RCTOntology.owl
type: Ontology
imports: assert.owl
imports: time
version info: 2.0

Conclusion Details
type: Class
disjoint with: Correction Details
disjoint with: Trial Entry Details
disjoint with: Background Details
disjoint with: Retraction Details
disjoint with: Fraud Details
disjoint with: Administrative Details
disjoint with: Publication Details
subclass of: Trial Details
disjoint with: Erratum Details
disjoint with: Stopping Details
comment: The scientific conclusions that are supported by the results of this study

Correction Details
type: Class
disjoint with: Background Details
disjoint with: Retraction Details
disjoint with: Publication Details
disjoint with: Fraud Details
subclass of: rctont resource:arc39acb30
disjoint with: Trial Entry Details
disjoint with: Erratum Details
subclass of: Trial Details
disjoint with: Stopping Details
comment: Complete description of previous data, what is changed, and source (who provided and/or authorized this change)
disjoint with: Administrative Details
disjoint with: Conclusion Details

Trial Entry Details
type: Class
disjoint with: Conclusion Details
disjoint with: Fraud Details
disjoint with: Administrative Details
disjoint with: Publication Details
disjoint with: Correction Details
subclass of: Trial Details
disjoint with: Stopping Details
disjoint with: Retraction Details
disjoint with: Background Details
disjoint with: Erratum Details
subclass of: rctont resource:arc39acb60

Background Details
type: Class
disjoint with: Fraud Details
disjoint with: Retraction Details
disjoint with: Publication Details
disjoint with: Stopping Details
subclass of: Trial Details
disjoint with: Trial Entry Details
disjoint with: Conclusion Details
disjoint with: Erratum Details
disjoint with: Administrative Details
disjoint with: Correction Details

Retraction Details
type: Class
disjoint with: Publication Details
disjoint with: Fraud Details
disjoint with: Trial Entry Details
disjoint with: Conclusion Details
comment: Description of what is retracted, if not the entire paper
disjoint with: Background Details
subclass of: Trial Details
disjoint with: Correction Details
subclass of: rctont resource:arc39acb8
disjoint with: Administrative Details
disjoint with: Erratum Details
disjoint with: Stopping Details

Fraud Details
type: Class
disjoint with: Erratum Details
disjoint with: Background Details
disjoint with: Correction Details
disjoint with: Stopping Details
comment: Date and source of fraud verification
disjoint with: Administrative Details
disjoint with: Retraction Details
disjoint with: Conclusion Details
disjoint with: Trial Entry Details
subclass of: Trial Details
disjoint with: Publication Details
subclass of: rctont resource:arc39acb33

Administrative Details
type: Class
disjoint with: Background Details
subclass of: Trial Details
comment: General comment about study funding.
disjoint with: Trial Entry Details
disjoint with: Publication Details
disjoint with: Conclusion Details
disjoint with: Correction Details
disjoint with: Fraud Details
disjoint with: Stopping Details
disjoint with: Retraction Details
disjoint with: Erratum Details

Publication Details
type: Class
disjoint with: Administrative Details
disjoint with: Background Details
disjoint with: Correction Details
disjoint with: Conclusion Details
disjoint with: Fraud Details
comment: Publications describing and citing this trial.
subclass of: Trial Details
disjoint with: Retraction Details
disjoint with: Stopping Details
disjoint with: Trial Entry Details
disjoint with: Erratum Details

Trial Details
type: Class
disjoint with: Concept
disjoint with: Secondary Study

Erratum Details
type: Class
disjoint with: Conclusion Details
disjoint with: Correction Details
subclass of: Trial Details
disjoint with: Background Details
disjoint with: Administrative Details
disjoint with: Stopping Details
disjoint with: Trial Entry Details
disjoint with: Retraction Details
disjoint with: Fraud Details
disjoint with: Publication Details

Stopping Details
type: Class
disjoint with: Conclusion Details
disjoint with: Fraud Details
disjoint with: Erratum Details
comment: When and why study was stopped.
disjoint with: Retraction Details
disjoint with: Trial Entry Details
disjoint with: Administrative Details
disjoint with: Background Details
disjoint with: Publication Details
disjoint with: Correction Details
subclass of: Trial Details

Secondary Study
type: Class
subclass of: rctont resource:arc39acb1
subclass of: Thing
disjoint with: Concept
disjoint with: Trial Details
comment: Additional investigation pertaining the same interventions as the primary study.

Concept
type: Class
disjoint with: Trial Details
disjoint with: Secondary Study

Clinical Rule
type: Class
disjoint with: Age Gender Rule
subclass of: Rule Concept

Age Gender Rule
type: Class
subclass of: Rule Concept
disjoint with: Clinical Rule
comment: Highest & Lowest range allowed in study.

Rule Concept
type: Class
disjoint with: TimeEntity
disjoint with: Situation
subclass of: Generic Concept

Comparison Arm
type: Class
comment: The regimen of intervention(s) used as control in the trial. The regimen may include placebo or standard therapy (treatment that experts agree is appropriate, accepted, and widely used) or no intervention.
subclass of: Intervention Arm
disjoint with: Experimental Arm

Intervention Arm
type: Class
disjoint with: Intervention
disjoint with: CoIntervention
disjoint with: Blinding Concept
disjoint with: Intervention Step
subclass of: Intervention Concept
subclass of: rctont resource:arc39acb47

Experimental Arm
type: Class
disjoint with: Comparison Arm
comment: The regimen of intervention(s) that was tested in the trial. Either the intervention or the regimen of administration may be experimental.
subclass of: Intervention Arm

Non Concurrent Situations
type: Class
disjoint with: Event Entity
disjoint with: Concurrent Situations
disjoint with: State
subclass of: Situation
subclass of: rctont resource:arc39acb2
comment: Pair of non-concurrent situations in which the duration between situations may be described.

Event Entity
type: Class
subclass of: Situation
disjoint with: Concurrent Situations
disjoint with: State
disjoint with: Non Concurrent Situations

Concurrent Situations
type: Class
disjoint with: State
disjoint with: Event Entity
disjoint with: Non Concurrent Situations
subclass of: Situation
comment: Descriptions of two or more situations that are concurrent

State
type: Class
subclass of: Situation
disjoint with: Event Entity
disjoint with: Concurrent Situations
disjoint with: Non Concurrent Situations

Situation
type: Class
disjoint with: Rule Concept
disjoint with: TimeEntity
subclass of: Generic Concept

Kaplan Meier Time Point
type: Class
subclass of: rctont resource:arc39acb3
subclass of: Result Entity
disjoint with: Survival Analysis And Results Entity
disjoint with: Subgroup Regression
disjoint with: Single Time X Comparison
disjoint with: Data Point Entity
disjoint with: All Comparisons At Time X

Kaplan Meier Data Point
type: Class
disjoint with: Cointervention Data Point
disjoint with: Summary Data Point
disjoint with: Generic Data Point
disjoint with: Blinding Efficacy Data Point
disjoint with: Baseline Data Point
subclass of: Data Point Entity
subclass of: rctont resource:arc39acb53

Result Entity
type: Class
subclass of: Outcome Concept
disjoint with: Miscellaneous Outcome Entity
disjoint with: Outcome Type
disjoint with: Risk of Bias
disjoint with: Special Variable Information
disjoint with: Outcome Value Entity

Survival Analysis And Results Entity
type: Class
disjoint with: Data Point Entity
disjoint with: Single Time X Comparison
disjoint with: All Comparisons At Time X
disjoint with: Subgroup Regression
disjoint with: Kaplan Meier Time Point
subclass of: Result Entity
subclass of: rctont resource:arc39acb41

Subgroup Regression
type: Class
disjoint with: Single Time X Comparison
disjoint with: Survival Analysis And Results Entity
subclass of: rctont resource:arc39acb55
disjoint with: All Comparisons At Time X
disjoint with: Kaplan Meier Time Point
disjoint with: Data Point Entity
subclass of: rctont resource:arc39acb56
subclass of: Result Entity

Single Time X Comparison
type: Class
disjoint with: Kaplan Meier Time Point
subclass of: rctont resource:arc39acb25
subclass of: rctont resource:arc39acb26
disjoint with: Data Point Entity
subclass of: Result Entity
subclass of: rctont resource:arc39acb27
comment: Pointers to the data for each group for this timepoint and this outcome, as well as to the ITT and efficacy analysis summaries (e.g., OR and 95% c.i.)
disjoint with: Subgroup Regression
disjoint with: All Comparisons At Time X
disjoint with: Survival Analysis And Results Entity

Data Point Entity
type: Class
subclass of: Result Entity
disjoint with: Survival Analysis And Results Entity
disjoint with: Subgroup Regression
disjoint with: Single Time X Comparison
disjoint with: Kaplan Meier Time Point
disjoint with: All Comparisons At Time X

All Comparisons At Time X
type: Class
disjoint with: Subgroup Regression
comment: The results in each study population group (e.g., control arm) for a particular outcome at a particular time, e.g., death at six months. If the duration from the reference timepoint is zero, then these are baseline data.
disjoint with: Survival Analysis And Results Entity
disjoint with: Kaplan Meier Time Point
subclass of: Result Entity
subclass of: rctont resource:arc39acb57
disjoint with: Data Point Entity
subclass of: rctont resource:arc39acb58
disjoint with: Single Time X Comparison

Some Kind Of Drug
type: Class
subclass of: Drug

Drug
type: Class
subclass of: Trial Details

No Treatment
type: Class
comment: The withholding of any treatment
subclass of: Intervention
disjoint with: Procedure
disjoint with: Usual Care
disjoint with: Placebo or Sham
disjoint with: Other Intervention
disjoint with: Study Process Intervention

Intervention
type: Class
disjoint with: CoIntervention
disjoint with: Intervention Step
disjoint with: Intervention Arm
disjoint with: Blinding Concept
subclass of: Intervention Concept
subclass of: rctont resource:arc39acb50
subclass of: rctont resource:arc39acb51

Procedure
type: Class
comment: Execution of a surgical or other invasive action
disjoint with: No Treatment
disjoint with: Placebo or Sham
disjoint with: Other Intervention
disjoint with: Usual Care
disjoint with: Study Process Intervention
subclass of: Intervention

Usual Care
type: Class
subclass of: Intervention
comment: The treatment administered before enrollment in the trial and continued during the trial.
disjoint with: Procedure
disjoint with: Placebo or Sham
disjoint with: No Treatment
disjoint with: Study Process Intervention
disjoint with: Other Intervention

Placebo or Sham
type: Class
disjoint with: Other Intervention
disjoint with: No Treatment
disjoint with: Procedure
disjoint with: Usual Care
disjoint with: Study Process Intervention
subclass of: Intervention
comment: Placebo-treatment: Administration of an inactive substance that looks the same as, and is given the same way as, an active drug being tested.

Other Intervention
type: Class
disjoint with: Usual Care
disjoint with: Procedure
disjoint with: No Treatment
disjoint with: Study Process Intervention
disjoint with: Placebo or Sham
subclass of: Intervention

Study Process Intervention
type: Class
disjoint with: Procedure
disjoint with: Usual Care
disjoint with: No Treatment
disjoint with: Other Intervention
disjoint with: Placebo or Sham
subclass of: Intervention

Trial Design
type: Class
subclass of: Design concept
disjoint with: Study Objective
disjoint with: Statistical Analysis And Results
disjoint with: Sample Size Calculation
disjoint with: Search Methods
disjoint with: Hypothesis Concept
subclass of: rctont resource:arc39acb4
disjoint with: Data collection analysis
disjoint with: Data Collection Description

Design concept
type: Class
subclass of: Concept
disjoint with: Outcome Concept
disjoint with: Intervention Concept
disjoint with: Protocol Concept
disjoint with: Generic Concept
disjoint with: Population Concept

Study Objective
type: Class
disjoint with: Data Collection Description
disjoint with: Statistical Analysis And Results
disjoint with: Sample Size Calculation
comment: Text statement of study objective
subclass of: Design concept
disjoint with: Data collection analysis
disjoint with: Hypothesis Concept
disjoint with: Search Methods
disjoint with: Trial Design

Statistical Analysis And Results
type: Class
subclass of: Design concept
disjoint with: Search Methods
subclass of: rctont resource:arc39acb37
disjoint with: Study Objective
subclass of: rctont resource:arc39acb38
disjoint with: Trial Design
disjoint with: Data Collection Description
disjoint with: Sample Size Calculation
disjoint with: Data collection analysis
disjoint with: Hypothesis Concept

Sample Size Calculation
type: Class
disjoint with: Search Methods
disjoint with: Data collection analysis
disjoint with: Study Objective
disjoint with: Statistical Analysis And Results
subclass of: Design concept
disjoint with: Data Collection Description
disjoint with: Trial Design
disjoint with: Hypothesis Concept

Search Methods
type: Class
disjoint with: Hypothesis Concept
disjoint with: Study Objective
disjoint with: Sample Size Calculation
disjoint with: Data collection analysis
subclass of: Design concept
disjoint with: Data Collection Description
disjoint with: Trial Design
disjoint with: Statistical Analysis And Results

Hypothesis Concept
type: Class
disjoint with: Statistical Analysis And Results
disjoint with: Data collection analysis
disjoint with: Sample Size Calculation
disjoint with: Study Objective
disjoint with: Trial Design
disjoint with: Search Methods
disjoint with: Data Collection Description
subclass of: Design concept

Blinding
type: Class
subclass of: Blinding Concept
comment: Whether an investigator, or person collecting or analyzing trial data, or otherwise affecting conduct of the trial, knows about the subjects' assigned intervention or interim trial results
disjoint with: Blinding Methods
disjoint with: Blinding Efficacy

Data collection analysis
type: Class
disjoint with: Study Objective
disjoint with: Trial Design
disjoint with: Statistical Analysis And Results
disjoint with: Sample Size Calculation
disjoint with: Hypothesis Concept
disjoint with: Search Methods
disjoint with: Data Collection Description
subclass of: Design concept

Data Collection Description
type: Class
disjoint with: Statistical Analysis And Results
disjoint with: Study Objective
disjoint with: Sample Size Calculation
disjoint with: Trial Design
disjoint with: Data collection analysis
disjoint with: Search Methods
subclass of: Design concept
disjoint with: Hypothesis Concept

Risk of Bias
type: Class
disjoint with: Miscellaneous Outcome Entity
disjoint with: Outcome Type
disjoint with: Result Entity
disjoint with: Outcome Value Entity
disjoint with: Special Variable Information
subclass of: Outcome Concept

Miscellaneous Outcome Entity
type: Class
disjoint with: Risk of Bias
disjoint with: Outcome Type
disjoint with: Special Variable Information
disjoint with: Result Entity
disjoint with: Outcome Value Entity
subclass of: Outcome Concept

Outcome Type
type: Class
subclass of: Outcome Concept
disjoint with: Miscellaneous Outcome Entity
disjoint with: Special Variable Information
disjoint with: Risk of Bias
disjoint with: Result Entity
disjoint with: Outcome Value Entity

Outcome Value Entity
type: Class
subclass of: Outcome Concept
disjoint with: Outcome Type
disjoint with: Miscellaneous Outcome Entity
disjoint with: Result Entity
disjoint with: Risk of Bias
disjoint with: Special Variable Information

Special Variable Information
type: Class
disjoint with: Outcome Type
disjoint with: Miscellaneous Outcome Entity
disjoint with: Result Entity
disjoint with: Outcome Value Entity
disjoint with: Risk of Bias
subclass of: Outcome Concept

Outcome Concept
type: Class
disjoint with: Protocol Concept
disjoint with: Population Concept
disjoint with: Intervention Concept
disjoint with: Generic Concept
disjoint with: Design concept
subclass of: Concept
subclass of: rctont resource:arc39acb59

Data Extraction Management
type: Class
comment: The method used to extract or obtain data from published reports or from the original researchers (for example, using a data collection form). Whether data are extracted independently by more than one author should be stated, along with how any disagreements are resolved. If relevant, methods for processing data in preparation for analysis should be described.
disjoint with: Heterogeneity
disjoint with: Subgroup Analysis
disjoint with: Unit Analysis Issues
disjoint with: Sensitivity Analysis
disjoint with: Missing Data
disjoint with: Reporting Bias
disjoint with: Assesment Risk Bias
disjoint with: Selection Of Studies
subclass of: Data collection analysis
disjoint with: Data Synthesis

Heterogeneity
type: Class
disjoint with: Unit Analysis Issues
disjoint with: Data Extraction Management
disjoint with: Sensitivity Analysis
comment: Approaches to addressing clinical heterogeneity should be described, along with how the authors will determine whether a meta-analysis is considered appropriate. Methods for identifying statistical heterogeneity should be stated
disjoint with: Data Synthesis
disjoint with: Missing Data
subclass of: Data collection analysis
disjoint with: Assesment Risk Bias
disjoint with: Subgroup Analysis
disjoint with: Selection Of Studies
disjoint with: Reporting Bias

Subgroup Analysis
type: Class
disjoint with: Unit Analysis Issues
disjoint with: Sensitivity Analysis
disjoint with: Assesment Risk Bias
disjoint with: Data Synthesis
subclass of: Data collection analysis
disjoint with: Missing Data
disjoint with: Heterogeneity
disjoint with: Selection Of Studies
disjoint with: Reporting Bias
disjoint with: Data Extraction Management

Unit Analysis Issues
type: Class
disjoint with: Assesment Risk Bias
disjoint with: Heterogeneity
disjoint with: Sensitivity Analysis
disjoint with: Selection Of Studies
disjoint with: Subgroup Analysis
disjoint with: Data Extraction Management
disjoint with: Reporting Bias
disjoint with: Data Synthesis
subclass of: Data collection analysis
disjoint with: Missing Data

Sensitivity Analysis
type: Class
disjoint with: Assesment Risk Bias
disjoint with: Selection Of Studies
subclass of: Data collection analysis
disjoint with: Reporting Bias
disjoint with: Missing Data
disjoint with: Subgroup Analysis
disjoint with: Unit Analysis Issues
comment: This should describe analyses aimed at determining whether conclusions are robust to decisions made during the review process, such as inclusion/exclusion of particular studies from a meta-analysis, imputing missing data or choice of a method for analysis.
disjoint with: Heterogeneity
disjoint with: Data Synthesis
disjoint with: Data Extraction Management

Missing Data
type: Class
subclass of: Data Collection Description
disjoint with: Heterogeneity
disjoint with: Selection Of Studies
disjoint with: Data Extraction Management
disjoint with: Data Synthesis
disjoint with: Assesment Risk Bias
disjoint with: Unit Analysis Issues
disjoint with: Subgroup Analysis
disjoint with: Sensitivity Analysis
disjoint with: Reporting Bias

Reporting Bias
type: Class
disjoint with: Heterogeneity
disjoint with: Assesment Risk Bias
disjoint with: Selection Of Studies
disjoint with: Data Synthesis
subclass of: Data Collection Description
subclass of: rctont resource:arc39acb48
disjoint with: Unit Analysis Issues
disjoint with: Sensitivity Analysis
disjoint with: Data Extraction Management
disjoint with: Missing Data
disjoint with: Subgroup Analysis
comment: This section should describe how publication bias and other reporting biases are addressed (for example, funnel plots, statistical tests, imputation). Authors should remember that asymmetric funnel plots are not necessarily caused by publication bias (and that publication bias does not necessarily cause asymmetry in a funnel plot).

Assesment Risk Bias
type: Class
disjoint with: Unit Analysis Issues
disjoint with: Reporting Bias
disjoint with: Subgroup Analysis
disjoint with: Data Synthesis
disjoint with: Selection Of Studies
disjoint with: Heterogeneity
disjoint with: Data Extraction Management
subclass of: Data collection analysis
comment: The method used to assess risk of bias (or methodological quality). Whether methods are applied independently by more than one author should be stated, along with how any disagreements are resolved. The tool(s) used should be described or referenced, with an indication of how the results are incorporated into the interpretation of the results.
disjoint with: Sensitivity Analysis
disjoint with: Missing Data

Selection Of Studies
type: Class
disjoint with: Missing Data
comment: The method used to apply the selection criteria. Whether they are applied independently by more than one author should be stated, along with how any disagreements are resolved.
disjoint with: Sensitivity Analysis
disjoint with: Assesment Risk Bias
disjoint with: Subgroup Analysis
disjoint with: Reporting Bias
disjoint with: Heterogeneity
subclass of: Data Collection Description
disjoint with: Data Synthesis
disjoint with: Unit Analysis Issues
disjoint with: Data Extraction Management

Data Synthesis
type: Class
comment: The choice of meta-analysis method should be stated, including whether a fixed-effect or a random-effects model is used. If meta-analyses are not undertaken, systematic approaches to synthesizing the findings of multiple studies should be described.
disjoint with: Data Extraction Management
disjoint with: Subgroup Analysis
disjoint with: Unit Analysis Issues
disjoint with: Sensitivity Analysis
disjoint with: Selection Of Studies
disjoint with: Missing Data
subclass of: Data collection analysis
disjoint with: Reporting Bias
disjoint with: Heterogeneity
disjoint with: Assesment Risk Bias

Primary Outcome
type: Class
comment: A characteristic of the study population evaluated at one or more time points during the trial that is expected to change in response to the experimental treatment and whose evaluation is of primary interest for the trial to show efficacy of the experimental treatment.
disjoint with: Side Effect
disjoint with: Ancillary Outcome
disjoint with: Secondary Outcome
subclass of: Study Outcome

Side Effect
type: Class
comment: A characteristic of the study population evaluated at one or more time points during the trial that may change in response to the experimental treatment and whose evaluation is of interest for the trial to show safety of the experimental treatment. Side effects cannot be of type cost, functional status, or life years: characteristics of those types are predefined study outcomes.
disjoint with: Secondary Outcome
disjoint with: Primary Outcome
disjoint with: Ancillary Outcome
subclass of: Study Outcome

Ancillary Outcome
type: Class
subclass of: Study Outcome
comment: A characteristic of the study population evaluated at one or more time points during the trial that may change in response to the experimental treatment and whose evaluation is of interest but that it is not directly related to the main objective of the trial.
disjoint with: Side Effect
disjoint with: Secondary Outcome
disjoint with: Primary Outcome

Secondary Outcome
type: Class
subclass of: Study Outcome
disjoint with: Side Effect
disjoint with: Ancillary Outcome
disjoint with: Primary Outcome
comment: A characteristic of the study population evaluated at one or more time points during the trial that is expected to change in response to the experimental treatment and whose evaluation is of secondary interest for the trial to show efficacy of the experimental treatment.

Study Outcome
type: Class
disjoint with: Baseline
subclass of: Outcome Type

All Subjects
type: Class
subclass of: Analyzed Population
disjoint with: Study Arm Population
disjoint with: Crossover Population
disjoint with: Subgroup Population
comment: The group of trial participants who are included in the study, the sum of all the intervention populations.

Analyzed Population
type: Class
subclass of: Population
disjoint with: Excluded Population
disjoint with: Site Enrollment
disjoint with: Recruited Population

Study Arm Population
type: Class
comment: The group of randomized participants that are assigned to a treatment arm of the trial.
subclass of: Analyzed Population
subclass of: rctont resource:arc39acb39
disjoint with: Subgroup Population
disjoint with: All Subjects
disjoint with: Crossover Population

Crossover Population
type: Class
disjoint with: Study Arm Population
disjoint with: All Subjects
disjoint with: Subgroup Population
subclass of: Analyzed Population
subclass of: rctont resource:arc39acb23
subclass of: rctont resource:arc39acb24
comment: Participants who 'cross over' to another arm's intervention off protocol (e.g., assigned to the medication arm but then received surgery like those in the surgery arm).

Subgroup Population
type: Class
comment: Descriptions of particular subgroups, defined in relation to an intervention group (experimental or comparison or all trial participants), or to other subgroups recursively. Thus, the |subgroup-of| slot must point to an INTERVENTION-POPULATION, or to another SUBGROUP-POPULATION. The assumption here is that the population of which this subgroup is an immediate subgroup will itself always be worth defining if this subgroup is being defined.
disjoint with: Study Arm Population
disjoint with: Crossover Population
disjoint with: All Subjects
subclass of: Analyzed Population

Some Second Kind Of Drug
type: Class
subclass of: Drug

Selective Reporting Risk
type: Class
subclass of: Risk of Bias
disjoint with: Allocation Risk
disjoint with: Potential Sources Bias Risk
disjoint with: Incomplete Outcome Data Risk
disjoint with: Blinding Risk

Allocation Risk
type: Class
disjoint with: Selective Reporting Risk
disjoint with: Potential Sources Bias Risk
disjoint with: Incomplete Outcome Data Risk
disjoint with: Blinding Risk
subclass of: Risk of Bias

Potential Sources Bias Risk
type: Class
subclass of: Risk of Bias
disjoint with: Allocation Risk
disjoint with: Selective Reporting Risk
disjoint with: Incomplete Outcome Data Risk
disjoint with: Blinding Risk

Incomplete Outcome Data Risk
type: Class
disjoint with: Allocation Risk
disjoint with: Potential Sources Bias Risk
disjoint with: Selective Reporting Risk
disjoint with: Blinding Risk
subclass of: Risk of Bias

Blinding Risk
type: Class
subclass of: Risk of Bias
disjoint with: Potential Sources Bias Risk
disjoint with: Incomplete Outcome Data Risk
disjoint with: Allocation Risk
disjoint with: Selective Reporting Risk

CoIntervention
type: Class
comment: Treatment not under investigation that is administered concomitantly with the treatment being tested
subclass of: Intervention Concept
subclass of: rctont resource:arc39acb5
disjoint with: Intervention Step
disjoint with: Intervention Arm
disjoint with: Intervention
disjoint with: Blinding Concept

Intervention Concept
type: Class
disjoint with: Outcome Concept
disjoint with: Protocol Concept
disjoint with: Population Concept
disjoint with: Generic Concept
disjoint with: Design concept
subclass of: Concept

Cointervention Data Point
type: Class
disjoint with: Kaplan Meier Data Point
disjoint with: Blinding Efficacy Data Point
disjoint with: Generic Data Point
subclass of: Data Point Entity
subclass of: rctont resource:arc39acb20
disjoint with: Baseline Data Point
comment: The number of people in this population taking this cointervention.
disjoint with: Summary Data Point

Intervention Step
type: Class
subclass of: Intervention Concept
disjoint with: CoIntervention
disjoint with: Intervention
disjoint with: Blinding Concept
disjoint with: Intervention Arm

Blinding Concept
type: Class
subclass of: Intervention Concept
disjoint with: CoIntervention
disjoint with: Intervention
disjoint with: Intervention Step
disjoint with: Intervention Arm

Drug Step
type: Class
disjoint with: Non Drug Intervention Step
comment: A discrete unit of administration of a drug treatment that ends after a specified time or when a specified state is reached.
subclass of: Intervention Step
subclass of: rctont resource:arc39acb6
subclass of: rctont resource:arc39acb7

Non Drug Intervention Step
type: Class
subclass of: rctont resource:arc39acb34
subclass of: rctont resource:arc39acb35
subclass of: Intervention Step
disjoint with: Drug Step
comment: A discrete unit of administration of a non-drug treatment that ends after a specified time or when a specified state is reached.

TimePoint
type: Class
subclass of: rctont resource:arc39acb17
subclass of: TimeEntity
comment: A point in time, defined directly here in text, or as an event-defined-timepoint, or a date-defined-timepoint. Alternatively, this timepoint can be defined in reference to a reference timepoint, by some duration before or after that reference timepoint.

Life Year
type: Class
subclass of: Special Variable Information
comment: Method used to quality adjust life years, if applicable.
disjoint with: Rate
disjoint with: Scored Instrument
disjoint with: Cost
disjoint with: Categorical

Rate
type: Class
disjoint with: Life Year
disjoint with: Scored Instrument
disjoint with: Categorical
disjoint with: Cost
subclass of: Special Variable Information

Scored Instrument
type: Class
disjoint with: Rate
disjoint with: Life Year
disjoint with: Categorical
disjoint with: Cost
subclass of: Special Variable Information

Cost
type: Class
disjoint with: Rate
disjoint with: Scored Instrument
disjoint with: Life Year
disjoint with: Categorical
comment: Description of the references used to define an outcome variable of type cost.
subclass of: Special Variable Information

Categorical
type: Class
comment: The categories for the categorical variable, assumed to be in the order in which they were entered.
disjoint with: Rate
disjoint with: Scored Instrument
disjoint with: Cost
disjoint with: Life Year
subclass of: rctont resource:arc39acb22
subclass of: Special Variable Information

Date
type: Class
comment: A point in time defined as a combination of day, month and year.
disjoint with: TimeRange
subclass of: TimeEntity

Subgroup
type: Class
comment: Definition of a subgroup, with pointers to the subgroups defined in each study arm population.
disjoint with: Recruitment Flow Chart
disjoint with: Population
subclass of: rctont resource:arc39acb9
subclass of: Population Concept
subclass of: rctont resource:arc39acb10

Recruitment Flow Chart
type: Class
disjoint with: Subgroup
disjoint with: Population
subclass of: Population Concept

Population
type: Class
disjoint with: Recruitment Flow Chart
disjoint with: Subgroup
subclass of: rctont resource:arc39acb54
subclass of: Population Concept

Population Concept
type: Class
subclass of: Concept
disjoint with: Outcome Concept
disjoint with: Intervention Concept
disjoint with: Protocol Concept
disjoint with: Generic Concept
disjoint with: Design concept

Inclusion Rule
type: Class
subclass of: Clinical Rule
comment: Condition that must be met for participation in the trial
disjoint with: Exclusion Rule

Exclusion Rule
type: Class
subclass of: Clinical Rule
disjoint with: Inclusion Rule
comment: Condition that, if met, precludes participation in the trial.

Eligible Population
type: Class
subclass of: Recruited Population
comment: The group of screened participants that satisfied all eligibility criteria for the trial.
disjoint with: Enrolled Population
disjoint with: Randomized Population
disjoint with: Screened Population

Recruited Population
type: Class
subclass of: Population
disjoint with: Site Enrollment
disjoint with: Excluded Population
disjoint with: Analyzed Population

Enrolled Population
type: Class
subclass of: Recruited Population
disjoint with: Randomized Population
disjoint with: Eligible Population
disjoint with: Screened Population
comment: The group of eligible participants that agreed to participate in the trial.

Randomized Population
type: Class
subclass of: Recruited Population
comment: The group of enrolled participants that was assigned to one of the intervention arms according to the randomization scheme.
disjoint with: Enrolled Population
disjoint with: Eligible Population
disjoint with: Screened Population

Screened Population
type: Class
disjoint with: Enrolled Population
disjoint with: Eligible Population
disjoint with: Randomized Population
subclass of: Recruited Population
comment: The group of recruited participants that underwent eligibility evaluation.

Generic Data Point
type: Class
disjoint with: Cointervention Data Point
disjoint with: Summary Data Point
disjoint with: Kaplan Meier Data Point
disjoint with: Blinding Efficacy Data Point
disjoint with: Baseline Data Point
subclass of: rctont resource:arc39acb11
subclass of: Data Point Entity

Summary Data Point
type: Class
comment: The lower confidence interval for this summary. The % interval is in confidence-interval-percent in STATISTICAL-ANALYSIS-AND-RESULTS for this outcome.
disjoint with: Blinding Efficacy Data Point
subclass of: rctont resource:arc39acb19
disjoint with: Kaplan Meier Data Point
subclass of: Data Point Entity
disjoint with: Baseline Data Point
disjoint with: Generic Data Point
disjoint with: Cointervention Data Point

Blinding Efficacy Data Point
type: Class
subclass of: Data Point Entity
disjoint with: Summary Data Point
comment: The actual number of people in this blindee group who did not guess at the study population's assigned treatment.
disjoint with: Cointervention Data Point
subclass of: rctont resource:arc39acb18
disjoint with: Generic Data Point
disjoint with: Baseline Data Point
disjoint with: Kaplan Meier Data Point

Baseline Data Point
type: Class
disjoint with: Summary Data Point
subclass of: rctont resource:arc39acb31
comment: The actual value of this baseline characteristic for this population.
disjoint with: Generic Data Point
subclass of: rctont resource:arc39acb32
disjoint with: Blinding Efficacy Data Point
disjoint with: Kaplan Meier Data Point
disjoint with: Cointervention Data Point
subclass of: Data Point Entity

Protocol Concept
type: Class
subclass of: Concept
disjoint with: Outcome Concept
disjoint with: Intervention Concept
disjoint with: Population Concept
disjoint with: Generic Concept
disjoint with: Design concept

Generic Concept
type: Class
subclass of: Concept
disjoint with: Protocol Concept
disjoint with: Outcome Concept
disjoint with: Intervention Concept
disjoint with: Population Concept
disjoint with: Design concept

Device
type: Class
subclass of: Trial Details

Data Point Population
type: Class
disjoint with: Data Point Crossover Population
subclass of: rctont resource:arc39acb12
subclass of: Generic Data Point
comment: The numerators and denominators of the results of an outcome assessed at a particular timepoint. The denominators reflect the degree of followup and outcome assessment achieved in this trial. This class is used for both main and subgroup populations. Crossover population datapoints should use DATAPOINT-OF-CROSSOVER-POP

Data Point Crossover Population
type: Class
disjoint with: Data Point Population
subclass of: rctont resource:arc39acb36
subclass of: Generic Data Point

Outcome Not Assessed
type: Class
disjoint with: Excluded Post Randomization
disjoint with: Not Randomized
disjoint with: Not Enrolled
disjoint with: Not Eligible
disjoint with: Off Assigned Intervention
disjoint with: Withdrawal Reason
subclass of: Reason

Excluded Post Randomization
type: Class
subclass of: Reason
disjoint with: Off Assigned Intervention
disjoint with: Outcome Not Assessed
disjoint with: Not Randomized
disjoint with: Not Enrolled
disjoint with: Not Eligible
disjoint with: Withdrawal Reason

Not Randomized
type: Class
disjoint with: Excluded Post Randomization
disjoint with: Not Enrolled
disjoint with: Not Eligible
disjoint with: Off Assigned Intervention
disjoint with: Withdrawal Reason
disjoint with: Outcome Not Assessed
subclass of: Reason

Not Enrolled
type: Class
disjoint with: Off Assigned Intervention
disjoint with: Excluded Post Randomization
disjoint with: Not Eligible
disjoint with: Withdrawal Reason
disjoint with: Outcome Not Assessed
disjoint with: Not Randomized
subclass of: Reason

Not Eligible
type: Class
disjoint with: Excluded Post Randomization
disjoint with: Off Assigned Intervention
disjoint with: Outcome Not Assessed
disjoint with: Not Randomized
disjoint with: Not Enrolled
disjoint with: Withdrawal Reason
subclass of: Reason

Off Assigned Intervention
type: Class
disjoint with: Outcome Not Assessed
disjoint with: Excluded Post Randomization
disjoint with: Not Randomized
disjoint with: Not Enrolled
disjoint with: Not Eligible
disjoint with: Withdrawal Reason
subclass of: Reason

Withdrawal Reason
type: Class
disjoint with: Not Randomized
disjoint with: Outcome Not Assessed
disjoint with: Not Enrolled
disjoint with: Excluded Post Randomization
disjoint with: Off Assigned Intervention
comment: Why a group of participants withdrew from the trial.
subclass of: Reason
disjoint with: Not Eligible

Reason
type: Class
disjoint with: Follow Up
disjoint with: Follow Up Activity
disjoint with: Cluster Individual Protocol
disjoint with: Protocol Change
disjoint with: Follow Up Compliance
disjoint with: Treatment Assignment
subclass of: Protocol Concept

Baseline
type: Class
subclass of: rctont resource:arc39acb28
subclass of: Outcome Type
comment: A characteristic of the study population evaluated at the beginning of the trial.
disjoint with: Study Outcome

Regularly Recurring Event
type: Class
disjoint with: Single or Irregular Event
comment: If the events are not exactly the same, the events must be described separately as single event. If the events are identical but the recurrence is irregular, then irregular interval between events can be individually described using NON-CONCURRENT-SITUATIONS. Alternatively, separate events occurring at specified times can be defined
subclass of: rctont resource:arc39acb13
subclass of: Event Entity
subclass of: rctont resource:arc39acb14

Single or Irregular Event
type: Class
subclass of: rctont resource:arc39acb43
subclass of: Event Entity
comment: A single event that occurs either in reference to a single (relative or absolute) timepoint or a single- or double-anchored interval, as modified by |time-operator| as necessary. Also can be an event that occurs at irregular intervals, each of which is described as a timepoint or interval.
disjoint with: Regularly Recurring Event

Clustered Randomized Trial
type: Class
subclass of: Unit Analysis Issues
disjoint with: Cross Over Trial

Cross Over Trial
type: Class
subclass of: Unit Analysis Issues
disjoint with: Clustered Randomized Trial

Missing Statistics
type: Class
subclass of: Missing Data

Follow Up Compliance
type: Class
subclass of: Protocol Concept
disjoint with: Reason
subclass of: rctont resource:arc39acb15
disjoint with: Protocol Change
disjoint with: Treatment Assignment
disjoint with: Follow Up
disjoint with: Cluster Individual Protocol
subclass of: rctont resource:arc39acb16
disjoint with: Follow Up Activity

Protocol Change
type: Class
disjoint with: Treatment Assignment
disjoint with: Follow Up
comment: Amendment of the original objective(s), design, methodology, statistical analysis, or organization of the trial.
disjoint with: Cluster Individual Protocol
disjoint with: Follow Up Compliance
disjoint with: Follow Up Activity
subclass of: Protocol Concept
disjoint with: Reason

Treatment Assignment
type: Class
disjoint with: Reason
disjoint with: Cluster Individual Protocol
comment: The process of assigning participants to interventions, also called treatment allocation.
disjoint with: Follow Up
disjoint with: Protocol Change
disjoint with: Follow Up Activity
disjoint with: Follow Up Compliance
subclass of: Protocol Concept

Follow Up
type: Class
disjoint with: Reason
disjoint with: Cluster Individual Protocol
subclass of: rctont resource:arc39acb61
subclass of: Protocol Concept
disjoint with: Follow Up Activity
disjoint with: Protocol Change
disjoint with: Treatment Assignment
disjoint with: Follow Up Compliance
comment: Information about followup in this study, including the date of last followup of a subject (|complete-fu-date|) for any trial-related activity, and the maximum duration of followup in the whole trial. The |follow-up-activity| slot points to one or more descriptions of activities, e.g,. N-ECHO if all groups undergo the same echo followup , or N-ENDOSCOPY-CONTROL and N-ENDOSCOPY-EXPERIMENTAL if the experimental and control groups have a different schedule of endoscopy followup.

Cluster Individual Protocol
type: Class
disjoint with: Follow Up Activity
disjoint with: Protocol Change
disjoint with: Follow Up Compliance
comment: Eligibility rules, outcomes, treatment assignment and other protocol details applied to the individual participants in a cluster-randomized trial.
subclass of: Protocol Concept
disjoint with: Follow Up
disjoint with: Treatment Assignment
disjoint with: Reason

Follow Up Activity
type: Class
disjoint with: Protocol Change
disjoint with: Follow Up
disjoint with: Follow Up Compliance
comment: Action(s) carried out by qualified personnel to verify and evaluate trial participants' adherence and response to experimental and comparison treatments.
disjoint with: Treatment Assignment
subclass of: rctont resource:arc39acb49
disjoint with: Reason
disjoint with: Cluster Individual Protocol
subclass of: Protocol Concept

Electronic Searching
type: Class
disjoint with: Hand Searching
subclass of: Search Methods

Hand Searching
type: Class
disjoint with: Electronic Searching
subclass of: Search Methods

Category
type: Class
disjoint with: Range
subclass of: Miscellaneous Outcome Entity

Range
type: Class
disjoint with: Category
subclass of: Miscellaneous Outcome Entity

Clinical Heterogeneity
type: Class
subclass of: Heterogeneity

Excluded Post Randomization Population
type: Class
disjoint with: Not Randomized Population
disjoint with: Not Enrolled Population
disjoint with: NotElligiblePopulation
subclass of: Excluded Population

Not Randomized Population
type: Class
subclass of: Excluded Population
disjoint with: Not Enrolled Population
disjoint with: NotElligiblePopulation
disjoint with: Excluded Post Randomization Population

Not Enrolled Population
type: Class
disjoint with: Not Randomized Population
disjoint with: NotElligiblePopulation
disjoint with: Excluded Post Randomization Population
subclass of: Excluded Population

Excluded Population
type: Class
disjoint with: Site Enrollment
disjoint with: Recruited Population
disjoint with: Analyzed Population
subclass of: Population
subclass of: rctont resource:arc39acb52

Trial
type: Class
comment: A prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices).
subclass of: Thing
subclass of: rctont resource:arc39acb21

Drug With Some Bad Effect
type: Class
subclass of: Some Kind Of Drug

Missing Participants
type: Class
subclass of: Missing Data

Wash Out
type: Class
comment: The phase following the administration of an intervention and preceding the administration of another intervention or of the next cycle of the same intervention.
subclass of: Study Process Intervention
disjoint with: Run In
disjoint with: Cross Over

Run In
type: Class
comment: The phase preceding the administration of an intervention.
disjoint with: Cross Over
disjoint with: Wash Out
subclass of: Study Process Intervention

Cross Over
type: Class
subclass of: Study Process Intervention
disjoint with: Run In
disjoint with: Wash Out
comment: The crossing from one INTERVENTION-ARM to another as defined in the study protocol, for crossover trials. This does not refer to participants who 'cross over' to another arm's intervention off protocol

Random Effects Model
type: Class
disjoint with: Fixed Effect Model
subclass of: Data Synthesis

Fixed Effect Model
type: Class
subclass of: Data Synthesis
disjoint with: Random Effects Model

Site Enrollment
type: Class
disjoint with: Excluded Population
disjoint with: Analyzed Population
disjoint with: Recruited Population
subclass of: rctont resource:arc39acb42
subclass of: Population Concept
comment: The number of trial participants enrolled at a site and the start and end date of enrollment.

Statistical Heterogeneity
type: Class
subclass of: Heterogeneity

Blinding Efficacy
type: Class
comment: The method used to determine how efficacious intervention blinding was, among various study subject and investigator groups.
subclass of: rctont resource:arc39acb29
subclass of: Blinding Concept
disjoint with: Blinding
disjoint with: Blinding Methods

Blinding Methods
type: Class
disjoint with: Blinding
disjoint with: Blinding Efficacy
comment: How an investigator, or person collecting or analyzing trial data, or otherwise affecting conduct of the trial, is prevented from knowing the subjects' assigned intervention or interim results
subclass of: Blinding Concept

Primary Hypothesis
type: Class
disjoint with: Secondary Hypothesis
subclass of: Hypothesis Concept

Secondary Hypothesis
type: Class
disjoint with: Primary Hypothesis
subclass of: rctont resource:arc39acb40
subclass of: Hypothesis Concept

Primary Recruitment Flow Chart
type: Class
subclass of: rctont resource:arc39acb44
subclass of: rctont resource:arc39acb45
subclass of: Recruitment Flow Chart
subclass of: rctont resource:arc39acb46
comment: A representation of the number of (potential) participants in each phase of the primary trial, from screening, to enrollment, to randomization to analysis.

ClinicalIntervention
type: Class
subclass of: Trial

Treatment
type: Class
subclass of: Trial Details

hasCheckpointDate
type: DatatypeProperty
comment: This datatype property should be changed to an object property if you decide to use the W3C time ontology or something similar
range: date
domain: Trial

hasStartDate
type: FunctionalProperty
domain: Trial
type: DatatypeProperty
range: date
comment: This datatype property should be changed to an object property if you decide to use the W3C time ontology or something similar

hasEndDate
type: FunctionalProperty
comment: This datatype property should be changed to an object property if you decide to use the W3C time ontology or something similar
range: date
domain: Trial
type: DatatypeProperty