FHIR IG analytics
| Package | hl7.fhir.uv.rwi-pharma |
| Resource Type | ImplementationGuide |
| Id | ImplementationGuide-hl7.fhir.uv.rwi-pharma.json |
| FHIR Version | R5 |
| Source | https://build.fhir.org/ig/HL7/reg-workflow-pharma/index.html |
| URL | http://hl7.org/fhir/uv/rwi-pharma/ImplementationGuide/hl7.fhir.uv.rwi-pharma |
| Version | 0.1.0 |
| Status | draft |
| Date | 2026-10-25T20:05:09+00:00 |
| Name | RWIpharma |
| Title | Regulatory Workflows and Interactions - pharma |
| Realm | uv |
| Authority | hl7 |
| Description | Regulatory exchange is globally fragmented across authorities, product lines, procedures, and technologies. This IG establishes a common Task- and Subscription-based framework for regulatory workflows and interactions, enabling them to be exchanged, tracked, and acted upon with machine-readable status and event-driven notifications. |
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Narrative
Note: links and images are rebased to the (stated) source
Generated Narrative: ImplementationGuide hl7.fhir.uv.rwi-pharma
Language: en
RWIpharma
The official URL for this implementation guide is:
http://hl7.org/fhir/uv/rwi-pharma/ImplementationGuide/hl7.fhir.uv.rwi-pharma
Regulatory exchange is globally fragmented across authorities, product lines, procedures, and technologies. This IG establishes a common Task- and Subscription-based framework for regulatory workflows and interactions, enabling them to be exchanged, tracked, and acted upon with machine-readable status and event-driven notifications.
Source1
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"jurisdiction": [
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}
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"name": "APIX CTD/eCTD Module Value Set",
"description": "Value set for CTD module codes used in APIX regulatory submissions",
"isExample": false
},
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"name": "APIX CTD/eCTD Section Code System",
"description": "Code system defining all relevant CTD/eCTD section codes used in APIX regulatory submissions to EMA, FDA, PMDA and other agencies. Based on ICH guidelines https://www.ich.org/page/ctd.",
"isExample": false
},
{
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"valueString": "StructureDefinition:resource"
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{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "StructureDefinition-endpoint-subscription-notify.html"
}
],
"reference": {
"reference": "StructureDefinition/endpoint-subscription-notify"
},
"name": "APIX Endpoint for FHIR Subscription Notifications",
"description": "Endpoint requiring identifier, name, and connectionType of hl7-fhir-subscription-notify.",
"isExample": false
},
{
"extension": [
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"valueUri": "CodeSystem-apix-demo.html"
}
],
"reference": {
"reference": "CodeSystem/apix-demo"
},
"name": "APIX Identifier Type Codes",
"description": "These codes are intended to be used to indicate specific APIX Identifier types",
"isExample": false
},
{
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},
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"valueUri": "StructureDefinition-apix-organization.html"
}
],
"reference": {
"reference": "StructureDefinition/apix-organization"
},
"name": "APIX Organization",
"description": "Organization profile for APIX regulatory workflows, derived from and compatible with ePI requirements.",
"isExample": false
},
{
"extension": [
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{
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"valueUri": "CodeSystem-apix-business-status.html"
}
],
"reference": {
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},
"name": "APIX Regulatory Business Status",
"description": "Code system for regulatory business status in APIX submissions",
"isExample": false
},
{
"extension": [
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},
{
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"valueUri": "StructureDefinition-apix-documentreference.html"
}
],
"reference": {
"reference": "StructureDefinition/apix-documentreference"
},
"name": "APIX Regulatory DocumentReference",
"description": "DocumentReference profile used in APIX regulatory submissions. Supports both embedded base64 data and referenced binaries via URL (Index Pattern). Includes support for versioning, lifecycle status, and CTD section categorization.",
"isExample": false
},
{
"extension": [
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},
{
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"valueUri": "StructureDefinition-apix-task.html"
}
],
"reference": {
"reference": "StructureDefinition/apix-task"
},
"name": "APIX Regulatory Task",
"description": "Task profile for APIX regulatory submission workflows",
"isExample": false
},
{
"extension": [
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}
],
"reference": {
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},
"name": "APIX Submission Types",
"description": "Value set for submission types in APIX regulatory procedures",
"isExample": false
},
{
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"valueUri": "StructureDefinition-apix-subscription.html"
}
],
"reference": {
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"name": "APIX Subscription",
"description": "Subscription Profile for APIX interactions.",
"isExample": false
},
{
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{
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"valueUri": "StructureDefinition-task-creation-with-organization-assigned-filter.html"
}
],
"reference": {
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},
"name": "APIX Task Assignment and Creation With Organization Filter",
"description": "SubscriptionTopic notifying an organization when a Task is created and assigned to them.",
"isExample": false
},
{
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"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "CodeSystem"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "CodeSystem-apix-task-code.html"
}
],
"reference": {
"reference": "CodeSystem/apix-task-code"
},
"name": "APIX Task Code System",
"description": "Code system for regulatory task types in APIX submissions",
"isExample": false
},
{
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"valueString": "CodeSystem"
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{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "CodeSystem-apix-task-input-output-type.html"
}
],
"reference": {
"reference": "CodeSystem/apix-task-input-output-type"
},
"name": "APIX Task Input and Output Types",
"description": "Types of documents and data exchanged as Task inputs and outputs. Inputs come from the requester; outputs come from the owner. This code system holds the types used by the IG's examples; see the Terminology page for a fuller example set.",
"isExample": false
},
{
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"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "StructureDefinition:resource"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "StructureDefinition-task-status-change-with-identifier-filter.html"
}
],
"reference": {
"reference": "StructureDefinition/task-status-change-with-identifier-filter"
},
"name": "APIX Task Status Change With Identifier Filter",
"description": "Triggers when a Task.status value changes and allows filtering by Task.identifier.",
"isExample": false
},
{
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"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "DocumentReference"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "DocumentReference-docref-epi-approved.html"
}
],
"reference": {
"reference": "DocumentReference/docref-epi-approved"
},
"name": "Approved ePI",
"description": "Approved product information. Points to the same Binary as the agreed clean ePI v5, so the approved text is identical to the agreed text.",
"isExample": true,
"profile": [
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]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "DocumentReference"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "DocumentReference-docref-cta-decision.html"
}
],
"reference": {
"reference": "DocumentReference/docref-cta-decision"
},
"name": "Authorisation decision",
"description": "Decision authorising clinical trial CT-2026-000789.",
"isExample": true,
"profile": [
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]
},
{
"extension": [
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"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Binary"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Binary-binary-1004.html"
}
],
"reference": {
"reference": "Binary/binary-1004"
},
"name": "binary-1004",
"description": "3.2.S.7.1_Stability_Summary_and_Conclusions_pdf",
"isExample": true
},
{
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"isExample": true
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"valueUri": "Binary-binary-cta-application-form.html"
}
],
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"name": "binary-cta-application-form",
"description": "cta-application-form.pdf",
"isExample": true
},
{
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"valueString": "Binary"
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}
],
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"name": "binary-cta-cover-letter",
"description": "cta-cover-letter.pdf",
"isExample": true
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{
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"valueString": "Binary"
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{
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"valueUri": "Binary-binary-cta-decision.html"
}
],
"reference": {
"reference": "Binary/binary-cta-decision"
},
"name": "binary-cta-decision",
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"isExample": true
},
{
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"valueString": "Binary"
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{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Binary-binary-cta-protocol.html"
}
],
"reference": {
"reference": "Binary/binary-cta-protocol"
},
"name": "binary-cta-protocol",
"description": "cta-protocol.pdf",
"isExample": true
},
{
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{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Binary-binary-cta-rfi.html"
}
],
"reference": {
"reference": "Binary/binary-cta-rfi"
},
"name": "binary-cta-rfi",
"description": "cta-request-for-information.pdf",
"isExample": true
},
{
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"valueString": "Binary"
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{
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"valueUri": "Binary-binary-cta-rfi-response.html"
}
],
"reference": {
"reference": "Binary/binary-cta-rfi-response"
},
"name": "binary-cta-rfi-response",
"description": "cta-response-to-questions.pdf",
"isExample": true
},
{
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"valueString": "Binary"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Binary-binary-cta-validation-report.html"
}
],
"reference": {
"reference": "Binary/binary-cta-validation-report"
},
"name": "binary-cta-validation-report",
"description": "cta-validation-report.pdf",
"isExample": true
},
{
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{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Binary"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Binary-binary-epi-annotated-v1.html"
}
],
"reference": {
"reference": "Binary/binary-epi-annotated-v1"
},
"name": "binary-epi-annotated-v1",
"description": "epi-annotated-v1.xml",
"isExample": true
},
{
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{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Binary"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Binary-binary-epi-annotated-v2.html"
}
],
"reference": {
"reference": "Binary/binary-epi-annotated-v2"
},
"name": "binary-epi-annotated-v2",
"description": "epi-annotated-v2.xml",
"isExample": true
},
{
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"valueString": "Binary"
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{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Binary-binary-epi-annotated-v3.html"
}
],
"reference": {
"reference": "Binary/binary-epi-annotated-v3"
},
"name": "binary-epi-annotated-v3",
"description": "epi-annotated-v3.xml",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Binary"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Binary-binary-epi-annotated-v4.html"
}
],
"reference": {
"reference": "Binary/binary-epi-annotated-v4"
},
"name": "binary-epi-annotated-v4",
"description": "epi-annotated-v4.xml",
"isExample": true
},
{
"extension": [
{
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"valueString": "Binary"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Binary-binary-epi-clean-v1.html"
}
],
"reference": {
"reference": "Binary/binary-epi-clean-v1"
},
"name": "binary-epi-clean-v1",
"description": "epi-clean-v1.xml",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Binary"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Binary-binary-epi-clean-v3.html"
}
],
"reference": {
"reference": "Binary/binary-epi-clean-v3"
},
"name": "binary-epi-clean-v3",
"description": "epi-clean-v3.xml",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Binary"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Binary-binary-epi-clean-v5.html"
}
],
"reference": {
"reference": "Binary/binary-epi-clean-v5"
},
"name": "binary-epi-clean-v5",
"description": "epi-clean-v5.xml",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Binary"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Binary-binary-icsr-2a-e2b-r2.html"
}
],
"reference": {
"reference": "Binary/binary-icsr-2a-e2b-r2"
},
"name": "binary-icsr-2a-e2b-r2",
"description": "icsr-2a-e2b-r2.xml",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Binary"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Binary-binary-icsr-2a-e2b-r2-acklog.html"
}
],
"reference": {
"reference": "Binary/binary-icsr-2a-e2b-r2-acklog"
},
"name": "binary-icsr-2a-e2b-r2-acklog",
"description": "icsr-2a-e2b-r2-acklog.xml",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Binary"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Binary-binary-icsr-2b-e2b-r2.html"
}
],
"reference": {
"reference": "Binary/binary-icsr-2b-e2b-r2"
},
"name": "binary-icsr-2b-e2b-r2",
"description": "icsr-2b-e2b-r2.xml",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Binary"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Binary-binary-icsr-2b-e2b-r2-acklog.html"
}
],
"reference": {
"reference": "Binary/binary-icsr-2b-e2b-r2-acklog"
},
"name": "binary-icsr-2b-e2b-r2-acklog",
"description": "icsr-2b-e2b-r2-acklog.xml",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Binary"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Binary-binary-icsr-2b-resubmission-e2b-r2.html"
}
],
"reference": {
"reference": "Binary/binary-icsr-2b-resubmission-e2b-r2"
},
"name": "binary-icsr-2b-resubmission-e2b-r2",
"description": "icsr-2b-resubmission-e2b-r2.xml",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Binary"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Binary-binary-icsr-2b-resubmission-e2b-r2-acklog.html"
}
],
"reference": {
"reference": "Binary/binary-icsr-2b-resubmission-e2b-r2-acklog"
},
"name": "binary-icsr-2b-resubmission-e2b-r2-acklog",
"description": "icsr-2b-resubmission-e2b-r2-acklog.xml",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Binary"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Binary-binary-icsr-2b-validation-report.html"
}
],
"reference": {
"reference": "Binary/binary-icsr-2b-validation-report"
},
"name": "binary-icsr-2b-validation-report",
"description": "icsr-2b-validation-report.pdf",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Binary"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Binary-binary-var-application-form.html"
}
],
"reference": {
"reference": "Binary/binary-var-application-form"
},
"name": "binary-var-application-form",
"description": "var-application-form.pdf",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Binary"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Binary-binary-var-approval-letter.html"
}
],
"reference": {
"reference": "Binary/binary-var-approval-letter"
},
"name": "binary-var-approval-letter",
"description": "var-approval-letter.pdf",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Binary"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Binary-binary-var-change-description.html"
}
],
"reference": {
"reference": "Binary/binary-var-change-description"
},
"name": "binary-var-change-description",
"description": "var-change-description.pdf",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Binary"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Binary-binary-var-cover-letter.html"
}
],
"reference": {
"reference": "Binary/binary-var-cover-letter"
},
"name": "binary-var-cover-letter",
"description": "var-cover-letter.pdf",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Binary"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Binary-binary-var-validation-report.html"
}
],
"reference": {
"reference": "Binary/binary-var-validation-report"
},
"name": "binary-var-validation-report",
"description": "var-validation-report.pdf",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "DocumentReference"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "DocumentReference-docref-var-change-description.html"
}
],
"reference": {
"reference": "DocumentReference/docref-var-change-description"
},
"name": "Change description and justification",
"description": "Current versus proposed product information, with justification.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/uv/apix/StructureDefinition/apix-documentreference"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "DocumentReference"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "DocumentReference-docref-epi-clean-v1.html"
}
],
"reference": {
"reference": "DocumentReference/docref-epi-clean-v1"
},
"name": "Clean ePI v1 (proposal)",
"description": "Proposed product information as clean ePI, version 1.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/uv/apix/StructureDefinition/apix-documentreference"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "DocumentReference"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "DocumentReference-docref-epi-clean-v3.html"
}
],
"reference": {
"reference": "DocumentReference/docref-epi-clean-v3"
},
"name": "Clean ePI v3 (counter-proposal, round 1)",
"description": "Clean ePI matching annotated v3.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/uv/apix/StructureDefinition/apix-documentreference"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "DocumentReference"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "DocumentReference-docref-epi-clean-v5.html"
}
],
"reference": {
"reference": "DocumentReference/docref-epi-clean-v5"
},
"name": "Clean ePI v5 (agreed text)",
"description": "Clean ePI with all round 2 changes accepted: the agreed product information.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/uv/apix/StructureDefinition/apix-documentreference"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "DocumentReference"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "DocumentReference-docref-cta-application-form.html"
}
],
"reference": {
"reference": "DocumentReference/docref-cta-application-form"
},
"name": "CTA application form",
"description": "Completed clinical trial application form for study WD-201.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/uv/apix/StructureDefinition/apix-documentreference"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "DocumentReference"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "DocumentReference-docref-cta-cover-letter.html"
}
],
"reference": {
"reference": "DocumentReference/docref-cta-cover-letter"
},
"name": "CTA cover letter",
"description": "Cover letter for the initial clinical trial application for study WD-201.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/uv/apix/StructureDefinition/apix-documentreference"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "DocumentReference"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "DocumentReference-docref-cta-validation-report.html"
}
],
"reference": {
"reference": "DocumentReference/docref-cta-validation-report"
},
"name": "CTA validation report",
"description": "Validation report: application complete; trial number assigned.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/uv/apix/StructureDefinition/apix-documentreference"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "DocumentReference"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "DocumentReference-doc1.html"
}
],
"reference": {
"reference": "DocumentReference/doc1"
},
"name": "doc1",
"description": "Example DocumentReference Cover Letter",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "DocumentReference"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "DocumentReference-doc2.html"
}
],
"reference": {
"reference": "DocumentReference/doc2"
},
"name": "doc2",
"description": "Example DocumentReference Application Form",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "DocumentReference"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "DocumentReference-doc3.html"
}
],
"reference": {
"reference": "DocumentReference/doc3"
},
"name": "doc3",
"description": "Example DocumentReference Annotated Label",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "DocumentReference"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "DocumentReference-doc4.html"
}
],
"reference": {
"reference": "DocumentReference/doc4"
},
"name": "doc4",
"description": "Example DocumentReference Clean Label",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "DocumentReference"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "DocumentReference-doc5.html"
}
],
"reference": {
"reference": "DocumentReference/doc5"
},
"name": "doc5",
"description": "Example DocumentReference Pack Mockup",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "DocumentReference"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "DocumentReference-doc6.html"
}
],
"reference": {
"reference": "DocumentReference/doc6"
},
"name": "doc6",
"description": "Example DocumentReference Stability Summary",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "DocumentReference"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "DocumentReference-doc7.html"
}
],
"reference": {
"reference": "DocumentReference/doc7"
},
"name": "doc7",
"description": "Example DocumentReference Stability Data",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "DocumentReference"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "DocumentReference-doc8.html"
}
],
"reference": {
"reference": "DocumentReference/doc8"
},
"name": "doc8",
"description": "Example DocumentReference Stability Data",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "DocumentReference"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "DocumentReference-docref-approval-letter.html"
}
],
"reference": {
"reference": "DocumentReference/docref-approval-letter"
},
"name": "docref approval letter",
"description": "Example DocumentReference Approval Letter",
"isExample": true,
"profile": [
"http://hl7.org/fhir/uv/apix/StructureDefinition/apix-documentreference"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "DocumentReference"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "DocumentReference-docref-assessment-report.html"
}
],
"reference": {
"reference": "DocumentReference/docref-assessment-report"
},
"name": "docref assessment report",
"description": "Example DocumentReference Assessment Report",
"isExample": true,
"profile": [
"http://hl7.org/fhir/uv/apix/StructureDefinition/apix-documentreference"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "DocumentReference"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "DocumentReference-docref-list-of-questions.html"
}
],
"reference": {
"reference": "DocumentReference/docref-list-of-questions"
},
"name": "docref list of questions",
"description": "Example DocumentReference Cover Letter",
"isExample": true,
"profile": [
"http://hl7.org/fhir/uv/apix/StructureDefinition/apix-documentreference"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "DocumentReference"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "DocumentReference-docref-payment-proof.html"
}
],
"reference": {
"reference": "DocumentReference/docref-payment-proof"
},
"name": "docref payment proof",
"description": "Example DocumentReference Proof of Payment",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "DocumentReference"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "DocumentReference-docref-responses-qresponse.html"
}
],
"reference": {
"reference": "DocumentReference/docref-responses-qresponse"
},
"name": "docref responses qresponse",
"description": "Example DocumentReference Cover Letter / Response",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "DocumentReference"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "DocumentReference-docref-stability-data-annex.html"
}
],
"reference": {
"reference": "DocumentReference/docref-stability-data-annex"
},
"name": "docref stability data annex",
"description": "Example DocumentReference Stability Data",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Endpoint"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Endpoint-1005.html"
}
],
"reference": {
"reference": "Endpoint/1005"
},
"name": "Example APIX interaction Endpoint with header",
"description": "Example APIX interaction Endpoint with header information; payload is very loosely defined, sufficient where payload considerations are handled internally and not exposed. Note identifier. n",
"isExample": true,
"profile": [
"http://hl7.org/fhir/uv/rwi-pharma/StructureDefinition/endpoint-subscription-notify"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Endpoint"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Endpoint-1003.html"
}
],
"reference": {
"reference": "Endpoint/1003"
},
"name": "Example basic APIX interaction Endpoint",
"description": "Example basic APIX interaction Endpoint, payload is very loosely defined; payload considerations are handled internally and not exposed. Note identifier.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/uv/rwi-pharma/StructureDefinition/endpoint-subscription-notify"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "DocumentReference"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "DocumentReference-docref-icsr-2a-acklog.html"
}
],
"reference": {
"reference": "DocumentReference/docref-icsr-2a-acklog"
},
"name": "ICSR acknowledgment log",
"description": "ICH E2B(R2) acknowledgment: transmission 01 (all reports loaded), report 01 (report loaded).",
"isExample": true,
"profile": [
"http://hl7.org/fhir/uv/apix/StructureDefinition/apix-documentreference"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "DocumentReference"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "DocumentReference-docref-icsr-2b-acklog.html"
}
],
"reference": {
"reference": "DocumentReference/docref-icsr-2b-acklog"
},
"name": "ICSR acknowledgment log (rejected)",
"description": "ICH E2B(R2) acknowledgment: transmission 02 (not all reports loaded), report 02 (report not loaded), with the error.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/uv/apix/StructureDefinition/apix-documentreference"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "DocumentReference"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "DocumentReference-docref-icsr-2b-resubmission-acklog.html"
}
],
"reference": {
"reference": "DocumentReference/docref-icsr-2b-resubmission-acklog"
},
"name": "ICSR acknowledgment log (resubmission)",
"description": "ICH E2B(R2) acknowledgment: transmission 01 (all reports loaded), report 01 (report loaded).",
"isExample": true,
"profile": [
"http://hl7.org/fhir/uv/apix/StructureDefinition/apix-documentreference"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "DocumentReference"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "DocumentReference-docref-icsr-2b-resubmission.html"
}
],
"reference": {
"reference": "DocumentReference/docref-icsr-2b-resubmission"
},
"name": "ICSR resubmission — case CH-SYNTHPHARMA-2026-000512",
"description": "Corrected ICH E2B(R2) ICSR for case CH-SYNTHPHARMA-2026-000512, with the MedDRA version added.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/uv/apix/StructureDefinition/apix-documentreference"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "DocumentReference"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "DocumentReference-docref-icsr-2b-validation-report.html"
}
],
"reference": {
"reference": "DocumentReference/docref-icsr-2b-validation-report"
},
"name": "ICSR validation report",
"description": "Validation report listing the error that caused the rejection.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/uv/apix/StructureDefinition/apix-documentreference"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "DocumentReference"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "DocumentReference-docref-icsr-2a.html"
}
],
"reference": {
"reference": "DocumentReference/docref-icsr-2a"
},
"name": "ICSR — case CH-SYNTHPHARMA-2026-000456",
"description": "ICH E2B(R2) ICSR for case CH-SYNTHPHARMA-2026-000456 (nausea with WonderDrug 50 mg).",
"isExample": true,
"profile": [
"http://hl7.org/fhir/uv/apix/StructureDefinition/apix-documentreference"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "DocumentReference"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "DocumentReference-docref-icsr-2b.html"
}
],
"reference": {
"reference": "DocumentReference/docref-icsr-2b"
},
"name": "ICSR — case CH-SYNTHPHARMA-2026-000512",
"description": "ICH E2B(R2) ICSR for case CH-SYNTHPHARMA-2026-000512 (dizziness with WonderDrug 50 mg). The MedDRA version is missing.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/uv/apix/StructureDefinition/apix-documentreference"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "DocumentReference"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "DocumentReference-docref-invoice.html"
}
],
"reference": {
"reference": "DocumentReference/docref-invoice"
},
"name": "Invoice for Regulatory Submission Review",
"description": "Example DocumentReference Invoice",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Organization"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Organization-1002.html"
}
],
"reference": {
"reference": "Organization/1002"
},
"name": "Organization example with Endpoint",
"description": "Organization example with Endpoint.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/uv/apix/StructureDefinition/apix-organization"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Organization"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Organization-org-ema-srm-hmed.html"
}
],
"reference": {
"reference": "Organization/org-ema-srm-hmed"
},
"name": "Organization Health Authority – Regulatory Review Division",
"description": "Example Organization Health Authority – Regulatory Review Division",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Organization"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Organization-org-synthpharma-ag.html"
}
],
"reference": {
"reference": "Organization/org-synthpharma-ag"
},
"name": "Organization SynthPharma AG",
"description": "Example Organization SynthPharma AG",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "DocumentReference"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "DocumentReference-output-ack.html"
}
],
"reference": {
"reference": "DocumentReference/output-ack"
},
"name": "output ack",
"description": "Example DocumentReference Acknowledgement of Receipt",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "DocumentReference"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "DocumentReference-output-validation.html"
}
],
"reference": {
"reference": "DocumentReference/output-validation"
},
"name": "output validation",
"description": "Example DocumentReference Validation Report",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "DocumentReference"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "DocumentReference-docref-cta-protocol.html"
}
],
"reference": {
"reference": "DocumentReference/docref-cta-protocol"
},
"name": "Protocol WD-201 v1.0",
"description": "Clinical trial protocol WD-201, version 1.0 (synopsis).",
"isExample": true,
"profile": [
"http://hl7.org/fhir/uv/apix/StructureDefinition/apix-documentreference"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "DocumentReference"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "DocumentReference-docref-cta-rfi.html"
}
],
"reference": {
"reference": "DocumentReference/docref-cta-rfi"
},
"name": "Request for information",
"description": "Request for information raised during assessment (three questions).",
"isExample": true,
"profile": [
"http://hl7.org/fhir/uv/apix/StructureDefinition/apix-documentreference"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "DocumentReference"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "DocumentReference-docref-cta-rfi-response.html"
}
],
"reference": {
"reference": "DocumentReference/docref-cta-rfi-response"
},
"name": "Response to request for information",
"description": "Sponsor response to the three questions.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/uv/apix/StructureDefinition/apix-documentreference"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Task"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Task-scenario1-01-initial-submission.html"
}
],
"reference": {
"reference": "Task/scenario1-01-initial-submission"
},
"name": "scenario1 01 initial submission",
"description": "Example Task Type IB Variation",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Task"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Task-scenario1-02-validation.html"
}
],
"reference": {
"reference": "Task/scenario1-02-validation"
},
"name": "scenario1 02 validation",
"description": "Example Task Type IB Variation",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Task"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Task-scenario1-03-finance-invoice.html"
}
],
"reference": {
"reference": "Task/scenario1-03-finance-invoice"
},
"name": "scenario1 03 finance invoice original Task",
"description": "Example Task Request Payment - original",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Task"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Task-scenario1-04-finance-payment.html"
}
],
"reference": {
"reference": "Task/scenario1-04-finance-payment"
},
"name": "scenario1 04 finance payment reflected by invoice Task update",
"description": "Example Task Request Payment - payment has been made",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Task"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Task-scenario1-05-technical-question.html"
}
],
"reference": {
"reference": "Task/scenario1-05-technical-question"
},
"name": "scenario1 05 technical question",
"description": "Example Task Information Request",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Task"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Task-scenario1-06-technical-response.html"
}
],
"reference": {
"reference": "Task/scenario1-06-technical-response"
},
"name": "scenario1 06 technical response",
"description": "Example Task Response to Information Request, fulfillment of information request Scenario1 05 technical question",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Task"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Task-scenario1-07-final-decision.html"
}
],
"reference": {
"reference": "Task/scenario1-07-final-decision"
},
"name": "scenario1-07-final-decision",
"description": "Completetion of Scenario 01 initial submission Task - Example Task Type IB Variation. This is the initial submision Task but in the completed form",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Task"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Task-scenario2a-01-icsr-submitted.html"
}
],
"reference": {
"reference": "Task/scenario2a-01-icsr-submitted"
},
"name": "scenario2a 01 ICSR submitted",
"description": "The marketing authorization holder posts an ICSR Task; the E2B(R2) message is the input.",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Task"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Task-scenario2a-02-icsr-accepted.html"
}
],
"reference": {
"reference": "Task/scenario2a-02-icsr-accepted"
},
"name": "scenario2a 02 ICSR accepted",
"description": "Version 2 of the ICSR Task (in production, the same Task as scenario2a-01). The report passed validation and was loaded; the regulator returns the E2B(R2) acknowledgment log.",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Task"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Task-scenario2a-03-icsr-complete.html"
}
],
"reference": {
"reference": "Task/scenario2a-03-icsr-complete"
},
"name": "scenario2a 03 ICSR complete",
"description": "Version 3 of the ICSR Task (in production, the same Task as scenario2a-01). Processing is complete and the Task is closed.",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Task"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Task-scenario2b-01-icsr-submitted.html"
}
],
"reference": {
"reference": "Task/scenario2b-01-icsr-submitted"
},
"name": "scenario2b 01 ICSR submitted",
"description": "The marketing authorization holder posts an ICSR Task; the E2B(R2) message is the input. The message has an error.",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Task"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Task-scenario2b-02-icsr-rejected.html"
}
],
"reference": {
"reference": "Task/scenario2b-02-icsr-rejected"
},
"name": "scenario2b 02 ICSR rejected",
"description": "Version 2 of the ICSR Task (in production, the same Task as scenario2b-01). The report failed validation; the regulator rejects the Task and returns the acknowledgment log and a validation report.",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Task"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Task-scenario2b-03-icsr-resubmitted.html"
}
],
"reference": {
"reference": "Task/scenario2b-03-icsr-resubmitted"
},
"name": "scenario2b 03 ICSR resubmitted",
"description": "The marketing authorization holder posts a new ICSR Task with the corrected E2B(R2) message. It has the same group identifier and is basedOn the rejected Task.",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Task"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Task-scenario2b-04-icsr-accepted.html"
}
],
"reference": {
"reference": "Task/scenario2b-04-icsr-accepted"
},
"name": "scenario2b 04 ICSR resubmission accepted",
"description": "Version 2 of the resubmission Task (in production, the same Task as scenario2b-03). The corrected report passed validation and was loaded; the regulator returns the acknowledgment log.",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Task"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Task-scenario2b-05-icsr-complete.html"
}
],
"reference": {
"reference": "Task/scenario2b-05-icsr-complete"
},
"name": "scenario2b 05 ICSR resubmission complete",
"description": "Version 3 of the resubmission Task (in production, the same Task as scenario2b-03). Processing is complete and the Task is closed.",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Task"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Task-scenario3-01-cta-submission.html"
}
],
"reference": {
"reference": "Task/scenario3-01-cta-submission"
},
"name": "scenario3 01 clinical trial application submitted",
"description": "The sponsor posts the clinical trial application Task with the cover letter, application form and protocol as inputs.",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Task"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Task-scenario3-02-cta-validated.html"
}
],
"reference": {
"reference": "Task/scenario3-02-cta-validated"
},
"name": "scenario3 02 clinical trial application validated",
"description": "Version 2 of the application Task (in production, the same Task as scenario3-01). The regulator accepts it, assigns the trial number and returns the validation report.",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Task"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Task-scenario3-03-cta-rfi.html"
}
],
"reference": {
"reference": "Task/scenario3-03-cta-rfi"
},
"name": "scenario3 03 request for information issued",
"description": "The regulator posts a request-for-information Task, based on the application Task. The regulator is the requester here, so the questions are the input and the sponsor owns the response.",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Task"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Task-scenario3-04-cta-rfi-response.html"
}
],
"reference": {
"reference": "Task/scenario3-04-cta-rfi-response"
},
"name": "scenario3 04 request for information answered",
"description": "Version 2 of the request-for-information Task (in production, the same Task as scenario3-03). The sponsor completes it with the response as the output; the clock restarts.",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Task"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Task-scenario3-05-cta-authorised.html"
}
],
"reference": {
"reference": "Task/scenario3-05-cta-authorised"
},
"name": "scenario3 05 clinical trial authorised",
"description": "Version 3 of the application Task (in production, the same Task as scenario3-01). The regulator completes it and returns the authorisation decision.",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Task"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Task-scenario4-01-variation-submitted.html"
}
],
"reference": {
"reference": "Task/scenario4-01-variation-submitted"
},
"name": "scenario4 01 Type II variation submitted",
"description": "The marketing authorisation holder posts a Type II variation adding nausea to the product information. The proposed label is an annotated ePI plus a clean ePI.",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Task"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Task-scenario4-02-variation-validated.html"
}
],
"reference": {
"reference": "Task/scenario4-02-variation-validated"
},
"name": "scenario4 02 Type II variation validated",
"description": "Version 2 of the variation Task (in production, the same Task as scenario4-01). The regulator validates it, assigns the procedure number and returns the validation report.",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Task"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Task-scenario4-03-variation-under-assessment.html"
}
],
"reference": {
"reference": "Task/scenario4-03-variation-under-assessment"
},
"name": "scenario4 03 Type II variation under assessment",
"description": "Version 3 of the variation Task (in production, the same Task as scenario4-01). Scientific assessment, including the proposed product information, has started.",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Task"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Task-scenario4-04-labelling-comments-round1.html"
}
],
"reference": {
"reference": "Task/scenario4-04-labelling-comments-round1"
},
"name": "scenario4 04 labelling comments round 1 issued",
"description": "The regulator posts round 1 of the label negotiation, based on the variation Task. Its tracked changes to the proposed ePI (annotated v2) are the input; the applicant owns the response.",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Task"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Task-scenario4-05-labelling-comments-round1-response.html"
}
],
"reference": {
"reference": "Task/scenario4-05-labelling-comments-round1-response"
},
"name": "scenario4 05 labelling comments round 1 answered with a counter-proposal",
"description": "Version 2 of the round 1 Task (in production, the same Task as scenario4-04). The applicant accepts the frequency change and counter-proposes the food wording, returning annotated and clean ePI v3.",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Task"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Task-scenario4-06-labelling-comments-round2.html"
}
],
"reference": {
"reference": "Task/scenario4-06-labelling-comments-round2"
},
"name": "scenario4 06 labelling comments round 2 issued",
"description": "The regulator posts round 2: it accepts the counter-proposal and makes one plain-language change to the leaflet (annotated v4).",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Task"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Task-scenario4-07-labelling-comments-round2-response.html"
}
],
"reference": {
"reference": "Task/scenario4-07-labelling-comments-round2-response"
},
"name": "scenario4 07 labelling comments round 2 accepted",
"description": "Version 2 of the round 2 Task (in production, the same Task as scenario4-06). The applicant accepts all changes and returns clean ePI v5.",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Task"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Task-scenario4-08-labelling-agreement.html"
}
],
"reference": {
"reference": "Task/scenario4-08-labelling-agreement"
},
"name": "scenario4 08 labelling agreement requested",
"description": "The regulator asks the applicant to confirm that clean ePI v5 is the final agreed product information.",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Task"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Task-scenario4-09-labelling-agreed.html"
}
],
"reference": {
"reference": "Task/scenario4-09-labelling-agreed"
},
"name": "scenario4 09 labelling agreed",
"description": "Version 2 of the agreement Task (in production, the same Task as scenario4-08). The applicant confirms; completing the Task is the confirmation, so there is no output document.",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Task"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Task-scenario4-10-variation-approved.html"
}
],
"reference": {
"reference": "Task/scenario4-10-variation-approved"
},
"name": "scenario4 10 Type II variation approved",
"description": "Version 4 of the variation Task (in production, the same Task as scenario4-01). The regulator approves it and returns the approval letter and the approved ePI.",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Subscription"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Subscription-Subscription-TaskStatusChange-FullResource.html"
}
],
"reference": {
"reference": "Subscription/Subscription-TaskStatusChange-FullResource"
},
"name": "Subscription for Task Status Change with Identifier Filter",
"description": "Subscription example to Task change status with an identifier filter, and sending full-resource.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/uv/rwi-pharma/StructureDefinition/apix-subscription"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "Bundle"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "Bundle-eee72492-c236-41f7-a7ba-3af356204f4c.html"
}
],
"reference": {
"reference": "Bundle/eee72492-c236-41f7-a7ba-3af356204f4c"
},
"name": "SubscriptionNotification Task ID Only",
"description": "SubscriptionNotification Bundle example Task id only.",
"isExample": true
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "SubscriptionTopic"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "SubscriptionTopic-TaskCreationWithOrganizationAssignedFilter.html"
}
],
"reference": {
"reference": "SubscriptionTopic/TaskCreationWithOrganizationAssignedFilter"
},
"name": "Task Assignment and Creation With Organization Filter",
"description": "SubscriptionTopic for a health authority to notify an organization when that organization has been assigned a new Task.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/uv/rwi-pharma/StructureDefinition/task-creation-with-organization-assigned-filter"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "SubscriptionTopic"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "SubscriptionTopic-TaskStatusChangeWithIdentifierFilter.html"
}
],
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},
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},
{
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{
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},
{
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}
],
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},
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},
{
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{
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},
{
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}
],
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},
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"isExample": false
},
{
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{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
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},
{
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}
],
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},
"name": "Value Set APIX Regulatory Business Status",
"description": "Value set for regulatory business status in APIX submissions",
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},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
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},
{
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}
],
"reference": {
"reference": "DocumentReference/docref-var-application-form"
},
"name": "Variation application form",
"description": "Completed Type II variation application form.",
"isExample": true,
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"http://hl7.org/fhir/uv/apix/StructureDefinition/apix-documentreference"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "DocumentReference"
},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
"valueUri": "DocumentReference-docref-var-approval-letter.html"
}
],
"reference": {
"reference": "DocumentReference/docref-var-approval-letter"
},
"name": "Variation approval letter",
"description": "Approval of Type II variation VAR-II-2027-0012.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/uv/apix/StructureDefinition/apix-documentreference"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
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},
{
"url": "http://hl7.org/fhir/StructureDefinition/implementationguide-page",
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}
],
"reference": {
"reference": "DocumentReference/docref-var-cover-letter"
},
"name": "Variation cover letter",
"description": "Cover letter for the Type II variation adding nausea to the WonderDrug product information.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/uv/apix/StructureDefinition/apix-documentreference"
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString": "DocumentReference"
},
{
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}
],
"reference": {
"reference": "DocumentReference/docref-var-validation-report"
},
"name": "Variation validation report",
"description": "Validation report: variation valid; procedure number assigned.",
"isExample": true,
"profile": [
"http://hl7.org/fhir/uv/apix/StructureDefinition/apix-documentreference"
]
}
],
"page": {
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{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
}
],
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"name": "toc.html",
"title": "Table of Contents",
"generation": "html",
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{
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{
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}
],
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"name": "index.html",
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"generation": "markdown"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
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}
],
"sourceUrl": "gettingstarted.html",
"name": "gettingstarted.html",
"title": "Getting Started",
"generation": "markdown"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
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}
],
"sourceUrl": "usecases.html",
"name": "usecases.html",
"title": "Use Cases",
"generation": "markdown",
"page": [
{
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{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
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}
],
"sourceUrl": "usecases-scenario-stability.html",
"name": "usecases-scenario-stability.html",
"title": "Scenario 1: Stability Update",
"generation": "markdown"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
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}
],
"sourceUrl": "usecases-scenario-icsr.html",
"name": "usecases-scenario-icsr.html",
"title": "Scenario 2: ICSR Accepted, and Rejected then Resubmitted",
"generation": "markdown"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
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}
],
"sourceUrl": "usecases-scenario-cta.html",
"name": "usecases-scenario-cta.html",
"title": "Scenario 3: Clinical Trial Application",
"generation": "markdown"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
}
],
"sourceUrl": "usecases-scenario-label-negotiation.html",
"name": "usecases-scenario-label-negotiation.html",
"title": "Scenario 4: Label Negotiation",
"generation": "markdown"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
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}
],
"sourceUrl": "usecases-status-tracking.html",
"name": "usecases-status-tracking.html",
"title": "Tracking and Dashboards",
"generation": "markdown"
}
]
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
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}
],
"sourceUrl": "workflow.html",
"name": "workflow.html",
"title": "Workflow",
"generation": "markdown"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
}
],
"sourceUrl": "subscriptions.html",
"name": "subscriptions.html",
"title": "Notifications",
"generation": "markdown"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
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}
],
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"name": "architecture.html",
"title": "Architecture",
"generation": "markdown"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
}
],
"sourceUrl": "apixinteractionpattern.html",
"name": "apixinteractionpattern.html",
"title": "Interaction Pattern",
"generation": "markdown"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
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}
],
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"name": "terminology.html",
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"generation": "markdown"
},
{
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{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
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}
],
"sourceUrl": "apixtask.html",
"name": "apixtask.html",
"title": "RWI-pharma Task Structure",
"generation": "markdown"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
}
],
"sourceUrl": "apixsubscription.html",
"name": "apixsubscription.html",
"title": "Subscription",
"generation": "markdown"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
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}
],
"sourceUrl": "apixsubscriptionTopic.html",
"name": "apixsubscriptionTopic.html",
"title": "SubscriptionTopic",
"generation": "markdown"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
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}
],
"sourceUrl": "apixsubscriptionNotificationAndStatus.html",
"name": "apixsubscriptionNotificationAndStatus.html",
"title": "Notification & Status",
"generation": "markdown"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
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}
],
"sourceUrl": "apixorganizationEndpoint.html",
"name": "apixorganizationEndpoint.html",
"title": "Organization & Endpoint",
"generation": "markdown"
},
{
"extension": [
{
"url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode": "informative"
}
],
"sourceUrl": "apixdocumentReference.html",
"name": "apixdocumentReference.html",
"title": "DocumentReference",
"generation": "markdown"
}
]
},
"parameter": [
{
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"system": "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code": "copyrightyear"
},
"value": "2025+"
},
{
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"code": "releaselabel"
},
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},
{
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},
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},
{
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},
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},
{
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},
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},
{
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"code": "apply-version"
},
"value": "true"
},
{
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"code": "apply-wg"
},
"value": "true"
},
{
"code": {
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"code": "path-history"
},
"value": "http://hl7.org/fhir/uv/rwi-pharma/history.html"
},
{
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"code": "autoload-resources"
},
"value": "true"
},
{
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"code": "path-resource"
},
"value": "input/capabilities"
},
{
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},
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},
{
"code": {
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},
"value": "input/extensions"
},
{
"code": {
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"code": "path-resource"
},
"value": "input/models"
},
{
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},
"value": "input/operations"
},
{
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},
"value": "input/profiles"
},
{
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},
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},
{
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},
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},
{
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},
"value": "input/maps"
},
{
"code": {
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},
"value": "input/testing"
},
{
"code": {
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},
"value": "input/history"
},
{
"code": {
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},
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},
{
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},
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},
{
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},
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},
{
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},
"value": "input/images"
},
{
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},
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},
{
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},
"value": "input/liquid"
},
{
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"code": "path-qa"
},
"value": "temp/qa"
},
{
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},
"value": "temp/pages"
},
{
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},
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},
{
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},
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},
{
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},
"value": "input/ignoreWarnings.txt"
},
{
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},
"value": "template-page.html"
},
{
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},
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},
{
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},
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},
{
"code": {
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"code": "apply-copyright"
},
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},
{
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"code": "apply-license"
},
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},
{
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"code": "active-tables"
},
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},
{
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},
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},
{
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},
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},
{
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},
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},
{
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"code": "tabbed-snapshots"
},
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},
{
"code": {
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"code": "i18n-default-lang"
},
"value": "en"
}
]
}
}
FHIRsmith