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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
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 DisplayInvestigation to increase healthcare-related patient-independent knowledge
Cardinality0..*
TypeDomainResource
Alternate NamesClinical Trial; Study
Summaryfalse
Comments

Need to make sure we encompass public health studies.

ResearchStudy.url
Definition

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

Short DisplayCanonical identifier for this study resource
Cardinality0..1
Typeuri
Summaryfalse
ResearchStudy.identifier
Definition

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

Short DisplayBusiness Identifier for study
NoteThis is a business identifier, not a resource identifier (see discussion)
Cardinality0..*
TypeIdentifier
Requirements

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

Summarytrue
ResearchStudy.version
Definition

The business version for the study record.

Short DisplayThe business version for the study record
NoteThis is a business versionId, not a resource version id (see discussion)
Cardinality0..1
Typestring
Summaryfalse
ResearchStudy.name
Definition

Name for this study (computer friendly).

Short DisplayName for this study (computer friendly)
Cardinality0..1
Typestring
Summaryfalse
ResearchStudy.title
Definition

The human readable name of the research study.

Short DisplayHuman readable name of the study
Cardinality0..1
Typestring
Summarytrue
ResearchStudy.label
Definition

Additional names for the study.

Short DisplayAdditional names for the study
Cardinality0..*
Summaryfalse
ResearchStudy.label.type
Definition

Kind of name.

Short Displayprimary | official | scientific | plain-language | subtitle | short-title | acronym | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid
Cardinality0..1
Terminology BindingTitle Type (Extensible)
TypeCodeableConcept
Summaryfalse
ResearchStudy.label.value
Definition

The name.

Short DisplayThe name
Cardinality0..1
Typestring
Summaryfalse
ResearchStudy.protocol
Definition

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

Short DisplaySteps followed in executing study
Cardinality0..*
TypeReference(PlanDefinition)
Summarytrue
ResearchStudy.partOf
Definition

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

Short DisplayPart of larger study
Cardinality0..*
TypeReference(ResearchStudy)
HierarchyThis 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 Namescontainer
Summarytrue
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 DisplayReferences, URLs, and attachments
Cardinality0..*
TypeRelatedArtifact
Summaryfalse
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 DisplayDate the resource last changed
Cardinality0..1
TypedateTime
Summaryfalse
ResearchStudy.status
Definition

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

Short Displaydraft | active | retired | unknown
Cardinality1..1
Terminology BindingPublicationStatus (Required)
Typecode
Is Modifiertrue (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)
Summarytrue
ResearchStudy.primaryPurposeType
Definition

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

Short Displaytreatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
Cardinality0..1
Terminology BindingResearch Study Primary Purpose Type (Preferred)
TypeCodeableConcept
Summarytrue
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 Displayn-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
Cardinality0..1
Terminology BindingResearch Study Phase (Example)
TypeCodeableConcept
Summarytrue
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 DisplayClassifications of the study design characteristics
Cardinality0..*
Terminology BindingStudy Design (Preferred)
TypeCodeableConcept
Summarytrue
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 DisplayDrugs, devices, etc. under study
Cardinality0..*
Terminology BindingResearch Study Focus Type (Example)
TypeCodeableReference(Medication | MedicinalProductDefinition | SubstanceDefinition | EvidenceVariable)
Summaryfalse
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 DisplayCondition being studied
Cardinality0..*
Terminology BindingCondition/Problem/Diagnosis Codes (Example)
TypeCodeableConcept
Summarytrue
ResearchStudy.keyword
Definition

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

Short DisplayUsed to search for the study
Cardinality0..*
Terminology BindingResearchStudyKeyword:
TypeCodeableConcept
Summarytrue
ResearchStudy.region
Definition

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

Short DisplayGeographic area for the study
Cardinality0..*
Terminology BindingJurisdiction ValueSet (Extensible)
TypeCodeableConcept
Summarytrue
ResearchStudy.descriptionSummary
Definition

A brief text for explaining the study.

Short DisplayBrief text explaining the study
Cardinality0..1
Typemarkdown
Summaryfalse
ResearchStudy.description
Definition

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

Short DisplayDetailed narrative of the study
Cardinality0..1
Typemarkdown
Summaryfalse
ResearchStudy.period
Definition

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

Short DisplayWhen the study began and ended
Cardinality0..1
TypePeriod
Alternate Namestiming
Summarytrue
ResearchStudy.site
Definition

A facility in which study activities are conducted.

Short DisplayFacility where study activities are conducted
Cardinality0..*
TypeReference(Location | ResearchStudy | Organization)
Summarytrue
ResearchStudy.note
Definition

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

Short DisplayComments made about the study
Cardinality0..*
TypeAnnotation
Summaryfalse
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 DisplayClassification for the study
Cardinality0..*
Terminology BindingResearch Study Classifiers (Example)
TypeCodeableConcept
Summaryfalse
ResearchStudy.associatedParty
Definition

Sponsors, collaborators, and other parties.

Short DisplaySponsors, collaborators, and other parties
Cardinality0..*
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.

Summaryfalse
Comments

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

ResearchStudy.associatedParty.name
Definition

Name of associated party.

Short DisplayName of associated party
Cardinality0..1
Typestring
Summaryfalse
ResearchStudy.associatedParty.role
Definition

Type of association.

Short Displaysponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-director | study-chair
Cardinality1..1
Terminology BindingResearch Study Party Role (Extensible)
TypeCodeableConcept
Summaryfalse
ResearchStudy.associatedParty.period
Definition

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

Short DisplayWhen active in the role
Cardinality0..*
TypePeriod
Summaryfalse
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
Definition

A categorization other than role for the associated party.

Short Displaynih | fda | government | nonprofit | academic | industry
Cardinality0..*
Terminology BindingResearch Study Party Organization Type (Example)
TypeCodeableConcept
Summaryfalse
ResearchStudy.associatedParty.party
Definition

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

Short DisplayIndividual or organization associated with study (use practitionerRole to specify their organisation)
Cardinality0..1
TypeReference(Practitioner | PractitionerRole | Organization)
Summaryfalse
Comments

Suggestions of a better attribute name are appreciated

ResearchStudy.progressStatus
Definition

Status of study with time for that status.

Short DisplayStatus of study with time for that status
Cardinality0..*
Summaryfalse
ResearchStudy.progressStatus.state
Definition

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

Short DisplayLabel for status or state (e.g. recruitment status)
Cardinality1..1
Terminology BindingResearch Study Status (Extensible)
TypeCodeableConcept
Summaryfalse
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 DisplayActual if true else anticipated
Cardinality0..1
Typeboolean
Summaryfalse
ResearchStudy.progressStatus.period
Definition

Date range.

Short DisplayDate range
Cardinality0..1
TypePeriod
Summaryfalse
ResearchStudy.whyStopped
Definition

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

Short Displayaccrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
Cardinality0..1
Terminology BindingResearch Study Reason Stopped (Example)
TypeCodeableConcept
Summarytrue
ResearchStudy.recruitment
Definition

Target or actual group of participants enrolled in study.

Short DisplayTarget or actual group of participants enrolled in study
Cardinality0..1
Summarytrue
ResearchStudy.recruitment.targetNumber
Definition

Estimated total number of participants to be enrolled.

Short DisplayEstimated total number of participants to be enrolled
Cardinality0..1
TypeunsignedInt
Summaryfalse
ResearchStudy.recruitment.actualNumber
Definition

Actual total number of participants enrolled in study.

Short DisplayActual total number of participants enrolled in study
Cardinality0..1
TypeunsignedInt
Summaryfalse
ResearchStudy.recruitment.eligibility
Definition

Inclusion and exclusion criteria.

Short DisplayInclusion and exclusion criteria
Cardinality0..1
TypeReference(Group | EvidenceVariable)
Summaryfalse
ResearchStudy.recruitment.actualGroup
Definition

Group of participants who were enrolled in study.

Short DisplayGroup of participants who were enrolled in study
Cardinality0..1
TypeReference(Group)
Summarytrue
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 DisplayDefined path through the study for a subject
Cardinality0..*
Alternate Namesarm
Summaryfalse
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
Definition

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

Short DisplayAllows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily
Cardinality0..1
Typeid
Summaryfalse
ResearchStudy.comparisonGroup.name
Definition

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

Short DisplayLabel for study comparisonGroup
Cardinality1..1
Typestring
Summaryfalse
ResearchStudy.comparisonGroup.type
Definition

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

Short DisplayCategorization of study comparisonGroup
Cardinality0..1
Terminology BindingResearch Study Arm Type (Extensible)
TypeCodeableConcept
Summaryfalse
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 DisplayShort explanation of study path
Cardinality0..1
Typemarkdown
Summaryfalse
ResearchStudy.comparisonGroup.intendedExposure
Definition

Interventions or exposures in this comparisonGroup or cohort.

Short DisplayInterventions or exposures in this comparisonGroup or cohort
Cardinality0..*
TypeReference(EvidenceVariable)
Requirements

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

Summaryfalse
ResearchStudy.comparisonGroup.observedGroup
Definition

Group of participants who were enrolled in study comparisonGroup.

Short DisplayGroup of participants who were enrolled in study comparisonGroup
Cardinality0..1
TypeReference(Group)
Requirements

This is necessary to relate comparisonGroups to actual groups

Summaryfalse
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 DisplayA goal for the study
Cardinality0..*
Summaryfalse
ResearchStudy.objective.name
Definition

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

Short DisplayLabel for the objective
Cardinality0..1
Typestring
Summaryfalse
ResearchStudy.objective.type
Definition

The kind of study objective.

Short Displayprimary | secondary | exploratory
Cardinality0..1
Terminology BindingResearch Study Objective Type (Preferred)
TypeCodeableConcept
Summaryfalse
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 DisplayDescription of the objective
Cardinality0..1
Typemarkdown
Summaryfalse
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 DisplayA variable measured during the study
Cardinality0..*
Summaryfalse
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
Definition

Label for the outcome.

Short DisplayLabel for the outcome
Cardinality0..1
Typestring
Summaryfalse
ResearchStudy.outcomeMeasure.type
Definition

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

Short Displayprimary | secondary | exploratory
Cardinality0..*
Terminology BindingResearch Study Objective Type (Preferred)
TypeCodeableConcept
Summaryfalse
ResearchStudy.outcomeMeasure.description
Definition

Description of the outcome.

Short DisplayDescription of the outcome
Cardinality0..1
Typemarkdown
Summaryfalse
ResearchStudy.outcomeMeasure.reference
Definition

Structured outcome definition.

Short DisplayStructured outcome definition
Cardinality0..1
TypeReference(EvidenceVariable)
Summaryfalse
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 DisplayLink to results generated during the study
Cardinality0..*
TypeReference(EvidenceReport | Citation | DiagnosticReport)
Summarytrue