---
type: "resource"
title: "ResearchStudy"
resource: "ResearchStudy"
---
# ResearchStudy
## Introduction
## Scope and Usage
This resource is a [_definition resource_](workflow#definition) from a FHIR workflow perspective - see [Workflow](workflow).
A process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge. This includes studies of safety, efficacy, comparative effectiveness and other information about medications, devices, therapies and other interventional and investigative techniques. A ResearchStudy involves the gathering of information about human or animal subjects or stability data about drug products or drug substances.
For clinical trials -- A research study is a scientific way to improve or develop new methods of health care. Studies are designed to answer specific questions on how to prevent, diagnose, or treat diseases and disorders. The ResearchStudy resource describes essential information about the study, including the purpose, objective, sponsor, investigator, therapy, condition being studied, schedule of activities, and other key items.
Uses for the ResearchStudy resource include:
- Registering a clinical trial in trial registry such as clinicaltrials.gov
- Communicating study protocol information between study stakeholders
- Supporting study set up of sites, forms
- Grouping Observation resources by study
- Setting up a Schedule of Activities for the study and its subjects
- Specifying Study information in support of Genomic, Proteomic and Stability studies
### Extensions
ResearchStudy is aimed at all forms of studies. For some study types specific extensions have been defined
**Extension: SiteRecruitment**
Some studies need to find sites according to specific criteria - for example site has a freezer capable of very low temperatures and a centrifuge.
**Extension: StudyRegistration**
Used to separate study registration activities from study progress status.
## Notes
## ResearchStudy State Machine
The following diagram reflects the "typical" state machine for ResearchStudy.
## StructureDefinition
### Elements (Simplified)
- **[ResearchStudy](/researchstudy-definitions#ResearchStudy)** [0..*]: - Investigation to increase healthcare-related patient-independent knowledge
- **[ResearchStudy.url](/researchstudy-definitions#ResearchStudy.url)** [0..1]: [uri](/uri) Canonical identifier for this study resource
- **[ResearchStudy.identifier](/researchstudy-definitions#ResearchStudy.identifier)** [0..*]: [Identifier](/Identifier) Business Identifier for study
- **[ResearchStudy.version](/researchstudy-definitions#ResearchStudy.version)** [0..1]: [string](/string) The business version for the study record
- **[ResearchStudy.name](/researchstudy-definitions#ResearchStudy.name)** [0..1]: [string](/string) Name for this study (computer friendly)
- **[ResearchStudy.title](/researchstudy-definitions#ResearchStudy.title)** [0..1]: [string](/string) Human readable name of the study
- **[ResearchStudy.label](/researchstudy-definitions#ResearchStudy.label)** [0..*]: [BackboneElement](/BackboneElement) Additional names for the study
- **[ResearchStudy.label.type](/researchstudy-definitions#ResearchStudy.label.type)** [0..1]: [CodeableConcept](/CodeableConcept) preferred:[title-type](/valueset-title-type) primary | official | scientific | plain-language | subtitle | short-title | acronym | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid
- **[ResearchStudy.label.value](/researchstudy-definitions#ResearchStudy.label.value)** [0..1]: [string](/string) The name
- **[ResearchStudy.label.language](/researchstudy-definitions#ResearchStudy.label.language)** [0..1]: [code](/code) required:[all-languages](/valueset-all-languages) Used to express the specific language
- **[ResearchStudy.protocol](/researchstudy-definitions#ResearchStudy.protocol)** [0..*]: Reference([PlanDefinition](/PlanDefinition)) Steps followed in executing study
- **[ResearchStudy.partOf](/researchstudy-definitions#ResearchStudy.partOf)** [0..*]: Reference([ResearchStudy](/ResearchStudy)) Part of larger study
- **[ResearchStudy.citeAs](/researchstudy-definitions#ResearchStudy.citeAs)** [0..1]: [markdown](/markdown) How to cite this ResearchStudy
- **[ResearchStudy.relatesTo](/researchstudy-definitions#ResearchStudy.relatesTo)** [0..*]: [BackboneElement](/BackboneElement) Relationships to other Resources
- **[ResearchStudy.relatesTo.type](/researchstudy-definitions#ResearchStudy.relatesTo.type)** [1..1]: [CodeableConcept](/CodeableConcept) extensible:[artifact-relationship-type](/valueset-artifact-relationship-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
- **[ResearchStudy.relatesTo.target[x]](/researchstudy-definitions#ResearchStudy.relatesTo.target%5Bx%5D)** [1..1]: [uri](/uri), [Attachment](/Attachment), [canonical](/canonical), Reference([Resource](/Resource)), [markdown](/markdown) The artifact that is related to this ResearchStudy
- **[ResearchStudy.date](/researchstudy-definitions#ResearchStudy.date)** [0..1]: [dateTime](/dateTime) Date the resource last changed
- **[ResearchStudy.status](/researchstudy-definitions#ResearchStudy.status)** [1..1]: [code](/code) required:[publication-status](/valueset-publication-status) draft | active | retired | unknown
- **[ResearchStudy.primaryPurposeType](/researchstudy-definitions#ResearchStudy.primaryPurposeType)** [0..1]: [CodeableConcept](/CodeableConcept) preferred:[research-study-prim-purp-type](/valueset-research-study-prim-purp-type) treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
- **[ResearchStudy.phase](/researchstudy-definitions#ResearchStudy.phase)** [0..1]: [CodeableConcept](/CodeableConcept) preferred:[research-study-phase](/valueset-research-study-phase) Classifier used for clinical trials
- **[ResearchStudy.studyDesign](/researchstudy-definitions#ResearchStudy.studyDesign)** [0..*]: [CodeableConcept](/CodeableConcept) preferred:[study-design](/valueset-study-design) Classifications of the study design characteristics
- **[ResearchStudy.focus](/researchstudy-definitions#ResearchStudy.focus)** [0..*]: [CodeableReference](/CodeableReference) example:[research-study-focus-type](/valueset-research-study-focus-type) Drugs, devices, etc. under study
- **[ResearchStudy.condition](/researchstudy-definitions#ResearchStudy.condition)** [0..*]: [CodeableConcept](/CodeableConcept) example:[condition-code](/valueset-condition-code) Condition being studied
- **[ResearchStudy.keyword](/researchstudy-definitions#ResearchStudy.keyword)** [0..*]: [CodeableConcept](/CodeableConcept) example:[research-study-focus-type](/valueset-research-study-focus-type) Used to search for the study
- **[ResearchStudy.region](/researchstudy-definitions#ResearchStudy.region)** [0..*]: [CodeableConcept](/CodeableConcept) preferred:[jurisdiction](/valueset-jurisdiction) Geographic area for the study
- **[ResearchStudy.descriptionSummary](/researchstudy-definitions#ResearchStudy.descriptionSummary)** [0..1]: [markdown](/markdown) Brief text explaining the study
- **[ResearchStudy.description](/researchstudy-definitions#ResearchStudy.description)** [0..1]: [markdown](/markdown) Detailed narrative of the study
- **[ResearchStudy.period](/researchstudy-definitions#ResearchStudy.period)** [0..1]: [Period](/Period) When the study began and ended
- **[ResearchStudy.site](/researchstudy-definitions#ResearchStudy.site)** [0..*]: [Reference(Location](/Reference(Location), [ResearchStudy](/ResearchStudy), [Organization)](/Organization)) Facility where study activities are conducted
- **[ResearchStudy.note](/researchstudy-definitions#ResearchStudy.note)** [0..*]: [Annotation](/Annotation) Comments made about the study
- **[ResearchStudy.classifier](/researchstudy-definitions#ResearchStudy.classifier)** [0..*]: [CodeableConcept](/CodeableConcept) example:[research-study-classifiers](/valueset-research-study-classifiers) Classification for the study
- **[ResearchStudy.associatedParty](/researchstudy-definitions#ResearchStudy.associatedParty)** [0..*]: [BackboneElement](/BackboneElement) Sponsors, collaborators, and other parties
- **[ResearchStudy.associatedParty.name](/researchstudy-definitions#ResearchStudy.associatedParty.name)** [0..1]: [string](/string) Name of associated party
- **[ResearchStudy.associatedParty.role](/researchstudy-definitions#ResearchStudy.associatedParty.role)** [1..1]: [CodeableConcept](/CodeableConcept) example:[research-study-party-role](/valueset-research-study-party-role) sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-chair | irb | data-monitoring
- **[ResearchStudy.associatedParty.period](/researchstudy-definitions#ResearchStudy.associatedParty.period)** [0..*]: [Period](/Period) When active in the role
- **[ResearchStudy.associatedParty.classifier](/researchstudy-definitions#ResearchStudy.associatedParty.classifier)** [0..*]: [CodeableConcept](/CodeableConcept) example:[research-study-party-organization-type](/valueset-research-study-party-organization-type) nih | fda | government | nonprofit | academic | industry
- **[ResearchStudy.associatedParty.party](/researchstudy-definitions#ResearchStudy.associatedParty.party)** [0..1]: [Reference(Practitioner](/Reference(Practitioner), [PractitionerRole](/PractitionerRole), [Organization)](/Organization)) Individual or organization associated with study (use practitionerRole to specify their organisation)
- **[ResearchStudy.progressStatus](/researchstudy-definitions#ResearchStudy.progressStatus)** [0..*]: [BackboneElement](/BackboneElement) Status of study with time for that status
- **[ResearchStudy.progressStatus.state](/researchstudy-definitions#ResearchStudy.progressStatus.state)** [1..1]: [CodeableConcept](/CodeableConcept) example:[research-study-status](/valueset-research-study-status) Label for status or state (e.g. recruitment status)
- **[ResearchStudy.progressStatus.actual](/researchstudy-definitions#ResearchStudy.progressStatus.actual)** [0..1]: [boolean](/boolean) Actual if true else anticipated
- **[ResearchStudy.progressStatus.period](/researchstudy-definitions#ResearchStudy.progressStatus.period)** [0..1]: [Period](/Period) Date range
- **[ResearchStudy.whyStopped](/researchstudy-definitions#ResearchStudy.whyStopped)** [0..1]: [CodeableConcept](/CodeableConcept) example:[research-study-reason-stopped](/valueset-research-study-reason-stopped) accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
- **[ResearchStudy.recruitment](/researchstudy-definitions#ResearchStudy.recruitment)** [0..1]: [BackboneElement](/BackboneElement) Target or actual group of participants enrolled in study
- **[ResearchStudy.recruitment.targetNumber](/researchstudy-definitions#ResearchStudy.recruitment.targetNumber)** [0..1]: [unsignedInt](/unsignedInt) Estimated total number of participants to be enrolled
- **[ResearchStudy.recruitment.actualNumber](/researchstudy-definitions#ResearchStudy.recruitment.actualNumber)** [0..1]: [unsignedInt](/unsignedInt) Actual total number of participants enrolled in study
- **[ResearchStudy.recruitment.eligibility](/researchstudy-definitions#ResearchStudy.recruitment.eligibility)** [0..1]: Reference([Group](/Group)) Inclusion and exclusion criteria
- **[ResearchStudy.recruitment.actualGroup](/researchstudy-definitions#ResearchStudy.recruitment.actualGroup)** [0..1]: Reference([Group](/Group)) Group of participants who were enrolled in study
- **[ResearchStudy.recruitment.description](/researchstudy-definitions#ResearchStudy.recruitment.description)** [0..1]: [markdown](/markdown) Description of the recruitment
- **[ResearchStudy.comparisonGroup](/researchstudy-definitions#ResearchStudy.comparisonGroup)** [0..*]: [BackboneElement](/BackboneElement) Defined path through the study for a subject
- **[ResearchStudy.comparisonGroup.targetNumber](/researchstudy-definitions#ResearchStudy.comparisonGroup.targetNumber)** [0..1]: [unsignedInt](/unsignedInt) Estimated total number of participants to be enrolled in the comparison group
- **[ResearchStudy.comparisonGroup.actualNumber](/researchstudy-definitions#ResearchStudy.comparisonGroup.actualNumber)** [0..1]: [unsignedInt](/unsignedInt) Actual total number of participants enrolled in the comparison group
- **[ResearchStudy.comparisonGroup.eligibility](/researchstudy-definitions#ResearchStudy.comparisonGroup.eligibility)** [0..1]: Reference([Group](/Group)) Inclusion and exclusion criteria for the comparison group
- **[ResearchStudy.comparisonGroup.observedGroup](/researchstudy-definitions#ResearchStudy.comparisonGroup.observedGroup)** [0..1]: Reference([Group](/Group)) Group of participants who were enrolled in the comparison group
- **[ResearchStudy.comparisonGroup.description](/researchstudy-definitions#ResearchStudy.comparisonGroup.description)** [0..1]: [markdown](/markdown) Description of the comparison Group
- **[ResearchStudy.objective](/researchstudy-definitions#ResearchStudy.objective)** [0..*]: [BackboneElement](/BackboneElement) A goal for the study
- **[ResearchStudy.objective.name](/researchstudy-definitions#ResearchStudy.objective.name)** [0..1]: [string](/string) Label for the objective
- **[ResearchStudy.objective.type](/researchstudy-definitions#ResearchStudy.objective.type)** [0..1]: [CodeableConcept](/CodeableConcept) preferred:[research-study-objective-type](/valueset-research-study-objective-type) primary | secondary | exploratory
- **[ResearchStudy.objective.description](/researchstudy-definitions#ResearchStudy.objective.description)** [0..1]: [markdown](/markdown) Description of the objective
- **[ResearchStudy.objective.outcomeMeasure](/researchstudy-definitions#ResearchStudy.objective.outcomeMeasure)** [0..*]: [BackboneElement](/BackboneElement) A variable measured during the study
- **[ResearchStudy.objective.outcomeMeasure.name](/researchstudy-definitions#ResearchStudy.objective.outcomeMeasure.name)** [0..1]: [string](/string) Label for the outcome measure
- **[ResearchStudy.objective.outcomeMeasure.type](/researchstudy-definitions#ResearchStudy.objective.outcomeMeasure.type)** [0..1]: [CodeableConcept](/CodeableConcept) preferred:[research-study-objective-type](/valueset-research-study-objective-type) primary | secondary | exploratory
- **[ResearchStudy.objective.outcomeMeasure.description](/researchstudy-definitions#ResearchStudy.objective.outcomeMeasure.description)** [0..1]: [markdown](/markdown) Description of the outcome measure
- **[ResearchStudy.objective.outcomeMeasure.endpoint](/researchstudy-definitions#ResearchStudy.objective.outcomeMeasure.endpoint)** [1..1]: Reference([EvidenceVariable](/EvidenceVariable)) Definition of the outcome measure
- **[ResearchStudy.objective.outcomeMeasure.population](/researchstudy-definitions#ResearchStudy.objective.outcomeMeasure.population)** [0..1]: Reference([Group](/Group)) Population for this estimand
- **[ResearchStudy.objective.outcomeMeasure.intervention](/researchstudy-definitions#ResearchStudy.objective.outcomeMeasure.intervention)** [0..1]: Reference([Group](/Group)) Comparison group of interest
- **[ResearchStudy.objective.outcomeMeasure.comparator](/researchstudy-definitions#ResearchStudy.objective.outcomeMeasure.comparator)** [0..1]: Reference([Group](/Group)) Comparison group for comparison
- **[ResearchStudy.objective.outcomeMeasure.summaryMeasure](/researchstudy-definitions#ResearchStudy.objective.outcomeMeasure.summaryMeasure)** [0..1]: [CodeableConcept](/CodeableConcept) example:[statistic-type](/valueset-statistic-type) Statistical measure for treatment effect estimate
- **[ResearchStudy.objective.outcomeMeasure.endpointAnalysisPlan](/researchstudy-definitions#ResearchStudy.objective.outcomeMeasure.endpointAnalysisPlan)** [0..1]: Reference([Evidence](/Evidence)) Statistical analysis plan for a single endpoint
- **[ResearchStudy.objective.outcomeMeasure.eventHandling](/researchstudy-definitions#ResearchStudy.objective.outcomeMeasure.eventHandling)** [0..*]: [BackboneElement](/BackboneElement) Handling of intercurrent event
- **[ResearchStudy.objective.outcomeMeasure.eventHandling.event](/researchstudy-definitions#ResearchStudy.objective.outcomeMeasure.eventHandling.event)** [0..1]: [CodeableConcept](/CodeableConcept) The event
- **[ResearchStudy.objective.outcomeMeasure.eventHandling.group](/researchstudy-definitions#ResearchStudy.objective.outcomeMeasure.eventHandling.group)** [0..1]: [CodeableConcept](/CodeableConcept) The group that is affected by this event handling
- **[ResearchStudy.objective.outcomeMeasure.eventHandling.handling](/researchstudy-definitions#ResearchStudy.objective.outcomeMeasure.eventHandling.handling)** [0..1]: [CodeableConcept](/CodeableConcept) How the data is handled
- **[ResearchStudy.objective.outcomeMeasure.eventHandling.description](/researchstudy-definitions#ResearchStudy.objective.outcomeMeasure.eventHandling.description)** [0..1]: [markdown](/markdown) Text summary of event handling
- **[ResearchStudy.result](/researchstudy-definitions#ResearchStudy.result)** [0..*]: [Reference(Composition](/Reference(Composition), [DiagnosticReport](/DiagnosticReport), [Evidence)](/Evidence)) Link to results generated during the study
## Mappings
- [ResearchStudy Mappings](/researchstudy-mappings) — 56 mapping entries
## Implementation Guide
### implementationguide-ResearchStudy-core.xml
```xml
```
## Resource Packs
### list-ResearchStudy-packs.xml
```xml
-
```
## Search Parameters
- [condition](/researchstudy-search#condition) — **token** — Condition being studied — `ResearchStudy.condition`
- [date](/researchstudy-search#date) — **date** — When the study began and ended — `ResearchStudy.period`
- [focus-code](/researchstudy-search#focus-code) — **token** — Drugs, devices, etc. under study, as a code — `ResearchStudy.focus.concept`
- [focus-reference](/researchstudy-search#focus-reference) — **reference** — Drugs, devices, etc. under study, as a reference — `ResearchStudy.focus.reference`
- [identifier](/researchstudy-search#identifier) — **token** — Business Identifier for study — `ResearchStudy.identifier`
- [keyword](/researchstudy-search#keyword) — **token** — Used to search for the study — `ResearchStudy.keyword`
- [region](/researchstudy-search#region) — **token** — Geographic area for the study — `ResearchStudy.region`
- [part-of](/researchstudy-search#part-of) — **reference** — Part of larger study — `ResearchStudy.partOf`
- [protocol](/researchstudy-search#protocol) — **reference** — Steps followed in executing study — `ResearchStudy.protocol`
- [recruitment-actual](/researchstudy-search#recruitment-actual) — **number** — Actual number of participants enrolled in study across all groups — `ResearchStudy.recruitment.actualNumber`
- [recruitment-target](/researchstudy-search#recruitment-target) — **number** — Target number of participants enrolled in study across all groups — `ResearchStudy.recruitment.targetNumber`
- [site](/researchstudy-search#site) — **reference** — Facility where study activities are conducted — `ResearchStudy.site`
- [status](/researchstudy-search#status) — **token** — active | active-but-not-recruiting | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | enrolling-by-invitation | in-review | not-yet-recruiting | recruiting | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | terminated | withdrawn — `ResearchStudy.status`
- [title](/researchstudy-search#title) — **string** — The human readable name of the research study — `ResearchStudy.title`
- [name](/researchstudy-search#name) — **string** — Name for this study — `ResearchStudy.name`
- [description](/researchstudy-search#description) — **string** — Detailed narrative of the study — `ResearchStudy.description`
- [phase](/researchstudy-search#phase) — **token** — The stage in the progression of a study — `ResearchStudy.phase`
- [classifier](/researchstudy-search#classifier) — **token** — Classification for the study — `ResearchStudy.classifier`
- [study-design](/researchstudy-search#study-design) — **token** — Classifications of the study design characteristics — `ResearchStudy.studyDesign`
- [objective-description](/researchstudy-search#objective-description) — **string** — Free text description of the objective of the study — `ResearchStudy.objective.description`
- [objective-type](/researchstudy-search#objective-type) — **token** — The kind of study objective — `ResearchStudy.objective.type`
- [eligibility](/researchstudy-search#eligibility) — **reference** — Inclusion and exclusion criteria — `ResearchStudy.recruitment.eligibility`
- [progress-state](/researchstudy-search#progress-state) — **token** — Label for status or state — `ResearchStudy.progressStatus.state`
- [progress-actual](/researchstudy-search#progress-actual) — **token** — Actual if true else anticipated — `ResearchStudy.progressStatus.actual`
- [progress-period](/researchstudy-search#progress-period) — **date** — Date range — `ResearchStudy.progressStatus.period`
- [progress-status-state-period](/researchstudy-search#progress-status-state-period) — **composite** — Status of study by state and period — `ResearchStudy.progressStatus`
- [progress-status-state-actual](/researchstudy-search#progress-status-state-actual) — **composite** — Status of study by state and actual — `ResearchStudy.progressStatus`
- [progress-status-state-period-actual](/researchstudy-search#progress-status-state-period-actual) — **composite** — Status of study by state, period and actual — `ResearchStudy.progressStatus`
[Full Search Parameters](/researchstudy-search)
## Examples
- [example-ctgov-study-record](/researchstudy-example-example-ctgov-study-record) — researchstudy-example-ctgov-study-record — ClinicalTrials.gov Study Record
- [researchstudy-example](/researchstudy-example-researchstudy-example) — researchstudy-example
- [researchstudy-example-ctgov-study-record](/researchstudy-example-researchstudy-example-ctgov-study-record) — researchstudy-example-ctgov-study-record
- [researchstudy-examples-header](/researchstudy-example-researchstudy-examples-header) — researchstudy-examples-header
[Full Examples](/researchstudy-examples)
## Mapping Exceptions
### researchstudy-fivews-mapping-exceptions.xml
### Divergent Elements
- **FiveWs.what[x]** → **ResearchStudy.condition**
### Unmapped Elements
- **FiveWs.recorded** — Unknown
- **FiveWs.author** — Unknown
- **FiveWs.actor** — Unknown
- **FiveWs.cause** — Unknown
- **FiveWs.version** — Unknown
- **FiveWs.witness** — Unknown
- **FiveWs.class** — Unknown
- **FiveWs.context** — Unknown
- **FiveWs.init** — Unknown
- **FiveWs.source** — Unknown
- **FiveWs.who** — Unknown
- **FiveWs.grade** — Unknown
- **FiveWs.planned** — Unknown