This profile describes a Research Subject in the Medical Informatics Initiative.
When including a person in a study (also in a MII use case), a ResearchSubject resource must be created for this person. There are the following variations:
Inclusion is by specific Informed Consent for a study.
Inclusion is based on Broad Informed Consent.
Inclusion is based on a specific legal basis (special law such as State Hospital Act, Infection Protection Act or Cancer Registry Act). This applies equally to the individuals in the study group, the control group and any form of reference population for which personal (or person-related) individual data are included in calculations.
The creation of the resource must occur at the time the data are retrieved for the study. Additional obligations and adjustments must be considered for each use case.
Name: ProfileResearchSubjectProbandIn (Simplifier Link)
Canonical: https://www.medizininformatik-initiative.de/fhir/core/modul-person/StructureDefinition/ResearchSubject
Differential
ProfileResearchSubjectProbandIn (ResearchSubject) | I | ResearchSubject | There are no (further) constraints on this element Element idResearchSubject Physical entity which is the primary unit of interest in the study Alternate namesStudy Subject DefinitionA physical entity which is the primary unit of operational and/or administrative interest in a study. Need to make sure we encompass public health studies.
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id | S Σ | 0..1 | string | There are no (further) constraints on this element Element idResearchSubject.id Logical id of this artifact DefinitionThe logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. The only time that a resource does not have an id is when it is being submitted to the server using a create operation. |
meta | S Σ | 0..1 | Meta | There are no (further) constraints on this element Element idResearchSubject.meta Metadata about the resource DefinitionThe 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.
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id | 0..1 | string | There are no (further) constraints on this element Element idResearchSubject.meta.id Unique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
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extension | I | 0..* | Extension | There are no (further) constraints on this element Element idResearchSubject.meta.extension Additional content defined by implementations Alternate namesextensions, user content DefinitionMay 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. 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. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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versionId | Σ | 0..1 | id | There are no (further) constraints on this element Element idResearchSubject.meta.versionId Version specific identifier DefinitionThe version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted. The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes.
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lastUpdated | Σ | 0..1 | instant | There are no (further) constraints on this element Element idResearchSubject.meta.lastUpdated When the resource version last changed DefinitionWhen the resource last changed - e.g. when the version changed. This value is always populated except when the resource is first being created. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a read interaction.
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source | S Σ | 0..1 | uri | There are no (further) constraints on this element Element idResearchSubject.meta.source Identifies where the resource comes from DefinitionA uri that identifies the source system of the resource. This provides a minimal amount of Provenance information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc. In the provenance resource, this corresponds to Provenance.entity.what[x]. The exact use of the source (and the implied Provenance.entity.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used. This element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL.
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profile | S Σ | 0..* | canonical(StructureDefinition) | There are no (further) constraints on this element Element idResearchSubject.meta.profile Profiles this resource claims to conform to DefinitionA list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url. It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set. canonical(StructureDefinition) Constraints
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security | Σ | 0..* | CodingBinding | There are no (further) constraints on this element Element idResearchSubject.meta.security Security Labels applied to this resource DefinitionSecurity labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure. The security labels can be updated without changing the stated version of the resource. The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored. Security Labels from the Healthcare Privacy and Security Classification System.
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tag | Σ | 0..* | Coding | There are no (further) constraints on this element Element idResearchSubject.meta.tag Tags applied to this resource DefinitionTags applied to this resource. Tags are intended to be used to identify and relate resources to process and workflow, and applications are not required to consider the tags when interpreting the meaning of a resource. The tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored. Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
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implicitRules | Σ ?! | 0..1 | uri | There are no (further) constraints on this element Element idResearchSubject.implicitRules A set of rules under which this content was created DefinitionA 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. 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.
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language | 0..1 | codeBinding | There are no (further) constraints on this element Element idResearchSubject.language Language of the resource content DefinitionThe base language in which the resource is written. 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). A human language.
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text | 0..1 | Narrative | There are no (further) constraints on this element Element idResearchSubject.text Text summary of the resource, for human interpretation Alternate namesnarrative, html, xhtml, display DefinitionA 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. 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.
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contained | 0..* | Resource | There are no (further) constraints on this element Element idResearchSubject.contained Contained, inline Resources Alternate namesinline resources, anonymous resources, contained resources DefinitionThese 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. 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.
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extension | I | 0..* | Extension | There are no (further) constraints on this element Element idResearchSubject.extension Additional content defined by implementations Alternate namesextensions, user content DefinitionMay 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. 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. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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modifierExtension | ?! I | 0..* | Extension | There are no (further) constraints on this element Element idResearchSubject.modifierExtension Extensions that cannot be ignored Alternate namesextensions, user content DefinitionMay 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). 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. 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. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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identifier | S Σ | 1..* | Identifier | Element idResearchSubject.identifier Business Identifier for research subject in a study DefinitionIdentifiers assigned to this research subject for a study. Unordered, Open, by $this(Pattern) Constraints
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subjectIdentificationCode | S Σ | 1..1 | IdentifierPattern | Element idResearchSubject.identifier:subjectIdentificationCode Business Identifier for research subject in a study DefinitionIdentifiers assigned to this research subject for a study.
{ "type": { "coding": [ { "system": "http://terminology.hl7.org/CodeSystem/v2-0203", "code": "ANON" } ] } }
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id | 0..1 | string | There are no (further) constraints on this element Element idResearchSubject.identifier:subjectIdentificationCode.id Unique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
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extension | I | 0..* | Extension | There are no (further) constraints on this element Element idResearchSubject.identifier:subjectIdentificationCode.extension Additional content defined by implementations Alternate namesextensions, user content DefinitionMay 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. 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. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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use | Σ ?! | 0..1 | codeBinding | There are no (further) constraints on this element Element idResearchSubject.identifier:subjectIdentificationCode.use usual | official | temp | secondary | old (If known) DefinitionThe purpose of this identifier. Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. Identifies the purpose for this identifier, if known .
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type | S Σ | 0..1 | CodeableConceptBindingPattern | There are no (further) constraints on this element Element idResearchSubject.identifier:subjectIdentificationCode.type Description of identifier DefinitionA coded type for the identifier that can be used to determine which identifier to use for a specific purpose. Allows users to make use of identifiers when the identifier system is not known. This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type. A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
{ "coding": [ { "system": "http://terminology.hl7.org/CodeSystem/v2-0203", "code": "ANON" } ] }
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system | S Σ | 1..1 | uri | There are no (further) constraints on this element Element idResearchSubject.identifier:subjectIdentificationCode.system The namespace for the identifier value DefinitionEstablishes the namespace for the value - that is, a URL that describes a set values that are unique. There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers. Identifier.system is always case sensitive.
General http://www.acme.com/identifiers/patient Mappings
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value | S Σ | 1..1 | string | There are no (further) constraints on this element Element idResearchSubject.identifier:subjectIdentificationCode.value The value that is unique DefinitionThe portion of the identifier typically relevant to the user and which is unique within the context of the system. If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension. Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.
General 123456 Mappings
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period | Σ I | 0..1 | Period | There are no (further) constraints on this element Element idResearchSubject.identifier:subjectIdentificationCode.period Time period when id is/was valid for use DefinitionTime period during which identifier is/was valid for use. A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. "the patient was an inpatient of the hospital for this time range") or one value from the range applies (e.g. "give to the patient between these two times"). Period is not used for a duration (a measure of elapsed time). See Duration.
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assigner | Σ I | 0..1 | Reference(Organization) | There are no (further) constraints on this element Element idResearchSubject.identifier:subjectIdentificationCode.assigner Organization that issued id (may be just text) DefinitionOrganization that issued/manages the identifier. The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.
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status | S Σ ?! | 1..1 | codeBinding | There are no (further) constraints on this element Element idResearchSubject.status candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn DefinitionThe current state of the subject. Note that FHIR strings SHALL NOT exceed 1MB in size Indicates the progression of a study subject through a study.
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period | S Σ I | 1..1 | Period | There are no (further) constraints on this element Element idResearchSubject.period Start and end of participation Alternate namestiming DefinitionThe dates the subject began and ended their participation in the study. A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. "the patient was an inpatient of the hospital for this time range") or one value from the range applies (e.g. "give to the patient between these two times"). Period is not used for a duration (a measure of elapsed time). See Duration.
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id | 0..1 | string | There are no (further) constraints on this element Element idResearchSubject.period.id Unique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
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extension | I | 0..* | Extension | There are no (further) constraints on this element Element idResearchSubject.period.extension Additional content defined by implementations Alternate namesextensions, user content DefinitionMay 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. 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. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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start | S Σ I | 1..1 | dateTime | There are no (further) constraints on this element Element idResearchSubject.period.start Starting time with inclusive boundary DefinitionThe start of the period. The boundary is inclusive. If the low element is missing, the meaning is that the low boundary is not known.
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end | S Σ I | 0..1 | dateTime | There are no (further) constraints on this element Element idResearchSubject.period.end End time with inclusive boundary, if not ongoing DefinitionThe end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. The start may be in the past, and the end date in the future, which means that period is expected/planned to end at that time. The high value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03. If the end of the period is missing, it means that the period is ongoing
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study | S Σ I | 1..1 | MII-Reference(ResearchStudy) | Element idResearchSubject.study A reference from one resource to another DefinitionA reference from one resource to another. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
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individual | S Σ I | 1..1 | MII-Reference(Patient) | Element idResearchSubject.individual A reference from one resource to another DefinitionA reference from one resource to another. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
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assignedArm | 0..1 | string | There are no (further) constraints on this element Element idResearchSubject.assignedArm What path should be followed DefinitionThe name of the arm in the study the subject is expected to follow as part of this study. Note that FHIR strings SHALL NOT exceed 1MB in size
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actualArm | 0..1 | string | There are no (further) constraints on this element Element idResearchSubject.actualArm What path was followed DefinitionThe name of the arm in the study the subject actually followed as part of this study. Note that FHIR strings SHALL NOT exceed 1MB in size
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consent | S I | 1..1 | MII-Reference(Consent) | Element idResearchSubject.consent A reference from one resource to another DefinitionA reference from one resource to another. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
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FHIR-Element | Explanation |
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Patient.id | Must-support, but optional |
Patient.meta | Must-support, but optional |
Patient.identifier:subjectIdentificationCode | Fixed naming system for uniform, cross-site query of the identifier (for evaluations) |
Patient.period.start | Start date (inclusion of the patient in the study) |
Patient.period.end | End date (completion of the study or exclusion of the patient) |
Patient.study | Reference to the metadata of the study in which the patient is participating. For further specifications, see the STUDIENDATEN extension module. |
Patient.individual | Each Research Subject must be assigned to a Patient. |
Patient.consent | Consent to the study or regulatory basis must be available. Further specifications for the modeling of consent may arise from other extension modules. |
FHIR-Element | Logical Data Set |
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ResearchSubject.identifier:subjectIdentificationCode | Person.Studienteilnehmer.SubjektIdentifizierungscode |
ResearchSubject.status | Person.Studienteilnehmer.StatusDerTeilnahme |
ResearchSubject.period.start | Person.Studienteilnehmer.BeginnTeilnahme |
ResearchSubject.period.end | Person.Studienteilnehmer.EndeTeilnahme |
ResearchSubject.consent | Person.Studienteilnehmer.Rechtsgrundlage |
Snapshot
ProfileResearchSubjectProbandIn (ResearchSubject) | I | ResearchSubject | There are no (further) constraints on this element Element idResearchSubject Physical entity which is the primary unit of interest in the study Alternate namesStudy Subject DefinitionA physical entity which is the primary unit of operational and/or administrative interest in a study. Need to make sure we encompass public health studies.
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id | S Σ | 0..1 | string | There are no (further) constraints on this element Element idResearchSubject.id Logical id of this artifact DefinitionThe logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. The only time that a resource does not have an id is when it is being submitted to the server using a create operation. |
meta | S Σ | 0..1 | Meta | There are no (further) constraints on this element Element idResearchSubject.meta Metadata about the resource DefinitionThe 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.
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id | 0..1 | string | There are no (further) constraints on this element Element idResearchSubject.meta.id Unique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
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extension | I | 0..* | Extension | There are no (further) constraints on this element Element idResearchSubject.meta.extension Additional content defined by implementations Alternate namesextensions, user content DefinitionMay 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. 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. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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versionId | Σ | 0..1 | id | There are no (further) constraints on this element Element idResearchSubject.meta.versionId Version specific identifier DefinitionThe version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted. The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes.
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lastUpdated | Σ | 0..1 | instant | There are no (further) constraints on this element Element idResearchSubject.meta.lastUpdated When the resource version last changed DefinitionWhen the resource last changed - e.g. when the version changed. This value is always populated except when the resource is first being created. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a read interaction.
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source | S Σ | 0..1 | uri | There are no (further) constraints on this element Element idResearchSubject.meta.source Identifies where the resource comes from DefinitionA uri that identifies the source system of the resource. This provides a minimal amount of Provenance information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc. In the provenance resource, this corresponds to Provenance.entity.what[x]. The exact use of the source (and the implied Provenance.entity.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used. This element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL.
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profile | S Σ | 0..* | canonical(StructureDefinition) | There are no (further) constraints on this element Element idResearchSubject.meta.profile Profiles this resource claims to conform to DefinitionA list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url. It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set. canonical(StructureDefinition) Constraints
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security | Σ | 0..* | CodingBinding | There are no (further) constraints on this element Element idResearchSubject.meta.security Security Labels applied to this resource DefinitionSecurity labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure. The security labels can be updated without changing the stated version of the resource. The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored. Security Labels from the Healthcare Privacy and Security Classification System.
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tag | Σ | 0..* | Coding | There are no (further) constraints on this element Element idResearchSubject.meta.tag Tags applied to this resource DefinitionTags applied to this resource. Tags are intended to be used to identify and relate resources to process and workflow, and applications are not required to consider the tags when interpreting the meaning of a resource. The tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored. Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
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implicitRules | Σ ?! | 0..1 | uri | There are no (further) constraints on this element Element idResearchSubject.implicitRules A set of rules under which this content was created DefinitionA 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. 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.
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language | 0..1 | codeBinding | There are no (further) constraints on this element Element idResearchSubject.language Language of the resource content DefinitionThe base language in which the resource is written. 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). A human language.
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text | 0..1 | Narrative | There are no (further) constraints on this element Element idResearchSubject.text Text summary of the resource, for human interpretation Alternate namesnarrative, html, xhtml, display DefinitionA 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. 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.
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contained | 0..* | Resource | There are no (further) constraints on this element Element idResearchSubject.contained Contained, inline Resources Alternate namesinline resources, anonymous resources, contained resources DefinitionThese 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. 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.
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extension | I | 0..* | Extension | There are no (further) constraints on this element Element idResearchSubject.extension Additional content defined by implementations Alternate namesextensions, user content DefinitionMay 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. 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. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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modifierExtension | ?! I | 0..* | Extension | There are no (further) constraints on this element Element idResearchSubject.modifierExtension Extensions that cannot be ignored Alternate namesextensions, user content DefinitionMay 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). 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. 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. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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identifier | S Σ | 1..* | Identifier | Element idResearchSubject.identifier Business Identifier for research subject in a study DefinitionIdentifiers assigned to this research subject for a study. Unordered, Open, by $this(Pattern) Constraints
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subjectIdentificationCode | S Σ | 1..1 | IdentifierPattern | Element idResearchSubject.identifier:subjectIdentificationCode Business Identifier for research subject in a study DefinitionIdentifiers assigned to this research subject for a study.
{ "type": { "coding": [ { "system": "http://terminology.hl7.org/CodeSystem/v2-0203", "code": "ANON" } ] } }
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id | 0..1 | string | There are no (further) constraints on this element Element idResearchSubject.identifier:subjectIdentificationCode.id Unique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
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extension | I | 0..* | Extension | There are no (further) constraints on this element Element idResearchSubject.identifier:subjectIdentificationCode.extension Additional content defined by implementations Alternate namesextensions, user content DefinitionMay 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. 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. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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use | Σ ?! | 0..1 | codeBinding | There are no (further) constraints on this element Element idResearchSubject.identifier:subjectIdentificationCode.use usual | official | temp | secondary | old (If known) DefinitionThe purpose of this identifier. Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. Identifies the purpose for this identifier, if known .
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type | S Σ | 0..1 | CodeableConceptBindingPattern | There are no (further) constraints on this element Element idResearchSubject.identifier:subjectIdentificationCode.type Description of identifier DefinitionA coded type for the identifier that can be used to determine which identifier to use for a specific purpose. Allows users to make use of identifiers when the identifier system is not known. This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type. A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
{ "coding": [ { "system": "http://terminology.hl7.org/CodeSystem/v2-0203", "code": "ANON" } ] }
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system | S Σ | 1..1 | uri | There are no (further) constraints on this element Element idResearchSubject.identifier:subjectIdentificationCode.system The namespace for the identifier value DefinitionEstablishes the namespace for the value - that is, a URL that describes a set values that are unique. There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers. Identifier.system is always case sensitive.
General http://www.acme.com/identifiers/patient Mappings
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value | S Σ | 1..1 | string | There are no (further) constraints on this element Element idResearchSubject.identifier:subjectIdentificationCode.value The value that is unique DefinitionThe portion of the identifier typically relevant to the user and which is unique within the context of the system. If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension. Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.
General 123456 Mappings
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period | Σ I | 0..1 | Period | There are no (further) constraints on this element Element idResearchSubject.identifier:subjectIdentificationCode.period Time period when id is/was valid for use DefinitionTime period during which identifier is/was valid for use. A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. "the patient was an inpatient of the hospital for this time range") or one value from the range applies (e.g. "give to the patient between these two times"). Period is not used for a duration (a measure of elapsed time). See Duration.
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assigner | Σ I | 0..1 | Reference(Organization) | There are no (further) constraints on this element Element idResearchSubject.identifier:subjectIdentificationCode.assigner Organization that issued id (may be just text) DefinitionOrganization that issued/manages the identifier. The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.
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status | S Σ ?! | 1..1 | codeBinding | There are no (further) constraints on this element Element idResearchSubject.status candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn DefinitionThe current state of the subject. Note that FHIR strings SHALL NOT exceed 1MB in size Indicates the progression of a study subject through a study.
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period | S Σ I | 1..1 | Period | There are no (further) constraints on this element Element idResearchSubject.period Start and end of participation Alternate namestiming DefinitionThe dates the subject began and ended their participation in the study. A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. "the patient was an inpatient of the hospital for this time range") or one value from the range applies (e.g. "give to the patient between these two times"). Period is not used for a duration (a measure of elapsed time). See Duration.
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id | 0..1 | string | There are no (further) constraints on this element Element idResearchSubject.period.id Unique id for inter-element referencing DefinitionUnique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
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extension | I | 0..* | Extension | There are no (further) constraints on this element Element idResearchSubject.period.extension Additional content defined by implementations Alternate namesextensions, user content DefinitionMay 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. 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. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints
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start | S Σ I | 1..1 | dateTime | There are no (further) constraints on this element Element idResearchSubject.period.start Starting time with inclusive boundary DefinitionThe start of the period. The boundary is inclusive. If the low element is missing, the meaning is that the low boundary is not known.
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end | S Σ I | 0..1 | dateTime | There are no (further) constraints on this element Element idResearchSubject.period.end End time with inclusive boundary, if not ongoing DefinitionThe end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. The start may be in the past, and the end date in the future, which means that period is expected/planned to end at that time. The high value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03. If the end of the period is missing, it means that the period is ongoing
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study | S Σ I | 1..1 | MII-Reference(ResearchStudy) | Element idResearchSubject.study A reference from one resource to another DefinitionA reference from one resource to another. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
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individual | S Σ I | 1..1 | MII-Reference(Patient) | Element idResearchSubject.individual A reference from one resource to another DefinitionA reference from one resource to another. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
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assignedArm | 0..1 | string | There are no (further) constraints on this element Element idResearchSubject.assignedArm What path should be followed DefinitionThe name of the arm in the study the subject is expected to follow as part of this study. Note that FHIR strings SHALL NOT exceed 1MB in size
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actualArm | 0..1 | string | There are no (further) constraints on this element Element idResearchSubject.actualArm What path was followed DefinitionThe name of the arm in the study the subject actually followed as part of this study. Note that FHIR strings SHALL NOT exceed 1MB in size
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consent | S I | 1..1 | MII-Reference(Consent) | Element idResearchSubject.consent A reference from one resource to another DefinitionA reference from one resource to another. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
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Examples
Example (complete):
{ "resourceType": "ResearchSubject", "id": "ExampleResearchSubjectStudienteilnehmer", "meta": { "profile": [ "https://www.medizininformatik-initiative.de/fhir/core/modul-person/StructureDefinition/ResearchSubject" ] }, "identifier": [ { "type": { "coding": [ { "system": "http://terminology.hl7.org/CodeSystem/v2-0203", "code": "ANON" } ] }, "system": "https://www.example.org/fhir/core/sid/SubjectIdentificationCode", "value": "12345" } ], "status": "candidate", "period": { "start": "2019-09-06" }, "study": { "reference": "ResearchStudy/MII-Beispielstudie" }, "individual": { "reference": "Patient/MII-Patient" }, "consent": { "reference": "Consent/MII-Consent" } }
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