abstractbaseDefinitioncopyrightdate- Values Differ
descriptionexperimentalfhirVersion- Values Differ
jurisdiction
jurisdiction[0]kindnamepublisher- Values Differ
purposestatustitletypeurlversion- 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' vs '2.0.0-ballot' |
| Information | StructureDefinition.date | Values for date differ: '2023-04-18T16:36:07+00:00' vs '2026-04-06T15:01:51+00:00' |
| Information | StructureDefinition.publisher | Values for publisher differ: 'HL7 International - Biomedical Research & Regulation Work Group' vs 'HL7 International / Biomedical Research and Regulation' |
| Warning | StructureDefinition.fhirVersion | Values for fhirVersion differ: '4.0.1' vs '6.0.0-ballot3' |
| Information | StructureDefinition.definition | Values for definition differ: '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.' 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: 'The only time that a resource does not have an id is when it is being submitted to the server using a create operation.' 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 resouce id depends on the given use case.' |
| Information | StructureDefinition.comment | Values for comment differ: 'Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.' vs 'Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.' |
| Information | StructureDefinition.comment | Values for comment differ: 'Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a 'text blob' or where text is additionally entered raw or narrated and encoded information is added later.' vs 'Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a 'text blob' or where text is additionally entered raw or narrated and encoded information is added later.' |
| Information | StructureDefinition.definition | Values for definition differ: 'These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.' vs 'These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.' |
| 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.definition | Values for definition differ: '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 manageable, 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.' 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.definition | Values for definition differ: 'May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).' vs 'May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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 is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).' |
| 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/R4/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: 'Name for this study' vs 'Human readable name of the study' |
| Information | StructureDefinition.definition | Values for definition differ: 'A short, descriptive user-friendly label for the study.' vs 'The human readable name of the research study.' |
| Information | StructureDefinition.short | Values for short differ: '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' vs 'draft | active | retired | unknown' |
| Information | StructureDefinition.definition | Values for definition differ: 'The current state of the study.' vs 'The publication state of the resource (not of the study).' |
| Information | StructureDefinition.definition | Values for definition differ: 'The type of study based upon the intent of the study's activities. A classification of the intent of the study.' vs 'The type of study based upon the intent of the study activities. A classification of the intent of the study.' |
| 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 ResearchStudySoa |
| Warning | ResearchStudy.focus | Elements differ in definition for mustSupport: 'true' vs 'false' |
| Information | StructureDefinition.short | Values for short differ: 'What this is study doing' vs 'Detailed narrative of the study' |
| Information | StructureDefinition.definition | Values for definition differ: 'A full description of how the study is being conducted.' vs 'A detailed and human-readable narrative of the study. E.g., study abstract.' |
| Warning | ResearchStudy.objective | Elements differ in definition for mustSupport: 'true' vs 'false' |
| Information | StructureDefinition.definition | Values for definition differ: '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 manageable, 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.' 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.definition | Values for definition differ: 'May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, 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. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).' vs 'May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).' |
| 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/R4/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).' |
| Warning | ResearchStudy.objective.name | Elements differ in definition for mustSupport: 'true' vs 'false' |
| Warning | ResearchStudy.objective.type | Elements differ in definition for mustSupport: 'true' vs 'false' |
| Information | ResearchStudy.objective.type | Example/preferred bindings differ at ResearchStudy.objective.type using binding from ResearchStudySoa |
| Name | Value | Comments | |
|---|---|---|---|
| abstract | false | ||
| baseDefinition | http://hl7.org/fhir/StructureDefinition/ResearchStudy | ||
| copyright | |||
| date | 2023-04-18T16:36:07+00:00 | 2026-04-06T15:01:51+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 | 6.0.0-ballot3 |
|
| 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 | HL7 International / Biomedical Research and Regulation |
|
| purpose | |||
| status | active | ||
| title | |||
| type | ResearchStudy | ||
| url | http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/ResearchStudySoa | ||
| version | 1.0.0 | 2.0.0-ballot |
|
| 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: ?? (preferred): 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 | |||||||||||
 extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
 modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored | ?!Σ | 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 | Human readable name of the 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 | draft | active | retired | unknown Binding: ?? (required): Codes that convey the current publication status of the research study resource. | |||||||||
| 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: ?? (preferred): 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 | Classifier used for clinical trials Binding: ?? (preferred): Classifiers of clinical trial progression for human use. |
| ||||||||
| category | SΣ | 0..* | CodeableConcept | Classifications for the study Binding Description: (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 Description: (example): Codes for medications, devices and other interventions. | 0..* | CodeableReference(Medication | MedicinalProductDefinition | SubstanceDefinition | DeviceDefinition | PlanDefinition) | Drugs, devices, etc. under study Binding: ?? (example): Some example codes of research study focus |
| |||||||||
| 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 |
| ||||||||||||
| relatedArtifact | S | 0..* | RelatedArtifact | References and dependencies |
| ||||||||||||
| keyword | SΣ | 0..* | CodeableConcept | Used to search for the study Binding Description: (example): Words associated with the study that may be useful in discovery. | SΣ | 0..* | CodeableConcept | Used to search for the study Binding: ?? (example): Some example codes. | |||||||||
| location | 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 | Detailed narrative of the study | |||||||||
| enrollment | 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 |
| ||||||||||||
| principalInvestigator | 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 | ResearchStudy | Organization) | 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. |
| ||||||||||||
| 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 |
| ||||||||||||
 objective | S | 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 | |||||||||||
| 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 | 0..1 | string | Label for the objective |
| |||||||||
| type | S | 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. |
| |||||||||
| description | 0..1 | markdown | Description of the objective |
| |||||||||||||
| outcomeMeasure | 0..* | BackboneElement | A variable measured during the study |
| |||||||||||||
| url | 0..1 | uri | Canonical identifier for this study resource |
| |||||||||||||
| version | 0..1 | string | The business version for the study record |
| |||||||||||||
| name | 0..1 | string | Name for this study (computer friendly) |
| |||||||||||||
| label | 0..* | BackboneElement | Additional names for the study |
| |||||||||||||
| citeAs | 0..1 | markdown | How to cite this ResearchStudy |
| |||||||||||||
| relatesTo | 0..* | BackboneElement | Relationships to other Resources |
| |||||||||||||
| date | 0..1 | dateTime | Date the resource last changed |
| |||||||||||||
| studyDesign | Σ | 0..* | CodeableConcept | Classifications of the study design characteristics Binding: ?? (preferred): This is a set of terms for study design characteristics. |
| ||||||||||||
| region | Σ | 0..* | CodeableConcept | Geographic area for the study Binding: ?? (extensible): Countries and regions within which this artifact is targeted for use. |
| ||||||||||||
| descriptionSummary | 0..1 | markdown | Brief text explaining the study |
| |||||||||||||
| classifier | 0..* | CodeableConcept | Classification for the study Binding: ?? (example): desc. |
| |||||||||||||
| associatedParty | 0..* | BackboneElement | Sponsors, collaborators, and other parties |
| |||||||||||||
| progressStatus | 0..* | BackboneElement | Status of study with time for that status |
| |||||||||||||
| 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. |
| ||||||||||||
| recruitment | Σ | 0..1 | BackboneElement | Target or actual group of participants enrolled in study |
| ||||||||||||
| comparisonGroup | 0..* | BackboneElement | Defined path through the study for a subject |
| |||||||||||||
| result | Σ | 0..* | Reference(Citation | Composition | DiagnosticReport | Evidence) | Link to results generated during the study |
| ||||||||||||
| Documentation for this format | |||||||||||||||||