FHIR CI-Build

This is the Continuous Integration Build of FHIR (will be incorrect/inconsistent at times).
See the Directory of published versions icon

8.25 Resource ResearchStudy - Content

Biomedical Research and Regulation icon Work GroupMaturity Level: 0 Trial UseSecurity Category: Business Compartments: Group

A scientific study intended to increase health-related knowledge. For example, clinical trials are research studies that involve people. These studies may be related to new ways to screen, prevent, diagnose, and treat disease. They may also study certain outcomes and certain groups of people by looking at data collected in the past or future.



8.25.1 Scope and Usage

This resource is a definition resource from a FHIR workflow perspective - see 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

8.25.1.1 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.

8.25.2 References to this Resource

8.25.3 Resource Content

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchStudy TU DomainResource Investigation to increase healthcare-related patient-independent knowledge

Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... url 0..1 uri Canonical identifier for this study resource
... identifier Σ 0..* Identifier Business Identifier for study

... version 0..1 string The business version for the study record
... name 0..1 string Name for this study (computer friendly)
... title Σ 0..1 string Human readable name of the study
... label 0..* BackboneElement Additional names for the study

.... type 0..1 CodeableConcept primary | official | scientific | plain-language | subtitle | short-title | acronym | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid
Binding: Title Type (Extensible)
.... value 0..1 string The name
... protocol Σ 0..* Reference(PlanDefinition) Steps followed in executing study

... partOf Σ 0..* Reference(ResearchStudy) Part of larger study

... citeAs 0..1 markdown How to cite this ResearchStudy
... relatesTo 0..* BackboneElement Relationships to other Resources

.... type 1..1 code documentation | justification | 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 | specification-of | created-with | cite-as | summarizes
Binding: Artifact Relationship Type (Required)
.... target[x] 1..1 The artifact that is related to this ResearchStudy
..... targetUri uri
..... targetAttachment Attachment
..... targetCanonical canonical(Any)
..... targetReference Reference(Any)
..... targetMarkdown markdown
... date 0..1 dateTime Date the resource last changed
... status ?!Σ 1..1 code draft | active | retired | unknown
Binding: PublicationStatus (Required)
... primaryPurposeType Σ 0..1 CodeableConcept treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
Binding: Research Study Primary Purpose Type (Preferred)
... phase Σ 0..1 CodeableConcept Classifier used for clinical trials
Binding: Research Study Trial Phase (Preferred)
... studyDesign Σ 0..* CodeableConcept Classifications of the study design characteristics
Binding: Study Design (Preferred)

... focus 0..* CodeableReference(Medication | MedicinalProductDefinition | SubstanceDefinition | DeviceDefinition | PlanDefinition) Drugs, devices, etc. under study
Binding: Research Study Focus Type (Example)

... condition Σ 0..* CodeableConcept Condition being studied
Binding: Condition/Problem/Diagnosis Codes (Example)

... keyword Σ 0..* CodeableConcept Used to search for the study
Binding: Research Study Focus Type (Example)

... region Σ 0..* CodeableConcept Geographic area for the study
Binding: Jurisdiction ValueSet (Extensible)

... descriptionSummary 0..1 markdown Brief text explaining the study
... description 0..1 markdown Detailed narrative of the study
... period Σ 0..1 Period When the study began and ended
... site Σ 0..* Reference(Location | ResearchStudy | Organization) Facility where study activities are conducted

... note 0..* Annotation Comments made about the study

... classifier 0..* CodeableConcept Classification for the study
Binding: Research Study Classifiers (Example)

... associatedParty 0..* BackboneElement Sponsors, collaborators, and other parties

.... name 0..1 string Name of associated party
.... role 1..1 CodeableConcept sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-chair | irb
Binding: Research Study Party Role (Extensible)
.... period 0..* Period When active in the role

.... classifier 0..* CodeableConcept nih | fda | government | nonprofit | academic | industry
Binding: Research Study Party Organization Type (Example)

.... party 0..1 Reference(Practitioner | PractitionerRole | Organization) Individual or organization associated with study (use practitionerRole to specify their organisation)
... progressStatus 0..* BackboneElement Status of study with time for that status

.... state 1..1 CodeableConcept Label for status or state (e.g. recruitment status)
Binding: Research Study Status (Extensible)
.... actual 0..1 boolean Actual if true else anticipated
.... period 0..1 Period Date range
... whyStopped Σ 0..1 CodeableConcept accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
Binding: Research Study Reason Stopped (Example)
... recruitment Σ 0..1 BackboneElement Target or actual group of participants enrolled in study
.... targetNumber 0..1 unsignedInt Estimated total number of participants to be enrolled
.... actualNumber 0..1 unsignedInt Actual total number of participants enrolled in study
.... eligibility 0..1 Reference(Group) Inclusion and exclusion criteria
.... actualGroup Σ 0..1 Reference(Group) Group of participants who were enrolled in study
... comparisonGroup 0..* BackboneElement Defined path through the study for a subject

.... targetNumber 0..1 unsignedInt Estimated total number of participants to be enrolled in the comparison group
.... actualNumber 0..1 unsignedInt Actual total number of participants enrolled in the comparison group
.... eligibility 0..1 Reference(Group) Inclusion and exclusion criteria for the comparison group
.... observedGroup 0..1 Reference(Group) Group of participants who were enrolled in the comparison group
... objective 0..* BackboneElement A goal for the study

.... name 0..1 string Label for the objective
.... type 0..1 CodeableConcept primary | secondary | exploratory
Binding: Research Study Objective Type (Preferred)
.... description 0..1 markdown Description of the objective
.... outcomeMeasure 0..* BackboneElement A variable measured during the study

..... name 0..1 string Label for the outcome measure
..... type 0..1 CodeableConcept primary | secondary | exploratory
Binding: Research Study Objective Type (Preferred)
..... description 0..1 markdown Description of the outcome measure
..... endpoint 1..1 Reference(EvidenceVariable) Definition of the outcome measure
..... population 0..1 Reference(Group) Population for this estimand
..... intervention 0..1 Reference(Group) Comparison group of interest
..... comparator 0..1 Reference(Group) Comparison group for comparison
..... summaryMeasure 0..1 CodeableConcept Statistical measure for treatment effect estimate
Binding: Statistic Type (Example)
..... eventHandling 0..* BackboneElement Handling of intercurrent event

...... event 0..1 CodeableConcept The event
...... group 0..1 CodeableConcept The group that is affected by this event handling
...... handling 0..1 CodeableConcept How the data is handled
...... description 0..1 markdown Text summary of event handling
... result Σ 0..* Reference(Citation | Composition | DiagnosticReport | Evidence) Link to results generated during the study


doco Documentation for this format icon

See the Extensions for this resource

 

Additional definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions, the spreadsheet version & the dependency analysis

8.25.3.1 Terminology Bindings

Path ValueSet Type Documentation
ResearchStudy.label.type TitleType Extensible

Used to express the reason and specific aspect for the variant title, such as language and specific language.
ResearchStudy.relatesTo.type ArtifactRelationshipType Required

Type of relationship to the related artifact.
ResearchStudy.status PublicationStatus Required

The lifecycle status of an artifact.
ResearchStudy.primaryPurposeType ResearchStudyPrimaryPurposeType (a valid code from ResearchStudy Primary Purpose Type Code System) Preferred

Codes for the main intent of the study.
ResearchStudy.phase ResearchStudyTrialPhase (a valid code from Study Design) Preferred

Classifiers of clinical trial progression for human use.
ResearchStudy.studyDesign StudyDesign Preferred

This is a set of terms for study design characteristics.
ResearchStudy.focus ResearchStudyFocusType Example

Some example codes of research study focus
ResearchStudy.condition ConditionProblemDiagnosisCodes Example

Example value set for Condition/Problem/Diagnosis codes.
ResearchStudy.keyword ResearchStudyFocusType Example

Some example codes of research study focus
ResearchStudy.region JurisdictionValueSet Extensible

This value set defines a base set of codes for country, country subdivision and region for indicating where a resource is intended to be used.

Note: The codes for countries and country subdivisions are taken from ISO 3166 icon while the codes for "supra-national" regions are from UN Standard country or area codes for statistical use (M49) icon.
ResearchStudy.classifier ResearchStudyClassifiers (a valid code from ResearchStudy Classifiers Code System) Example

Codes that convey the type of label that is provided.
ResearchStudy.associatedParty.role ResearchStudyPartyRole Extensible

This is a ResearchStudy's party role.
ResearchStudy.associatedParty.classifier ResearchStudyPartyOrgType (a valid code from ResearchStudy Party Organization Type Code System) Example

This is a ResearchStudy's party organization type.
ResearchStudy.progressStatus.state ResearchStudyStatus Extensible

Codes that convey the current status of the research study.
ResearchStudy.whyStopped ResearchStudyReasonStopped (a valid code from ResearchStudy Reason Stopped Code System) Example

Codes for why the study ended prematurely.
ResearchStudy.objective.type ResearchStudyObjectiveType (a valid code from ResearchStudy Objective Type Code System) Preferred

Codes for the kind of study objective.
ResearchStudy.objective.outcomeMeasure.type ResearchStudyObjectiveType (a valid code from ResearchStudy Objective Type Code System) Preferred

Codes for the kind of study objective.
ResearchStudy.objective.outcomeMeasure.summaryMeasure StatisticType (a valid code from StatisticStatisticType icon) Example

The type of a statistic, e.g. relative risk or mean



8.25.4 ResearchStudy State Machine

The following diagram reflects the "typical" state machine for ResearchStudy.

Diagram showing typical state machine for the ResearchStudy resource

8.25.5 Search Parameters

Search parameters for this resource. See also the full list of search parameters for this resource, and check the Extensions registry for search parameters on extensions related to this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.

Name Type Description Expression In Common
classifier token Classification for the study ResearchStudy.classifier
condition token Condition being studied ResearchStudy.condition
date date When the study began and ended ResearchStudy.period
description string Detailed narrative of the study ResearchStudy.description
eligibility reference Inclusion and exclusion criteria ResearchStudy.recruitment.eligibility
(Group)
focus-code token Drugs, devices, etc. under study, as a code ResearchStudy.focus.concept
focus-reference reference Drugs, devices, etc. under study, as a reference ResearchStudy.focus.reference
identifier token Business Identifier for study ResearchStudy.identifier
keyword token Used to search for the study ResearchStudy.keyword
name string Name for this study ResearchStudy.name
objective-description string Free text description of the objective of the study ResearchStudy.objective.description
objective-type token The kind of study objective ResearchStudy.objective.type
part-of reference Part of larger study ResearchStudy.partOf
(ResearchStudy)
phase token The stage in the progression of a study ResearchStudy.phase
progress-actual token Actual if true else anticipated ResearchStudy.progressStatus.actual
progress-period date Date range ResearchStudy.progressStatus.period
progress-state token Label for status or state ResearchStudy.progressStatus.state
progress-status-state-actual composite Status of study by state and actual On ResearchStudy.progressStatus:
  progress-state: progress-state
  progress-actual: progress-actual
progress-status-state-period composite Status of study by state and period On ResearchStudy.progressStatus:
  progress-state: progress-state
  progress-period: progress-period
progress-status-state-period-actual composite Status of study by state, period and actual On ResearchStudy.progressStatus:
  progress-state: progress-state
  progress-period: progress-period
  progress-actual: progress-actual
protocol reference Steps followed in executing study ResearchStudy.protocol
(PlanDefinition)
recruitment-actual number Actual number of participants enrolled in study across all groups ResearchStudy.recruitment.actualNumber
recruitment-target number Target number of participants enrolled in study across all groups ResearchStudy.recruitment.targetNumber
region token Geographic area for the study ResearchStudy.region
site reference Facility where study activities are conducted ResearchStudy.site
(Organization, Location, ResearchStudy)
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
study-design token Classifications of the study design characteristics ResearchStudy.studyDesign
title string The human readable name of the research study ResearchStudy.title