type: resource-definitionsresource: ResearchStudy

ResearchStudy Definitions

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

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

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

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

ResearchStudy.version

The business version for the study record

Definition: The business version for the study record.

Cardinality: 0..1

Type: string

ResearchStudy.name

Name for this study (computer friendly)

Definition: Name for this study (computer friendly).

Cardinality: 0..1

Type: string

ResearchStudy.title

Human readable name of the study

Definition: The human readable name of the research study.

Cardinality: 0..1

Type: 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)

ResearchStudy.label

Additional names for the study

Definition: Additional names for the study.

Cardinality: 0..*

Type: BackboneElement

ResearchStudy.label.type

Definition: Kind of name.

Cardinality: 0..1

Type: CodeableConcept

Binding: preferred:title-type

ResearchStudy.label.value

The name

Definition: The name.

Cardinality: 0..1

Type: string

ResearchStudy.label.language

Used to express the specific language

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

Cardinality: 0..1

Type: code

Binding: required:all-languages

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)

Summary: true

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

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)

Summary: true

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

ResearchStudy.citeAs

How to cite this ResearchStudy

Definition: Display of the bibliographic citation of this ResearchStudy.

Cardinality: 0..1

Type: markdown

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

ResearchStudy.relatesTo.type

Definition: The type of relationship to the related artifact.

Cardinality: 1..1

Type: CodeableConcept

Binding: extensible:artifact-relationship-type

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, Attachment, canonical, Reference(Resource), markdown

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

ResearchStudy.status

draft | active | retired | unknown

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

Cardinality: 1..1

Type: code

Binding: required: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

ResearchStudy.primaryPurposeType

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

Binding: preferred:research-study-prim-purp-type

Summary: true

Mappings: BRIDG5.1=StudyProtocolVersion.primaryPurposeTypeCode

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

Binding: preferred:research-study-phase

Summary: true

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

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

Binding: preferred: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

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

Binding: example:research-study-focus-type

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

Binding: example:condition-code

Summary: true

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

ResearchStudy.keyword

Used to search for the study

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

Cardinality: 0..*

Type: CodeableConcept

Binding: example:research-study-focus-type

Summary: true

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

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

Binding: preferred:jurisdiction

Summary: true

Mappings: BRIDG5.1=StudyProtocolVersion.participatingLocationCode

ResearchStudy.descriptionSummary

Brief text explaining the study

Definition: A brief text for explaining the study.

Cardinality: 0..1

Type: markdown

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

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

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

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

ResearchStudy.site

Facility where study activities are conducted

Definition: A facility in which study activities are conducted.

Cardinality: 0..*

Type: Reference(Location, ResearchStudy, Organization)

Summary: true

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

ResearchStudy.note

Comments made about the study

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

Cardinality: 0..*

Type: Annotation

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

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

Binding: example:research-study-classifiers

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

ResearchStudy.associatedParty.name

Name of associated party

Definition: Name of associated party.

Cardinality: 0..1

Type: string

ResearchStudy.associatedParty.role

Definition: Type of association.

Cardinality: 1..1

Type: CodeableConcept

Binding: example:research-study-party-role

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

ResearchStudy.associatedParty.classifier

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

Cardinality: 0..*

Type: CodeableConcept

Binding: example:research-study-party-organization-type

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, PractitionerRole, Organization)

ResearchStudy.progressStatus

Status of study with time for that status

Definition: Status of study with time for that status.

Cardinality: 0..*

Type: BackboneElement

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

Binding: example:research-study-status

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

ResearchStudy.progressStatus.period

Date range

Definition: Date range.

Cardinality: 0..1

Type: Period

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

Binding: example:research-study-reason-stopped

Summary: true

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

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

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

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

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

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)

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)

Summary: true

ResearchStudy.recruitment.description

Description of the recruitment

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

Cardinality: 0..1

Type: markdown

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

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

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

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

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)

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)

ResearchStudy.comparisonGroup.description

Description of the comparison Group

Cardinality: 0..1

Type: markdown

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

Mappings: BRIDG5.1=StudyObjective

ResearchStudy.objective.name

Label for the objective

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

Cardinality: 0..1

Type: string

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

ResearchStudy.objective.type

primary | secondary | exploratory

Definition: The kind of study objective.

Cardinality: 0..1

Type: CodeableConcept

Binding: preferred:research-study-objective-type

Mappings: BRIDG5.1=StudyObjective.typeCode

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

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

ResearchStudy.objective.outcomeMeasure.name

Label for the outcome measure

Definition: Label for the outcome measure.

Cardinality: 0..1

Type: string

ResearchStudy.objective.outcomeMeasure.type

primary | secondary | exploratory

Definition: The kind of outcome measure.

Cardinality: 0..1

Type: CodeableConcept

Binding: preferred:research-study-objective-type

ResearchStudy.objective.outcomeMeasure.description

Description of the outcome measure

Definition: Description of the outcome measure.

Cardinality: 0..1

Type: markdown

ResearchStudy.objective.outcomeMeasure.endpoint

Definition of the outcome measure

Definition: Definition of the outcome measure.

Cardinality: 1..1

Type: Reference(EvidenceVariable)

ResearchStudy.objective.outcomeMeasure.population

Population for this estimand

Definition: Population for this estimand.

Cardinality: 0..1

Type: Reference(Group)

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)

ResearchStudy.objective.outcomeMeasure.comparator

Comparison group for comparison

Definition: Comparison group for comparison.

Cardinality: 0..1

Type: Reference(Group)

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

Binding: example:statistic-type

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)

ResearchStudy.objective.outcomeMeasure.eventHandling

Handling of intercurrent event

Definition: Handling of intercurrent event.

Cardinality: 0..*

Type: BackboneElement

ResearchStudy.objective.outcomeMeasure.eventHandling.event

The event

Definition: The event.

Cardinality: 0..1

Type: CodeableConcept

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

ResearchStudy.objective.outcomeMeasure.eventHandling.handling

How the data is handled

Cardinality: 0..1

Type: CodeableConcept

ResearchStudy.objective.outcomeMeasure.eventHandling.description

Text summary of event handling

Cardinality: 0..1

Type: markdown

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, DiagnosticReport, Evidence)

Summary: true