| TEMPLATE ID | Consent |
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| Concept | Consent |
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| Description | Not Specified |
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| Purpose | Not Specified |
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| References | |
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| Authors | date: 2024-10-18 |
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| Other Details Language | date: 2024-10-18 |
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| Other Details (Language Independent) | - Sem Ver: 5.0.1
- MD5-CAM-1.0.1: bf925a2ecd6dd06bf2a461472d0d0631
- PARENT:MD5-CAM-1.0.1: 005501C1FA493A4838F5F1121F2870EC
- Original Language: ISO_639-1::de
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| Language used | en |
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| Citeable Identifier | 1246.169.3637 |
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| Root archetype id | openEHR-EHR-COMPOSITION.report.v1 |
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| Consent | Consent: Document to communicate information to others, commonly in response to a request from another party. |
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| Other Context | |
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| Report ID | Report ID: Identification information about the report. |
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| Status | Status: The status of the entire report. Note: This is not the status of any of the report components. |
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| Einwilligungserklärung | Einwilligungserklärung: Record of status and details of informed consent from an individual (or the individual's agent/proxy) for a proposed procedure, trial or other healthcare-related activity (including treatments and investigations), based upon a clear appreciation and understanding of the facts, implications, and possible future consequences by the consenting party. |
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| Description | |
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| Procedure/Trial/Activity | Procedure/Trial/Activity: Identification of the procedure, clinical trial or healthcare-related activity (including correct side/correct site, where appropriate) against which the consent status and details are recorded. |
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| Procedure/Trial/Activity description | Procedure/Trial/Activity description: Narrative description of the procedure, clinical trial or healthcare-related activity.
Value set: terminology:http://terminology.hl7.org/CodeSystem/consentscope?subset=/terminology.hl7.org/CodeSystem/consentscope/null |
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| Intent | Intent: Description of the intent of the procedure, clinical trial or healthcare-related activity.
Value set: terminology:http://hl7.org/fhir/ValueSet/consent-category?subset=/hl7.org/fhir/ValueSet/consent-category/null |
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| Consent description | Consent description: Narrative description of the informed consent required or recorded prior to performing the proposed procedure, clinical trial or healthcare-related activity.
Value set: terminology:https://simplifier.net/packages/hl7.fhir.r4.core/4.0.1/files/83577?subset=/simplifier.net/packages/hl7.fhir.r4.core/4.0.1/files/83577/null |
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| Study participation | Study participation: Details about participation in a clinical trial, observational study, registry study, diagnostic study, therapeutic study, or other medical research project in the role of a study patient or subject. |
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| Status | Status: Participation status.
From the time a patient is eligible and informed to be a participant in a study, their participation may go through different statuses.
 Coded Text- Informed
- Consented
- Screening phase
- Included
- Revoked
- Cancelled/Excluded
- Follow-up
- Completed
- Potential Candidate
- Not Registered
 Text
|
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| Identification | Identification: The name or identifier of the patient in the study.
A unique identifier of the patient in the study, usually called a usually called a Patient/Subject number or Patient ID/Subject ID. |
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| Start of participation | Start of participation: Date when the patient was enrolled in the study.
The date field may be left blank if the participation status is set to 'Informed' or 'Consented'. |
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| End of participation | End of participation: Date when the patient completed the study.
The date field can be left blank if the participation status is set to 'Informed', 'Consented', 'Screening Phase', 'Included' or 'Follow-up'. |
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| Einwilligungsnachweis (Policy) | Einwilligungsnachweis (Policy): Link to evidence of consent.
For example, a hyperlink to the evidence held elsewhere in the health record. |
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| Comment | Comment: Additional narrative about the informed consent activity, not captured in other fields. |
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| Provision | Provision: Provision |
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| Einwilligungsstatus | Einwilligungsstatus: *
Default value: false |
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| Beginn | Beginn: * |
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| Ende | Ende: * |
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| Provision | Provision: Provision |
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| Einwilligungsstatus | Einwilligungsstatus: *
Default value: true |
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| Beginn | Beginn: * |
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| Ende | Ende: * |
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| Einschränkungen | Einschränkungen: *
Value set: terminology:https://www.medizininformatik-initiative.de/fhir/ValueSet/MiiConsentPolicyValueSet |
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| Protocol | |
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| Consent document used | Consent document used: Identification of the form or document used to obtain consent. |
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| Review date | Review date: Date when consent status is due for review. |
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| Organisation | Organisation: An entity comprising one or more people and having a particular purpose.
For example: a company, institution, association, network, department, community group, healthcare practice group, payer/insurer, care team, or a group of neighbours who provide care or support. |
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| Name | Name: The unstructured name or label for the organisation.
For example: 'Royal Children's Hospital'; 'ABC District Nursing Service'; 'YNWA Oslo' or 'JB Smith Lawyers'. |
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| Identifier | Identifier: Identifier associated with the organisation.
Occurrences for this data element is set to 0..* to allow for more than one Identifier to be recorded. Note that the ID data type contains multiple subcomponents for recording the ID value, type, issuer and assigner.
 Identifier- Text
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| Role | Role: The relationship or role of the organisation to the individual or subject of care.
For example: oncologist; palliative care home nursing service; or informal support network. |
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| Comment | Comment: Additional narrative about the organisation not captured in other fields. |
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| Person | Person: An individual human being. |
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| Name | Name: The unstructured name for the individual.
The content of this data element may be derived from one or more components from CLUSTER.structured_name combined together as a text string. For example: 'John Markham', 'Professor Sir John Markham', 'John Markham Jnr MP'. |
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| Label | Label: A label for the individual.
For example: 'Neighbour in the house with the red door'. |
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| Identifier | Identifier: Identifier associated with the individual.
Occurrences for this data element is set to 0..* to allow for more than one Identifier to be recorded. Note that the DV_IDENTIFIER data type contains multiple subcomponents for recording the ID value, type, issuer and assigned. For example - social security number; driver's license; or passport number.
- Identifier
- Text
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| Role | Role: The relationship or role of the individual to the subject of the health record.
For example - the copyholder of an advance care record; contact person in an organisation; relative in a family history entry; specimen collector; or witness to a fall or accident. If the individual being described using this archetype is the subject of the health record, then this data element is redundant. |
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| Comment | Comment: Additional narrative about the individual not captured in other fields. |
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