ResearchStudy

Introduction

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

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 [0..*]: - Investigation to increase healthcare-related patient-independent knowledge
• ResearchStudy.url [0..1]: uri Canonical identifier for this study resource
• ResearchStudy.identifier [0..*]: Identifier Business Identifier for study
• ResearchStudy.version [0..1]: string The business version for the study record
• ResearchStudy.name [0..1]: string Name for this study (computer friendly)
• ResearchStudy.title [0..1]: string Human readable name of the study
• ResearchStudy.label [0..*]: BackboneElement Additional names for the study
• ResearchStudy.label.type [0..1]: CodeableConcept preferred: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 [0..1]: string The name
• ResearchStudy.label.language [0..1]: code required:all-languages Used to express the specific language
• ResearchStudy.protocol [0..*]: Reference(PlanDefinition) Steps followed in executing study
• ResearchStudy.partOf [0..*]: Reference(ResearchStudy) Part of larger study
• ResearchStudy.citeAs [0..1]: markdown How to cite this ResearchStudy
• ResearchStudy.relatesTo [0..*]: BackboneElement Relationships to other Resources
• ResearchStudy.relatesTo.type [1..1]: CodeableConcept extensible: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] [1..1]: uri, Attachment, canonical, Reference(Resource), markdown The artifact that is related to this ResearchStudy
• ResearchStudy.date [0..1]: dateTime Date the resource last changed
• ResearchStudy.status [1..1]: code required:publication-status draft | active | retired | unknown
• ResearchStudy.primaryPurposeType [0..1]: CodeableConcept preferred:research-study-prim-purp-type treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
• ResearchStudy.phase [0..1]: CodeableConcept preferred:research-study-phase Classifier used for clinical trials
• ResearchStudy.studyDesign [0..*]: CodeableConcept preferred:study-design Classifications of the study design characteristics
• ResearchStudy.focus [0..*]: CodeableReference example:research-study-focus-type Drugs, devices, etc. under study
• ResearchStudy.condition [0..*]: CodeableConcept example:condition-code Condition being studied
• ResearchStudy.keyword [0..*]: CodeableConcept example:research-study-focus-type Used to search for the study
• ResearchStudy.region [0..*]: CodeableConcept preferred:jurisdiction Geographic area for the study
• ResearchStudy.descriptionSummary [0..1]: markdown Brief text explaining the study
• ResearchStudy.description [0..1]: markdown Detailed narrative of the study
• ResearchStudy.period [0..1]: Period When the study began and ended
• ResearchStudy.site [0..*]: [Reference(Location](/Reference(Location), ResearchStudy, Organization)) Facility where study activities are conducted
• ResearchStudy.note [0..*]: Annotation Comments made about the study
• ResearchStudy.classifier [0..*]: CodeableConcept example:research-study-classifiers Classification for the study
• ResearchStudy.associatedParty [0..*]: BackboneElement Sponsors, collaborators, and other parties
• ResearchStudy.associatedParty.name [0..1]: string Name of associated party
• ResearchStudy.associatedParty.role [1..1]: CodeableConcept example: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 [0..*]: Period When active in the role
• ResearchStudy.associatedParty.classifier [0..*]: CodeableConcept example:research-study-party-organization-type nih | fda | government | nonprofit | academic | industry
• ResearchStudy.associatedParty.party [0..1]: [Reference(Practitioner](/Reference(Practitioner), PractitionerRole, Organization)) Individual or organization associated with study (use practitionerRole to specify their organisation)
• ResearchStudy.progressStatus [0..*]: BackboneElement Status of study with time for that status
• ResearchStudy.progressStatus.state [1..1]: CodeableConcept example:research-study-status Label for status or state (e.g. recruitment status)
• ResearchStudy.progressStatus.actual [0..1]: boolean Actual if true else anticipated
• ResearchStudy.progressStatus.period [0..1]: Period Date range
• ResearchStudy.whyStopped [0..1]: CodeableConcept example: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 [0..1]: BackboneElement Target or actual group of participants enrolled in study
• ResearchStudy.recruitment.targetNumber [0..1]: unsignedInt Estimated total number of participants to be enrolled
• ResearchStudy.recruitment.actualNumber [0..1]: unsignedInt Actual total number of participants enrolled in study
• ResearchStudy.recruitment.eligibility [0..1]: Reference(Group) Inclusion and exclusion criteria
• ResearchStudy.recruitment.actualGroup [0..1]: Reference(Group) Group of participants who were enrolled in study
• ResearchStudy.recruitment.description [0..1]: markdown Description of the recruitment
• ResearchStudy.comparisonGroup [0..*]: BackboneElement Defined path through the study for a subject
• ResearchStudy.comparisonGroup.targetNumber [0..1]: unsignedInt Estimated total number of participants to be enrolled in the comparison group
• ResearchStudy.comparisonGroup.actualNumber [0..1]: unsignedInt Actual total number of participants enrolled in the comparison group
• ResearchStudy.comparisonGroup.eligibility [0..1]: Reference(Group) Inclusion and exclusion criteria for the comparison group
• ResearchStudy.comparisonGroup.observedGroup [0..1]: Reference(Group) Group of participants who were enrolled in the comparison group
• ResearchStudy.comparisonGroup.description [0..1]: markdown Description of the comparison Group
• ResearchStudy.objective [0..*]: BackboneElement A goal for the study
• ResearchStudy.objective.name [0..1]: string Label for the objective
• ResearchStudy.objective.type [0..1]: CodeableConcept preferred:research-study-objective-type primary | secondary | exploratory
• ResearchStudy.objective.description [0..1]: markdown Description of the objective
• ResearchStudy.objective.outcomeMeasure [0..*]: BackboneElement A variable measured during the study
• ResearchStudy.objective.outcomeMeasure.name [0..1]: string Label for the outcome measure
• ResearchStudy.objective.outcomeMeasure.type [0..1]: CodeableConcept preferred:research-study-objective-type primary | secondary | exploratory
• ResearchStudy.objective.outcomeMeasure.description [0..1]: markdown Description of the outcome measure
• ResearchStudy.objective.outcomeMeasure.endpoint [1..1]: Reference(EvidenceVariable) Definition of the outcome measure
• ResearchStudy.objective.outcomeMeasure.population [0..1]: Reference(Group) Population for this estimand
• ResearchStudy.objective.outcomeMeasure.intervention [0..1]: Reference(Group) Comparison group of interest
• ResearchStudy.objective.outcomeMeasure.comparator [0..1]: Reference(Group) Comparison group for comparison
• ResearchStudy.objective.outcomeMeasure.summaryMeasure [0..1]: CodeableConcept example:statistic-type Statistical measure for treatment effect estimate
• ResearchStudy.objective.outcomeMeasure.endpointAnalysisPlan [0..1]: Reference(Evidence) Statistical analysis plan for a single endpoint
• ResearchStudy.objective.outcomeMeasure.eventHandling [0..*]: BackboneElement Handling of intercurrent event
• ResearchStudy.objective.outcomeMeasure.eventHandling.event [0..1]: CodeableConcept The event
• ResearchStudy.objective.outcomeMeasure.eventHandling.group [0..1]: CodeableConcept The group that is affected by this event handling
• ResearchStudy.objective.outcomeMeasure.eventHandling.handling [0..1]: CodeableConcept How the data is handled
• ResearchStudy.objective.outcomeMeasure.eventHandling.description [0..1]: markdown Text summary of event handling
• ResearchStudy.result [0..*]: [Reference(Composition](/Reference(Composition), DiagnosticReport, Evidence)) Link to results generated during the study

Mappings

• ResearchStudy Mappings — 56 mapping entries

Implementation Guide

implementationguide-ResearchStudy-core.xml

<?xml version="1.0" encoding="UTF-8"?>

<ImplementationGuide xmlns="http://hl7.org/fhir">
  <id value="ResearchStudy-core"/>
  <version value="0.01"/>
  <name value="ResearchStudyHL7Extensions"/>
  <title value="Research Study  H L7  Extensions"/>
  <status value="draft"/>
  <date value="2021-03-31T00:00:00+00:00"/>
  <publisher value="HL7"/>
  <description value="Defines common extensions used with or related to the ResearchStudy resource"/>
</ImplementationGuide>

Resource Packs

list-ResearchStudy-packs.xml

<?xml version="1.0" encoding="UTF-8"?>

<List xmlns="http://hl7.org/fhir">
  <id value="ResearchStudy-packs"/>
  <status value="current"/>
  <mode value="working"/>
  <entry>
    <item>
      <reference value="ImplementationGuide/ResearchStudy-core"/>
    </item>
  </entry>
</List>

Search Parameters

• condition — token — Condition being studied — ResearchStudy.condition
• date — date — When the study began and ended — ResearchStudy.period
• 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
• region — token — Geographic area for the study — ResearchStudy.region
• part-of — reference — Part of larger study — ResearchStudy.partOf
• protocol — reference — Steps followed in executing study — ResearchStudy.protocol
• 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
• site — reference — Facility where study activities are conducted — ResearchStudy.site
• 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 — string — The human readable name of the research study — ResearchStudy.title
• name — string — Name for this study — ResearchStudy.name
• description — string — Detailed narrative of the study — ResearchStudy.description
• phase — token — The stage in the progression of a study — ResearchStudy.phase
• classifier — token — Classification for the study — ResearchStudy.classifier
• study-design — token — Classifications of the study design characteristics — ResearchStudy.studyDesign
• 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
• eligibility — reference — Inclusion and exclusion criteria — ResearchStudy.recruitment.eligibility
• progress-state — token — Label for status or state — ResearchStudy.progressStatus.state
• progress-actual — token — Actual if true else anticipated — ResearchStudy.progressStatus.actual
• progress-period — date — Date range — ResearchStudy.progressStatus.period
• progress-status-state-period — composite — Status of study by state and period — ResearchStudy.progressStatus
• progress-status-state-actual — composite — Status of study by state and actual — ResearchStudy.progressStatus
• progress-status-state-period-actual — composite — Status of study by state, period and actual — ResearchStudy.progressStatus

Full Search Parameters

Examples

• example-ctgov-study-record — researchstudy-example-ctgov-study-record — ClinicalTrials.gov Study Record
• researchstudy-example — researchstudy-example
• researchstudy-example-ctgov-study-record — researchstudy-example-ctgov-study-record
• researchstudy-examples-header — researchstudy-examples-header

Full 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