Release 5 Draft Ballot
Biomedical Research and Regulation Work GroupMaturity Level: 0 Trial UseSecurity Category: Business Compartments: Practitioner

Detailed Descriptions for the elements in the ResearchStudy resource.

ResearchStudy
Element IdResearchStudy
Definition

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.

Cardinality0..*
TypeDomainResource
Alternate NamesClinical Trial; Study
Summaryfalse
Comments

Need to make sure we encompass public health studies.

ResearchStudy.url
Element IdResearchStudy.url
Definition

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

Cardinality0..1
Typeuri
Summaryfalse
ResearchStudy.identifier
Element IdResearchStudy.identifier
Definition

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

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
Element IdResearchStudy.version
Definition

Business identifier for the study record.

NoteThis is a business versionId, not a resource version id (see discussion)
Cardinality0..1
Typestring
Summaryfalse
ResearchStudy.name
Element IdResearchStudy.name
Definition

Name for this study (computer friendly).

Cardinality0..1
Typestring
Summaryfalse
ResearchStudy.title
Element IdResearchStudy.title
Definition

A short, descriptive label for the study particularly for compouter use.

Cardinality0..1
Typestring
Summarytrue
ResearchStudy.label
Element IdResearchStudy.label
Definition

Additional names for the study.

Cardinality0..*
Summaryfalse
ResearchStudy.label.type
Element IdResearchStudy.label.type
Definition

Kind of name.

Cardinality0..1
Terminology BindingResearchStudyTitleType :
TypeCodeableConcept
Summaryfalse
ResearchStudy.label.value
Element IdResearchStudy.label.value
Definition

The name.

Cardinality0..1
Typestring
Summaryfalse
ResearchStudy.protocol
Element IdResearchStudy.protocol
Definition

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

Cardinality0..*
TypeReference(PlanDefinition)
Summarytrue
ResearchStudy.partOf
Element IdResearchStudy.partOf
Definition

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

Cardinality0..*
TypeReference(ResearchStudy)
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
Element IdResearchStudy.relatedArtifact
Definition

Citations, references and other related documents.

Cardinality0..*
TypeRelatedArtifact
Summaryfalse
ResearchStudy.date
Element IdResearchStudy.date
Definition

Date the resource last changed.

Cardinality0..1
TypedateTime
Summaryfalse
ResearchStudy.status
Element IdResearchStudy.status
Definition

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

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
Element IdResearchStudy.primaryPurposeType
Definition

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

Cardinality0..1
Terminology BindingResearchStudyPrimaryPurposeType (Extensible)
TypeCodeableConcept
Summarytrue
ResearchStudy.phase
Element IdResearchStudy.phase
Definition

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

Cardinality0..1
Terminology BindingResearchStudyPhase (Example)
TypeCodeableConcept
Summarytrue
ResearchStudy.category
Element IdResearchStudy.category
Definition

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

Cardinality0..*
Terminology BindingResearchStudyCategory:
TypeCodeableConcept
Summarytrue
ResearchStudy.focus
Element IdResearchStudy.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.

Cardinality0..*
Summaryfalse
ResearchStudy.focus.productCode
Element IdResearchStudy.focus.productCode
Definition

Identification of product under study. This may be any combination of code and/or name.

Cardinality0..1
Terminology BindingResearchStudyFocus:
TypeCodeableConcept
Summarytrue
ResearchStudy.focus.focusType
Element IdResearchStudy.focus.focusType
Definition

Indicates whether the focus is a medication, a device, a procedure, a specific factor or some other intervention or characteristic.

Cardinality0..*
Terminology BindingResearchStudyFocusType :
TypeCodeableConcept
Summaryfalse
ResearchStudy.focus.factor
Element IdResearchStudy.focus.factor
Definition

A factor corresponds to an independent variable manipulated by the experimentalist with the intention to affect biological systems in a way that can be measured by an assay.

Cardinality0..1
Typemarkdown
Summaryfalse
ResearchStudy.condition
Element IdResearchStudy.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.

Cardinality0..*
Terminology BindingCondition/Problem/Diagnosis Codes (Example)
TypeCodeableConcept
Summarytrue
ResearchStudy.keyword
Element IdResearchStudy.keyword
Definition

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

Cardinality0..*
Terminology BindingResearchStudyKeyword:
TypeCodeableConcept
Summarytrue
ResearchStudy.location
Element IdResearchStudy.location
Definition

Indicates a country, state or other region where the study is taking place.

Cardinality0..*
Terminology BindingJurisdiction (Extensible)
TypeCodeableConcept
Summarytrue
ResearchStudy.descriptionSummary
Element IdResearchStudy.descriptionSummary
Definition

A brief summary of the study description.

Cardinality0..1
Typemarkdown
Summaryfalse
ResearchStudy.description
Element IdResearchStudy.description
Definition

A full description of how the study is being conducted. For a description of what the study objectives are see ResearchStudy.objective.description.

Cardinality0..1
Typemarkdown
Summaryfalse
ResearchStudy.period
Element IdResearchStudy.period
Definition

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

Cardinality0..1
TypePeriod
Alternate Namestiming
Summarytrue
ResearchStudy.contact
Element IdResearchStudy.contact
Definition

Contact details to assist a user in learning more about or engaging with the study.

Cardinality0..*
TypeContactDetail
Summarytrue
ResearchStudy.sponsor
Element IdResearchStudy.sponsor
Definition

An organization that initiates the investigation and is legally responsible for the study.

Cardinality0..1
TypeReference(Organization)
Summarytrue
ResearchStudy.principalInvestigator
Element IdResearchStudy.principalInvestigator
Definition

A researcher in a study who oversees multiple aspects of the study, such as concept development, protocol writing, protocol submission for IRB approval, participant recruitment, informed consent, data collection, analysis, interpretation and presentation.

Cardinality0..1
TypeReference(Practitioner | PractitionerRole)
PatternsReference(Practitioner,PractitionerRole): Common patterns = Participant
Summarytrue
ResearchStudy.site
Element IdResearchStudy.site
Definition

A facility in which study activities are conducted.

Cardinality0..*
TypeReference(Location | ResearchStudy | Organization)
PatternsReference(Location,ResearchStudy,Organization): No common pattern
Summarytrue
ResearchStudy.note
Element IdResearchStudy.note
Definition

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

Cardinality0..*
TypeAnnotation
Summaryfalse
ResearchStudy.classification
Element IdResearchStudy.classification
Definition

Classification for the study.

Cardinality0..*
Summaryfalse
ResearchStudy.classification.type
Element IdResearchStudy.classification.type
Definition

Type of classifier.

Cardinality0..1
Terminology BindingResearchStudyCLassificationType :
TypeCodeableConcept
Summaryfalse
ResearchStudy.classification.classifier
Element IdResearchStudy.classification.classifier
Definition

Value of classifier.

Cardinality0..*
Terminology BindingResearchStudyClassificationClassifier :
TypeCodeableConcept
Summaryfalse
ResearchStudy.associatedParty
Element IdResearchStudy.associatedParty
Definition

Sponsors, 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
Element IdResearchStudy.associatedParty.name
Definition

Name of associated party.

Cardinality0..1
Typestring
Summaryfalse
ResearchStudy.associatedParty.role
Element IdResearchStudy.associatedParty.role
Definition

Type of association.

Cardinality1..1
Terminology BindingResearchStudyPartyType :
TypeCodeableConcept
Summaryfalse
ResearchStudy.associatedParty.classifier
Element IdResearchStudy.associatedParty.classifier
Definition

Organisational type of association.

Cardinality0..*
Terminology BindingResearchStudyPartyOrganizationType :
TypeCodeableConcept
Summaryfalse
ResearchStudy.associatedParty.party
Element IdResearchStudy.associatedParty.party
Definition

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

Cardinality0..1
TypeReference(Practitioner | PractitionerRole | Organization)
PatternsReference(Practitioner,PractitionerRole,Organization): Common patterns = Participant
Summaryfalse
Comments

Suggestions of a better attribute name are appreciated

ResearchStudy.currentState
Element IdResearchStudy.currentState
Definition

Current status of the study.

Cardinality0..*
Terminology BindingResearchStudyStatus (Extensible)
TypeCodeableConcept
Summaryfalse
ResearchStudy.statusDate
Element IdResearchStudy.statusDate
Definition

Status of study with time for that status.

Cardinality0..*
Summaryfalse
ResearchStudy.statusDate.activity
Element IdResearchStudy.statusDate.activity
Definition

Label for status or state.

Cardinality1..1
Terminology BindingResearchStudyStatusActivity :
TypeCodeableConcept
Summaryfalse
ResearchStudy.statusDate.actual
Element IdResearchStudy.statusDate.actual
Definition

Actual if true else anticipated.

Cardinality0..1
Typeboolean
Summaryfalse
ResearchStudy.statusDate.period
Element IdResearchStudy.statusDate.period
Definition

Date range.

Cardinality1..1
TypePeriod
Summaryfalse
ResearchStudy.whyStopped
Element IdResearchStudy.whyStopped
Definition

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

Cardinality0..1
Terminology BindingResearchStudyReasonStopped (Example)
TypeCodeableConcept
Summarytrue
ResearchStudy.recruitment
Element IdResearchStudy.recruitment
Definition

Target or actual group of participants enrolled in study.

Cardinality0..1
Summarytrue
ResearchStudy.recruitment.targetNumber
Element IdResearchStudy.recruitment.targetNumber
Definition

Estimated total number of participants to be enrolled.

Cardinality0..1
TypeunsignedInt
Summaryfalse
ResearchStudy.recruitment.actualNumber
Element IdResearchStudy.recruitment.actualNumber
Definition

Actual total number of participants enrolled in study.

Cardinality0..1
TypeunsignedInt
Summaryfalse
ResearchStudy.recruitment.eligibility
Element IdResearchStudy.recruitment.eligibility
Definition

Inclusion and exclusion criteria.

Cardinality0..1
TypeReference(Group)
Summaryfalse
ResearchStudy.recruitment.actualGroup
Element IdResearchStudy.recruitment.actualGroup
Definition

Group of participants who were enrolled in study.

Cardinality0..1
TypeReference(Group)
Summarytrue
ResearchStudy.comparisonGroup
Element IdResearchStudy.comparisonGroup
Definition

Describes an expected sequence of events for one of the participants of a study. E.g. Exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up.

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.identifier[x]
Element IdResearchStudy.comparisonGroup.identifier[x]
Definition

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

Cardinality0..1
Typeuri|Identifier
[x] NoteSee Choice of Data Types for further information about how to use [x]
Summaryfalse
ResearchStudy.comparisonGroup.name
Element IdResearchStudy.comparisonGroup.name
Definition

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

Cardinality1..1
Typestring
Summaryfalse
ResearchStudy.comparisonGroup.type
Element IdResearchStudy.comparisonGroup.type
Definition

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

Cardinality0..1
Terminology BindingResearchStudyArmType :
TypeCodeableConcept
Summaryfalse
ResearchStudy.comparisonGroup.description
Element IdResearchStudy.comparisonGroup.description
Definition

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

Cardinality0..1
Typemarkdown
Summaryfalse
ResearchStudy.comparisonGroup.intendedExposure
Element IdResearchStudy.comparisonGroup.intendedExposure
Definition

Interventions 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
Element IdResearchStudy.comparisonGroup.observedGroup
Definition

Group 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
Element IdResearchStudy.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.

Cardinality0..*
Summaryfalse
ResearchStudy.objective.name
Element IdResearchStudy.objective.name
Definition

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

Cardinality0..1
Typestring
Summaryfalse
ResearchStudy.objective.type
Element IdResearchStudy.objective.type
Definition

The kind of study objective.

Cardinality0..1
Terminology BindingResearchStudyObjectiveType (Preferred)
TypeCodeableConcept
Summaryfalse
ResearchStudy.objective.description
Element IdResearchStudy.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).

Cardinality0..1
Typemarkdown
Summaryfalse
ResearchStudy.outcomeMeasure
Element IdResearchStudy.outcomeMeasure
Definition

An outcome or planned variable to measure during the study.

Cardinality0..*
Summaryfalse
ResearchStudy.outcomeMeasure.name
Element IdResearchStudy.outcomeMeasure.name
Definition

Label for the outcome.

Cardinality0..1
Typestring
Summaryfalse
ResearchStudy.outcomeMeasure.type
Element IdResearchStudy.outcomeMeasure.type
Definition

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

Cardinality0..*
Terminology BindingResearchStudyObjectiveType (Preferred)
TypeCodeableConcept
Summaryfalse
ResearchStudy.outcomeMeasure.description
Element IdResearchStudy.outcomeMeasure.description
Definition

Description of the outcome.

Cardinality0..1
Typemarkdown
Summaryfalse
ResearchStudy.outcomeMeasure.reference
Element IdResearchStudy.outcomeMeasure.reference
Definition

Structured outcome definition.

Cardinality0..1
TypeReference(EvidenceVariable)
Summaryfalse
ResearchStudy.result
Element IdResearchStudy.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.

Cardinality0..*
TypeReference(EvidenceReport | Citation | DiagnosticReport)
PatternsReference(EvidenceReport,Citation,DiagnosticReport): No common pattern
Summarytrue
ResearchStudy.webLocation
Element IdResearchStudy.webLocation
Definition

A general storage or archive location for the study. This may contain an assortment of content which is not specified in advance.

Cardinality0..*
Summaryfalse
ResearchStudy.webLocation.type
Element IdResearchStudy.webLocation.type
Definition

Describes the nature of the location being specified.

Cardinality0..1
Terminology BindingResearchStudyUrlType :
TypeCodeableConcept
Summaryfalse
ResearchStudy.webLocation.url
Element IdResearchStudy.webLocation.url
Definition

The location address.

Cardinality1..1
Typeuri
Summaryfalse