by virtue of the bearer's physical expression of sexual characteristics.
imported from: pato.owl
has_obo_namespace: quality
id: PATO:0001894
in subset: attribute slim

organismal quality
type: Class
subclass of: physical object quality
textual definition: A quality that inheres in an entire organism or part of an organism.
imported from: pato.owl
has_obo_namespace: quality
id: PATO:0001995

condition
type: Class
subclass of: information content entity
has curation status: metadata incomplete
textual definition: An information content entity that describes some relationships between some entities and whose truthfullness is a prerequisite for something.
textual definition: Une entité de contenu informationnel qui décrit des relations entre certaines entités et dont la véracité est un prérequis pour quelque chose. @fr
imported from: pdro.owl

vaccination
type: Class
subclass of: medical intervention
textual definition: a medical intervention that involves in adding vaccine into a host (e.g., human, mouse) in vivo with the intent to invoke an adaptive immune response.
imported from: oae.owl
imported from: vo.owl

phase 1 vaccine trial
type: Class
subclass of: vaccine clinical trial
textual definition: A vaccine clinical trial that investigates the safety profile of a vaccine in a small group (10-50) of healthy volunteers.
definition editor: YH
imported from: vo.owl

phase 2 vaccine trial
type: Class
subclass of: vaccine clinical trial
textual definition: A vaccine clinical trial that studies vaccine efficacy with a target population (numbering 50-100). Different dosage levels will also be explored at this stage to determine the optimum dose.
definition editor: YH
imported from: vo.owl

phase 3 vaccine trial
type: Class
subclass of: vaccine clinical trial
textual definition: A vaccine clinical trial that takes the trial to a large-scale safety and efficacy study in a relevant patient population, usually in excess of 3,000.
definition editor: YH
imported from: vo.owl

phase 4 vaccine trial
type: Class
subclass of: vaccine clinical trial
textual definition: The final stage of vaccine clinical evaluation. Phase IV occurs after a vaccine or therapy is licensed and is being used by large numbers of people. These studies are not always required or completed.
definition editor: YH
imported from: vo.owl

vaccine clinical trial
type: Class
subclass of: human study
textual definition: A processual entity by which a vaccine is tested clinically for safety and effectiveness. Clinical trials are conducted in phases. Classically, clinical trials unfold in three phases in order to gather data and information about a vaccine and its performance. This will form the basis of a dossier submitted to regulatory authorities by way of an application for licensure. After a vaccine is licensed and is being used by large numbers of people, a Phase IV study may or may not be taken for vaccine clinical evaluation.
editor note: Most vaccines against a pathogen (e.g., HIV) are not tested by vaccinating people and then deliberately exposing them to virulent pathogen (e.g., HIV). This strategy is never for a vaccine against a disease as serious as HIV. The best way to determine if a vaccine is effective is to test it in a randomized, controlled, double-blind clinical trial. This type of trial is often referred to as the gold standard in medical research and provides the strongest evidence for the efficacy of a vaccine.
definition editor: YH
imported from: vo.owl

Case-control study
type: Class
subclass of: Observational study
textual definition: A case control study is an observational study that compares people with a specific disease or outcome of interest (cases) to people from the same population without that disease or outcome (controls), and which seeks to find associations between the outcome and prior exposure to particular risk factors. [Glossary of Terms in The Cochrane Collaboration]
textual definition: Group of individuals with specific characteristics (for example, conditions or exposures) compared to group(s) with different characteristics, but otherwise similar.
imported from: ero.owl
curator: Simona

Axiom
annotated source: Case-control study
annotated property: textual definition
annotated target: Group of individuals with specific characteristics (for example, conditions or exposures) compared to group(s) with different characteristics, but otherwise similar.
definition source: https://prsinfo.clinicaltrials.gov/definitions.html

Case-crossover study
type: Class
subclass of: Observational study
textual definition: A case-crossover study is an observational study that aims to answer the question, “Was this event triggered by something unusual that happened just before?” The key feature of the design is that each case serves as its own control. The method is analogous to a crossover experiment viewed retrospectively, except that the investigator does not control when a patient starts and stops being exposed to the potential trigger. Also, the exposure frequency is typically measured in only a sample of the total time when the patient was at risk of the injury or disease onset. Thus it usually resembles a case-control study more than a retrospective cohort study. The simplest case-crossover design is closely analogous to a traditional matched-pair case-control design. In both designs, each case has a matched control. In a traditional matched-pair case-control study, the control is a different person at a similar time. In the matched-pair case-crossover design, the control is the same person at a different time [Annu Rev Public Health. 2000;21:193-221.]
textual definition: Characteristics of case immediately prior to disease onset (sometimes called the hazard period) compared to characteristics of same case at a prior time (that is, control period).
imported from: ero.owl
curator: Simona

Axiom
annotated source: Case-crossover study
annotated property: textual definition
annotated target: Characteristics of case immediately prior to disease onset (sometimes called the hazard period) compared to characteristics of same case at a prior time (that is, control period).
definition source: https://prsinfo.clinicaltrials.gov/definitions.html

Cohort study
type: Class
subclass of: Observational study
textual definition: A cohort study is an observational study in which a defined group of people (the cohort) is followed over time. The outcomes of people in subsets of this cohort are compared, to examine people who were exposed or not exposed (or exposed at different levels) to a particular intervention or other factor of interest. A prospective cohort study assembles participants and follows them into the future. A retrospective (or historical) cohort study identifies subjects from past records and follows them from the time of those records to the present. [Glossary of Terms in The Cochrane Collaboration]
textual definition: Group of individuals, initially defined and composed, with common characteristics (for example, condition, birth year), who are examined or traced over a given time period.
imported from: ero.owl
curator: Simona

Axiom
annotated source: Cohort study
annotated property: textual definition
annotated target: Group of individuals, initially defined and composed, with common characteristics (for example, condition, birth year), who are examined or traced over a given time period.
definition source: https://prsinfo.clinicaltrials.gov/definitions.html

Cross-sectional study
type: Class
subclass of: Observational study
textual definition: A cross-sectional study is an observational study measuring the distribution of some characteristic(s) in a population at a particular point in time. (Also called survey.) [adapted from: Glossary of Terms in The Cochrane Collaboration]
imported from: ero.owl
curator: Simona

Interventional study
type: Class
subclass of: Quantitative human study
textual definition: An interventional study is a quantitative study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiologic procedures, devices, behavioural treatments, process-of-care changes, preventive care, etc. [adapted from: WHO, available at: http://www.who.int/ictrp/en/]
textual definition: Participants are assigned prospectively to an intervention or interventions according to a protocol to evaluate the effect of the intervention(s) on biomedical or other health related outcomes.
imported from: ero.owl
curator: Simona
develop comment: Simona: to be reviewed
has exact synonym: clinical trail

Axiom
annotated source: Interventional study
annotated property: textual definition
annotated target: Participants are assigned prospectively to an intervention or interventions according to a protocol to evaluate the effect of the intervention(s) on biomedical or other health related outcomes.
definition source: https://prsinfo.clinicaltrials.gov/definitions.html

Axiom
annotated source: Interventional study
annotated property: has exact synonym
annotated target: clinical trail

Observational study
type: Class
subclass of: Quantitative human study
textual definition: An observational study is a quantitative study in which the investigators do not seek to intervene, and simply observe the course of events. [adapted from: Glossary of Terms in The Cochrane Collaboration]
textual definition: Studies in human beings in which biomedical and/or health outcomes are assessed in pre-defined groups of individuals. Participants in the study may receive diagnostic, therapeutic, or other interventions, but the investigator does not assign specific interventions to the study participants. This includes when participants receive interventions as part of routine medical care, and a researcher studies the effect of the intervention.
imported from: ero.owl
curator: Simona

Axiom
annotated source: Observational study
annotated property: textual definition
annotated target: Studies in human beings in which biomedical and/or health outcomes are assessed in pre-defined groups of individuals. Participants in the study may receive diagnostic, therapeutic, or other interventions, but the investigator does not assign specific interventions to the study participants. This includes when participants receive interventions as part of routine medical care, and a researcher studies the effect of the intervention.
definition source: https://prsinfo.clinicaltrials.gov/definitions.html

Parallel group study
type: Class
subclass of: Interventional study
textual definition: A parallel group study is an interventional study that compares across at least two allocation groups concurrently, each receiving a regimen of interventions (which can be "no intervention").
textual definition: Participants are assigned to one of two or more groups in parallel for the duration of the study
imported from: ero.owl
curator: Simona
develop comment: Simona: to be reviewed.

Axiom
annotated source: Parallel group study
annotated property: textual definition
annotated target: Participants are assigned to one of two or more groups in parallel for the duration of the study
definition source: https://prsinfo.clinicaltrials.gov/definitions.html

Qualitative human study
type: Class
subclass of: human study
textual definition: A qualitative study is an individual-human study whose primary mode of inquiry is qualitative.
imported from: ero.owl
curator: Simona

Quantitative human study
type: Class
subclass of: human study
textual definition: A quantitative study is an individual-human study whose primary mode of inquiry is quantitative.
imported from: ero.owl
curator: Simona

Crossover study
type: Class
subclass of: Interventional study
textual definition: A crossover study is an interventional study where the population is a more than a single human subject, in which at least two regimens of interventions are given alternatingly. Upon completion of one regimen, participants are switched to the other. For example, for a comparison of regimens A and B, the participants are randomly allocated to receive them in either the order A, B or the order B, A. Regimens are assigned to and data are analyzed within more than one participant at a time.
textual definition: Participants receive one of two (or more) alternative interventions during the initial phase of the study and receive the other intervention during the second phase of the study
imported from: ero.owl
curator: Simona
develop comment: Simona: to be reviewed

Axiom
annotated source: Crossover study
annotated property: textual definition
annotated target: Participants receive one of two (or more) alternative interventions during the initial phase of the study and receive the other intervention during the second phase of the study
definition source: https://prsinfo.clinicaltrials.gov/definitions.html

N-of-1 crossover study
type: Class
subclass of: Interventional study
textual definition: An N-of-1 crossover study is an interventional study where the population is a single human subject and in which at least two regimens of interventions are given alternatingly. Regimens are assigned to and data are analyzed within one participant at a time.
imported from: ero.owl
curator: Simona
develop comment: Simona: to be reviewed

Single group study
type: Class
subclass of: Interventional study
textual definition: A single group study is an interventional study that has only a single allocation group and no contemporaneuos comparison group. A study in which an individual acts has his/her own comparison does not fall into this category, since an individual is not a group.
textual definition: Clinical trials with a single arm
imported from: ero.owl
curator: Simona
develop comment: Simona: to be reviewed

Axiom
annotated source: Single group study
annotated property: textual definition
annotated target: Clinical trials with a single arm
definition source: https://prsinfo.clinicaltrials.gov/definitions.html

secondary identifier
type: Class
subclass of: information content entity
textual definition: An identifier(s) (ID), if any, other than the organization's Unique Protocol Identification Number or the NCT number that is assigned to the clinical study. This includes any unique clinical study identifiers assigned by other publicly available clinical trial registries. If the clinical study is funded in whole or in part by a U.S. Federal Government agency, the complete grant or contract number must be submitted as a Secondary ID.
textual definition: Other identifiers besides the Trial Identifying Number allocated by the Primary Registry, if any.

Axiom
annotated source: secondary identifier
annotated property: textual definition
annotated target: An identifier(s) (ID), if any, other than the organization's Unique Protocol Identification Number or the NCT number that is assigned to the clinical study. This includes any unique clinical study identifiers assigned by other publicly available clinical trial registries. If the clinical study is funded in whole or in part by a U.S. Federal Government agency, the complete grant or contract number must be submitted as a Secondary ID.
definition source: https://prsinfo.clinicaltrials.gov/definitions.html

Axiom
annotated source: secondary identifier
annotated property: textual definition
annotated target: Other identifiers besides the Trial Identifying Number allocated by the Primary Registry, if any.
definition source: https://www.who.int/ictrp/network/trds/en/

Australian New Zealand clinical trials registry identifier
type: Class
subclass of: Clinical Trial Registry Identifier
textual definition: A centrally registered identifier that is assigned for a specific clinical trial registered in the Australian New Zealand clinical trials registry (ANZCTR). The format for the registry number is “ACTRN” followed by a 14-digit number, e.g., ACTRN12620000457943.
has exact synonym: ANZCTR identifier

Australian New Zealand clinical trials registry
type: Class
subclass of: primary registry
textual definition: Australian New Zealand Clinical Trials Registry is a primary clinical trial registry recognised by WHO and ICMJE that enables the registration of clinical trials.
has exact synonym: ANZCTR

Peruvian clinical trial registry identifier
type: Class
subclass of: Clinical Trial Registry Identifier
textual definition: A centrally registered identifier that is assigned for a specific clinical trial registered in the Peruvian clinical trial registry (REPEC). The format for the registry number is “PER-” followed by a 3-digit number, followed by a hyphen, followed by a 2-digit number e.g., PER-010-20.
has exact synonym: REPEC identifier

masking design
type: Class
subclass of: study design
textual definition: The party or parties involved in the clinical trial who are prevented from having knowledge of the interventions assigned to individual participants.
has_related_synonym: blinding
has_related_synonym: masking

Axiom
annotated source: masking design
annotated property: textual definition
annotated target: The party or parties involved in the clinical trial who are prevented from having knowledge of the interventions assigned to individual participants.
definition source: https://prsinfo.clinicaltrials.gov/definitions.html

non-random allocation
type: Class
subclass of: Allocation
textual definition: Participants are expressly assigned to intervention groups through a non-random method, such as physician choice
has exact synonym: non-randomized
has exact synonym: nonrandomized

Axiom
annotated source: non-random allocation
annotated property: textual definition
annotated target: Participants are expressly assigned to intervention groups through a non-random method, such as physician choice
definition source: https://prsinfo.clinicaltrials.gov/definitions.html

study summary result
type: Class
subclass of: report
textual definition: A study record that includes the summary results posted in the ClinicalTrials.gov results database. Summary results information includes participant flow, baseline characteristics, outcome measures, and adverse events (including serious adverse events).
has exact synonym: summary results

Axiom
annotated source: study summary result
annotated property: textual definition
annotated target: A study record that includes the summary results posted in the ClinicalTrials.gov results database. Summary results information includes participant flow, baseline characteristics, outcome measures, and adverse events (including serious adverse events).
definition source: https://clinicaltrials.gov/ct2/about-studies/glossary

secondary outcome measure information
type: Class
subclass of: outcome specification
textual definition: A description of each secondary outcome measure (or for observational studies, specific secondary measurement[s] or observation[s] used to describe patterns of diseases or traits or associations with exposures, risk factors or treatment). Each secondary outcome measure information includes title, description and time frame.
definition source: https://prsinfo.clinicaltrials.gov/definitions.html
has_related_synonym: key secondary outcome

Axiom
annotated source: secondary outcome measure information
annotated property: has_related_synonym
annotated target: key secondary outcome

Iranian registry of clinical trials
type: Class
subclass of: primary registry
textual definition: The Iranian registry of clinical trials is a primary clinical trial registry recognised by WHO and ICMJE that enables the registration of clinical trials.
has exact synonym: IRCT

other outcome measure information
type: Class
subclass of: outcome specification
textual definition: Any other measurements, excluding post-hoc measures, that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study. Each primary outcome measure information includes title, description and time frame.
definition source: https://prsinfo.clinicaltrials.gov/definitions.html
has exact synonym: other pre-specified outcome measures

Indian clinical trials registry
type: Class
subclass of: primary registry
textual definition: The Indian clinical trials registry is a primary clinical trial registry recognised by WHO and ICMJE that enables the registration of clinical trials.
has exact synonym: CTRI
has exact synonym: clinical trials registry - India

The Netherlands national trial register
type: Class
subclass of: primary registry
textual definition: The Netherlands national trial register is a primary clinical trial registry recognised by WHO and ICMJE that enables the registration of clinical trials.
has exact synonym: NTR

Iranian registry of clinical trials identifier
type: Class
subclass of: Clinical Trial Registry Identifier
textual definition: A centrally registered identifier that is assigned for a specific clinical trial registered in the Iranian registry of clinical trials (IRCT). The format for the registry number is “IRCT” followed by a 14-digit number, one letter and again one or two numbers, e.g., IRCT20100228003449N29.
has exact synonym: IRCT identifier

German clinical trials register identifier
type: Class
subclass of: Clinical Trial Registry Identifier
textual definition: A centrally registered identifier that is assigned for a specific clinical trial registered in the German clinical trials register (DRKS). The format for the registry number is “DRKS” followed by a 8-digit number, e.g., DRKS00000494.
has exact synonym: DRKS identifier

Cuban public registry of clinical trials
type: Class
subclass of: primary registry
textual definition: The Cuban public registry of clinical trials is a primary clinical trial registry recognised by WHO and ICMJE that enables the registration of clinical trials.
has exact synonym: RPCEC

outcome measure
type: Class
textual definition: For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.

Axiom
annotated source: outcome measure
annotated property: textual definition
annotated target: For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
definition source: https://clinicaltrials.gov/ct2/about-studies/glossary

Pan African clinical trial registry
type: Class
subclass of: primary registry
textual definition: The Pan African clinical trial registry is a primary clinical trial registry recognised by WHO and ICMJE that enables the registration of clinical trials.
has exact synonym: PACTR

The Netherlands national trial register identifier
type: Class
subclass of: Clinical Trial Registry Identifier
textual definition: A centrally registered identifier that is assigned for a specific clinical trial registered in the The Netherlands national trial register (NTR). The format for the registry number is “NTR” followed by a 1 to 4-digit number, e.g., NL8498.
has exact synonym: NTR identifier

JAPIC clinical trials registry
type: Class
subclass of: primary registry
textual definition: The JAPIC (Japan Pharmaceutical Information Center) clinical trials registry is a primary clinical trial registry recognised by WHO and ICMJE that enables the registration of clinical trials.
has exact synonym: JapicCTI

Pan African clinical trial registry identifier
type: Class
subclass of: Clinical Trial Registry Identifier
textual definition: A centrally registered identifier that is assigned for a specific clinical trial registered in the Pan African clinical trial register. The format for the registry number is “KCT” followed by a 15-digit number, e.g., PACTR202004893013257.
has exact synonym: PACTR identifier

Chinese clinical trail registry identifier
type: Class
subclass of: Clinical Trial Registry Identifier
textual definition: A centrally registered identifier that is assigned for a specific clinical trial registered in the Chinese clinical trials register (ChiCTR). The format for the registry number is “ChiCTR” followed by a 10-digit number, e.g., ChiCTR2000031589.
alternative term: ChiCTR identifier
has exact synonym: Chinese Clinical Trial Register number

Lebanese clinical trials registry
type: Class
subclass of: primary registry
textual definition: The Lebanese clinical trials registry is a primary clinical trial registry recognised by WHO and ICMJE that enables the registration of clinical trials.
has exact synonym: LBCTR

German clinical trials register
type: Class
subclass of: primary registry
textual definition: German clinical trials register is a primary clinical trial registry recognised by WHO and ICMJE that enables the registration of clinical trials.
has exact synonym: DRKS

JMACCT clinical trials registry
type: Class
subclass of: primary registry
textual definition: The JMACCT (Japan Medical Association, Center for Clinical Trials) clinical trials registry is a primary clinical trial registry recognised by WHO and ICMJE that enables the registration of clinical trials.
has exact synonym: JMACCT

age_between_18_and_64
type: Class
subclass of: Age
has exact synonym: adult (18-64)

number of participants
type: Class
subclass of: data item
textual definition: The actual total number of participants that are enrolled in a clinical study
definition source: https://prsinfo.clinicaltrials.gov/definitions.html
has_related_synonym: enrollment
has_related_synonym: sample size

Axiom
annotated source: number of participants
annotated property: has_related_synonym
annotated target: enrollment

Axiom
annotated source: number of participants
annotated property: has_related_synonym
annotated target: sample size

Brazilian clinical trial registry identifier
type: Class
subclass of: Clinical Trial Registry Identifier
textual definition: A centrally registered identifier that is assigned for a specific clinical trial registered in Brazilian Registry of Clinical Trials (ReBEC). The format for the ReBEC registry number is “RBR-” followed by 6 characters, e.g., RBR-4hb9qs.
has exact synonym: Brazilian Registry of Clinical Trials identifier
has exact synonym: ReBEC identifier

clinical trial phase 2/3
type: Class
subclass of: clinical trial phase
textual definition: Clinical trial phase that is a combination of phases 2 and 3.
has exact synonym: Phase 2/3
has exact synonym: Phase 2/Phase 3
has exact synonym: Phase I/II

study result
type: Class
subclass of: data item
textual definition: data item ....

healthy volunteer criterion
type: Class
subclass of: inclusion criterion
textual definition: A type of eligibility criteria that indicates whether people who do not have the condition/disease being studied can participate in that clinical study.
textual definition: Indication that participants who do not have a disease or condition, or related conditions or symptoms, under study in the clinical study are permitted to participate in the clinical study.
has exact synonym: accepts healthy volunteers

Axiom
annotated source: healthy volunteer criterion
annotated property: textual definition
annotated target: A type of eligibility criteria that indicates whether people who do not have the condition/disease being studied can participate in that clinical study.
definition source: https://clinicaltrials.gov/ct2/about-studies/glossary

Axiom
annotated source: healthy volunteer criterion
annotated property: textual definition
annotated target: Indication that participants who do not have a disease or condition, or related conditions or symptoms, under study in the clinical study are permitted to participate in the clinical study.
definition source: https://prsinfo.clinicaltrials.gov/definitions.html

age_between_birth_and_17_years
type: Class
subclass of: Age
has exact synonym: child (birth-17)

primary outcome measure information
type: Class
subclass of: outcome specification
textual definition: A description of each primary outcome measure (or for observational studies, specific key measurement[s] or observation[s] used to describe patterns of diseases or traits or associations with exposures, risk factors or treatment). Each primary outcome measure information includes title, description and time frame.
definition source: https://prsinfo.clinicaltrials.gov/definitions.html
has_related_synonym: primary end point
has_related_synonym: primary outcome(s)

Axiom
annotated source: primary outcome measure information
annotated property: has_related_synonym
annotated target: primary end point

Axiom
annotated source: primary outcome measure information
annotated property: has_related_synonym
annotated target: primary outcome(s)

EU clinical trials register
type: Class
subclass of: primary registry
textual definition: The EU clinical trials register is a primary clinical trial registry recognised by WHO and ICMJE that enables the registration of clinical trials.
has exact synonym: EU-CTR

UMIN clinical trials registry
type: Class
subclass of: primary registry
textual definition: The UMIN (University Hospital Medical Information Network Center) clinical trials registry is a Japanese primary clinical trial registry recognised by WHO and ICMJE that enables the registration of clinical trials.
has exact synonym: UMIN CTR

age_older_than_64
type: Class
subclass of: Age
has exact synonym: older adult (65+)

outcome measure result
type: Class
subclass of: report
textual definition: Data generated from measurement of experimental variables in a study, or for observational studies, from descriptions of patterns of diseases or traits or associations with exposures, risk factors or treatment.

human subjects protection review board status
type: Class
subclass of: status
textual definition: Indicate whether a clinical study has been reviewed and approved by at least one human subjects protection review board or such review is not required per applicable law (for example, 21 CFR Part 56, 45 CFR Part 46, or other applicable regulation).

Axiom
annotated source: human subjects protection review board status
annotated property: textual definition
annotated target: Indicate whether a clinical study has been reviewed and approved by at least one human subjects protection review board or such review is not required per applicable law (for example, 21 CFR Part 56, 45 CFR Part 46, or other applicable regulation).
definition source: https://prsinfo.clinicaltrials.gov/definitions.html

Korean clinical trials registry
type: Class
subclass of: primary registry
textual definition: ClinicalTrials.gov is a registry of clinical trials.
textual definition: The Korean clinical trials registry (Clinical Research Information Service (CRiS), Republic of Korea) is a primary clinical trial registry recognised by WHO and ICMJE that enables the registration of clinical trials.
has exact synonym: CRiS
has exact synonym: Clinical Research Information Service, Republic of Korea

phase not applicable
type: Class
subclass of: clinical trial phase
textual definition: Trials without phases (for example, studies of devices or behavioral interventions).
has exact synonym: N/A

Axiom
annotated source: phase not applicable
annotated property: textual definition
annotated target: Trials without phases (for example, studies of devices or behavioral interventions).
definition source: https://prsinfo.clinicaltrials.gov/definitions.html

retrospective study design
type: Class
subclass of: study design
textual definition: Look back using observations collected predominantly prior to subject selection and enrollment

Axiom
annotated source: retrospective study design
annotated property: textual definition
annotated target: Look back using observations collected predominantly prior to subject selection and enrollment
definition source: https://prsinfo.clinicaltrials.gov/definitions.html

International standard randomised controlled trial register identifier
type: Class
subclass of: Clinical Trial Registry Identifier
textual definition: A centrally registered identifier that is assigned for a specific clinical trial registered in the international standard randomised controlled trial register (ISRCT). The format for the registry number is “ISRCTN” followed by a 8-digit number, e.g., ISRCTN14966673.
has exact synonym: ISRCTN
has exact synonym: International Standard Randomised Controlled Trial Number

clinical trial phase 1/2
type: Class
subclass of: clinical trial phase
textual definition: Clinical trial phase that is a combination of phases 1 and 2.
has exact synonym: Phase 1/2
has exact synonym: Phase 1/Phase 2
has exact synonym: Phase I/II

prospective study design
type: Class
subclass of: study design
textual definition: Look forward using periodic observations collected predominantly following subject enrollment

Axiom
annotated source: prospective study design
annotated property: textual definition
annotated target: Look forward using periodic observations collected predominantly following subject enrollment
definition source: https://prsinfo.clinicaltrials.gov/definitions.html

Thai clinical trials registry identifier
type: Class
subclass of: Clinical Trial Registry Identifier
textual definition: A centrally registered identifier that is assigned for a specific clinical trial registered in the Thai clinical trials registry (TCTR). The format for the registry number is “TCTR” followed by a 11-digit number, e.g., TCTR20200405001
has exact synonym: TCTR identifier

Chinese clinical trial registry
type: Class
subclass of: primary registry
textual definition: The Chinese clinical trial registry is a primary clinical trial registry recognised by WHO and ICMJE that enables the registration of clinical trials.
has exact synonym: ChiCTR

Thai clinical trials registry
type: Class
subclass of: primary registry
textual definition: The Thai clinical trials registry is a primary clinical trial registry recognised by WHO and ICMJE that enables the registration of clinical trials.
has exact synonym: TCTR

outcome specification
type: Class
subclass of: directive information entity
textual definition: A description of the outcome measure in an interventional study or for observational studies, specific key measurement[s] or observation[s] used to describe patterns of diseases or traits or associations with exposures, risk factors or treatment.

Indian clinical trial registry identifier
type: Class
subclass of: Clinical Trial Registry Identifier
textual definition: A centrally registered identifier that is assigned for a specific clinical trial registered in the Indian clinical trial register. The format for the registry number is “CRTI/” followed by a 4-digit number, followed by a slash, followed a 2-digit number, followed by a slash, followed a 6-digit number, e.g., CTRI/2020/03/024402.
has exact synonym: CRTI identifier
has exact synonym: Clinical Trials Registry - India identifier

Brazilian clinical trials registry
type: Class
subclass of: primary registry
textual definition: The Brazilian clinical trials registry is a primary clinical trial registry recognised by WHO and ICMJE that enables the registration of clinical trials.
has exact synonym: ReBec

jRCT clinical trial identifier
type: Class
subclass of: Japan clinical trial identifier
textual definition: A centrally registered identifier that is assigned for a specific clinical trial registered in the Japan Registry of Clinical Trials (jRCT). The format for the registry number is “jRCTs” followed by a 9-digit number, e.g., JPRN-jRCTs031190227
has exact synonym: Japan registry of clinical trials identifier

Cuban public registry of clinical trials identifier
type: Class
subclass of: Clinical Trial Registry Identifier
textual definition: A centrally registered identifier that is assigned for a specific clinical trial registered in the Cuban public registry of clinical trials (RPCEC). The format for the registry number is “RPCEC” followed by a 8-digit number, e.g., RPCEC00000306.
has exact synonym: RPCEC identifier

Lebanese clinical trials registry identifier
type: Class
subclass of: Clinical Trial Registry Identifier
textual definition: A centrally registered identifier that is assigned for a specific clinical trial registered in the Lebanese clinical trials registry (LBCTR). The format for the registry number is “LBCTR” followed by a 10-digit number, e.g., LBCTR2020043459.
see also: LBCTR identifier

primary registry
type: Class
subclass of: ClinicalTrial.gov registry
textual definition: A primary registry is clinical trial registry in the WHO registry network that meet specific criteria for content, quality and validity, accessibility, unique identification, technical capacity and administration. Primary registries also meet the requirements of the International Clinical Trials Registry Platform (ICMJE).

Peruvian clinical trial registry
type: Class
subclass of: primary registry
textual definition: The Peruvian clinical trial registry is a primary clinical trial registry recognised by WHO and ICMJE that enables the registration of clinical trials.
has exact synonym: REPEC

Sri Lanka clinical trials registry
type: Class
subclass of: primary registry
textual definition: The Sri Lanka clinical trials registry is a primary clinical trial registry recognised by WHO and ICMJE that enables the registration of clinical trials.
has exact synonym: SLCTR

ClinicalTrial.gov registry
type: Class
subclass of: clinical trials registry
textual definition: ClinicalTrials.gov is a registry for clinical trials.
has exact synonym: ClinicalTrials.gov

clinical trials registry
type: Class
subclass of: registry
textual definition: A clinical trials registry is a specifc registry type that enables the registration and documentation of clinical trials.

ready for release
type: Thing
type: NamedIndividual
type: curation status specification

metadata incomplete
type: Thing
type: NamedIndividual
type: curation status specification

pending final vetting
type: Thing
type: NamedIndividual
type: curation status specification

Korean clinical trial registry identifier
textual definition: A centrally registered identifier that is assigned for a specific clinical trial registered in the Korean Clinical Research Information Service (CRIS). The format for the registry number is “KCT” followed by a 7-digit number, e.g., KCT0004537.
has exact synonym: CRIS identifier

Sri Lanka clinical trials registry identifier
textual definition: A centrally registered identifier that is assigned for a specific clinical trial registered in the Sri Lanka clinical trials registry (SLCTR ). The format for the registry number is “SLCTR /” followed by a 4-digit number, followed by a slash, followed a 3-digit number, e.g., SLCTR/2020/010
has exact synonym: SLCTR identifier

jRTC clinical trials register
textual definition: The jRTC (Japan Registry of Clinical Trials) clinical trial registry is a primary clinical trial registry recognised by WHO and ICMJE that enables the registration of clinical trials.
has exact synonym: Japan Registry of Clinical Trials
has exact synonym: jRTC

International standard randomised controlled trial register
has exact synonym: ISRCTN
textual definition: The international standard randomised controlled trial register is a primary clinical trial registry recognised by WHO and ICMJE that enables the registration of clinical trials.