| Package | hl7.fhir.uv.ae-research-ig |
| Type | ImplementationGuide |
| Id | Id |
| FHIR Version | R5 |
| Source | http://hl7.org/fhir/uv/ae-research-ig/https://build.fhir.org/ig/HL7/fhir-ae-research-ig/index.html |
| Url | http://hl7.org/fhir/uv/ae-research-ig/ImplementationGuide/hl7.fhir.uv.ae-research-ig |
| Version | 1.0.1 |
| Status | active |
| Date | 2023-07-01 |
| Name | AdverseEventClinicalResearch |
| Title | Adverse Event Clinical Research |
| Experimental | False |
| Realm | uv |
| Authority | hl7 |
| Description | ### Intent The intent of this guide is to provide a profile on the FHIR AdverseEvent Resource suitable for Clinical Research. ### Overview A single Adverse Event (AE) may need to be reported in multiple ways. Choosing the appropriate form of the reporting is dependent upon workflow patterns. In particular, the implementation guides for Clinical Care adverse events and Clinical Research adverse events provide important extensions, value-sets and examples for implementing AdverseEvent. This guide, the Clinical Research adverse event implementation guide, is for the clinical research setting. In this setting, the event is tracked and evaluated as part of the clinical research process for the research study. In the research setting an adverse event is the result of an intervention that caused unintentional harm to a specific subject or group of subjects (this is surfaced in the profile as a constraint of ‘actual’ for the value of ‘actuality’). An example of an adverse event in the clinical research setting would be a patient develops renal failure while on a study drug. These events are characterized by the need to capture cause-and-effect (although they might not be known at the time of the event), severity, and outcome. The context of an adverse event is also important, and captured in the AdverseEvent Clinical Research Profile data elements. A subject may have condition(s) or current treatments (medications, diet, devices) that impact their response to a newly introduced medication, device or procedure. Knowledge of these variables is essential in establishing a cause-and-effect relationship for an adverse event. This information is represented with corresponding resources (e.g. Procedure Resource for procedures, etc.) and referenced. A potential adverse event may also be called a near miss or an error, these are not reported with the AdverseEvent Clinical Research Profile. ### Scope This FHIR IG enables the collection of adverse events in real-world data (RWD) sources such as electronic health records (EHR) and personal health records (PHR) that occur during clinical trials. It ensures the appropriate AE representation required to support clinical research trials within a regulated environment. As the AEs are collected in RWD sources, the data can be transmitted via FHIR to clinical trial management systems, regulatory agencies, sponsors, and clinical research organizations for further processing and reporting. In the pre-market clinical research setting, serious adverse events must be reported to the sponsor, clinical research organization, and regulatory agencies within a specific time frame for Institutional Review Boards (IRBs) and Data Safety Monitoring Board (DSMB) review. By using this IG, a clinical investigator can document an AE in the EHR, it can be received by a secondary clinical trial management system for triage and then forwarded to the sponsor and regulatory agencies. Similarly, a patient on a clinical trial can record an adverse event in their PHR that is then shared with the clinical investigator and reported to the sponsor and regulatory agencies as necessary. In a post-market situation, a patient, provider, or manufacturer can record the adverse event in a system and then report it to the FDA as a FHIR based MedWatch form. Within this guide are several examples. Every effort has been made to capture the most important details of the use of the AdverseEvent profile. However, some examples may provide only a stub to referenced resources (e.g. instances of Patient Resource will be referenced using logical ids but are not resolvable, implementation of Patient is left for other guidance and is not the subject of this guide). Connectathons are ideal opportunities to create, compare and consider the holistic implementation of all FHIR Resources. |
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Note: links and images are rebased to the (stated) source
The official URL for this implementation guide is:
http://hl7.org/fhir/uv/ae-research-ig/ImplementationGuide/hl7.fhir.uv.ae-research-ig
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><h2>AdverseEventClinicalResearch</h2><p>The official URL for this implementation guide is: </p><pre>http://hl7.org/fhir/uv/ae-research-ig/ImplementationGuide/hl7.fhir.uv.ae-research-ig</pre><div><h3>Intent The intent of this guide is to provide a profile on the FHIR AdverseEvent Resource suitable for Clinical Research. ### Overview A single Adverse Event (AE) may need to be reported in multiple ways. Choosing the appropriate form of the reporting is dependent upon workflow patterns. In particular, the implementation guides for Clinical Care adverse events and Clinical Research adverse events provide important extensions, value-sets and examples for implementing AdverseEvent. This guide, the Clinical Research adverse event implementation guide, is for the clinical research setting. In this setting, the event is tracked and evaluated as part of the clinical research process for the research study. In the research setting an adverse event is the result of an intervention that caused unintentional harm to a specific subject or group of subjects (this is surfaced in the profile as a constraint of ‘actual’ for the value of ‘actuality’). An example of an adverse event in the clinical research setting would be a patient develops renal failure while on a study drug. These events are characterized by the need to capture cause-and-effect (although they might not be known at the time of the event), severity, and outcome. The context of an adverse event is also important, and captured in the AdverseEvent Clinical Research Profile data elements. A subject may have condition(s) or current treatments (medications, diet, devices) that impact their response to a newly introduced medication, device or procedure. Knowledge of these variables is essential in establishing a cause-and-effect relationship for an adverse event. This information is represented with corresponding resources (e.g. Procedure Resource for procedures, etc.) and referenced. A potential adverse event may also be called a near miss or an error, these are not reported with the AdverseEvent Clinical Research Profile. ### Scope This FHIR IG enables the collection of adverse events in real-world data (RWD) sources such as electronic health records (EHR) and personal health records (PHR) that occur during clinical trials. It ensures the appropriate AE representation required to support clinical research trials within a regulated environment. As the AEs are collected in RWD sources, the data can be transmitted via FHIR to clinical trial management systems, regulatory agencies, sponsors, and clinical research organizations for further processing and reporting. In the pre-market clinical research setting, serious adverse events must be reported to the sponsor, clinical research organization, and regulatory agencies within a specific time frame for Institutional Review Boards (IRBs) and Data Safety Monitoring Board (DSMB) review. By using this IG, a clinical investigator can document an AE in the EHR, it can be received by a secondary clinical trial management system for triage and then forwarded to the sponsor and regulatory agencies. Similarly, a patient on a clinical trial can record an adverse event in their PHR that is then shared with the clinical investigator and reported to the sponsor and regulatory agencies as necessary. In a post-market situation, a patient, provider, or manufacturer can record the adverse event in a system and then report it to the FDA as a FHIR based MedWatch form. Within this guide are several examples. Every effort has been made to capture the most important details of the use of the AdverseEvent profile. However, some examples may provide only a stub to referenced resources (e.g. instances of Patient Resource will be referenced using logical ids but are not resolvable, implementation of Patient is left for other guidance and is not the subject of this guide). Connectathons are ideal opportunities to create, compare and consider the holistic implementation of all FHIR Resources.</h3>\n</div></div>"
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"description" : "### Intent The intent of this guide is to provide a profile on the FHIR AdverseEvent Resource suitable for Clinical Research. ### Overview A single Adverse Event (AE) may need to be reported in multiple ways. Choosing the appropriate form of the reporting is dependent upon workflow patterns. In particular, the implementation guides for Clinical Care adverse events and Clinical Research adverse events provide important extensions, value-sets and examples for implementing AdverseEvent. This guide, the Clinical Research adverse event implementation guide, is for the clinical research setting. In this setting, the event is tracked and evaluated as part of the clinical research process for the research study. In the research setting an adverse event is the result of an intervention that caused unintentional harm to a specific subject or group of subjects (this is surfaced in the profile as a constraint of ‘actual’ for the value of ‘actuality’). An example of an adverse event in the clinical research setting would be a patient develops renal failure while on a study drug. These events are characterized by the need to capture cause-and-effect (although they might not be known at the time of the event), severity, and outcome. The context of an adverse event is also important, and captured in the AdverseEvent Clinical Research Profile data elements. A subject may have condition(s) or current treatments (medications, diet, devices) that impact their response to a newly introduced medication, device or procedure. Knowledge of these variables is essential in establishing a cause-and-effect relationship for an adverse event. This information is represented with corresponding resources (e.g. Procedure Resource for procedures, etc.) and referenced. A potential adverse event may also be called a near miss or an error, these are not reported with the AdverseEvent Clinical Research Profile. ### Scope This FHIR IG enables the collection of adverse events in real-world data (RWD) sources such as electronic health records (EHR) and personal health records (PHR) that occur during clinical trials. It ensures the appropriate AE representation required to support clinical research trials within a regulated environment. As the AEs are collected in RWD sources, the data can be transmitted via FHIR to clinical trial management systems, regulatory agencies, sponsors, and clinical research organizations for further processing and reporting. In the pre-market clinical research setting, serious adverse events must be reported to the sponsor, clinical research organization, and regulatory agencies within a specific time frame for Institutional Review Boards (IRBs) and Data Safety Monitoring Board (DSMB) review. By using this IG, a clinical investigator can document an AE in the EHR, it can be received by a secondary clinical trial management system for triage and then forwarded to the sponsor and regulatory agencies. Similarly, a patient on a clinical trial can record an adverse event in their PHR that is then shared with the clinical investigator and reported to the sponsor and regulatory agencies as necessary. In a post-market situation, a patient, provider, or manufacturer can record the adverse event in a system and then report it to the FDA as a FHIR based MedWatch form. Within this guide are several examples. Every effort has been made to capture the most important details of the use of the AdverseEvent profile. However, some examples may provide only a stub to referenced resources (e.g. instances of Patient Resource will be referenced using logical ids but are not resolvable, implementation of Patient is left for other guidance and is not the subject of this guide). Connectathons are ideal opportunities to create, compare and consider the holistic implementation of all FHIR Resources.",
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"display" : "Provenance for Janet weight Observation"
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"name" : "Provenance for Janet weight Observation",
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"name" : "Janet Blood Pressure Observation",
"description" : "Janet Blood Pressure Observation"
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"display" : "Provenance for Janet Blood Pressure Observation"
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"name" : "Provenance for Janet Blood Pressure Observation",
"description" : "Provenance for Janet Blood Pressure Observation"
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"reference" : "MedicationStatement/example001",
"display" : "Janet Tylenol PM med"
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"name" : "Janet Tylenol PM med",
"description" : "Self reported Janet Tylenol PM med"
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"display" : "Janet allergy med"
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"name" : "Janet allergy med",
"description" : "Self reported Janet allergy med"
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"reference" : {
"reference" : "MedicationAdministration/medicationAdministration-for-bresentrik",
"display" : "Medication Administration for bresentrik"
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"name" : "Medication Administration for bresentrik",
"description" : "Study medication info Medication Administration for bresentrik"
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{
"extension" : [
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"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Medication"
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"reference" : {
"reference" : "Medication/bresentrik",
"display" : "Medication is bresentrik"
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"name" : "Medication is bresentrik",
"description" : "Study medication, bresentrik"
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"reference" : {
"reference" : "MedicationRequest/medicationrequest-for-bresentrik",
"display" : "Medication Request for bresentrik"
},
"name" : "Medication Request for bresentrik",
"description" : "Study medication info Medication Request for bresentrik"
},
{
"extension" : [
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"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "MedicationAdministration"
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],
"reference" : {
"reference" : "MedicationAdministration/medadmin0301",
"display" : "Medication Administration of Med0301"
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"name" : "Medication Administration of Med0301",
"description" : "Medication administration example"
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],
"reference" : {
"reference" : "MedicationRequest/medicationrequest-for-study-medication-administration-ABC",
"display" : "Medication Request for discontinued clinical trial medication ABC"
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"name" : "Medication Request for discontinued clinical trial medication ABC",
"description" : "Study medication info Medication Request for clinical trial medication ABC - discontinued"
},
{
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"reference" : {
"reference" : "MedicationRequest/medicationrequest0301-discontinue",
"display" : "Medication Request for discontinued clinical trial medication 0301"
},
"name" : "Medication Request for discontinued clinical trial medication 0301",
"description" : "Study medication info Medication Request for clinical trial medication 0301 - discontinued"
},
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"extension" : [
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],
"reference" : {
"reference" : "Condition/janetReported-condition",
"display" : "Problem"
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"name" : "Problem",
"description" : "Patient reported AE problem"
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{
"extension" : [
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"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "AdverseEvent"
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],
"reference" : {
"reference" : "AdverseEvent/clinical-research-ae-example-medwatch-patient-report",
"display" : "Patient reported AE during research study"
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"name" : "Patient reported AE during research study",
"description" : "Patient report of Adverse Event, example of data that would be on MedWatch form as reported by Patient",
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},
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"extension" : [
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],
"reference" : {
"reference" : "Patient/patient-example-kaitlyn-b",
"display" : "patient-example-kaitlyn-b"
},
"name" : "patient-example-kaitlyn-b",
"description" : "Compass Trial example patient Kaitlyn"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Practitioner"
}
],
"reference" : {
"reference" : "Practitioner/practitioner-oncology-nurse-jane",
"display" : "practitioner-oncology-nurse-jane"
},
"name" : "practitioner-oncology-nurse-jane",
"description" : "Example RN practitioner"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Practitioner"
}
],
"reference" : {
"reference" : "Practitioner/practitioner-owen-oncologist",
"display" : "practitioner-owen-oncologist"
},
"name" : "practitioner-owen-oncologist",
"description" : "Example Oncologist"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "MedicationRequest"
}
],
"reference" : {
"reference" : "MedicationRequest/medication-request-example-kadcyla",
"display" : "medication-request-example-kadcyla"
},
"name" : "medication-request-example-kadcyla",
"description" : "Example showing clinical trial medication Kadcyla"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "MedicationRequest"
}
],
"reference" : {
"reference" : "MedicationRequest/medication-request-example-tucatinib",
"display" : "medication-request-example-tucatinib"
},
"name" : "medication-request-example-tucatinib",
"description" : "Example showing clinical trial medication Tucatinib"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "MedicationAdministration"
}
],
"reference" : {
"reference" : "MedicationAdministration/medication-administration-kadcyla",
"display" : "medication-administration-kadcyla"
},
"name" : "medication-administration-kadcyla",
"description" : "Example showing clinical trial medication administration Kadcyla"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "MedicationAdministration"
}
],
"reference" : {
"reference" : "MedicationAdministration/medication-administration-tucatinib",
"display" : "medication-administration-tucatinib"
},
"name" : "medication-administration-tucatinib",
"description" : "Example showing clinical trial medication administration Tucatinib"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ResearchStudy"
}
],
"reference" : {
"reference" : "ResearchStudy/clinical-trial-example-compass",
"display" : "clinical-trial-example-compass"
},
"name" : "clinical-trial-example-compass",
"description" : "Alliance COMPASS Protocol A011801"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ResearchSubject"
}
],
"reference" : {
"reference" : "ResearchSubject/clinical-trial-example-subject",
"display" : "clinical-trial-example-subject"
},
"name" : "clinical-trial-example-subject",
"description" : "Alliance COMPASS trial research subject"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "MedicationAdministration"
}
],
"reference" : {
"reference" : "MedicationAdministration/medication-administration-kadcyla-reduced",
"display" : "medication-administration-kadcyla-reduced"
},
"name" : "medication-administration-kadcyla-reduced",
"description" : "Example reduced dose of clinical trial medication administration Kadcyla"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "MedicationAdministration"
}
],
"reference" : {
"reference" : "MedicationAdministration/medication-administration-tucatinib-reduced",
"display" : "medication-administration-tucatinib-reduced"
},
"name" : "medication-administration-tucatinib-reduced",
"description" : "Example reduced does of clinical trial medication administration Tucatinib"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "AdverseEvent"
}
],
"reference" : {
"reference" : "AdverseEvent/adverse-event-compass-ex1",
"display" : "adverse-event-compass-ex1"
},
"name" : "adverse-event-compass-ex1",
"description" : "Grade 1 ALT",
"profile" : [
"http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/AdverseEvent-clinical-research"
]
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "AdverseEvent"
}
],
"reference" : {
"reference" : "AdverseEvent/adverse-event-compass-ex1a",
"display" : "adverse-event-compass-ex1a"
},
"name" : "adverse-event-compass-ex1a",
"description" : "Grade 3 ALT",
"profile" : [
"http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/AdverseEvent-clinical-research"
]
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "AdverseEvent"
}
],
"reference" : {
"reference" : "AdverseEvent/adverse-event-compass-ex1b",
"display" : "adverse-event-compass-ex1b"
},
"name" : "adverse-event-compass-ex1b",
"description" : "ALT back to grade 1 and resolved",
"profile" : [
"http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/AdverseEvent-clinical-research"
]
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "MedicationRequest"
}
],
"reference" : {
"reference" : "MedicationRequest/medication-request-example-zofran",
"display" : "medication-request-example-zofran"
},
"name" : "medication-request-example-zofran",
"description" : "Example for medication Zofran"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "AdverseEvent"
}
],
"reference" : {
"reference" : "AdverseEvent/adverse-event-compass-ex2",
"display" : "adverse-event-compass-ex2"
},
"name" : "adverse-event-compass-ex2",
"description" : "Grade 1 Nausea/vomiting // both are AEs, which to use or make them separate?",
"profile" : [
"http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/AdverseEvent-clinical-research"
]
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Condition"
}
],
"reference" : {
"reference" : "Condition/GIBleed",
"display" : "GIBleed"
},
"name" : "GIBleed",
"description" : "Gastrointestinal (GI) bleed"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ResearchStudy"
}
],
"reference" : {
"reference" : "ResearchStudy/research-study-XYZ",
"display" : "research-study-XYZ"
},
"name" : "research-study-XYZ",
"description" : "Research Study XYZ"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Medication"
}
],
"reference" : {
"reference" : "Medication/study-medication-ABC",
"display" : "study-medication-ABC"
},
"name" : "study-medication-ABC",
"description" : "Example study medication ABC"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "MedicationAdministration"
}
],
"reference" : {
"reference" : "MedicationAdministration/study-medication-administration-ABC",
"display" : "study-medication-administration-ABC"
},
"name" : "study-medication-administration-ABC",
"description" : "Example for clinical trial medication ABC"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Procedure"
}
],
"reference" : {
"reference" : "Procedure/procedure-upper-endoscopy",
"display" : "procedure-upper-endoscopy"
},
"name" : "procedure-upper-endoscopy",
"description" : "Example Procedure Upper Endoscopy"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ResearchStudy"
}
],
"reference" : {
"reference" : "ResearchStudy/research-study-DISNEY",
"display" : "research-study-DISNEY"
},
"name" : "research-study-DISNEY",
"description" : "Research Study DISNEY"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Medication"
}
],
"reference" : {
"reference" : "Medication/study-medication-MMD",
"display" : "study-medication-MMD"
},
"name" : "study-medication-MMD",
"description" : "Example study medication MMD"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "MedicationAdministration"
}
],
"reference" : {
"reference" : "MedicationAdministration/study-medication-administration-MMD",
"display" : "study-medication-administration-MMD"
},
"name" : "study-medication-administration-MMD",
"description" : "Example for clinical trial medication MMD"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Medication"
}
],
"reference" : {
"reference" : "Medication/medication-tylenol",
"display" : "medication-tylenol"
},
"name" : "medication-tylenol",
"description" : "Example medication for Tylenol"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "MedicationAdministration"
}
],
"reference" : {
"reference" : "MedicationAdministration/medication-administration-tylenol",
"display" : "medication-administration-tylenol"
},
"name" : "medication-administration-tylenol",
"description" : "Example of Tylenol"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ResearchStudy"
}
],
"reference" : {
"reference" : "ResearchStudy/research-study-acme",
"display" : "research-study-acme"
},
"name" : "research-study-acme",
"description" : "Research Study ACME"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ResearchSubject"
}
],
"reference" : {
"reference" : "ResearchSubject/clinical-trial-acme-subject",
"display" : "clinical-trial-acme-subject"
},
"name" : "clinical-trial-acme-subject",
"description" : "Clinical trial ACME research subject"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Procedure"
}
],
"reference" : {
"reference" : "Procedure/clinical-trial-acme-procedure",
"display" : "clinical-trial-acme-procedure"
},
"name" : "clinical-trial-acme-procedure",
"description" : "Clinical trial ACME protocol-prescribed procedure of a Lung CT Scan, with contrast dye"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "MedicationAdministration"
}
],
"reference" : {
"reference" : "MedicationAdministration/study-medication-administration-WBY",
"display" : "study-medication-administration-WBY"
},
"name" : "study-medication-administration-WBY",
"description" : "Example for clinical trial medication WBY"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Medication"
}
],
"reference" : {
"reference" : "Medication/medication-contrast-dye",
"display" : "medication-contrast-dye"
},
"name" : "medication-contrast-dye",
"description" : "Example contrast dye medication"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "MedicationAdministration"
}
],
"reference" : {
"reference" : "MedicationAdministration/medication-administration-contrast-dye",
"display" : "medication-administration-contrast-dye"
},
"name" : "medication-administration-contrast-dye",
"description" : "Example medication administration for contrast dye"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Medication"
}
],
"reference" : {
"reference" : "Medication/medication-forhives",
"display" : "medication-forhives"
},
"name" : "medication-forhives",
"description" : "Example medication for hives"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "MedicationAdministration"
}
],
"reference" : {
"reference" : "MedicationAdministration/medication-administration-forhives",
"display" : "medication-administration-forhives"
},
"name" : "medication-administration-forhives",
"description" : "Example medication administration for hives"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Condition"
}
],
"reference" : {
"reference" : "Condition/AEModeratehives",
"display" : "AEModeratehives"
},
"name" : "AEModeratehives",
"description" : "Moderate hives"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "AdverseEvent"
}
],
"reference" : {
"reference" : "AdverseEvent/AdverseEventFromProcedureNotStudyDrug",
"display" : "AdverseEventFromProcedureNotStudyDrug"
},
"name" : "AdverseEventFromProcedureNotStudyDrug",
"description" : "Adverse event from procedure, not study drug",
"profile" : [
"http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/AdverseEvent-clinical-research"
]
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Medication"
}
],
"reference" : {
"reference" : "Medication/resstudy-medication-WBY",
"display" : "resstudy-medication-WBY"
},
"name" : "resstudy-medication-WBY",
"description" : "Example clinical trial medication WBY"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "AdverseEvent"
}
],
"reference" : {
"reference" : "AdverseEvent/SeriousAdverseEventResearchStudy",
"display" : "SeriousAdverseEventResearchStudy"
},
"name" : "SeriousAdverseEventResearchStudy",
"description" : "Serious Adverse Event Research Study Medication Example",
"profile" : [
"http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/AdverseEvent-clinical-research"
]
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Patient"
}
],
"reference" : {
"reference" : "Patient/patient-moumic",
"display" : "Patient MOUMIC"
},
"name" : "Patient MOUMIC",
"description" : "Patient MOUMIC on Research Study DISNEY"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Condition"
}
],
"reference" : {
"reference" : "Condition/AEHeadache",
"display" : "AEHeadache"
},
"name" : "AEHeadache",
"description" : "Headache"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "AdverseEvent"
}
],
"reference" : {
"reference" : "AdverseEvent/NonSeriousAdverseEventResearchStudyMed",
"display" : "NonSeriousAdverseEventResearchStudyMed"
},
"name" : "NonSeriousAdverseEventResearchStudyMed",
"description" : "Non-Serious Adverse Event Research Study Medication Example",
"profile" : [
"http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/AdverseEvent-clinical-research"
]
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Patient"
}
],
"reference" : {
"reference" : "Patient/patient-slp",
"display" : "Example patient SLP"
},
"name" : "Example patient SLP",
"description" : "Patient enrolled in ACME study, taking Study Medication WBY 10 mg orally daily every morning for moderate asthma"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "AdverseEvent"
}
],
"reference" : {
"reference" : "AdverseEvent/adverse-event-device-death",
"display" : "adverse-event-device-death"
},
"name" : "adverse-event-device-death",
"description" : "Device suspected entity",
"profile" : [
"http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/AdverseEvent-clinical-research"
]
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Device"
}
],
"reference" : {
"reference" : "Device/device-infuser",
"display" : "Device - Infuser that exploded"
},
"name" : "Device - Infuser that exploded",
"description" : "Device - Infuser that exploded"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "ResearchSubject"
}
],
"reference" : {
"reference" : "ResearchSubject/clinical-trial-example-subject1",
"display" : "clinical-trial-example-subject1"
},
"name" : "clinical-trial-example-subject1",
"description" : "Alliance COMPASS trial research subject"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "MedicationAdministration"
}
],
"reference" : {
"reference" : "MedicationAdministration/medication-administration-kadcyla1",
"display" : "medication-administration-kadcyla1"
},
"name" : "medication-administration-kadcyla1",
"description" : "Example showing clinical trial medication administration Kadcyla"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "MedicationRequest"
}
],
"reference" : {
"reference" : "MedicationRequest/medication-request-example-kadcyla1",
"display" : "medication-request-example-kadcyla1"
},
"name" : "medication-request-example-kadcyla1",
"description" : "Example showing clinical trial medication Kadcyla"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "Patient"
}
],
"reference" : {
"reference" : "Patient/patient-example-kaitlyn-b1",
"display" : "patient-example-kaitlyn-b1"
},
"name" : "patient-example-kaitlyn-b1",
"description" : "Compass Trial example patient Kaitlynn B1"
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:extension"
}
],
"reference" : {
"reference" : "StructureDefinition/ae-grade"
},
"name" : "Adverse Event Grade",
"description" : "For cancer related trials, severity is represented as a grade. Describes the grade of the adverse event, in relation to the subject not the resulting condition. In the context of clinical research, it is the investigator’s assessment of severity, in oncology related trials this is reported as grade."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:extension"
}
],
"reference" : {
"reference" : "StructureDefinition/ae-severity"
},
"name" : "Adverse Event Severity",
"description" : "Describes the severity of the adverse event, in relation to the subject not the resulting condition. In the context of clinical research, it is the investigator’s assessment of severity."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:extension"
}
],
"reference" : {
"reference" : "StructureDefinition/caused-subject-to-discontinue-study"
},
"name" : "Adverse event caused subject to discontinue the study",
"description" : "Indicates if the subject discontinued the study due to the adverse event."
},
{
"extension" : [
{
"url" : "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
"valueString" : "StructureDefinition:extension"
}
],
"reference" : {
"reference" : "StructureDefinition/seriousness-criteria"
},
"name" : "Criteria reviewed in determining serious adverse event",
"description" : "Element to capture the presence or absence of specific factors (criteria) associated with serious adverse events."
}
],
"page" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode" : "informative"
}
],
"sourceUrl" : "index.html",
"name" : "index.html",
"title" : "AdverseEvents for Clinical Research Home Page",
"generation" : "html",
"page" : [
{
"sourceUrl" : "background.html",
"name" : "background.html",
"title" : "Background and Workflow",
"generation" : "markdown"
},
{
"sourceUrl" : "examples.html",
"name" : "examples.html",
"title" : "Real World examples",
"generation" : "markdown",
"page" : [
{
"sourceUrl" : "exampleCancerClinicalTrial.html",
"name" : "exampleCancerClinicalTrial.html",
"title" : "Cancer Clinical Trial Example",
"generation" : "markdown"
}
]
},
{
"sourceUrl" : "security.html",
"name" : "security.html",
"title" : "Security Note",
"generation" : "markdown"
},
{
"sourceUrl" : "downloads.html",
"name" : "downloads.html",
"title" : "Useful Downloads",
"generation" : "markdown"
},
{
"sourceUrl" : "changes.html",
"name" : "changes.html",
"title" : "IG Change History",
"generation" : "html"
}
]
},
"parameter" : [
{
"code" : {
"system" : "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code" : "copyrightyear"
},
"value" : "2020+"
},
{
"code" : {
"system" : "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code" : "releaselabel"
},
"value" : "STU1"
},
{
"code" : {
"system" : "http://hl7.org/fhir/guide-parameter-code",
"code" : "path-resource"
},
"value" : "input\\history"
},
{
"code" : {
"system" : "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code" : "path-liquid"
},
"value" : "templates\\liquid"
},
{
"code" : {
"system" : "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code" : "shownav"
},
"value" : "true"
},
{
"code" : {
"system" : "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code" : "autoload-resources"
},
"value" : "true"
},
{
"code" : {
"system" : "http://hl7.org/fhir/guide-parameter-code",
"code" : "path-resource"
},
"value" : "input/capabilities"
},
{
"code" : {
"system" : "http://hl7.org/fhir/guide-parameter-code",
"code" : "path-resource"
},
"value" : "input/examples"
},
{
"code" : {
"system" : "http://hl7.org/fhir/guide-parameter-code",
"code" : "path-resource"
},
"value" : "input/extensions"
},
{
"code" : {
"system" : "http://hl7.org/fhir/guide-parameter-code",
"code" : "path-resource"
},
"value" : "input/models"
},
{
"code" : {
"system" : "http://hl7.org/fhir/guide-parameter-code",
"code" : "path-resource"
},
"value" : "input/operations"
},
{
"code" : {
"system" : "http://hl7.org/fhir/guide-parameter-code",
"code" : "path-resource"
},
"value" : "input/profiles"
},
{
"code" : {
"system" : "http://hl7.org/fhir/guide-parameter-code",
"code" : "path-resource"
},
"value" : "input/resources"
},
{
"code" : {
"system" : "http://hl7.org/fhir/guide-parameter-code",
"code" : "path-resource"
},
"value" : "input/vocabulary"
},
{
"code" : {
"system" : "http://hl7.org/fhir/guide-parameter-code",
"code" : "path-resource"
},
"value" : "input/testing"
},
{
"code" : {
"system" : "http://hl7.org/fhir/guide-parameter-code",
"code" : "path-resource"
},
"value" : "input/history"
},
{
"code" : {
"system" : "http://hl7.org/fhir/guide-parameter-code",
"code" : "path-resource"
},
"value" : "fsh-generated/resources"
},
{
"code" : {
"system" : "http://hl7.org/fhir/guide-parameter-code",
"code" : "path-pages"
},
"value" : "template/config"
},
{
"code" : {
"system" : "http://hl7.org/fhir/guide-parameter-code",
"code" : "path-pages"
},
"value" : "input/images"
},
{
"code" : {
"system" : "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code" : "path-liquid"
},
"value" : "template/liquid"
},
{
"code" : {
"system" : "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code" : "path-liquid"
},
"value" : "input/liquid"
},
{
"code" : {
"system" : "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code" : "path-qa"
},
"value" : "temp/qa"
},
{
"code" : {
"system" : "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code" : "path-temp"
},
"value" : "temp/pages"
},
{
"code" : {
"system" : "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code" : "path-output"
},
"value" : "output"
},
{
"code" : {
"system" : "http://hl7.org/fhir/guide-parameter-code",
"code" : "path-tx-cache"
},
"value" : "input-cache/txcache"
},
{
"code" : {
"system" : "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code" : "path-suppressed-warnings"
},
"value" : "input/ignoreWarnings.txt"
},
{
"code" : {
"system" : "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code" : "path-history"
},
"value" : "http://hl7.org/fhir/uv/ae-research-ig/history.html"
},
{
"code" : {
"system" : "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code" : "template-html"
},
"value" : "template-page.html"
},
{
"code" : {
"system" : "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code" : "template-md"
},
"value" : "template-page-md.html"
},
{
"code" : {
"system" : "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code" : "apply-contact"
},
"value" : "true"
},
{
"code" : {
"system" : "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code" : "apply-context"
},
"value" : "true"
},
{
"code" : {
"system" : "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code" : "apply-copyright"
},
"value" : "true"
},
{
"code" : {
"system" : "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code" : "apply-jurisdiction"
},
"value" : "true"
},
{
"code" : {
"system" : "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code" : "apply-license"
},
"value" : "true"
},
{
"code" : {
"system" : "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code" : "apply-publisher"
},
"value" : "true"
},
{
"code" : {
"system" : "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code" : "apply-version"
},
"value" : "true"
},
{
"code" : {
"system" : "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code" : "apply-wg"
},
"value" : "true"
},
{
"code" : {
"system" : "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code" : "active-tables"
},
"value" : "true"
},
{
"code" : {
"system" : "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code" : "fmm-definition"
},
"value" : "http://hl7.org/fhir/versions.html#maturity"
},
{
"code" : {
"system" : "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code" : "propagate-status"
},
"value" : "true"
},
{
"code" : {
"system" : "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code" : "excludelogbinaryformat"
},
"value" : "true"
},
{
"code" : {
"system" : "http://hl7.org/fhir/tools/CodeSystem/ig-parameters",
"code" : "tabbed-snapshots"
},
"value" : "true"
}
]
}
}
XIG built as of ??metadata-date??. Found ??metadata-resources?? resources in ??metadata-packages?? packages.