Release 5 Draft Ballot

8.22 Resource ResearchStudy - Content

Biomedical Research and Regulation Work GroupMaturity Level: 0 Trial UseSecurity Category: Business Compartments: Practitioner

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

Trial-Use Note: In terms of scope and usage, the BR and RR workgroup wish to draw the attention of reviewers and implementers to the following issue:

  1. This is a major restructuring of the resource. We are seeking input from the implementation community on the appropriateness of these changes

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

A research study is a scientific way to improve or develop new methods of health care. Studies are designed to answer specific questions on how to prevent, diagnose, or treat diseases and disorders. The ResearchStudy resource describes essential information about the study, including the purpose, objective, sponsor, investigator, therapy, condition being studied, schedule of activities, and other key items.

Uses for the ResearchStudy resource include:

  • Registering a clinical trial in trial registry such as clinicaltrials.gov
  • Communicating study protocol information between study stakeholders
  • Supporting study set up of sites, forms
  • Grouping Observation resources by study
  • Setting up a Schedule of Activities for the study and its subjects

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

Extension: RelatesTo

Many clinical studies have a component sub-study and the partOf attribute should be used for this. There may also be documents such as a PDF of the protocol or consent forms and these should be linked using relatedAretfact. However there may be more complex relations to other studies people organizations or artefacts and the RelatesTo extension is provided to record these.

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.

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

This resource does not implement any patterns.

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..1stringBusiness identifier for the study record
... name 0..1stringName for this study (computer friendly)
... title Σ0..1stringName for this study (for computers)
... label 0..*BackboneElementAdditional names for the study
.... type 0..1CodeableConceptshort | public | scientific
ResearchStudyTitleType (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)
... category Σ0..*CodeableConceptClassifications for the study
ResearchStudyCategory (Example)
... 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)
... location Σ0..*CodeableConceptGeographic region(s) for study
Jurisdiction (Extensible)
... descriptionSummary 0..1markdownA brief summary of the study description
... description 0..1markdownWhat this is study doing
... period Σ0..1PeriodWhen the study began and ended
... contact Σ0..*ContactDetailContact details for the study
... sponsor Σ0..1Reference(Organization)Organization that initiates and is legally responsible for the study
... principalInvestigator Σ0..1Reference(Practitioner | PractitionerRole)Researcher who oversees multiple aspects of the study
... site Σ0..*Reference(Location | ResearchStudy | Organization)Facility where study activities are conducted
... note 0..*AnnotationComments made about the study
... classification 0..*BackboneElementClassification for the study
.... type 0..1CodeableConceptphase | category | keyword
ResearchStudyCLassificationType (Extensible)
.... classifier 0..*CodeableConceptn-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
ResearchStudyClassificationClassifier (Extensible)
... associatedParty 0..*BackboneElementSponsors, collaborators, and other parties
.... name 0..1stringName of associated party
.... role 1..1CodeableConceptsponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | recruitment-contact | sub-investigator | study-director | study-chair
ResearchStudyPartyType (Extensible)
.... classifier 0..*CodeableConceptnih | fda
ResearchStudyPartyOrganizationType (Extensible)
.... party 0..1Reference(Practitioner | PractitionerRole | Organization)Individual or organization associated with study (use practitionerRole to specify their organisation)
... currentState 0..*CodeableConceptactive | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn
ResearchStudyStatus (Extensible)
... statusDate 0..*BackboneElementStatus of study with time for that status
.... activity 1..1CodeableConceptRecord-Verification | Overall-Study | Primary-Outcome-Data-Collection | Registration-Submission | Registration-Submission-QC | Registration-Posting | Results-Submission | Results-Submission-QC | Results-Posting | Disposition-Submission | Disposition-Submission-QC | Disposition-Posting | Update-Submission | Update-Posting
ResearchStudyStatusActivity (Extensible)
.... actual 0..1booleanActual if true else anticipated
.... period 1..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)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
.... type 0..1CodeableConceptregistry-page|recruitment-page|contact-page
ResearchStudyUrlType (Extensible)
.... url 1..1uriThe location address

doco Documentation for this format

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..*]Business identifier for the study recordversion : string [0..1]Name for this study (computer friendly)name : string [0..1]A short, descriptive label for the study particularly for compouter usetitle : 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..*]Date the resource last changeddate : 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, etccategory : CodeableConcept [0..*] « null (Strength=Example)ResearchStudyCategory?? »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) Condition/Problem/DiagnosisCo...?? »Key terms to aid in searching for or filtering the studykeyword : CodeableConcept [0..*] « null (Strength=Example)ResearchStudyKeyword?? »Indicates a country, state or other region where the study is taking placelocation : CodeableConcept [0..*] « null (Strength=Extensible)Jurisdiction ValueSet+ »A brief summary of the study descriptiondescriptionSummary : markdown [0..1]A full description of how the study is being conducted. For a description of what the study objectives are see ResearchStudy.objective.descriptiondescription : markdown [0..1]Identifies the start date and the expected (or actual, depending on status) end date for the studyperiod : Period [0..1]Contact details to assist a user in learning more about or engaging with the studycontact : ContactDetail [0..*]An organization that initiates the investigation and is legally responsible for the studysponsor : Reference [0..1] « Organization »A researcher in a study who oversees multiple aspects of the study, such as concept development, protocol writing, protocol submission for IRB approval, participant recruitment, informed consent, data collection, analysis, interpretation and presentationprincipalInvestigator : Reference [0..1] « Practitioner| PractitionerRole »A facility in which study activities are conductedsite : Reference [0..*] « Location|ResearchStudy|Organization »Comments made about the study by the performer, subject or other participantsnote : Annotation [0..*]Current status of the studycurrentState : CodeableConcept [0..*] « null (Strength=Extensible)ResearchStudyStatus+ »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)ResearchStudyTitleType+ »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]ClassificationType of classifiertype : CodeableConcept [0..1] « null (Strength=Extensible)ResearchStudyCLassificationTy...+ »Value of classifierclassifier : CodeableConcept [0..*] « null (Strength=Extensible) ResearchStudyClassificationCl...+ »AssociatedPartyName of associated partyname : string [0..1]Type of associationrole : CodeableConcept [1..1] « null (Strength=Extensible)ResearchStudyPartyType+ »Organisational type of associationclassifier : CodeableConcept [0..*] « null (Strength=Extensible) ResearchStudyPartyOrganizatio...+ »Individual or organization associated with study (use practitionerRole to specify their organisation)party : Reference [0..1] « Practitioner|PractitionerRole| Organization »StatusDateLabel for status or stateactivity : CodeableConcept [1..1] « null (Strength=Extensible)ResearchStudyStatusActivity+ »Actual if true else anticipatedactual : boolean [0..1]Date rangeperiod : Period [1..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 »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 specifiedtype : CodeableConcept [0..1] « null (Strength=Extensible)ResearchStudyUrlType+ »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..*]Classification for the studyclassification[0..*]Sponsors, collaborators, and other partiesassociatedParty[0..*]Status of study with time for that statusstatusDate[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 Business identifier for the study record -->
 <name value="[string]"/><!-- 0..1 Name for this study (computer friendly) -->
 <title value="[string]"/><!-- 0..1 Name for this study (for computers) -->
 <label>  <!-- 0..* Additional names for the study -->
  <type><!-- 0..1 CodeableConcept short | public | scientific  --></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>
 <category><!-- 0..* CodeableConcept Classifications for the study --></category>
 <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>
 <location><!-- 0..* CodeableConcept Geographic region(s) for study --></location>
 <descriptionSummary value="[markdown]"/><!-- 0..1 A brief summary of the study description -->
 <description value="[markdown]"/><!-- 0..1 What this is study doing -->
 <period><!-- 0..1 Period When the study began and ended --></period>
 <contact><!-- 0..* ContactDetail Contact details for the study --></contact>
 <sponsor><!-- 0..1 Reference(Organization) Organization that initiates and is legally responsible for the study --></sponsor>
 <principalInvestigator><!-- 0..1 Reference(Practitioner|PractitionerRole) Researcher who oversees multiple aspects of the study --></principalInvestigator>
 <site><!-- 0..* Reference(Location|Organization|ResearchStudy) Facility where study activities are conducted --></site>
 <note><!-- 0..* Annotation Comments made about the study --></note>
 <classification>  <!-- 0..* Classification for the study -->
  <type><!-- 0..1 CodeableConcept phase | category | keyword   --></type>
  <classifier><!-- 0..* CodeableConcept n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4  --></classifier>
 </classification>
 <associatedParty>  <!-- 0..* Sponsors, collaborators, and other parties -->
  <name value="[string]"/><!-- 0..1 Name of associated party -->
  <role><!-- 1..1 CodeableConcept sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | recruitment-contact | sub-investigator | study-director | study-chair  --></role>
  <classifier><!-- 0..* CodeableConcept nih | fda  --></classifier>
  <party><!-- 0..1 Reference(Organization|Practitioner|PractitionerRole) Individual or organization associated with study (use practitionerRole to specify their organisation) --></party>
 </associatedParty>
 <currentState><!-- 0..* CodeableConcept active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn --></currentState>
 <statusDate>  <!-- 0..* Status of study with time for that status -->
  <activity><!-- 1..1 CodeableConcept Record-Verification | Overall-Study | Primary-Outcome-Data-Collection | Registration-Submission | Registration-Submission-QC | Registration-Posting | Results-Submission | Results-Submission-QC | Results-Posting | Disposition-Submission | Disposition-Submission-QC | Disposition-Posting | Update-Submission | Update-Posting  --></activity>
  <actual value="[boolean]"/><!-- 0..1 Actual if true else anticipated -->
  <period><!-- 1..1 Period Date range --></period>
 </statusDate>
 <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(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 -->
  <type><!-- 0..1 CodeableConcept registry-page|recruitment-page|contact-page  --></type>
  <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>", // Business identifier for the study record
  "name" : "<string>", // Name for this study (computer friendly)
  "title" : "<string>", // Name for this study (for computers)
  "label" : [{ // Additional names for the study
    "type" : { CodeableConcept }, // short | public | scientific 
    "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
  "category" : [{ CodeableConcept }], // Classifications for the study
  "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
  "location" : [{ CodeableConcept }], // Geographic region(s) for study
  "descriptionSummary" : "<markdown>", // A brief summary of the study description
  "description" : "<markdown>", // What this is study doing
  "period" : { Period }, // When the study began and ended
  "contact" : [{ ContactDetail }], // Contact details for the study
  "sponsor" : { Reference(Organization) }, // Organization that initiates and is legally responsible for the study
  "principalInvestigator" : { Reference(Practitioner|PractitionerRole) }, // Researcher who oversees multiple aspects of the study
  "site" : [{ Reference(Location|Organization|ResearchStudy) }], // Facility where study activities are conducted
  "note" : [{ Annotation }], // Comments made about the study
  "classification" : [{ // Classification for the study
    "type" : { CodeableConcept }, // phase | category | keyword  
    "classifier" : [{ CodeableConcept }] // n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 
  }],
  "associatedParty" : [{ // Sponsors, collaborators, and other parties
    "name" : "<string>", // Name of associated party
    "role" : { CodeableConcept }, // R!  sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | recruitment-contact | sub-investigator | study-director | study-chair 
    "classifier" : [{ CodeableConcept }], // nih | fda 
    "party" : { Reference(Organization|Practitioner|PractitionerRole) } // Individual or organization associated with study (use practitionerRole to specify their organisation)
  }],
  "currentState" : [{ CodeableConcept }], // active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn
  "statusDate" : [{ // Status of study with time for that status
    "activity" : { CodeableConcept }, // R!  Record-Verification | Overall-Study | Primary-Outcome-Data-Collection | Registration-Submission | Registration-Submission-QC | Registration-Posting | Results-Submission | Results-Submission-QC | Results-Posting | Disposition-Submission | Disposition-Submission-QC | Disposition-Posting | Update-Submission | Update-Posting 
    "actual" : <boolean>, // Actual if true else anticipated
    "period" : { Period } // R!  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(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
    "type" : { 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 Business identifier for the study record
  fhir:ResearchStudy.name [ string ]; # 0..1 Name for this study (computer friendly)
  fhir:ResearchStudy.title [ string ]; # 0..1 Name for this study (for computers)
  fhir:ResearchStudy.label [ # 0..* Additional names for the study
    fhir:ResearchStudy.label.type [ CodeableConcept ]; # 0..1 short | public | scientific
    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.category [ CodeableConcept ], ... ; # 0..* Classifications for the study
  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.location [ CodeableConcept ], ... ; # 0..* Geographic region(s) for study
  fhir:ResearchStudy.descriptionSummary [ markdown ]; # 0..1 A brief summary of the study description
  fhir:ResearchStudy.description [ markdown ]; # 0..1 What this is study doing
  fhir:ResearchStudy.period [ Period ]; # 0..1 When the study began and ended
  fhir:ResearchStudy.contact [ ContactDetail ], ... ; # 0..* Contact details for the study
  fhir:ResearchStudy.sponsor [ Reference(Organization) ]; # 0..1 Organization that initiates and is legally responsible for the study
  fhir:ResearchStudy.principalInvestigator [ Reference(Practitioner|PractitionerRole) ]; # 0..1 Researcher who oversees multiple aspects of the study
  fhir:ResearchStudy.site [ Reference(Location|Organization|ResearchStudy) ], ... ; # 0..* Facility where study activities are conducted
  fhir:ResearchStudy.note [ Annotation ], ... ; # 0..* Comments made about the study
  fhir:ResearchStudy.classification [ # 0..* Classification for the study
    fhir:ResearchStudy.classification.type [ CodeableConcept ]; # 0..1 phase | category | keyword 
    fhir:ResearchStudy.classification.classifier [ CodeableConcept ], ... ; # 0..* n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
  ], ...;
  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 | sponsor-investigator | primary-investigator | collaborator | funding-source | recruitment-contact | sub-investigator | study-director | study-chair
    fhir:ResearchStudy.associatedParty.classifier [ CodeableConcept ], ... ; # 0..* nih | fda
    fhir:ResearchStudy.associatedParty.party [ Reference(Organization|Practitioner|PractitionerRole) ]; # 0..1 Individual or organization associated with study (use practitionerRole to specify their organisation)
  ], ...;
  fhir:ResearchStudy.currentState [ CodeableConcept ], ... ; # 0..* active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn
  fhir:ResearchStudy.statusDate [ # 0..* Status of study with time for that status
    fhir:ResearchStudy.statusDate.activity [ CodeableConcept ]; # 1..1 Record-Verification | Overall-Study | Primary-Outcome-Data-Collection | Registration-Submission | Registration-Submission-QC | Registration-Posting | Results-Submission | Results-Submission-QC | Results-Posting | Disposition-Submission | Disposition-Submission-QC | Disposition-Posting | Update-Submission | Update-Posting
    fhir:ResearchStudy.statusDate.actual [ boolean ]; # 0..1 Actual if true else anticipated
    fhir:ResearchStudy.statusDate.period [ Period ]; # 1..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(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.type [ CodeableConcept ]; # 0..1 registry-page|recruitment-page|contact-page
    fhir:ResearchStudy.webLocation.url [ uri ]; # 1..1 The location address
  ], ...;
]

Changes since R3

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|4.6.0
ResearchStudy.focus
  • Type changed from CodeableConcept to BackboneElement
ResearchStudy.focus.productCode
  • Added Element
ResearchStudy.focus.focusType
  • Added Element
ResearchStudy.focus.factor
  • Added Element
ResearchStudy.descriptionSummary
  • Added Element
ResearchStudy.site
  • Type Reference: Added Target Types ResearchStudy, Organization
ResearchStudy.classification
  • Added Element
ResearchStudy.classification.type
  • Added Element
ResearchStudy.classification.classifier
  • Added Element
ResearchStudy.associatedParty
  • Added Element
ResearchStudy.associatedParty.name
  • Added Element
ResearchStudy.associatedParty.role
  • Added Mandatory Element
ResearchStudy.associatedParty.classifier
  • Added Element
ResearchStudy.associatedParty.party
  • Added Element
ResearchStudy.currentState
  • Added Element
ResearchStudy.statusDate
  • Added Element
ResearchStudy.statusDate.activity
  • Added Mandatory Element
ResearchStudy.statusDate.actual
  • Added Element
ResearchStudy.statusDate.period
  • Added Mandatory 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.type
  • Added Element
ResearchStudy.webLocation.url
  • Added Mandatory Element
ResearchStudy.enrollment
  • 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..1stringBusiness identifier for the study record
... name 0..1stringName for this study (computer friendly)
... title Σ0..1stringName for this study (for computers)
... label 0..*BackboneElementAdditional names for the study
.... type 0..1CodeableConceptshort | public | scientific
ResearchStudyTitleType (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)
... category Σ0..*CodeableConceptClassifications for the study
ResearchStudyCategory (Example)
... 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)
... location Σ0..*CodeableConceptGeographic region(s) for study
Jurisdiction (Extensible)
... descriptionSummary 0..1markdownA brief summary of the study description
... description 0..1markdownWhat this is study doing
... period Σ0..1PeriodWhen the study began and ended
... contact Σ0..*ContactDetailContact details for the study
... sponsor Σ0..1Reference(Organization)Organization that initiates and is legally responsible for the study
... principalInvestigator Σ0..1Reference(Practitioner | PractitionerRole)Researcher who oversees multiple aspects of the study
... site Σ0..*Reference(Location | ResearchStudy | Organization)Facility where study activities are conducted
... note 0..*AnnotationComments made about the study
... classification 0..*BackboneElementClassification for the study
.... type 0..1CodeableConceptphase | category | keyword
ResearchStudyCLassificationType (Extensible)
.... classifier 0..*CodeableConceptn-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
ResearchStudyClassificationClassifier (Extensible)
... associatedParty 0..*BackboneElementSponsors, collaborators, and other parties
.... name 0..1stringName of associated party
.... role 1..1CodeableConceptsponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | recruitment-contact | sub-investigator | study-director | study-chair
ResearchStudyPartyType (Extensible)
.... classifier 0..*CodeableConceptnih | fda
ResearchStudyPartyOrganizationType (Extensible)
.... party 0..1Reference(Practitioner | PractitionerRole | Organization)Individual or organization associated with study (use practitionerRole to specify their organisation)
... currentState 0..*CodeableConceptactive | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn
ResearchStudyStatus (Extensible)
... statusDate 0..*BackboneElementStatus of study with time for that status
.... activity 1..1CodeableConceptRecord-Verification | Overall-Study | Primary-Outcome-Data-Collection | Registration-Submission | Registration-Submission-QC | Registration-Posting | Results-Submission | Results-Submission-QC | Results-Posting | Disposition-Submission | Disposition-Submission-QC | Disposition-Posting | Update-Submission | Update-Posting
ResearchStudyStatusActivity (Extensible)
.... actual 0..1booleanActual if true else anticipated
.... period 1..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)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
.... type 0..1CodeableConceptregistry-page|recruitment-page|contact-page
ResearchStudyUrlType (Extensible)
.... url 1..1uriThe location address

doco Documentation for this format

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..*]Business identifier for the study recordversion : string [0..1]Name for this study (computer friendly)name : string [0..1]A short, descriptive label for the study particularly for compouter usetitle : 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..*]Date the resource last changeddate : 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, etccategory : CodeableConcept [0..*] « null (Strength=Example)ResearchStudyCategory?? »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) Condition/Problem/DiagnosisCo...?? »Key terms to aid in searching for or filtering the studykeyword : CodeableConcept [0..*] « null (Strength=Example)ResearchStudyKeyword?? »Indicates a country, state or other region where the study is taking placelocation : CodeableConcept [0..*] « null (Strength=Extensible)Jurisdiction ValueSet+ »A brief summary of the study descriptiondescriptionSummary : markdown [0..1]A full description of how the study is being conducted. For a description of what the study objectives are see ResearchStudy.objective.descriptiondescription : markdown [0..1]Identifies the start date and the expected (or actual, depending on status) end date for the studyperiod : Period [0..1]Contact details to assist a user in learning more about or engaging with the studycontact : ContactDetail [0..*]An organization that initiates the investigation and is legally responsible for the studysponsor : Reference [0..1] « Organization »A researcher in a study who oversees multiple aspects of the study, such as concept development, protocol writing, protocol submission for IRB approval, participant recruitment, informed consent, data collection, analysis, interpretation and presentationprincipalInvestigator : Reference [0..1] « Practitioner| PractitionerRole »A facility in which study activities are conductedsite : Reference [0..*] « Location|ResearchStudy|Organization »Comments made about the study by the performer, subject or other participantsnote : Annotation [0..*]Current status of the studycurrentState : CodeableConcept [0..*] « null (Strength=Extensible)ResearchStudyStatus+ »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)ResearchStudyTitleType+ »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]ClassificationType of classifiertype : CodeableConcept [0..1] « null (Strength=Extensible)ResearchStudyCLassificationTy...+ »Value of classifierclassifier : CodeableConcept [0..*] « null (Strength=Extensible) ResearchStudyClassificationCl...+ »AssociatedPartyName of associated partyname : string [0..1]Type of associationrole : CodeableConcept [1..1] « null (Strength=Extensible)ResearchStudyPartyType+ »Organisational type of associationclassifier : CodeableConcept [0..*] « null (Strength=Extensible) ResearchStudyPartyOrganizatio...+ »Individual or organization associated with study (use practitionerRole to specify their organisation)party : Reference [0..1] « Practitioner|PractitionerRole| Organization »StatusDateLabel for status or stateactivity : CodeableConcept [1..1] « null (Strength=Extensible)ResearchStudyStatusActivity+ »Actual if true else anticipatedactual : boolean [0..1]Date rangeperiod : Period [1..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 »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 specifiedtype : CodeableConcept [0..1] « null (Strength=Extensible)ResearchStudyUrlType+ »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..*]Classification for the studyclassification[0..*]Sponsors, collaborators, and other partiesassociatedParty[0..*]Status of study with time for that statusstatusDate[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 Business identifier for the study record -->
 <name value="[string]"/><!-- 0..1 Name for this study (computer friendly) -->
 <title value="[string]"/><!-- 0..1 Name for this study (for computers) -->
 <label>  <!-- 0..* Additional names for the study -->
  <type><!-- 0..1 CodeableConcept short | public | scientific  --></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>
 <category><!-- 0..* CodeableConcept Classifications for the study --></category>
 <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>
 <location><!-- 0..* CodeableConcept Geographic region(s) for study --></location>
 <descriptionSummary value="[markdown]"/><!-- 0..1 A brief summary of the study description -->
 <description value="[markdown]"/><!-- 0..1 What this is study doing -->
 <period><!-- 0..1 Period When the study began and ended --></period>
 <contact><!-- 0..* ContactDetail Contact details for the study --></contact>
 <sponsor><!-- 0..1 Reference(Organization) Organization that initiates and is legally responsible for the study --></sponsor>
 <principalInvestigator><!-- 0..1 Reference(Practitioner|PractitionerRole) Researcher who oversees multiple aspects of the study --></principalInvestigator>
 <site><!-- 0..* Reference(Location|Organization|ResearchStudy) Facility where study activities are conducted --></site>
 <note><!-- 0..* Annotation Comments made about the study --></note>
 <classification>  <!-- 0..* Classification for the study -->
  <type><!-- 0..1 CodeableConcept phase | category | keyword   --></type>
  <classifier><!-- 0..* CodeableConcept n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4  --></classifier>
 </classification>
 <associatedParty>  <!-- 0..* Sponsors, collaborators, and other parties -->
  <name value="[string]"/><!-- 0..1 Name of associated party -->
  <role><!-- 1..1 CodeableConcept sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | recruitment-contact | sub-investigator | study-director | study-chair  --></role>
  <classifier><!-- 0..* CodeableConcept nih | fda  --></classifier>
  <party><!-- 0..1 Reference(Organization|Practitioner|PractitionerRole) Individual or organization associated with study (use practitionerRole to specify their organisation) --></party>
 </associatedParty>
 <currentState><!-- 0..* CodeableConcept active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn --></currentState>
 <statusDate>  <!-- 0..* Status of study with time for that status -->
  <activity><!-- 1..1 CodeableConcept Record-Verification | Overall-Study | Primary-Outcome-Data-Collection | Registration-Submission | Registration-Submission-QC | Registration-Posting | Results-Submission | Results-Submission-QC | Results-Posting | Disposition-Submission | Disposition-Submission-QC | Disposition-Posting | Update-Submission | Update-Posting  --></activity>
  <actual value="[boolean]"/><!-- 0..1 Actual if true else anticipated -->
  <period><!-- 1..1 Period Date range --></period>
 </statusDate>
 <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(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 -->
  <type><!-- 0..1 CodeableConcept registry-page|recruitment-page|contact-page  --></type>
  <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>", // Business identifier for the study record
  "name" : "<string>", // Name for this study (computer friendly)
  "title" : "<string>", // Name for this study (for computers)
  "label" : [{ // Additional names for the study
    "type" : { CodeableConcept }, // short | public | scientific 
    "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
  "category" : [{ CodeableConcept }], // Classifications for the study
  "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
  "location" : [{ CodeableConcept }], // Geographic region(s) for study
  "descriptionSummary" : "<markdown>", // A brief summary of the study description
  "description" : "<markdown>", // What this is study doing
  "period" : { Period }, // When the study began and ended
  "contact" : [{ ContactDetail }], // Contact details for the study
  "sponsor" : { Reference(Organization) }, // Organization that initiates and is legally responsible for the study
  "principalInvestigator" : { Reference(Practitioner|PractitionerRole) }, // Researcher who oversees multiple aspects of the study
  "site" : [{ Reference(Location|Organization|ResearchStudy) }], // Facility where study activities are conducted
  "note" : [{ Annotation }], // Comments made about the study
  "classification" : [{ // Classification for the study
    "type" : { CodeableConcept }, // phase | category | keyword  
    "classifier" : [{ CodeableConcept }] // n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 
  }],
  "associatedParty" : [{ // Sponsors, collaborators, and other parties
    "name" : "<string>", // Name of associated party
    "role" : { CodeableConcept }, // R!  sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | recruitment-contact | sub-investigator | study-director | study-chair 
    "classifier" : [{ CodeableConcept }], // nih | fda 
    "party" : { Reference(Organization|Practitioner|PractitionerRole) } // Individual or organization associated with study (use practitionerRole to specify their organisation)
  }],
  "currentState" : [{ CodeableConcept }], // active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn
  "statusDate" : [{ // Status of study with time for that status
    "activity" : { CodeableConcept }, // R!  Record-Verification | Overall-Study | Primary-Outcome-Data-Collection | Registration-Submission | Registration-Submission-QC | Registration-Posting | Results-Submission | Results-Submission-QC | Results-Posting | Disposition-Submission | Disposition-Submission-QC | Disposition-Posting | Update-Submission | Update-Posting 
    "actual" : <boolean>, // Actual if true else anticipated
    "period" : { Period } // R!  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(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
    "type" : { 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 Business identifier for the study record
  fhir:ResearchStudy.name [ string ]; # 0..1 Name for this study (computer friendly)
  fhir:ResearchStudy.title [ string ]; # 0..1 Name for this study (for computers)
  fhir:ResearchStudy.label [ # 0..* Additional names for the study
    fhir:ResearchStudy.label.type [ CodeableConcept ]; # 0..1 short | public | scientific
    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.category [ CodeableConcept ], ... ; # 0..* Classifications for the study
  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.location [ CodeableConcept ], ... ; # 0..* Geographic region(s) for study
  fhir:ResearchStudy.descriptionSummary [ markdown ]; # 0..1 A brief summary of the study description
  fhir:ResearchStudy.description [ markdown ]; # 0..1 What this is study doing
  fhir:ResearchStudy.period [ Period ]; # 0..1 When the study began and ended
  fhir:ResearchStudy.contact [ ContactDetail ], ... ; # 0..* Contact details for the study
  fhir:ResearchStudy.sponsor [ Reference(Organization) ]; # 0..1 Organization that initiates and is legally responsible for the study
  fhir:ResearchStudy.principalInvestigator [ Reference(Practitioner|PractitionerRole) ]; # 0..1 Researcher who oversees multiple aspects of the study
  fhir:ResearchStudy.site [ Reference(Location|Organization|ResearchStudy) ], ... ; # 0..* Facility where study activities are conducted
  fhir:ResearchStudy.note [ Annotation ], ... ; # 0..* Comments made about the study
  fhir:ResearchStudy.classification [ # 0..* Classification for the study
    fhir:ResearchStudy.classification.type [ CodeableConcept ]; # 0..1 phase | category | keyword 
    fhir:ResearchStudy.classification.classifier [ CodeableConcept ], ... ; # 0..* n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
  ], ...;
  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 | sponsor-investigator | primary-investigator | collaborator | funding-source | recruitment-contact | sub-investigator | study-director | study-chair
    fhir:ResearchStudy.associatedParty.classifier [ CodeableConcept ], ... ; # 0..* nih | fda
    fhir:ResearchStudy.associatedParty.party [ Reference(Organization|Practitioner|PractitionerRole) ]; # 0..1 Individual or organization associated with study (use practitionerRole to specify their organisation)
  ], ...;
  fhir:ResearchStudy.currentState [ CodeableConcept ], ... ; # 0..* active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn
  fhir:ResearchStudy.statusDate [ # 0..* Status of study with time for that status
    fhir:ResearchStudy.statusDate.activity [ CodeableConcept ]; # 1..1 Record-Verification | Overall-Study | Primary-Outcome-Data-Collection | Registration-Submission | Registration-Submission-QC | Registration-Posting | Results-Submission | Results-Submission-QC | Results-Posting | Disposition-Submission | Disposition-Submission-QC | Disposition-Posting | Update-Submission | Update-Posting
    fhir:ResearchStudy.statusDate.actual [ boolean ]; # 0..1 Actual if true else anticipated
    fhir:ResearchStudy.statusDate.period [ Period ]; # 1..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(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.type [ CodeableConcept ]; # 0..1 registry-page|recruitment-page|contact-page
    fhir:ResearchStudy.webLocation.url [ uri ]; # 1..1 The location address
  ], ...;
]

Changes since Release 3

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|4.6.0
ResearchStudy.focus
  • Type changed from CodeableConcept to BackboneElement
ResearchStudy.focus.productCode
  • Added Element
ResearchStudy.focus.focusType
  • Added Element
ResearchStudy.focus.factor
  • Added Element
ResearchStudy.descriptionSummary
  • Added Element
ResearchStudy.site
  • Type Reference: Added Target Types ResearchStudy, Organization
ResearchStudy.classification
  • Added Element
ResearchStudy.classification.type
  • Added Element
ResearchStudy.classification.classifier
  • Added Element
ResearchStudy.associatedParty
  • Added Element
ResearchStudy.associatedParty.name
  • Added Element
ResearchStudy.associatedParty.role
  • Added Mandatory Element
ResearchStudy.associatedParty.classifier
  • Added Element
ResearchStudy.associatedParty.party
  • Added Element
ResearchStudy.currentState
  • Added Element
ResearchStudy.statusDate
  • Added Element
ResearchStudy.statusDate.activity
  • Added Mandatory Element
ResearchStudy.statusDate.actual
  • Added Element
ResearchStudy.statusDate.period
  • Added Mandatory 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.type
  • Added Element
ResearchStudy.webLocation.url
  • Added Mandatory Element
ResearchStudy.enrollment
  • 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.)

 

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

PathDefinitionTypeReference
ResearchStudy.label.type Extensiblehttp://hl7.org/fhir/ValueSet/research-study-title-type
ResearchStudy.status RequiredPublicationStatus
ResearchStudy.primaryPurposeType ExtensibleResearchStudyPrimaryPurposeType
ResearchStudy.phase ExampleResearchStudyPhase
ResearchStudy.category Example??
ResearchStudy.focus.productCode Example??
ResearchStudy.focus.focusType Extensiblehttp://hl7.org/fhir/ValueSet/research-study-focus-type
ResearchStudy.condition ExampleCondition/Problem/DiagnosisCodes
ResearchStudy.keyword Example??
ResearchStudy.location ExtensibleJurisdiction ValueSet
ResearchStudy.classification.type Extensiblehttp://hl7.org/fhir/ValueSet/research-study-classification-type
ResearchStudy.classification.classifier Extensiblehttp://hl7.org/fhir/ValueSet/research-study-classification-classifier
ResearchStudy.associatedParty.role Extensiblehttp://hl7.org/fhir/ValueSet/research-study-party-type
ResearchStudy.associatedParty.classifier Extensiblehttp://hl7.org/fhir/ValueSet/research-study-party-org-type
ResearchStudy.currentState ExtensibleResearchStudyStatus
ResearchStudy.statusDate.activity Extensiblehttp://hl7.org/fhir/ValueSet/research-study-statusDate-activity
ResearchStudy.whyStopped ExampleResearchStudyReasonStopped
ResearchStudy.comparisonGroup.type Extensiblehttp://hl7.org/fhir/ValueSet/research-study-arm-type
ResearchStudy.objective.type PreferredResearchStudyObjectiveType
ResearchStudy.outcomeMeasure.type PreferredResearchStudyObjectiveType
ResearchStudy.webLocation.type Extensiblehttp://hl7.org/fhir/ValueSet/research-study-url-type

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
categorytokenClassifications for the studyResearchStudy.category
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
locationtokenGeographic region(s) for studyResearchStudy.location
partofreferencePart of larger studyResearchStudy.partOf
(ResearchStudy)
principalinvestigatorreferenceResearcher who oversees multiple aspects of the studyResearchStudy.principalInvestigator
(Practitioner, PractitionerRole)
protocolreferenceSteps followed in executing studyResearchStudy.protocol
(PlanDefinition)
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
sitereferenceFacility where study activities are conductedResearchStudy.site
(Organization, Location, ResearchStudy)
sponsorreferenceOrganization that initiates and is legally responsible for the studyResearchStudy.sponsor
(Organization)
status Ntokenactive | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawnResearchStudy.status
title NstringName for this studyResearchStudy.title