Smart Bear Implementation Guide
3.2.2 - ci-build
Smart Bear Implementation Guide - Local Development build (v3.2.2). See the Directory of published versions
Active as of 2022-05-25 |
Definitions for the SmartBearResearchSubject resource profile.
1. ResearchSubject | |||||
Definition | A physical entity which is the primary unit of operational and/or administrative interest in a study. | ||||
Control | 0..* | ||||
Alternate Names | Study Subject | ||||
Comments | Need to make sure we encompass public health studies. | ||||
Invariants | Defined on this element dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (: contained.contained.empty()) dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()) dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()) dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (: contained.meta.security.empty()) dom-6: A resource should have narrative for robust management (: text.`div`.exists()) | ||||
2. ResearchSubject.id | |||||
Definition | The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. | ||||
Control | 0..1 | ||||
Type | string | ||||
Comments | The only time that a resource does not have an id is when it is being submitted to the server using a create operation. | ||||
3. ResearchSubject.meta | |||||
Definition | The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource. | ||||
Control | 0..1 | ||||
Type | Meta | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
4. ResearchSubject.implicitRules | |||||
Definition | 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. | ||||
Control | 0..1 | ||||
Type | uri | ||||
Is Modifier | true | ||||
Comments | 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. | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
5. ResearchSubject.language | |||||
Definition | The base language in which the resource is written. | ||||
Control | 0..1 | ||||
Binding | The codes SHOULD be taken from CommonLanguages
A human language.
| ||||
Type | code | ||||
Comments | Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute). | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
6. ResearchSubject.text | |||||
Definition | A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety. | ||||
Control | 0..1 | ||||
Type | Narrative | ||||
Alternate Names | narrative, html, xhtml, display | ||||
Comments | 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. | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
7. ResearchSubject.contained | |||||
Definition | 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. | ||||
Control | 0..* | ||||
Type | Resource | ||||
Alternate Names | inline resources, anonymous resources, contained resources | ||||
Comments | 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. | ||||
8. ResearchSubject.extension | |||||
Definition | An Extension | ||||
Control | 0..* | ||||
Type | Extension | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists()) | ||||
Slicing | This element introduces a set of slices on ResearchSubject.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
| ||||
9. ResearchSubject.extension:sourcereferral | |||||
SliceName | sourcereferral | ||||
Definition | Categorization of the source of referral | ||||
Control | 0..1 This element is affected by the following invariants: ele-1 | ||||
Type | Extension(SourceReferral) (Extension Type: Coding) | ||||
Must Support | true | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists()) | ||||
10. ResearchSubject.modifierExtension | |||||
Definition | 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). | ||||
Control | 0..* | ||||
Type | Extension | ||||
Is Modifier | true | ||||
Requirements | 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. | ||||
Alternate Names | extensions, user content | ||||
Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (: extension.exists() != value.exists()) | ||||
11. ResearchSubject.identifier | |||||
Definition | Identifiers assigned to this research subject for a study. | ||||
Note | This is a business identifier, not a resource identifier (see discussion) | ||||
Control | 0..* | ||||
Type | Identifier | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
12. ResearchSubject.status | |||||
Definition | The current state of the subject. | ||||
Control | 1..1 | ||||
Binding | The codes SHALL be taken from ResearchSubjectStatus Indicates the progression of a study subject through a study. | ||||
Type | code | ||||
Is Modifier | true | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
13. ResearchSubject.period | |||||
Definition | The dates the subject began and ended their participation in the study. | ||||
Control | 0..1 | ||||
Type | Period | ||||
Alternate Names | timing | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
14. ResearchSubject.study | |||||
Definition | Reference to the study the subject is participating in. | ||||
Control | 1..1 | ||||
Type | Reference(ResearchStudy) | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
15. ResearchSubject.individual | |||||
Definition | The record of the person or animal who is involved in the study. | ||||
Control | 1..1 | ||||
Type | Reference(Patient) | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
16. ResearchSubject.assignedArm | |||||
Definition | The name of the arm in the study the subject is expected to follow as part of this study. | ||||
Control | 0..1 | ||||
Type | string | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
17. ResearchSubject.actualArm | |||||
Definition | The name of the arm in the study the subject actually followed as part of this study. | ||||
Control | 0..1 | ||||
Type | string | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) | ||||
18. ResearchSubject.consent | |||||
Definition | A record of the patient's informed agreement to participate in the study. | ||||
Control | 0..1 | ||||
Type | Reference(Consent) | ||||
Invariants | Defined on this element ele-1: All FHIR elements must have a @value or children (: hasValue() or (children().count() > id.count())) |