abstractbaseDefinitioncopyrightdate- Values Differ
descriptionexperimentalfhirVersionjurisdiction
jurisdiction[0]kindnamepublisherpurposestatustitletypeurlversion- Values Differ
| Left: | ResearchStudySoa (http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/ResearchStudySoa) |
| Right: | ResearchStudySoa (http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/ResearchStudySoa) |
| Error | StructureDefinition.version | Values for version differ: '1.0.0-ballot' vs '1.0.0' |
| Information | StructureDefinition.date | Values for date differ: '2022-12-04T20:07:19+00:00' vs '2023-04-18T16:36:07+00:00' |
| Name | Value | Comments | |
|---|---|---|---|
| abstract | false | ||
| baseDefinition | http://hl7.org/fhir/StructureDefinition/ResearchStudy | ||
| copyright | |||
| date | 2022-12-04T20:07:19+00:00 | 2023-04-18T16:36:07+00:00 |
|
| description | A profile that lists the data elements of a Research Study that must be supported when used to schedule activities. | ||
| experimental | |||
| fhirVersion | 4.0.1 | ||
| jurisdiction | |||
| jurisdiction[0] | http://unstats.un.org/unsd/methods/m49/m49.htm#001 | ||
| kind | resource | ||
| name | ResearchStudySoa | ||
| publisher | HL7 International - Biomedical Research & Regulation Work Group | ||
| purpose | |||
| status | active | ||
| title | |||
| type | ResearchStudy | ||
| url | http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/ResearchStudySoa | ||
| version | 1.0.0-ballot | 1.0.0 |
|
| Name | L Flags | L Card. | L Type | L Description & Constraints | R Flags | R Card. | L Type | L 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: ?? (preferred): A human language.
| 0..1 | code | Language of the resource content Binding: ?? (preferred): A human language.
| |||||||||||
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||||||||
| contained | 0..* | Resource | Contained, inline Resources | 0..* | Resource | Contained, inline Resources | |||||||||||
 extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
 modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored | ?! | 0..* | Extension | Extensions that cannot be ignored | |||||||||
| identifier | SΣ | 0..* | Identifier | Business Identifier for study | SΣ | 0..* | Identifier | Business Identifier for study | |||||||||
| title | SΣ | 0..1 | string | Name for this study | SΣ | 0..1 | string | Name for this study | |||||||||
| protocol | SΣ | 0..* | Reference(StudyProtocolSoa) | Steps followed in executing study | SΣ | 0..* | Reference(StudyProtocolSoa) | Steps followed in executing study | |||||||||
| partOf | Σ | 0..* | Reference(ResearchStudy) | Part of larger study | Σ | 0..* | Reference(ResearchStudy) | Part of larger study | |||||||||
| status | ?!SΣ | 1..1 | code | 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 Binding: ?? (required): Codes that convey the current status of the research study. | ?!SΣ | 1..1 | code | 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 Binding: ?? (required): Codes that convey the current status of the research study. | |||||||||
| primaryPurposeType | SΣ | 0..1 | CodeableConcept | treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility Binding: ?? (extensible): Codes for the main intent of the study. | SΣ | 0..1 | CodeableConcept | treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility Binding: ?? (extensible): Codes for the main intent of the study. | |||||||||
| phase | SΣ | 0..1 | CodeableConcept | 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. | SΣ | 0..1 | CodeableConcept | 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. | |||||||||
| category | SΣ | 0..* | CodeableConcept | Classifications for the study Binding: ?? (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc. | SΣ | 0..* | CodeableConcept | Classifications for the study Binding: ?? (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc. | |||||||||
| focus | SΣ | 0..* | CodeableConcept | Drugs, devices, etc. under study Binding: ?? (example): Codes for medications, devices and other interventions. | SΣ | 0..* | CodeableConcept | Drugs, devices, etc. under study Binding: ?? (example): Codes for medications, devices and other interventions. | |||||||||
| condition | SΣ | 0..* | CodeableConcept | Condition being studied Binding: ?? (example): Identification of the condition or diagnosis. | SΣ | 0..* | CodeableConcept | Condition being studied Binding: ?? (example): Identification of the condition or diagnosis. | |||||||||
| contact | SΣ | 0..* | ContactDetail | Contact details for the study | SΣ | 0..* | ContactDetail | Contact details for the study | |||||||||
| relatedArtifact | S | 0..* | RelatedArtifact | References and dependencies | S | 0..* | RelatedArtifact | References and dependencies | |||||||||
| keyword | SΣ | 0..* | CodeableConcept | Used to search for the study Binding: ?? (example): Words associated with the study that may be useful in discovery. | SΣ | 0..* | CodeableConcept | Used to search for the study Binding: ?? (example): Words associated with the study that may be useful in discovery. | |||||||||
| location | Σ | 0..* | CodeableConcept | Geographic region(s) for study Binding: ?? (extensible): Countries and regions within which this artifact is targeted for use. | Σ | 0..* | CodeableConcept | Geographic region(s) for study Binding: ?? (extensible): Countries and regions within which this artifact is targeted for use. | |||||||||
| description | S | 0..1 | markdown | What this is study doing | S | 0..1 | markdown | What this is study doing | |||||||||
| enrollment | Σ | 0..* | Reference(Group) | Inclusion & exclusion criteria | Σ | 0..* | Reference(Group) | Inclusion & exclusion criteria | |||||||||
| period | Σ | 0..1 | Period | When the study began and ended | Σ | 0..1 | Period | When the study began and ended | |||||||||
| sponsor | SΣ | 0..1 | Reference(Organization) | Organization that initiates and is legally responsible for the study | SΣ | 0..1 | Reference(Organization) | Organization that initiates and is legally responsible for the study | |||||||||
| principalInvestigator | SΣ | 0..1 | Reference(Practitioner | PractitionerRole) | Researcher who oversees multiple aspects of the study | SΣ | 0..1 | Reference(Practitioner | PractitionerRole) | Researcher who oversees multiple aspects of the study | |||||||||
| site | Σ | 0..* | Reference(Location) | Facility where study activities are conducted | Σ | 0..* | Reference(Location) | Facility where study activities are conducted | |||||||||
| reasonStopped | SΣ | 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. | SΣ | 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. | |||||||||
| note | 0..* | Annotation | Comments made about the study | 0..* | Annotation | Comments made about the study | |||||||||||
 arm | S | 0..* | BackboneElement | Defined path through the study for a subject | S | 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 | |||||||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
| name | S | 1..1 | string | Label for study arm | S | 1..1 | string | Label for study arm | |||||||||
| type | S | 0..1 | CodeableConcept | Categorization of study arm | S | 0..1 | CodeableConcept | Categorization of study arm | |||||||||
| description | S | 0..1 | string | Short explanation of study path | S | 0..1 | string | Short explanation of study path | |||||||||
 objective | S | 0..* | BackboneElement | A goal for the study | S | 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 | |||||||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
| name | S | 0..1 | string | Label for the objective | S | 0..1 | string | Label for the objective | |||||||||
| type | S | 0..1 | CodeableConcept | primary | secondary | exploratory Binding: ?? (preferred): Codes for the kind of study objective. | S | 0..1 | CodeableConcept | primary | secondary | exploratory Binding: ?? (preferred): Codes for the kind of study objective. | |||||||||
| Documentation for this format | |||||||||||||||||