| 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 '2025-12-12T11:10:49+00:00' |
| Warning | StructureDefinition.fhirVersion | Values for fhirVersion differ: '6.0.0-ballot2' vs '6.0.0-ballot3' |
| 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 scientific study intended to increase health-related knowledge. 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.' |
| 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: '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.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 | ResearchStudy.primaryPurposeType | Example/preferred bindings differ at ResearchStudy.primaryPurposeType using binding from SystematicReview |
| 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.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' |
| 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: '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 |
| Name | Value | Comments | |
|---|---|---|---|
abstract | false | ||
baseDefinition | http://hl7.org/fhir/StructureDefinition/ResearchStudy | ||
copyright | |||
date | 2025-03-28T17:11:38+00:00 | 2025-12-12T11:10:49+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-ballot3 |
|
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![]() | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
![]() | 0..* | ResearchStudy | Investigation to increase healthcare-related patient-independent knowledge | 0..* | ResearchStudy | Investigation to increase healthcare-related patient-independent knowledge | |||||||||||
![]() ![]() | Σ | 0..1 | id | Logical id of this artifact | Σ | 0..1 | id | Logical id of this artifact | |||||||||
![]() ![]() | Σ | 0..1 | Meta | Metadata about the resource | Σ | 0..1 | Meta | Metadata about the resource | |||||||||
![]() ![]() | ?!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 | |||||||||
![]() ![]() | 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
| |||||||||||
![]() ![]() | 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 | |||||||||||
![]() ![]() | 0..* | Resource | Contained, inline Resources | 0..* | Resource | Contained, inline Resources | |||||||||||
![]() ![]() | 0..* | Extension | Extension Slice: Unordered, Open by value:url | 0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||||||||
![]() ![]() | ?!Σ | 0..* | Extension | Extensions that cannot be ignored | ?!Σ | 0..* | Extension | Extensions that cannot be ignored | |||||||||
![]() ![]() | 0..1 | uri | Canonical identifier for this study resource | 0..1 | uri | Canonical identifier for this study resource | |||||||||||
![]() ![]() | Σ | 0..* | Identifier | Business Identifier for study | Σ | 0..* | Identifier | Business Identifier for study | |||||||||
![]() ![]() | 0..1 | string | The business version for the study record | 0..1 | string | The business version for the study record | |||||||||||
![]() ![]() | 0..1 | string | Name for this study (computer friendly) | 0..1 | string | Name for this study (computer friendly) | |||||||||||
![]() ![]() | Σ | 0..1 | string | Human readable name of the study | Σ | 0..1 | string | Human readable name of the study | |||||||||
![]() ![]() | 0..* | BackboneElement | Additional names for the study | 0..* | BackboneElement | Additional names for the study | |||||||||||
![]() ![]() ![]() | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
![]() ![]() ![]() | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
![]() ![]() ![]() | 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: ?? (extensible): desc. | |||||||||||
![]() ![]() ![]() | 0..1 | string | The name | 0..1 | string | The name | |||||||||||
![]() ![]() | Σ | 0..* | Reference(PlanDefinition) | Steps followed in executing study | Σ | 0..* | Reference(PlanDefinition) | Steps followed in executing study | |||||||||
![]() ![]() | Σ | 0..* | Reference(ResearchStudy) | Part of larger study | Σ | 0..* | Reference(ResearchStudy) | Part of larger study | |||||||||
![]() ![]() | 0..* | RelatedArtifact | References, URLs, and attachments |
| |||||||||||||
![]() ![]() | 0..1 | dateTime | Date the resource last changed | 0..1 | dateTime | Date the resource last changed | |||||||||||
![]() ![]() | ?!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. | |||||||||
![]() ![]() | 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. | 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. |
| ||||||||
![]() ![]() | 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. |
| ||||||||||
![]() ![]() | 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. |
| ||||||||
![]() ![]() | 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 | |||||||||||
![]() ![]() | 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. | |||||||||
![]() ![]() | 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. | |||||||||
![]() ![]() | 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: ?? (extensible): Countries and regions within which this artifact is targeted for use. | |||||||||
![]() ![]() | 0..1 | markdown | Brief text explaining the study | 0..1 | markdown | Brief text explaining the study | |||||||||||
![]() ![]() | 0..1 | markdown | Detailed narrative of the study | 0..1 | markdown | Detailed narrative of the study | |||||||||||
![]() ![]() | Σ | 0..1 | Period | When the study began and ended | Σ | 0..1 | Period | When the study began and ended | |||||||||
![]() ![]() | Σ | 0..* | Reference(Location | ResearchStudy | Organization) | Facility where study activities are conducted | Σ | 0..* | Reference(Location | ResearchStudy | Organization) | Facility where study activities are conducted | |||||||||
![]() ![]() | 0..* | Annotation | Comments made about the study | 0..* | Annotation | Comments made about the study | |||||||||||
![]() ![]() | 0..* | CodeableConcept | Classification for the study Binding: ?? (example): desc. | 0..* | CodeableConcept | Classification for the study Binding: ?? (example): desc. | |||||||||||
![]() ![]() | 0..* | BackboneElement | Sponsors, collaborators, and other parties | 0..* | BackboneElement | Sponsors, collaborators, and other parties | |||||||||||
![]() ![]() ![]() | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
![]() ![]() ![]() | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
![]() ![]() ![]() | 0..1 | string | Name of associated party | 0..1 | string | Name of associated party | |||||||||||
![]() ![]() ![]() | 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 Binding: ?? (extensible): desc. | |||||||||||
![]() ![]() ![]() | 0..* | Period | When active in the role | 0..* | Period | When active in the role | |||||||||||
![]() ![]() ![]() | 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. | |||||||||||
![]() ![]() ![]() | 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) | |||||||||||
![]() ![]() | 0..* | BackboneElement | Status of study with time for that status | 0..* | BackboneElement | Status of study with time for that status | |||||||||||
![]() ![]() ![]() | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
![]() ![]() ![]() | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
![]() ![]() ![]() | 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: ?? (extensible): defn. | |||||||||||
![]() ![]() ![]() | 0..1 | boolean | Actual if true else anticipated | 0..1 | boolean | Actual if true else anticipated | |||||||||||
![]() ![]() ![]() | 0..1 | Period | Date range | 0..1 | Period | Date range | |||||||||||
![]() ![]() | 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. | |||||||||
![]() ![]() | Σ | 0..0 | Target or actual group of participants enrolled in study | Σ | 0..0 | Target or actual group of participants enrolled in study | |||||||||||
![]() ![]() ![]() | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
![]() ![]() ![]() | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
![]() ![]() ![]() | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
![]() ![]() ![]() | 0..1 | unsignedInt | Estimated total number of participants to be enrolled | 0..1 | unsignedInt | Estimated total number of participants to be enrolled | |||||||||||
![]() ![]() ![]() | 0..1 | unsignedInt | Actual total number of participants enrolled in study | 0..1 | unsignedInt | Actual total number of participants enrolled in study | |||||||||||
![]() ![]() ![]() | 0..1 | Reference(Group | EvidenceVariable) | Inclusion and exclusion criteria | 0..1 | Reference(Group) | Inclusion and exclusion criteria | |||||||||||
![]() ![]() ![]() | 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 | |||||||||
![]() ![]() | 0..* | BackboneElement | Defined path through the study for a subject | 0..* | BackboneElement | Defined path through the study for a subject | |||||||||||
![]() ![]() ![]() | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
![]() ![]() ![]() | 0..* | Extension | Extension Slice: Unordered, Open by value:url | 0..* | Extension | Additional content defined by implementations | |||||||||||
![]() ![]() ![]() | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
![]() ![]() ![]() | 0..1 | id | Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily |
| |||||||||||||
![]() ![]() ![]() | 1..1 | string | Label for study comparisonGroup |
| |||||||||||||
![]() ![]() ![]() | 0..1 | CodeableConcept | Categorization of study comparisonGroup Binding: ?? (extensible): desc. |
| |||||||||||||
![]() ![]() ![]() | 0..1 | markdown | Short explanation of study path |
| |||||||||||||
![]() ![]() ![]() | 0..* | Reference(EvidenceVariable) | Interventions or exposures in this comparisonGroup or cohort |
| |||||||||||||
![]() ![]() ![]() | 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 | |||||||||||
![]() ![]() ![]() | 0..1 | unsignedInt | Estimated total number of participants to be enrolled in the comparison group |
| |||||||||||||
![]() ![]() ![]() | 0..1 | unsignedInt | Actual total number of participants enrolled in the comparison group |
| |||||||||||||
![]() ![]() ![]() | 0..1 | Reference(Group) | Inclusion and exclusion criteria for the comparison group |
| |||||||||||||
![]() ![]() | 0..* | BackboneElement | A goal for the study | 0..* | BackboneElement | A goal for the study | |||||||||||
![]() ![]() ![]() | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
![]() ![]() ![]() | 0..* | Extension | Extension Slice: Unordered, Open by value:url | 0..* | Extension | Additional content defined by implementations | |||||||||||
![]() ![]() ![]() | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
![]() ![]() ![]() | 0..1 | string | Label for the objective | 0..1 | string | Label for the objective | |||||||||||
![]() ![]() ![]() | 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. |
| ||||||||||
![]() ![]() ![]() | 0..1 | markdown | Description of the objective | 0..1 | markdown | Description of the objective | |||||||||||
![]() ![]() ![]() | 0..* | BackboneElement | A variable measured during the study |
| |||||||||||||
![]() ![]() | 0..* | BackboneElement | A variable measured during the study |
| |||||||||||||
![]() ![]() | Σ | 0..* | Reference(Citation | Composition | DiagnosticReport) | Link to results generated during the study | Σ | 0..* | Reference(Citation | Composition | DiagnosticReport | Evidence) | Link to results generated during the study | |||||||||
![]() ![]() | 0..1 | markdown | How to cite this ResearchStudy |
| |||||||||||||
![]() ![]() | 0..* | BackboneElement | Relationships to other Resources |
| |||||||||||||
Documentation for this format | |||||||||||||||||