MII-Initiative

MII IG Person EN v2024

ResearchSubject (ResearchSubject)

Description

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.

NameStatusVersionCanonicalBase
MII_PR_Person_Probandretired2025.0.1https://www.medizininformatik-initiative.de/fhir/core/modul-person/StructureDefinition/ResearchSubjecthttp://hl7.org/fhir/StructureDefinition/ResearchSubject

Inhalt

idS Σ0..1string
id0..1string
extensionC0..*Extension
versionIdΣ0..1id
lastUpdatedΣ0..1instant
sourceΣ0..1uri
profileS Σ0..*canonical(StructureDefinition)
securityΣ0..*CodingBinding
tagΣ0..*Coding
implicitRulesΣ ?!0..1uri
language0..1codeBinding
text0..1Narrative
contained0..*Resource
extensionC0..*Extension
modifierExtension?! C0..*Extension
id0..1string
extensionC0..*Extension
useΣ ?!0..1codeBinding
typeS Σ0..1CodeableConceptBindingPattern
systemS Σ1..1uri
valueS Σ1..1string
periodΣ C0..1Period
assignerΣ C0..1Reference(Organization)
statusS Σ ?!1..1codeBinding
id0..1string
extensionC0..*Extension
startS Σ C1..1dateTime
endS Σ C0..1dateTime
studyS Σ C1..1Reference(ResearchStudy)
individualS Σ C1..1Reference(Patient)
assignedArm0..1string
actualArm0..1string
consentS C1..1Reference(Consent)

Dieses Profil beschreibt eine Proband*in in der Medizininformatik-Initiative.

Fieldname
ResearchSubject.id
ResearchSubject.meta
ResearchSubject.meta.profile
ResearchSubject.identifier
ResearchSubject.identifier:subjectIdentificationCode
ResearchSubject.identifier:subjectIdentificationCode.type
ResearchSubject.identifier:subjectIdentificationCode.system
ResearchSubject.identifier:subjectIdentificationCode.value
ResearchSubject.status
ResearchSubject.period
ResearchSubject.period.start
ResearchSubject.period.end
ResearchSubject.study
ResearchSubject.individual
ResearchSubject.consent
<StructureDefinition xmlns="http://hl7.org/fhir">
<id value="mii-pr-person-proband" />
<url value="https://www.medizininformatik-initiative.de/fhir/core/modul-person/StructureDefinition/ResearchSubject" />
<version value="2025.0.1" />
<name value="MII_PR_Person_Proband" />
<title value="MII PR Person Proband" />
<status value="retired" />
<date value="2024-11-11" />
<publisher value="Medizininformatik Initiative" />
<contact>
<telecom>
<system value="url" />
<value value="https://www.medizininformatik-initiative.de" />
</telecom>
</contact>
<description value="Dieses Profil beschreibt eine Proband*in in der Medizininformatik-Initiative." />
<fhirVersion value="4.0.1" />
<kind value="resource" />
<abstract value="false" />
<type value="ResearchSubject" />
<baseDefinition value="http://hl7.org/fhir/StructureDefinition/ResearchSubject" />
<derivation value="constraint" />
<differential>
<element id="ResearchSubject.id">
<path value="ResearchSubject.id" />
<mustSupport value="true" />
</element>
<element id="ResearchSubject.meta">
<path value="ResearchSubject.meta" />
<mustSupport value="true" />
</element>
<element id="ResearchSubject.meta.profile">
<path value="ResearchSubject.meta.profile" />
<mustSupport value="true" />
</element>
<element id="ResearchSubject.identifier">
<path value="ResearchSubject.identifier" />
<slicing>
<discriminator>
<type value="pattern" />
<path value="$this" />
</discriminator>
<rules value="open" />
</slicing>
<min value="1" />
<mustSupport value="true" />
</element>
<element id="ResearchSubject.identifier:subjectIdentificationCode">
<path value="ResearchSubject.identifier" />
<sliceName value="subjectIdentificationCode" />
<min value="1" />
<max value="1" />
<patternIdentifier>
<type>
<coding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0203" />
<code value="ANON" />
</coding>
</type>
</patternIdentifier>
<mustSupport value="true" />
</element>
<element id="ResearchSubject.identifier:subjectIdentificationCode.type">
<path value="ResearchSubject.identifier.type" />
<mustSupport value="true" />
</element>
<element id="ResearchSubject.identifier:subjectIdentificationCode.system">
<path value="ResearchSubject.identifier.system" />
<min value="1" />
<mustSupport value="true" />
</element>
<element id="ResearchSubject.identifier:subjectIdentificationCode.value">
<path value="ResearchSubject.identifier.value" />
<min value="1" />
<mustSupport value="true" />
</element>
<element id="ResearchSubject.status">
<path value="ResearchSubject.status" />
<mustSupport value="true" />
</element>
<element id="ResearchSubject.period">
<path value="ResearchSubject.period" />
<min value="1" />
<mustSupport value="true" />
</element>
<element id="ResearchSubject.period.start">
<path value="ResearchSubject.period.start" />
<min value="1" />
<mustSupport value="true" />
</element>
<element id="ResearchSubject.period.end">
<path value="ResearchSubject.period.end" />
<mustSupport value="true" />
</element>
<element id="ResearchSubject.study">
<path value="ResearchSubject.study" />
<mustSupport value="true" />
</element>
<element id="ResearchSubject.individual">
<path value="ResearchSubject.individual" />
<mustSupport value="true" />
</element>
<element id="ResearchSubject.consent">
<path value="ResearchSubject.consent" />
<min value="1" />
<mustSupport value="true" />
</element>
</differential>
</StructureDefinition>
{
"resourceType": "StructureDefinition",
"id": "mii-pr-person-proband",
"url": "https://www.medizininformatik-initiative.de/fhir/core/modul-person/StructureDefinition/ResearchSubject",
"version": "2025.0.1",
"name": "MII_PR_Person_Proband",
"title": "MII PR Person Proband",
"status": "retired",
"date": "2024-11-11",
"publisher": "Medizininformatik Initiative",
"contact": [
{
"telecom": [
{
"system": "url",
"value": "https://www.medizininformatik-initiative.de"
}
]
}
],
"description": "Dieses Profil beschreibt eine Proband*in in der Medizininformatik-Initiative.",
"fhirVersion": "4.0.1",
"kind": "resource",
"abstract": false,
"type": "ResearchSubject",
"baseDefinition": "http://hl7.org/fhir/StructureDefinition/ResearchSubject",
"derivation": "constraint",
"differential": {
"element": [
{
"id": "ResearchSubject.id",
"path": "ResearchSubject.id",
"mustSupport": true
},
{
"id": "ResearchSubject.meta",
"path": "ResearchSubject.meta",
"mustSupport": true
},
{
"id": "ResearchSubject.meta.profile",
"path": "ResearchSubject.meta.profile",
"mustSupport": true
},
{
"id": "ResearchSubject.identifier",
"path": "ResearchSubject.identifier",
"slicing": {
"discriminator": [
{
"type": "pattern",
"path": "$this"
}
],
"rules": "open"
},
"min": 1,
"mustSupport": true
},
{
"id": "ResearchSubject.identifier:subjectIdentificationCode",
"path": "ResearchSubject.identifier",
"sliceName": "subjectIdentificationCode",
"min": 1,
"max": "1",
"patternIdentifier": {
"type": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/v2-0203",
"code": "ANON"
}
]
}
},
"mustSupport": true
},
{
"id": "ResearchSubject.identifier:subjectIdentificationCode.type",
"path": "ResearchSubject.identifier.type",
"mustSupport": true
},
{
"id": "ResearchSubject.identifier:subjectIdentificationCode.system",
"path": "ResearchSubject.identifier.system",
"min": 1,
"mustSupport": true
},
{
"id": "ResearchSubject.identifier:subjectIdentificationCode.value",
"path": "ResearchSubject.identifier.value",
"min": 1,
"mustSupport": true
},
{
"id": "ResearchSubject.status",
"path": "ResearchSubject.status",
"mustSupport": true
},
{
"id": "ResearchSubject.period",
"path": "ResearchSubject.period",
"min": 1,
"mustSupport": true
},
{
"id": "ResearchSubject.period.start",
"path": "ResearchSubject.period.start",
"min": 1,
"mustSupport": true
},
{
"id": "ResearchSubject.period.end",
"path": "ResearchSubject.period.end",
"mustSupport": true
},
{
"id": "ResearchSubject.study",
"path": "ResearchSubject.study",
"mustSupport": true
},
{
"id": "ResearchSubject.individual",
"path": "ResearchSubject.individual",
"mustSupport": true
},
{
"id": "ResearchSubject.consent",
"path": "ResearchSubject.consent",
"min": 1,
"mustSupport": true
}
]
}
}
MII PR Person Proband

Notes

FHIR-Element Explanation
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.

Mappings

FHIR-Element Logical Data Set
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

SearchParameters

The following SearchParameters are relevant for the module Person, also in combination:

  1. The SearchParameter "_id" MUST be supported:

    Example:

    GET [base]/ResearchSubject?_id=103270

    Note: Additional information regarding the search using "_id" can be found in FHIR Core Specification - Section "Parameters for all resources".

  2. The SearchParameter "_profile" MUST be supported:

    Example:

    GET [base]/ResearchSubject?_profile=https://www.medizininformatik-initiative.de/fhir/core/modul-person/StructureDefinition/ResearchSubject

    Note: Additional information regarding the search using "_profile" can be found in FHIR Core Specification - Section "Parameters for all resources".

  3. The SearchParameter "identifier" MUST be supported:

    Example:

    GET [base]/ResearchSubject?identifier=http://fhir.krankenhaus.example/sid/subjectIdentificationCode|1032702

    Note: Additional information regarding the search using "ResearchSubject.identifier" can be found in FHIR Core Specification - Section "Token Search".

  4. The SearchParameter "status" MUST be supported:

    Example:

    GET [base]/ResearchSubject?status=candidate

    Note: Additional information regarding the search using "ResearchSubject.status" can be found in FHIR Core Specification - Section "Token Search".

  5. The SearchParameter "date" MUST be supported:

    Example:

    GET [base]/ResearchSubject?date=2022-01-01

    Note: Additional information regarding the search using "ResearchSubject.period" can be found in FHIR Core Specification - Section "Date Search".

  6. The SearchParameter "study" MUST be supported:

    Example:

    GET [base]/ResearchSubject?study=ResearchStudy/study

    Note: Additional information regarding the search using "ResearchStudy.study" can be found in FHIR Core Specification - Section "reference".

  7. The SearchParameter "individual" MUST be supported:

    Example:

    GET [base]/ResearchSubject?individual=Patient/test

    Note: Additional information regarding the search using "ResearchStudy.individual" can be found in FHIR Core Specification - Section "reference".

  8. The SearchParameter "consent" MUST be supported:

    Example:

    GET [base]/ResearchSubject?consent=Consent/test

    Note: Additional information regarding the search using "ResearchStudy.consent" can be found in FHIR Core Specification - Section "reference".

Examples

Example (complete):

Command 'json' could not render: File not found for 'subject=fsh-generated/resources/ResearchSubject-mii-exa-person-researchsubject-studienteilnehmer.json'

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