Release 4B Ballot #1

This page is part of the FHIR Specification v4.1.0: R4B Ballot. About the R4B version of FHIR. The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B R4 R3

8.22 Resource ResearchStudy - Content

Biomedical Research and Regulation Work GroupMaturity Level: 1 Trial UseSecurity Category: Business Compartments: Practitioner

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.

8.22.1 Scope and Usage

This resource is an definition resource from a FHIR workflow perspective - see Workflow.

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

8.22.2 References

This resource is referenced by UsageContext, AdverseEvent, MedicinalProductDefinition, RegulatedAuthorization, itself and ResearchSubject.

This resource does not implement any patterns.

8.22.3 Resource Content

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchStudy TUDomainResourceInvestigation to increase healthcare-related patient-independent knowledge
Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... identifier Σ0..*IdentifierBusiness Identifier for study
... title Σ0..1stringName for this study
... protocol Σ0..*Reference(PlanDefinition)Steps followed in executing study
... status ?!Σ1..1codeactive | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn
ResearchStudyStatus (Required)
... primaryPurposeType Σ0..1CodeableConcepttreatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
ResearchStudyPrimaryPurposeType (Extensible)
... phase Σ0..1CodeableConceptn-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
ResearchStudyPhase (Example)
... category Σ0..*CodeableConceptClassifications for the study
ResearchStudyCategory (Example)
... focus Σ0..*CodeableConceptDrugs, devices, etc. under study
ResearchStudyFocus (Example)
... condition Σ0..*CodeableConceptCondition being studied
Condition/Problem/Diagnosis Codes (Example)
... contact Σ0..*ContactDetailContact details for the study
... relatedArtifact 0..*RelatedArtifactReferences and dependencies
... keyword Σ0..*CodeableConceptUsed to search for the study
ResearchStudyKeyword (Example)
... location Σ0..*CodeableConceptGeographic region(s) for study
Jurisdiction (Extensible)
... description 0..1markdownWhat this is study doing
... enrollment Σ0..*Reference(Group)Inclusion & exclusion criteria
... period Σ0..1PeriodWhen the study began and ended
... sponsor Σ0..1Reference(Organization)Organization that initiates and is legally responsible for the study
... principalInvestigator Σ0..1Reference(Practitioner | PractitionerRole)Researcher who oversees multiple aspects of the study
... site Σ0..*Reference(Location)Facility where study activities are conducted
... reasonStopped Σ0..1CodeableConceptaccrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
ResearchStudyReasonStopped (Example)
... note 0..*AnnotationComments made about the study
... arm 0..*BackboneElementDefined path through the study for a subject
.... name 1..1stringLabel for study arm
.... type 0..1CodeableConceptCategorization of study arm
.... description 0..1stringShort explanation of study path
... objective 0..*BackboneElementA goal for the study
.... name 0..1stringLabel for the objective
.... type 0..1CodeableConceptprimary | secondary | exploratory
ResearchStudyObjectiveType (Preferred)

doco Documentation for this format

UML Diagram (Legend)

ResearchStudy (DomainResource)Identifiers assigned to this research study by the sponsor or other systemsidentifier : Identifier [0..*]A short, descriptive user-friendly label for the studytitle : string [0..1]The set of steps expected to be performed as part of the execution of the studyprotocol : Reference [0..*] « PlanDefinition »A larger research study of which this particular study is a component or steppartOf : Reference [0..*] « ResearchStudy »The current state of the study (this element modifies the meaning of other elements)status : code [1..1] « Codes that convey the current status of the research study. (Strength=Required)ResearchStudyStatus! »The type of study based upon the intent of the study's activities. A classification of the intent of the studyprimaryPurposeType : CodeableConcept [0..1] « Codes for the main intent of the study. (Strength=Extensible) ResearchStudyPrimaryPurposeTy...+ »The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluationphase : CodeableConcept [0..1] « Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation. (Strength=Example)ResearchStudyPhase?? »Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etccategory : CodeableConcept [0..*] « Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc. (Strength=Example)ResearchStudyCategory?? »The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information aboutfocus : CodeableConcept [0..*] « Codes for medications, devices and other interventions. (Strength=Example)ResearchStudyFocus?? »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 codecondition : CodeableConcept [0..*] « Identification of the condition or diagnosis. (Strength=Example) Condition/Problem/DiagnosisCo...?? »Contact details to assist a user in learning more about or engaging with the studycontact : ContactDetail [0..*]Citations, references and other related documentsrelatedArtifact : RelatedArtifact [0..*]Key terms to aid in searching for or filtering the studykeyword : CodeableConcept [0..*] « Words associated with the study that may be useful in discovery. (Strength=Example)ResearchStudyKeyword?? »Indicates a country, state or other region where the study is taking placelocation : CodeableConcept [0..*] « Countries and regions within which this artifact is targeted for use. (Strength=Extensible)Jurisdiction ValueSet+ »A full description of how the study is being conducteddescription : markdown [0..1]Reference to a Group that defines the criteria for and quantity of subjects participating in the study. E.g. " 200 female Europeans between the ages of 20 and 45 with early onset diabetes"enrollment : Reference [0..*] « Group »Identifies the start date and the expected (or actual, depending on status) end date for the studyperiod : Period [0..1]An organization that initiates the investigation and is legally responsible for the studysponsor : Reference [0..1] « Organization »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 presentationprincipalInvestigator : Reference [0..1] « Practitioner| PractitionerRole »A facility in which study activities are conductedsite : Reference [0..*] « Location »A description and/or code explaining the premature termination of the studyreasonStopped : CodeableConcept [0..1] « Codes for why the study ended prematurely. (Strength=Example)ResearchStudyReasonStopped?? »Comments made about the study by the performer, subject or other participantsnote : Annotation [0..*]ArmUnique, human-readable label for this arm of the studyname : string [1..1]Categorization of study arm, e.g. experimental, active comparator, placebo comparatertype : CodeableConcept [0..1]A succinct description of the path through the study that would be followed by a subject adhering to this armdescription : string [0..1]ObjectiveUnique, human-readable label for this objective of the studyname : string [0..1]The kind of study objectivetype : CodeableConcept [0..1] « Codes for the kind of study objective. (Strength=Preferred)ResearchStudyObjectiveType? »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-uparm[0..*]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 studyobjective[0..*]

XML Template

<ResearchStudy xmlns="http://hl7.org/fhir"> doco
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..* Identifier Business Identifier for study --></identifier>
 <title value="[string]"/><!-- 0..1 Name for this study -->
 <protocol><!-- 0..* Reference(PlanDefinition) Steps followed in executing study --></protocol>
 <partOf><!-- 0..* Reference(ResearchStudy) Part of larger study --></partOf>
 <status value="[code]"/><!-- 1..1 active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn -->
 <primaryPurposeType><!-- 0..1 CodeableConcept treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility --></primaryPurposeType>
 <phase><!-- 0..1 CodeableConcept n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 --></phase>
 <category><!-- 0..* CodeableConcept Classifications for the study --></category>
 <focus><!-- 0..* CodeableConcept Drugs, devices, etc. under study --></focus>
 <condition><!-- 0..* CodeableConcept Condition being studied --></condition>
 <contact><!-- 0..* ContactDetail Contact details for the study --></contact>
 <relatedArtifact><!-- 0..* RelatedArtifact References and dependencies --></relatedArtifact>
 <keyword><!-- 0..* CodeableConcept Used to search for the study --></keyword>
 <location><!-- 0..* CodeableConcept Geographic region(s) for study --></location>
 <description value="[markdown]"/><!-- 0..1 What this is study doing -->
 <enrollment><!-- 0..* Reference(Group) Inclusion & exclusion criteria --></enrollment>
 <period><!-- 0..1 Period When the study began and ended --></period>
 <sponsor><!-- 0..1 Reference(Organization) Organization that initiates and is legally responsible for the study --></sponsor>
 <principalInvestigator><!-- 0..1 Reference(Practitioner|PractitionerRole) Researcher who oversees multiple aspects of the study --></principalInvestigator>
 <site><!-- 0..* Reference(Location) Facility where study activities are conducted --></site>
 <reasonStopped><!-- 0..1 CodeableConcept accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design --></reasonStopped>
 <note><!-- 0..* Annotation Comments made about the study --></note>
 <arm>  <!-- 0..* Defined path through the study for a subject -->
  <name value="[string]"/><!-- 1..1 Label for study arm -->
  <type><!-- 0..1 CodeableConcept Categorization of study arm --></type>
  <description value="[string]"/><!-- 0..1 Short explanation of study path -->
 </arm>
 <objective>  <!-- 0..* A goal for the study -->
  <name value="[string]"/><!-- 0..1 Label for the objective -->
  <type><!-- 0..1 CodeableConcept primary | secondary | exploratory --></type>
 </objective>
</ResearchStudy>

JSON Template

{doco
  "resourceType" : "ResearchStudy",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // Business Identifier for study
  "title" : "<string>", // Name for this study
  "protocol" : [{ Reference(PlanDefinition) }], // Steps followed in executing study
  "partOf" : [{ Reference(ResearchStudy) }], // Part of larger study
  "status" : "<code>", // R!  active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn
  "primaryPurposeType" : { CodeableConcept }, // treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
  "phase" : { CodeableConcept }, // n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
  "category" : [{ CodeableConcept }], // Classifications for the study
  "focus" : [{ CodeableConcept }], // Drugs, devices, etc. under study
  "condition" : [{ CodeableConcept }], // Condition being studied
  "contact" : [{ ContactDetail }], // Contact details for the study
  "relatedArtifact" : [{ RelatedArtifact }], // References and dependencies
  "keyword" : [{ CodeableConcept }], // Used to search for the study
  "location" : [{ CodeableConcept }], // Geographic region(s) for study
  "description" : "<markdown>", // What this is study doing
  "enrollment" : [{ Reference(Group) }], // Inclusion & exclusion criteria
  "period" : { Period }, // When the study began and ended
  "sponsor" : { Reference(Organization) }, // Organization that initiates and is legally responsible for the study
  "principalInvestigator" : { Reference(Practitioner|PractitionerRole) }, // Researcher who oversees multiple aspects of the study
  "site" : [{ Reference(Location) }], // Facility where study activities are conducted
  "reasonStopped" : { CodeableConcept }, // accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
  "note" : [{ Annotation }], // Comments made about the study
  "arm" : [{ // Defined path through the study for a subject
    "name" : "<string>", // R!  Label for study arm
    "type" : { CodeableConcept }, // Categorization of study arm
    "description" : "<string>" // Short explanation of study path
  }],
  "objective" : [{ // A goal for the study
    "name" : "<string>", // Label for the objective
    "type" : { CodeableConcept } // primary | secondary | exploratory
  }]
}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .doco


[ a fhir:ResearchStudy;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:ResearchStudy.identifier [ Identifier ], ... ; # 0..* Business Identifier for study
  fhir:ResearchStudy.title [ string ]; # 0..1 Name for this study
  fhir:ResearchStudy.protocol [ Reference(PlanDefinition) ], ... ; # 0..* Steps followed in executing study
  fhir:ResearchStudy.partOf [ Reference(ResearchStudy) ], ... ; # 0..* Part of larger study
  fhir:ResearchStudy.status [ code ]; # 1..1 active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn
  fhir:ResearchStudy.primaryPurposeType [ CodeableConcept ]; # 0..1 treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
  fhir:ResearchStudy.phase [ CodeableConcept ]; # 0..1 n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
  fhir:ResearchStudy.category [ CodeableConcept ], ... ; # 0..* Classifications for the study
  fhir:ResearchStudy.focus [ CodeableConcept ], ... ; # 0..* Drugs, devices, etc. under study
  fhir:ResearchStudy.condition [ CodeableConcept ], ... ; # 0..* Condition being studied
  fhir:ResearchStudy.contact [ ContactDetail ], ... ; # 0..* Contact details for the study
  fhir:ResearchStudy.relatedArtifact [ RelatedArtifact ], ... ; # 0..* References and dependencies
  fhir:ResearchStudy.keyword [ CodeableConcept ], ... ; # 0..* Used to search for the study
  fhir:ResearchStudy.location [ CodeableConcept ], ... ; # 0..* Geographic region(s) for study
  fhir:ResearchStudy.description [ markdown ]; # 0..1 What this is study doing
  fhir:ResearchStudy.enrollment [ Reference(Group) ], ... ; # 0..* Inclusion & exclusion criteria
  fhir:ResearchStudy.period [ Period ]; # 0..1 When the study began and ended
  fhir:ResearchStudy.sponsor [ Reference(Organization) ]; # 0..1 Organization that initiates and is legally responsible for the study
  fhir:ResearchStudy.principalInvestigator [ Reference(Practitioner|PractitionerRole) ]; # 0..1 Researcher who oversees multiple aspects of the study
  fhir:ResearchStudy.site [ Reference(Location) ], ... ; # 0..* Facility where study activities are conducted
  fhir:ResearchStudy.reasonStopped [ CodeableConcept ]; # 0..1 accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
  fhir:ResearchStudy.note [ Annotation ], ... ; # 0..* Comments made about the study
  fhir:ResearchStudy.arm [ # 0..* Defined path through the study for a subject
    fhir:ResearchStudy.arm.name [ string ]; # 1..1 Label for study arm
    fhir:ResearchStudy.arm.type [ CodeableConcept ]; # 0..1 Categorization of study arm
    fhir:ResearchStudy.arm.description [ string ]; # 0..1 Short explanation of study path
  ], ...;
  fhir:ResearchStudy.objective [ # 0..* A goal for the study
    fhir:ResearchStudy.objective.name [ string ]; # 0..1 Label for the objective
    fhir:ResearchStudy.objective.type [ CodeableConcept ]; # 0..1 primary | secondary | exploratory
  ], ...;
]

Changes since R3

ResearchStudy
ResearchStudy.status
  • Change value set from http://hl7.org/fhir/ValueSet/research-study-status|4.0.0 to http://hl7.org/fhir/ValueSet/research-study-status|4.1.0

See the Full Difference for further information

This analysis is available as XML or JSON.

See R3 <--> R4 Conversion Maps (status = 1 test that all execute ok. All tests pass round-trip testing and all r3 resources are valid.)

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. ResearchStudy TUDomainResourceInvestigation to increase healthcare-related patient-independent knowledge
Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... identifier Σ0..*IdentifierBusiness Identifier for study
... title Σ0..1stringName for this study
... protocol Σ0..*Reference(PlanDefinition)Steps followed in executing study
... status ?!Σ1..1codeactive | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn
ResearchStudyStatus (Required)
... primaryPurposeType Σ0..1CodeableConcepttreatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
ResearchStudyPrimaryPurposeType (Extensible)
... phase Σ0..1CodeableConceptn-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
ResearchStudyPhase (Example)
... category Σ0..*CodeableConceptClassifications for the study
ResearchStudyCategory (Example)
... focus Σ0..*CodeableConceptDrugs, devices, etc. under study
ResearchStudyFocus (Example)
... condition Σ0..*CodeableConceptCondition being studied
Condition/Problem/Diagnosis Codes (Example)
... contact Σ0..*ContactDetailContact details for the study
... relatedArtifact 0..*RelatedArtifactReferences and dependencies
... keyword Σ0..*CodeableConceptUsed to search for the study
ResearchStudyKeyword (Example)
... location Σ0..*CodeableConceptGeographic region(s) for study
Jurisdiction (Extensible)
... description 0..1markdownWhat this is study doing
... enrollment Σ0..*Reference(Group)Inclusion & exclusion criteria
... period Σ0..1PeriodWhen the study began and ended
... sponsor Σ0..1Reference(Organization)Organization that initiates and is legally responsible for the study
... principalInvestigator Σ0..1Reference(Practitioner | PractitionerRole)Researcher who oversees multiple aspects of the study
... site Σ0..*Reference(Location)Facility where study activities are conducted
... reasonStopped Σ0..1CodeableConceptaccrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
ResearchStudyReasonStopped (Example)
... note 0..*AnnotationComments made about the study
... arm 0..*BackboneElementDefined path through the study for a subject
.... name 1..1stringLabel for study arm
.... type 0..1CodeableConceptCategorization of study arm
.... description 0..1stringShort explanation of study path
... objective 0..*BackboneElementA goal for the study
.... name 0..1stringLabel for the objective
.... type 0..1CodeableConceptprimary | secondary | exploratory
ResearchStudyObjectiveType (Preferred)

doco Documentation for this format

UML Diagram (Legend)

ResearchStudy (DomainResource)Identifiers assigned to this research study by the sponsor or other systemsidentifier : Identifier [0..*]A short, descriptive user-friendly label for the studytitle : string [0..1]The set of steps expected to be performed as part of the execution of the studyprotocol : Reference [0..*] « PlanDefinition »A larger research study of which this particular study is a component or steppartOf : Reference [0..*] « ResearchStudy »The current state of the study (this element modifies the meaning of other elements)status : code [1..1] « Codes that convey the current status of the research study. (Strength=Required)ResearchStudyStatus! »The type of study based upon the intent of the study's activities. A classification of the intent of the studyprimaryPurposeType : CodeableConcept [0..1] « Codes for the main intent of the study. (Strength=Extensible) ResearchStudyPrimaryPurposeTy...+ »The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluationphase : CodeableConcept [0..1] « Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation. (Strength=Example)ResearchStudyPhase?? »Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etccategory : CodeableConcept [0..*] « Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc. (Strength=Example)ResearchStudyCategory?? »The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information aboutfocus : CodeableConcept [0..*] « Codes for medications, devices and other interventions. (Strength=Example)ResearchStudyFocus?? »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 codecondition : CodeableConcept [0..*] « Identification of the condition or diagnosis. (Strength=Example) Condition/Problem/DiagnosisCo...?? »Contact details to assist a user in learning more about or engaging with the studycontact : ContactDetail [0..*]Citations, references and other related documentsrelatedArtifact : RelatedArtifact [0..*]Key terms to aid in searching for or filtering the studykeyword : CodeableConcept [0..*] « Words associated with the study that may be useful in discovery. (Strength=Example)ResearchStudyKeyword?? »Indicates a country, state or other region where the study is taking placelocation : CodeableConcept [0..*] « Countries and regions within which this artifact is targeted for use. (Strength=Extensible)Jurisdiction ValueSet+ »A full description of how the study is being conducteddescription : markdown [0..1]Reference to a Group that defines the criteria for and quantity of subjects participating in the study. E.g. " 200 female Europeans between the ages of 20 and 45 with early onset diabetes"enrollment : Reference [0..*] « Group »Identifies the start date and the expected (or actual, depending on status) end date for the studyperiod : Period [0..1]An organization that initiates the investigation and is legally responsible for the studysponsor : Reference [0..1] « Organization »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 presentationprincipalInvestigator : Reference [0..1] « Practitioner| PractitionerRole »A facility in which study activities are conductedsite : Reference [0..*] « Location »A description and/or code explaining the premature termination of the studyreasonStopped : CodeableConcept [0..1] « Codes for why the study ended prematurely. (Strength=Example)ResearchStudyReasonStopped?? »Comments made about the study by the performer, subject or other participantsnote : Annotation [0..*]ArmUnique, human-readable label for this arm of the studyname : string [1..1]Categorization of study arm, e.g. experimental, active comparator, placebo comparatertype : CodeableConcept [0..1]A succinct description of the path through the study that would be followed by a subject adhering to this armdescription : string [0..1]ObjectiveUnique, human-readable label for this objective of the studyname : string [0..1]The kind of study objectivetype : CodeableConcept [0..1] « Codes for the kind of study objective. (Strength=Preferred)ResearchStudyObjectiveType? »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-uparm[0..*]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 studyobjective[0..*]

XML Template

<ResearchStudy xmlns="http://hl7.org/fhir"> doco
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..* Identifier Business Identifier for study --></identifier>
 <title value="[string]"/><!-- 0..1 Name for this study -->
 <protocol><!-- 0..* Reference(PlanDefinition) Steps followed in executing study --></protocol>
 <partOf><!-- 0..* Reference(ResearchStudy) Part of larger study --></partOf>
 <status value="[code]"/><!-- 1..1 active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn -->
 <primaryPurposeType><!-- 0..1 CodeableConcept treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility --></primaryPurposeType>
 <phase><!-- 0..1 CodeableConcept n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 --></phase>
 <category><!-- 0..* CodeableConcept Classifications for the study --></category>
 <focus><!-- 0..* CodeableConcept Drugs, devices, etc. under study --></focus>
 <condition><!-- 0..* CodeableConcept Condition being studied --></condition>
 <contact><!-- 0..* ContactDetail Contact details for the study --></contact>
 <relatedArtifact><!-- 0..* RelatedArtifact References and dependencies --></relatedArtifact>
 <keyword><!-- 0..* CodeableConcept Used to search for the study --></keyword>
 <location><!-- 0..* CodeableConcept Geographic region(s) for study --></location>
 <description value="[markdown]"/><!-- 0..1 What this is study doing -->
 <enrollment><!-- 0..* Reference(Group) Inclusion & exclusion criteria --></enrollment>
 <period><!-- 0..1 Period When the study began and ended --></period>
 <sponsor><!-- 0..1 Reference(Organization) Organization that initiates and is legally responsible for the study --></sponsor>
 <principalInvestigator><!-- 0..1 Reference(Practitioner|PractitionerRole) Researcher who oversees multiple aspects of the study --></principalInvestigator>
 <site><!-- 0..* Reference(Location) Facility where study activities are conducted --></site>
 <reasonStopped><!-- 0..1 CodeableConcept accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design --></reasonStopped>
 <note><!-- 0..* Annotation Comments made about the study --></note>
 <arm>  <!-- 0..* Defined path through the study for a subject -->
  <name value="[string]"/><!-- 1..1 Label for study arm -->
  <type><!-- 0..1 CodeableConcept Categorization of study arm --></type>
  <description value="[string]"/><!-- 0..1 Short explanation of study path -->
 </arm>
 <objective>  <!-- 0..* A goal for the study -->
  <name value="[string]"/><!-- 0..1 Label for the objective -->
  <type><!-- 0..1 CodeableConcept primary | secondary | exploratory --></type>
 </objective>
</ResearchStudy>

JSON Template

{doco
  "resourceType" : "ResearchStudy",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // Business Identifier for study
  "title" : "<string>", // Name for this study
  "protocol" : [{ Reference(PlanDefinition) }], // Steps followed in executing study
  "partOf" : [{ Reference(ResearchStudy) }], // Part of larger study
  "status" : "<code>", // R!  active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn
  "primaryPurposeType" : { CodeableConcept }, // treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
  "phase" : { CodeableConcept }, // n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
  "category" : [{ CodeableConcept }], // Classifications for the study
  "focus" : [{ CodeableConcept }], // Drugs, devices, etc. under study
  "condition" : [{ CodeableConcept }], // Condition being studied
  "contact" : [{ ContactDetail }], // Contact details for the study
  "relatedArtifact" : [{ RelatedArtifact }], // References and dependencies
  "keyword" : [{ CodeableConcept }], // Used to search for the study
  "location" : [{ CodeableConcept }], // Geographic region(s) for study
  "description" : "<markdown>", // What this is study doing
  "enrollment" : [{ Reference(Group) }], // Inclusion & exclusion criteria
  "period" : { Period }, // When the study began and ended
  "sponsor" : { Reference(Organization) }, // Organization that initiates and is legally responsible for the study
  "principalInvestigator" : { Reference(Practitioner|PractitionerRole) }, // Researcher who oversees multiple aspects of the study
  "site" : [{ Reference(Location) }], // Facility where study activities are conducted
  "reasonStopped" : { CodeableConcept }, // accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
  "note" : [{ Annotation }], // Comments made about the study
  "arm" : [{ // Defined path through the study for a subject
    "name" : "<string>", // R!  Label for study arm
    "type" : { CodeableConcept }, // Categorization of study arm
    "description" : "<string>" // Short explanation of study path
  }],
  "objective" : [{ // A goal for the study
    "name" : "<string>", // Label for the objective
    "type" : { CodeableConcept } // primary | secondary | exploratory
  }]
}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .doco


[ a fhir:ResearchStudy;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:ResearchStudy.identifier [ Identifier ], ... ; # 0..* Business Identifier for study
  fhir:ResearchStudy.title [ string ]; # 0..1 Name for this study
  fhir:ResearchStudy.protocol [ Reference(PlanDefinition) ], ... ; # 0..* Steps followed in executing study
  fhir:ResearchStudy.partOf [ Reference(ResearchStudy) ], ... ; # 0..* Part of larger study
  fhir:ResearchStudy.status [ code ]; # 1..1 active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn
  fhir:ResearchStudy.primaryPurposeType [ CodeableConcept ]; # 0..1 treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
  fhir:ResearchStudy.phase [ CodeableConcept ]; # 0..1 n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
  fhir:ResearchStudy.category [ CodeableConcept ], ... ; # 0..* Classifications for the study
  fhir:ResearchStudy.focus [ CodeableConcept ], ... ; # 0..* Drugs, devices, etc. under study
  fhir:ResearchStudy.condition [ CodeableConcept ], ... ; # 0..* Condition being studied
  fhir:ResearchStudy.contact [ ContactDetail ], ... ; # 0..* Contact details for the study
  fhir:ResearchStudy.relatedArtifact [ RelatedArtifact ], ... ; # 0..* References and dependencies
  fhir:ResearchStudy.keyword [ CodeableConcept ], ... ; # 0..* Used to search for the study
  fhir:ResearchStudy.location [ CodeableConcept ], ... ; # 0..* Geographic region(s) for study
  fhir:ResearchStudy.description [ markdown ]; # 0..1 What this is study doing
  fhir:ResearchStudy.enrollment [ Reference(Group) ], ... ; # 0..* Inclusion & exclusion criteria
  fhir:ResearchStudy.period [ Period ]; # 0..1 When the study began and ended
  fhir:ResearchStudy.sponsor [ Reference(Organization) ]; # 0..1 Organization that initiates and is legally responsible for the study
  fhir:ResearchStudy.principalInvestigator [ Reference(Practitioner|PractitionerRole) ]; # 0..1 Researcher who oversees multiple aspects of the study
  fhir:ResearchStudy.site [ Reference(Location) ], ... ; # 0..* Facility where study activities are conducted
  fhir:ResearchStudy.reasonStopped [ CodeableConcept ]; # 0..1 accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
  fhir:ResearchStudy.note [ Annotation ], ... ; # 0..* Comments made about the study
  fhir:ResearchStudy.arm [ # 0..* Defined path through the study for a subject
    fhir:ResearchStudy.arm.name [ string ]; # 1..1 Label for study arm
    fhir:ResearchStudy.arm.type [ CodeableConcept ]; # 0..1 Categorization of study arm
    fhir:ResearchStudy.arm.description [ string ]; # 0..1 Short explanation of study path
  ], ...;
  fhir:ResearchStudy.objective [ # 0..* A goal for the study
    fhir:ResearchStudy.objective.name [ string ]; # 0..1 Label for the objective
    fhir:ResearchStudy.objective.type [ CodeableConcept ]; # 0..1 primary | secondary | exploratory
  ], ...;
]

Changes since Release 3

ResearchStudy
ResearchStudy.status
  • Change value set from http://hl7.org/fhir/ValueSet/research-study-status|4.0.0 to http://hl7.org/fhir/ValueSet/research-study-status|4.1.0

See the Full Difference for further information

This analysis is available as XML or JSON.

See R3 <--> R4 Conversion Maps (status = 1 test that all execute ok. All tests pass round-trip testing and all r3 resources are valid.)

 

See the Profiles & Extensions and the alternate definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions & the dependency analysis

8.22.3.1 Terminology Bindings

PathDefinitionTypeReference
ResearchStudy.status Codes that convey the current status of the research study.RequiredResearchStudyStatus
ResearchStudy.primaryPurposeType Codes for the main intent of the study.ExtensibleResearchStudyPrimaryPurposeType
ResearchStudy.phase Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.ExampleResearchStudyPhase
ResearchStudy.category Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.Example??
ResearchStudy.focus Codes for medications, devices and other interventions.Example??
ResearchStudy.condition Identification of the condition or diagnosis.ExampleCondition/Problem/DiagnosisCodes
ResearchStudy.keyword Words associated with the study that may be useful in discovery.Example??
ResearchStudy.location Countries and regions within which this artifact is targeted for use.ExtensibleJurisdiction ValueSet
ResearchStudy.reasonStopped Codes for why the study ended prematurely.ExampleResearchStudyReasonStopped
ResearchStudy.objective.type Codes for the kind of study objective.PreferredResearchStudyObjectiveType

8.22.4 ResearchStudy State Machine

The following diagram reflects the "typical" state machine for ResearchStudy.

Diagram showing typical state machine for the ResearchStudy resource

8.22.5 Search Parameters

Search parameters for this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.

NameTypeDescriptionExpressionIn Common
categorytokenClassifications for the studyResearchStudy.category
datedateWhen the study began and endedResearchStudy.period
focustokenDrugs, devices, etc. under studyResearchStudy.focus
identifiertokenBusiness Identifier for studyResearchStudy.identifier
keywordtokenUsed to search for the studyResearchStudy.keyword
locationtokenGeographic region(s) for studyResearchStudy.location
partofreferencePart of larger studyResearchStudy.partOf
(ResearchStudy)
principalinvestigatorreferenceResearcher who oversees multiple aspects of the studyResearchStudy.principalInvestigator
(Practitioner, PractitionerRole)
protocolreferenceSteps followed in executing studyResearchStudy.protocol
(PlanDefinition)
sitereferenceFacility where study activities are conductedResearchStudy.site
(Location)
sponsorreferenceOrganization that initiates and is legally responsible for the studyResearchStudy.sponsor
(Organization)
statustokenactive | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawnResearchStudy.status
titlestringName for this studyResearchStudy.title