R4 Ballot #1 (Mixed Normative/Trial use) Current Build
This page was published as part of FHIR v3.3.0: R4 Ballot #1 : Mixed Normative/Trial use (First Normative ballot). It has been superceded by R4 . For a full list of available versions, see the Directory of published versions .

8.25 8.22 Resource ResearchStudy - Content

Biomedical Research and Regulation Work Group Maturity Level : 0   Draft Trial Use Security 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.

This resource supports the HL7 mission to create and promote HL7 standards by developing Biomedical Research and Regulation standards is an definition resource from a FHIR workflow perspective - see Workflow .

A research study is a scientific way to improve or enhance information management during clinical research and regulatory evaluation develop new methods of the safety, efficacy health care. Studies are designed to answer specific questions on how to prevent, diagnose, or treat diseases and quality disorders. The ResearchStudy resource describes essential information about the study, including the purpose, objective, sponsor, investigator, therapy, condition being studied, schedule of therapeutic products activities, and procedures worldwide. 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

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

This resource does not implement any patterns.

Structure

Name Flags Card. Type Description & Constraints doco
. . ResearchStudy D TU DomainResource Investigation to increase healthcare-related patient-independent knowledge
Elements defined in Ancestors: id , meta , implicitRules , language , text , contained , extension , modifierExtension
. . . identifier Σ 0..* Identifier Business Identifier for study
. . . title Σ 0..1 string Name for this study
. . . protocol Σ 0..* Reference ( PlanDefinition ) Steps followed in executing study
. . . partOf Σ 0..* Reference ( ResearchStudy ) Part of larger study
. . . status ?! Σ 1..1 code 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
ResearchStudyStatus ( Required )
. . . primaryPurposeType Σ 0..1 CodeableConcept treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
ResearchStudyPrimaryPurposeType ( Extensible )
. . . phase Σ 0..1 CodeableConcept n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
ResearchStudyPhase ( Example )
. . . category Σ 0..* CodeableConcept Classifications for the study
. . . focus Σ 0..* CodeableConcept Drugs, devices, etc. under study
. . . condition Σ 0..* Reference ( Condition CodeableConcept ) Condition being studied
Condition/Problem/Diagnosis Codes ( Example )
. . . contact Σ 0..* ContactDetail Contact details for the study
. . . relatedArtifact 0..* RelatedArtifact References and dependencies
. . . keyword Σ 0..* CodeableConcept Used to search for the study
. . . location Σ 0..* CodeableConcept Geographic region(s) for study
Jurisdiction ValueSet ( Extensible )
. . . description 0..1 markdown What this is study doing
. . . enrollment Σ 0..* Reference ( Group ) Inclusion & exclusion criteria
. . . period Σ 0..1 Period When the study began and ended
. . . sponsor Σ 0..1 Reference ( Organization ) Organization that initiates and is legally responsible for the study
. . . principalInvestigator Σ 0..1 Reference ( Practitioner | PractitionerRole ) Researcher who oversees multiple aspects of the study
. . . site Σ 0..* Reference ( Location ) Facility where study activities are conducted
. . . reasonStopped Σ 0..1 CodeableConcept accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
ResearchStudyReasonStopped ( Example )
. . . note 0..* Annotation Comments made about the study
. . . arm 0..* BackboneElement Defined path through the study for a subject
. . . . name 1..1 string Label for study arm
. . . . type 0..1 CodeableConcept Categorization of study arm
. . . . description 0..1 string Short explanation of study path
. . . objective 0..* BackboneElement A goal for the study
. . . . name 0..1 string Label for the objective
. . . . type 0..1 CodeableConcept primary | 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 systems identifier : Identifier [0..*] A short, descriptive user-friendly label for the study title : string [0..1] The set of steps expected to be performed as part of the execution of the study protocol : Reference [0..*] « PlanDefinition » A larger research study of which this particular study is a component or step partOf : 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 study. (Strength=Required) ResearchStudyStatus ! » The type of study based upon the intent of the study's activities. A classification of the intent of the study primaryPurposeType : CodeableConcept [0..1] « Codes for the main intent of the study study. (Strength=Extensible) ResearchStudyPrimaryPurposeTy... + » The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation phase : 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, etc category : CodeableConcept [0..*] The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about focus : CodeableConcept [0..*] 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 condition : Reference CodeableConcept [0..*] « Condition 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 study contact : ContactDetail [0..*] Citations, references and other related documents relatedArtifact : RelatedArtifact [0..*] Key terms to aid in searching for or filtering the study keyword : CodeableConcept [0..*] Indicates a country, state or other region where the study is taking place location : CodeableConcept [0..*] « Countries and regions within which this artifact is targeted for use use. (Strength=Extensible) Jurisdiction ValueSet + » A full description of how the study is being conducted description : 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 study period : Period [0..1] An organization that initiates the investigation and is legally responsible for the study sponsor : 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 presentation principalInvestigator : Reference [0..1] « Practitioner | PractitionerRole » A facility in which study activities are conducted site : Reference [0..*] « Location » A description and/or code explaining the premature termination of the study reasonStopped : CodeableConcept [0..1] « Codes for why the study ended prematurely prematurely. (Strength=Example) ResearchStudyReasonStopped ?? » Comments made about the study by the performer, subject or other participants note : Annotation [0..*] Arm Unique, human-readable label for this arm of the study name : string [1..1] Categorization of study arm, e.g. experimental, active comparator, placebo comparater type : CodeableConcept [0..1] A succinct description of the path through the study that would be followed by a subject adhering to this arm description : string [0..1] Objective Unique, human-readable label for this objective of the study name : string [0..1] The kind of study objective type : CodeableConcept [0..1] « Codes for the kind of study objective 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-up arm [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 study objective [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>

 <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>

 <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:

  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:

  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.primaryPurposeType Added Element ResearchStudy.phase Added Element ResearchStudy.condition Added Element ResearchStudy.location Added Element ResearchStudy.arm.type Added Element ResearchStudy.objective Added Element ResearchStudy.objective.name Added Element ResearchStudy.objective.type Added Element ResearchStudy.jurisdiction deleted
ResearchStudy
ResearchStudy.arm.code ResearchStudy.status
  • deleted 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

Name Flags Card. Type Description & Constraints doco
. . ResearchStudy D TU DomainResource Investigation to increase healthcare-related patient-independent knowledge
Elements defined in Ancestors: id , meta , implicitRules , language , text , contained , extension , modifierExtension
. . . identifier Σ 0..* Identifier Business Identifier for study
. . . title Σ 0..1 string Name for this study
. . . protocol Σ 0..* Reference ( PlanDefinition ) Steps followed in executing study
. . . partOf Σ 0..* Reference ( ResearchStudy ) Part of larger study
. . . status ?! Σ 1..1 code 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
ResearchStudyStatus ( Required )
. . . primaryPurposeType Σ 0..1 CodeableConcept treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
ResearchStudyPrimaryPurposeType ( Extensible )
. . . phase Σ 0..1 CodeableConcept n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
ResearchStudyPhase ( Example )
. . . category Σ 0..* CodeableConcept Classifications for the study
. . . focus Σ 0..* CodeableConcept Drugs, devices, etc. under study
. . . condition Σ 0..* Reference ( Condition CodeableConcept ) Condition being studied
Condition/Problem/Diagnosis Codes ( Example )
. . . contact Σ 0..* ContactDetail Contact details for the study
. . . relatedArtifact 0..* RelatedArtifact References and dependencies
. . . keyword Σ 0..* CodeableConcept Used to search for the study
. . . location Σ 0..* CodeableConcept Geographic region(s) for study
Jurisdiction ValueSet ( Extensible )
. . . description 0..1 markdown What this is study doing
. . . enrollment Σ 0..* Reference ( Group ) Inclusion & exclusion criteria
. . . period Σ 0..1 Period When the study began and ended
. . . sponsor Σ 0..1 Reference ( Organization ) Organization that initiates and is legally responsible for the study
. . . principalInvestigator Σ 0..1 Reference ( Practitioner | PractitionerRole ) Researcher who oversees multiple aspects of the study
. . . site Σ 0..* Reference ( Location ) Facility where study activities are conducted
. . . reasonStopped Σ 0..1 CodeableConcept accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
ResearchStudyReasonStopped ( Example )
. . . note 0..* Annotation Comments made about the study
. . . arm 0..* BackboneElement Defined path through the study for a subject
. . . . name 1..1 string Label for study arm
. . . . type 0..1 CodeableConcept Categorization of study arm
. . . . description 0..1 string Short explanation of study path
. . . objective 0..* BackboneElement A goal for the study
. . . . name 0..1 string Label for the objective
. . . . type 0..1 CodeableConcept primary | 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 systems identifier : Identifier [0..*] A short, descriptive user-friendly label for the study title : string [0..1] The set of steps expected to be performed as part of the execution of the study protocol : Reference [0..*] « PlanDefinition » A larger research study of which this particular study is a component or step partOf : 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 study. (Strength=Required) ResearchStudyStatus ! » The type of study based upon the intent of the study's activities. A classification of the intent of the study primaryPurposeType : CodeableConcept [0..1] « Codes for the main intent of the study study. (Strength=Extensible) ResearchStudyPrimaryPurposeTy... + » The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation phase : 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, etc category : CodeableConcept [0..*] The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about focus : CodeableConcept [0..*] 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 condition : Reference CodeableConcept [0..*] « Condition 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 study contact : ContactDetail [0..*] Citations, references and other related documents relatedArtifact : RelatedArtifact [0..*] Key terms to aid in searching for or filtering the study keyword : CodeableConcept [0..*] Indicates a country, state or other region where the study is taking place location : CodeableConcept [0..*] « Countries and regions within which this artifact is targeted for use use. (Strength=Extensible) Jurisdiction ValueSet + » A full description of how the study is being conducted description : 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 study period : Period [0..1] An organization that initiates the investigation and is legally responsible for the study sponsor : 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 presentation principalInvestigator : Reference [0..1] « Practitioner | PractitionerRole » A facility in which study activities are conducted site : Reference [0..*] « Location » A description and/or code explaining the premature termination of the study reasonStopped : CodeableConcept [0..1] « Codes for why the study ended prematurely prematurely. (Strength=Example) ResearchStudyReasonStopped ?? » Comments made about the study by the performer, subject or other participants note : Annotation [0..*] Arm Unique, human-readable label for this arm of the study name : string [1..1] Categorization of study arm, e.g. experimental, active comparator, placebo comparater type : CodeableConcept [0..1] A succinct description of the path through the study that would be followed by a subject adhering to this arm description : string [0..1] Objective Unique, human-readable label for this objective of the study name : string [0..1] The kind of study objective type : CodeableConcept [0..1] « Codes for the kind of study objective 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-up arm [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 study objective [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>

 <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>

 <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:

  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:

  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 DSTU2 Release 3

ResearchStudy.primaryPurposeType Added Element ResearchStudy.phase Added Element ResearchStudy.condition Added Element ResearchStudy.location Added Element ResearchStudy.arm.type Added Element ResearchStudy.objective Added Element ResearchStudy.objective.name Added Element ResearchStudy.objective.type Added Element ResearchStudy.jurisdiction deleted
ResearchStudy
ResearchStudy.arm.code ResearchStudy.status
  • deleted 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.)

 

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

Path Definition Type Reference
ResearchStudy.status Codes that convey the current status of the research study study. Required ResearchStudyStatus
ResearchStudy.primaryPurposeType Codes for the main intent of the study study. Extensible ResearchStudyPrimaryPurposeType
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. Example ResearchStudyPhase
ResearchStudy.category Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc. Unknown No details provided yet
ResearchStudy.focus Codes for medications, devices and other interventions interventions. Unknown No details provided yet
ResearchStudy.condition Identification of the condition or diagnosis. Example Condition/Problem/DiagnosisCodes
ResearchStudy.keyword Words associated with the study that may be useful in discovery discovery. Unknown No details provided yet
ResearchStudy.location Countries and regions within which this artifact is targeted for use use. Extensible Jurisdiction ValueSet
ResearchStudy.reasonStopped Codes for why the study ended prematurely prematurely. Example ResearchStudyReasonStopped
ResearchStudy.objective.type Codes for the kind of study objective objective. Preferred ResearchStudyObjectiveType

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

Diagram showing typical state machine for the ResearchStudy resource

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

Name Type Description Expression In Common
category token Classifications for the study ResearchStudy.category
date date When the study began and ended ResearchStudy.period
focus token Drugs, devices, etc. under study ResearchStudy.focus
identifier token Business Identifier for study ResearchStudy.identifier
keyword token Used to search for the study ResearchStudy.keyword
location token Geographic region(s) for study ResearchStudy.location
partof reference Part of larger study ResearchStudy.partOf
( ResearchStudy )
principalinvestigator reference Researcher who oversees multiple aspects of the study ResearchStudy.principalInvestigator
( Practitioner , PractitionerRole )
protocol reference Steps followed in executing study ResearchStudy.protocol
( PlanDefinition )
site reference Facility where study activities are conducted ResearchStudy.site
( Location )
sponsor reference Organization that initiates and is legally responsible for the study ResearchStudy.sponsor
( Organization )
status token 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 ResearchStudy.status
title string Name for this study ResearchStudy.title