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An ontology for the planning, execution and analysis of clinical research including logitudinal studies and clinical trials. This is designed to be used in conjunction with domain specific models of diseases and measurements which conform to the shared ontology of clinical concepts to provide specific models of studies and trials.
An ontology of objects and relationships in statistics that are useful for describing statistical analysis used in human studies. It is part of the Ontology for Clinical Research (OCRe).
An ontology of study design descriptors and categorization of study design types in terms of their design descriptors.
Concept imported from BRIDG that related to the defined activities and schedules of a study protocol.
$Revision$
Revision 258
editor preferred term
The concise, meaningful, and human-friendly name for a class or property preferred by the ontology developers. (US-English)
PERSON:Daniel Schober
GROUP:OBI:<http://purl.obolibrary.org/obo/obi>
editor preferred term
example
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
PERSON:Daniel Schober
GROUP:OBI:<http://purl.obolibrary.org/obo/obi>
example of usage
in branch
An annotation property indicating which module the terms belong to. This is currently experimental and not implemented yet.
GROUP:OBI
OBI_0000277
in branch
has curation status
PERSON:Alan Ruttenberg
PERSON:Bill Bug
PERSON:Melanie Courtot
OBI_0000281
has curation status
definition
The official definition, explaining the meaning of a class or property. Shall be Aristotelian, formalized and normalized. Can be augmented with colloquial definitions.
PERSON:Daniel Schober
GROUP:OBI:<http://purl.obolibrary.org/obo/obi>
definition
editor note
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.
PERSON:Daniel Schober
GROUP:OBI:<http://purl.obfoundry.org/obo/obi>
editor note
definition editor
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
PERSON:Daniel Schober
GROUP:OBI:<http://purl.obolibrary.org/obo/obi>
definition editor
alternative term
An alternative name for a class or property which means the same thing as the preferred name (semantically equivalent)
PERSON:Daniel Schober
GROUP:OBI:<http://purl.obolibrary.org/obo/obi>
alternative term
definition source
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
PERSON:Daniel Schober
Discussion on obo-discuss mailing-list, see http://bit.ly/hgm99w
GROUP:OBI:<http://purl.obolibrary.org/obo/obi>
definition source
has obsolescence reason
Relates an annotation property to an obsolescence reason. The values of obsolescence reasons come from a list of predefined terms, instances of the class obsolescence reason specification.
PERSON:Alan Ruttenberg
PERSON:Melanie Courtot
has obsolescence reason
curator note
An administrative note of use for a curator but of no use for a user
PERSON:Alan Ruttenberg
curator note
is denotator type
relates an class defined in an ontology, to the type of it's denotator
In OWL 2 add AnnotationPropertyRange('is denotator type' 'denotator type')
Alan Ruttenberg
is denotator type
imported from
For external terms/classes, the ontology from which the term was imported
PERSON:Alan Ruttenberg
PERSON:Melanie Courtot
GROUP:OBI:<http://purl.obolibrary.org/obo/obi>
imported from
expand expression to
ObjectProperty: RO_0002104
Label: has plasma membrane part
Annotations: IAO_0000424 "http://purl.obolibrary.org/obo/BFO_0000051 some (http://purl.org/obo/owl/GO#GO_0005886 and http://purl.obolibrary.org/obo/BFO_0000051 some ?Y)"
A macro expansion tag applied to an object property (or possibly a data property) which can be used by a macro-expansion engine to generate more complex expressions from simpler ones
Chris Mungall
expand expression to
expand assertion to
ObjectProperty: RO???
Label: spatially disjoint from
Annotations: expand_assertion_to "DisjointClasses: (http://purl.obolibrary.org/obo/BFO_0000051 some ?X) (http://purl.obolibrary.org/obo/BFO_0000051 some ?Y)"
A macro expansion tag applied to an annotation property which can be expanded into a more detailed axiom.
Chris Mungall
expand assertion to
first order logic expression
PERSON:Alan Ruttenberg
first order logic expression
antisymmetric property
part_of antisymmetric property xsd:true
use boolean value xsd:true to indicate that the property is an antisymmetric property
Alan Ruttenberg
antisymmetric property
OBO foundry unique label
An alternative name for a class or property which is unique across the OBO Foundry.
The intended usage of that property is as follow: OBO foundry unique labels are automatically generated based on regular expressions provided by each ontology, so that SO could specify unique label = 'sequence ' + [label], etc. , MA could specify 'mouse + [label]' etc. Upon importing terms, ontology developers can choose to use the 'OBO foundry unique label' for an imported term or not. The same applies to tools .
PERSON:Alan Ruttenberg
PERSON:Bjoern Peters
PERSON:Chris Mungall
PERSON:Melanie Courtot
GROUP:OBO Foundry <http://obofoundry.org/>
OBO foundry unique label
term replaced by
Use on obsolete terms, relating the term to another term that can be used as a substitute
Person:Alan Ruttenberg
Person:Alan Ruttenberg
term replaced by
The annotation that specifies which of the subclasses of a class should have derived complex types
has subclass
The class annotation that denotes the type of subclass derivation (restriction or extension) that the complex type corresponding to the class uses.
has subclass type
The class annotation that specifies a property that should be represented as an element tag in the complex type or group corresponding to the class.
data element
An ontology annotation that denotes the class that should become the root element in a XSD schema export.
xsd root
The class anootation that denotes the parent from which the complex type corresponding to the class is derived.
has single parent
A annotation on a property that specifies the string that should be used as the element tag (corresponding to the property) in an XML Schema export.
xsd label
For classes that are defined as unions of other classes, the XML Schema export should generates a complex type chooses one of the groups that correspond to the children classes specified using this annotation. Thus, for example, if C = A union B. The xsd should contain group A, B each of which has the same component tags as the complex types A, B. The complex type C should be a selection from group A or B.
select group
has value set type
element order
deprecated:definition
is administrative relation of
has study
has data element
has schema parent
has type
An encompassing statement of what the investigator's objectives are. The main objective o a study may be to compare drug A and B, and other objectives may be to evaluate the compliance to treatment and the side effects.
has study objective
has intervention assignment scheme
has study characteristic
has participant
administrative property
has laboratory agreement
is study assessment/intervention agreement of
has study performance agreement
is laboratory agreement of
has funding relation
is IRB process of
has sponsoring relation
has oversight agreement
is sponsoring relation of
is recruitment agreement of
has actor
has study assessment/intervention agreement
is oversight agreement of
has recruitment agreement
has IRB process
is funding relation of
is study objective of
is study performance agreement of
is an actor of
has administrative relation
Old definition to be updated: The hypothesis of a study pertains the result of primary outcome (also used to calculate sample size)
has study hypothesis
has priority
is study hypothesis of
is factor variable of
is outcome variable of
has study design
has comparative intent
is dependent variable of
has allocation type
has target subject
is independent variable of
"has study design characteristics" is a superproperty of "has study design" and "has study characteristics". Therefore, if a study has design X, and X has design characteristics Y, then the study has study design characteristics Y.
has study design characteristic
has study status
has design characteristic
The reference time point against which a relative time is defined (e.g., the "enrollment" time in "3 weeks after enrollment").
has anchor time
annotation
has biospecimen availability
has biospecimen preservation method
has biospecimen tissue source
has biospecimen type
A code is the terminology code of a concept
code for
The duration of an interval or the offset from an anchor time point.
duration
The finding associated with a clinical event
has finding
"elements" denotes members in the sense of a collection (i.e., object aggregate) containing its elements. It is distinguished from "members" in the sense of social relationship between an organization and its members.
has element
has factor variable
The population is composed of the indicated study subjects.
has member
has variable characteristic
A single research event (a clinical situation itself) has multiple clinical situations as part of its definition.
includes situation
is defined by
is code for
is element of
is member of
has offset
A performed activity operationalize a planned activity
operationalize
operationalized_by
If C and C' are entities or events, C has_part C' if C' is in "part of" relationship with C
has part
A component of is a "part-whole" relationship with another component. The component can either be an entity or an event.
part of
The first event occurs before the second event in time.
precedes
The procedured performed in a Performed procedure clinical event
procedure
has_semantic_constraint links syntactic criterion (e.g., eligibility criteria) to a class expression involving other entities and events that describes the things that satisfy the meaning of the criterion
has semantic constraint
The start time (lower bound) of a time interval
has start time
The stop time (upper bound) of a time interval
has stop time
study design object property
The first event is the last event occuring immediately before the second event in time.
immediately_precedes
derives
An outcome is_analyzied_using some statistical method
has analysis method
has analysis type
has assessment method
HL7 RIM
has effective time
has biospecimen collected
has factor phenomenon
A statistical analysis is performed on the outcome variables of designated groups of subjects
has group
has health condition studied
has popoulation
ocre:is_derived_from o ocre:has_outcome_phenomenon
has study phenomenon
has study protocol
The phenomenon associated with an outcome may be a clinical phenotype some other phenomenon of interest
has term code
A relationship between instances Variable specification signifying that the domain variable specification is derived from the range variable specification through some function involving the range variable specification
Samson
is derived from
is studied in trial
is design characteristic of
is study phenomenon of
outcome related property
has outcome analysis
The property chain "outcome phenomenon o term code => outcome code, causes Pellet to complain about subproperty chain being unsupported feature.
has outcome code
has outcome variable
The study has the identified events.
has study event
The study has the identified populations.
has study population
study population property
The study has the identified subjects.
has study subject
The identified clinical situation has the identified clinical subject as its sole or primary subject.
has subject
has age restriction
has eligibility criterion
is eligibility criterion of
has gender restriction
The substrance administered in a Substance Administration event
has subjstance administered
The unit component of a Quantity
has unit
The identified clinical subject is the sole or primary subject of the identified clinical situation.
is subject of
executed at
A StudySite executes some Study Protocol (from BRIDG 1.1.1)
executes
A healthcare organization functions as a study site (from BRIDG 1).1.1
function as
has address
has contact for public queries
has identifier
has principal investigator
has recruitment status
has scheme
is address of
A Role is played by some Organization or Entity
is played by
is principal investigator of
A social institution or entity plays some role
plays
is sponsor of
has laboratory site
is laboratory site of
has study
is recruitment site of
is funder of
has performance site
has IRB
has sponsor
has funder
has recruitment site
is IRB of
A property of a statistical concept
statistics property
The probability distribution of a variable in a plan for statistical analysis
has distribution
has dependent variable
Specifies that a Variable specification is an independent variable of an Outcome analysis specification
has independent variable
A statistical analysis for which a statistical method is permissible, given the data types of the variables involved
is permissible method of
A permissible statistical method of a statistical analysis, given the data types of the variables involved
has permissible method
The data type of a variable in a plan for statistical analysis
has measurement dimension
entity conclusions are about
entity directly observed
entity assigned
entity recruited or selected
entity subject to intervention or exposure
finest-grained entity available for analysis
This is a relationship between two acts. This relationship asserts that an epoch must be a division of one and only one study protocol. This relationship also asserts that a study protocol must be divided into one or more epochs.
is divided into
This is a relationship between two acts. This relationship asserts that an epoch must be a division of one and only one study protocol. This relationship also asserts that a study protocol must be divided into one or more epochs.
is a division of
dose
composite
daily dose total
dose frequency code
has code
has planned component relationship
occurs in
component
contains
route of administration
top study protocol object property
has public description
has value
has scientific description
has country
has funding number
A postal code designating a region defined by the postal service.
Simona
has zip
has recruitment in the past
study design data property
Simona: it does not seem right tha actual sample size is a sub-property of study design data property.
has actual sample size
has case definition
has planned sample size
has power calculation
Source of participants and method of recruitment
has recruitment
administrative data property
address
has address string
has date of first enrollment
has date of last enrollment
has public title
has scientific title
has description date
has recruitment in the present
has recruitment in the future
concept descriptor property
The plain code symbol defined by the code system, or an expression in a syntax defined by the code system which describes the concept.
The unique code of a term in a controlled vocabulary.
Simona
HL7 Abstract Data Type specification Release 2
has code
The common name of the coding system.
The code system name has no computational value.
Note: The purpose of a code system name is to assist an unaided human interpreter of a code value to interpret code system.
Simona
HL7 Abstract Data Type specification Release 2
has code system name
If applicable, a version descriptor defined specifically for the given code system.
Simona
HL7 Abstract Data Type specification Release 2
has code system version
A name, title, or representation for the code or expression as it exists in the code system.
The preferred name of a term in a coding system
Was: has preferred name
Simona
HL7 Abstract Data Type specification Release 2
has display name
Textual description
has description
has name
first name of a person
has first name
last name of a person
has last name
The number of subjects expected to be included in the given population, either for statistical power calculations or based on demographic prediction.
has target number
The number of individuals who failed to complete the process, procedure or assessment specified because the subject died during the events.
has number lost because of death
The number of individuals who failed to complete the process, procedure or assessment specified because the subject chose not to complete.
has number lost because of refusal
The number of individuals who failed to complete the process, procedure or assessment specified because the clinician chose not to complete.
has number lost because of rejection
The number of individuals who failed to completed the process, procedure or assessment specified for whatever reason. N(considered) = N(completed) + N(lost)
has number lost
The number of individuals who successfully completed the process, procedure or assessment specified. N(considered) = N(completed) + N(lost)
has completed population number
The number of individuals who started the process, procedure or assessment specified. N(considered) = N(completed) + N(lost)
has considered population number
has study population number
A unique identifier that guarantees the global uniqueness of the instance identifier. The root alone may be the entire instance identifier.
has root
A character string as a unique identifier within the scope of the identifier root.
has extension
This is a human-readable name for the namespace represented in the root. It is a descriptive name for the actual namespace. e.g. "California, U.S. Driver's License Number, 1970-".
has identifier name
instance identifier property
Randomization is the process of randomly allocating participants into one of the arms of a controlled trial. There are two components to randomisation: the generation of a random sequence [allocation scheme], and its implementation [allocation concealment method], ideally in a way so that those entering participants into a study are not aware of the sequence (concealment of allocation).
Examples:
- Centralized (e.g., allocation by a central office unaware of subject characteristics) or pharmacy-controlled.
- On-site computer system holding a locked unreadable computer file that can be accessed only after the characteristics of an enrolled participant have been entered.
- Sequentially numbered, opaque, sealed envelopes.
Simona
Glossary in The Cochrane Collaboration. Available at http://www.cochrane.org/glossary
Allocation concealment method describes the process used to ensure that the person deciding to enter a participant into a randomised controlled trial does not know the comparison group into which that individual will be allocated. This is distinct from blinding, and is aimed at preventing selection bias. Some attempts at concealing allocation are more prone to manipulation than others, and the method of allocation concealment is used as an assessment of the quality of a trial. [Glossary of Terms in The Cochrane Collaboration]
Examples:
- Centralized (e.g., allocation by a central office unaware of subject characteristics) or pharmacy-controlled.
- On-site computer system holding a locked unreadable computer file that can be accessed only after the characteristics of an enrolled participant have been entered.
- Sequentially numbered, opaque, sealed envelopes.
has allocation concealment method
Study includes an analysis of cost.
Simona: used ot be a class
has analysis of cost
[In a case-control study:] Choosing one or more controls with particular matching attributes for each case. Researchers match cases and controls according to particular variables that are thought to be important, such as age and sex.
In cohort and cross-sectional studies, matching is done for analysis.
Simona
Glossary in The Cochrane Collaboration. Available at http://www.cochrane.org/glossary
has matching
In a pooled data study, the analysis is performed on subject-level results collected in two or more studies, with their own protocol(s). A study can include both original (de novo) data collection and the use of data pooled from one or more other studies. This is different from meta-analysis, where summary results from different studies are combined.
Simona
Simona: used to be a class.
has pooled data
has sequence number
repeat quantity
IAO:0000027
data item
IAO:0000030
information content entity
IAO:0000078
curation status specification
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.
Better to represent curation as a process with parts and then relate labels to that process (in IAO meeting)
PERSON:Bill Bug
GROUP:OBI:<http://purl.obolibrary.org/obo/obi>
OBI_0000266
curation status specification
IAO:0000102
data about an ontology part is a data item about a part of an ontology, for example a term
Person:Alan Ruttenberg
data about an ontology part
IAO:0000225
obsolescence reason specification
The reason for which a term has been deprecated. 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.
The creation of this class has been inspired in part by Werner Ceusters' paper, Applying evolutionary terminology auditing to the Gene Ontology.
PERSON: Alan Ruttenberg
PERSON: Melanie Courtot
obsolescence reason specification
IAO:0000409
The Basic Formal Ontology ontology makes a distinction between Universals and defined classes, where the formal are "natural kinds" and the latter arbitrary collections of entities.
A denotator type indicates how a term should be interpreted from an ontological perspective.
Alan Ruttenberg
Barry Smith, Werner Ceusters
denotator type
HSDB_OCRe:OCRE536811
An enumeration of the types of subclassing that are possible in XML Schema (extension and restriction)
Subclass type
OCRE001000
A study status applied to a study that has been approved by the relevant regulatory agency (if applicable) and for which protocol-dictated activities are occurring.
Simona
Study active
false
false
true
OCRE085000
A "recruitment not yet started study" is a study for which participants are not yet being recruited.
Simona
Recruitment not yet started study
OCRE158000
A study population followed prospectively over time.
Simona
Cohort population
OCRE182000
A cohort population whose members share the same assigned intervention.
Note: arm population is defined only within the context of an interventional study.
Simona
Arm population
OCRe:OCRE200107
A univariate analysis where the independent variable is dichotomous and the dependent variable is quantitative
I dichotomous D quantitative
OCRE261000
A recruitment status applied to a study for which participants will not be recruited, because the study is withdrawn.
Simona
Recruitment will not start
OCRE316000
A "terminated study" is a study that was halted prematurely and will not resume.
Simona
Terminated study
OCRE364000
Priority
OCRE386000
A "suspended study" is a study for which protocol-dictated activities have halted prematurely but potentially will resume.
Simona
Suspended study
OCRE400000
A study status applied to a study in the planning stage: protocol is being developed and has not yet been submitted for regulatory approval (if applicable).
Simona
Study planned
OCRE400001
An instance identifier is an identifier that uniquely identifies a thing or object. Examples are object identifier for HL7 RIM objects, medical record number, order id, service catalog item id, Vehicle Identification Number (VIN), etc. Instance identifiers are defined based on ISO object identifiers.
Simona
HL7 Data Types Abstract specification. Available at http://healthinfo.med.dal.ca/hl7intro/CDA_R2_NormativeWebEdition/infrastructure/datatypes/datatypes.htm
Instance identifier
1
2
OCRE400002
A term imported from some external standard terminology
Domain term
OCRE400003
ocre:OCRE400003
The recruitment status describes the overall accrual (enrollment) activity for the study.
Simona
Recruitment status
OCRE400004
An event is a processual entity [span:ProcessualEntity] that is a maximally connected spatiotemporal whole and has bona fide beginnings and endings corresponding to real discontinuities.
Examples: the life of an organism, the process of sleeping, the process of cell-division
Simona
BFO
Process
Event
OCRE400005
The scheme used to describe the telecommunication address (e.g., ftp, http, etc.)
Simona
Telecommunication scheme
OCRE400006
A study status applied to a study halted prematurely, prior to enrollment of first participant.
Simona
ClinicalTrials.gov Protocol Data Element Definitions for Overall recruitment status Withdrawn. Available at http://prsinfo.clinicaltrials.gov/definitions.html
Study withdrawn
true
false
true
OCRE400009
A "recruitment suspended study" is a study for which recruiting or enrolling participants has halted prematurely but potentially will resume.
Simona
Recruitment suspended study
OCRE400010
OCRe:OCRE400010
ocre:OCRE400010
Classes that define sets of permissible values.
Simona
Value set
OCRE400012
A relative time point is a time point defined in terms of an offset duration before or after a reference or anchor time point (e.g., 2 months after the start of treatment).
Relative time point
OCRE400013
Biospecimen availability describes whether, for a study, biospecimens are available.
Simona
Biospecimen availability
OCRE400014
ocre:OCRE400014
A telecommunications address specified according to Internet standard RFC 2396 [http://www.ietf.org/rfc/rfc2396.txt]. The URI specifies the protocol and the contact point defined by that protocol for the resource. Notable uses of the telecommunication address data type are for telephone and telefax numbers, e-mail addresses, Hypertext references, FTP references, etc.
Samson
HL7 Data Types Abstract specification. Available at http://healthinfo.med.dal.ca/hl7intro/CDA_R2_NormativeWebEdition/infrastructure/datatypes/datatypes.htm
Telecommunication address
OCRE400015
A physical entity is an entity that has existence in time and space. An entity is that which is perceived or known or inferred to have its own distinct existence (living or nonliving)
Simona
bfo:material entity
Physical entity
OCRE400016
ocre:OCRE400016
A recruitment status applied to a study for which participants are currently being recruited.
Simona
ClinicalTrials.gov Protocol Data Element Definition for Overall recruitment status Recruiting. Available at http://prsinfo.clinicaltrials.gov/definitions.html
Recruitment active
OCRE400018
OTC media is a biospecimen preservation method whereby a fresh specimen is frozen onto a sectioning planchet using OCT (Optimum Cutting Temperature) and then stored frozen
Herb
OCT media
OCRE400019
Fast freeze is a biospecimen preservation method whereby the specimen is placed into typically liquid nitrogen or dry ice so the specimen is frozen in seconds then stored colder than (-160° C)
Herb
Fast freeze
OCRE400020
Biospecimen preservation method describes the method used to preserve a biospecimen.
Simona
Biospecimen preservation method
OCRE400021
A physical substance. For example, drug, device, specimen
Simona
BRIDG 3.0 Available at http://bridgmodel.nci.nih.gov/
Material
OCRE400022
Formalin fixation is a biospecimen preservation method whereby the specimen is typically fixed overnight in buffered formalin and then embedded in paraffin and stored at room temperature
Herb
Formalin fixation
OCRE400023
The quantity data type is an abstract generalization for all data types (1) whose value set has an order relation (less-or-equal) and (2) where difference is defined in all of the data type's totally ordered value subsets
Quantity
OCRE400024
A point on the time axis of a coordinate system.
Time point
OCRE400025
An anatomical structure consisting of similarly specialized cells and intercellular matrix, aggregated according to genetically determined spatial relationships, performing a specific function.
Simona
NCI thesaurus entry for Tissue. Available at http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C12801
Tissue
OCRE400026
A variable is a placeholder for one or a set of data values
Variable
OCRE400027
The function played by entity in some process. When applied to person it implies a set of behavior, rights, and obligations.
Role
OCRE400028
A description of the variables whose data are collected in the study.
Samson
Study data specification
OCRE400029
ocre:OCRE400029
A study is a program of data collection and of analysis of the data collected to answer a particular question, to reach conclusions about subject(s) or situation(s).
Study
9
4
3
8
10
11
6
14
13
12
2
18
16
1
15
7
5
17
OCRE400030
A recruitment status applied to a study that has concluded recruitment as planned (i.e., last patient in has occurred)
Simona
Recruitment completed
OCRE400031
An abstract data type that is the generalization of all concrete data types
Data value
OCRE400032
ocre:OCRE400032
A physical thing, group of physical things, an organization or information content that can exist in multiple forms.
Entity
OCRE400033
A collection of organisms.
Simona
Organism collection
OCRE400034
A tissue with red blood cells, white blood cells, platelets, and other substances suspended in fluid called plasma. Blood takes oxygen and nutrients to the tissues, and carries away wastes.
Simona
NCI Glossary
Blood
OCRE400035
One or more of the smallest units of living structure capable of independent existence, composed of a membrane-enclosed mass of protoplasm and containing a nucleus or nucleoid.
Simona
NCI Thesaurus entry for Cell. Available at http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C12508
Cells
OCRE400038
An interval on the time axis of a coordinate system
Time interval
OCRE400039
ocre:OCRE400039
A postal address is a mailing and home or office address. A sequence of address parts, such as street or post office Box, city, postal code, country, etc.
Simona
HL7 Data Types Abstract specification. Available at http://healthinfo.med.dal.ca/hl7intro/CDA_R2_NormativeWebEdition/infrastructure/datatypes/datatypes.htm
Postal address
2
1
OCRE400040
ocre:OCRE400040
An address includes the particulars of where a person or organization has the mail delivered (postal address) or can be reached with means other than mail (telecommunication address).
Simona
Address
1
OCRE400041
A phenomenon is a fact or event of interest susceptible to scientific description and explanation
Simona
Merriam-Webster's Dictionary entry for phenomenon. Available at http://www.merriam-webster.com/dictionary/phenomenon
Study phenomenon
OCRE400042
Criterion is a placeholder class that represent a Boolean expression (e.g., an eligibility criterion)
Criterion
OCRE400044
A collection is a group of things or people.
Simona
New Oxford American Dictionary
Collection
OCRE400046
An observation is an activity whose intention is to obtain a result by observing, monitoring, measuring or otherwise qualitatively or quantitatively gathering data or information about one or more aspects of a study subject's or experimental unit's physiologic or psychologic state.
Examples: blood chemistry panel, body mass index calculation, blood pressure measurement.
Simona
BRIDG 3.0.3 definition of DefinedObservation. Available at http://bridgmodel.nci.nih.gov/
Observation
OCRE400047
A meta-level characterization of a study
Study characteristic
OCRE400048
A "withdrawn study" is a study halted prematurely, prior to enrollment of first participant.
Simona
Withdrawn study
OCRE400049
Method for assessing an outcome, such as a questionnaire or laboratory test.
Samson
Assessment method specification
OCRE400050
ocre:OCRE400050
A description of the variable whose values are the quantitative or enumerable data collected in a study
Samson
Variable specification
true
false
false
OCRE400052
A "recruitment terminated study" is a study for which recruiting or enrolling participants has halted prematurely and will not resume.
Simona
Recruitment terminated study
OCRE400053
A study status applied to a study in which all data has been collected (last patient's last visit has occurred) and the analysis performed. Results may or may not have been published.
Simona
Study completed
OCRE400054
Any fluid in the body including blood, urine, saliva, sputum, tears, semen, milk, or vaginal secretions
Simona
Bodily fluid
OCRE400055
OCRe:OCRE400055
A CD (concept descriptor) represents any kind of concept usually by giving a code defined in a code system. A concept descriptor can contain the original text or phrase that served as the basis of the coding and one or more translations into different coding systems. A concept descriptor can also contain qualifiers to describe, e.g., the concept of a "left foot" as a postcoordinated term built from the primary code "FOOT" and the qualifier "LEFT". In cases of an exceptional value, the concept descriptor need not contain a code but only the original text describing that concept.
CD (concept descriptor) is a more general form of Coded value (CV).
In HL7 datatype specification CV constrains CE so that there can be neither qualifiers not translations, and only a single concept is allowed.
Samson
HL7 Abstract Data Type specification Release 2
CD
2
3
4
1
OCRE400056
An ecologic study is a non individual-human study in which the unit of observation is a population or community.
Simona
Adapted from: Epidemiology for the Uninitiated. Available at: http://www.bmj.com/epidem/epid.html
Ecologic study
OCRE400057
OCRe:OCRE400057
The quantity of time as measured in some unit
A physical quantity of time.
Duration
OCRE400059
Information entity is a structure whose purpose is to hold information. The structure itself is not a model of world. For example, a terminology code has properties such as terminology system, the code for a term (e.g.,"heart failure"), but the code is not a representation of thing that the term designate.
Samson Tu
Information entity
OCRE400061
The collection of organisms that are formally enrolled in a study.
Simona
Enrolled population
Study population
OCRE400064
DEFINITION:
Any individual living (or previously living) being.
Simona
BRIDG 3.0.3 definition of BiologicEntity. Available at http://bridgmodel.nci.nih.gov/
Organism
OCRE400065
Any material sample taken from a biological entity for testing, diagnostic, propagation, treatment or research purposes, including a sample obtained from a living organism or taken from the biological object after halting of all its life functions. Biospecimen can contain one or more components including but not limited to cellular molecules, cells, tissues, organs, body fluids, embryos, and body excretory products.
Simona
NCI Thesaurus entry for Biospecimen. Available at http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C70699
Biospecimen
OCRE400066
Slow freeze is a biospecimen preservation method whereby a specimen placed into environment (>or= -80° C) and allowed to freeze over minutes
Herb
Slow freeze
OCRE400067
Para-formaldehyde fixation is a biospecimen preservation method whereby a specimen is typically fixed in para-formaldehyde for hours to days and then embedded in plastic and stored at room temperature
Herb
Para-formaldehyde fixation
OCRE400068
A recruitment status applied to a study for which recruiting or enrolling participants has halted prematurely and will not resume.
Simona
ClinicalTrials.gov Protocol Data Element Definition Overall recruitment status Terminated (only the part pertaining enrollment). Available at http://prsinfo.clinicaltrials.gov/definitions.html
Recruitment terminated
true
OCRE400069
A "recruitment active study" is a study for which participants are currently being recruited.
Simona
Recruitment active study
OCRE400070
A clinical event is an event during which an assessment of, or intervention on a study subject occurs.
Simona
Clinical event
true
false
false
OCRE400071
A "recruitment completed study" is a study that has concluded recruitment (i.e., last patient in has occurred).
Simona
Recruitment completed study
OCRE400072
The specification of how an outcome of the study should be analyzed through the use of statistical methods. It includes the specification of the relevant outcome and predictor variables, the cohort groups, time of outcome assessments, and the statistical method to be used.
Samson
Outcome analysis specification
OCRE400073
A recruitment status applied to a study for which participants are not yet being recruited.
Simona
ClinicalTrials.gov Protocol Data Element Definition for Overall recruitment status Not yet recruiting. Available at http://prsinfo.clinicaltrials.gov/definitions.html
Recruitment not yet started
OCRE400074
The study status describes where the study is in its life-cycle.
Simona
Study status
OCRE400075
A recruitment status applied to a study for which recruiting or enrolling participants has halted prematurely but potentially will resume.
Simona
ClinicalTrials.gov Protocol Data Element Definition for Overall recruitment status Suspended. Available at http://prsinfo.clinicaltrials.gov/definitions.html
Recruitment suspended
OCRE400076
ocre:OCRE400076
A human being
Person
5
1
2
4
3
OCRE400078
Expression is an information entity that represent a data value or an entity that can be evaluated to yield a data value.
Expression
1
OCRE400079
ocre:OCRE400079
A formalized group of persons or other organizations collected together for a common purpose (such as administrative, legal, political) and the infrastructure to carry out that purpose.
Simona
BRIDG 3.0.3 Available at http://bridgmodel.nci.nih.gov/
Organization
1
3
2
OCRE400080
The type of a material sample taken from a biological entity for testing, diagnostic, propagation, treatment or research purposes. This includes particular types of cellular molecules, cells, tissues, organs, body fluids, embryos, and body excretory substances.
Simona
NCI Thesaurus entry for Biospecimen type. Available at: http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C70713
Biospecimen type
OCRE400115
A physical quantity is a dimensioned quantity expressing the result of measuring.
Simona
HL7 Data Types Abstract specification. Available at http://healthinfo.med.dal.ca/hl7intro/CDA_R2_NormativeWebEdition/infrastructure/datatypes/datatypes.htm
Physical quantity
OCRE449000
An "completed study" is a study in which all data has been collected (last patient's last visit has occurred) and the analysis performed. Results may or may not have been published.
Simona
Completed study
OCRE50034
ocre:OCRE50034
DEFINITION:
Fiscal support for research from industry, government, or non-commercial, non-governmental organizations.
EXAMPLE(S):
Funding from pharmaceutical, device or biotechnology companies, the US NIH or the Gates Foundation.
Simona
BRIDG 3.0.3 Available at http://bridgmodel.nci.nih.gov/
Funding
1
2
OCRE50048
Study administrative relation is a kind of relationship that an entity enters into in the design, conduct, and analysis of a study. The relationship starts when the organization agrees to undertake the activity entailed by the relationship. "Agreement to perform study activity"doesn't mean performance of a specific study activity (e.g., administration of a drug) itself, but agreement to do so. An organization becomes a "participating site" once it agrees to perform activities specified in the study protocol. It doesn't have to perform any of activities yet.
Samson
Study administrative relation
OCRE513134
ocre:OCRE513134
"Agreement to perform study activity" is a study administrative relation. It doesn't mean performance of a specific study activity (e.g., administration of a drug) itself, but agreement to do so.
Simona
Agreement to perform study activity
OCRE535847
ocre:OCRE535847
"Agreement to perform overisight" is a study administrative relation that entails agreement to perform some study activity. It doesn't mean performance of oversight per se (e.g., data safety monitoring), but agreement to do so.
Simona
Agreement to perform oversight
OCRE541581
ocre:OCRE541581
An established society, corporation, foundation or other organization founded and united for a specific purpose, e.g. for health-related research.
NCI Thesaurus entry for Institution. Available at http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C41206
Simona
Social institution
OCRE557116
ocre:OCRE557116
A person's permanent place of residence.
Simona
NCI Thesaurus entry for Home. Available at: http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C18002
Home
OCRE568687
ocre:OCRE568687
The ethics approval process is a study administrative relation whereby a study is submitted to a committee that is formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the research subjects.
Simona
Ethics approval process
OCRE581634
ocre:OCRE581634
Sponsoring is a study administrative relation whereby a person or organization takes responsibility for the initiation and management, and financing (or arranging the financing) of a clinical trial.
Simona
Sponsoring
1
2
OCRE584000
An "active study" is a study for which protocol-dictated activities are occurring.
Simona
Active study
OCRE590011
ocre:OCRE590011
"Agreement to perform study subject assessment" is a study administrative relation that entails agreement to perform some study subject assessment. It doesn't mean performance of study subject assessment per se (e.g., neorologic evaluation), but agreement to do so.
Simona
Agreement to perform study subject assessment or intervention
OCRE591890
ocre:OCRE591890
"Agreement to perform study laboratory processing" is a study administrative relation that entails agreement to perform some study activity. It doesn't mean performance of study laboratory processing per se (e.g., blood or urine tests), but agreement to do so.
Simona
Agreement to perform study laboratory processing
OCRE595405
ocre:OCRE595405
Agreement to recruit
OCRE740000
A "planned study" is a study in the planning stage: protocol is being developed and has not yet been submitted for regulatory approval (if applicable).
Simona
Planned study
OCRE793000
Objective
OCRe:OCRE817858
Cf BRIDG 3.03 DefinedSubstanceAdministraiotn definition
An activity that is an action of applying, dispensing or otherwise giving medications or other substances.
Example: Administration of methotrexate as part of chemotherapy.
Simona
BRIDG 3.0.3 definition of DefinedSubstanceAdministration. Available at http://bridgmodel.nci.nih.gov/
Planned substance administration
OCRE824000
A status applied to a study for which protocol-dictated activities have halted prematurely but potentially will resume.
Simona
Study suspended
OCRE831288
Study classified by study status
OCRE832477
Study that recruit study subjects
OCRE873851
The collection of screened organisms that satisfies all eligibility criteria for a study.
Simona
Eligible population
OCRE882000
Hypothesis
OCRe:OCRE900300
A univariate analysis where the independent variable is dichotomous and the dependent variable is nominal with cardinality greater than 2
I dichotomous D nominalGT2
OCRe:OCRE900301
A univariate analysis where the independent variable nominal with cardinality greater than 2 and the dependent dependent variable is nominal with cardinality greater than 2
I nominalGT2 D nominalGT2
OCRe:OCRE900302
A univariate analysis where the independent variable is ordinal and the dependent variable is nominal with cardinality greater than 2
I ordinal D nominalGT2
OCRe:OCRE900303
A univariate analysis where the independent variable is quantitative and the dependent variable is nominal with cardinality greater than 2
I quantitative D nominalGT2
OCRe:OCRE900304
A univariate analysis where the independent variable is dichotomous and the dependent variable is ordinal
I dichotomous D ordinal
OCRe:OCRE900305
A univariate analysis where the independent variable is nominal with cardinality greater than 2 and the dependent variable is ordinal
I nominalGT2 D ordinal
OCRe:OCRE900306
A univariate analysis where the independent variable is ordinal and the dependent variable is ordinal
I ordinal D ordinal
OCRe:OCRE900307
A univariate analysis where the independent variable is quantitative and the dependent variable is ordinal
I quantitative D ordinal
OCRe:OCRE900308
A univariate analysis where the independent variable is nominal with cardinality greater than 2 and the dependent variable is quantitative
I nominalGT2 D quantitative
OCRe:OCRE900309
A univariate analysis where the independent variable is ordinal and the dependent variable is quantitative
I ordinal D quantitative
OCRe:OCRE900310
A univariate analysis where the independent variable is quantitative and the dependent variable is quantitative
I quantitative D quantitative
OCRe:OCRE900311
A univariate analysis where the independent variable is dichotomous and the dependent variable is survival
I dichotomous D survival data
OCRe:OCRE900312
A univariate analysis where the independent variable is ordinal and the dependent variable is survival
I ordinal D survival data
OCRE908000
A status applied to a study for which protocol-dictated activities have halted prematurely and will not resume.
Simona
Study terminated
false
false
false
OCRE992000
A "recruitment will not start study" is a study for which participants have not, are not, and will not be recruited.
Simona
Recruitment will not start study
OCRE400043
A study site is a participating site in which study subject assessments or interventions are conducted.
Simona
Study site
OCRE441000
Recruitment not active
OCRE500000
An IRB [Institutiona Review Board] is a specially constituted independent review body comprised of medical, scientific and non-scientific members established and designated by an entity to ensure the protection of the rights, safety and well-being of human subjects recruited to participate in biomedical or behavioral research according to the requirements outlined in Title 38, part 16 (same as Title 45, part 46 and Title 21, part 56) of the U.S. Code of Federal Regulations. IRB responsibility include but not limited to the reviewing, approving, and providing continuing review of trial protocol and amendments and of the methods and material(s) to be used in obtaining and documenting informed consent of the trial. Other equivalent committees with the same or similar functions are also considered to be IRBs.
Simona
NCI Thesaurus entry for Institutional Review Board. Available at http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C16741
ERB
IEC
IRB
OCRE511747
A recruitment site is a study site where finding and enrolling appropriate study subjects (those selected on the basis of the protocol's inclusion/exclusion criteria) into a study occurs.
Simona
Recruitment site
OCRE534000
An organization or a person that underwrites financial support for projects of a particular type. Typically, they process applications and award funds to the chosen qualified applicants.
Simona
NCI Thesaurus entry for Funding Agency. Available at http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C39409
Funder
OCRE534515
An organization that approves, monitors and reviews biomedical research to protect the rights, safety and welfare of the study subjects. This committee performs critical oversight functions for research conducted on human study subjects that are scientific, ethical, and regulatory.
EXAMPLE(S):
Institutional Review Board (IRB), ethics committee, research ethics board, etc.
Data safety monitoring committee, protocol review and monitoring committee (or board)
Simona
BRIDG 3.0.3 Available at http://bridgmodel.nci.nih.gov/
Oversight committee
OCRE546280
A human being OR A formalized group of persons or other organizations collected together for a common purpose (such as administrative, legal, political) and the infrastructure to carry out that purpose.
Simona
Person or Organization
OCRE560892
Person or Social institution
OCRE571000
Sponsor means a person who initiates a clinical investigation, but who does not actually conduct the investigation, i.e., the test article is administered or dispensed to or used involving, a subject under the immediate direction of another individual. A person other than an individual (e.g., corporation or agency) that uses one or more of its own employees to conduct a clinical investigation it has initiated is considered to be a sponsor (not a sponsor-investigator), and the employees are considered to be investigators.
Simona
Code of Federal Regulations, Title 21, Volume 1, Revised as of April 1, 2010: 21CFR50.3. Available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=50.3
Sponsor
OCRE598434
A laboratory site is an organization where some laboratory processing for the study occurs.
Simona
Laboratory site
OCRE598730
A participating site is a social institution where study activities are conducted
Simona
Participating site
OCRe_ext:OCRE867266
An enumeration of different representations of value sets in the ontology.
Value set type
OCRE200000
Variables whose values are one or more labels for predefined categories that enumerate possble states of some characteristic (e.g., blood types A, B, AB, or O). AKA "categorical data"
Nominal scale level
OCRE200001
Measurements whose values are in one of two possible states, these often being labeled 0 and 1.
Samson
adapted from Cambridge Dictionary of Statistics 3rd edition
Dichotomous
OCRE200002
A typology of scales measure
Dimensions about how data can be ordered
Samson
Variable dimension
OCRE200003
A numeric characteristic of a distribution or of a random variable
Samson
Descriptive statistics
Distributional metric
OCRE200004
A chi-square test (also chi squared test or χ2 test) is any statistical hypothesis test in which the sampling distribution of the test statistic is a chi-square distribution when the null hypothesis is true, or any in which this is asymptotically true, meaning that the sampling distribution (if the null hypothesis is true) can be made to approximate a chi-square distribution as closely as desired by making the sample size large enough.
Simona
Wikipedia entry for Chi-square test. Available at http://en.wikipedia.org/wiki/Chi-square_test
Chi-square test
OCRE200005
Mixed linear model
OCRE200006
[see standard reference]
Linear regression
OCRE200007
The range is the difference between the lowest and highest numerical values; the limits or scale of variation.
Simona
NCI Thesaurus entry for Range. Available at http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C38013
Range
OCRE200008
The right boundary is not included in the interval
[ )
Simona
Right open
OCRE200009
[see standard reference]
Poisson regression
OCRE200010
An index of performance of a discriminant test calculated as the percentage of correct positives in all true postives
Samson
recall
Sensitivity
OCRE200011
A ratio is a quotient of quantities of the same kind for different components within the same system.
Simona
NCI Thesaurus entry for Ratio. Available at http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C44256
Ratio
OCRE200012
Exact test
OCRE200013
The Kruskal-Wallis one-way analysis of variance by ranks (named after William Kruskal and W. Allen Wallis) is a non-parametric method for testing equality of population medians among groups. It is identical to a one-way analysis of variance with the data replaced by their ranks. It is an extension of the Mann-Whitney U test to 3 or more groups.
Simona
Wikipedia entry for Kruskal–Wallis one-way analysis of variance. Available at http://en.wikipedia.org/wiki/Wallis_statistic
Kruskal Wallis method
OCRE200014
A plan for multivariate analysis where the independent variable is nominal and the dependent variable is quantitative
Simona: needs review; labels and definitions in this subtree are not clear.
Multivariate I nominal D quantitative
OCRE200015
A measurement that allows a sample of individuals to be ranked with respect to some characteristics but where differences at different points of the scale are not necessarily equivalent. (Cambridge Dictionary of Statistics 3nd ed.)
Ordinal scale level
OCRE200016
A univariate analysis where the independent variable is nominal
Independent variable nominal
OCRE200017
In S. Steven's typology of measurement scale, a variable is "a continuous variable that has an arbitrary zero point."
Cannot meaningfully compute ratios
Cambridge Dictionary of Statistics 3rd edition
Interval scale level
OCRE200018
A univariate analysis where the independent variable is quantitative and the dependent variable is dichotomous
I quantitative D dichotomous
OCRE200019
[see standard reference]
Robust regression
OCRE200020
In point observation, the width of the censoring interval is 0.
The frequency of measurements prevents one from being more accurate in time, or one of the possible states cannot be observed.
Example: we are all biallelic, but sometimes we cannot observe both allels
[x, y] x=y
Simona
Point observation
OCRE200021
The event occurred within an interval, but it is not known exactly when.
Example: the last measurement day one person was HIV negative and the first measurement day the person was positive are known, but when the seroconversion happened within that interval is not known
[x, y] x~=y
Simona
Interval censored
OCRE200022
A univariate analysis where the independent variable is nominal with cardinality greater than 2 and the dependent variable is dichotomous
I nominalGT2 D dichotomous
OCRE200023
A distribution function used to describe the occurrence of rare events or to describe the sampling distribution of isolated counts in a continuum of time or space. This special probability distribution can apply to the number of discrete independent random events occurring in a given interval when knowing their average rate of occurrence over a very long interval.
Simona
NCI Thesaurus entry for Poisson distribution. Available at http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C53212
Poisson distribution
OCRE200024
A metric measuring the "middle" or "expected" value of a distribution or of a random variable
Samson
Central tendency
OCRE200025
A proportion is a measure of the frequency of some phenomenon of interest within an average population
Ranges from 0 to 1. One way to summarize count data.
Proportion
OCRE200026
Method for deriving a variable by scoring from multiple observations or aggregating from multiple events in a subject or from multiple subjects
E.g., population-level variables
Scoring or aggregation method
OCRE200027
[see standard reference]
Logistic regression
OCRE200028
A quotient is the result obtained by dividing one quantity by another
Simona
Quotient
OCRE200029
[see standard reference]
Z-test
OCRE200030
Infinite non-countable
OCRE200031
Both boundaries are included in the interval
[ ]
Simona
Closed
OCRE200032
A univariate analysis where the dependent variable is nominal with cardinality greater than 2
Dependent variable nominalGT2
OCRE200033
The analysis of variance is a collection of statistical models, and their associated procedures, in which the observed variance is partitioned into components due to different explanatory variables. [source: Wikipedia] The total variation displayed by a set of observations, as measured by the sums of squares of deviations from the mean, may in certain circumstances be separated into components associated with defined sources of variation used as criteria of classification for the observations. Such an analysis is called an analysis of variance, although in the strict sense it is an analysis of sums of squares.
Simona
OECD Glossary of Statistical Terms entry for Variance Analysis. Available at http://stats.oecd.org/glossary/detail.asp?ID=3885
Analysis of variance
OCRE200034
How measurements of "equal value" of interval data can be differentiated
Whether 0, 1 or both interval boundaries are included.
Simona
Interval data tie-breaking distinction
OCRE200035
Variables derived from taking the sum of two other variables
Sum
OCRE200036
Variables whose values are unitary measurements that cannot be defined from other variables
Scale level
OCRE200037
The lambda co-efficient of an exponential distribution
Lambda
OCRE200038
Ties are exact
Discrete
OCRE200039
The median is the middle value in a data set: i.e., the value which has an equal number of values greater and less than it.
Simona
Median
OCRE200040
Variables derived from taking the difference of two other variables. For example, the first difference of a time series {yt} is defined as Dyt = yt - yt-1
Difference
OCRE200041
In probability theory and statistics, the exponential distribution (a.k.a. negative exponential distribution) is a family of continuous probability distributions. It describes the time between events in a Poisson process, i.e. a process in which events occur continuously and independently at a constant average rate.
A class of probability distribution with probability density function (pdf) of f(x;lambda) = 1 - exp(-lambda*x) for x >-0 ; 0 otherwise
Simona
Wikipedia entry for Exponential distribution. Available at http://en.wikipedia.org/wiki/Exponential_distribution
Exponential distribution
OCRE200042
A rate is a quantity per unit of time.
(Cambridge Dictionary of Statistics 3nd ed.) A measure of the frequency of some phenomenon of interest given by rate: number of events in specified period / average population during the period.
The (Cambridge Dictionary of Statistics 3nd ed.) definition of rate is our definition of proportion.
Rate
OCRE200043
In probability theory, a log-normal distribution is a probability distribution of a random variable whose logarithm is normally distributed. If X is a random variable with a normal distribution, then Y = exp(X) has a log-normal distribution; likewise, if Y is log-normally distributed, then X = log(Y) is normally distributed. (This is true regardless of the base of the logarithmic function: if loga(Y) is normally distributed, then so is logb(Y), for any two positive numbers a, b ≠ 1.)
Simona
Wikipedia entry for Log-normal distribution. Available at http://en.wikipedia.org/wiki/Log-normal_distribution
Log-normal distribution
OCRE200044
[see standard reference]
Polychotomous regression
OCRE200045
A univariate analysis where the independent variable is dichotomous and the dependent variable is dichotomous
I dichotomous D dichotomous
OCRE200046
A plan for multivariate analysis where the independent variable is nominal and the dependent variable is nominal with cardinality greater than 2
Simona: needs review; labels and definitions in this subtree are not clear.
Multivariate I nominal D nominalGT2
OCRE200047
A categorical method is a statistical technique that uses categorical (nominal) data.
Simona
Categorical method
OCRE200048
The left boundary is not included in the interval
( ]
Simona
Left open
OCRE200049
Quantitative scale level
OCRE200050
In probability theory and statistics, the chi-square distribution (also chi-squared or χ²-distribution) with k degrees of freedom is the distribution of a sum of the squares of k independent standard normal random variables.
Simona
Wikipedia entry for Chi-square distribution. Available at http://en.wikipedia.org/wiki/Chi-square_distribution
Chi-square distribution
OCRE200051
Non-linear model
OCRE200052
Neither boundary is included in the interval
( )
Simona
Open
OCRE200053
statistics:OCRE200053
Meta data characterizing the plan to analyze a set of data
Statistical analysis type
2
OCRE200054
[see standard reference]
Cox regression
OCRE200055
The variate distance between the upper and lower quartiles. This range contains one half of the total frequency and provides a simple measure of dispersion which is useful in descriptive statistics
OECD glossary of Statistical Terms entry for Interquartile range. Available at http://stats.oecd.org/glossary/detail.asp?ID=3761
Interquartile range
OCRE200056
[see standard reference]
Quantile regression
OCRE200057
The mean is the sum of a set of values divided by the number of values in the set.
Simona
NCI thesaurus entry for Mean Available at http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C53319
Statistical mean
Mean
OCRE200058
The mode is the value which occurs most often in a set of values. If no value is repeated, there is no mode. If more than one value occurs with the same greatest frequency, each value is a mode.
Simona
NCI thesaurus entry for Mode. Available at http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C53320
Mode
OCRE200059
A univariate analysis where the independent variable is ordinal with cardinality greater than 2 and the dependent variable is dichotomous
I ordinalGT2 D dichotomous
OCRE200060
A univariate analysis where the dependent variable is ordinal
Dependent variable ordinal
OCRE200061
statistics:OCRE200061
A procedure for performing statistical inference
Note that we are excluding descriptive statistical method
Statistical method
OCRE200062
Ties are not exact
Continuous
OCRE200063
In probability theory and statistics, the gamma distribution is a two-parameter family of continuous probability distributions. It has a scale parameter θ and a shape parameter k. If k is an integer, then the distribution represents an Erlang distribution, i.e., the sum of k independent exponentially distributed random variables, each of which has a mean of θ (which is equivalent to a rate parameter of θ −1) .
The gamma distribution is frequently a probability model for waiting times; for instance, in life testing, the waiting time until death is a random variable that is frequently modeled with a gamma distribution.
Simona
Wikipedia entry for Gamma distribution. Available at http://en.wikipedia.org/wiki/Gamma_distribution
Gamma distribution
OCRE200064
The event occurred some time before the last measurement, but it is not known exactly when.
Example: one person tests HIV positive, but there is no negative test result, so it is not possible to estalish a time interval for seroconversion
[x, y], x unknown
Simona
Left censored
OCRE200065
In probability theory and statistics, the binomial distribution is the discrete probability distribution of the number of successes in a sequence of n independent yes/no experiments, each of which yields success with probability p. Such a success/failure experiment is also called a Bernoulli experiment or Bernoulli trial.
Simona
Wikipedia entry for Binomial distribution. Available at http://en.wikipedia.org/wiki/Binomial_distribution
Binomial distribution
OCRE200066
[see standard reference]
Spearmans rank correlation coefficient
OCRE200067
General estimating equation
OCRE200068
Odds is a quotient in which the relative likelihood that an event will occur is divided by the the relative likelihood that it won't. In probability theory and statistics, where the variable "p" is the probability in favor of the event, and the probability against the event is 1-p, "the odds" of the event are the quotient of the two, or p / (1-p)
Simona
Odds
OCRE200069
A plan for multivariate analysis where the independent variable is multivariate and the dependent variable is ordinal
Simona: needs review; labels and definitions in this subtree are not clear.
Multivariate D ordinal
OCRE200070
[see standard reference]
Student's t-test
OCRE200071
Generalized linear model
OCRE200072
Object and values that related to the description of statistical analysis
Statistical concept
1
OCRE200073
Logrank test
Simona: changed label to 'Product limit estimation', which can be tested with a logrank test and the result is the Kaplan-Meier curve. The logrank test allows to compare two or more KM curves
Product limit estimation
OCRE200074
The analysis of covariance (ANCOVA) is a general linear model with one continuous outcome variable (quantitative) and one or more factor variables (qualitative). ANCOVA is a merger of ANOVA and regression for continuous variables. ANCOVA tests whether certain factors have an effect on the outcome variable after removing the variance for which quantitative predictors (covariates) account.
Simona
Wikipedia entry for Analysis of covariance. Available at: http://en.wikipedia.org/wiki/Analysis_of_covariance
Analysis of covariance
OCRE200075
The variance is the mean square deviation of the variable around the average value. It reflects the dispersion of the empirical values around its mean. (http://stats.oecd.org/glossary/detail.asp?ID=5160)
Variance
OCRE200076
Number of possible outcomes
Describe background of data, how to present data when you plot it
Granularity
OCRE200077
A plot of the sensitivity of a discriminant test against one minus its specificity
ROC curve
OCRE200078
The normal distribution is a family of probability density functions whose mean, median and mode are identical. The function generates a symmetrical curve, whose position and shape is determined by its location and scale parameters, the mean and standard deviation respectively. The standard normal distribution has a location parameter of 0 and a scale parameter of 1.
Simona
NCI Thesaurus entry for Normal distribution. Available at http://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C53215
Normal distribution
OCRE200079
A univariate analysis where the dependent variable is dichotomous
Dependent variable dichotomous
OCRE200080
A distribution metric of the exponential distribution
Exponential distribution metric
OCRE200081
[see standard reference]
Wilcoxon rank sum test
OCRE200082
A plan for multivariate analysis where the independent variable is multivariate and the dependent variable is survival data
Simona: needs review; labels and definitions in this subtree are not clear.
Multivariate D survival data
OCRE200083
In probability theory and statistics, the discrete uniform distribution is a probability distribution whereby a finite number of equally spaced values are equally likely to be observed; every one of n values has equal probability 1/n. Another way of saying "discrete uniform distribution" would be "a known, finite number of equally spaced outcomes equally likely to happen."
If a random variable has any of n possible values that are equally spaced and equally probable, then it has a discrete uniform distribution. The probability of any outcome ki is 1 / n. A simple example of the discrete uniform distribution is throwing a fair die.
Simona
Wikipedia entry for Uniform distribution (discrete). Available at http://en.wikipedia.org/wiki/Uniform_distribution_(discrete)
Discrete uniform distribution
OCRE200084
Categorical variables with more than two categories
Polychotomous
OCRE200085
How measurements of "equal value" can be differentiated
Simona
Tie-breaking distinction
OCRE200086
A measure of a test's accuracy defined as the harmonic mean of sensitivity and specificity F= 2*(specificity * sensitivity)/(specificity + sensitivity)
F1 score
F measure
OCRE200087
For a discrete random variable, a mathematical formula that gives the probability of each value of the variable. For a continuous random variable, a curve described by a mathematical formula which specifies, by way of areas under the curve, the probability that the variable falls within a particular interval.
Cambridge Dictionary of Statistics 3rd edition
Probability distribution
OCRE200088
Censoring type is a particular type of interval creation.
Censoring means that one event prevents another event from being observed (e.g., end of study prevents possible evidence of success or failure from being observed).
Though usually employed in the context of time-to-failure, this is not only about time, but it can be about any dimension of interest (e.g., if the measurement is above the maximum value in the scale used, then the measurement is right censored; if it is lower than the minimum detectable, then it is left censored).
Simona
Censoring type
OCRE200089
In S. Steven's typology of measurement scale, a ratio variable is "a continuous variable that has a fixed rather than an arbitrary zero point."
Examples: weight, height, temperature measured in degrees Kelvin
Can compute ratios
Cambridge Dictionary of Statistics 3rd edition
Absolute scale level
OCRE200090
An index of performance of a discriminant test calculated as the percentage of negatives in all true negatives
Samson
Specificity
OCRE200091
Polychotomous finite
1
OCRE200092
A plan for statistical analysis where there is only one independent variable
Univariate analysis
OCRE200093
A metric measuring the variability of a distribution or of a random variable
Dispersion
OCRE200094
Polarity
OCRE200095
An time-to-failure method is a statistical technique relating to preparation of mortality and other analytical tables. It uses data from the past to predict the future.
Simona
Time-to-failure method
OCRE200096
In probability theory and statistics, the continuous uniform distribution or rectangular distribution is a family of probability distributions such that for each member of the family, all intervals of the same length on the distribution's support are equally probable. The support is defined by the two parameters, a and b, which are its minimum and maximum values. The distribution is often abbreviated U(a,b).
Simona
Wikipedia entry for Uniform distribution (continuous). Available at http://en.wikipedia.org/wiki/Uniform_distribution_(continuous)
Simona: Wikipedia entry "does not cite any references or sources" Confirmation needed
Continuous uniform distribution
2
OCRE200097
A plan for statistical analysis where there is more than one independent variable and some of those variables are not of the ordinal scale
Multivariate analysis I non-ordinal
OCRE200098
A univariate analysis where the dependent variable is interval/absolute scale level
Dependent variable quantitative scale
OCRE200099
A plan for multivariate analysis where some independent variables are non-ordinal and the dependent variable is dichotomous
Simona: needs review; labels and definitions in this subtree are not clear.
Multivariate I non-ordinal D dichotomous
OCRE200100
An index of performance of a discriminant test with binary outcome
Samson
Classification analysis metric
OCRE200101
In mathematics, a countable set is a set with the same cardinality (number of elements) as some subset of the set of natural numbers.
Simona
Wikipedia entry for Countable set. Available at http://en.wikipedia.org/wiki/Countable_set
Infinite countable
OCRE200102
Linear mixed effect model
OCRE200103
Data representing the times of the occurrances of events of interest
On scale of time. Often censored. A difference in time.
Also whether an event occurs (lowerbound of time to event) Measurement can be one number or an interval. 3 categories: same L & Ul, right censoring (know lowerbound), an interval
Survival data
Time to event
OCRE200104
Non linear mixed effect model
OCRE200105
The event my have occurred some time after the last measurement, but it is not known exactly whether it has, because there are no further observations.
Example: one person tests HIV negative at some point, but there are no further observations (e.g., the individual moved, or died), so it is not known whether the person has seroconverted or not
[x, y], x unknown
Simona
Right censored
OCRE200106
A univariate analysis where the dependent variable is survival data
Dependent variable survival data
OCRE693000
How measurements of "equal value" of point data can be differentiated
Simona
Point data tie-breaking distinction
study_design:OCRE100001
Each case serves as its own control
Simona
Case and control in same experimental unit
study_design:OCRE100002
In the context of a study where the main comparison is within experimental units, investigator assigns regimen of interventions to an allocation group made up of one (single) or of more than one (multiple) experimental unit.
Simona
Allocation group cardinality
study_design:OCRE100003
The scheme used to assign regimens of interventions: single factor or factorial.
Simona
Intervention assignment scheme
study_design:OCRE100004
Cases and controls (or exposed and unexposed) are drawn from the same study cohort/sample.
Simona
Nested
study_design:OCRE100005
A meta-level characterization of the design of a study
Simona
Study design characteristic
study_design:OCRE100006
Probability sampling is an exclusively random process to guarantee that each participant or population has specified chance of selection, such as simple random sampling, systematic sampling, stratified random sampling, cluster sampling, and consecutive patient sampling
Simona
ClinicalTrials.gov Protocol Data Element Definitions (DRAFT). Available at http://prsinfo.clinicaltrials.gov/definitions.html
Probability sampling
study_design:OCRE100007
An interventional study is a quantitative study that prospectively assigns experimental units (human participants or groups of humans or part of human participants) 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.
Simona
WHO Available at: http://www.who.int/ictrp/en/
Simona: to be reviewed
Interventional study design
study_design:OCRE100008
Open label indicates that no blinding is in effect: the investigator and participant are aware which intervention is being used for which participant (i.e. not blinded)
Simona
Glossary in The Cochrane Collaboration. Available at http://www.cochrane.org/glossary
Open label
study_design:OCRE100009
The investigator does not actively assign study experimental units to regimens of interventions.
Simona
Investigator assigns no intervention
study_design:OCRE100011
Superiority is a type of comparative intent.
When the aim of the study is to show that an experimental (E) treatment is superior to a control (C) treatment, the RCT is called a superiority trial and the associated statistical test is a superiority test. With a significant result, one concludes in a superiority trial that E is different in effect from C, and when the observed result is in favor of E, we conclude that E is statistically, significantly better performing than C.
Simona
Bull NYU Hosp Jt Dis. 2008;66(2):150-4.
Superiority
study_design:OCRE100012
Equivalence is a type of comparative intent.
An equivalence trial is designed to determine whether the response to two or more treatments differs by an amount that is clinically unimportant. This is usually demonstrated by showing that the true treatment difference is likely to lie between a lower and an upper equivalence level of clinically acceptable differences.
Simona
Glossary in The Cochrane Collaboration. Available at http://www.cochrane.org/glossary
Equivalence
study_design:OCRE100013
In an observational study, the main variable on which the selection of experimental units is based is a predictor variable.
In this study, prospective inference occurs, i.e., from exposure to outcome.
Simona
Experimental unit selection based on predictor variable
study_design:OCRE100014
The outcome assessor does not know to which treatment group a particular participant belongs
Simona
Outcome assessor blinded
study_design:OCRE100015
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 an experimental unit 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 experimental unit 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 experimental unit at a similar time. In the matched-pair case-crossover design, the control is the same experimental unit at a different time.
Simona
Annu Rev Public Health. 2000;21:193-221.
Case-crossover study design
study_design:OCRE100016
The concept of phase is not applicable to trials studying certain interventions (e.g., device, procedure, behavioral)
Simona
Phase not applicable
study_design:OCRE100018
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]
Simona
Case-control study design
study_design:OCRE100019
Non-probability sampling is any one of a variety of non random sampling processes, such as convenience sampling or invitation to volunteer
Simona
ClinicalTrials.gov Protocol Data Element Definitions (DRAFT). Available at http://prsinfo.clinicaltrials.gov/definitions.html
Non-probability sampling
study_design:OCRE100020
A crossover study is an interventional study where the population is a more than a single experimental unit, in which at least two regimens of interventions are given alternatingly. Upon completion of one regimen, experimental units are switched to the other. For example, for a comparison of regimens A and B, the experimental units 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 experimental unit at a time.
Simona
Crossover study design
study_design:OCRE100021
Allocation scheme describes the way in which each experimental unit in an interventional trial is allocated to a treatment group.
Simona
Allocation scheme
study_design:OCRE100022
Whether cases and controls (or exposed and unexposed) are drawn from the same study cohort/sample.
Not applicable to case-crossover studies.
Simona
Control group type
study_design:OCRE100023
A cohort study in which outcomes occurred after the start of the study.
Simona
Prospective
study_design:OCRE100024
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.
Simona
Simona: to be reviewed
N-of-1 crossover study design
study_design:OCRE100025
Stratified randomization is restricted randomization used to ensure that equal numbers of participants with a characteristic thought to affect prognosis or response to the intervention will be allocated to each comparison group. For example, in a trial of women with breast cancer, it may be important to have similar numbers of pre-menopausal and postmenopausal women in each comparison group. Stratified randomisation could be used to allocate equal numbers of pre- and post-menopausal women to each treatment group. Stratified randomisation is performed by performing separate randomisation (often using random permuted blocks) for each strata.
Simona
Glossary in The Cochrane Collaboration. Available at http://www.cochrane.org/glossary
Stratified randomization
study_design:OCRE100026
The investigator actively assigns the study experimental units to one or more regimens of interventions (each including one or more interventions, or no intervention).
Simona
Investigator assigns intervention
study_design:OCRE100027
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").
Simona
Simona: to be reviewed.
Parallel group study design
study_design:OCRE100028
Mode of inquiry refers to the research method used in a study
Simona
Mode of inquiry
study_design:OCRE100029
In the context of a study where the main comparison is within experimental units, investigator assigns regimen of interventions to an allocation group made up of more than one experimental unit.
Simona
Multiple experimental unit allocation group
study_design:OCRE100030
Restricted randomization is a random allocation scheme used to control the randomization to achieve balance between groups in size (or other characteristics).
Different types of restricted randomization are as follows:
- Blocking: Blocking is used to ensure close balance of the numbers in each group at any time during the study. After every block the number of participants in each group would be equal. Of course blocking tends to reduce the unpredictability of randomization. Therefore it is recommended to use random block sizes when using block randomization.
- Stratification: Stratification ensures that the numbers of participants receiving each intervention are closely balanced within each stratum. Stratified randomization is achieved by performing a separate randomization procedure within each of two or more subsets of participants
- Minimization: Minimization is not a method of randomization. Indeed it is the only non-random method which is an acceptable alternative to randomization. Minimization ensures balance between intervention groups for several patient factors. Randomization lists are not set up in advance. The first patient is truly randomly allocated; for each subsequent patient, the treatment allocation is identified, which minimizes the imbalance between groups at that time.
Simona
http://mahmoodsaghaei.tripod.com/Softwares/randalloc.html
Simona: should we put the 3 schemes elsewhere?
Restricted randomization
study_design:OCRE100031
A quantitative research method is a deductive research process that uses statistical techniques to test a specific claim or statement about a phenomenon (a hypothesis) by collecting and analyzing data to decide whether the claim is true (i.e., accept or reject the null or alternative hypothesis).
Simona
http://www.utexas.edu/academic/ctl/assessment/iar/research/plan/types.php
Quantitative inquiry mode
study_design:OCRE100032
Quasi-random allocation is an allocation scheme that is not random, but is intended to produce similar groups when used to allocate experimental units. Quasi-random methods include: allocation by the person's date of birth, by the day of the week or month of the year, by a person's medical record number, or just allocating every alternate person. In practice, these methods of allocation are relatively easy to manipulate, introducing selection bias.
Simona
Glossary in The Cochrane Collaboration. Available at http://www.cochrane.org/glossary
Quasi-random allocation
study_design:OCRE100033
Random allocation is an allocation scheme that uses the play of chance to assign participants to comparison groups in a trial, e.g. by using a random numbers table or a computer-generated random sequence. Random allocation implies that each individual or unit being entered into a trial has the same chance of receiving each of the possible interventions. It also implies that the probability that an individual will receive a particular intervention is independent of the probability that any other individual will receive the same intervention.
Randomization is the process of randomly allocating experimental units into one of the arms of a controlled trial. There are two components to randomisation: the generation of a random sequence [allocation scheme], and its implementation [allocation concealment method], ideally in a way so that those entering participants into a study are not aware of the sequence (concealment of allocation).
Simona
Glossary in The Cochrane Collaboration. Available at http://www.cochrane.org/glossary
Random allocation
study_design:OCRE100034
Non-cases were selected based on genetic relation
Simona
Genetically related non-cases
study_design:OCRE100035
Multiple regimens of intervention, each including one or more individual interventions (treatments) or no treatment, each assigned to one allocation group. This means the study has at least one contemporaneous comparison group.
Simona
Multiple regimen
study_design:OCRE100036
The caregiver does not know to which treatment group a particular participant belongs
Simona
Caregiver blinded
study_design:OCRE100037
A single regimen of intervention, which includes one or more individual interventions (treatments), is assigned to one allocation group. This means the study has no contemporaneous comparison group.
Simona
Single regimen
study_design:OCRE100038
Phase describes the level of a trial required of drugs before (and after) they are routinely used in clinical practice:
- Phase 1 trials assess toxic effects on humans (not many people participate in them, and usually without controls);
- Phase 2 trials assess therapeutic benefit (usually involving a few hundred people, usually with controls, but not always);
- Phase 3 trials compare the new treatment against standard (or placebo) treatment (usually a full randomised controlled trial). At this point, a drug can be approved for community use.
- Phase 4 monitors a new treatment in the community, often to evaluate longterm safety and effectiveness. [Glossary of Terms in The Cochrane Collaboration]
A trial can be of a combination phase (e.g., 1/2).
The concept of phase is not applicable to trials studying certain interventions (e.g., device, procedure, behavioral)
Simona
Glossary in The Cochrane Collaboration. Available at http://www.cochrane.org/glossary
Phase
study_design:OCRE100039
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.)
Simona
Glossary in The Cochrane Collaboration. Available at: http://www.cochrane.org/glossary
Cross-sectional study design
study_design:OCRE100040
Block randomization (or Random permuted blocks) is a restricted randomisation that ensures that, at any point in a trial, roughly equal numbers of participants have been allocated to all the comparison groups. Permuted blocks should be used in trials using stratified randomisation.
Simona
Glossary in The Cochrane Collaboration. Available at http://www.cochrane.org/glossary
Block randomization
study_design:OCRE100041
The unit that is assigned to the alternative regimens of interventions being investigated in a trial. Most commonly, the unit will be an individual person, but in a cluster randomised trial, groups of people will be assigned together to one or the other of the regimens of interventions. In some other trials, different parts of a person (such as the left or right eye) might be assigned to receive different regimens of interventions.
Simona
Glossary in The Cochrane Collaboration. Available at http://www.cochrane.org/glossary
Unit of allocation
study_design:OCRE100042
The number of regimens of interventions in a study. Each regimen includes one or more individual interventions (treatments) or no intervention.
Simona
Simona: to be reviewed
Regimen cardinality
study_design:OCRE100043
The unit that is assigned to the alternative regimens of interventions being investigated in a trial. In a cluster randomised trial, groups of experimental units will be assigned together to one or the other of the regimens of interventions.
Simona
Glossary in The Cochrane Collaboration. Available at http://www.cochrane.org/glossary
Cluster as unit of allocation
study_design:OCRE100044
A quantitative study is an individual-human study whose primary mode of inquiry is quantitative.
Simona
Quantitative study design
study_design:OCRE100045
[In a controlled trial:] Blinding is the process of preventing those involved in a trial from knowing to which comparison group a particular participant belongs. The risk of bias is minimised when as few people as possible know who is receiving the experimental intervention and who the control intervention. Participants, caregivers, outcome assessors, and analysts are all candidates for being blinded. Blinding of certain groups is not always possible, for example surgeons in surgical trials. The terms single blind, double blind and triple blind are in common use, but are not used consistently and so are ambiguous unless the specific people who are blinded are listed. (Also called masking)
Simona
Glossary in The Cochrane Collaboration. Available at http://www.cochrane.org/glossary
Blinding type
study_design:OCRE100046
In the context of a study where the main comparison is within experimental units, whether data is analyzed within a single study experimental unit or within multiple experimental units.
Simona
Data analysis within experimental units
study_design:OCRE100047
A qualitative study is an individual-human study whose primary mode of inquiry is qualitative.
Simona
Qualitative study design
study_design:OCRE100048
Characteristics of the assignment experimental units (e.g., participant, eye) to a regimen of interventions
Simona
Assignment characteristics
study_design:OCRE100049
Method of sampling in observational studies.
Simona
Sampling method
study_design:OCRE100052
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.
Simona
Simona: to be reviewed
Single group study design
study_design:OCRE100053
The care provider does not know to which treatment group a particular participant belongs
Simona
Care provider blinded
study_design:OCRE100055
An observational study is a quantitative study in which the investigators do not seek to intervene, and simply observe the course of events.
Simona
Glossary in The Cochrane Collaboration. Available at http://www.cochrane.org/glossary
Observational study design
study_design:OCRE100056
A study design is a common pattern of relationships (in time and causation) among various study elements (e.g., time of intervention to outcomes assessment in which participants).
Simona
Study design
study_design:OCRE100057
A qualitative research method is an inductive research process that involves the collection and analysis of qualitative (i.e., non-numerical) data to search for patterns, themes, and holistic features.
Simona
http://www.utexas.edu/academic/ctl/assessment/iar/research/plan/types.php
For other definitions, see http://www.google.com/search?hl=en&client=safari&rls=en&defl=en&q=define:Qualitative+research
Qualitative inquiry mode
study_design:OCRE100058
The role the investigator plays in the assignment of study experimental units to one or more regimens of interventions (each including one or more interventions, or no intervention).
Simona
Investigator assignment role
study_design:OCRE100059
In a retrospective observational study (i.e., an observational study where the main variable on which experimental units selection is based is an outcome variable), experimental units with the same outcome (cases) can be compared to themselves or to other experimental units (controls).
Simona
Comparison of experimental units with the main outcome
study_design:OCRE100060
Have outcomes occurred before the study start? If yes, the cohort study is historical; if no, the cohort study is prospective.
Simona
Outcomes occurred before or after study start
study_design:OCRE100061
The main comparison is across study experimental units.
Simona
Main comparison across experimental units
study_design:OCRE100062
Cases and controls (or exposed and unexposed) are not drawn from the same cohort/sample.
[aka double cohort for cohort studies]
Simona
Non-nested
study_design:OCRE100063
Data is analyzed within multiple study experimental units.
Simona
Data analyzed within multiple experimental units
study_design:OCRE100064
The subject or individual participant does not know to which treatment group he or she or each experimental unit on him/her belongs.
or Individual participant blinded
Simona
Subject blinded
study_design:OCRE100065
In a single-factor design, an intervention is compared with one or more alternatives, or a placebo.
Simona
Glossary in The Cochrane Collaboration. Available at http://www.cochrane.org/glossary
Single-factor
study_design:OCRE100066
A Phase 4 study monitors FDA-approved drug to delineate additional information including the drug's risks, benefits, and optimal use.
Simona
ClinicalTrials.gov Protocol Data Element Definitions (DRAFT). Available at http://prsinfo.clinicaltrials.gov/definitions.html
Phase 4
study_design:OCRE100067
A Phase 1 trial 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.
Simona
ClinicalTrials.gov Protocol Data Element Definitions (DRAFT). Available at http://prsinfo.clinicaltrials.gov/definitions.html
Phase 1
study_design:OCRE100068
A Phase 0 trial is an exploratory trial involving very limited human exposure, with no therapeutic or diagnostic intent (e.g., screening study, microdose study).
Simona
ClinicalTrials.gov Protocol Data Element Definitions (DRAFT). Available at http://prsinfo.clinicaltrials.gov/definitions.html
Phase 0
study_design:OCRE100069
A Phase 3 trial includes expanded controlled and uncontrolled trials 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 and provide an adequate basis for physician labeling.
Simona
ClinicalTrials.gov Protocol Data Element Definitions (DRAFT). Available at http://prsinfo.clinicaltrials.gov/definitions.html
Phase 3
study_design:OCRE100070
A Phase 2 trial includes 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.
Simona
ClinicalTrials.gov Protocol Data Element Definitions (DRAFT). Available at http://prsinfo.clinicaltrials.gov/definitions.html
Phase 2
study_design:OCRE100071
The unit that is assigned to the alternative regimens of interventions being investigated in a trial. Most commonly, the unit will be an individual person. In some other trials, different parts of a person (such as the left or right eye) might be assigned to receive different regimens of interventions.
Simona
Individual as unit of allocation
study_design:OCRE100072
Comparative intent is an additional descriptor: Intent of comparison made in a study with two or more arms.
Simona
Comparative intent
study_design:OCRE100073
Whether the main comparison is across or within study experimental units
Simona
Main comparison and experimental units
study_design:OCRE100074
A method of allocation used to provide comparison groups that are closely similar for several variables. The next participant is assessed with regard to several characteristics, and assigned to the treatment group that has so far had fewer such people assigned to it. It can be done with a component of randomisation, where the chance of allocation to the group with fewer similar participants is less than one. Minimisation is best performed centrally with the aid of a computer program to ensure concealment of allocation.
Simona
Glossary in The Cochrane Collaboration. Available at http://www.cochrane.org/glossary
Minimization
study_design:OCRE100075
In the context of a study where the main comparison is within experimental units, investigator assigns regimen of interventions to an allocation group made up of a single experimental unit.
Simona
Single experimental unit allocation group
study_design:OCRE100076
A non-inferiority trial is designed to determine whether the effect of a new treatment is not worse than a standard treatment by more than a pre-specified amount. A one-sided version of an equivalence trial. [Glossary of Terms in The Cochrane Collaboration]
Simona
Glossary in The Cochrane Collaboration. Available at http://www.cochrane.org/glossary
Non-inferiority
study_design:OCRE100077
Non-random (or Deterministic) allocation is an allocation scheme that follows a non-random rule (e.g., sequential allocation).
Simona
Non-random allocation
study_design:OCRE100078
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.
Simona
Glossary in The Cochrane Collaboration. Available at: http://www.cochrane.org/glossary
The DL definiition of cohort study design says that a cohort study design has the characteristics "Main control group defined by exposure status" and "outcome measured after measurement of predictors."
A study design involves identification of factor variables and outcome variables. Factor variables are measured before the measurement of outcome variables.
Let C be a member of the control groups of a study S
Let SA be the set of statistical analysis of S
Let F(sa) be the independent variables of a statistical analysis sa in SA
Let O(sa) be the set of dependent variables of sa
S has 'cohort study design" if and only if
For all sa in SA,
There exists times t1 < t2 such that
there exists f in F(sa) such that for all c in C, f is measured at time t1 and f(c) = constant AND for all o in O(sa), o is measured at t2
Cohort study design
study_design:OCRE100079
In an observational study, the main variable on which the selection of experimental units is based is an outcome variable.
In this study, retrospectie inference occurs, i.e., from outcome to exposure.
Simona
Experimental unit selection based on outcome variable
study_design:OCRE100080
The statistician does not know to which treatment group a particular participant belongs
Simona
Statistician blinded
study_design:OCRE100081
The main comparison is within study experimental units.
Simona
Main comparison within experimental units
study_design:OCRE100082
Relation between cases and non-cases
Simona
Relation between cases and non-cases
study_design:OCRE100083
Simple randomization is a random allocation scheme that has no restriction, i.e. a single sequence of random assignment. When the sample size is relatively large, simple randomization is expected to produce equal sized treatment groups.
Simona
http://mahmoodsaghaei.tripod.com/Softwares/randalloc.html
Simple randomization
study_design:OCRE100084
The investigator does not know to which treatment group a particular participant belongs
Simona
Investigator blinded
study_design:OCRE100085
Data is analyzed within a single study experimental unit.
Simona
Data analyzed within single experimental unit
study_design:OCRE100086
Non-cases were not selected based on genetic relation
Simona
Genetically unrelated non-cases
study_design:OCRE100087
A cohort study in which outcomes occurred before the start of the study.
Simona
Historical
study_design:OCRE100088
A case does not serve as its own control
Simona
Case and control not in same experimental unit
study_design:OCRE100089
Factorial design is a trial design used to assess the individual contribution of treatments given in combination, as well as any interactive effect they may have... In a trial using a 2x2 factorial design, participants are allocated to one of four possible combinations... This type of study is usually carried out in circumstances where no interaction is likely.
Example: in a factorial-design study where regimens of interventions A and B are tested, the 4 possible combinations are: A, B, A and B, neither A nor B (placebo).
Simona
Glossary in The Cochrane Collaboration. Available at http://www.cochrane.org/glossary
Factorial
study_design:OCRE498000
In an observational study, the main varibale on which the selection of experimental units is based is neither an outcome nor an exposure variable.
Simona
Experimental unit selection based on neither outcome nor predictor variable
study_design:OCRE9000030
An aggregated human study is a human study in which the entity observed, recruited or selected, or subject to intervention or exposure is a population that contains persons
Simona
Aggregated-human study
study_design:OCRE9000031
An individual-human study is a human study in which the entity observed, recruited or selected, or subject to intervention or exposure is a person, or a part of a person.
Simona
Individual-human study
study_design:OCRE900028
A human study is a study in which the entity observed, recruited or selected, or subject to intervention or exposure is a person, a population of persons, or a part of a person.
Human study
study_design:OCRE900029
A non-organismal study is a study in which neither the entity observed, nor the entity recruited or selected, nor the entity subject to intervention or exposure is an organism, a population of organisms, or a part of an organism.
Simona
Non-organismal study
study_design:OCRE900032
A decision analysis is a non-organismal study technique that formally identifies the options in a decision-making process, quantifies the probable outcomes (and costs) of each (and the uncertainty around them), determines the option that best meets the objectives of the decision-maker and assesses the robustness of this conclusion.
Cost-benefit analysis, cost-effectiveness analysis and cost-utility analysis are special cases of decision analysis.
Note that this type of analysis can also be applied to outcomes in a human study.
Simona
Glossary in The Cochrane Collaboration. Available at http://www.cochrane.org/glossary
Decision analysis
study_design:OCRE900033
A policy analysis is a non-organismal study that can be defined as determining which of various alternative policies will most achieve a given set of goals in light of the relations between the policies and the goals. Policy analysis emphasizes systematic analytic methods that can be quantitative or qualitative.
Simona
Nagel, Stuart S. (Ed.), 1999, Policy Analysis Methods. New Science Publishers, Inc., pages 3 and 4
Policy analysis
study_design:OCRE900034
A technology study is a non-organismal study that uses or collects measurements or assessments about a man-made object (e.g., a device) in terms of its technical/physical performance.
Simona
Technology study
study_design:OCRE900036
An organismal study is a study in which the entity observed, recruited or selected, or subject to intervention or exposure is an organism, a population of organisms, or a part of an organism.
Organismal study
study_design:OCRE900037
A non-human organism study is a study in which the entity observed, recruited or selected, and subject to intervention or exposure is non-human organism, a population of non-human organisms, or a part of a non-human organism.
Simona
Non-human organism study
study_design:OCRE900040
A systematic review is a meta study (i.e., a study in which observations are acquired from journal articles, abstracts, etc. reporting on other studies).
A systematic review uses systematic and explicit methods to identify, select, and critically appraise relevant research, and to collect and analyse data from the studies that are included in the review. Statistical methods (meta-analysis) may or may not be used to analyse and summarise the results of the included studies.
Meta-analysis is the use of statistical techniques in a systematic review to integrate the summary results of included studies. Sometimes misused as a synonym for systematic reviews, where the review includes a meta-analysis.
Simona
Glossary in The Cochrane Collaboration. Available at http://www.cochrane.org/glossary
Systematic review
study_design:OCRE942000
In an observational study, the main variable on which the selection of experimental units is based can be an outcome variable, a predictor variable, or a variable that is neither an outcome nor a predictor one.
Simona
Main variable on which experimental unit selection is based
OCRE300000
study_protocol:OCRE300000
DEFINITION:
One of a set of ordered partitions of an experimental unit's participation in a study. An Epoch represents a state within a study such that subjects in separate arms within that state are comparable.
Each epoch serves a purpose in the trial as a whole, typically exposing the subject to a treatment or preparing them for a treatment, or gathering post-treatment data. Activities and activity results control the subject's movement from one epoch to another.
EXAMPLE(S):
A study designed to assess the effects of treatments might have 3 epochs.
A Screening Epoch in which subjects' eligibility is determined and baseline measurements are made.
A Treatment Epoch during which treatments are given and effects of treatment are assessed.
A Follow-up Epoch during which post-treatment assessments are conducted.
NOTE(S):
A subject moves from one epoch to another and can only be in one epoch at a time. The subject can only move to an epoch with a greater sequenceNumber. Activities in the same epoch but a different arm need not be similar in time and pattern. Subjects in different arms will not necessarily pass through the same epochs.
DEFINITION:
One of a set of ordered partitions of an experimental unit's planned time in a study.
Each Epoch serves a purpose in the trial as a whole, typically exposing the subject to a treatment or preparing them for a treatment, or gathering post-treatment data. Epoch-specific (state) transition rules control the subject's movement from one Epoch to another.
For example, a study designed to assess the effects of treatments might have 3 epochs, a Screening epoch in which subjects' eligibility is determined and baseline measurements are made, a Treatment epoch during which treatments are given and effects of treatment are assessed, and a Follow-up epoch during which post-treatment assessments are conducted.
NOTE: A subject moves from one Epoch to another and can only be in one epoch at a time. The subject can only move to an Epoch with a greater sequenceNumber. The main purpose of the Epoch is to organize the Arms for comparison purposes. Activities in the same Epoch but a different Arm need not be similar in time and pattern. [BRIDG Release 3]
Simona
BRIDG 3.0.3 Available at http://bridgmodel.nci.nih.gov/
Epoch
1
2
OCRE300001
study_protocol:OCRE300001
DEFINITION:
A path through the study which describes what activities the study subject or experimental unit will be involved in as they pass through the study, and is typically equivalent to a treatment group in a parallel design trial. Generally, each subject is assigned to an arm, and the design of the study is reflected in the number and composition of the individual arms. This intended path through which the subject progresses in a trial is composed of time point events (study cell) for each epoch of the study. Each time point event, in turn, has a pattern of child time points through which the subject would pass. This planned path thus describes how subjects assigned to the arm will be treated.
EXAMPLE(S):
A study could have 2 arms named IV-Oral and Oral-IV. The name IV-Oral reflects a path that passes through IV treatment, then Oral treatment.
OTHER NAME(S):
Group (CTRR Observational Studies)
Simona
BRIDG 3.0.3 Available at http://bridgmodel.nci.nih.gov/
Arm
1
2
OCRE300004
Samson Tu
Planned administrative activity
OCRE300006
Samson Tu
Planned specimen collection
OCRE300008
Samson Tu
Planned observation
OCRE300009
Samson Tu
Planned procedure
OCRE300010
study_protocol:OCRE300010
DEFINITION:
A relationship between a composite activity and the component activities that comprise it, i.e. parent and child activities where all activities are intended to occur at some point in the context of a particular study.
EXAMPLE(S):
A battery of tests may be composed of multiple routine labs that are always ordered together as a group.
A glucose tolerance test which is comprised of administering glucose and taking multiple timed blood samples which are then tested for glucose.
OTHER NAME(S):
NOTE(S):
This class helps represent an AND relationship between siblings with the same parent activity.
Samson Tu
BRIDG 3.0.3 Available at http://bridgmodel.nci.nih.gov/
Planned composition relationship
OCRE300011
study_protocol:OCRE300011
An activity that is intended to occur or start at some point in the context of a particular study.
EXAMPLE(S):
Pregnancy tests are planned for StudySubjects who are females of childbearing potential.
OTHER NAME(S):
NOTE(S):
A PlannedActivity may be a container of other activities and have a complex structure involving components, options and contingencies using the associated relationship classes. This structure allows BRIDG 3.0 to represent concepts in previous versions of BRIDG such as StudyCells, StudySegments and StudySubjectEncounters.
A PlannedActivity could also be thought of as an activity at a particular stage in the business process in which the activities occur, i.e., in the "planned" stage rather than the "scheduled" stage or the "performed" stage. An instance of a planned activity is not assigned to a particular StudySubject, but to a "kind of" StudySubject.
Samson Tu
BRIDG 3.0.3 Available at http://bridgmodel.nci.nih.gov/
Planned activity
2
1
3
OCRE300012
study_protocol:OCRE300012
A discrete, structured plan (that persists over time) of a formal investigation to assess some outcome phenomena in relation to other study phenomena.
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.
BRIDG 3.0.3 Available at http://bridgmodel.nci.nih.gov/
Previous definition: An action plan for a pre-clinical or clinical study which defines all activities planned to achieve the objectives of the study. The plan specifies, for example, the design of the study, including the subject to be included, the outcome to be studied, data to be collected, and method of analysis. A study protocol is an informational entity that is ontologically distinct from events that occur as part of the study.
BRIDG Release 2.2 definition: An action plan for a formal investigation to assess the utility, impact, pharmacological, physiological, and psychological effects of a particular treatment, procedure, drug, device, biologic, food product, cosmetic, care plan, or subject characteristic.
Note: Among other things, the action plan may include the design, statistical considerations and all activities to test a particular hypothesis that is the basis of the study. The study may be of any type that involves StudySubjects, including prevention, therapeutic, interventional or observational. Subjects may be biological entities (human, animal, specimen, tissue, organ, etc.) or products.
Simona
Study protocol
2
1
OCRE300015
Cf: BRIDG 3.03 DefinedSubjectActivityGroup DEFINITION:
A collection of activities from a global library that would be performed on a common subject.
EXAMPLE(S):
Clinic visit during which a physical exam, a blood test, and a substance administration occur
Telephone contact during which temperature, blood pressure and adverse events are reported
Recording multiple observation results in a diary
A treatment strategy that consists of drug administrations with rules for modifying doses
OTHER NAME(S):
study segment, course, treatment strategy, period, cycle
NOTE(S):
Planned subject activity group
OCRE307000
study_protocol:OCRE307000
DEFINITION:
A physical entity which is the primary unit of interest in a specific research objective. In an interventional study, the experimental unit is assigned to an intervention. The experimental unit is also the unit of primary statistical analysis. Commonly the individual study subject (animal, person or product) is the experimental unit. Different experimental units must be capable of receiving different experimental interventions.
EXAMPLE(S):
If all pigs in a pen receive the same intervention in their feed, and the primary observations and analyses of interest are associated with the entire pen (e.g. total feed consumed, total weight of all pigs combined), then the pen of pigs rather than the individual animal is the experimental unit. [CDISC/HL7 Study Participation RMIM, PORT_RM100001UV]
A human StudySubject may have 10 patches of skin each considered an ExperimentalUnit, or a Product StudySubject may have 10 bearings in it, each considered an ExperimentalUnit. Alternatively, each StudySubject may be an ExperimentalUnit.
OTHER NAME(S):
NOTE(S):
Depending on the research objectives, a single study may have multiple levels of experimental units, such as whole people and patches of skin.
Simona
BRIDG 3.0.3 Available at http://bridgmodel.nci.nih.gov/
ExperimentalUnit
OCRE892807
study_protocol:OCRE892807
Intervention study protocol
fma3:OCRE9000027
A material anatomical entity is a physical anatomical entity which has mass. Examples: hemoglobin molecule, mitochondrion, hepatocyte, erythrocyte, heart, head, blood, urine.
Simona
Foundational Model of Anatomy (FMA) class definition of Material anatomical entity. Available at http://bioportal.bioontology.org/visualize/44507
Material anatomical entity
oboInOwl:DbXref
oboInOwl:Definition
oboInOwl:Subset
oboInOwl:Synonym
oboInOwl:SynonymType
snap:GenericallyDependentContinuant
A continuant [snap:Continuant] that is dependent on one or other independent continuant [snap:IndependentContinuant] bearers. For every instance of A requires some instance of (an independent continuant [snap:IndependentContinuant] type) B but which instance of B serves can change from time to time.
http://biomedgt.nci.nih.gov/wiki/index.php/Category:BFO_generically_dependent_continuant(GenericallyDependentContinuant)
GeneriallyDependentContinuant
owl:Thing
Thing
example to be eventually removed
The term was used used in an attempt to structure part of the ontology but in retrospect failed to do a good job
Person:Alan Ruttenberg
failed exploratory term
Class has all its metadata, but is either not guaranteed to be in its final location in the asserted IS_A hierarchy or refers to another class that is not complete.
metadata complete
term created to ease viewing/sort terms for development purpose, and will not be included in a release
organizational term
Class has undergone final review, is ready for use, and will be included in the next release. Any class lacking "ready_for_release" should be considered likely to change place in hierarchy, have its definition refined, or be obsoleted in the next release. Those classes deemed "ready_for_release" will also derived from a chain of ancestor classes that are also "ready_for_release."
ready for release
Class is being worked on; however, the metadata (including definition) are not complete or sufficiently clear to the branch editors.
metadata incomplete
Nothing done yet beyond assigning a unique class ID and proposing a preferred term.
uncurated
All definitions, placement in the asserted IS_A hierarchy and required minimal metadata are complete. The class is awaiting a final review by someone other than the definition editor.
pending final vetting
Core is an instance of a grouping of terms from an ontology or ontologies. It is used by the ontology to identify main classes.
PERSON: Alan Ruttenberg
PERSON: Melanie Courtot
core
placeholder removed
An editor note should explain what were the merged terms and the reason for the merge.
terms merged
This is to be used when the original term has been replaced by a term imported from an other ontology. An editor note should indicate what is the URI of the new term to use.
term imported
This is to be used when a term has been split in two or more new terms. An editor note should indicate the reason for the split and indicate the URIs of the new terms created.
term split
This is to be used if none of the existing instances cover the reason for obsolescence. An editor note should indicate this new reason.
We expect to be able to mine these new reasons and add instances as required.
other
Hard to give a definition for. Intuitively a "natural kind" rather than a collection of any old things, which a class is able to be, formally. At the meta level, universals are defined as positives, are disjoint with their siblings, have single asserted parents.
Alan Ruttenberg
A Formal Theory of Substances, Qualities, and Universals, http://ontology.buffalo.edu/bfo/SQU.pdf
universal
"definitions", in some readings, always are given by necessary and sufficient conditions. So one must be careful (and this is difficult sometimes) to distinguish between defined classes and universal.
A defined class is a class that is defined by a set of logically necessary and sufficient conditions but is not a universal
Alan Ruttenberg
defined class
A named class expression is a logical expression that is given a name. The name can be used in place of the expression.
named class expressions are used in order to have more concise logical definition but their extensions may not be interesting classes on their own. In languages such as OWL, with no provisions for macros, these show up as actuall classes. Tools may with to not show them as such, and to replace uses of the macros with their expansions
Alan Ruttenberg
named class expression
Terms with this status should eventually replaced with a term from another ontology.
Alan Ruttenberg
group:OBI
to be replaced with external ontology term
A term that is metadata complete, has been reviewed, and problems have been identified that require discussion before release. Such a term requires editor note(s) to identify the outstanding issues.
Alan Ruttenberg
group:OBI
requires discussion
restriction
extension
secondary
http
mailto
tel
x-text-fax
Biospecimen availability NA
Biospecimen available
Biospecimen not available
primary
Leaf subclass
Subclass including root
External query
Individual
Subclass excluding root
$Revision$
Revision 258
en
$Revision$
Revision 258
An ontology for the planning, execution and analysis of clinical research including logitudinal studies and clinical trials. This is designed to be used in conjunction with domain specific models of diseases and measurements which conform to the shared ontology of clinical concepts to provide specific models of studies and trials.
Revision 258
An ontology of objects and relationships in statistics that are useful for describing statistical analysis used in human studies. It is part of the Ontology for Clinical Research (OCRe).
An ontology of study design descriptors and categorization of study design types in terms of their design descriptors.
Concept imported from BRIDG that related to the defined activities and schedules of a study protocol.