abstractbaseDefinitioncopyrightdate- Values Differ
descriptionexperimentalfhirVersion- Values Differ
jurisdiction
jurisdiction[0]kindnamepublisherpurposestatus- Values Differ
titletypeurlversion- Values Differ
| Left: | SystematicReview (http://hl7.org/fhir/uv/ebm/StructureDefinition/systematic-review) |
| Right: | SystematicReview (http://hl7.org/fhir/uv/ebm/StructureDefinition/systematic-review) |
| Error | StructureDefinition.version | Values for version differ: '1.0.0-ballot2' vs '1.0.0-ballot3' |
| Information | StructureDefinition.status | Values for status differ: 'draft' vs 'active' |
| Information | StructureDefinition.date | Values for date differ: '2025-03-28T17:11:38+00:00' vs '2026-09-10T16:38:22+00:00' |
| Warning | StructureDefinition.fhirVersion | Values for fhirVersion differ: '6.0.0-ballot2' vs '6.0.0-ballot5' |
| Information | StructureDefinition.definition | Values for definition differ: '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.' vs 'A research study is a scientific investigation designed to generate health-related knowledge. This can include clinical trials involving human participants (or animals in the case of veterinary clinical trials). These studies may be related to new ways to screen, prevent, diagnose, and treat disease. Research studies may also analyze data collected from individuals in the past (retrospective studies) or future (prospective studies) to understand specific outcomes or trends in particular populations.' |
| Information | StructureDefinition.comment | Values for comment differ: 'Need to make sure we encompass public health studies.' vs 'The ResearchStudy Resource may be used for any type of research study, such as public health studies evaluating populations or systematic reviews evaluating research studies, and is not limited to clinical trials or limited to studies of individual people.' |
| Information | StructureDefinition.comment | Values for comment differ: 'Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.' vs 'Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resource id depends on the given use case.' |
| Information | StructureDefinition.definition | Values for definition differ: 'A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.' vs 'A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc. For DomainResources, if more than one implicitRules policy applies, additional policies may be conveyed using the [additionalImplicitRules](https://build.fhir.org/ig/HL7/fhir-extensions/StructureDefinition-additionalImplicitRules.html) extension.' |
| Information | StructureDefinition.comment | Values for comment differ: 'This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.' vs 'This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels. Contained resources may be a resource type defined in the FHIR specification, or an [additional resource](http://build.fhir.org/resource.html#additional).' |
| Information | StructureDefinition.short | Values for short differ: 'Extension' vs 'Additional content defined by implementations' |
| Information | StructureDefinition.definition | Values for definition differ: 'An Extension' vs 'May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.' |
| Information | StructureDefinition.requirements | Values for requirements differ: 'Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/6.0.0-ballot2/extensibility.html#modifierExtension).' vs 'Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://build.fhir.org/extensibility.html#modifierExtension).' |
| Information | StructureDefinition.requirements | Values for requirements differ: 'Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/6.0.0-ballot2/extensibility.html#modifierExtension).' vs 'Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://build.fhir.org/extensibility.html#modifierExtension).' |
| Information | StructureDefinition.short | Values for short differ: 'n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4' vs 'Classifier used for clinical trials' |
| Information | ResearchStudy.phase | Example/preferred bindings differ at ResearchStudy.phase using binding from SystematicReview |
| Information | ResearchStudy.studyDesign | Example/preferred bindings differ at ResearchStudy.studyDesign using binding from SystematicReview |
| Information | StructureDefinition.definition | Values for definition differ: 'The condition that is the focus of the study. For example, In a study to examine risk factors for Lupus, might have as an inclusion criterion 'healthy volunteer', but the target condition code would be a Lupus SNOMED code.' vs 'The condition that is the focus of the study. For example, In a study to examine risk factors for Lupus, might have as an inclusion criterion 'healthy volunteer', but the target condition code would be a Lupus SNOMED code.' |
| Information | StructureDefinition.requirements | Values for requirements differ: 'Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/6.0.0-ballot2/extensibility.html#modifierExtension).' vs 'Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://build.fhir.org/extensibility.html#modifierExtension).' |
| Information | StructureDefinition.short | Values for short differ: 'sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-director | study-chair' vs 'sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-chair | irb | data-monitoring' |
| Information | StructureDefinition.short | Values for short differ: 'Status of study with time for that status' vs 'Dates for status changes for the conduct of the study, or study registry and administrative actions' |
| Information | StructureDefinition.definition | Values for definition differ: 'Status of study with time for that status.' vs 'Dates for status changes for the conduct of the study, or study registry and administrative actions.' |
| Information | StructureDefinition.requirements | Values for requirements differ: 'Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/6.0.0-ballot2/extensibility.html#modifierExtension).' vs 'Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://build.fhir.org/extensibility.html#modifierExtension).' |
| Information | StructureDefinition.requirements | Values for requirements differ: 'Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/6.0.0-ballot2/extensibility.html#modifierExtension).' vs 'Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://build.fhir.org/extensibility.html#modifierExtension).' |
| Information | StructureDefinition.definition | Values for definition differ: 'Inclusion and exclusion criteria.' vs 'Inclusion and exclusion criteria. The referenced Group Resource should have a membership element value of either 'definitional' or 'conceptual'.' |
| Information | StructureDefinition.definition | Values for definition differ: 'Group of participants who were enrolled in study.' vs 'Group of participants who were enrolled in study. The referenced Group Resource should have a membership element value of 'enumerated'.' |
| Information | StructureDefinition.short | Values for short differ: 'Extension' vs 'Additional content defined by implementations' |
| Information | StructureDefinition.definition | Values for definition differ: 'An Extension' vs 'May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.' |
| Information | StructureDefinition.requirements | Values for requirements differ: 'Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/6.0.0-ballot2/extensibility.html#modifierExtension).' vs 'Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://build.fhir.org/extensibility.html#modifierExtension).' |
| Information | StructureDefinition.short | Values for short differ: 'Label for study comparisonGroup' vs 'A simple label for the comparison Group' |
| Information | StructureDefinition.definition | Values for definition differ: 'Unique, human-readable label for this comparisonGroup of the study.' vs 'A simple label for the comparison Group.' |
| Information | ResearchStudy.comparisonGroup.name | Element minimum cardinalities differ: '1' vs '0' |
| Information | StructureDefinition.short | Values for short differ: 'Short explanation of study path' vs 'Description of the comparison Group' |
| Information | StructureDefinition.definition | Values for definition differ: 'A succinct description of the path through the study that would be followed by a subject adhering to this comparisonGroup.' vs 'Description of the comparison Group.' |
| Information | StructureDefinition.short | Values for short differ: 'Group of participants who were enrolled in study comparisonGroup' vs 'Group of participants who were enrolled in the comparison group' |
| Information | StructureDefinition.definition | Values for definition differ: 'Group of participants who were enrolled in study comparisonGroup.' vs 'Group of participants who were enrolled in the comparison group as a subset of those enrolled in the overall study. The referenced Group Resource should have a membership element value of 'enumerated'.' |
| Information | StructureDefinition.short | Values for short differ: 'Extension' vs 'Additional content defined by implementations' |
| Information | StructureDefinition.definition | Values for definition differ: 'An Extension' vs 'May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.' |
| Information | StructureDefinition.requirements | Values for requirements differ: 'Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/6.0.0-ballot2/extensibility.html#modifierExtension).' vs 'Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://build.fhir.org/extensibility.html#modifierExtension).' |
| Information | ResearchStudy.objective.type | Example/preferred bindings differ at ResearchStudy.objective.type using binding from SystematicReview |
| Information | StructureDefinition.definition | Values for definition differ: '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).' vs '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).' |
| Information | StructureDefinition.definition | Values for definition differ: '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.gov.' vs '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.gov.' |
| Error | ResearchStudy.result | Type Mismatch: Reference([CanonicalType[http://hl7.org/fhir/StructureDefinition/Citation], CanonicalType[http://hl7.org/fhir/StructureDefinition/Composition], CanonicalType[http://hl7.org/fhir/StructureDefinition/DiagnosticReport]]) vs Reference([CanonicalType[http://hl7.org/fhir/StructureDefinition/Composition|6.0.0-ballot5], CanonicalType[http://hl7.org/fhir/StructureDefinition/DiagnosticReport|6.0.0-ballot5], CanonicalType[http://hl7.org/fhir/StructureDefinition/DocumentReference|6.0.0-ballot5], CanonicalType[http://hl7.org/fhir/StructureDefinition/Evidence|6.0.0-ballot5]]) |
| Name | Value | Comments | |
|---|---|---|---|
| abstract | false | ||
| baseDefinition | http://hl7.org/fhir/StructureDefinition/ResearchStudy | ||
| copyright | |||
| date | 2025-03-28T17:11:38+00:00 | 2026-09-10T16:38:22+00:00 |
|
| description | Profile of ResearchStudy for Evidence Based Medicine IG. The SystematicReview Profile is used for a scientific study based on a protocol that includes search and selection of eligible studies, study quality assessment, data extraction, and synthesis. | ||
| experimental | |||
| fhirVersion | 6.0.0-ballot2 | 6.0.0-ballot5 |
|
| jurisdiction | |||
| jurisdiction[0] | http://unstats.un.org/unsd/methods/m49/m49.htm#001 | ||
| kind | resource | ||
| name | SystematicReview | ||
| publisher | HL7 International / Clinical Decision Support | ||
| purpose | |||
| status | draft | active |
|
| title | |||
| type | ResearchStudy | ||
| url | http://hl7.org/fhir/uv/ebm/StructureDefinition/systematic-review | ||
| version | 1.0.0-ballot2 | 1.0.0-ballot3 |
|
| Name | L Flags | L Card. | L Type | L Description & Constraints | R Flags | R Card. | R Type | R Description & Constraints | Comments | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
 ResearchStudy | 0..* | ResearchStudy | Investigation to increase healthcare-related patient-independent knowledge | 0..* | ResearchStudy | Investigation to increase healthcare-related patient-independent knowledge | |||||||||||
 id | Σ | 0..1 | id | Logical id of this artifact | Σ | 0..1 | id | Logical id of this artifact | |||||||||
| meta | Σ | 0..1 | Meta | Metadata about the resource | Σ | 0..1 | Meta | Metadata about the resource | |||||||||
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ?!Σ | 0..1 | uri | A set of rules under which this content was created | |||||||||
| language | 0..1 | code | Language of the resource content Binding: ?? (required): IETF language tag for a human language
| 0..1 | code | Language of the resource content Binding: ?? (required): IETF language tag for a human language
| |||||||||||
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements | 0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements | |||||||||||
| contained | 0..* | Resource | Contained, inline Resources | 0..* | Resource | Contained, inline Resources | |||||||||||
 Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||||||||
 modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored | ?!Σ | 0..* | Extension | Extensions that cannot be ignored Slice: Unordered, Open by value:url | |||||||||
| url | 0..1 | uri | Canonical identifier for this study resource | 0..1 | uri | Canonical identifier for this study resource | |||||||||||
| identifier | Σ | 0..* | Identifier | Business Identifier for study | Σ | 0..* | Identifier | Business Identifier for study | |||||||||
| version | 0..1 | string | The business version for the study record | 0..1 | string | The business version for the study record | |||||||||||
| name | 0..1 | string | Name for this study (computer friendly) | 0..1 | string | Name for this study (computer friendly) | |||||||||||
| title | Σ | 0..1 | string | Human readable name of the study | Σ | 0..1 | string | Human readable name of the study | |||||||||
 label | 0..* | BackboneElement | Additional names for the study | 0..* | BackboneElement | Additional names for the study | |||||||||||
 id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||||||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url | |||||||||
| type | 0..1 | CodeableConcept | primary | official | scientific | plain-language | subtitle | short-title | acronym | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid Binding: ?? (extensible): desc. | 0..1 | CodeableConcept | primary | official | scientific | plain-language | subtitle | short-title | acronym | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid Binding: ?? (preferred): desc. | |||||||||||
| value | 0..1 | string | The name | 0..1 | string | The name | |||||||||||
| language | 0..1 | code | Used to express the specific language Binding: ?? (required): IETF language tag for a human language
|
| |||||||||||||
| protocol | Σ | 0..* | Reference(PlanDefinition) | Steps followed in executing study | Σ | 0..* | Reference(PlanDefinition) | Steps followed in executing study | |||||||||
| partOf | Σ | 0..* | Reference(ResearchStudy) | Part of larger study | Σ | 0..* | Reference(ResearchStudy) | Part of larger study | |||||||||
| relatedArtifact | 0..* | RelatedArtifact | References, URLs, and attachments |
| |||||||||||||
| date | 0..1 | dateTime | Date the resource last changed | 0..1 | dateTime | Date the resource last changed | |||||||||||
| status | ?!Σ | 1..1 | code | draft | active | retired | unknown Binding: ?? (required): Codes that convey the current publication status of the research study resource. | ?!Σ | 1..1 | code | draft | active | retired | unknown Binding: ?? (required): Codes that convey the current publication status of the research study resource. | |||||||||
| primaryPurposeType | Σ | 0..1 | CodeableConcept | treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility Binding: ?? (preferred): Codes for the main intent of the study. |
| ||||||||||||
| phase | Σ | 0..0 | n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 Binding: ?? (example): Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation. | Σ | 0..0 | Classifier used for clinical trials Binding: ?? (preferred): Classifiers of clinical trial progression for human use. |
| ||||||||||
| studyDesign | Σ | 0..* | CodeableConcept | Classifications of the study design characteristics Binding: ?? (preferred): This is a set of terms for study design characteristics. | Σ | 0..* | CodeableConcept | Classifications of the study design characteristics Binding: ?? (preferred): This is a set of terms for study design characteristics. |
| ||||||||
| focus | 0..* | CodeableReference(Medication | MedicinalProductDefinition | SubstanceDefinition | EvidenceVariable) | Drugs, devices, etc. under study Binding: ?? (example): Common codes of research study focus | 0..* | CodeableReference(Medication | MedicinalProductDefinition | SubstanceDefinition | DeviceDefinition | PlanDefinition) | Drugs, devices, etc. under study Binding: ?? (example): Some example codes of research study focus | |||||||||||
| condition | Σ | 0..* | CodeableConcept | Condition being studied Binding: ?? (example): Identification of the condition or diagnosis. | Σ | 0..* | CodeableConcept | Condition being studied Binding: ?? (example): Identification of the condition or diagnosis. | |||||||||
| keyword | Σ | 0..* | CodeableConcept | Used to search for the study Binding Description: (example): Words associated with the study that may be useful in discovery. | Σ | 0..* | CodeableConcept | Used to search for the study Binding: ?? (example): Some example codes. | |||||||||
| region | Σ | 0..* | CodeableConcept | Geographic area for the study Binding: ?? (extensible): Countries and regions within which this artifact is targeted for use. | Σ | 0..* | CodeableConcept | Geographic area for the study Binding: ?? (preferred): Countries and regions within which this artifact is targeted for use. | |||||||||
| descriptionSummary | 0..1 | markdown | Brief text explaining the study | 0..1 | markdown | Brief text explaining the study | |||||||||||
| description | 0..1 | markdown | Detailed narrative of the study | 0..1 | markdown | Detailed narrative of the study | |||||||||||
| period | Σ | 0..1 | Period | When the study began and ended | Σ | 0..1 | Period | When the study began and ended | |||||||||
| site | Σ | 0..* | Reference(Location | ResearchStudy | Organization) | Facility where study activities are conducted | Σ | 0..* | Reference(Location | ResearchStudy | Organization) | Facility where study activities are conducted | |||||||||
| note | 0..* | Annotation | Comments made about the study | 0..* | Annotation | Comments made about the study | |||||||||||
| classifier | 0..* | CodeableConcept | Classification for the study Binding: ?? (example): desc. | 0..* | CodeableConcept | Classification for the study Binding: ?? (example): desc. | |||||||||||
| associatedParty | 0..* | BackboneElement | Sponsors, collaborators, and other parties | 0..* | BackboneElement | Sponsors, collaborators, and other parties | |||||||||||
| id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||||||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url | |||||||||
| name | 0..1 | string | Name of associated party | 0..1 | string | 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 Binding: ?? (extensible): desc. | 1..1 | CodeableConcept | sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-chair | irb | data-monitoring Binding: ?? (preferred): This is a ResearchStudy's party role. | |||||||||||
| period | 0..* | Period | When active in the role | 0..* | Period | When active in the role | |||||||||||
| classifier | 0..* | CodeableConcept | nih | fda | government | nonprofit | academic | industry Binding: ?? (example): A characterization or type of the entity. | 0..* | CodeableConcept | nih | fda | government | nonprofit | academic | industry Binding: ?? (example): A characterization or type of the entity. | |||||||||||
| party | 0..1 | Reference(Practitioner | PractitionerRole | Organization) | Individual or organization associated with study (use practitionerRole to specify their organisation) | 0..1 | Reference(Practitioner | PractitionerRole | Organization) | Individual or organization associated with study (use practitionerRole to specify their organisation) | |||||||||||
| progressStatus | 0..* | BackboneElement | Status of study with time for that status | 0..* | BackboneElement | Dates for status changes for the conduct of the study, or study registry and administrative actions | |||||||||||
| id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||||||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url | |||||||||
| state | 1..1 | CodeableConcept | Label for status or state (e.g. recruitment status) Binding: ?? (extensible): defn. | 1..1 | CodeableConcept | Label for status or state (e.g. recruitment status) Binding: ?? (preferred): Codes that convey the current status of the research study. | |||||||||||
| actual | 0..1 | boolean | Actual if true else anticipated | 0..1 | boolean | Actual if true else anticipated | |||||||||||
| period | 0..1 | Period | Date range | 0..1 | Period | Date range | |||||||||||
| whyStopped | Σ | 0..1 | CodeableConcept | accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design Binding: ?? (example): Codes for why the study ended prematurely. | Σ | 0..1 | CodeableConcept | accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design Binding: ?? (example): Codes for why the study ended prematurely. | |||||||||
| recruitment | Σ | 0..0 | Target or actual group of participants enrolled in study | Σ | 0..0 | Target or actual group of participants enrolled in study | |||||||||||
| id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||||||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url | |||||||||
| targetNumber | 0..1 | unsignedInt | Estimated total number of participants to be enrolled | 0..1 | unsignedInt | Estimated total number of participants to be enrolled | |||||||||||
| actualNumber | 0..1 | unsignedInt | Actual total number of participants enrolled in study | 0..1 | unsignedInt | Actual total number of participants enrolled in study | |||||||||||
| eligibility | 0..1 | Reference(Group | EvidenceVariable) | Inclusion and exclusion criteria | 0..1 | Reference(Group) | Inclusion and exclusion criteria | |||||||||||
| actualGroup | Σ | 0..1 | Reference(Group) | Group of participants who were enrolled in study | Σ | 0..1 | Reference(Group) | Group of participants who were enrolled in study | |||||||||
| description | 0..1 | markdown | Description of the recruitment |
| |||||||||||||
| comparisonGroup | 0..* | BackboneElement | Defined path through the study for a subject | 0..* | BackboneElement | Defined path through the study for a subject | |||||||||||
| id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
| Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||||||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url | |||||||||
| linkId | 0..1 | id | Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily |
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| name | 1..1 | string | Label for study comparisonGroup | 0..1 | string | A simple label for the comparison Group |
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| type | 0..1 | CodeableConcept | Categorization of study comparisonGroup Binding: ?? (extensible): desc. |
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| description | 0..1 | markdown | Short explanation of study path | 0..1 | markdown | Description of the comparison Group | |||||||||||
| intendedExposure | 0..* | Reference(EvidenceVariable) | Interventions or exposures in this comparisonGroup or cohort |
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| observedGroup | 0..1 | Reference(Group) | Group of participants who were enrolled in study comparisonGroup | 0..1 | Reference(Group) | Group of participants who were enrolled in the comparison group | |||||||||||
| targetNumber | 0..1 | unsignedInt | Estimated total number of participants to be enrolled in the comparison group |
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| actualNumber | 0..1 | unsignedInt | Actual total number of participants enrolled in the comparison group |
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| eligibility | 0..1 | Reference(Group) | Inclusion and exclusion criteria for the comparison group |
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| objective | 0..* | BackboneElement | A goal for the study | 0..* | BackboneElement | A goal for the study | |||||||||||
| id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
| Slices for extension | 0..* | Extension | Extension Slice: Unordered, Open by value:url | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||||||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url | |||||||||
| name | 0..1 | string | Label for the objective | 0..1 | string | Label for the objective | |||||||||||
| type | 0..1 | CodeableConcept | primary | secondary | exploratory Binding: ?? (preferred): Codes for the kind of study objective. | 0..1 | CodeableConcept | primary | secondary | exploratory Binding: ?? (preferred): Codes for the kind of study objective. |
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| description | 0..1 | markdown | Description of the objective | 0..1 | markdown | Description of the objective | |||||||||||
| outcomeMeasure | 0..* | BackboneElement | A variable measured during the study |
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| outcomeMeasure | 0..* | BackboneElement | A variable measured during the study |
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| result | Σ | 0..* | Reference(Citation | Composition | DiagnosticReport) | Link to results generated during the study | Σ | 0..* | Reference(Composition | DiagnosticReport | DocumentReference | Evidence) | Link to results generated during the study |
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| citeAs | 0..1 | markdown | How to cite this ResearchStudy |
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| relatesTo | 0..* | BackboneElement | Relationships to other Resources |
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| purposeType | Σ | 0..* | CodeableConcept | treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility Binding: ?? (preferred): Codes for the main intent of the study. |
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| Documentation for this format | |||||||||||||||||