FHIR CI-Build

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Biomedical Research and Regulation icon Work GroupMaturity Level: 0 Trial UseSecurity Category: Business Compartments: No defined compartments

Detailed Descriptions for the elements in the ResearchStudy resource.

ResearchStudy
Element Id ResearchStudy
Definition

A scientific study of nature that sometimes includes processes involved in health and disease. 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.

Short Display Investigation to increase healthcare-related patient-independent knowledge
Cardinality 0..*
Type DomainResource
Alternate Names Clinical Trial; Study
Summary false
Comments

Need to make sure we encompass public health studies.

ResearchStudy.url
Element Id ResearchStudy.url
Definition

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

Short Display Canonical identifier for this study resource
Cardinality 0..1
Type uri
Summary false
ResearchStudy.identifier
Element Id ResearchStudy.identifier
Definition

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

Short Display Business Identifier for study
Note This is a business identifier, not a resource identifier (see discussion)
Cardinality 0..*
Type Identifier
Requirements

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

Summary true
ResearchStudy.version
Element Id ResearchStudy.version
Definition

The business version for the study record.

Short Display The business version for the study record
Note This is a business versionId, not a resource version id (see discussion)
Cardinality 0..1
Type string
Summary false
ResearchStudy.name
Element Id ResearchStudy.name
Definition

Name for this study (computer friendly).

Short Display Name for this study (computer friendly)
Cardinality 0..1
Type string
Summary false
ResearchStudy.title
Element Id ResearchStudy.title
Definition

The human readable name of the research study.

Short Display Human readable name of the study
Cardinality 0..1
Type string
Summary true
ResearchStudy.label
Element Id ResearchStudy.label
Definition

Additional names for the study.

Short Display Additional names for the study
Cardinality 0..*
Summary false
ResearchStudy.label.type
Element Id ResearchStudy.label.type
Definition

Kind of name.

Short Display primary | official | scientific | plain-language | subtitle | short-title | acronym | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid
Cardinality 0..1
Terminology Binding Title Type (Extensible)
Type CodeableConcept
Summary false
ResearchStudy.label.value
Element Id ResearchStudy.label.value
Definition

The name.

Short Display The name
Cardinality 0..1
Type string
Summary false
ResearchStudy.protocol
Element Id ResearchStudy.protocol
Definition

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

Short Display Steps followed in executing study
Cardinality 0..*
Type Reference(PlanDefinition)
Summary true
ResearchStudy.partOf
Element Id ResearchStudy.partOf
Definition

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

Short Display Part of larger study
Cardinality 0..*
Type Reference(ResearchStudy)
Hierarchy This reference is part of a strict Hierarchy
Requirements

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

Alternate Names container
Summary true
ResearchStudy.relatedArtifact
Element Id ResearchStudy.relatedArtifact
Definition

Citations, references, URLs and other related documents. When using relatedArtifact to share URLs, the relatedArtifact.type will often be set to one of "documentation" or "supported-with" and the URL value will often be in relatedArtifact.document.url but another possible location is relatedArtifact.resource when it is a canonical URL.

Short Display References, URLs, and attachments
Cardinality 0..*
Type RelatedArtifact
Summary false
ResearchStudy.date
Element Id ResearchStudy.date
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.

Short Display Date the resource last changed
Cardinality 0..1
Type dateTime
Summary false
ResearchStudy.status
Element Id ResearchStudy.status
Definition

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

Short Display draft | active | retired | unknown
Cardinality 1..1
Terminology Binding PublicationStatus (Required)
Type code
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)
Summary true
ResearchStudy.primaryPurposeType
Element Id ResearchStudy.primaryPurposeType
Definition

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

Short Display treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
Cardinality 0..1
Terminology Binding Research Study Primary Purpose Type (Preferred)
Type CodeableConcept
Summary true
ResearchStudy.phase
Element Id ResearchStudy.phase
Definition

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

Short Display n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
Cardinality 0..1
Terminology Binding Research Study Phase (Example)
Type CodeableConcept
Summary true
ResearchStudy.studyDesign
Element Id ResearchStudy.studyDesign
Definition

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

Short Display Classifications of the study design characteristics
Cardinality 0..*
Terminology Binding Study Design (Preferred)
Type CodeableConcept
Summary true
ResearchStudy.focus
Element Id ResearchStudy.focus
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.

Short Display Drugs, devices, etc. under study
Cardinality 0..*
Terminology Binding Research Study Focus Type (Example)
Type CodeableReference(Medication | MedicinalProductDefinition | SubstanceDefinition | EvidenceVariable)
Summary false
ResearchStudy.condition
Element Id ResearchStudy.condition
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.

Short Display Condition being studied
Cardinality 0..*
Terminology Binding Condition/Problem/Diagnosis Codes (Example)
Type CodeableConcept
Summary true
ResearchStudy.keyword
Element Id ResearchStudy.keyword
Definition

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

Short Display Used to search for the study
Cardinality 0..*
Terminology Binding ResearchStudyKeyword:
Type CodeableConcept
Summary true
ResearchStudy.region
Element Id ResearchStudy.region
Definition

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

Short Display Geographic area for the study
Cardinality 0..*
Terminology Binding Jurisdiction ValueSet (Extensible)
Type CodeableConcept
Summary true
ResearchStudy.descriptionSummary
Element Id ResearchStudy.descriptionSummary
Definition

A brief text for explaining the study.

Short Display Brief text explaining the study
Cardinality 0..1
Type markdown
Summary false
ResearchStudy.description
Element Id ResearchStudy.description
Definition

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

Short Display Detailed narrative of the study
Cardinality 0..1
Type markdown
Summary false
ResearchStudy.period
Element Id ResearchStudy.period
Definition

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

Short Display When the study began and ended
Cardinality 0..1
Type Period
Alternate Names timing
Summary true
ResearchStudy.site
Element Id ResearchStudy.site
Definition

A facility in which study activities are conducted.

Short Display Facility where study activities are conducted
Cardinality 0..*
Type Reference(Location | ResearchStudy | Organization)
Summary true
ResearchStudy.note
Element Id ResearchStudy.note
Definition

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

Short Display Comments made about the study
Cardinality 0..*
Type Annotation
Summary false
ResearchStudy.classifier
Element Id ResearchStudy.classifier
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.

Short Display Classification for the study
Cardinality 0..*
Terminology Binding Research Study Classifiers (Example)
Type CodeableConcept
Summary false
ResearchStudy.associatedParty
Element Id ResearchStudy.associatedParty
Definition

Sponsors, collaborators, and other parties.

Short Display Sponsors, collaborators, and other parties
Cardinality 0..*
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.

Summary false
Comments

For a Sponsor or a PrincipalInvestigator use the dedicated attributes provided.

ResearchStudy.associatedParty.name
Element Id ResearchStudy.associatedParty.name
Definition

Name of associated party.

Short Display Name of associated party
Cardinality 0..1
Type string
Summary false
ResearchStudy.associatedParty.role
Element Id ResearchStudy.associatedParty.role
Definition

Type of association.

Short Display sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-director | study-chair
Cardinality 1..1
Terminology Binding Research Study Party Role (Extensible)
Type CodeableConcept
Summary false
ResearchStudy.associatedParty.period
Element Id ResearchStudy.associatedParty.period
Definition

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

Short Display When active in the role
Cardinality 0..*
Type Period
Summary false
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.

ResearchStudy.associatedParty.classifier
Element Id ResearchStudy.associatedParty.classifier
Definition

A categorization other than role for the associated party.

Short Display nih | fda | government | nonprofit | academic | industry
Cardinality 0..*
Terminology Binding Research Study Party Organization Type (Example)
Type CodeableConcept
Summary false
ResearchStudy.associatedParty.party
Element Id ResearchStudy.associatedParty.party
Definition

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

Short Display Individual or organization associated with study (use practitionerRole to specify their organisation)
Cardinality 0..1
Type Reference(Practitioner | PractitionerRole | Organization)
Summary false
Comments

Suggestions of a better attribute name are appreciated

ResearchStudy.progressStatus
Element Id ResearchStudy.progressStatus
Definition

Status of study with time for that status.

Short Display Status of study with time for that status
Cardinality 0..*
Summary false
ResearchStudy.progressStatus.state
Element Id ResearchStudy.progressStatus.state
Definition

Label for status or state (e.g. recruitment status).

Short Display Label for status or state (e.g. recruitment status)
Cardinality 1..1
Terminology Binding Research Study Status (Extensible)
Type CodeableConcept
Summary false
ResearchStudy.progressStatus.actual
Element Id ResearchStudy.progressStatus.actual
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.

Short Display Actual if true else anticipated
Cardinality 0..1
Type boolean
Summary false
ResearchStudy.progressStatus.period
Element Id ResearchStudy.progressStatus.period
Definition

Date range.

Short Display Date range
Cardinality 0..1
Type Period
Summary false
ResearchStudy.whyStopped
Element Id ResearchStudy.whyStopped
Definition

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

Short Display accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
Cardinality 0..1
Terminology Binding Research Study Reason Stopped (Example)
Type CodeableConcept
Summary true
ResearchStudy.recruitment
Element Id ResearchStudy.recruitment
Definition

Target or actual group of participants enrolled in study.

Short Display Target or actual group of participants enrolled in study
Cardinality 0..1
Summary true
ResearchStudy.recruitment.targetNumber
Element Id ResearchStudy.recruitment.targetNumber
Definition

Estimated total number of participants to be enrolled.

Short Display Estimated total number of participants to be enrolled
Cardinality 0..1
Type unsignedInt
Summary false
ResearchStudy.recruitment.actualNumber
Element Id ResearchStudy.recruitment.actualNumber
Definition

Actual total number of participants enrolled in study.

Short Display Actual total number of participants enrolled in study
Cardinality 0..1
Type unsignedInt
Summary false
ResearchStudy.recruitment.eligibility
Element Id ResearchStudy.recruitment.eligibility
Definition

Inclusion and exclusion criteria.

Short Display Inclusion and exclusion criteria
Cardinality 0..1
Type Reference(Group | EvidenceVariable)
Summary false
ResearchStudy.recruitment.actualGroup
Element Id ResearchStudy.recruitment.actualGroup
Definition

Group of participants who were enrolled in study.

Short Display Group of participants who were enrolled in study
Cardinality 0..1
Type Reference(Group)
Summary true
ResearchStudy.comparisonGroup
Element Id ResearchStudy.comparisonGroup
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}.

Short Display Defined path through the study for a subject
Cardinality 0..*
Alternate Names arm
Summary false
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.

ResearchStudy.comparisonGroup.linkId
Element Id ResearchStudy.comparisonGroup.linkId
Definition

Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily.

Short Display Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily
Cardinality 0..1
Type id
Summary false
ResearchStudy.comparisonGroup.name
Element Id ResearchStudy.comparisonGroup.name
Definition

Unique, human-readable label for this comparisonGroup of the study.

Short Display Label for study comparisonGroup
Cardinality 1..1
Type string
Summary false
ResearchStudy.comparisonGroup.type
Element Id ResearchStudy.comparisonGroup.type
Definition

Categorization of study comparisonGroup, e.g. experimental, active comparator, placebo comparater.

Short Display Categorization of study comparisonGroup
Cardinality 0..1
Terminology Binding Research Study Arm Type (Extensible)
Type CodeableConcept
Summary false
ResearchStudy.comparisonGroup.description
Element Id ResearchStudy.comparisonGroup.description
Definition

A succinct description of the path through the study that would be followed by a subject adhering to this comparisonGroup.

Short Display Short explanation of study path
Cardinality 0..1
Type markdown
Summary false
ResearchStudy.comparisonGroup.intendedExposure
Element Id ResearchStudy.comparisonGroup.intendedExposure
Definition

Interventions or exposures in this comparisonGroup or cohort.

Short Display Interventions or exposures in this comparisonGroup or cohort
Cardinality 0..*
Type Reference(EvidenceVariable)
Requirements

this is necessary for ClinicalTrials.gov use which relates 1 to many interventions to comparisonGroups (aka arms)

Summary false
ResearchStudy.comparisonGroup.observedGroup
Element Id ResearchStudy.comparisonGroup.observedGroup
Definition

Group of participants who were enrolled in study comparisonGroup.

Short Display Group of participants who were enrolled in study comparisonGroup
Cardinality 0..1
Type Reference(Group)
Requirements

This is necessary to relate comparisonGroups to actual groups

Summary false
ResearchStudy.objective
Element Id ResearchStudy.objective
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.

Short Display A goal for the study
Cardinality 0..*
Summary false
ResearchStudy.objective.name
Element Id ResearchStudy.objective.name
Definition

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

Short Display Label for the objective
Cardinality 0..1
Type string
Summary false
ResearchStudy.objective.type
Element Id ResearchStudy.objective.type
Definition

The kind of study objective.

Short Display primary | secondary | exploratory
Cardinality 0..1
Terminology Binding Research Study Objective Type (Preferred)
Type CodeableConcept
Summary false
ResearchStudy.objective.description
Element Id ResearchStudy.objective.description
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).

Short Display Description of the objective
Cardinality 0..1
Type markdown
Summary false
ResearchStudy.outcomeMeasure
Element Id ResearchStudy.outcomeMeasure
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.

Short Display A variable measured during the study
Cardinality 0..*
Summary false
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

ResearchStudy.outcomeMeasure.name
Element Id ResearchStudy.outcomeMeasure.name
Definition

Label for the outcome.

Short Display Label for the outcome
Cardinality 0..1
Type string
Summary false
ResearchStudy.outcomeMeasure.type
Element Id ResearchStudy.outcomeMeasure.type
Definition

The parameter or characteristic being assessed as one of the values by which the study is assessed.

Short Display primary | secondary | exploratory
Cardinality 0..*
Terminology Binding Research Study Objective Type (Preferred)
Type CodeableConcept
Summary false
ResearchStudy.outcomeMeasure.description
Element Id ResearchStudy.outcomeMeasure.description
Definition

Description of the outcome.

Short Display Description of the outcome
Cardinality 0..1
Type markdown
Summary false
ResearchStudy.outcomeMeasure.reference
Element Id ResearchStudy.outcomeMeasure.reference
Definition

Structured outcome definition.

Short Display Structured outcome definition
Cardinality 0..1
Type Reference(EvidenceVariable)
Summary false
ResearchStudy.result
Element Id ResearchStudy.result
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.

Short Display Link to results generated during the study
Cardinality 0..*
Type Reference(Citation | Composition | DiagnosticReport)
Summary true