---
type: "resource-definitions"
title: "ResearchStudy Definitions"
resource: "ResearchStudy"
---

# ResearchStudy Definitions

<a id="ResearchStudy"></a>

## ResearchStudy
Investigation to increase healthcare-related patient-independent knowledge

**Definition:** A research study is a scientific investigation designed to generate health-related knowledge. This can include clinical trials involving human participants (or animals in the case of veterinary clinical trials). These studies may be related to new ways to screen, prevent, diagnose, and treat disease. Research studies may also analyze data collected from individuals in the past (retrospective studies) or future (prospective studies) to understand specific outcomes or trends in particular populations.

**Comments:** The ResearchStudy Resource may be used for any type of research study, such as public health studies evaluating populations or systematic reviews evaluating research studies, and is not limited to clinical trials or limited to studies of individual people.

**Aliases:** Study

**Cardinality:** 0..*

**Mappings:** BRIDG5.1=ObservationalStudyProtocolVersion; Study;
StudyProtocolVersion; v2=OBX; rim=Observation[classCode=CLNTRL, moodCode=EVN]; w5=clinical.diagnostics


<a id="ResearchStudy.url"></a>

## ResearchStudy.url
Canonical identifier for this study resource

**Definition:** Canonical identifier for this study resource, represented as a globally unique URI.

**Cardinality:** 0..1

**Type:** [uri](/uri)


<a id="ResearchStudy.identifier"></a>

## ResearchStudy.identifier
Business Identifier for study

**Definition:** Identifiers assigned to this research study by the sponsor or other systems.

**Requirements:** Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.

**Cardinality:** 0..*

**Type:** [Identifier](/Identifier)

**Summary:** true

**Mappings:** clinicaltrials-gov=Organization's Unique Protocol ID; Secondary IDs; w5=FiveWs.identifier; BRIDG5.1=No BRIDG mapping (although there is  DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic); rim=.identifier


<a id="ResearchStudy.version"></a>

## ResearchStudy.version
The business version for the study record

**Definition:** The business version for the study record.

**Cardinality:** 0..1

**Type:** [string](/string)


<a id="ResearchStudy.name"></a>

## ResearchStudy.name
Name for this study (computer friendly)

**Definition:** Name for this study (computer friendly).

**Cardinality:** 0..1

**Type:** [string](/string)


<a id="ResearchStudy.title"></a>

## ResearchStudy.title
Human readable name of the study

**Definition:** The human readable name of the research study.

**Cardinality:** 0..1

**Type:** [string](/string)

**Summary:** true

**Mappings:** clinicaltrials-gov=Brief Title; BRIDG5.1=No BRIDG mapping (although there is  StudyProtocolDocumentVersionPublicTitle this is arguably a different semantic: title of a document vs title of a research study)


<a id="ResearchStudy.label"></a>

## ResearchStudy.label
Additional names for the study

**Definition:** Additional names for the study.

**Cardinality:** 0..*

**Type:** [BackboneElement](/BackboneElement)


<a id="ResearchStudy.label.type"></a>

## ResearchStudy.label.type
primary | official | scientific | plain-language | subtitle | short-title | acronym | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid

**Definition:** Kind of name.

**Cardinality:** 0..1

**Type:** [CodeableConcept](/CodeableConcept)

**Binding:** preferred:[title-type](/valueset-title-type)


<a id="ResearchStudy.label.value"></a>

## ResearchStudy.label.value
The name

**Definition:** The name.

**Cardinality:** 0..1

**Type:** [string](/string)


<a id="ResearchStudy.label.language"></a>

## ResearchStudy.label.language
Used to express the specific language

**Definition:** Used to express the specific language of the title.

**Cardinality:** 0..1

**Type:** [code](/code)

**Binding:** required:[all-languages](/valueset-all-languages)


<a id="ResearchStudy.protocol"></a>

## ResearchStudy.protocol
Steps followed in executing study

**Definition:** The set of steps expected to be performed as part of the execution of the study.

**Cardinality:** 0..*

**Type:** Reference([PlanDefinition](/PlanDefinition))

**Summary:** true

**Mappings:** clinicaltrials-gov=Interventions; Arm/Intervention Cross-Reference; BRIDG5.1=StudyProtocolDocumentVersionPublicTitle.name; rim=.outboundRelationship[typeCode=DEFN].target


<a id="ResearchStudy.partOf"></a>

## ResearchStudy.partOf
Part of larger study

**Definition:** A larger research study of which this particular study is a component or step.

**Requirements:** Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc.

**Aliases:** container

**Cardinality:** 0..*

**Type:** Reference([ResearchStudy](/ResearchStudy))

**Summary:** true

**Mappings:** BRIDG5.1=CompanionStudyRelationship; rim=.inboundRelationship[typeCode=COMP].source[moodCode=EVN]


<a id="ResearchStudy.citeAs"></a>

## ResearchStudy.citeAs
How to cite this ResearchStudy

**Definition:** Display of the bibliographic citation of this ResearchStudy.

**Cardinality:** 0..1

**Type:** [markdown](/markdown)


<a id="ResearchStudy.relatesTo"></a>

## ResearchStudy.relatesTo
Relationships to other Resources

**Definition:** Relationships that this ResearchStudy has with other FHIR or non-FHIR resources that already exist.

**Cardinality:** 0..*

**Type:** [BackboneElement](/BackboneElement)


<a id="ResearchStudy.relatesTo.type"></a>

## ResearchStudy.relatesTo.type
documentation | justification | citation | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | documents | specification-of | created-with | cite-as | reprint | reprint-of | summarizes

**Definition:** The type of relationship to the related artifact.

**Cardinality:** 1..1

**Type:** [CodeableConcept](/CodeableConcept)

**Binding:** extensible:[artifact-relationship-type](/valueset-artifact-relationship-type)


<a id="ResearchStudy.relatesTo.target[x]"></a>

## ResearchStudy.relatesTo.target[x]
The artifact that is related to this ResearchStudy

**Definition:** The artifact that is related to this ResearchStudy Resource.

**Comments:** A targetReference using a DocumentReference allows providing metadata regarding the referenced document.

**Cardinality:** 1..1

**Type:** [uri](/uri), [Attachment](/Attachment), [canonical](/canonical), Reference([Resource](/Resource)), [markdown](/markdown)


<a id="ResearchStudy.date"></a>

## ResearchStudy.date
Date the resource last changed

**Definition:** The date (and optionally time) when the ResearchStudy Resource was last significantly changed. The date must change when the business version changes and it must change if the status code changes. In addition, it should change when the substantive content of the ResearchStudy Resource changes.

**Cardinality:** 0..1

**Type:** [dateTime](/dateTime)


<a id="ResearchStudy.status"></a>

## ResearchStudy.status
draft | active | retired | unknown

**Definition:** The publication state of the resource (not of the study).

**Cardinality:** 1..1

**Type:** [code](/code)

**Binding:** required:[publication-status](/valueset-publication-status)

**Summary:** true

**Is Modifier:** true (Reason: This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid)

**Mappings:** w5=FiveWs.status; BRIDG5.1=StudyOverallStatus.code; rim=.status


<a id="ResearchStudy.primaryPurposeType"></a>

## ResearchStudy.primaryPurposeType
treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility

**Definition:** The type of study based upon the intent of the study activities. A classification of the intent of the study.

**Cardinality:** 0..1

**Type:** [CodeableConcept](/CodeableConcept)

**Binding:** preferred:[research-study-prim-purp-type](/valueset-research-study-prim-purp-type)

**Summary:** true

**Mappings:** BRIDG5.1=StudyProtocolVersion.primaryPurposeTypeCode


<a id="ResearchStudy.phase"></a>

## ResearchStudy.phase
Classifier used for clinical trials

**Definition:** The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.

**Cardinality:** 0..1

**Type:** [CodeableConcept](/CodeableConcept)

**Binding:** preferred:[research-study-phase](/valueset-research-study-phase)

**Summary:** true

**Mappings:** clinicaltrials-gov=Study Phase; BRIDG5.1=StudyProtocolVersion.phaseCode


<a id="ResearchStudy.studyDesign"></a>

## ResearchStudy.studyDesign
Classifications of the study design characteristics

**Definition:** Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.

**Comments:** See the Evidence Based Medicine on FHIR Implementation Guide (https://hl7.org/fhir/uv/ebm) for Extensible and Preferred value sets for evidence-related terminologies.

**Cardinality:** 0..*

**Type:** [CodeableConcept](/CodeableConcept)

**Binding:** preferred:[study-design](/valueset-study-design)

**Summary:** true

**Mappings:** clinicaltrials-gov=Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention; BRIDG5.1=InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode


<a id="ResearchStudy.focus"></a>

## ResearchStudy.focus
Drugs, devices, etc. under study

**Definition:** The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about.

**Cardinality:** 0..*

**Type:** [CodeableReference](/CodeableReference)

**Binding:** example:[research-study-focus-type](/valueset-research-study-focus-type)


<a id="ResearchStudy.condition"></a>

## ResearchStudy.condition
Condition being studied

**Definition:** The condition that is the focus of the study. For example, In a study to examine risk factors for Lupus, might have as an inclusion criterion "healthy volunteer", but the target condition code would be a Lupus SNOMED code.

**Cardinality:** 0..*

**Type:** [CodeableConcept](/CodeableConcept)

**Binding:** example:[condition-code](/valueset-condition-code)

**Summary:** true

**Mappings:** clinicaltrials-gov=Conditions; w5=FiveWs.what[x]; BRIDG5.1=StudyCondition.code


<a id="ResearchStudy.keyword"></a>

## ResearchStudy.keyword
Used to search for the study

**Definition:** Key terms to aid in searching for or filtering the study.

**Cardinality:** 0..*

**Type:** [CodeableConcept](/CodeableConcept)

**Binding:** example:[research-study-focus-type](/valueset-research-study-focus-type)

**Summary:** true

**Mappings:** clinicaltrials-gov=Keywords; BRIDG5.1=DocumentVersion.keywordCode; DocumentVersion.keywordText


<a id="ResearchStudy.region"></a>

## ResearchStudy.region
Geographic area for the study

**Definition:** A country, state or other area where the study is taking place rather than its precise geographic location or address.

**Cardinality:** 0..*

**Type:** [CodeableConcept](/CodeableConcept)

**Binding:** preferred:[jurisdiction](/valueset-jurisdiction)

**Summary:** true

**Mappings:** BRIDG5.1=StudyProtocolVersion.participatingLocationCode


<a id="ResearchStudy.descriptionSummary"></a>

## ResearchStudy.descriptionSummary
Brief text explaining the study

**Definition:** A brief text for explaining the study.

**Cardinality:** 0..1

**Type:** [markdown](/markdown)


<a id="ResearchStudy.description"></a>

## ResearchStudy.description
Detailed narrative of the study

**Definition:** A detailed and human-readable narrative of the study. E.g., study abstract.

**Cardinality:** 0..1

**Type:** [markdown](/markdown)

**Mappings:** clinicaltrials-gov=Detailed Description; BRIDG5.1=StudyProtocolDocumentVersion.publicDescription


<a id="ResearchStudy.period"></a>

## ResearchStudy.period
When the study began and ended

**Definition:** Identifies the start date and the expected (or actual, depending on status) end date for the study.

**Aliases:** timing

**Cardinality:** 0..1

**Type:** [Period](/Period)

**Summary:** true

**Mappings:** clinicaltrials-gov=Study Start Date (start); Study Completion Date (end); w5=FiveWs.done[x]; BRIDG5.1=ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration; rim=.effectiveTime


<a id="ResearchStudy.site"></a>

## ResearchStudy.site
Facility where study activities are conducted

**Definition:** A facility in which study activities are conducted.

**Cardinality:** 0..*

**Type:** Reference([Location](/Location), [ResearchStudy](/ResearchStudy), [Organization](/Organization))

**Summary:** true

**Mappings:** clinicaltrials-gov=Facility; w5=FiveWs.where[x]; BRIDG5.1=PlannedStudySite; StudySite


<a id="ResearchStudy.note"></a>

## ResearchStudy.note
Comments made about the study

**Definition:** Comments made about the study by the performer, subject or other participants.

**Cardinality:** 0..*

**Type:** [Annotation](/Annotation)

**Mappings:** BRIDG5.1=No BRIDG mapping; rim=.inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST]


<a id="ResearchStudy.classifier"></a>

## ResearchStudy.classifier
Classification for the study

**Definition:** Additional grouping mechanism or categorization of a research study. Example: FDA regulated device, FDA regulated drug, MPG Paragraph 23b (a German legal requirement), IRB-exempt, etc. Implementation Note: do not use the classifier element to support existing semantics that are already supported thru explicit elements in the resource.

**Cardinality:** 0..*

**Type:** [CodeableConcept](/CodeableConcept)

**Binding:** example:[research-study-classifiers](/valueset-research-study-classifiers)


<a id="ResearchStudy.associatedParty"></a>

## ResearchStudy.associatedParty
Sponsors, collaborators, and other parties

**Definition:** Sponsors, collaborators, and other parties.

**Comments:** For a Sponsor or a PrincipalInvestigator use the dedicated attributes provided.

**Requirements:** While there are explicit attributes for a Sponsor and a PrincipalInvestigator many trial record a range of other organizations and individuals in key roles.

**Cardinality:** 0..*

**Type:** [BackboneElement](/BackboneElement)


<a id="ResearchStudy.associatedParty.name"></a>

## ResearchStudy.associatedParty.name
Name of associated party

**Definition:** Name of associated party.

**Cardinality:** 0..1

**Type:** [string](/string)


<a id="ResearchStudy.associatedParty.role"></a>

## ResearchStudy.associatedParty.role
sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-chair | irb | data-monitoring

**Definition:** Type of association.

**Cardinality:** 1..1

**Type:** [CodeableConcept](/CodeableConcept)

**Binding:** example:[research-study-party-role](/valueset-research-study-party-role)


<a id="ResearchStudy.associatedParty.period"></a>

## ResearchStudy.associatedParty.period
When active in the role

**Definition:** Identifies the start date and the end date of the associated party in the role.

**Comments:** The cardinality is 0..* due to the fact that an associated party may be intermittently active in a given role over multiple time periods.

**Cardinality:** 0..*

**Type:** [Period](/Period)


<a id="ResearchStudy.associatedParty.classifier"></a>

## ResearchStudy.associatedParty.classifier
nih | fda | government | nonprofit | academic | industry

**Definition:** A categorization other than role for the associated party.

**Cardinality:** 0..*

**Type:** [CodeableConcept](/CodeableConcept)

**Binding:** example:[research-study-party-organization-type](/valueset-research-study-party-organization-type)


<a id="ResearchStudy.associatedParty.party"></a>

## ResearchStudy.associatedParty.party
Individual or organization associated with study (use practitionerRole to specify their organisation)

**Definition:** Individual or organization associated with study (use practitionerRole to specify their organisation).

**Comments:** Suggestions of a better attribute name are appreciated

**Cardinality:** 0..1

**Type:** Reference([Practitioner](/Practitioner), [PractitionerRole](/PractitionerRole), [Organization](/Organization))


<a id="ResearchStudy.progressStatus"></a>

## ResearchStudy.progressStatus
Status of study with time for that status

**Definition:** Status of study with time for that status.

**Cardinality:** 0..*

**Type:** [BackboneElement](/BackboneElement)


<a id="ResearchStudy.progressStatus.state"></a>

## ResearchStudy.progressStatus.state
Label for status or state (e.g. recruitment status)

**Definition:** Label for status or state (e.g. recruitment status).

**Cardinality:** 1..1

**Type:** [CodeableConcept](/CodeableConcept)

**Binding:** example:[research-study-status](/valueset-research-study-status)


<a id="ResearchStudy.progressStatus.actual"></a>

## ResearchStudy.progressStatus.actual
Actual if true else anticipated

**Definition:** An indication of whether or not the date is a known date when the state changed or will change. A value of true indicates a known date. A value of false indicates an estimated date.

**Cardinality:** 0..1

**Type:** [boolean](/boolean)


<a id="ResearchStudy.progressStatus.period"></a>

## ResearchStudy.progressStatus.period
Date range

**Definition:** Date range.

**Cardinality:** 0..1

**Type:** [Period](/Period)


<a id="ResearchStudy.whyStopped"></a>

## ResearchStudy.whyStopped
accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design

**Definition:** A description and/or code explaining the premature termination of the study.

**Cardinality:** 0..1

**Type:** [CodeableConcept](/CodeableConcept)

**Binding:** example:[research-study-reason-stopped](/valueset-research-study-reason-stopped)

**Summary:** true

**Mappings:** clinicaltrials-gov=Why Study Stopped; w5=FiveWs.why[x]; BRIDG5.1=StudyOverallStatus.studyStoppedReasonCode


<a id="ResearchStudy.recruitment"></a>

## ResearchStudy.recruitment
Target or actual group of participants enrolled in study

**Definition:** Target or actual group of participants enrolled in study.

**Cardinality:** 0..1

**Type:** [BackboneElement](/BackboneElement)

**Summary:** true

**Mappings:** clinicaltrials-gov=Enrollment; Number of Groups/Cohorts (= number of "enrollment" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria); w5=FiveWs.subject; BRIDG5.1=InterventionalStudyProtocol.interventionGroupQuantity; rim=.participation[typeCode=SBJ].role


<a id="ResearchStudy.recruitment.targetNumber"></a>

## ResearchStudy.recruitment.targetNumber
Estimated total number of participants to be enrolled

**Definition:** Estimated total number of participants to be enrolled.

**Cardinality:** 0..1

**Type:** [unsignedInt](/unsignedInt)


<a id="ResearchStudy.recruitment.actualNumber"></a>

## ResearchStudy.recruitment.actualNumber
Actual total number of participants enrolled in study

**Definition:** Actual total number of participants enrolled in study.

**Cardinality:** 0..1

**Type:** [unsignedInt](/unsignedInt)


<a id="ResearchStudy.recruitment.eligibility"></a>

## ResearchStudy.recruitment.eligibility
Inclusion and exclusion criteria

**Definition:** Inclusion and exclusion criteria. The referenced Group Resource should have a membership element value of either 'definitional' or 'conceptual'.

**Cardinality:** 0..1

**Type:** Reference([Group](/Group))


<a id="ResearchStudy.recruitment.actualGroup"></a>

## ResearchStudy.recruitment.actualGroup
Group of participants who were enrolled in study

**Definition:** Group of participants who were enrolled in study. The referenced Group Resource should have a membership element value of 'enumerated'.

**Cardinality:** 0..1

**Type:** Reference([Group](/Group))

**Summary:** true

**Mappings:** clinicaltrials-gov=Enrollment; Number of Groups/Cohorts (= number of "enrollment" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria); w5=FiveWs.subject; BRIDG5.1=InterventionalStudyProtocol.interventionGroupQuantity; rim=.participation[typeCode=SBJ].role


<a id="ResearchStudy.recruitment.description"></a>

## ResearchStudy.recruitment.description
Description of the recruitment

**Definition:** Free text description of the recruitment of the study.

**Cardinality:** 0..1

**Type:** [markdown](/markdown)


<a id="ResearchStudy.comparisonGroup"></a>

## ResearchStudy.comparisonGroup
Defined path through the study for a subject

**Definition:** Describes an expected event or sequence of events for one of the subjects of a study. E.g. for a living subject: exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up. E.g. for a stability study: {store sample from lot A at 25 degrees for 1 month}, {store sample from lot A at 40 degrees for 1 month}.

**Comments:** In many clinical trials this is refered to as the ARM of the study, but such a term is not used in other sorts of trials even when there is a comparison between two or more groups.

**Aliases:** arm

**Cardinality:** 0..*

**Type:** [BackboneElement](/BackboneElement)

**Mappings:** clinicaltrials-gov=Arms; BRIDG5.1=Arm


<a id="ResearchStudy.comparisonGroup.targetNumber"></a>

## ResearchStudy.comparisonGroup.targetNumber
Estimated total number of participants to be enrolled in the comparison group

**Definition:** Estimated total number of participants to be enrolled in the comparison group.

**Cardinality:** 0..1

**Type:** [unsignedInt](/unsignedInt)


<a id="ResearchStudy.comparisonGroup.actualNumber"></a>

## ResearchStudy.comparisonGroup.actualNumber
Actual total number of participants enrolled in the comparison group

**Definition:** Actual total number of participants enrolled in the comparison group.

**Cardinality:** 0..1

**Type:** [unsignedInt](/unsignedInt)


<a id="ResearchStudy.comparisonGroup.eligibility"></a>

## ResearchStudy.comparisonGroup.eligibility
Inclusion and exclusion criteria for the comparison group

**Definition:** Inclusion and exclusion criteria for the comparison group as a subset of the eligibility for the overall study. The referenced Group Resource should have a membership element value of either 'definitional' or 'conceptual'.

**Cardinality:** 0..1

**Type:** Reference([Group](/Group))


<a id="ResearchStudy.comparisonGroup.observedGroup"></a>

## ResearchStudy.comparisonGroup.observedGroup
Group of participants who were enrolled in the comparison group

**Definition:** Group of participants who were enrolled in the comparison group as a subset of those enrolled in the overall study. The referenced Group Resource should have a membership element value of 'enumerated'.

**Cardinality:** 0..1

**Type:** Reference([Group](/Group))


<a id="ResearchStudy.comparisonGroup.description"></a>

## ResearchStudy.comparisonGroup.description
Description of the comparison Group

**Cardinality:** 0..1

**Type:** [markdown](/markdown)


<a id="ResearchStudy.objective"></a>

## ResearchStudy.objective
A goal for the study

**Definition:** A goal that the study is aiming to achieve in terms of a scientific question to be answered by the analysis of data collected during the study.

**Cardinality:** 0..*

**Type:** [BackboneElement](/BackboneElement)

**Mappings:** BRIDG5.1=StudyObjective


<a id="ResearchStudy.objective.name"></a>

## ResearchStudy.objective.name
Label for the objective

**Definition:** Unique, human-readable label for this objective of the study.

**Cardinality:** 0..1

**Type:** [string](/string)

**Mappings:** BRIDG5.1=No BRIDG mapping (BRIDG has a description, but not a name)


<a id="ResearchStudy.objective.type"></a>

## ResearchStudy.objective.type
primary | secondary | exploratory

**Definition:** The kind of study objective.

**Cardinality:** 0..1

**Type:** [CodeableConcept](/CodeableConcept)

**Binding:** preferred:[research-study-objective-type](/valueset-research-study-objective-type)

**Mappings:** BRIDG5.1=StudyObjective.typeCode


<a id="ResearchStudy.objective.description"></a>

## ResearchStudy.objective.description
Description of the objective

**Definition:** Free text description of the objective of the study. This is what the study is trying to achieve rather than how it is going to achieve it (see ResearchStudy.description).

**Cardinality:** 0..1

**Type:** [markdown](/markdown)


<a id="ResearchStudy.objective.outcomeMeasure"></a>

## ResearchStudy.objective.outcomeMeasure
A variable measured during the study

**Definition:** An "outcome measure", "endpoint", "effect measure" or "measure of effect" is a specific measurement or observation used to quantify the effect of experimental variables on the participants in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment.

**Comments:** A study may have multiple distinct outcome measures that can be used to assess the overall goal for a study. The goal of a study is in the objective whereas the metric by which the goal is assessed is the outcomeMeasure. Examples: Time to Local Recurrence (TLR), Disease-free Survival (DFS), 30 Day Mortality, Systolic BP

**Cardinality:** 0..*

**Type:** [BackboneElement](/BackboneElement)


<a id="ResearchStudy.objective.outcomeMeasure.name"></a>

## ResearchStudy.objective.outcomeMeasure.name
Label for the outcome measure

**Definition:** Label for the outcome measure.

**Cardinality:** 0..1

**Type:** [string](/string)


<a id="ResearchStudy.objective.outcomeMeasure.type"></a>

## ResearchStudy.objective.outcomeMeasure.type
primary | secondary | exploratory

**Definition:** The kind of outcome measure.

**Cardinality:** 0..1

**Type:** [CodeableConcept](/CodeableConcept)

**Binding:** preferred:[research-study-objective-type](/valueset-research-study-objective-type)


<a id="ResearchStudy.objective.outcomeMeasure.description"></a>

## ResearchStudy.objective.outcomeMeasure.description
Description of the outcome measure

**Definition:** Description of the outcome measure.

**Cardinality:** 0..1

**Type:** [markdown](/markdown)


<a id="ResearchStudy.objective.outcomeMeasure.endpoint"></a>

## ResearchStudy.objective.outcomeMeasure.endpoint
Definition of the outcome measure

**Definition:** Definition of the outcome measure.

**Cardinality:** 1..1

**Type:** Reference([EvidenceVariable](/EvidenceVariable))


<a id="ResearchStudy.objective.outcomeMeasure.population"></a>

## ResearchStudy.objective.outcomeMeasure.population
Population for this estimand

**Definition:** Population for this estimand.

**Cardinality:** 0..1

**Type:** Reference([Group](/Group))


<a id="ResearchStudy.objective.outcomeMeasure.intervention"></a>

## ResearchStudy.objective.outcomeMeasure.intervention
Comparison group of interest

**Definition:** Comparison group of interest.

**Comments:** To re-use and reference a Group represented in ResearchStudy.comparisonGroup.eligibility, one may include the Group Resource in ResearchStudy.contained and then reference the same (internal) Group by its id

**Cardinality:** 0..1

**Type:** Reference([Group](/Group))


<a id="ResearchStudy.objective.outcomeMeasure.comparator"></a>

## ResearchStudy.objective.outcomeMeasure.comparator
Comparison group for comparison

**Definition:** Comparison group for comparison.

**Comments:** To re-use and reference a Group represented in ResearchStudy.comparisonGroup.eligibility, one may include the Group Resource in ResearchStudy.contained and then reference the same (internal) Group by its id

**Cardinality:** 0..1

**Type:** Reference([Group](/Group))


<a id="ResearchStudy.objective.outcomeMeasure.summaryMeasure"></a>

## ResearchStudy.objective.outcomeMeasure.summaryMeasure
Statistical measure for treatment effect estimate

**Definition:** Statistical measure for treatment effect estimate.

**Comments:** See the Evidence Based Medicine on FHIR Implementation Guide (https://hl7.org/fhir/uv/ebm) for Extensible and Preferred value sets for evidence-related terminologies.

**Cardinality:** 0..1

**Type:** [CodeableConcept](/CodeableConcept)

**Binding:** example:[statistic-type](/valueset-statistic-type)


<a id="ResearchStudy.objective.outcomeMeasure.endpointAnalysisPlan"></a>

## ResearchStudy.objective.outcomeMeasure.endpointAnalysisPlan
Statistical analysis plan for a single endpoint

**Definition:** The planned statistical model for analysis of a single endpoint.

**Cardinality:** 0..1

**Type:** Reference([Evidence](/Evidence))


<a id="ResearchStudy.objective.outcomeMeasure.eventHandling"></a>

## ResearchStudy.objective.outcomeMeasure.eventHandling
Handling of intercurrent event

**Definition:** Handling of intercurrent event.

**Cardinality:** 0..*

**Type:** [BackboneElement](/BackboneElement)


<a id="ResearchStudy.objective.outcomeMeasure.eventHandling.event"></a>

## ResearchStudy.objective.outcomeMeasure.eventHandling.event
The event

**Definition:** The event.

**Cardinality:** 0..1

**Type:** [CodeableConcept](/CodeableConcept)


<a id="ResearchStudy.objective.outcomeMeasure.eventHandling.group"></a>

## ResearchStudy.objective.outcomeMeasure.eventHandling.group
The group that is affected by this event handling

**Definition:** The group that is affected by this event handling.

**Cardinality:** 0..1

**Type:** [CodeableConcept](/CodeableConcept)


<a id="ResearchStudy.objective.outcomeMeasure.eventHandling.handling"></a>

## ResearchStudy.objective.outcomeMeasure.eventHandling.handling
How the data is handled

**Cardinality:** 0..1

**Type:** [CodeableConcept](/CodeableConcept)


<a id="ResearchStudy.objective.outcomeMeasure.eventHandling.description"></a>

## ResearchStudy.objective.outcomeMeasure.eventHandling.description
Text summary of event handling

**Cardinality:** 0..1

**Type:** [markdown](/markdown)


<a id="ResearchStudy.result"></a>

## ResearchStudy.result
Link to results generated during the study

**Definition:** Link to one or more sets of results generated by the study. Could also link to a research registry holding the results such as ClinicalTrials.gov.

**Cardinality:** 0..*

**Type:** Reference([Composition](/Composition), [DiagnosticReport](/DiagnosticReport), [Evidence](/Evidence))

**Summary:** true