description: Dieses Profil beschreibt eine Studie in der Medizininformatik-Initiative. package_name: de.medizininformatikinitiative.kerndatensatz.studie derivation: constraint name: MII_PR_Studie_Studie type: ResearchStudy elements: category: short: Klassifikationen für die Studie. _short: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: de} - {url: content, valueString: Klassifikationen für die Studie.} - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: en} - {url: content, valueString: Classifications for the study.} _definition: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: de} - {url: content, valueString: 'Codes zur Kategorisierung des Studientyps, wie z. B. experimentell vs. beobachtend, Art der Verblindung, Art der Randomisierung, Sicherheit vs. Wirksamkeit usw.'} - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: en} - {url: content, valueString: 'Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.'} mustSupport: true index: 15 arm: short: Definierter Weg durch die Studie für ein Subjekt. _short: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: de} - {url: content, valueString: Definierter Weg durch die Studie für ein Subjekt.} - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: en} - {url: content, valueString: Defined path through the study for a subject.} _definition: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: de} - {url: content, valueString: 'Beschreibt eine erwartete Abfolge von Ereignissen für einen der Teilnehmer einer Studie. Z. B. Exposition gegenüber Medikament A, Auswaschphase, Exposition gegenüber Medikament B, Auswaschphase, Nachverfolgung.'} - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: en} - {url: content, valueString: 'Describes an expected sequence of events for one of the participants of a study. E.g. Exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up.'} mustSupport: true index: 20 elements: name: {mustSupport: true, index: 21} title: short: Name für diese Studie _short: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: de} - {url: content, valueString: Name für diese Studie.} - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: en} - {url: content, valueString: Name for this study.} _definition: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: de} - {url: content, valueString: 'Ein kurzer, beschreibender und benutzerfreundlicher Bezeichner für die Studie.'} - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: en} - {url: content, valueString: 'A short, descriptive user-friendly label for the study.'} mustSupport: true index: 12 extension: mustSupport: true index: 0 slicing: slices: Label: match: {} schema: short: Label _definition: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: de} - {url: content, valueString: Optionales Erweiterungselement – in allen Ressourcen vorhanden.} - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: en} - {url: content, valueString: Optional Extension Element - found in all resources.} type: Extension mustSupport: true _short: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: de} - {url: content, valueString: MII EX Studie Backport Label} - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: en} - {url: content, valueString: MII EX Studie Backport Label} url: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label index: 1 min: 0 AssociatedParty: match: {} schema: short: AssociatedParty _definition: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: de} - {url: content, valueString: Optionales Erweiterungselement – in allen Ressourcen vorhanden.} - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: en} - {url: content, valueString: Optional Extension Element - found in all resources.} type: Extension mustSupport: true _short: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: de} - {url: content, valueString: MII EX Studie Backport AssociatedParty} - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: en} - {url: content, valueString: MII EX Studie Backport AssociatedParty} url: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty index: 2 min: 0 Ethikvotum: match: {} schema: short: Ethikvotum _definition: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: de} - {url: content, valueString: Optionales Erweiterungselement – in allen Ressourcen vorhanden.} - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: en} - {url: content, valueString: Optional Extension Element - found in all resources.} type: Extension mustSupport: true _short: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: de} - {url: content, valueString: MII EX Studie Ethikvotum} - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: en} - {url: content, valueString: MII EX Studie Ethikvotum} url: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-ethikvotum index: 3 min: 0 Studienregister: match: {} schema: short: Studienregister _definition: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: de} - {url: content, valueString: Optionales Erweiterungselement – in allen Ressourcen vorhanden.} - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: en} - {url: content, valueString: Optional Extension Element - found in all resources.} type: Extension mustSupport: true _short: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: de} - {url: content, valueString: MII EX Studie Studienregister} - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: en} - {url: content, valueString: MII EX Studie Studienregister} url: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-studienregister index: 4 min: 0 Eligibility: match: {} schema: short: Eligibility _definition: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: de} - {url: content, valueString: Optionales Erweiterungselement – in allen Ressourcen vorhanden.} - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: en} - {url: content, valueString: Optional Extension Element - found in all resources.} type: Extension mustSupport: true _short: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: de} - {url: content, valueString: MII EX Studie Eligibility} - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: en} - {url: content, valueString: MII EX Studie Eligibility} url: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-eligibility index: 5 min: 0 max: 1 Akronym: match: {} schema: short: Akronym _definition: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: de} - {url: content, valueString: Optionales Erweiterungselement – in allen Ressourcen vorhanden.} - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: en} - {url: content, valueString: Optional Extension Element - found in all resources.} type: Extension mustSupport: true _short: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: de} - {url: content, valueString: MII EX Studie Akronym} - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: en} - {url: content, valueString: MII EX Studie Akronym} url: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-akronym index: 6 min: 0 max: 1 Rekrutierung: match: {} schema: short: Rekrutierung _definition: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: de} - {url: content, valueString: Optionales Erweiterungselement – in allen Ressourcen vorhanden.} - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: en} - {url: content, valueString: Optional Extension Element - found in all resources.} type: Extension mustSupport: true _short: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: de} - {url: content, valueString: MII EX Studie Rekrutierung} - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: en} - {url: content, valueString: MII EX Studie Rekrutierung} url: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-rekrutierung index: 7 min: 0 max: 1 Finanzierung: match: {} schema: short: Finanzierung _definition: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: de} - {url: content, valueString: Optionales Erweiterungselement – in allen Ressourcen vorhanden.} - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: en} - {url: content, valueString: Optional Extension Element - found in all resources.} type: Extension mustSupport: true _short: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: de} - {url: content, valueString: MII EX Studie Finanzierung} - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: en} - {url: content, valueString: MII EX Studie Finanzierung} url: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-finanzierung index: 8 min: 0 keyword: short: Wird verwendet, um nach der Studie zu suchen. _short: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: de} - {url: content, valueString: 'Wird verwendet, um nach der Studie zu suchen.'} - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: en} - {url: content, valueString: Used to search for the study.} _definition: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: de} - {url: content, valueString: 'Schlüsselbegriffe, die bei der Suche nach oder Filterung der Studie helfen.'} - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: en} - {url: content, valueString: Key terms to aid in searching for or filtering the study.} mustSupport: true index: 18 elements: text: {mustSupport: true, index: 19} status: short: aktiv | administrativ abgeschlossen | genehmigt | für Rekrutierung geschlossen | für Rekrutierung und Intervention geschlossen | abgeschlossen | abgelehnt | in Überprüfung | vorübergehend für Rekrutierung geschlossen | vorübergehend für Rekrutierung und Intervention geschlossen | zurückgezogen _short: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: de} - {url: content, valueString: aktiv | administrativ abgeschlossen | genehmigt | für Rekrutierung geschlossen | für Rekrutierung und Intervention geschlossen | abgeschlossen | abgelehnt | in Überprüfung | vorübergehend für Rekrutierung geschlossen | vorübergehend für Rekrutierung und Intervention geschlossen | zurückgezogen} - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: en} - {url: content, valueString: active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn} _definition: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: de} - {url: content, valueString: Der aktuelle Status der Studie.} - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: en} - {url: content, valueString: The current state of the study.} mustSupport: true index: 14 identifier: short: Name für diese Studie _short: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: de} - {url: content, valueString: Name für diese Studie.} - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: en} - {url: content, valueString: Business Identifier for study.} _definition: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: de} - {url: content, valueString: 'Kennungen, die dieser Forschungsstudie vom Sponsor oder anderen Systemen zugewiesen wurden.'} - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: en} - {url: content, valueString: Identifiers assigned to this research study by the sponsor or other systems.} mustSupport: true index: 9 elements: system: {mustSupport: true, index: 10} value: {mustSupport: true, index: 11} focus: short: Untersuchte Medikamente, Geräte usw. _short: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: de} - {url: content, valueString: 'Untersuchte Medikamente, Geräte usw.'} - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: en} - {url: content, valueString: 'Drugs, devices, etc. under study'} _definition: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: de} - {url: content, valueString: 'Die Medikamente, Nahrungsmittel, Therapien, Geräte oder andere Anliegen oder Interventionen, über die die Studie mehr Informationen gewinnen möchte.'} - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: en} - {url: content, valueString: 'The medication, food, therapy, device or other concerns or interventions that the study is seeking to gain more information about.'} mustSupport: true index: 16 elements: text: {mustSupport: true, index: 17} partOf: short: Teil einer größeren Studie. _short: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: de} - {url: content, valueString: Teil einer größeren Studie.} - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: en} - {url: content, valueString: Part of larger study.} _definition: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: de} - {url: content, valueString: 'Eine größere Forschungsstudie, von der diese spezielle Studie ein Bestandteil oder ein Schritt ist.'} - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: en} - {url: content, valueString: A larger research study of which this particular study is a component or step.} mustSupport: true index: 13 package_version: 2026.0.1 extensions: Label: url: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label min: 0 short: Label _definition: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: de} - {url: content, valueString: Optionales Erweiterungselement – in allen Ressourcen vorhanden.} - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: en} - {url: content, valueString: Optional Extension Element - found in all resources.} type: Extension mustSupport: true _short: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: de} - {url: content, valueString: MII EX Studie Backport Label} - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: en} - {url: content, valueString: MII EX Studie Backport Label} index: 1 AssociatedParty: url: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty min: 0 short: AssociatedParty _definition: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: de} - {url: content, valueString: Optionales Erweiterungselement – in allen Ressourcen vorhanden.} - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: en} - {url: content, valueString: Optional Extension Element - found in all resources.} type: Extension mustSupport: true _short: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: de} - {url: content, valueString: MII EX Studie Backport AssociatedParty} - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: en} - {url: content, valueString: MII EX Studie Backport AssociatedParty} index: 2 Ethikvotum: url: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-ethikvotum min: 0 short: Ethikvotum _definition: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: de} - {url: content, valueString: Optionales Erweiterungselement – in allen Ressourcen vorhanden.} - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: en} - {url: content, valueString: Optional Extension Element - found in all resources.} type: Extension mustSupport: true _short: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: de} - {url: content, valueString: MII EX Studie Ethikvotum} - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: en} - {url: content, valueString: MII EX Studie Ethikvotum} index: 3 Studienregister: url: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-studienregister min: 0 short: Studienregister _definition: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: de} - {url: content, valueString: Optionales Erweiterungselement – in allen Ressourcen vorhanden.} - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: en} - {url: content, valueString: Optional Extension Element - found in all resources.} type: Extension mustSupport: true _short: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: de} - {url: content, valueString: MII EX Studie Studienregister} - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: en} - {url: content, valueString: MII EX Studie Studienregister} index: 4 Eligibility: min: 0 short: Eligibility index: 5 _definition: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: de} - {url: content, valueString: Optionales Erweiterungselement – in allen Ressourcen vorhanden.} - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: en} - {url: content, valueString: Optional Extension Element - found in all resources.} type: Extension mustSupport: true _short: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: de} - {url: content, valueString: MII EX Studie Eligibility} - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: en} - {url: content, valueString: MII EX Studie Eligibility} max: 1 url: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-eligibility Akronym: min: 0 short: Akronym index: 6 _definition: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: de} - {url: content, valueString: Optionales Erweiterungselement – in allen Ressourcen vorhanden.} - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: en} - {url: content, valueString: Optional Extension Element - found in all resources.} type: Extension mustSupport: true _short: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: de} - {url: content, valueString: MII EX Studie Akronym} - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: en} - {url: content, valueString: MII EX Studie Akronym} max: 1 url: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-akronym Rekrutierung: min: 0 short: Rekrutierung index: 7 _definition: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: de} - {url: content, valueString: Optionales Erweiterungselement – in allen Ressourcen vorhanden.} - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: en} - {url: content, valueString: Optional Extension Element - found in all resources.} type: Extension mustSupport: true _short: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: de} - {url: content, valueString: MII EX Studie Rekrutierung} - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: en} - {url: content, valueString: MII EX Studie Rekrutierung} max: 1 url: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-rekrutierung Finanzierung: url: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-ex-studie-finanzierung min: 0 short: Finanzierung _definition: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: de} - {url: content, valueString: Optionales Erweiterungselement – in allen Ressourcen vorhanden.} - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: en} - {url: content, valueString: Optional Extension Element - found in all resources.} type: Extension mustSupport: true _short: extension: - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: de} - {url: content, valueString: MII EX Studie Finanzierung} - url: http://hl7.org/fhir/StructureDefinition/translation extension: - {url: lang, valueCode: en} - {url: content, valueString: MII EX Studie Finanzierung} index: 8 class: profile kind: resource url: https://www.medizininformatik-initiative.de/fhir/modul-studie/StructureDefinition/mii-pr-studie-studie base: http://hl7.org/fhir/StructureDefinition/ResearchStudy version: 2026.0.1