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8.22 Resource ResearchStudy - Content

Regulated Clinical Research Information Management

Work Group

Maturity Level: 0

Draft

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 supports the HL7 mission to create and promote HL7 standards by developing RCRIM standards to improve or enhance information management during clinical research and regulatory evaluation of the safety, efficacy and quality of therapeutic products and procedures worldwide.

This resource is referenced by AdverseEvent and ResearchSubject

Structure

Name	Flags	Card.	Type	Description & Constraints
ResearchStudy			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	draft \| in-progress \| suspended \| stopped \| completed \| entered-in-error ResearchStudyStatus (Required)
category	Σ	0..*	CodeableConcept	Classifications for the study
focus	Σ	0..*	CodeableConcept	Drugs, devices, conditions, etc. under study
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
jurisdiction	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 responsible for the study
principalInvestigator	Σ	0..1	Reference(Practitioner)	The individual responsible for the study
site	Σ	0..*	Reference(Location)	Location involved in study execution
reasonStopped	Σ	0..1	CodeableConcept	Reason for terminating study early
note		0..*	Annotation	Comments made about the event
arm		0..*	BackboneElement	Defined path through the study for a subject
name		1..1	string	Label for study arm
code		0..1	CodeableConcept	Categorization of study arm
description		0..1	string	Short explanation of study path
Documentation for this format

UML Diagram (Legend)

XML Template

<ResearchStudy xmlns="http://hl7.org/fhir"> 
 <!-- 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 draft | in-progress | suspended | stopped | completed | entered-in-error -->
 <category><!-- 0..* CodeableConcept Classifications for the study --></category>
 <focus><!-- 0..* CodeableConcept Drugs, devices, conditions, etc. under study --></focus>
 <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>
 <jurisdiction><!-- 0..* CodeableConcept Geographic region(s) for study --></jurisdiction>
 <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 responsible for the study --></sponsor>
 <principalInvestigator><!-- 0..1 Reference(Practitioner) The individual responsible for the study --></principalInvestigator>
 <site><!-- 0..* Reference(Location) Location involved in study execution --></site>
 <reasonStopped><!-- 0..1 CodeableConcept Reason for terminating study early --></reasonStopped>
 <note><!-- 0..* Annotation Comments made about the event --></note>
 <arm>  <!-- 0..* Defined path through the study for a subject -->
  <name value="[string]"/><!-- 1..1 Label for study arm -->
  <code><!-- 0..1 CodeableConcept Categorization of study arm --></code>
  <description value="[string]"/><!-- 0..1 Short explanation of study path -->
 </arm>
</ResearchStudy>

JSON Template

{
  "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!  draft | in-progress | suspended | stopped | completed | entered-in-error
  "category" : [{ CodeableConcept }], // Classifications for the study
  "focus" : [{ CodeableConcept }], // Drugs, devices, conditions, etc. under study
  "contact" : [{ ContactDetail }], // Contact details for the study
  "relatedArtifact" : [{ RelatedArtifact }], // References and dependencies
  "keyword" : [{ CodeableConcept }], // Used to search for the study
  "jurisdiction" : [{ 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 responsible for the study
  "principalInvestigator" : { Reference(Practitioner) }, // The individual responsible for the study
  "site" : [{ Reference(Location) }], // Location involved in study execution
  "reasonStopped" : { CodeableConcept }, // Reason for terminating study early
  "note" : [{ Annotation }], // Comments made about the event
  "arm" : [{ // Defined path through the study for a subject
    "name" : "<string>", // R!  Label for study arm
    "code" : { CodeableConcept }, // Categorization of study arm
    "description" : "<string>" // Short explanation of study path
  }]
}

Turtle Template

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


[ 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 draft | in-progress | suspended | stopped | completed | entered-in-error
  fhir:ResearchStudy.category [ CodeableConcept ], ... ; # 0..* Classifications for the study
  fhir:ResearchStudy.focus [ CodeableConcept ], ... ; # 0..* Drugs, devices, conditions, etc. under study
  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.jurisdiction [ 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 responsible for the study
  fhir:ResearchStudy.principalInvestigator [ Reference(Practitioner) ]; # 0..1 The individual responsible for the study
  fhir:ResearchStudy.site [ Reference(Location) ], ... ; # 0..* Location involved in study execution
  fhir:ResearchStudy.reasonStopped [ CodeableConcept ]; # 0..1 Reason for terminating study early
  fhir:ResearchStudy.note [ Annotation ], ... ; # 0..* Comments made about the event
  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.code [ CodeableConcept ]; # 0..1 Categorization of study arm
    fhir:ResearchStudy.arm.description [ string ]; # 0..1 Short explanation of study path
  ], ...;
]

Changes since DSTU2

This resource did not exist in Release 2

This analysis is available as XML or JSON.

Structure

Name	Flags	Card.	Type	Description & Constraints
ResearchStudy			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	draft \| in-progress \| suspended \| stopped \| completed \| entered-in-error ResearchStudyStatus (Required)
category	Σ	0..*	CodeableConcept	Classifications for the study
focus	Σ	0..*	CodeableConcept	Drugs, devices, conditions, etc. under study
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
jurisdiction	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 responsible for the study
principalInvestigator	Σ	0..1	Reference(Practitioner)	The individual responsible for the study
site	Σ	0..*	Reference(Location)	Location involved in study execution
reasonStopped	Σ	0..1	CodeableConcept	Reason for terminating study early
note		0..*	Annotation	Comments made about the event
arm		0..*	BackboneElement	Defined path through the study for a subject
name		1..1	string	Label for study arm
code		0..1	CodeableConcept	Categorization of study arm
description		0..1	string	Short explanation of study path
Documentation for this format

UML Diagram (Legend)

XML Template

<ResearchStudy xmlns="http://hl7.org/fhir"> 
 <!-- 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 draft | in-progress | suspended | stopped | completed | entered-in-error -->
 <category><!-- 0..* CodeableConcept Classifications for the study --></category>
 <focus><!-- 0..* CodeableConcept Drugs, devices, conditions, etc. under study --></focus>
 <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>
 <jurisdiction><!-- 0..* CodeableConcept Geographic region(s) for study --></jurisdiction>
 <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 responsible for the study --></sponsor>
 <principalInvestigator><!-- 0..1 Reference(Practitioner) The individual responsible for the study --></principalInvestigator>
 <site><!-- 0..* Reference(Location) Location involved in study execution --></site>
 <reasonStopped><!-- 0..1 CodeableConcept Reason for terminating study early --></reasonStopped>
 <note><!-- 0..* Annotation Comments made about the event --></note>
 <arm>  <!-- 0..* Defined path through the study for a subject -->
  <name value="[string]"/><!-- 1..1 Label for study arm -->
  <code><!-- 0..1 CodeableConcept Categorization of study arm --></code>
  <description value="[string]"/><!-- 0..1 Short explanation of study path -->
 </arm>
</ResearchStudy>

JSON Template

{
  "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!  draft | in-progress | suspended | stopped | completed | entered-in-error
  "category" : [{ CodeableConcept }], // Classifications for the study
  "focus" : [{ CodeableConcept }], // Drugs, devices, conditions, etc. under study
  "contact" : [{ ContactDetail }], // Contact details for the study
  "relatedArtifact" : [{ RelatedArtifact }], // References and dependencies
  "keyword" : [{ CodeableConcept }], // Used to search for the study
  "jurisdiction" : [{ 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 responsible for the study
  "principalInvestigator" : { Reference(Practitioner) }, // The individual responsible for the study
  "site" : [{ Reference(Location) }], // Location involved in study execution
  "reasonStopped" : { CodeableConcept }, // Reason for terminating study early
  "note" : [{ Annotation }], // Comments made about the event
  "arm" : [{ // Defined path through the study for a subject
    "name" : "<string>", // R!  Label for study arm
    "code" : { CodeableConcept }, // Categorization of study arm
    "description" : "<string>" // Short explanation of study path
  }]
}

Turtle Template

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


[ 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 draft | in-progress | suspended | stopped | completed | entered-in-error
  fhir:ResearchStudy.category [ CodeableConcept ], ... ; # 0..* Classifications for the study
  fhir:ResearchStudy.focus [ CodeableConcept ], ... ; # 0..* Drugs, devices, conditions, etc. under study
  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.jurisdiction [ 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 responsible for the study
  fhir:ResearchStudy.principalInvestigator [ Reference(Practitioner) ]; # 0..1 The individual responsible for the study
  fhir:ResearchStudy.site [ Reference(Location) ], ... ; # 0..* Location involved in study execution
  fhir:ResearchStudy.reasonStopped [ CodeableConcept ]; # 0..1 Reason for terminating study early
  fhir:ResearchStudy.note [ Annotation ], ... ; # 0..* Comments made about the event
  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.code [ CodeableConcept ]; # 0..1 Categorization of study arm
    fhir:ResearchStudy.arm.description [ string ]; # 0..1 Short explanation of study path
  ], ...;
]

Changes since DSTU2

This resource did not exist in Release 2

This analysis is available as XML or JSON.

Alternate definitions: Master Definition (XML, JSON), XML Schema/Schematron (for ) + JSON Schema, ShEx (for Turtle)

8.22.2.1 Terminology Bindings

Path	Definition	Type	Reference
ResearchStudy.status	Codes that convey the current status of the research study	Required	ResearchStudyStatus
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, conditions and other interventions	Unknown	No details provided yet
ResearchStudy.keyword	Words associated with the study that may be useful in discovery	Unknown	No details provided yet
ResearchStudy.jurisdiction	Countries and regions within which this artifact is targeted for use	Extensible	Jurisdiction ValueSet

Path

Definition

Type

Reference

ResearchStudy.status

Codes that convey the current status of the research study

Required

ResearchStudyStatus

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, conditions and other interventions

Unknown

No details provided yet

ResearchStudy.keyword

Words associated with the study that may be useful in discovery

Unknown

No details provided yet

ResearchStudy.jurisdiction

Countries and regions within which this artifact is targeted for use

Extensible

Jurisdiction ValueSet

8.22.3 Search Parameters

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, conditions, etc. under study	ResearchStudy.focus
identifier	token	Business Identifier for study	ResearchStudy.identifier
jurisdiction	token	Geographic region(s) for study	ResearchStudy.jurisdiction
keyword	token	Used to search for the study	ResearchStudy.keyword
partof	reference	Part of larger study	ResearchStudy.partOf (ResearchStudy)
principalinvestigator	reference	The individual responsible for the study	ResearchStudy.principalInvestigator (Practitioner)
protocol	reference	Steps followed in executing study	ResearchStudy.protocol (PlanDefinition)
site	reference	Location involved in study execution	ResearchStudy.site (Location)
sponsor	reference	Organization responsible for the study	ResearchStudy.sponsor (Organization)
status	token	draft \| in-progress \| suspended \| stopped \| completed \| entered-in-error	ResearchStudy.status
title	string	Name for this study	ResearchStudy.title