Adverse Event Clinical Research R4 Backport
1.0.1 - STU1

Adverse Event Clinical Research R4 Backport, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-ae-research-backport-ig/ and changes regularly. See the Directory of published versions

## Artifacts Summary

This page provides a list of the FHIR artifacts defined as part of this implementation guide.

### Structures: Resource Profiles

These define constraints on FHIR resources for systems conforming to this implementation guide.

Adverse Event Clinical Research | Convenience backport into R4 of FHIR R5 Foundational profile of AdverseEvent for Clinical Research communications.

### Structures: Extension Definitions

These define constraints on FHIR data types for systems conforming to this implementation guide.

Adverse Event Grade | 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.
Adverse Event resolution date | The date the adverse event was resolved.
Adverse event caused subject to discontinue the study | Indicates if the subject discontinued the study due to the adverse event.
Contributing Factor | The contributing factors suspected to have increased the probability or severity of the adverse event.
Criteria reviewed in determining serious adverse event | Element to capture the presence or absence of specific factors (criteria) associated with serious adverse events.
Expected In Research Study | Considered likely or probable or anticipated in the research study. Whether the reported event matches any of the outcomes for the patient that are considered by the study as known or likely.
Mitigating Action | Ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm.
Note | Comments made about the adverse event by the performer, subject or other participants.
Participant | Indicates who or what participated in the adverse event and how they were involved.
Research Subject record of subject | Communicates Research Subject related metadata.
Resulting Effect | Information about the condition that occurred as a result of the adverse event.
Supporting information relevant to the event | Relevant past history for the subject. In a clinical care context, an example being a patient had an adverse event following a penicillin administration and the patient had a previously documented penicillin allergy. In a clinical trials context, an example is a bunion or rash that was present prior to the study. Additionally, the supporting item can be a document that is relevant to this instance of the adverse event that is not part of the subject’s medical history. For example, a clinical note, staff list, or material safety data sheet (MSDS). Supporting information is not a contributing factor, preventive action, or mitigating action.
Suspect Entity | Describes the entity that is suspected to have caused the adverse event.
Workflow Status | The current workflow state of the adverse event or potential adverse event. This is not the reporting of the event to any regulatory or quality organization. This is not the outcome of the patient’s condition.

### Terminology: Value Sets

These define sets of codes used by systems conforming to this implementation guide.

Adverse Event Participant Functions | This value set includes codes that describe the type of involvement of the actor in the adverse event.
Adverse Event Status | Codes identifying the lifecycle stage of an adverse event.
AdverseEvent Contributing Factor | This value set includes codes that describe the contributing factors suspected to have increased the probability or severity of the adverse event.
AdverseEvent Mitigating Action | This value set includes codes that describe the ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm.
AdverseEvent Seriousness Non-serious Codes Only | This value set includes codes that describe the ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm.
AdverseEvent Supporting Information | This value set includes codes that describe the supporting information relevant to the event.
AdverseEvent Type | This value set includes codes that describe the adverse event or incident that occurred or was averted.

### Example: Example Instances

These are example instances that show what data produced and consumed by systems conforming with this implementation guide might look like.

AdverseEventFromProcedureNotStudyDrug | Adverse event from procedure, not study drug
ClinicalTrialSignificantAdverseEvent | example
NonSeriousAdverseEventResearchStudyMed | Non-Serious Adverse Event Research Study Medication Example
Patient reported AE during research study | Patient report of Adverse Event, example of data that would be on MedWatch form as reported by Patient
SeriousAdverseEventResearchStudy | Serious Adverse Event Research Study Medication Example
adverse-event-compass-ex1 | Grade 1 ALT
adverse-event-compass-ex1a | Grade 3 ALT
adverse-event-compass-ex1b | ALT back to grade 1 and resolved
adverse-event-compass-ex2 | Grade 1 Nausea/vomiting // both are AEs, which to use or make them separate?
adverse-event-device-death | Device suspected entity

### Other

These are resources that are used within this implementation guide that do not fit into one of the other categories.

AEHeadache | Headache
AEHepaticFailure | The fifth subject enrolled in the trial develops severe hepatic failure complicated by encephalopathy one month after starting the study. The study sponsors determined that is an unanticipated problem that must be reported because although the risk of mild liver injury was foreseen, severe liver injury resulting in hepatic failure was unexpected in severity; possibly related to participation in the research; and serious.
AEHepaticFailurecomplication | The fifth subject enrolled in the trial develops severe hepatic failure complicated by encephalopathy one month after starting the study. The study sponsors determined that is an unanticipated problem that must be reported because although the risk of mild liver injury was foreseen, severe liver injury resulting in hepatic failure was unexpected in severity; possibly related to participation in the research; and serious.
AEModeratehives | Moderate hives
Breast Cancer Trial | Breast Cancer clinical trial example
ClinicalTrialSubject5 | Clinical Trial subject number 5. Acute Hepatic Failure.
Device - Infuser that exploded | Device - Infuser that exploded
Example patient SLP | Patient enrolled in ACME study, taking Study Medication WBY 10 mg orally daily every morning for moderate asthma
GIBleed | Gastrointestinal (GI) bleed
Janet Blood Pressure Observation | Janet Blood Pressure Observation
Janet Patient | Patient Janet, 64-year old woman on clinical trial
Janet Tylenol PM med | Self reported Janet Tylenol PM med
Janet allergy med | Self reported Janet allergy med
Janet pill for water retention med not known | Self reported Janet pill for water retention med not known
Janet weight Observation | Janet weight observation
Medication Administration for bresentrik | Study medication info Medication Administration for bresentrik
Medication Administration of Med0301 | Medication administration example
Medication Request for bresentrik | Study medication info Medication Request for bresentrik
Medication Request for discontinued clinical trial medication 0301 | Study medication info Medication Request for clinical trial medication 0301 - discontinued
Medication Request for discontinued clinical trial medication ABC | Study medication info Medication Request for clinical trial medication ABC - discontinued
Medication is bresentrik | Study medication, bresentrik
Patient MOUMIC | Patient MOUMIC on Research Study DISNEY
Problem | Patient reported AE problem
Serious Adverse Event | SAE Patient SCHJO on Research Study XYZ, Study ID XYZ-123, Subject number XYZ-123-002.
clinical-trial-acme-procedure | Clinical trial ACME protocol-prescribed procedure of a Lung CT Scan, with contrast dye
clinical-trial-acme-subject | Clinical trial ACME research subject
clinical-trial-example-compass | Alliance COMPASS Protocol A011801
clinical-trial-example-subject | Alliance COMPASS trial research subject
clinical-trial-example-subject1 | Alliance COMPASS trial research subject
medication-administration-contrast-dye | Example medication administration for contrast dye
medication-administration-forhives | Example medication administration for hives
medication-administration-kadcyla | Example showing clinical trial medication administration Kadcyla
medication-administration-kadcyla-reduced | Example reduced dose of clinical trial medication administration Kadcyla
medication-administration-kadcyla1 | Example showing clinical trial medication administration Kadcyla
medication-administration-tucatinib | Example showing clinical trial medication administration Tucatinib
medication-administration-tucatinib-reduced | Example reduced does of clinical trial medication administration Tucatinib
medication-administration-tylenol | Example of Tylenol
medication-contrast-dye | Example contrast dye medication
medication-forhives | Example medication for hives
medication-request-example-kadcyla | Example showing clinical trial medication Kadcyla
medication-request-example-kadcyla1 | Example showing clinical trial medication Kadcyla
medication-request-example-tucatinib | Example showing clinical trial medication Tucatinib
medication-request-example-zofran | Example for medication Zofran
medication-tylenol | Example medication for Tylenol
patient-example-kaitlyn-b | Compass Trial example patient Kaitlyn
patient-example-kaitlyn-b1 | Compass Trial example patient Kaitlynn B1
practitioner-oncology-nurse-jane | Example RN practitioner
practitioner-owen-oncologist | Example Oncologist
procedure-upper-endoscopy | Example Procedure Upper Endoscopy
research-study-DISNEY | Research Study DISNEY
research-study-XYZ | Research Study XYZ
research-study-acme | Use Case 17 Research Study ACME
resstudy-medication-WBY | Example clinical trial medication WBY
study-medication-ABC | Example study medication ABC
study-medication-MMD | Example study medication MMD
study-medication-administration-ABC | Example for clinical trial medication ABC
study-medication-administration-MMD | Example for clinical trial medication MMD
study-medication-administration-WBY | Example for clinical trial medication WBY