MII-Initiative

MII IG Molekulares Tumorboard DE v2025

Studieneinschluss (Studie): ResearchStudy


Inhalt

Dieses Profil beschreibt als Teil der Studieneinschlussempfehlung die Studie, in die der Einschluss empfohlen wird.


Verknüpfungen zu anderen Ressourcen


Zeitliche Zuordnung im Verlauf

NameStatusVersionCanonicalBasis
MII_PR_MTB_Studiedraft2024.0.0-ballothttps://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/StructureDefinition/mii-pr-mtb-studiehttps://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-studie

Inhalt

idΣ0..1string
metaS Σ0..1Meta
implicitRulesΣ ?!0..1uri
language0..1codeBinding
text0..1Narrative
contained0..*Resource
LabelS I0..*Extension(Complex)
AssociatedPartyS I0..*Extension(Complex)
EthikvotumS I0..*Extension(Complex)
StudienregisterS I0..*Extension(Reference(Library))
EligibilityS I0..1Extension(Reference(Group | EvidenceVariable))
AkronymS I0..1Extension(string)
RekrutierungS I0..1Extension(Complex)
FinanzierungS I0..*Extension(string)
OnkologischeDiagnoseS I0..*Extension(Reference(MII_PR_MTB_Diagnose_Primaertumor | Condition))
id0..1string
extensionI0..0Extension
url1..1uriFixed Value
valueReferenceReference(MII_PR_MTB_Therapieplan)
modifierExtension?! I0..*Extension
id0..1string
extensionI0..*Extension
useΣ ?!0..1codeBinding
typeΣ0..1CodeableConceptBinding
systemS Σ0..1uri
valueS Σ0..1string
periodΣ0..1Period
assignerΣ0..1Reference(Organization)
id0..1string
extensionI0..*Extension
useΣ ?!0..1codeBinding
typeΣ0..1CodeableConceptBinding
systemS Σ1..1uriPattern
valueS Σ1..1string
periodΣ0..1Period
assignerΣ0..1Reference(Organization)
id0..1string
extensionI0..*Extension
useΣ ?!0..1codeBinding
typeΣ0..1CodeableConceptBinding
systemS Σ1..1uriPattern
valueS Σ1..1string
periodΣ0..1Period
assignerΣ0..1Reference(Organization)
id0..1string
extensionI0..*Extension
useΣ ?!0..1codeBinding
typeΣ0..1CodeableConceptBinding
systemS Σ1..1uriPattern
valueS Σ1..1string
periodΣ0..1Period
assignerΣ0..1Reference(Organization)
titleS Σ0..1string
protocolΣ0..*Reference(PlanDefinition)
partOfS Σ0..*Reference(ResearchStudy)
statusS Σ ?!1..1codeBinding
primaryPurposeTypeΣ0..1CodeableConceptBinding
phaseΣ0..1CodeableConcept
categoryS Σ0..*CodeableConcept
id0..1string
extensionI0..*Extension
codingΣ0..*Coding
textS Σ0..1string
conditionΣ0..*CodeableConcept
contactΣ0..*ContactDetail
relatedArtifact0..*RelatedArtifact
id0..1string
extensionI0..*Extension
codingΣ0..*Coding
textS Σ0..1string
locationΣ0..*CodeableConceptBinding
description0..1markdown
enrollmentΣ0..*Reference(Group)
periodΣ0..1Period
sponsorΣ0..1Reference(Organization)
principalInvestigatorΣ0..1Reference(Practitioner | PractitionerRole)
siteΣ0..*Reference(Location)
reasonStoppedΣ0..1CodeableConcept
note0..*Annotation
id0..1string
extensionI0..*Extension
modifierExtensionΣ ?! I0..*Extension
nameS1..1string
type0..1CodeableConcept
description0..1string
id0..1string
extensionI0..*Extension
modifierExtensionΣ ?! I0..*Extension
name0..1string
type0..1CodeableConceptBinding

Onkologische Studie

Feldname
ResearchStudy.meta
ResearchStudy.extension:OnkologischeDiagnose
ResearchStudy.extension:Therapieplan
<StructureDefinition xmlns="http://hl7.org/fhir">
    <id value="mii-pr-mtb-studie" />
    <url value="https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/StructureDefinition/mii-pr-mtb-studie" />
    <version value="2024.0.0-ballot" />
    <name value="MII_PR_MTB_Studie" />
    <title value="MII PR MTB Studie" />
    <status value="draft" />
    <publisher value="Medizininformatik Initiative" />
    <contact>
        <telecom>
            <system value="url" />
            <value value="https://www.medizininformatik-initiative.de" />
        </telecom>
    </contact>
    <description value="Onkologische Studie" />
    <fhirVersion value="4.0.1" />
    <kind value="resource" />
    <abstract value="false" />
    <type value="ResearchStudy" />
    <baseDefinition value="https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-studie" />
    <derivation value="constraint" />
    <differential>
        <element id="ResearchStudy.meta">
            <path value="ResearchStudy.meta" />
            <mustSupport value="true" />
        </element>
        <element id="ResearchStudy.extension:OnkologischeDiagnose">
            <path value="ResearchStudy.extension" />
            <sliceName value="OnkologischeDiagnose" />
            <min value="0" />
            <max value="*" />
            <type>
                <code value="Extension" />
                <profile value="https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/StructureDefinition/mii-ex-mtb-diagnose" />
            </type>
            <mustSupport value="true" />
        </element>
        <element id="ResearchStudy.extension:Therapieplan">
            <path value="ResearchStudy.extension" />
            <sliceName value="Therapieplan" />
            <min value="0" />
            <max value="*" />
            <type>
                <code value="Extension" />
                <profile value="http://hl7.org/fhir/StructureDefinition/event-basedOn" />
            </type>
            <mustSupport value="true" />
        </element>
        <element id="ResearchStudy.extension:Therapieplan.value[x]">
            <path value="ResearchStudy.extension.value[x]" />
            <type>
                <code value="Reference" />
                <targetProfile value="https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/StructureDefinition/mii-pr-mtb-therapieplan" />
            </type>
        </element>
        <element id="ResearchStudy.identifier">
            <path value="ResearchStudy.identifier" />
            <slicing>
                <discriminator>
                    <type value="value" />
                    <path value="system" />
                </discriminator>
                <description value="Slice f&#252;r Identifikator eines Studienregisters bzw. studiendurchf&#252;hrenden Organisation anhand von `system`" />
                <ordered value="false" />
                <rules value="open" />
            </slicing>
        </element>
        <element id="ResearchStudy.identifier:NCT">
            <path value="ResearchStudy.identifier" />
            <sliceName value="NCT" />
            <min value="0" />
            <max value="1" />
        </element>
        <element id="ResearchStudy.identifier:NCT.system">
            <path value="ResearchStudy.identifier.system" />
            <min value="1" />
            <patternUri value="https://www.medizininformatik-initiative.de/fhir/modul-mtb/sid/nct" />
        </element>
        <element id="ResearchStudy.identifier:NCT.value">
            <path value="ResearchStudy.identifier.value" />
            <min value="1" />
        </element>
        <element id="ResearchStudy.identifier:DRKS">
            <path value="ResearchStudy.identifier" />
            <sliceName value="DRKS" />
            <min value="0" />
            <max value="1" />
        </element>
        <element id="ResearchStudy.identifier:DRKS.system">
            <path value="ResearchStudy.identifier.system" />
            <min value="1" />
            <patternUri value="https://www.medizininformatik-initiative.de/fhir/modul-studie/sid/drks" />
        </element>
        <element id="ResearchStudy.identifier:DRKS.value">
            <path value="ResearchStudy.identifier.value" />
            <min value="1" />
        </element>
        <element id="ResearchStudy.identifier:EudraCT">
            <path value="ResearchStudy.identifier" />
            <sliceName value="EudraCT" />
            <min value="0" />
            <max value="1" />
        </element>
        <element id="ResearchStudy.identifier:EudraCT.system">
            <path value="ResearchStudy.identifier.system" />
            <min value="1" />
            <patternUri value="https://www.medizininformatik-initiative.de/fhir/modul-studie/sid/eudract" />
        </element>
        <element id="ResearchStudy.identifier:EudraCT.value">
            <path value="ResearchStudy.identifier.value" />
            <min value="1" />
        </element>
    </differential>
</StructureDefinition>
{
    "resourceType": "StructureDefinition",
    "id": "mii-pr-mtb-studie",
    "url": "https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/StructureDefinition/mii-pr-mtb-studie",
    "version": "2024.0.0-ballot",
    "name": "MII_PR_MTB_Studie",
    "title": "MII PR MTB Studie",
    "status": "draft",
    "publisher": "Medizininformatik Initiative",
    "contact":  [
        {
            "telecom":  [
                {
                    "system": "url",
                    "value": "https://www.medizininformatik-initiative.de"
                }
            ]
        }
    ],
    "description": "Onkologische Studie",
    "fhirVersion": "4.0.1",
    "kind": "resource",
    "abstract": false,
    "type": "ResearchStudy",
    "baseDefinition": "https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-studie",
    "derivation": "constraint",
    "differential": {
        "element":  [
            {
                "id": "ResearchStudy.meta",
                "path": "ResearchStudy.meta",
                "mustSupport": true
            },
            {
                "id": "ResearchStudy.extension:OnkologischeDiagnose",
                "path": "ResearchStudy.extension",
                "sliceName": "OnkologischeDiagnose",
                "min": 0,
                "max": "*",
                "type":  [
                    {
                        "code": "Extension",
                        "profile":  [
                            "https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/StructureDefinition/mii-ex-mtb-diagnose"
                        ]
                    }
                ],
                "mustSupport": true
            },
            {
                "id": "ResearchStudy.extension:Therapieplan",
                "path": "ResearchStudy.extension",
                "sliceName": "Therapieplan",
                "min": 0,
                "max": "*",
                "type":  [
                    {
                        "code": "Extension",
                        "profile":  [
                            "http://hl7.org/fhir/StructureDefinition/event-basedOn"
                        ]
                    }
                ],
                "mustSupport": true
            },
            {
                "id": "ResearchStudy.extension:Therapieplan.value[x]",
                "path": "ResearchStudy.extension.value[x]",
                "type":  [
                    {
                        "code": "Reference",
                        "targetProfile":  [
                            "https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/StructureDefinition/mii-pr-mtb-therapieplan"
                        ]
                    }
                ]
            },
            {
                "id": "ResearchStudy.identifier",
                "path": "ResearchStudy.identifier",
                "slicing": {
                    "discriminator":  [
                        {
                            "type": "value",
                            "path": "system"
                        }
                    ],
                    "rules": "open",
                    "description": "Slice für Identifikator eines Studienregisters bzw. studiendurchführenden Organisation anhand von `system`",
                    "ordered": false
                }
            },
            {
                "id": "ResearchStudy.identifier:NCT",
                "path": "ResearchStudy.identifier",
                "sliceName": "NCT",
                "min": 0,
                "max": "1"
            },
            {
                "id": "ResearchStudy.identifier:NCT.system",
                "path": "ResearchStudy.identifier.system",
                "min": 1,
                "patternUri": "https://www.medizininformatik-initiative.de/fhir/modul-mtb/sid/nct"
            },
            {
                "id": "ResearchStudy.identifier:NCT.value",
                "path": "ResearchStudy.identifier.value",
                "min": 1
            },
            {
                "id": "ResearchStudy.identifier:DRKS",
                "path": "ResearchStudy.identifier",
                "sliceName": "DRKS",
                "min": 0,
                "max": "1"
            },
            {
                "id": "ResearchStudy.identifier:DRKS.system",
                "path": "ResearchStudy.identifier.system",
                "min": 1,
                "patternUri": "https://www.medizininformatik-initiative.de/fhir/modul-studie/sid/drks"
            },
            {
                "id": "ResearchStudy.identifier:DRKS.value",
                "path": "ResearchStudy.identifier.value",
                "min": 1
            },
            {
                "id": "ResearchStudy.identifier:EudraCT",
                "path": "ResearchStudy.identifier",
                "sliceName": "EudraCT",
                "min": 0,
                "max": "1"
            },
            {
                "id": "ResearchStudy.identifier:EudraCT.system",
                "path": "ResearchStudy.identifier.system",
                "min": 1,
                "patternUri": "https://www.medizininformatik-initiative.de/fhir/modul-studie/sid/eudract"
            },
            {
                "id": "ResearchStudy.identifier:EudraCT.value",
                "path": "ResearchStudy.identifier.value",
                "min": 1
            }
        ]
    }
}

Mapping Datensatz zu FHIR


Suchparameter

Folgende Suchparameter sind für das Modul Onkologie relevant, auch in Kombination:

  1. Der Suchparameter "_id" MUSS unterstützt werden:

    Beispiele:

    GET [base]/ResearchStudy?_id=12345

    Anwendungshinweise: Weitere Informationen zur Suche nach "_id" finden sich in der FHIR-Basisspezifikation - Abschnitt "Parameters for all resources".


Beispiele