{
"description": null,
"_filename": "Questionnaire-sirb-adverse-event-questionnaire-populate.json",
"package_name": "hl7.fhir.us.sirb",
"subjectType": [ "ResearchStudy" ],
"date": "2023-04-20T13:44:05+00:00",
"publisher": "HL7 International - BR&R Work Group",
"jurisdiction": [ {
"text": "United States of America",
"coding": [ {
"code": "US",
"system": "urn:iso:std:iso:3166",
"display": "United States of America"
} ]
} ],
"name": "AE_Questionnaire",
"item": [ {
"item": [ {
"item": [ {
"text": "Short title of the study, the same title listed on the Informed Consent",
"type": "display",
"linkId": "mae1.1_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Study Title",
"type": "string",
"linkId": "mae1.1",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.descendants().where(linkId = 'in1.2').answer.value"
}
} ]
}, {
"item": [ {
"text": "Number assigned by IRB; this number is the same as that on the Consent Form",
"type": "display",
"linkId": "mae1.2_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "IRB Protocol Number",
"type": "string",
"linkId": "mae1.2",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.descendants().where(linkId = 'in1.3').answer.value"
}
} ]
}, {
"item": [ {
"text": "Select the study type, either Interventional (Clinical Trial) or Observational (Non-Interventional)",
"type": "display",
"linkId": "mae1.3_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Study Type",
"type": "choice",
"linkId": "mae1.3",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
}, {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.descendants().where(linkId = 'in1.4').answer.valueCoding"
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "INT",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Interventional"
}
}, {
"valueCoding": {
"code": "OBS",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Observational"
}
} ]
}, {
"linkId": "mae1.4",
"repeats": false,
"item": [ {
"text": "Indicator for use of FDA regulated product",
"type": "display",
"linkId": "mae1.4_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"type": "choice",
"answerOption": [ {
"valueCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "Yes"
}
}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No"
}
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
}, {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.descendants().where(linkId = 'in9.1').answer.valueCoding"
}
} ],
"readOnly": false,
"required": false,
"text": "Does this protocol require an FDA exemption?"
}, {
"linkId": "mae1.5",
"repeats": false,
"item": [ {
"text": "Is an Investigational New Drug (IND) or Investigational Device Exemption (IDE) being used?",
"type": "display",
"linkId": "mae1.5_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"type": "choice",
"answerOption": [ {
"valueCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "Yes"
}
}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No"
}
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
}, {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.descendants().where(linkId = 'in9.2').answer.valueCoding"
}
} ],
"readOnly": false,
"required": false,
"text": "Is an IND or IDE being used in this study?"
}, {
"linkId": "mae1.6",
"repeats": false,
"type": "choice",
"enableWhen": [ {
"operator": "=",
"question": "mae1.5",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "IND",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "IND"
}
}, {
"valueCoding": {
"code": "IDE",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "IDE"
}
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
}, {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.descendants().where(linkId = 'in9.4').answer.valueCoding"
}
} ],
"readOnly": false,
"required": false,
"text": "Select whether Investigational New Drug (IND) or Investigational Device Exemption (IDE):"
}, {
"text": "IND/IDE Number",
"type": "string",
"linkId": "mae1.7",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.descendants().where(linkId = 'in9.3').answer.value"
}
} ],
"enableWhen": [ {
"operator": "=",
"question": "mae1.5",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
} ],
"text": "Research Study",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 150%"
} ]
},
"linkId": "mae1",
"required": false
}, {
"item": [ {
"item": [ {
"item": [ {
"text": "This question and its answer will not print on the Adverse Medical Event Form but are necessary for the form logic. Select \"Yes\" if the Adverse Medical Event occurred at the lead principal investigator site, the study coordinating center or other administrative unit for the overall study.",
"type": "display",
"linkId": "mae4.1.7_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Did the Adverse Medical Event occur at the lead principal investigator site?",
"type": "choice",
"linkId": "mae4.1.7",
"required": true,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "Yes"
}
}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No"
}
} ]
}, {
"text": "External Data For linkId mae4.1.1",
"type": "open-choice",
"linkId": "ExternalDataFor_mae4.1.1",
"repeats": true,
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.repeat(item).where(linkId = 'in8.9').answer.value"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
"valueBoolean": true
}, {
"url": "http://hl7.org/fhir/StructureDefinition/designNote",
"valueMarkdown": "See FHIR Specification Feedback Jira ticket FHIR-36338. Information obtained from other types of external sources (e.g. launch context, fhir-x-query, etc.) SHOULD only be used for initialExpression and calculatedExpression logic. Other behavior such as enableWhen or answerExpression should always be driven off of answers within the Questionnaire (even if they are hidden answers that are populated from an initialExpression)."
} ]
}, {
"item": [ {
"text": "This question and its answer will not print on the Adverse Medical Event Form but are necessary for the form logic. If you do not want pre-population to occur, leave this question blank and manually fill in the relying institution and relying site principal investigator details.",
"type": "display",
"linkId": "mae4.1.1_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "If the Adverse Medical Event occurred at one of the relying sites, select the relying site in order to pre-populate the the relying institution and relying site principal investigator details below.",
"type": "choice",
"linkId": "mae4.1.1",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
}, {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-answerExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%resource.repeat(item).where(linkId = 'ExternalDataFor_mae4.1.1').answer.value"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/designNote",
"valueMarkdown": "See FHIR Specification Feedback Jira ticket FHIR-36338. Information obtained from other types of external sources (e.g. launch context, fhir-x-query, etc.) SHOULD only be used for initialExpression and calculatedExpression logic. Other behavior such as enableWhen or answerExpression should always be driven off of answers within the Questionnaire (even if they are hidden answers that are populated from an initialExpression)."
} ],
"enableWhen": [ {
"operator": "=",
"question": "mae4.1.7",
"answerCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
}, {
"text": "Name of organization/site where the event occurred",
"type": "string",
"linkId": "mae4.1.2",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "iif(%eventOccurredAtLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.1.1').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.1.1').answer.value)"
}
} ],
"enableWhen": [ {
"operator": "exists",
"question": "mae4.1.7",
"answerBoolean": true
} ]
}, {
"text": "Location where Adverse Medical Event occurred. Adverse Medical Event is any untoward medical occurrence associated with a participant in research, whether or not associated with the participant's activities in the research.",
"type": "display",
"linkId": "mae4.1_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Where Adverse Medical Event Occurred",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#2a623d; font-size: 125%"
} ]
},
"linkId": "mae4.1",
"repeats": false,
"required": false
}, {
"item": [ {
"item": [ {
"text": "First or given name of the principal investigator at site where Adverse Medical Event occurred",
"type": "display",
"linkId": "mae4.7.1_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "First Name",
"type": "string",
"linkId": "mae4.7.1",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "iif(%eventOccurredAtLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.1').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.1').answer.value)"
}
} ]
}, {
"item": [ {
"text": "Surname or family name",
"type": "display",
"linkId": "mae4.7.2_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Last Name",
"type": "string",
"linkId": "mae4.7.2",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "iif(%eventOccurredAtLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.2').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.2').answer.value)"
}
} ]
}, {
"item": [ {
"text": "Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc.",
"type": "display",
"linkId": "mae4.7.5_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Suffix",
"type": "string",
"linkId": "mae4.7.5",
"repeats": false,
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "iif(%eventOccurredAtLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.3').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.3').answer.value)"
}
} ]
}, {
"item": [ {
"text": "Professional and Academic degrees of the principal investigator at site where Adverse Medical Event occurred",
"type": "display",
"linkId": "mae4.7.6_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Degree(s)",
"type": "string",
"linkId": "mae4.7.6",
"repeats": false,
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "iif(%eventOccurredAtLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.4').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.4').answer.value)"
}
} ]
}, {
"item": [ {
"text": "10-digit phone number, including area code",
"type": "display",
"linkId": "mae4.7.3_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Phone",
"type": "string",
"linkId": "mae4.7.3",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "iif(%eventOccurredAtLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.5').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.5').answer.value)"
}
} ]
}, {
"text": "Email",
"type": "string",
"linkId": "mae4.7.4",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "iif(%eventOccurredAtLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.6').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.6').answer.value)"
}
} ]
}, {
"text": "Principal Investigator at site where Adverse Medical Event occurred",
"type": "display",
"linkId": "mae4.7_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Site Principal Investigator",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#2a623d; font-size: 125%"
} ]
},
"linkId": "mae4.7",
"repeats": false,
"required": false,
"enableWhen": [ {
"operator": "exists",
"question": "mae4.1.7",
"answerBoolean": true
} ]
}, {
"item": [ {
"item": [ {
"text": "Select \"Yes\" if the Adverse Medical Event is being recorded by the lead principal investigator site, the study coordinating center or other administrative unit for the overall study.",
"type": "display",
"linkId": "mae4.9.1_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "If the Adverse Medical Event occurred at a relying site, will the lead principal investigator site be recording the Adverse Non-Medical Event?",
"type": "choice",
"linkId": "mae4.9.1",
"required": true,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"enableWhen": [ {
"operator": "=",
"question": "mae4.1.7",
"answerCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "Yes"
}
}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No"
}
} ]
}, {
"item": [ {
"text": "Location where adverse event is recorded",
"type": "display",
"linkId": "mae4.9.2_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Name of organization/site which is recording the Adverse Medical event",
"type": "string",
"linkId": "mae4.9.2",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "iif(%eventOccurredAtLeadPISite = 'Y' or %relyingSiteEventReportedByLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.1.1').answer.value, iif(%relyingSiteEventReportedByLeadPISite = 'N', %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.1.1').answer.value) )"
}
} ],
"enableWhen": [ {
"operator": "=",
"question": "mae4.1.7",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
}, {
"operator": "exists",
"question": "mae4.9.1",
"answerBoolean": true
} ],
"enableBehavior": "any"
} ],
"text": "Responsibility for Adverse Medical Event Reporting",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#2a623d; font-size: 125%"
} ]
},
"linkId": "mae4.9",
"repeats": false,
"required": false,
"enableWhen": [ {
"operator": "exists",
"question": "mae4.1.7",
"answerBoolean": true
} ]
} ],
"text": "Organization/Site",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 150%"
} ]
},
"linkId": "mae4",
"required": false
}, {
"item": [ {
"text": "Personnel completing the adverse medical event documentation at the lead or relying site",
"type": "display",
"linkId": "mae3_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
}, {
"item": [ {
"text": "First or given name",
"type": "display",
"linkId": "mae3.1_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "First Name",
"type": "string",
"linkId": "mae3.1",
"repeats": false,
"readOnly": false,
"required": false
}, {
"item": [ {
"text": "Surname or family name",
"type": "display",
"linkId": "mae3.2_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Last Name",
"type": "string",
"linkId": "mae3.2",
"required": false
}, {
"item": [ {
"text": "10-digit phone number, including area code",
"type": "display",
"linkId": "mae3.3_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Phone",
"type": "string",
"linkId": "mae3.3",
"required": false
}, {
"text": "Email",
"type": "string",
"linkId": "mae3.4",
"required": false
} ],
"text": "Primary Contact",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 150%"
} ]
},
"linkId": "mae3",
"required": false
}, {
"item": [ {
"item": [ {
"text": "Participant identifier from study case report form",
"type": "display",
"linkId": "mae5.1_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Patient ID",
"type": "string",
"linkId": "mae5.1",
"required": false
}, {
"text": "Age",
"type": "string",
"linkId": "mae5.2",
"required": false
}, {
"text": "Birth Sex",
"type": "choice",
"linkId": "mae5.3",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "F",
"system": "http://terminology.hl7.org/CodeSystem/v2-0001",
"display": "Female"
}
}, {
"valueCoding": {
"code": "M",
"system": "http://terminology.hl7.org/CodeSystem/v2-0001",
"display": "Male"
}
}, {
"valueCoding": {
"code": "O",
"system": "http://terminology.hl7.org/CodeSystem/v2-0001",
"display": "Other"
}
}, {
"valueCoding": {
"code": "U",
"system": "http://terminology.hl7.org/CodeSystem/v2-0001",
"display": "Unknown"
}
} ]
}, {
"item": [ {
"text": "Select pounds or kilograms",
"type": "display",
"linkId": "mae5.4_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Weight",
"type": "quantity",
"linkId": "mae5.4",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-unitOption",
"valueCoding": {
"display": "[lb]"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-unitOption",
"valueCoding": {
"display": "[kg]"
}
} ]
}, {
"item": [ {
"text": "Select inches, feet, centimeters, meters",
"type": "display",
"linkId": "mae5.5_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Height",
"type": "quantity",
"linkId": "mae5.5",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-unitOption",
"valueCoding": {
"display": "[in]"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-unitOption",
"valueCoding": {
"display": "[ft]"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-unitOption",
"valueCoding": {
"display": "[cm]"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-unitOption",
"valueCoding": {
"display": "[m]"
}
} ]
}, {
"text": "Ethnicity",
"type": "choice",
"linkId": "mae5.6",
"repeats": false,
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "2135-2",
"system": "http://terminology.hl7.org/CodeSystem/v3-Ethnicity",
"display": "Hispanic or Latino"
}
}, {
"valueCoding": {
"code": "2186-5",
"system": "http://terminology.hl7.org/CodeSystem/v3-Ethnicity",
"display": "Not Hispanic or Latino"
}
} ]
}, {
"text": "Race",
"type": "choice",
"linkId": "mae5.7",
"repeats": true,
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Check-box",
"coding": [ {
"code": "check-box",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Check-box"
} ]
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-choiceOrientation",
"valueCode": "vertical"
} ],
"answerOption": [ {
"valueCoding": {
"code": "2028-9",
"system": "http://terminology.hl7.org/CodeSystem/v3-Race",
"display": "Asian"
}
}, {
"valueCoding": {
"code": "1002-5",
"system": "http://terminology.hl7.org/CodeSystem/v3-Race",
"display": "American Indian or Alaska Native"
}
}, {
"valueCoding": {
"code": "2054-5",
"system": "http://terminology.hl7.org/CodeSystem/v3-Race",
"display": "Black or African American"
}
}, {
"valueCoding": {
"code": "2076-8",
"system": "http://terminology.hl7.org/CodeSystem/v3-Race",
"display": "Native Hawaiian or Other Pacific Islander"
}
}, {
"valueCoding": {
"code": "2106-3",
"system": "http://terminology.hl7.org/CodeSystem/v3-Race",
"display": "White"
}
} ]
}, {
"item": [ {
"text": "Patient's treatment strategy assignment, if known.",
"type": "display",
"linkId": "mae5.8_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Which Arm/Cohort/treatment group was the participant assigned to (if known)?",
"type": "string",
"linkId": "mae5.8",
"required": false
}, {
"linkId": "mae5.9",
"repeats": false,
"item": [ {
"text": "Did the participant receive the investigational agent? If answer is unknown due to blinding, select No Information.",
"type": "display",
"linkId": "mae5.9_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"type": "choice",
"answerOption": [ {
"valueCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "Yes"
}
}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No"
}
}, {
"valueCoding": {
"code": "NI",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No Information"
}
}, {
"valueCoding": {
"code": "NA",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "not applicable"
}
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"readOnly": false,
"required": false,
"text": "Participant dosed or received study agent"
}, {
"enableBehavior": "any",
"linkId": "mae5.10",
"item": [ {
"text": "investigational agent or placebo or blinded study",
"type": "display",
"linkId": "mae5.10_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"type": "choice",
"enableWhen": [ {
"operator": "=",
"question": "mae5.9",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
}, {
"operator": "=",
"question": "mae5.9",
"answerCoding": {
"code": "NI",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "SA",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Study Agent"
}
}, {
"valueCoding": {
"code": "PLACEBO",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Placebo"
}
}, {
"valueCoding": {
"code": "BSA",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Blinded Study Agent"
}
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"required": false,
"text": "What study agent was received:"
}, {
"item": [ {
"text": "Indicator if adverse medical event occurred with protocol deviation, violation, exception",
"type": "display",
"linkId": "mae5.11_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Were there any Protocol Deviations/Violations/Exceptions for this participant?",
"type": "choice",
"linkId": "mae5.11",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "Yes"
}
}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No"
}
} ]
}, {
"item": [ {
"text": "Description of protocol deviations, violations, or exceptions that occurred for this participant",
"type": "display",
"linkId": "mae5.12_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"coding": [ {
"code": "flyover",
"system": "http://hl7.org/fhir/questionnaire-item-control"
} ]
}
} ]
} ],
"text": "Describe the Protocol Deviations/Violations/Exceptions",
"type": "text",
"linkId": "mae5.12",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "mae5.11",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
} ],
"text": "Participant Information",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 150%"
} ]
},
"linkId": "mae5",
"required": false
}, {
"item": [ {
"item": [ {
"text": "Initial: the first time that the adverse medical event is reported \r\nor\r\nUpdate: update on a previously reported adverse medical event",
"type": "display",
"linkId": "mae6.1_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Submission Type",
"type": "choice",
"linkId": "mae6.1",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "INITIAL",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Initial"
}
}, {
"valueCoding": {
"code": "UPDATE",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Update"
}
} ]
}, {
"item": [ {
"text": "Date adverse event started",
"type": "display",
"linkId": "mae6.2_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Start Date",
"type": "date",
"linkId": "mae6.2",
"required": false
}, {
"item": [ {
"text": "Date of this report",
"type": "display",
"linkId": "mae6.3_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Reported Date",
"type": "date",
"linkId": "mae6.3",
"required": false
}, {
"item": [ {
"text": "Date this adverse event was first recorded",
"type": "display",
"linkId": "mae6.4_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Recorded Date",
"type": "date",
"linkId": "mae6.4",
"required": false
}, {
"item": [ {
"text": "Event is considered serious and reportable to the FDA in the following outcomes: death, life-threatening, hospitalization, disability or permanent damage, congenital anaomaly/birth defect, need for required intervention to prevent permanent impairment or damage. See FDA Guidance: https://www.fda.gov/safety/reporting-serious-problems-fda/what-serious-adverse-event",
"type": "display",
"linkId": "mae6.10_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Is the Adverse Medical Event Serious?",
"type": "choice",
"linkId": "mae6.10",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "serious",
"system": "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness",
"display": "Serious"
}
}, {
"valueCoding": {
"code": "non-serious",
"system": "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness",
"display": "Non-serious"
}
} ]
}, {
"item": [ {
"text": "Physician assessment using sponsor defined categories",
"type": "display",
"linkId": "mae6.9_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Severity",
"type": "choice",
"linkId": "mae6.9",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "mild",
"system": "http://terminology.hl7.org/CodeSystem/adverse-event-severity",
"display": "Mild"
}
}, {
"valueCoding": {
"code": "moderate",
"system": "http://terminology.hl7.org/CodeSystem/adverse-event-severity",
"display": "Moderate"
}
}, {
"valueCoding": {
"code": "severe",
"system": "http://terminology.hl7.org/CodeSystem/adverse-event-severity",
"display": "Severe"
}
} ]
}, {
"item": [ {
"text": "Description of the SAE including chronological clinical presentation and evolution of the SAE and associated signs/symptoms. Serious Medical Event criteria are defined in the protocol.",
"type": "display",
"linkId": "mae6.40_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
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"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Narrative of the Adverse Event:",
"type": "text",
"linkId": "mae6.40",
"required": false,
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"operator": "=",
"question": "mae6.10",
"answerCoding": {
"code": "serious",
"system": "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness"
}
} ]
}, {
"item": [ {
"text": "Diagnosis associated with adverse event. Any untoward medical occurrence associated with the use of a drug or device, whether or not considered related to the drug or device.",
"type": "display",
"linkId": "mae6.5_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Medical Description of Adverse Event",
"type": "text",
"linkId": "mae6.5",
"repeats": false,
"readOnly": false,
"required": false
}, {
"item": [ {
"text": "Indicator if the adverse event is still continuing or has been resolved.",
"type": "display",
"linkId": "mae6.6_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Is the Adverse Medical event still ongoing?",
"type": "choice",
"linkId": "mae6.6",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "Yes"
}
}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No"
}
} ]
}, {
"item": [ {
"text": "Date that the event resolved",
"type": "display",
"linkId": "mae6.7_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Stop Date",
"type": "date",
"linkId": "mae6.7",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "mae6.6",
"answerCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
}, {
"item": [ {
"text": "Indicator that Adverse Medical Event was expected or not expected.",
"type": "display",
"linkId": "mae6.8_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Was the event expected?",
"type": "choice",
"linkId": "mae6.8",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0239",
"display": "Yes"
}
}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0239",
"display": "No"
}
} ]
}, {
"item": [ {
"item": [ {
"text": "An adverse event is considered \"serious\" if, in the view of either the investigator or sponsor, it results in any of the following outcomes: Death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. DFR Title 21, Part 312, Subpart B, Sec. 312.32",
"type": "display",
"linkId": "mae6.11.1_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Seriousness",
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"linkId": "mae6.11.1",
"required": false,
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"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
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"question": "mae6.10",
"answerCoding": {
"code": "serious",
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} ],
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"valueCoding": {
"code": "ResultsInDeath",
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}, {
"valueCoding": {
"code": "IsLifeThreatening",
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"display": "Is Life-threatening"
}
}, {
"valueCoding": {
"code": "ResultsInHospitalization",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Requires or prolongs inpatient hospitalization"
}
}, {
"valueCoding": {
"code": "IsBirthDefect",
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"display": "Is a congenital anomaly/birth defect"
}
}, {
"valueCoding": {
"code": "ResultsInDisability",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
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}
}, {
"valueCoding": {
"code": "RequiresPreventImpairment",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
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}
}, {
"valueCoding": {
"code": "Other",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Other"
}
} ]
}, {
"item": [ {
"text": "Describe other serious consequences or other medically important condition",
"type": "display",
"linkId": "mae6.11.2_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Other-specify",
"type": "text",
"linkId": "mae6.11.2",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "mae6.11.1",
"answerCoding": {
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"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"
}
} ]
} ],
"text": "Seriousness",
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"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#2a623d; font-size: 125%"
} ]
},
"linkId": "mae6.11",
"enableWhen": [ {
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"question": "mae6.10",
"answerCoding": {
"code": "serious",
"system": "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness"
}
} ]
}, {
"item": [ {
"text": "Date adverse event was deemed as serious",
"type": "display",
"linkId": "mae6.12_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "What is the date Adverse Medical Event became serious?",
"type": "date",
"linkId": "mae6.12",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "mae6.10",
"answerCoding": {
"code": "serious",
"system": "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness"
}
} ]
}, {
"item": [ {
"text": "Participant's status after the adverse event",
"type": "display",
"linkId": "mae6.13_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Outcome of Adverse Medical Event",
"type": "choice",
"linkId": "mae6.13",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "RCVRED",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "recovered/resolved"
}
}, {
"valueCoding": {
"code": "RCVRING",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "recovering/resolving"
}
}, {
"valueCoding": {
"code": "NRCVRED",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "not recovered/not resolved/ongoing"
}
}, {
"valueCoding": {
"code": "SEQL",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "recovered/resolved with sequelae"
}
}, {
"valueCoding": {
"code": "FATAL",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "fatal"
}
}, {
"valueCoding": {
"code": "UNK",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
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}
} ]
}, {
"item": [ {
"text": "Indicator if participant was autopsied",
"type": "display",
"linkId": "mae6.14_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Was autopsy performed?",
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"linkId": "mae6.14",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
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"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
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"question": "mae6.13",
"answerCoding": {
"code": "FATAL",
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}
} ],
"answerOption": [ {
"valueCoding": {
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}
}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
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}
}, {
"valueCoding": {
"code": "UNK",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "Unknown"
}
} ]
}, {
"text": "Relationship of Adverse Medical Event to Study Intervention",
"type": "choice",
"linkId": "mae6.15",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "certain",
"system": "http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess",
"display": "Certain"
}
}, {
"valueCoding": {
"code": "probably-likely",
"system": "http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess",
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}
}, {
"valueCoding": {
"code": "possible",
"system": "http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess",
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}
}, {
"valueCoding": {
"code": "unlikely",
"system": "http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess",
"display": "Unlikely"
}
}, {
"valueCoding": {
"code": "conditional-classified",
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}
}, {
"valueCoding": {
"code": "unassessable-unclassifiable",
"system": "http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess",
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}
} ]
}, {
"item": [ {
"text": "Explanation for relationship between study intervention and adverse event. You may also discuss why the AE appears to be unrelated or why it is not possible to determine the relationship.",
"type": "display",
"linkId": "mae6.16_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Rationale for relationship with study intervention",
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"linkId": "mae6.16",
"required": false
}, {
"item": [ {
"text": "Reason for possible alternative serious adverse event causes",
"type": "display",
"linkId": "mae6.17_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
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"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "If applicable, what are possible alternate causes of the Adverse Medical Event?",
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"linkId": "mae6.17",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
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}
}, {
"valueCoding": {
"code": "STDYPRO",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Study Procedure"
}
}, {
"valueCoding": {
"code": "PRE",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Pre-existing condition"
}
}, {
"valueCoding": {
"code": "UNDERLYINGDIS",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Underlying disease"
}
}, {
"valueCoding": {
"code": "CONCMITMED",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Concomitant medication"
}
}, {
"valueCoding": {
"code": "OTHERCAUSE",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Other known or suspected cause"
}
} ]
}, {
"item": [ {
"text": "Study procedure associated with SAE",
"type": "display",
"linkId": "mae6.18_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Study Procedure-specify",
"type": "text",
"linkId": "mae6.18",
"required": false,
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"question": "mae6.17",
"answerCoding": {
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}
} ]
}, {
"item": [ {
"text": "Pre-existing condition associated with SAE",
"type": "display",
"linkId": "mae6.19_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Pre-existing condition-specify",
"type": "text",
"linkId": "mae6.19",
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"question": "mae6.17",
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"code": "PRE",
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}
} ]
}, {
"item": [ {
"text": "Underlying disease associated with SAE",
"type": "display",
"linkId": "mae6.20_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Underlying disease-specify",
"type": "text",
"linkId": "mae6.20",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "mae6.17",
"answerCoding": {
"code": "UNDERLYINGDIS",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"
}
} ]
}, {
"item": [ {
"text": "Concomitant medication associated with SAE",
"type": "display",
"linkId": "mae6.21_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Concomittant medication-specify",
"type": "text",
"linkId": "mae6.21",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "mae6.17",
"answerCoding": {
"code": "CONCMITMED",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"
}
} ]
}, {
"item": [ {
"text": "Description of other causal reason associated with SAE",
"type": "display",
"linkId": "mae6.22_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Other known or suspected cause-specify",
"type": "text",
"linkId": "mae6.22",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "mae6.17",
"answerCoding": {
"code": "OTHERCAUSE",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"
}
} ]
}, {
"item": [ {
"item": [ {
"text": "Changes to study intervention made after adverse event was detected",
"type": "display",
"linkId": "mae6.23.1_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Action Taken Regarding Study Intervention",
"type": "choice",
"linkId": "mae6.23.1",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "WP",
"system": "http://terminology.hl7.org/CodeSystem/v2-0251",
"display": "Product withdrawn permanently"
}
}, {
"valueCoding": {
"code": "WT",
"system": "http://terminology.hl7.org/CodeSystem/v2-0251",
"display": "Product withdrawn temporarily"
}
}, {
"valueCoding": {
"code": "DR",
"system": "http://terminology.hl7.org/CodeSystem/v2-0251",
"display": "Product dose or frequency of use reduced"
}
}, {
"valueCoding": {
"code": "DI",
"system": "http://terminology.hl7.org/CodeSystem/v2-0251",
"display": "Product dose or frequency of use increased"
}
}, {
"valueCoding": {
"code": "NC",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Product dose or frequency of use not changed"
}
}, {
"valueCoding": {
"code": "UNK",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Unknown"
}
}, {
"valueCoding": {
"code": "NA",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Not applicable"
}
} ]
} ],
"text": "Action Taken",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#2a623d; font-size: 125%"
} ]
},
"linkId": "mae6.23",
"required": false
}, {
"linkId": "mae6.24",
"repeats": false,
"item": [ {
"text": "Adverse event diminished/abated after study intervention was discontinued, interrupted, or dose reduced (dechallenged)",
"type": "display",
"linkId": "mae6.24_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"type": "choice",
"answerOption": [ {
"valueCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "Yes"
}
}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No"
}
}, {
"valueCoding": {
"code": "NA",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "not applicable"
}
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"readOnly": false,
"required": false,
"text": "If study intervention was discontinued, interrupted, or dose reduced (dechallenged), did Adverse Medical Event diminish/abate?"
}, {
"linkId": "mae6.25",
"repeats": false,
"item": [ {
"text": "Adverse event recurred when the study intervention was restarted",
"type": "display",
"linkId": "mae6.25_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"type": "choice",
"answerOption": [ {
"valueCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "Yes"
}
}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No"
}
}, {
"valueCoding": {
"code": "NA",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "not applicable"
}
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"readOnly": false,
"required": false,
"text": "If study intervention was restarted (rechallenge) did AE recur?"
}, {
"item": [ {
"text": "Did the participant receive any relevant concomitant medications in response to the SAE?",
"type": "choice",
"linkId": "mae6.50.26",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"enableWhen": [ {
"operator": "=",
"question": "mae6.10",
"answerCoding": {
"code": "serious",
"system": "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness"
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "Yes"
}
}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No"
}
} ]
}, {
"item": [ {
"item": [ {
"text": "Name of concomitant medication given to participant in response to SAE",
"type": "display",
"linkId": "mae6.50.28.1_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Medication Name",
"type": "string",
"linkId": "mae6.50.28.1",
"required": false
}, {
"item": [ {
"text": "Indication for giving the concomitant medication to participant",
"type": "display",
"linkId": "mae6.50.28.2_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Indication",
"type": "string",
"linkId": "mae6.50.28.2",
"required": false
}, {
"item": [ {
"text": "Start date for the concomitant medication given to participant",
"type": "display",
"linkId": "mae6.50.28.3_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Start Date",
"type": "date",
"linkId": "mae6.50.28.3",
"required": false
}, {
"item": [ {
"text": "Stop date for the concomitant medication given to the participant",
"type": "display",
"linkId": "mae6.50.28.4_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Stop Date",
"type": "date",
"linkId": "mae6.50.28.4",
"required": false
}, {
"item": [ {
"text": "Is concomitant medication administration for participant ongoing?",
"type": "display",
"linkId": "mae6.50.28.5_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Ongoing",
"type": "choice",
"linkId": "mae6.50.28.5",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Group Table",
"coding": [ {
"code": "gtable",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Group Table"
} ]
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "Yes"
}
}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No"
}
} ]
}, {
"text": "Concomitant medication associated with SAE",
"type": "display",
"linkId": "mae6.50.28_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "SAE Concomitant Medications",
"type": "group",
"linkId": "mae6.50.28",
"repeats": true,
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "mae6.50.26",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
}, {
"item": [ {
"text": "Treatments/procedures administered in response to SAE",
"type": "display",
"linkId": "mae6.50.29_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Did the participant receive any treatments/procedures in response to the SAE?",
"type": "choice",
"linkId": "mae6.50.29",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"enableWhen": [ {
"operator": "=",
"question": "mae6.10",
"answerCoding": {
"code": "serious",
"system": "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness"
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "Yes"
}
}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No"
}
} ]
}, {
"item": [ {
"item": [ {
"text": "Name of SAE treatment/procedure participant received",
"type": "display",
"linkId": "mae6.50.30.1_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Treatment/Procedure",
"type": "string",
"linkId": "mae6.50.30.1",
"required": false
}, {
"item": [ {
"text": "Start date for SAE treatment/procedure participant received",
"type": "display",
"linkId": "mae6.50.30.2_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Start Date",
"type": "date",
"linkId": "mae6.50.30.2",
"required": false
}, {
"item": [ {
"text": "Stop date for SAE treatment/procedure participant received",
"type": "display",
"linkId": "mae6.50.30.3_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Stop Date",
"type": "date",
"linkId": "mae6.50.30.3",
"required": false
}, {
"item": [ {
"text": "Is the SAE treatment/procedure for the participant ongoing",
"type": "display",
"linkId": "mae6.50.30.4_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Ongoing",
"type": "choice",
"linkId": "mae6.50.30.4",
"required": false,
"answerOption": [ {
"valueCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "Yes"
}
}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No"
}
} ]
}, {
"text": "SAE treatment/procedure participant received",
"type": "display",
"linkId": "mae6.50.30_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "SAE Treatments/Procedures",
"type": "group",
"linkId": "mae6.50.30",
"repeats": true,
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Group Table",
"coding": [ {
"code": "gtable",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Group Table"
} ]
}
} ],
"enableWhen": [ {
"operator": "=",
"question": "mae6.50.29",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
}, {
"item": [ {
"text": "Were any laboratory or diagnostic tests administered to the participant in response to the SAE?",
"type": "display",
"linkId": "mae6.50.37_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Did the participant receive relevant laboratory or diagnostic tests in response to the SAE?",
"type": "choice",
"linkId": "mae6.50.37",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"enableWhen": [ {
"operator": "=",
"question": "mae6.10",
"answerCoding": {
"code": "serious",
"system": "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness"
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "Yes"
}
}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No"
}
} ]
}, {
"item": [ {
"text": "Lab/Diagnostic Test",
"type": "string",
"linkId": "mae6.50.38.1",
"required": false
}, {
"text": "Date",
"type": "date",
"linkId": "mae6.50.38.2",
"required": false
}, {
"text": "Result",
"type": "string",
"linkId": "mae6.50.38.3",
"required": false
}, {
"text": "Low Range",
"type": "string",
"linkId": "mae6.50.38.4",
"required": false
}, {
"text": "High Range",
"type": "string",
"linkId": "mae6.50.38.5",
"required": false
}, {
"text": "Comments",
"type": "string",
"linkId": "mae6.50.38.6",
"required": false
}, {
"text": "Laboratory or diagnostic tests obtained in response to SAE",
"type": "display",
"linkId": "mae6.50.38_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "SAE Laboratory or Diagnostic Tests",
"type": "group",
"linkId": "mae6.50.38",
"repeats": true,
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Group Table",
"coding": [ {
"code": "gtable",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Group Table"
} ]
}
} ],
"enableWhen": [ {
"operator": "=",
"question": "mae6.50.37",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
} ],
"text": "SAE Concomitant Medications, Treatments/Procedures and Tests",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#2a623d; font-size: 125%"
} ]
},
"linkId": "mae6.50",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "mae6.10",
"answerCoding": {
"code": "serious",
"system": "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness"
}
} ]
}, {
"text": "An event that (1) is more likely than not related to study activities; and (2) represents a new risk; and (3) is unanticipated. In addition, an expected event that is occurring at a frequency or intensity greater than originally anticipated.",
"type": "display",
"linkId": "mae6_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Adverse Medical Event Information",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 150%"
} ]
},
"linkId": "mae6",
"required": false
}, {
"item": [ {
"text": "Describe the file that is being attached (optional)",
"type": "string",
"linkId": "mae11.1"
}, {
"text": "Attachment",
"type": "attachment",
"linkId": "mae11.2"
}, {
"text": "Attachments related to the Adverse Event Report can be included here.",
"type": "display",
"linkId": "mae11_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Optional Attachments",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 150%"
} ]
},
"linkId": "mae11",
"repeats": true,
"required": false
}, {
"item": [ {
"text": "Link ID prefix",
"type": "string",
"linkId": "ADMIN01",
"initial": [ {
"valueString": "mae"
} ],
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
"valueBoolean": true
} ]
}, {
"text": "Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any",
"type": "string",
"linkId": "ADMIN02",
"initial": [ {
"valueString": "temporarily unavailable"
} ],
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
"valueBoolean": true
}, {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.descendants().where(linkId = 'ADMIN02').answer.value"
}
} ]
}, {
"text": "ID of the Research Study FHIR Resource associated with the study Questionnaire Responses",
"type": "string",
"linkId": "ADMIN03",
"initial": [ {
"valueString": "temporarily unavailable"
} ],
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
"valueBoolean": true
}, {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.descendants().where(linkId = 'ADMIN03').answer.value"
}
} ]
}, {
"text": "Questionnaire Response ID of the local considerations Questionnaire Response, if any",
"type": "string",
"linkId": "ADMIN04",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
"valueBoolean": true
} ]
} ],
"text": "Administrative Use Only",
"type": "group",
"linkId": "ADMIN00",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
"valueBoolean": true
} ]
} ],
"type": null,
"experimental": null,
"resourceType": "Questionnaire",
"title": "Adverse Medical Event Questionnaire",
"package_version": "1.0.0",
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-launchContext",
"extension": [ {
"url": "name",
"valueCoding": {
"code": "sourceQuestionnaireResponse",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "The content of the Questionnaire Response transferred to this Questionnaire during form launch"
}
}, {
"url": "type",
"valueCode": "QuestionnaireResponse"
}, {
"url": "description",
"valueString": "The Initiate a Study Questionnaire Response content that will be used to pre-populate this Questionnaire"
} ]
}, {
"url": "http://hl7.org/fhir/StructureDefinition/variable",
"valueExpression": {
"name": "lookupInitiateStudy",
"language": "text/fhirpath",
"expression": "%sourceQuestionnaireResponse",
"description": "variable to store the incoming data from the launchContext extension for populate and other expressions"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/variable",
"valueExpression": {
"name": "eventOccurredAtLeadPISite",
"language": "text/fhirpath",
"expression": "%resource.descendants().where(linkId = 'mae4.1.7').answer.valueCoding.code",
"description": "event happened at the lead PI site/coordinating center"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/variable",
"valueExpression": {
"name": "relyingSiteForForm",
"language": "text/fhirpath",
"expression": "%resource.descendants().where(linkId = 'mae4.1.1').answer.value.display",
"description": "relying site where AE occurred"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/variable",
"valueExpression": {
"name": "relyingSiteEventReportedByLeadPISite",
"language": "text/fhirpath",
"expression": "%resource.descendants().where(linkId = 'mae4.9.1').answer.valueCoding.code",
"description": "being reported by lead PI site"
}
} ],
"status": "draft",
"id": "3f32a17d-7dbd-40fb-b723-8d5c7c665470",
"kind": null,
"url": "http://hl7.org/fhir/us/sirb/Questionnaire/sirb-adverse-event-questionnaire-populate",
"version": "1.0.0",
"contact": [ {
"name": "HL7 International - Biomedical Research and Regulation",
"telecom": [ {
"value": "http://www.hl7.org/Special/committees/rcrim",
"system": "url"
} ]
} ]
}