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8.22 Resource ResearchStudy - Content

Biomedical Research and Regulation icon Work GroupMaturity Level: 0 Trial UseSecurity Category: Business Compartments: Not linked to any defined compartments

A scientific study of nature that sometimes includes processes involved in health and disease. For example, clinical trials are research studies that involve people. These studies may be related to new ways to screen, prevent, diagnose, and treat disease. They may also study certain outcomes and certain groups of people by looking at data collected in the past or future.

Note to Balloters: Ballot Questions: In terms of scope and usage, the BR&R workgroup wish to draw the attention of reviewers and implementers to the following topics:

  1. The resource has been refined and revised to remove duplication in few areas. We are seeking input from the community on the appropriateness of these changes.
  2. One major topic that the WG has discussed is the scope of this resource. One proposal under consideration is that the ResearchStudy resource would be a base resource that supports all kinds of research. Use case specific profiles would be developed in the near future to support a) Regulated Clinical Trial Profile, b) Basic Research Study Profile, etc. Below is an illustration of the proposal under consideration.
    Image showing the relationship between resources representing people
  3. WG seeks input in how research study sites should be represented in FHIR. There are two proposals under consideration. Option 1: Develop a ResearchStudySite Profile of ResearchStudy resource, Option 2: Develop a NEW FHIR resource called ResearchStudySite. For now, the WG is doing analysis to see if the profile option (Option 1) would work. All input is welcome.

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

A process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge. This includes studies of safety, efficacy, comparative effectiveness and other information about medications, devices, therapies and other interventional and investigative techniques. A ResearchStudy involves the gathering of information about human or animal subjects or stability data about drug products or drug substances.

For clinical trials -- 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
  • Specifying Study information in support of Genomic, Proteomic and Stability studies

ResearchStudy is aimed at all forms of studies. For some study types specific extensions have been defined

Extension: SiteRecruitment

Some studies need to find sites according to specific criteria - for example site has a freezer capable of very low temperatures and a centrifuge.

Extension: StudyRegistration

Used to separate study registration activities from study progress status.

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
... url 0..1uriCanonical identifier for this study resource
... identifier Σ0..*IdentifierBusiness Identifier for study

... version 0..1stringThe business version for the study record
... name 0..1stringName for this study (computer friendly)
... title Σ0..1stringHuman readable name of the study
... label 0..*BackboneElementAdditional names for the study

.... type 0..1CodeableConceptprimary | official | scientific | plain-language | subtitle | short-title | acronym | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid
TitleType (Extensible)
.... value 0..1stringThe name
... protocol Σ0..*Reference(PlanDefinition)Steps followed in executing study

... partOf Σ0..*Reference(ResearchStudy)Part of larger study

... relatedArtifact 0..*RelatedArtifactReferences and dependencies

... date 0..1dateTimeDate the resource last changed
... status ?!Σ1..1codedraft | active | retired | unknown
PublicationStatus (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)
... studyDesign Σ0..*CodeableConceptClassifications of the study design characteristics
Study Design (Preferred)

... focus 0..*BackboneElementDrugs, devices, etc. under study

.... productCode Σ0..1CodeableConceptIdentification of product under study
ResearchStudyFocus (Example)
.... focusType 0..*CodeableConceptmedication | device | intervention | factor
ResearchStudyFocusType (Extensible)

.... factor 0..1markdownAn independent variable manipulated by the experimentalist
... condition Σ0..*CodeableConceptCondition being studied
Condition/Problem/Diagnosis Codes (Example)

... keyword Σ0..*CodeableConceptUsed to search for the study
ResearchStudyKeyword (Example)

... region Σ0..*CodeableConceptGeographic area for the study
Jurisdiction ValueSet (Extensible)

... descriptionSummary 0..1markdownBrief text explaining the study
... description 0..1markdownDetailed narrative of the study
... period Σ0..1PeriodWhen the study began and ended
... site Σ0..*Reference(Location | ResearchStudy | Organization)Facility where study activities are conducted

... note 0..*AnnotationComments made about the study

... classifier 0..*CodeableConceptClassification for the study
Research Study Classifiers (Example)

... associatedParty 0..*BackboneElementSponsors, collaborators, and other parties

.... name 0..1stringName of associated party
.... role 1..1CodeableConceptsponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-director | study-chair
Research Study Party Role (Extensible)
.... period 0..*PeriodWhen active in the role

.... classifier 0..*CodeableConceptnih | fda | government | nonprofit | academic | industry
Research Study Party Organization Type (Example)

.... party 0..1Reference(Practitioner | PractitionerRole | Organization)Individual or organization associated with study (use practitionerRole to specify their organisation)
... progressStatus 0..*BackboneElementStatus of study with time for that status

.... state 1..1CodeableConceptLabel for status or state (e.g. recruitment status)
ResearchStudyStatus (Extensible)
.... actual 0..1booleanActual if true else anticipated
.... period 0..1PeriodDate range
... whyStopped Σ0..1CodeableConceptaccrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
ResearchStudyReasonStopped (Example)
... recruitment Σ0..1BackboneElementTarget or actual group of participants enrolled in study
.... targetNumber 0..1unsignedIntEstimated total number of participants to be enrolled
.... actualNumber 0..1unsignedIntActual total number of participants enrolled in study
.... eligibility 0..1Reference(Group | EvidenceVariable)Inclusion and exclusion criteria
.... actualGroup Σ0..1Reference(Group)Group of participants who were enrolled in study
... comparisonGroup 0..*BackboneElementDefined path through the study for a subject

.... identifier[x] 0..1Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily
..... identifierUriuri
..... identifierIdentifierIdentifier
.... name 1..1stringLabel for study comparisonGroup
.... type 0..1CodeableConceptCategorization of study comparisonGroup
ResearchStudyArmType (Extensible)
.... description 0..1markdownShort explanation of study path
.... intendedExposure 0..*Reference(EvidenceVariable)Interventions or exposures in this comparisonGroup or cohort

.... observedGroup 0..1Reference(Group)Group of participants who were enrolled in study comparisonGroup
... objective 0..*BackboneElementA goal for the study

.... name 0..1stringLabel for the objective
.... type 0..1CodeableConceptprimary | secondary | exploratory
ResearchStudyObjectiveType (Preferred)
.... description 0..1markdownDescription of the objective
... outcomeMeasure 0..*BackboneElementAn outcome or planned variable to measure during the study

.... name 0..1stringLabel for the outcome
.... type 0..*CodeableConceptprimary | secondary | exploratory
ResearchStudyObjectiveType (Preferred)

.... description 0..1markdownDescription of the outcome
.... reference 0..1Reference(EvidenceVariable)Structured outcome definition
... result Σ0..*Reference(EvidenceReport | Citation | DiagnosticReport)Link to results generated during the study

... webLocation 0..*BackboneElementArchive location for the study

.... classifier 0..1CodeableConceptregistry-page|recruitment-page|contact-page
ArtifactUrlClassifier (Example)
.... url 1..1uriThe location address

doco Documentation for this format

See the Extensions for this resource

UML Diagram (Legend)

ResearchStudy (DomainResource)Canonical identifier for this study resource, represented as a globally unique URIurl : uri [0..1]Identifiers assigned to this research study by the sponsor or other systemsidentifier : Identifier [0..*]The business version for the study recordversion : string [0..1]Name for this study (computer friendly)name : string [0..1]The human readable name of the research 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 »Citations, references and other related documentsrelatedArtifact : RelatedArtifact [0..*]The date (and optionally time) when the ResearchStudy Resource was published. The date must change when the business version changes and it must change if the status code changes. In addition, it should change when the substantive content of the ResearchStudy Resource changesdate : dateTime [0..1]The publication state of the resource (not of the study) (this element modifies the meaning of other elements)status : code [1..1] « null (Strength=Required)PublicationStatus! »The type of study based upon the intent of the study activities. A classification of the intent of the studyprimaryPurposeType : CodeableConcept [0..1] « null (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] « null (Strength=Example)ResearchStudyPhase?? »Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etcstudyDesign : CodeableConcept [0..*] « null (Strength=Preferred)StudyDesign? »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..*] « null (Strength=Example)ConditionProblemDiagnosisCodes?? »Key terms to aid in searching for or filtering the studykeyword : CodeableConcept [0..*] « null (Strength=Example)ResearchStudyKeyword?? »A country, state or other area where the study is taking place rather than its precise geographic location or addressregion : CodeableConcept [0..*] « null (Strength=Extensible)JurisdictionValueSet+ »A brief text for explaining the studydescriptionSummary : markdown [0..1]A detailed and human-readable narrative of the study. E.g., study abstractdescription : markdown [0..1]Identifies the start date and the expected (or actual, depending on status) end date for the studyperiod : Period [0..1]A facility in which study activities are conductedsite : Reference [0..*] « Location|ResearchStudy|Organization »Comments made about the study by the performer, subject or other participantsnote : Annotation [0..*]Additional grouping mechanism or categorization of a research study. Example: FDA regulated device, FDA regulated drug, MPG Paragraph 23b (a German legal requirement), IRB-exempt, etc. Implementation Note: do not use the classifier element to support existing semantics that are already supported thru explicit elements in the resourceclassifier : CodeableConcept [0..*] « null (Strength=Example)ResearchStudyClassifiers?? »A description and/or code explaining the premature termination of the studywhyStopped : CodeableConcept [0..1] « null (Strength=Example)ResearchStudyReasonStopped?? »Link to one or more sets of results generated by the study. Could also link to a research registry holding the results such as ClinicalTrials.govresult : Reference [0..*] « EvidenceReport|Citation|DiagnosticReport »LabelKind of nametype : CodeableConcept [0..1] « null (Strength=Extensible)TitleType+ »The namevalue : string [0..1]FocusIdentification of product under study. This may be any combination of code and/or nameproductCode : CodeableConcept [0..1] « null (Strength=Example)ResearchStudyFocus?? »Indicates whether the focus is a medication, a device, a procedure, a specific factor or some other intervention or characteristicfocusType : CodeableConcept [0..*] « null (Strength=Extensible)ResearchStudyFocusType+ »A factor corresponds to an independent variable manipulated by the experimentalist with the intention to affect biological systems in a way that can be measured by an assayfactor : markdown [0..1]AssociatedPartyName of associated partyname : string [0..1]Type of associationrole : CodeableConcept [1..1] « null (Strength=Extensible)ResearchStudyPartyRole+ »Identifies the start date and the end date of the associated party in the roleperiod : Period [0..*]A categorization other than role for the associated partyclassifier : CodeableConcept [0..*] « null (Strength=Example)ResearchStudyPartyOrgType?? »Individual or organization associated with study (use practitionerRole to specify their organisation)party : Reference [0..1] « Practitioner|PractitionerRole| Organization »ProgressStatusLabel for status or state (e.g. recruitment status)state : CodeableConcept [1..1] « null (Strength=Extensible)ResearchStudyStatus+ »An indication of whether or not the date is a known date when the state changed or will change. A value of true indicates a known date. A value of false indicates an estimated dateactual : boolean [0..1]Date rangeperiod : Period [0..1]RecruitmentEstimated total number of participants to be enrolledtargetNumber : unsignedInt [0..1]Actual total number of participants enrolled in studyactualNumber : unsignedInt [0..1]Inclusion and exclusion criteriaeligibility : Reference [0..1] « Group|EvidenceVariable »Group of participants who were enrolled in studyactualGroup : Reference [0..1] « Group »ComparisonGroupAllows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easilyidentifier[x] : DataType [0..1] « uri|Identifier »Unique, human-readable label for this comparisonGroup of the studyname : string [1..1]Categorization of study comparisonGroup, e.g. experimental, active comparator, placebo comparatertype : CodeableConcept [0..1] « null (Strength=Extensible)ResearchStudyArmType+ »A succinct description of the path through the study that would be followed by a subject adhering to this comparisonGroupdescription : markdown [0..1]Interventions or exposures in this comparisonGroup or cohortintendedExposure : Reference [0..*] « EvidenceVariable »Group of participants who were enrolled in study comparisonGroupobservedGroup : Reference [0..1] « Group »ObjectiveUnique, human-readable label for this objective of the studyname : string [0..1]The kind of study objectivetype : CodeableConcept [0..1] « null (Strength=Preferred)ResearchStudyObjectiveType? »Free text description of the objective of the study. This is what the study is trying to achieve rather than how it is going to achieve it (see ResearchStudy.description)description : markdown [0..1]OutcomeMeasureLabel for the outcomename : string [0..1]The parameter or characteristic being assessed as one of the values by which the study is assessedtype : CodeableConcept [0..*] « null (Strength=Preferred)ResearchStudyObjectiveType? »Description of the outcomedescription : markdown [0..1]Structured outcome definitionreference : Reference [0..1] « EvidenceVariable »WebLocationDescribes the nature of the location being specifiedclassifier : CodeableConcept [0..1] « null (Strength=Example)ArtifactUrlClassifier?? »The location addressurl : uri [1..1]Additional names for the studylabel[0..*]The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information aboutfocus[0..*]Sponsors, collaborators, and other partiesassociatedParty[0..*]Status of study with time for that statusprogressStatus[0..*]Target or actual group of participants enrolled in studyrecruitment[0..1]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-upcomparisonGroup[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..*]An outcome or planned variable to measure during the studyoutcomeMeasure[0..*]A general storage or archive location for the study. This may contain an assortment of content which is not specified in advancewebLocation[0..*]

XML Template

<ResearchStudy xmlns="http://hl7.org/fhir"> doco
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <url value="[uri]"/><!-- 0..1 Canonical identifier for this study resource -->
 <identifier><!-- 0..* Identifier Business Identifier for study --></identifier>
 <version value="[string]"/><!-- 0..1 The business version for the study record -->
 <name value="[string]"/><!-- 0..1 Name for this study (computer friendly) -->
 <title value="[string]"/><!-- 0..1 Human readable name of the study -->
 <label>  <!-- 0..* Additional names for the study -->
  <type><!-- 0..1 CodeableConcept primary | official | scientific | plain-language | subtitle | short-title | acronym | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid --></type>
  <value value="[string]"/><!-- 0..1 The name -->
 </label>
 <protocol><!-- 0..* Reference(PlanDefinition) Steps followed in executing study --></protocol>
 <partOf><!-- 0..* Reference(ResearchStudy) Part of larger study --></partOf>
 <relatedArtifact><!-- 0..* RelatedArtifact References and dependencies --></relatedArtifact>
 <date value="[dateTime]"/><!-- 0..1 Date the resource last changed -->
 <status value="[code]"/><!-- 1..1 draft | active | retired | unknown -->
 <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>
 <studyDesign><!-- 0..* CodeableConcept Classifications of the study design characteristics --></studyDesign>
 <focus>  <!-- 0..* Drugs, devices, etc. under study -->
  <productCode><!-- 0..1 CodeableConcept Identification of product under study --></productCode>
  <focusType><!-- 0..* CodeableConcept medication | device | intervention | factor --></focusType>
  <factor value="[markdown]"/><!-- 0..1 An independent variable manipulated by the experimentalist -->
 </focus>
 <condition><!-- 0..* CodeableConcept Condition being studied --></condition>
 <keyword><!-- 0..* CodeableConcept Used to search for the study --></keyword>
 <region><!-- 0..* CodeableConcept Geographic area for the study --></region>
 <descriptionSummary value="[markdown]"/><!-- 0..1 Brief text explaining the study -->
 <description value="[markdown]"/><!-- 0..1 Detailed narrative of the study -->
 <period><!-- 0..1 Period When the study began and ended --></period>
 <site><!-- 0..* Reference(Location|Organization|ResearchStudy) Facility where study activities are conducted --></site>
 <note><!-- 0..* Annotation Comments made about the study --></note>
 <classifier><!-- 0..* CodeableConcept Classification for the study --></classifier>
 <associatedParty>  <!-- 0..* Sponsors, collaborators, and other parties -->
  <name value="[string]"/><!-- 0..1 Name of associated party -->
  <role><!-- 1..1 CodeableConcept sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-director | study-chair --></role>
  <period><!-- 0..* Period When active in the role --></period>
  <classifier><!-- 0..* CodeableConcept nih | fda | government | nonprofit | academic | industry --></classifier>
  <party><!-- 0..1 Reference(Organization|Practitioner|PractitionerRole) Individual or organization associated with study (use practitionerRole to specify their organisation) --></party>
 </associatedParty>
 <progressStatus>  <!-- 0..* Status of study with time for that status -->
  <state><!-- 1..1 CodeableConcept Label for status or state (e.g. recruitment status) --></state>
  <actual value="[boolean]"/><!-- 0..1 Actual if true else anticipated -->
  <period><!-- 0..1 Period Date range --></period>
 </progressStatus>
 <whyStopped><!-- 0..1 CodeableConcept accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design --></whyStopped>
 <recruitment>  <!-- 0..1 Target or actual group of participants enrolled in study -->
  <targetNumber value="[unsignedInt]"/><!-- 0..1 Estimated total number of participants to be enrolled -->
  <actualNumber value="[unsignedInt]"/><!-- 0..1 Actual total number of participants enrolled in study -->
  <eligibility><!-- 0..1 Reference(EvidenceVariable|Group) Inclusion and exclusion criteria --></eligibility>
  <actualGroup><!-- 0..1 Reference(Group) Group of participants who were enrolled in study --></actualGroup>
 </recruitment>
 <comparisonGroup>  <!-- 0..* Defined path through the study for a subject -->
  <identifier[x]><!-- 0..1 uri|Identifier Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily --></identifier[x]>
  <name value="[string]"/><!-- 1..1 Label for study comparisonGroup -->
  <type><!-- 0..1 CodeableConcept Categorization of study comparisonGroup --></type>
  <description value="[markdown]"/><!-- 0..1 Short explanation of study path -->
  <intendedExposure><!-- 0..* Reference(EvidenceVariable) Interventions or exposures in this comparisonGroup or cohort --></intendedExposure>
  <observedGroup><!-- 0..1 Reference(Group) Group of participants who were enrolled in study comparisonGroup --></observedGroup>
 </comparisonGroup>
 <objective>  <!-- 0..* A goal for the study -->
  <name value="[string]"/><!-- 0..1 Label for the objective -->
  <type><!-- 0..1 CodeableConcept primary | secondary | exploratory --></type>
  <description value="[markdown]"/><!-- 0..1 Description of the objective -->
 </objective>
 <outcomeMeasure>  <!-- 0..* An outcome or planned variable to measure during the study -->
  <name value="[string]"/><!-- 0..1 Label for the outcome -->
  <type><!-- 0..* CodeableConcept primary | secondary | exploratory --></type>
  <description value="[markdown]"/><!-- 0..1 Description of the outcome -->
  <reference><!-- 0..1 Reference(EvidenceVariable) Structured outcome definition --></reference>
 </outcomeMeasure>
 <result><!-- 0..* Reference(Citation|DiagnosticReport|EvidenceReport) Link to results generated during the study --></result>
 <webLocation>  <!-- 0..* Archive location for the study -->
  <classifier><!-- 0..1 CodeableConcept registry-page|recruitment-page|contact-page --></classifier>
  <url value="[uri]"/><!-- 1..1 The location address -->
 </webLocation>
</ResearchStudy>

JSON Template

{doco
  "resourceType" : "ResearchStudy",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "url" : "<uri>", // Canonical identifier for this study resource
  "identifier" : [{ Identifier }], // Business Identifier for study
  "version" : "<string>", // The business version for the study record
  "name" : "<string>", // Name for this study (computer friendly)
  "title" : "<string>", // Human readable name of the study
  "label" : [{ // Additional names for the study
    "type" : { CodeableConcept }, // primary | official | scientific | plain-language | subtitle | short-title | acronym | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid
    "value" : "<string>" // The name
  }],
  "protocol" : [{ Reference(PlanDefinition) }], // Steps followed in executing study
  "partOf" : [{ Reference(ResearchStudy) }], // Part of larger study
  "relatedArtifact" : [{ RelatedArtifact }], // References and dependencies
  "date" : "<dateTime>", // Date the resource last changed
  "status" : "<code>", // R!  draft | active | retired | unknown
  "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
  "studyDesign" : [{ CodeableConcept }], // Classifications of the study design characteristics
  "focus" : [{ // Drugs, devices, etc. under study
    "productCode" : { CodeableConcept }, // Identification of product under study
    "focusType" : [{ CodeableConcept }], // medication | device | intervention | factor
    "factor" : "<markdown>" // An independent variable manipulated by the experimentalist
  }],
  "condition" : [{ CodeableConcept }], // Condition being studied
  "keyword" : [{ CodeableConcept }], // Used to search for the study
  "region" : [{ CodeableConcept }], // Geographic area for the study
  "descriptionSummary" : "<markdown>", // Brief text explaining the study
  "description" : "<markdown>", // Detailed narrative of the study
  "period" : { Period }, // When the study began and ended
  "site" : [{ Reference(Location|Organization|ResearchStudy) }], // Facility where study activities are conducted
  "note" : [{ Annotation }], // Comments made about the study
  "classifier" : [{ CodeableConcept }], // Classification for the study
  "associatedParty" : [{ // Sponsors, collaborators, and other parties
    "name" : "<string>", // Name of associated party
    "role" : { CodeableConcept }, // R!  sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-director | study-chair
    "period" : [{ Period }], // When active in the role
    "classifier" : [{ CodeableConcept }], // nih | fda | government | nonprofit | academic | industry
    "party" : { Reference(Organization|Practitioner|PractitionerRole) } // Individual or organization associated with study (use practitionerRole to specify their organisation)
  }],
  "progressStatus" : [{ // Status of study with time for that status
    "state" : { CodeableConcept }, // R!  Label for status or state (e.g. recruitment status)
    "actual" : <boolean>, // Actual if true else anticipated
    "period" : { Period } // Date range
  }],
  "whyStopped" : { CodeableConcept }, // accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
  "recruitment" : { // Target or actual group of participants enrolled in study
    "targetNumber" : "<unsignedInt>", // Estimated total number of participants to be enrolled
    "actualNumber" : "<unsignedInt>", // Actual total number of participants enrolled in study
    "eligibility" : { Reference(EvidenceVariable|Group) }, // Inclusion and exclusion criteria
    "actualGroup" : { Reference(Group) } // Group of participants who were enrolled in study
  },
  "comparisonGroup" : [{ // Defined path through the study for a subject
    // identifier[x]: 
      Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily. One of these 2:
    "identifierUri" : "<uri>",
    "identifierIdentifier" : { Identifier },
    "name" : "<string>", // R!  Label for study comparisonGroup
    "type" : { CodeableConcept }, // Categorization of study comparisonGroup
    "description" : "<markdown>", // Short explanation of study path
    "intendedExposure" : [{ Reference(EvidenceVariable) }], // Interventions or exposures in this comparisonGroup or cohort
    "observedGroup" : { Reference(Group) } // Group of participants who were enrolled in study comparisonGroup
  }],
  "objective" : [{ // A goal for the study
    "name" : "<string>", // Label for the objective
    "type" : { CodeableConcept }, // primary | secondary | exploratory
    "description" : "<markdown>" // Description of the objective
  }],
  "outcomeMeasure" : [{ // An outcome or planned variable to measure during the study
    "name" : "<string>", // Label for the outcome
    "type" : [{ CodeableConcept }], // primary | secondary | exploratory
    "description" : "<markdown>", // Description of the outcome
    "reference" : { Reference(EvidenceVariable) } // Structured outcome definition
  }],
  "result" : [{ Reference(Citation|DiagnosticReport|EvidenceReport) }], // Link to results generated during the study
  "webLocation" : [{ // Archive location for the study
    "classifier" : { CodeableConcept }, // registry-page|recruitment-page|contact-page
    "url" : "<uri>" // R!  The location address
  }]
}

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.url [ uri ]; # 0..1 Canonical identifier for this study resource
  fhir:ResearchStudy.identifier [ Identifier ], ... ; # 0..* Business Identifier for study
  fhir:ResearchStudy.version [ string ]; # 0..1 The business version for the study record
  fhir:ResearchStudy.name [ string ]; # 0..1 Name for this study (computer friendly)
  fhir:ResearchStudy.title [ string ]; # 0..1 Human readable name of the study
  fhir:ResearchStudy.label [ # 0..* Additional names for the study
    fhir:ResearchStudy.label.type [ CodeableConcept ]; # 0..1 primary | official | scientific | plain-language | subtitle | short-title | acronym | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid
    fhir:ResearchStudy.label.value [ string ]; # 0..1 The name
  ], ...;
  fhir:ResearchStudy.protocol [ Reference(PlanDefinition) ], ... ; # 0..* Steps followed in executing study
  fhir:ResearchStudy.partOf [ Reference(ResearchStudy) ], ... ; # 0..* Part of larger study
  fhir:ResearchStudy.relatedArtifact [ RelatedArtifact ], ... ; # 0..* References and dependencies
  fhir:ResearchStudy.date [ dateTime ]; # 0..1 Date the resource last changed
  fhir:ResearchStudy.status [ code ]; # 1..1 draft | active | retired | unknown
  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.studyDesign [ CodeableConcept ], ... ; # 0..* Classifications of the study design characteristics
  fhir:ResearchStudy.focus [ # 0..* Drugs, devices, etc. under study
    fhir:ResearchStudy.focus.productCode [ CodeableConcept ]; # 0..1 Identification of product under study
    fhir:ResearchStudy.focus.focusType [ CodeableConcept ], ... ; # 0..* medication | device | intervention | factor
    fhir:ResearchStudy.focus.factor [ markdown ]; # 0..1 An independent variable manipulated by the experimentalist
  ], ...;
  fhir:ResearchStudy.condition [ CodeableConcept ], ... ; # 0..* Condition being studied
  fhir:ResearchStudy.keyword [ CodeableConcept ], ... ; # 0..* Used to search for the study
  fhir:ResearchStudy.region [ CodeableConcept ], ... ; # 0..* Geographic area for the study
  fhir:ResearchStudy.descriptionSummary [ markdown ]; # 0..1 Brief text explaining the study
  fhir:ResearchStudy.description [ markdown ]; # 0..1 Detailed narrative of the study
  fhir:ResearchStudy.period [ Period ]; # 0..1 When the study began and ended
  fhir:ResearchStudy.site [ Reference(Location|Organization|ResearchStudy) ], ... ; # 0..* Facility where study activities are conducted
  fhir:ResearchStudy.note [ Annotation ], ... ; # 0..* Comments made about the study
  fhir:ResearchStudy.classifier [ CodeableConcept ], ... ; # 0..* Classification for the study
  fhir:ResearchStudy.associatedParty [ # 0..* Sponsors, collaborators, and other parties
    fhir:ResearchStudy.associatedParty.name [ string ]; # 0..1 Name of associated party
    fhir:ResearchStudy.associatedParty.role [ CodeableConcept ]; # 1..1 sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-director | study-chair
    fhir:ResearchStudy.associatedParty.period [ Period ], ... ; # 0..* When active in the role
    fhir:ResearchStudy.associatedParty.classifier [ CodeableConcept ], ... ; # 0..* nih | fda | government | nonprofit | academic | industry
    fhir:ResearchStudy.associatedParty.party [ Reference(Organization|Practitioner|PractitionerRole) ]; # 0..1 Individual or organization associated with study (use practitionerRole to specify their organisation)
  ], ...;
  fhir:ResearchStudy.progressStatus [ # 0..* Status of study with time for that status
    fhir:ResearchStudy.progressStatus.state [ CodeableConcept ]; # 1..1 Label for status or state (e.g. recruitment status)
    fhir:ResearchStudy.progressStatus.actual [ boolean ]; # 0..1 Actual if true else anticipated
    fhir:ResearchStudy.progressStatus.period [ Period ]; # 0..1 Date range
  ], ...;
  fhir:ResearchStudy.whyStopped [ CodeableConcept ]; # 0..1 accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
  fhir:ResearchStudy.recruitment [ # 0..1 Target or actual group of participants enrolled in study
    fhir:ResearchStudy.recruitment.targetNumber [ unsignedInt ]; # 0..1 Estimated total number of participants to be enrolled
    fhir:ResearchStudy.recruitment.actualNumber [ unsignedInt ]; # 0..1 Actual total number of participants enrolled in study
    fhir:ResearchStudy.recruitment.eligibility [ Reference(EvidenceVariable|Group) ]; # 0..1 Inclusion and exclusion criteria
    fhir:ResearchStudy.recruitment.actualGroup [ Reference(Group) ]; # 0..1 Group of participants who were enrolled in study
  ];
  fhir:ResearchStudy.comparisonGroup [ # 0..* Defined path through the study for a subject
    # ResearchStudy.comparisonGroup.identifier[x] : 0..1 Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily. One of these 2
      fhir:ResearchStudy.comparisonGroup.identifierUri [ uri ]
      fhir:ResearchStudy.comparisonGroup.identifierIdentifier [ Identifier ]
    fhir:ResearchStudy.comparisonGroup.name [ string ]; # 1..1 Label for study comparisonGroup
    fhir:ResearchStudy.comparisonGroup.type [ CodeableConcept ]; # 0..1 Categorization of study comparisonGroup
    fhir:ResearchStudy.comparisonGroup.description [ markdown ]; # 0..1 Short explanation of study path
    fhir:ResearchStudy.comparisonGroup.intendedExposure [ Reference(EvidenceVariable) ], ... ; # 0..* Interventions or exposures in this comparisonGroup or cohort
    fhir:ResearchStudy.comparisonGroup.observedGroup [ Reference(Group) ]; # 0..1 Group of participants who were enrolled in study comparisonGroup
  ], ...;
  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
    fhir:ResearchStudy.objective.description [ markdown ]; # 0..1 Description of the objective
  ], ...;
  fhir:ResearchStudy.outcomeMeasure [ # 0..* An outcome or planned variable to measure during the study
    fhir:ResearchStudy.outcomeMeasure.name [ string ]; # 0..1 Label for the outcome
    fhir:ResearchStudy.outcomeMeasure.type [ CodeableConcept ], ... ; # 0..* primary | secondary | exploratory
    fhir:ResearchStudy.outcomeMeasure.description [ markdown ]; # 0..1 Description of the outcome
    fhir:ResearchStudy.outcomeMeasure.reference [ Reference(EvidenceVariable) ]; # 0..1 Structured outcome definition
  ], ...;
  fhir:ResearchStudy.result [ Reference(Citation|DiagnosticReport|EvidenceReport) ], ... ; # 0..* Link to results generated during the study
  fhir:ResearchStudy.webLocation [ # 0..* Archive location for the study
    fhir:ResearchStudy.webLocation.classifier [ CodeableConcept ]; # 0..1 registry-page|recruitment-page|contact-page
    fhir:ResearchStudy.webLocation.url [ uri ]; # 1..1 The location address
  ], ...;
]

Changes since R4

ResearchStudy
ResearchStudy.url
  • Added Element
ResearchStudy.version
  • Added Element
ResearchStudy.name
  • Added Element
ResearchStudy.label
  • Added Element
ResearchStudy.label.type
  • Added Element
ResearchStudy.label.value
  • Added Element
ResearchStudy.date
  • Added Element
ResearchStudy.status
  • Change value set from http://hl7.org/fhir/ValueSet/research-study-status|4.0.0 to http://hl7.org/fhir/ValueSet/publication-status|5.0.0-cibuild
  • Change value set from http://hl7.org/fhir/ValueSet/research-study-status|4.0.0 to http://hl7.org/fhir/ValueSet/publication-status|5.0.0-cibuild
ResearchStudy.primaryPurposeType
  • Change code system for extensibly bound codes from "http://terminology.hl7.org/CodeSystem/research-study-prim-purp-type" to "http://hl7.org/fhir/research-study-classifiers"
  • Change code system for extensibly bound codes from "http://terminology.hl7.org/CodeSystem/research-study-prim-purp-type" to "http://hl7.org/fhir/research-study-classifiers"
ResearchStudy.studyDesign
  • Added Element
ResearchStudy.focus
  • Type changed from CodeableConcept to BackboneElement
  • Type changed from CodeableConcept to BackboneElement
ResearchStudy.focus.productCode
  • Added Element
ResearchStudy.focus.focusType
  • Added Element
ResearchStudy.focus.factor
  • Added Element
ResearchStudy.region
  • Added Element
ResearchStudy.descriptionSummary
  • Added Element
ResearchStudy.site
  • Type Reference: Added Target Types ResearchStudy, Organization
  • Type Reference: Added Target Types ResearchStudy, Organization
ResearchStudy.classifier
  • Added Element
ResearchStudy.associatedParty
  • Added Element
ResearchStudy.associatedParty.name
  • Added Element
ResearchStudy.associatedParty.role
  • Added Mandatory Element
ResearchStudy.associatedParty.period
  • Added Element
ResearchStudy.associatedParty.classifier
  • Added Element
ResearchStudy.associatedParty.party
  • Added Element
ResearchStudy.progressStatus
  • Added Element
ResearchStudy.progressStatus.state
  • Added Mandatory Element
ResearchStudy.progressStatus.actual
  • Added Element
ResearchStudy.progressStatus.period
  • Added Element
ResearchStudy.whyStopped
  • Added Element
ResearchStudy.recruitment
  • Added Element
ResearchStudy.recruitment.targetNumber
  • Added Element
ResearchStudy.recruitment.actualNumber
  • Added Element
ResearchStudy.recruitment.eligibility
  • Added Element
ResearchStudy.recruitment.actualGroup
  • Added Element
ResearchStudy.comparisonGroup
  • Added Element
ResearchStudy.comparisonGroup.identifier[x]
  • Added Element
ResearchStudy.comparisonGroup.name
  • Added Mandatory Element
ResearchStudy.comparisonGroup.type
  • Added Element
ResearchStudy.comparisonGroup.description
  • Added Element
ResearchStudy.comparisonGroup.intendedExposure
  • Added Element
ResearchStudy.comparisonGroup.observedGroup
  • Added Element
ResearchStudy.objective.description
  • Added Element
ResearchStudy.outcomeMeasure
  • Added Element
ResearchStudy.outcomeMeasure.name
  • Added Element
ResearchStudy.outcomeMeasure.type
  • Added Element
ResearchStudy.outcomeMeasure.description
  • Added Element
ResearchStudy.outcomeMeasure.reference
  • Added Element
ResearchStudy.result
  • Added Element
ResearchStudy.webLocation
  • Added Element
ResearchStudy.webLocation.classifier
  • Added Element
ResearchStudy.webLocation.url
  • Added Mandatory Element
ResearchStudy.category
  • deleted
ResearchStudy.contact
  • deleted
ResearchStudy.location
  • deleted
ResearchStudy.enrollment
  • deleted
ResearchStudy.sponsor
  • deleted
ResearchStudy.principalInvestigator
  • deleted
ResearchStudy.reasonStopped
  • deleted
ResearchStudy.arm
  • deleted

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
... url 0..1uriCanonical identifier for this study resource
... identifier Σ0..*IdentifierBusiness Identifier for study

... version 0..1stringThe business version for the study record
... name 0..1stringName for this study (computer friendly)
... title Σ0..1stringHuman readable name of the study
... label 0..*BackboneElementAdditional names for the study

.... type 0..1CodeableConceptprimary | official | scientific | plain-language | subtitle | short-title | acronym | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid
TitleType (Extensible)
.... value 0..1stringThe name
... protocol Σ0..*Reference(PlanDefinition)Steps followed in executing study

... partOf Σ0..*Reference(ResearchStudy)Part of larger study

... relatedArtifact 0..*RelatedArtifactReferences and dependencies

... date 0..1dateTimeDate the resource last changed
... status ?!Σ1..1codedraft | active | retired | unknown
PublicationStatus (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)
... studyDesign Σ0..*CodeableConceptClassifications of the study design characteristics
Study Design (Preferred)

... focus 0..*BackboneElementDrugs, devices, etc. under study

.... productCode Σ0..1CodeableConceptIdentification of product under study
ResearchStudyFocus (Example)
.... focusType 0..*CodeableConceptmedication | device | intervention | factor
ResearchStudyFocusType (Extensible)

.... factor 0..1markdownAn independent variable manipulated by the experimentalist
... condition Σ0..*CodeableConceptCondition being studied
Condition/Problem/Diagnosis Codes (Example)

... keyword Σ0..*CodeableConceptUsed to search for the study
ResearchStudyKeyword (Example)

... region Σ0..*CodeableConceptGeographic area for the study
Jurisdiction ValueSet (Extensible)

... descriptionSummary 0..1markdownBrief text explaining the study
... description 0..1markdownDetailed narrative of the study
... period Σ0..1PeriodWhen the study began and ended
... site Σ0..*Reference(Location | ResearchStudy | Organization)Facility where study activities are conducted

... note 0..*AnnotationComments made about the study

... classifier 0..*CodeableConceptClassification for the study
Research Study Classifiers (Example)

... associatedParty 0..*BackboneElementSponsors, collaborators, and other parties

.... name 0..1stringName of associated party
.... role 1..1CodeableConceptsponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-director | study-chair
Research Study Party Role (Extensible)
.... period 0..*PeriodWhen active in the role

.... classifier 0..*CodeableConceptnih | fda | government | nonprofit | academic | industry
Research Study Party Organization Type (Example)

.... party 0..1Reference(Practitioner | PractitionerRole | Organization)Individual or organization associated with study (use practitionerRole to specify their organisation)
... progressStatus 0..*BackboneElementStatus of study with time for that status

.... state 1..1CodeableConceptLabel for status or state (e.g. recruitment status)
ResearchStudyStatus (Extensible)
.... actual 0..1booleanActual if true else anticipated
.... period 0..1PeriodDate range
... whyStopped Σ0..1CodeableConceptaccrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
ResearchStudyReasonStopped (Example)
... recruitment Σ0..1BackboneElementTarget or actual group of participants enrolled in study
.... targetNumber 0..1unsignedIntEstimated total number of participants to be enrolled
.... actualNumber 0..1unsignedIntActual total number of participants enrolled in study
.... eligibility 0..1Reference(Group | EvidenceVariable)Inclusion and exclusion criteria
.... actualGroup Σ0..1Reference(Group)Group of participants who were enrolled in study
... comparisonGroup 0..*BackboneElementDefined path through the study for a subject

.... identifier[x] 0..1Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily
..... identifierUriuri
..... identifierIdentifierIdentifier
.... name 1..1stringLabel for study comparisonGroup
.... type 0..1CodeableConceptCategorization of study comparisonGroup
ResearchStudyArmType (Extensible)
.... description 0..1markdownShort explanation of study path
.... intendedExposure 0..*Reference(EvidenceVariable)Interventions or exposures in this comparisonGroup or cohort

.... observedGroup 0..1Reference(Group)Group of participants who were enrolled in study comparisonGroup
... objective 0..*BackboneElementA goal for the study

.... name 0..1stringLabel for the objective
.... type 0..1CodeableConceptprimary | secondary | exploratory
ResearchStudyObjectiveType (Preferred)
.... description 0..1markdownDescription of the objective
... outcomeMeasure 0..*BackboneElementAn outcome or planned variable to measure during the study

.... name 0..1stringLabel for the outcome
.... type 0..*CodeableConceptprimary | secondary | exploratory
ResearchStudyObjectiveType (Preferred)

.... description 0..1markdownDescription of the outcome
.... reference 0..1Reference(EvidenceVariable)Structured outcome definition
... result Σ0..*Reference(EvidenceReport | Citation | DiagnosticReport)Link to results generated during the study

... webLocation 0..*BackboneElementArchive location for the study

.... classifier 0..1CodeableConceptregistry-page|recruitment-page|contact-page
ArtifactUrlClassifier (Example)
.... url 1..1uriThe location address

doco Documentation for this format

See the Extensions for this resource

UML Diagram (Legend)

ResearchStudy (DomainResource)Canonical identifier for this study resource, represented as a globally unique URIurl : uri [0..1]Identifiers assigned to this research study by the sponsor or other systemsidentifier : Identifier [0..*]The business version for the study recordversion : string [0..1]Name for this study (computer friendly)name : string [0..1]The human readable name of the research 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 »Citations, references and other related documentsrelatedArtifact : RelatedArtifact [0..*]The date (and optionally time) when the ResearchStudy Resource was published. The date must change when the business version changes and it must change if the status code changes. In addition, it should change when the substantive content of the ResearchStudy Resource changesdate : dateTime [0..1]The publication state of the resource (not of the study) (this element modifies the meaning of other elements)status : code [1..1] « null (Strength=Required)PublicationStatus! »The type of study based upon the intent of the study activities. A classification of the intent of the studyprimaryPurposeType : CodeableConcept [0..1] « null (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] « null (Strength=Example)ResearchStudyPhase?? »Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etcstudyDesign : CodeableConcept [0..*] « null (Strength=Preferred)StudyDesign? »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..*] « null (Strength=Example)ConditionProblemDiagnosisCodes?? »Key terms to aid in searching for or filtering the studykeyword : CodeableConcept [0..*] « null (Strength=Example)ResearchStudyKeyword?? »A country, state or other area where the study is taking place rather than its precise geographic location or addressregion : CodeableConcept [0..*] « null (Strength=Extensible)JurisdictionValueSet+ »A brief text for explaining the studydescriptionSummary : markdown [0..1]A detailed and human-readable narrative of the study. E.g., study abstractdescription : markdown [0..1]Identifies the start date and the expected (or actual, depending on status) end date for the studyperiod : Period [0..1]A facility in which study activities are conductedsite : Reference [0..*] « Location|ResearchStudy|Organization »Comments made about the study by the performer, subject or other participantsnote : Annotation [0..*]Additional grouping mechanism or categorization of a research study. Example: FDA regulated device, FDA regulated drug, MPG Paragraph 23b (a German legal requirement), IRB-exempt, etc. Implementation Note: do not use the classifier element to support existing semantics that are already supported thru explicit elements in the resourceclassifier : CodeableConcept [0..*] « null (Strength=Example)ResearchStudyClassifiers?? »A description and/or code explaining the premature termination of the studywhyStopped : CodeableConcept [0..1] « null (Strength=Example)ResearchStudyReasonStopped?? »Link to one or more sets of results generated by the study. Could also link to a research registry holding the results such as ClinicalTrials.govresult : Reference [0..*] « EvidenceReport|Citation|DiagnosticReport »LabelKind of nametype : CodeableConcept [0..1] « null (Strength=Extensible)TitleType+ »The namevalue : string [0..1]FocusIdentification of product under study. This may be any combination of code and/or nameproductCode : CodeableConcept [0..1] « null (Strength=Example)ResearchStudyFocus?? »Indicates whether the focus is a medication, a device, a procedure, a specific factor or some other intervention or characteristicfocusType : CodeableConcept [0..*] « null (Strength=Extensible)ResearchStudyFocusType+ »A factor corresponds to an independent variable manipulated by the experimentalist with the intention to affect biological systems in a way that can be measured by an assayfactor : markdown [0..1]AssociatedPartyName of associated partyname : string [0..1]Type of associationrole : CodeableConcept [1..1] « null (Strength=Extensible)ResearchStudyPartyRole+ »Identifies the start date and the end date of the associated party in the roleperiod : Period [0..*]A categorization other than role for the associated partyclassifier : CodeableConcept [0..*] « null (Strength=Example)ResearchStudyPartyOrgType?? »Individual or organization associated with study (use practitionerRole to specify their organisation)party : Reference [0..1] « Practitioner|PractitionerRole| Organization »ProgressStatusLabel for status or state (e.g. recruitment status)state : CodeableConcept [1..1] « null (Strength=Extensible)ResearchStudyStatus+ »An indication of whether or not the date is a known date when the state changed or will change. A value of true indicates a known date. A value of false indicates an estimated dateactual : boolean [0..1]Date rangeperiod : Period [0..1]RecruitmentEstimated total number of participants to be enrolledtargetNumber : unsignedInt [0..1]Actual total number of participants enrolled in studyactualNumber : unsignedInt [0..1]Inclusion and exclusion criteriaeligibility : Reference [0..1] « Group|EvidenceVariable »Group of participants who were enrolled in studyactualGroup : Reference [0..1] « Group »ComparisonGroupAllows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easilyidentifier[x] : DataType [0..1] « uri|Identifier »Unique, human-readable label for this comparisonGroup of the studyname : string [1..1]Categorization of study comparisonGroup, e.g. experimental, active comparator, placebo comparatertype : CodeableConcept [0..1] « null (Strength=Extensible)ResearchStudyArmType+ »A succinct description of the path through the study that would be followed by a subject adhering to this comparisonGroupdescription : markdown [0..1]Interventions or exposures in this comparisonGroup or cohortintendedExposure : Reference [0..*] « EvidenceVariable »Group of participants who were enrolled in study comparisonGroupobservedGroup : Reference [0..1] « Group »ObjectiveUnique, human-readable label for this objective of the studyname : string [0..1]The kind of study objectivetype : CodeableConcept [0..1] « null (Strength=Preferred)ResearchStudyObjectiveType? »Free text description of the objective of the study. This is what the study is trying to achieve rather than how it is going to achieve it (see ResearchStudy.description)description : markdown [0..1]OutcomeMeasureLabel for the outcomename : string [0..1]The parameter or characteristic being assessed as one of the values by which the study is assessedtype : CodeableConcept [0..*] « null (Strength=Preferred)ResearchStudyObjectiveType? »Description of the outcomedescription : markdown [0..1]Structured outcome definitionreference : Reference [0..1] « EvidenceVariable »WebLocationDescribes the nature of the location being specifiedclassifier : CodeableConcept [0..1] « null (Strength=Example)ArtifactUrlClassifier?? »The location addressurl : uri [1..1]Additional names for the studylabel[0..*]The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information aboutfocus[0..*]Sponsors, collaborators, and other partiesassociatedParty[0..*]Status of study with time for that statusprogressStatus[0..*]Target or actual group of participants enrolled in studyrecruitment[0..1]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-upcomparisonGroup[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..*]An outcome or planned variable to measure during the studyoutcomeMeasure[0..*]A general storage or archive location for the study. This may contain an assortment of content which is not specified in advancewebLocation[0..*]

XML Template

<ResearchStudy xmlns="http://hl7.org/fhir"> doco
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <url value="[uri]"/><!-- 0..1 Canonical identifier for this study resource -->
 <identifier><!-- 0..* Identifier Business Identifier for study --></identifier>
 <version value="[string]"/><!-- 0..1 The business version for the study record -->
 <name value="[string]"/><!-- 0..1 Name for this study (computer friendly) -->
 <title value="[string]"/><!-- 0..1 Human readable name of the study -->
 <label>  <!-- 0..* Additional names for the study -->
  <type><!-- 0..1 CodeableConcept primary | official | scientific | plain-language | subtitle | short-title | acronym | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid --></type>
  <value value="[string]"/><!-- 0..1 The name -->
 </label>
 <protocol><!-- 0..* Reference(PlanDefinition) Steps followed in executing study --></protocol>
 <partOf><!-- 0..* Reference(ResearchStudy) Part of larger study --></partOf>
 <relatedArtifact><!-- 0..* RelatedArtifact References and dependencies --></relatedArtifact>
 <date value="[dateTime]"/><!-- 0..1 Date the resource last changed -->
 <status value="[code]"/><!-- 1..1 draft | active | retired | unknown -->
 <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>
 <studyDesign><!-- 0..* CodeableConcept Classifications of the study design characteristics --></studyDesign>
 <focus>  <!-- 0..* Drugs, devices, etc. under study -->
  <productCode><!-- 0..1 CodeableConcept Identification of product under study --></productCode>
  <focusType><!-- 0..* CodeableConcept medication | device | intervention | factor --></focusType>
  <factor value="[markdown]"/><!-- 0..1 An independent variable manipulated by the experimentalist -->
 </focus>
 <condition><!-- 0..* CodeableConcept Condition being studied --></condition>
 <keyword><!-- 0..* CodeableConcept Used to search for the study --></keyword>
 <region><!-- 0..* CodeableConcept Geographic area for the study --></region>
 <descriptionSummary value="[markdown]"/><!-- 0..1 Brief text explaining the study -->
 <description value="[markdown]"/><!-- 0..1 Detailed narrative of the study -->
 <period><!-- 0..1 Period When the study began and ended --></period>
 <site><!-- 0..* Reference(Location|Organization|ResearchStudy) Facility where study activities are conducted --></site>
 <note><!-- 0..* Annotation Comments made about the study --></note>
 <classifier><!-- 0..* CodeableConcept Classification for the study --></classifier>
 <associatedParty>  <!-- 0..* Sponsors, collaborators, and other parties -->
  <name value="[string]"/><!-- 0..1 Name of associated party -->
  <role><!-- 1..1 CodeableConcept sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-director | study-chair --></role>
  <period><!-- 0..* Period When active in the role --></period>
  <classifier><!-- 0..* CodeableConcept nih | fda | government | nonprofit | academic | industry --></classifier>
  <party><!-- 0..1 Reference(Organization|Practitioner|PractitionerRole) Individual or organization associated with study (use practitionerRole to specify their organisation) --></party>
 </associatedParty>
 <progressStatus>  <!-- 0..* Status of study with time for that status -->
  <state><!-- 1..1 CodeableConcept Label for status or state (e.g. recruitment status) --></state>
  <actual value="[boolean]"/><!-- 0..1 Actual if true else anticipated -->
  <period><!-- 0..1 Period Date range --></period>
 </progressStatus>
 <whyStopped><!-- 0..1 CodeableConcept accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design --></whyStopped>
 <recruitment>  <!-- 0..1 Target or actual group of participants enrolled in study -->
  <targetNumber value="[unsignedInt]"/><!-- 0..1 Estimated total number of participants to be enrolled -->
  <actualNumber value="[unsignedInt]"/><!-- 0..1 Actual total number of participants enrolled in study -->
  <eligibility><!-- 0..1 Reference(EvidenceVariable|Group) Inclusion and exclusion criteria --></eligibility>
  <actualGroup><!-- 0..1 Reference(Group) Group of participants who were enrolled in study --></actualGroup>
 </recruitment>
 <comparisonGroup>  <!-- 0..* Defined path through the study for a subject -->
  <identifier[x]><!-- 0..1 uri|Identifier Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily --></identifier[x]>
  <name value="[string]"/><!-- 1..1 Label for study comparisonGroup -->
  <type><!-- 0..1 CodeableConcept Categorization of study comparisonGroup --></type>
  <description value="[markdown]"/><!-- 0..1 Short explanation of study path -->
  <intendedExposure><!-- 0..* Reference(EvidenceVariable) Interventions or exposures in this comparisonGroup or cohort --></intendedExposure>
  <observedGroup><!-- 0..1 Reference(Group) Group of participants who were enrolled in study comparisonGroup --></observedGroup>
 </comparisonGroup>
 <objective>  <!-- 0..* A goal for the study -->
  <name value="[string]"/><!-- 0..1 Label for the objective -->
  <type><!-- 0..1 CodeableConcept primary | secondary | exploratory --></type>
  <description value="[markdown]"/><!-- 0..1 Description of the objective -->
 </objective>
 <outcomeMeasure>  <!-- 0..* An outcome or planned variable to measure during the study -->
  <name value="[string]"/><!-- 0..1 Label for the outcome -->
  <type><!-- 0..* CodeableConcept primary | secondary | exploratory --></type>
  <description value="[markdown]"/><!-- 0..1 Description of the outcome -->
  <reference><!-- 0..1 Reference(EvidenceVariable) Structured outcome definition --></reference>
 </outcomeMeasure>
 <result><!-- 0..* Reference(Citation|DiagnosticReport|EvidenceReport) Link to results generated during the study --></result>
 <webLocation>  <!-- 0..* Archive location for the study -->
  <classifier><!-- 0..1 CodeableConcept registry-page|recruitment-page|contact-page --></classifier>
  <url value="[uri]"/><!-- 1..1 The location address -->
 </webLocation>
</ResearchStudy>

JSON Template

{doco
  "resourceType" : "ResearchStudy",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "url" : "<uri>", // Canonical identifier for this study resource
  "identifier" : [{ Identifier }], // Business Identifier for study
  "version" : "<string>", // The business version for the study record
  "name" : "<string>", // Name for this study (computer friendly)
  "title" : "<string>", // Human readable name of the study
  "label" : [{ // Additional names for the study
    "type" : { CodeableConcept }, // primary | official | scientific | plain-language | subtitle | short-title | acronym | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid
    "value" : "<string>" // The name
  }],
  "protocol" : [{ Reference(PlanDefinition) }], // Steps followed in executing study
  "partOf" : [{ Reference(ResearchStudy) }], // Part of larger study
  "relatedArtifact" : [{ RelatedArtifact }], // References and dependencies
  "date" : "<dateTime>", // Date the resource last changed
  "status" : "<code>", // R!  draft | active | retired | unknown
  "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
  "studyDesign" : [{ CodeableConcept }], // Classifications of the study design characteristics
  "focus" : [{ // Drugs, devices, etc. under study
    "productCode" : { CodeableConcept }, // Identification of product under study
    "focusType" : [{ CodeableConcept }], // medication | device | intervention | factor
    "factor" : "<markdown>" // An independent variable manipulated by the experimentalist
  }],
  "condition" : [{ CodeableConcept }], // Condition being studied
  "keyword" : [{ CodeableConcept }], // Used to search for the study
  "region" : [{ CodeableConcept }], // Geographic area for the study
  "descriptionSummary" : "<markdown>", // Brief text explaining the study
  "description" : "<markdown>", // Detailed narrative of the study
  "period" : { Period }, // When the study began and ended
  "site" : [{ Reference(Location|Organization|ResearchStudy) }], // Facility where study activities are conducted
  "note" : [{ Annotation }], // Comments made about the study
  "classifier" : [{ CodeableConcept }], // Classification for the study
  "associatedParty" : [{ // Sponsors, collaborators, and other parties
    "name" : "<string>", // Name of associated party
    "role" : { CodeableConcept }, // R!  sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-director | study-chair
    "period" : [{ Period }], // When active in the role
    "classifier" : [{ CodeableConcept }], // nih | fda | government | nonprofit | academic | industry
    "party" : { Reference(Organization|Practitioner|PractitionerRole) } // Individual or organization associated with study (use practitionerRole to specify their organisation)
  }],
  "progressStatus" : [{ // Status of study with time for that status
    "state" : { CodeableConcept }, // R!  Label for status or state (e.g. recruitment status)
    "actual" : <boolean>, // Actual if true else anticipated
    "period" : { Period } // Date range
  }],
  "whyStopped" : { CodeableConcept }, // accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
  "recruitment" : { // Target or actual group of participants enrolled in study
    "targetNumber" : "<unsignedInt>", // Estimated total number of participants to be enrolled
    "actualNumber" : "<unsignedInt>", // Actual total number of participants enrolled in study
    "eligibility" : { Reference(EvidenceVariable|Group) }, // Inclusion and exclusion criteria
    "actualGroup" : { Reference(Group) } // Group of participants who were enrolled in study
  },
  "comparisonGroup" : [{ // Defined path through the study for a subject
    // identifier[x]: 
      Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily. One of these 2:
    "identifierUri" : "<uri>",
    "identifierIdentifier" : { Identifier },
    "name" : "<string>", // R!  Label for study comparisonGroup
    "type" : { CodeableConcept }, // Categorization of study comparisonGroup
    "description" : "<markdown>", // Short explanation of study path
    "intendedExposure" : [{ Reference(EvidenceVariable) }], // Interventions or exposures in this comparisonGroup or cohort
    "observedGroup" : { Reference(Group) } // Group of participants who were enrolled in study comparisonGroup
  }],
  "objective" : [{ // A goal for the study
    "name" : "<string>", // Label for the objective
    "type" : { CodeableConcept }, // primary | secondary | exploratory
    "description" : "<markdown>" // Description of the objective
  }],
  "outcomeMeasure" : [{ // An outcome or planned variable to measure during the study
    "name" : "<string>", // Label for the outcome
    "type" : [{ CodeableConcept }], // primary | secondary | exploratory
    "description" : "<markdown>", // Description of the outcome
    "reference" : { Reference(EvidenceVariable) } // Structured outcome definition
  }],
  "result" : [{ Reference(Citation|DiagnosticReport|EvidenceReport) }], // Link to results generated during the study
  "webLocation" : [{ // Archive location for the study
    "classifier" : { CodeableConcept }, // registry-page|recruitment-page|contact-page
    "url" : "<uri>" // R!  The location address
  }]
}

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.url [ uri ]; # 0..1 Canonical identifier for this study resource
  fhir:ResearchStudy.identifier [ Identifier ], ... ; # 0..* Business Identifier for study
  fhir:ResearchStudy.version [ string ]; # 0..1 The business version for the study record
  fhir:ResearchStudy.name [ string ]; # 0..1 Name for this study (computer friendly)
  fhir:ResearchStudy.title [ string ]; # 0..1 Human readable name of the study
  fhir:ResearchStudy.label [ # 0..* Additional names for the study
    fhir:ResearchStudy.label.type [ CodeableConcept ]; # 0..1 primary | official | scientific | plain-language | subtitle | short-title | acronym | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid
    fhir:ResearchStudy.label.value [ string ]; # 0..1 The name
  ], ...;
  fhir:ResearchStudy.protocol [ Reference(PlanDefinition) ], ... ; # 0..* Steps followed in executing study
  fhir:ResearchStudy.partOf [ Reference(ResearchStudy) ], ... ; # 0..* Part of larger study
  fhir:ResearchStudy.relatedArtifact [ RelatedArtifact ], ... ; # 0..* References and dependencies
  fhir:ResearchStudy.date [ dateTime ]; # 0..1 Date the resource last changed
  fhir:ResearchStudy.status [ code ]; # 1..1 draft | active | retired | unknown
  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.studyDesign [ CodeableConcept ], ... ; # 0..* Classifications of the study design characteristics
  fhir:ResearchStudy.focus [ # 0..* Drugs, devices, etc. under study
    fhir:ResearchStudy.focus.productCode [ CodeableConcept ]; # 0..1 Identification of product under study
    fhir:ResearchStudy.focus.focusType [ CodeableConcept ], ... ; # 0..* medication | device | intervention | factor
    fhir:ResearchStudy.focus.factor [ markdown ]; # 0..1 An independent variable manipulated by the experimentalist
  ], ...;
  fhir:ResearchStudy.condition [ CodeableConcept ], ... ; # 0..* Condition being studied
  fhir:ResearchStudy.keyword [ CodeableConcept ], ... ; # 0..* Used to search for the study
  fhir:ResearchStudy.region [ CodeableConcept ], ... ; # 0..* Geographic area for the study
  fhir:ResearchStudy.descriptionSummary [ markdown ]; # 0..1 Brief text explaining the study
  fhir:ResearchStudy.description [ markdown ]; # 0..1 Detailed narrative of the study
  fhir:ResearchStudy.period [ Period ]; # 0..1 When the study began and ended
  fhir:ResearchStudy.site [ Reference(Location|Organization|ResearchStudy) ], ... ; # 0..* Facility where study activities are conducted
  fhir:ResearchStudy.note [ Annotation ], ... ; # 0..* Comments made about the study
  fhir:ResearchStudy.classifier [ CodeableConcept ], ... ; # 0..* Classification for the study
  fhir:ResearchStudy.associatedParty [ # 0..* Sponsors, collaborators, and other parties
    fhir:ResearchStudy.associatedParty.name [ string ]; # 0..1 Name of associated party
    fhir:ResearchStudy.associatedParty.role [ CodeableConcept ]; # 1..1 sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-director | study-chair
    fhir:ResearchStudy.associatedParty.period [ Period ], ... ; # 0..* When active in the role
    fhir:ResearchStudy.associatedParty.classifier [ CodeableConcept ], ... ; # 0..* nih | fda | government | nonprofit | academic | industry
    fhir:ResearchStudy.associatedParty.party [ Reference(Organization|Practitioner|PractitionerRole) ]; # 0..1 Individual or organization associated with study (use practitionerRole to specify their organisation)
  ], ...;
  fhir:ResearchStudy.progressStatus [ # 0..* Status of study with time for that status
    fhir:ResearchStudy.progressStatus.state [ CodeableConcept ]; # 1..1 Label for status or state (e.g. recruitment status)
    fhir:ResearchStudy.progressStatus.actual [ boolean ]; # 0..1 Actual if true else anticipated
    fhir:ResearchStudy.progressStatus.period [ Period ]; # 0..1 Date range
  ], ...;
  fhir:ResearchStudy.whyStopped [ CodeableConcept ]; # 0..1 accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
  fhir:ResearchStudy.recruitment [ # 0..1 Target or actual group of participants enrolled in study
    fhir:ResearchStudy.recruitment.targetNumber [ unsignedInt ]; # 0..1 Estimated total number of participants to be enrolled
    fhir:ResearchStudy.recruitment.actualNumber [ unsignedInt ]; # 0..1 Actual total number of participants enrolled in study
    fhir:ResearchStudy.recruitment.eligibility [ Reference(EvidenceVariable|Group) ]; # 0..1 Inclusion and exclusion criteria
    fhir:ResearchStudy.recruitment.actualGroup [ Reference(Group) ]; # 0..1 Group of participants who were enrolled in study
  ];
  fhir:ResearchStudy.comparisonGroup [ # 0..* Defined path through the study for a subject
    # ResearchStudy.comparisonGroup.identifier[x] : 0..1 Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily. One of these 2
      fhir:ResearchStudy.comparisonGroup.identifierUri [ uri ]
      fhir:ResearchStudy.comparisonGroup.identifierIdentifier [ Identifier ]
    fhir:ResearchStudy.comparisonGroup.name [ string ]; # 1..1 Label for study comparisonGroup
    fhir:ResearchStudy.comparisonGroup.type [ CodeableConcept ]; # 0..1 Categorization of study comparisonGroup
    fhir:ResearchStudy.comparisonGroup.description [ markdown ]; # 0..1 Short explanation of study path
    fhir:ResearchStudy.comparisonGroup.intendedExposure [ Reference(EvidenceVariable) ], ... ; # 0..* Interventions or exposures in this comparisonGroup or cohort
    fhir:ResearchStudy.comparisonGroup.observedGroup [ Reference(Group) ]; # 0..1 Group of participants who were enrolled in study comparisonGroup
  ], ...;
  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
    fhir:ResearchStudy.objective.description [ markdown ]; # 0..1 Description of the objective
  ], ...;
  fhir:ResearchStudy.outcomeMeasure [ # 0..* An outcome or planned variable to measure during the study
    fhir:ResearchStudy.outcomeMeasure.name [ string ]; # 0..1 Label for the outcome
    fhir:ResearchStudy.outcomeMeasure.type [ CodeableConcept ], ... ; # 0..* primary | secondary | exploratory
    fhir:ResearchStudy.outcomeMeasure.description [ markdown ]; # 0..1 Description of the outcome
    fhir:ResearchStudy.outcomeMeasure.reference [ Reference(EvidenceVariable) ]; # 0..1 Structured outcome definition
  ], ...;
  fhir:ResearchStudy.result [ Reference(Citation|DiagnosticReport|EvidenceReport) ], ... ; # 0..* Link to results generated during the study
  fhir:ResearchStudy.webLocation [ # 0..* Archive location for the study
    fhir:ResearchStudy.webLocation.classifier [ CodeableConcept ]; # 0..1 registry-page|recruitment-page|contact-page
    fhir:ResearchStudy.webLocation.url [ uri ]; # 1..1 The location address
  ], ...;
]

Changes since Release 4

ResearchStudy
ResearchStudy.url
  • Added Element
ResearchStudy.version
  • Added Element
ResearchStudy.name
  • Added Element
ResearchStudy.label
  • Added Element
ResearchStudy.label.type
  • Added Element
ResearchStudy.label.value
  • Added Element
ResearchStudy.date
  • Added Element
ResearchStudy.status
  • Change value set from http://hl7.org/fhir/ValueSet/research-study-status|4.0.0 to http://hl7.org/fhir/ValueSet/publication-status|5.0.0-cibuild
  • Change value set from http://hl7.org/fhir/ValueSet/research-study-status|4.0.0 to http://hl7.org/fhir/ValueSet/publication-status|5.0.0-cibuild
ResearchStudy.primaryPurposeType
  • Change code system for extensibly bound codes from "http://terminology.hl7.org/CodeSystem/research-study-prim-purp-type" to "http://hl7.org/fhir/research-study-classifiers"
  • Change code system for extensibly bound codes from "http://terminology.hl7.org/CodeSystem/research-study-prim-purp-type" to "http://hl7.org/fhir/research-study-classifiers"
ResearchStudy.studyDesign
  • Added Element
ResearchStudy.focus
  • Type changed from CodeableConcept to BackboneElement
  • Type changed from CodeableConcept to BackboneElement
ResearchStudy.focus.productCode
  • Added Element
ResearchStudy.focus.focusType
  • Added Element
ResearchStudy.focus.factor
  • Added Element
ResearchStudy.region
  • Added Element
ResearchStudy.descriptionSummary
  • Added Element
ResearchStudy.site
  • Type Reference: Added Target Types ResearchStudy, Organization
  • Type Reference: Added Target Types ResearchStudy, Organization
ResearchStudy.classifier
  • Added Element
ResearchStudy.associatedParty
  • Added Element
ResearchStudy.associatedParty.name
  • Added Element
ResearchStudy.associatedParty.role
  • Added Mandatory Element
ResearchStudy.associatedParty.period
  • Added Element
ResearchStudy.associatedParty.classifier
  • Added Element
ResearchStudy.associatedParty.party
  • Added Element
ResearchStudy.progressStatus
  • Added Element
ResearchStudy.progressStatus.state
  • Added Mandatory Element
ResearchStudy.progressStatus.actual
  • Added Element
ResearchStudy.progressStatus.period
  • Added Element
ResearchStudy.whyStopped
  • Added Element
ResearchStudy.recruitment
  • Added Element
ResearchStudy.recruitment.targetNumber
  • Added Element
ResearchStudy.recruitment.actualNumber
  • Added Element
ResearchStudy.recruitment.eligibility
  • Added Element
ResearchStudy.recruitment.actualGroup
  • Added Element
ResearchStudy.comparisonGroup
  • Added Element
ResearchStudy.comparisonGroup.identifier[x]
  • Added Element
ResearchStudy.comparisonGroup.name
  • Added Mandatory Element
ResearchStudy.comparisonGroup.type
  • Added Element
ResearchStudy.comparisonGroup.description
  • Added Element
ResearchStudy.comparisonGroup.intendedExposure
  • Added Element
ResearchStudy.comparisonGroup.observedGroup
  • Added Element
ResearchStudy.objective.description
  • Added Element
ResearchStudy.outcomeMeasure
  • Added Element
ResearchStudy.outcomeMeasure.name
  • Added Element
ResearchStudy.outcomeMeasure.type
  • Added Element
ResearchStudy.outcomeMeasure.description
  • Added Element
ResearchStudy.outcomeMeasure.reference
  • Added Element
ResearchStudy.result
  • Added Element
ResearchStudy.webLocation
  • Added Element
ResearchStudy.webLocation.classifier
  • Added Element
ResearchStudy.webLocation.url
  • Added Mandatory Element
ResearchStudy.category
  • deleted
ResearchStudy.contact
  • deleted
ResearchStudy.location
  • deleted
ResearchStudy.enrollment
  • deleted
ResearchStudy.sponsor
  • deleted
ResearchStudy.principalInvestigator
  • deleted
ResearchStudy.reasonStopped
  • deleted
ResearchStudy.arm
  • deleted

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.)

 

Additional definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions, the spreadsheet version & the dependency analysis

PathDefinitionTypeReference
ResearchStudy.label.type

Used to express the reason and specific aspect for the variant title, such as language and specific language.

ExtensibleTitleType
ResearchStudy.status

The lifecycle status of an artifact.

RequiredPublicationStatus
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.studyDesign

This is a set of terms for study design characteristics.

PreferredStudyDesign
ResearchStudy.focus.productCode Example??
ResearchStudy.focus.focusType

Codes for the main intent of the study.

ExtensibleResearchStudyFocusType
ResearchStudy.condition

Example value set for Condition/Problem/Diagnosis codes.

ExampleConditionProblemDiagnosisCodes
ResearchStudy.keyword Example??
ResearchStudy.region

This value set defines a base set of codes for country, country subdivision and region for indicating where a resource is intended to be used.

Note: The codes for countries and country subdivisions are taken from ISO 3166 icon while the codes for "supra-national" regions are from UN Standard country or area codes for statistical use (M49) icon.

ExtensibleJurisdictionValueSet
ResearchStudy.classifier

Codes that convey the type of label that is provided.

ExampleResearchStudyClassifiers
ResearchStudy.associatedParty.role

This is a ResearchStudy's party role.

ExtensibleResearchStudyPartyRole
ResearchStudy.associatedParty.classifier

This is a ResearchStudy's party organization type.

ExampleResearchStudyPartyOrgType
ResearchStudy.progressStatus.state

Codes that convey the current status of the research study.

ExtensibleResearchStudyStatus
ResearchStudy.whyStopped

Codes for why the study ended prematurely.

ExampleResearchStudyReasonStopped
ResearchStudy.comparisonGroup.type

Codes for the main intent of the study.

ExtensibleResearchStudyArmType
ResearchStudy.objective.type

Codes for the kind of study objective.

PreferredResearchStudyObjectiveType
ResearchStudy.outcomeMeasure.type

Codes for the kind of study objective.

PreferredResearchStudyObjectiveType
ResearchStudy.webLocation.classifier

Code the reason for different URLs, eg abstract and full-text.

ExampleArtifactUrlClassifier

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.

NameTypeDescriptionExpressionIn Common
conditiontokenCondition being studiedResearchStudy.condition
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
partofreferencePart of larger studyResearchStudy.partOf
(ResearchStudy)
protocolreferenceSteps followed in executing studyResearchStudy.protocol
(PlanDefinition)
recruitment_actualnumberActual number of participants enrolled in study across all groupsResearchStudy.recruitment.actualNumber
recruitment_targetnumberTarget number of participants enrolled in study across all groupsResearchStudy.recruitment.targetNumber
regiontokenGeographic area for the studyResearchStudy.region
sitereferenceFacility where study activities are conductedResearchStudy.site
(Organization, Location, ResearchStudy)
status Ntokenactive | active-but-not-recruiting | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | enrolling-by-invitation | in-review | not-yet-recruiting | recruiting | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | terminated | withdrawnResearchStudy.status
title NstringName for this studyResearchStudy.title