2025.0.1 - ci-build-obligations

MII_IG_Person - Local Development build (v2025.0.1) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: MII_PR_Person_Proband - Detailed Descriptions

Retired as of 2024-11-11

Definitions for the mii-pr-person-proband resource profile.

Guidance on how to interpret the contents of this table can be found here

0. ResearchSubject
Definition

A physical entity which is the primary unit of operational and/or administrative interest in a study.

ShortPhysical entity which is the primary unit of interest in the study
Comments

Need to make sure we encompass public health studies.

Control0..*
Alternate NamesStudy Subject
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.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-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-6: A resource should have narrative for robust management (text.`div`.exists())
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
2. ResearchSubject.id
Definition

The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

ShortLogical id of this artifact
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.

Control0..1
Typeidstring
Must Supporttrue
Summarytrue
4. 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.

ShortMetadata about the resource
Control0..1
This element is affected by the following invariants: ele-1
TypeMeta
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
6. ResearchSubject.meta.profile
Definition

A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url.


A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url.

ShortProfiles this resource claims to conform to
Comments

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.

Control0..*
This element is affected by the following invariants: ele-1
Typecanonical(StructureDefinition)
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
8. 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.

ShortA set of rules under which this content was created
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.

Control0..1
This element is affected by the following invariants: ele-1
Typeuri
Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
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).

ShortExtensions that cannot be ignored
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.

Control0..*
This element is affected by the following invariants: ele-1
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Standard StatusNormative (from Trial Use)
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 Namesextensions, user content
Invariantsele-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())
SlicingThis element introduces a set of slices on ResearchSubject.modifierExtension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 12. ResearchSubject.identifier
    Definition

    Identifiers assigned to this research subject for a study.

    ShortBusiness Identifier for research subject in a study
    NoteThis is a business identifier, not a resource identifier (see discussion)
    Control10..*
    This element is affected by the following invariants: ele-1
    TypeIdentifier
    Must Supporttrue
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    SlicingThis element introduces a set of slices on ResearchSubject.identifier. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • pattern @ $this
    • 14. ResearchSubject.identifier:subjectIdentificationCode
      Slice NamesubjectIdentificationCode
      Definition

      Identifiers assigned to this research subject for a study.

      ShortBusiness Identifier for research subject in a study
      NoteThis is a business identifier, not a resource identifier (see discussion)
      Control10..1*
      This element is affected by the following invariants: ele-1
      TypeIdentifier
      Must Supporttrue
      Summarytrue
      Pattern Value{
        "type" : {
          "coding" : [{
            "system" : "http://terminology.hl7.org/CodeSystem/v2-0203",
            "code" : "ANON"
          }]
        }
      }
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      16. ResearchSubject.identifier:subjectIdentificationCode.use
      Definition

      The purpose of this identifier.

      Shortusual | official | temp | secondary | old (If known)
      Comments

      Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

      Control0..1
      This element is affected by the following invariants: ele-1
      BindingThe codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|4.0.1
      (required to http://hl7.org/fhir/ValueSet/identifier-use|4.0.1)

      Identifies the purpose for this identifier, if known .

      Typecode
      Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Summarytrue
      Requirements

      Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      18. ResearchSubject.identifier:subjectIdentificationCode.type
      Definition

      A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

      ShortDescription of identifier
      Comments

      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.

      Control0..1
      This element is affected by the following invariants: ele-1
      BindingUnless not suitable, these codes SHALL be taken from Identifier Type Codeshttp://hl7.org/fhir/ValueSet/identifier-type
      (extensible to http://hl7.org/fhir/ValueSet/identifier-type)

      A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

      TypeCodeableConcept
      Must Supporttrue
      Summarytrue
      Requirements

      Allows users to make use of identifiers when the identifier system is not known.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      20. ResearchSubject.identifier:subjectIdentificationCode.system
      Definition

      Establishes the namespace for the value - that is, a URL that describes a set values that are unique.

      ShortThe namespace for the identifier value
      Comments

      Identifier.system is always case sensitive.

      Control10..1
      This element is affected by the following invariants: ele-1
      Typeuri
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supporttrue
      Summarytrue
      Requirements

      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.

      Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      22. ResearchSubject.identifier:subjectIdentificationCode.value
      Definition

      The portion of the identifier typically relevant to the user and which is unique within the context of the system.

      ShortThe value that is unique
      Comments

      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.

      Control10..1
      This element is affected by the following invariants: ele-1
      Typestring
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supporttrue
      Summarytrue
      Example<br/><b>General</b>:123456
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      24. ResearchSubject.status
      Definition

      The current state of the subject.

      Shortcandidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn
      Comments

      Note that FHIR strings SHALL NOT exceed 1MB in size

      Control1..1
      This element is affected by the following invariants: ele-1
      BindingThe codes SHALL be taken from ResearchSubjectStatushttp://hl7.org/fhir/ValueSet/research-subject-status|4.0.1
      (required to http://hl7.org/fhir/ValueSet/research-subject-status|4.0.1)

      Indicates the progression of a study subject through a study.

      Typecode
      Is Modifiertrue because This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supporttrue
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      26. ResearchSubject.period
      Definition

      The dates the subject began and ended their participation in the study.

      ShortStart and end of participation
      Comments

      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.

      Control10..1
      This element is affected by the following invariants: ele-1
      TypePeriod
      Must Supporttrue
      Summarytrue
      Alternate Namestiming
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      per-1: If present, start SHALL have a lower value than end (start.hasValue().not() or end.hasValue().not() or (start <= end))
      28. ResearchSubject.period.start
      Definition

      The start of the period. The boundary is inclusive.

      ShortStarting time with inclusive boundary
      Comments

      If the low element is missing, the meaning is that the low boundary is not known.

      Control10..1
      This element is affected by the following invariants: ele-1, per-1
      TypedateTime
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supporttrue
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      30. ResearchSubject.period.end
      Definition

      The 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.

      ShortEnd time with inclusive boundary, if not ongoing
      Comments

      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.

      Control0..1
      This element is affected by the following invariants: ele-1, per-1
      TypedateTime
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supporttrue
      Summarytrue
      Meaning if MissingIf the end of the period is missing, it means that the period is ongoing
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      32. ResearchSubject.study
      Definition

      Reference to the study the subject is participating in.

      ShortStudy subject is part of
      Comments

      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.

      Control1..1
      This element is affected by the following invariants: ele-1
      TypeReference(ResearchStudy)
      Must Supporttrue
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
      34. ResearchSubject.individual
      Definition

      The record of the person or animal who is involved in the study.

      ShortWho is part of study
      Comments

      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.

      Control1..1
      This element is affected by the following invariants: ele-1
      TypeReference(Patient)
      Must Supporttrue
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
      36. ResearchSubject.consent
      Definition

      A record of the patient's informed agreement to participate in the study.

      ShortAgreement to participate in study
      Comments

      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.

      Control10..1
      This element is affected by the following invariants: ele-1
      TypeReference(Consent)
      Must Supporttrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))

      Guidance on how to interpret the contents of this table can be found here

      0. ResearchSubject
      2. ResearchSubject.id
      Must Supporttrue
      4. ResearchSubject.meta
      Must Supporttrue
      6. ResearchSubject.meta.profile
      Must Supporttrue
      8. ResearchSubject.identifier
      NoteThis is a business identifier, not a resource identifier (see discussion)
      Control1..?
      Must Supporttrue
      SlicingThis element introduces a set of slices on ResearchSubject.identifier. The slices areUnordered and Open, and can be differentiated using the following discriminators:
      • pattern @ $this
      • 10. ResearchSubject.identifier:subjectIdentificationCode
        Slice NamesubjectIdentificationCode
        NoteThis is a business identifier, not a resource identifier (see discussion)
        Control1..1
        Must Supporttrue
        Pattern Value{
          "type" : {
            "coding" : [{
              "system" : "http://terminology.hl7.org/CodeSystem/v2-0203",
              "code" : "ANON"
            }]
          }
        }
        12. ResearchSubject.identifier:subjectIdentificationCode.type
        Must Supporttrue
        14. ResearchSubject.identifier:subjectIdentificationCode.system
        Control1..?
        Must Supporttrue
        16. ResearchSubject.identifier:subjectIdentificationCode.value
        Control1..?
        Must Supporttrue
        18. ResearchSubject.status
        Must Supporttrue
        20. ResearchSubject.period
        Control1..?
        Must Supporttrue
        22. ResearchSubject.period.start
        Control1..?
        Must Supporttrue
        24. ResearchSubject.period.end
        Must Supporttrue
        26. ResearchSubject.study
        Must Supporttrue
        28. ResearchSubject.individual
        Must Supporttrue
        30. ResearchSubject.consent
        Control1..?
        Must Supporttrue

        Guidance on how to interpret the contents of this table can be found here

        0. ResearchSubject
        Definition

        A physical entity which is the primary unit of operational and/or administrative interest in a study.

        ShortPhysical entity which is the primary unit of interest in the study
        Comments

        Need to make sure we encompass public health studies.

        Control0..*
        Alternate NamesStudy Subject
        Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.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-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-6: A resource should have narrative for robust management (text.`div`.exists())
        dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
        2. ResearchSubject.id
        Definition

        The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

        ShortLogical id of this artifact
        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.

        Control0..1
        Typeid
        Must Supporttrue
        Summarytrue
        4. 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.

        ShortMetadata about the resource
        Control0..1
        This element is affected by the following invariants: ele-1
        TypeMeta
        Must Supporttrue
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        6. ResearchSubject.meta.id
        Definition

        Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

        ShortUnique id for inter-element referencing
        Control0..1
        Typestring
        XML FormatIn the XML format, this property is represented as an attribute.
        8. ResearchSubject.meta.extension
        Definition

        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.

        ShortAdditional content defined by implementations
        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.

        Control0..*
        This element is affected by the following invariants: ele-1
        TypeExtension
        Standard StatusNormative (from Trial Use)
        Alternate Namesextensions, user content
        Invariantsele-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())
        SlicingThis element introduces a set of slices on ResearchSubject.meta.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
        • value @ url
        • 10. ResearchSubject.meta.versionId
          Definition

          The version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted.

          ShortVersion specific identifier
          Comments

          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.

          Control0..1
          This element is affected by the following invariants: ele-1
          Typeid
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          12. ResearchSubject.meta.lastUpdated
          Definition

          When the resource last changed - e.g. when the version changed.

          ShortWhen the resource version last changed
          Comments

          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.

          Control0..1
          This element is affected by the following invariants: ele-1
          Typeinstant
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          14. ResearchSubject.meta.source
          Definition

          A 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.

          ShortIdentifies where the resource comes from
          Comments

          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.

          Control0..1
          This element is affected by the following invariants: ele-1
          Typeuri
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          16. ResearchSubject.meta.profile
          Definition

          A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url.

          ShortProfiles this resource claims to conform to
          Comments

          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.

          Control0..*
          This element is affected by the following invariants: ele-1
          Typecanonical(StructureDefinition)
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supporttrue
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          18. ResearchSubject.meta.security
          Definition

          Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure.

          ShortSecurity Labels applied to this resource
          Comments

          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.

          Control0..*
          This element is affected by the following invariants: ele-1
          BindingUnless not suitable, these codes SHALL be taken from All Security Labels
          (extensible to http://hl7.org/fhir/ValueSet/security-labels)

          Security Labels from the Healthcare Privacy and Security Classification System.

          TypeCoding
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          20. ResearchSubject.meta.tag
          Definition

          Tags 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.

          ShortTags applied to this resource
          Comments

          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.

          Control0..*
          This element is affected by the following invariants: ele-1
          BindingFor example codes, see CommonTags
          (example to http://hl7.org/fhir/ValueSet/common-tags)

          Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".

          TypeCoding
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          22. 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.

          ShortA set of rules under which this content was created
          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.

          Control0..1
          This element is affected by the following invariants: ele-1
          Typeuri
          Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          24. ResearchSubject.language
          Definition

          The base language in which the resource is written.

          ShortLanguage of the resource content
          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).

          Control0..1
          This element is affected by the following invariants: ele-1
          BindingThe codes SHOULD be taken from CommonLanguages
          (preferred to http://hl7.org/fhir/ValueSet/languages)

          A human language.

          Additional BindingsPurpose
          AllLanguagesMax Binding
          Typecode
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          26. 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.

          ShortText summary of the resource, for human interpretation
          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.

          Control0..1
          This element is affected by the following invariants: ele-1
          TypeNarrative
          Alternate Namesnarrative, html, xhtml, display
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          28. 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.

          ShortContained, inline 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.

          Control0..*
          TypeResource
          Alternate Namesinline resources, anonymous resources, contained resources
          30. ResearchSubject.extension
          Definition

          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.

          ShortAdditional content defined by implementations
          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.

          Control0..*
          This element is affected by the following invariants: ele-1
          TypeExtension
          Standard StatusNormative (from Trial Use)
          Alternate Namesextensions, user content
          Invariantsele-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())
          SlicingThis element introduces a set of slices on ResearchSubject.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
          • value @ url
          • 32. 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).

            ShortExtensions that cannot be ignored
            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.

            Control0..*
            This element is affected by the following invariants: ele-1
            TypeExtension
            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
            Standard StatusNormative (from Trial Use)
            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 Namesextensions, user content
            Invariantsele-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())
            SlicingThis element introduces a set of slices on ResearchSubject.modifierExtension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
            • value @ url
            • 34. ResearchSubject.identifier
              Definition

              Identifiers assigned to this research subject for a study.

              ShortBusiness Identifier for research subject in a study
              NoteThis is a business identifier, not a resource identifier (see discussion)
              Control1..*
              This element is affected by the following invariants: ele-1
              TypeIdentifier
              Must Supporttrue
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              SlicingThis element introduces a set of slices on ResearchSubject.identifier. The slices areUnordered and Open, and can be differentiated using the following discriminators:
              • pattern @ $this
              • 36. ResearchSubject.identifier:subjectIdentificationCode
                Slice NamesubjectIdentificationCode
                Definition

                Identifiers assigned to this research subject for a study.

                ShortBusiness Identifier for research subject in a study
                NoteThis is a business identifier, not a resource identifier (see discussion)
                Control1..1
                This element is affected by the following invariants: ele-1
                TypeIdentifier
                Must Supporttrue
                Summarytrue
                Pattern Value{
                  "type" : {
                    "coding" : [{
                      "system" : "http://terminology.hl7.org/CodeSystem/v2-0203",
                      "code" : "ANON"
                    }]
                  }
                }
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                38. ResearchSubject.identifier:subjectIdentificationCode.id
                Definition

                Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                ShortUnique id for inter-element referencing
                Control0..1
                Typestring
                XML FormatIn the XML format, this property is represented as an attribute.
                40. ResearchSubject.identifier:subjectIdentificationCode.extension
                Definition

                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.

                ShortAdditional content defined by implementations
                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.

                Control0..*
                This element is affected by the following invariants: ele-1
                TypeExtension
                Standard StatusNormative (from Trial Use)
                Alternate Namesextensions, user content
                Invariantsele-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())
                SlicingThis element introduces a set of slices on ResearchSubject.identifier.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                • value @ url
                • 42. ResearchSubject.identifier:subjectIdentificationCode.use
                  Definition

                  The purpose of this identifier.

                  Shortusual | official | temp | secondary | old (If known)
                  Comments

                  Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

                  Control0..1
                  This element is affected by the following invariants: ele-1
                  BindingThe codes SHALL be taken from IdentifierUse
                  (required to http://hl7.org/fhir/ValueSet/identifier-use|4.0.1)

                  Identifies the purpose for this identifier, if known .

                  Typecode
                  Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Summarytrue
                  Requirements

                  Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  44. ResearchSubject.identifier:subjectIdentificationCode.type
                  Definition

                  A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

                  ShortDescription of identifier
                  Comments

                  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.

                  Control0..1
                  This element is affected by the following invariants: ele-1
                  BindingUnless not suitable, these codes SHALL be taken from Identifier Type Codes
                  (extensible to http://hl7.org/fhir/ValueSet/identifier-type)

                  A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

                  TypeCodeableConcept
                  Must Supporttrue
                  Summarytrue
                  Requirements

                  Allows users to make use of identifiers when the identifier system is not known.

                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  46. ResearchSubject.identifier:subjectIdentificationCode.system
                  Definition

                  Establishes the namespace for the value - that is, a URL that describes a set values that are unique.

                  ShortThe namespace for the identifier value
                  Comments

                  Identifier.system is always case sensitive.

                  Control1..1
                  This element is affected by the following invariants: ele-1
                  Typeuri
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Must Supporttrue
                  Summarytrue
                  Requirements

                  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.

                  Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  48. ResearchSubject.identifier:subjectIdentificationCode.value
                  Definition

                  The portion of the identifier typically relevant to the user and which is unique within the context of the system.

                  ShortThe value that is unique
                  Comments

                  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.

                  Control1..1
                  This element is affected by the following invariants: ele-1
                  Typestring
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Must Supporttrue
                  Summarytrue
                  Example<br/><b>General</b>:123456
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  50. ResearchSubject.identifier:subjectIdentificationCode.period
                  Definition

                  Time period during which identifier is/was valid for use.

                  ShortTime period when id is/was valid for use
                  Comments

                  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.

                  Control0..1
                  This element is affected by the following invariants: ele-1
                  TypePeriod
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  per-1: If present, start SHALL have a lower value than end (start.hasValue().not() or end.hasValue().not() or (start <= end))
                  52. ResearchSubject.identifier:subjectIdentificationCode.assigner
                  Definition

                  Organization that issued/manages the identifier.

                  ShortOrganization that issued id (may be just text)
                  Comments

                  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.

                  Control0..1
                  This element is affected by the following invariants: ele-1
                  TypeReference(Organization)
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                  54. ResearchSubject.status
                  Definition

                  The current state of the subject.

                  Shortcandidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn
                  Comments

                  Note that FHIR strings SHALL NOT exceed 1MB in size

                  Control1..1
                  This element is affected by the following invariants: ele-1
                  BindingThe codes SHALL be taken from ResearchSubjectStatus
                  (required to http://hl7.org/fhir/ValueSet/research-subject-status|4.0.1)

                  Indicates the progression of a study subject through a study.

                  Typecode
                  Is Modifiertrue because This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Must Supporttrue
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  56. ResearchSubject.period
                  Definition

                  The dates the subject began and ended their participation in the study.

                  ShortStart and end of participation
                  Comments

                  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.

                  Control1..1
                  This element is affected by the following invariants: ele-1
                  TypePeriod
                  Must Supporttrue
                  Summarytrue
                  Alternate Namestiming
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  per-1: If present, start SHALL have a lower value than end (start.hasValue().not() or end.hasValue().not() or (start <= end))
                  58. ResearchSubject.period.id
                  Definition

                  Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                  ShortUnique id for inter-element referencing
                  Control0..1
                  Typestring
                  XML FormatIn the XML format, this property is represented as an attribute.
                  60. ResearchSubject.period.extension
                  Definition

                  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.

                  ShortAdditional content defined by implementations
                  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.

                  Control0..*
                  This element is affected by the following invariants: ele-1
                  TypeExtension
                  Standard StatusNormative (from Trial Use)
                  Alternate Namesextensions, user content
                  Invariantsele-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())
                  SlicingThis element introduces a set of slices on ResearchSubject.period.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                  • value @ url
                  • 62. ResearchSubject.period.start
                    Definition

                    The start of the period. The boundary is inclusive.

                    ShortStarting time with inclusive boundary
                    Comments

                    If the low element is missing, the meaning is that the low boundary is not known.

                    Control1..1
                    This element is affected by the following invariants: ele-1, per-1
                    TypedateTime
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Must Supporttrue
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    64. ResearchSubject.period.end
                    Definition

                    The 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.

                    ShortEnd time with inclusive boundary, if not ongoing
                    Comments

                    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.

                    Control0..1
                    This element is affected by the following invariants: ele-1, per-1
                    TypedateTime
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Must Supporttrue
                    Summarytrue
                    Meaning if MissingIf the end of the period is missing, it means that the period is ongoing
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    66. ResearchSubject.study
                    Definition

                    Reference to the study the subject is participating in.

                    ShortStudy subject is part of
                    Comments

                    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.

                    Control1..1
                    This element is affected by the following invariants: ele-1
                    TypeReference(ResearchStudy)
                    Must Supporttrue
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                    68. ResearchSubject.individual
                    Definition

                    The record of the person or animal who is involved in the study.

                    ShortWho is part of study
                    Comments

                    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.

                    Control1..1
                    This element is affected by the following invariants: ele-1
                    TypeReference(Patient)
                    Must Supporttrue
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
                    70. ResearchSubject.assignedArm
                    Definition

                    The name of the arm in the study the subject is expected to follow as part of this study.

                    ShortWhat path should be followed
                    Comments

                    Note that FHIR strings SHALL NOT exceed 1MB in size

                    Control0..1
                    This element is affected by the following invariants: ele-1
                    Typestring
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    72. ResearchSubject.actualArm
                    Definition

                    The name of the arm in the study the subject actually followed as part of this study.

                    ShortWhat path was followed
                    Comments

                    Note that FHIR strings SHALL NOT exceed 1MB in size

                    Control0..1
                    This element is affected by the following invariants: ele-1
                    Typestring
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    74. ResearchSubject.consent
                    Definition

                    A record of the patient's informed agreement to participate in the study.

                    ShortAgreement to participate in study
                    Comments

                    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.

                    Control1..1
                    This element is affected by the following invariants: ele-1
                    TypeReference(Consent)
                    Must Supporttrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))