{
"description": null,
"_filename": "example/Questionnaire-sirb-adverse-event-questionnaire.json",
"package_name": "hl7.fhir.us.sirb",
"subjectType": [ "ResearchStudy" ],
"date": "2021-08-10T13:15:03+00:00",
"meta": {
"source": "#eJyAreQbrlvM9daT",
"versionId": "30",
"lastUpdated": "2021-07-25T19:43:52.262+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": "Study Title from 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
}, {
"item": [ {
"text": "Number assigned to the protocol by IRB",
"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
}, {
"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"
} ]
}
} ],
"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"
}
} ]
}, {
"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"
} ]
}
} ]
} ],
"text": "Does this protocol require an FDA exemption?",
"type": "choice",
"linkId": "mae1.4",
"repeats": false,
"readOnly": false,
"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"
}
} ]
}, {
"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"
} ]
}
} ]
} ],
"text": "Is an IND or IDE being used in this study?",
"type": "choice",
"linkId": "mae1.5",
"repeats": false,
"readOnly": false,
"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": "IND/IDE Number",
"type": "string",
"linkId": "mae1.6",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "mae1.5",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
} ],
"text": "RESEARCH STUDY",
"type": "group",
"linkId": "mae1",
"required": false
}, {
"item": [ {
"item": [ {
"text": "First or given name associated with the site principal investigator",
"type": "display",
"linkId": "mae2.1_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": "mae2.1",
"required": false
}, {
"item": [ {
"text": "Surname or family name associated with the site principal investigator",
"type": "display",
"linkId": "mae2.2_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": "mae2.2",
"required": false
}, {
"item": [ {
"text": "Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc. associated with the site principal investigator's name",
"type": "display",
"linkId": "mae2.5_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": "mae2.5",
"repeats": false,
"readOnly": false,
"required": false
}, {
"item": [ {
"text": "Professional and Academic degrees associated with the site investigator",
"type": "display",
"linkId": "mae2.6_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": "mae2.6",
"repeats": false,
"readOnly": false,
"required": false
}, {
"text": "Phone",
"type": "string",
"linkId": "mae2.3",
"required": false
}, {
"text": "Email",
"type": "string",
"linkId": "mae2.4",
"required": false
} ],
"text": "Site Principal Investigator",
"type": "group",
"linkId": "mae2",
"required": false
}, {
"item": [ {
"text": "Personnel completing the adverse event documentation at the 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"
} ]
}
} ]
}, {
"text": "First Name",
"type": "string",
"linkId": "mae3.1",
"repeats": false,
"readOnly": false,
"required": false
}, {
"text": "Last Name",
"type": "string",
"linkId": "mae3.2",
"required": false
}, {
"text": "Phone",
"type": "string",
"linkId": "mae3.3",
"required": false
}, {
"text": "Email",
"type": "string",
"linkId": "mae3.4",
"required": false
} ],
"text": "Primary Contact",
"type": "group",
"linkId": "mae3",
"required": false
}, {
"item": [ {
"text": "Location where adverse event is recorded",
"type": "display",
"linkId": "mae4_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 where the event occurred",
"type": "string",
"linkId": "mae4.1",
"required": false
}, {
"text": "Name of organization/site which is recording the Adverse Medical event",
"type": "string",
"linkId": "mae4.2",
"required": false
} ],
"text": "Site/Organization",
"type": "group",
"linkId": "mae4",
"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"
}
} ]
}, {
"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]"
}
} ]
}, {
"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
}, {
"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"
} ]
}
} ]
} ],
"text": "Participant dosed or received study agent",
"type": "choice",
"linkId": "mae5.9",
"repeats": false,
"readOnly": false,
"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"
}
}, {
"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"
}
} ]
}, {
"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",
"linkId": "mae5",
"required": false
}, {
"item": [ {
"item": [ {
"text": "Type of adverse event report being submitted",
"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",
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"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Recorded Date",
"type": "date",
"linkId": "mae6.4",
"required": false
}, {
"item": [ {
"text": "Provide a discussion of the Adverse Event. If a Serious Medical Event, narrative must provide a 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": "mae6.5a_help",
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"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": "Narrative of the Adverse Event:",
"type": "text",
"linkId": "mae6.5a",
"required": false
}, {
"item": [ {
"text": "Diagnosis associated with adverse event. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.",
"type": "display",
"linkId": "mae6.5b_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": "mae6.5b",
"repeats": false,
"readOnly": false,
"required": false
}, {
"item": [ {
"text": "Indicator if adverse event is still continuing",
"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?",
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"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": "Adverse event was expected or not",
"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": [ {
"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",
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"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": "Indicator if an undesirable experience is associated with use of a medical product",
"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": "Serious criteria are defined in the protocol",
"type": "display",
"linkId": "mae6.11_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": "Seriousness",
"type": "choice",
"linkId": "mae6.11",
"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"
} ]
}
} ],
"enableWhen": [ {
"operator": "=",
"question": "mae6.10",
"answerCoding": {
"code": "serious",
"system": "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness"
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "D",
"system": "http://terminology.hl7.org/CodeSystem/v2-0240",
"display": "Death"
}
}, {
"valueCoding": {
"code": "L",
"system": "http://terminology.hl7.org/CodeSystem/v2-0240",
"display": "Life threatening"
}
}, {
"valueCoding": {
"code": "H",
"system": "http://terminology.hl7.org/CodeSystem/v2-0240",
"display": "Caused hospitalized"
}
}, {
"valueCoding": {
"code": "P",
"system": "http://terminology.hl7.org/CodeSystem/v2-0240",
"display": "Prolonged hospitalization"
}
}, {
"valueCoding": {
"code": "O",
"system": "http://terminology.hl7.org/CodeSystem/v2-0240",
"display": "Other"
}
}, {
"valueCoding": {
"code": "C",
"system": "http://terminology.hl7.org/CodeSystem/v2-0240",
"display": "Congenital anomaly/birth defect"
}
}, {
"valueCoding": {
"code": "I",
"system": "http://terminology.hl7.org/CodeSystem/v2-0240",
"display": "Incapacity which is significant, persistent or permanent"
}
}, {
"valueCoding": {
"code": "J",
"system": "http://terminology.hl7.org/CodeSystem/v2-0240",
"display": "Disability which is significant, persistent or permanent"
}
}, {
"valueCoding": {
"code": "R",
"system": "http://terminology.hl7.org/CodeSystem/v2-0240",
"display": "Required intervention to prevent permanent impairment/damage"
}
} ]
}, {
"item": [ {
"text": "Describe other serious consequences or other medically important condition",
"type": "display",
"linkId": "mae6.11b_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": "mae6.11b",
"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": "mae6.11",
"answerCoding": {
"code": "O",
"system": "http://terminology.hl7.org/CodeSystem/v2-0240"
}
} ]
}, {
"item": [ {
"text": "Date adverse event qualified 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": "F",
"system": "http://terminology.hl7.org/CodeSystem/v2-0241",
"display": "Fully recovered"
}
}, {
"valueCoding": {
"code": "R",
"system": "http://terminology.hl7.org/CodeSystem/v2-0241",
"display": "Recovering"
}
}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0241",
"display": "Not recovering/unchanged"
}
}, {
"valueCoding": {
"code": "S",
"system": "http://terminology.hl7.org/CodeSystem/v2-0241",
"display": "Sequelae"
}
}, {
"valueCoding": {
"code": "D",
"system": "http://terminology.hl7.org/CodeSystem/v2-0241",
"display": "Died"
}
}, {
"valueCoding": {
"code": "W",
"system": "http://terminology.hl7.org/CodeSystem/v2-0241",
"display": "Worsening"
}
}, {
"valueCoding": {
"code": "U",
"system": "http://terminology.hl7.org/CodeSystem/v2-0241",
"display": "Unknown"
}
} ]
}, {
"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?",
"type": "choice",
"linkId": "mae6.14",
"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": "mae6.13",
"answerCoding": {
"code": "D",
"system": "http://terminology.hl7.org/CodeSystem/v2-0241"
}
} ],
"answerOption": [ {
"valueCoding": {
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"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
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}
}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No"
}
}, {
"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": {
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"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
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}
} ],
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}
}, {
"valueCoding": {
"code": "I",
"system": "http://terminology.hl7.org/CodeSystem/v2-0250",
"display": "Improbable"
}
}, {
"valueCoding": {
"code": "S",
"system": "http://terminology.hl7.org/CodeSystem/v2-0250",
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}
}, {
"valueCoding": {
"code": "M",
"system": "http://terminology.hl7.org/CodeSystem/v2-0250",
"display": "Moderately probable"
}
}, {
"valueCoding": {
"code": "H",
"system": "http://terminology.hl7.org/CodeSystem/v2-0250",
"display": "Highly probable"
}
} ]
}, {
"enableBehavior": "any",
"linkId": "mae6.16",
"repeats": false,
"item": [ {
"text": "Explanation for relationship between study intervention and adverse event",
"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"
} ]
}
} ]
} ],
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"question": "mae6.15",
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"code": "S",
"system": "http://terminology.hl7.org/CodeSystem/v2-0250"
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}, {
"operator": "=",
"question": "mae6.15",
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}
}, {
"operator": "=",
"question": "mae6.15",
"answerCoding": {
"code": "H",
"system": "http://terminology.hl7.org/CodeSystem/v2-0250"
}
} ],
"readOnly": false,
"required": false,
"text": "Rationale for relationship with study intervention"
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"enableBehavior": "any",
"linkId": "mae6.17",
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"type": "display",
"linkId": "mae6.17_help",
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"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
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"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"type": "choice",
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"question": "mae6.15",
"answerCoding": {
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}, {
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"question": "mae6.15",
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} ],
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}
}, {
"valueCoding": {
"code": "STDYPRO",
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"display": "Study Procedure"
}
}, {
"valueCoding": {
"code": "PRE",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
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}
}, {
"valueCoding": {
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}
}, {
"valueCoding": {
"code": "CONCMITMED",
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"display": "Concomitant medication"
}
}, {
"valueCoding": {
"code": "OTHERCAUSE",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
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}
} ],
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} ],
"required": false,
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}, {
"item": [ {
"text": "Study procedure associated with SAE",
"type": "display",
"linkId": "mae6.18_help",
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"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
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"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
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} ]
}
} ]
} ],
"text": "Study Procedure-specify",
"type": "text",
"linkId": "mae6.18",
"required": false,
"enableWhen": [ {
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"question": "mae6.17",
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"code": "STDYPRO",
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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",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "mae6.17",
"answerCoding": {
"code": "PRE",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"
}
} ]
}, {
"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": "Other causal reason was 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": [ {
"text": "Changes to study intervention made after adverse event was detected",
"type": "display",
"linkId": "mae6.23_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",
"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": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0251",
"display": "None"
}
}, {
"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": "OT",
"system": "http://terminology.hl7.org/CodeSystem/v2-0251",
"display": "Other"
}
} ]
}, {
"item": [ {
"text": "Describe other changes to intervention made after adverse event was detected",
"type": "display",
"linkId": "mae6.23b_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": "mae6.23b",
"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": "mae6.23",
"answerCoding": {
"code": "OT",
"system": "http://terminology.hl7.org/CodeSystem/v2-0251"
}
} ],
"enableBehavior": "any"
}, {
"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"
} ]
}
} ]
} ],
"text": "If study intervention was discontinued, interrupted, or dose reduced (dechallenged), did AE diminish/abate?",
"type": "choice",
"linkId": "mae6.24",
"repeats": false,
"readOnly": false,
"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"
}
}, {
"valueCoding": {
"code": "NA",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "not applicable"
}
} ]
}, {
"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"
} ]
}
} ]
} ],
"text": "If study intervention was restarted (rechallenge) did AE recur?",
"type": "choice",
"linkId": "mae6.25",
"repeats": false,
"readOnly": false,
"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"
}
}, {
"valueCoding": {
"code": "NA",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "not applicable"
}
} ]
}, {
"text": "Did the participant receive any relevant concomitant medications in response to the SAE?",
"type": "choice",
"linkId": "mae6.26",
"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": [ {
"text": "Concomitant medication associated with SAE",
"type": "display",
"linkId": "mae6.27_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": "Name of concomitant medication given to participant in response to SAE",
"type": "display",
"linkId": "mae6.28.1_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": "mae6.28.1",
"required": false
}, {
"item": [ {
"text": "Indication for giving the concomitant medication to participant",
"type": "display",
"linkId": "mae6.28.2_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": "mae6.28.2",
"required": false
}, {
"item": [ {
"text": "Start date for the concomitant medication given to participant",
"type": "display",
"linkId": "mae6.28.3_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": "mae6.28.3",
"required": false
}, {
"item": [ {
"text": "Stop date for the concomitant medication given to the participant",
"type": "display",
"linkId": "mae6.28.4_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": "mae6.28.4",
"required": false
}, {
"item": [ {
"text": "Is concomitant medication administration for participant ongoing?",
"type": "display",
"linkId": "mae6.28.5_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": "mae6.28.5",
"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 Concomitant Medications",
"type": "group",
"linkId": "mae6.27",
"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": "mae6.26",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
}, {
"item": [ {
"text": "Treatments/procedures administered in response to SAE",
"type": "display",
"linkId": "mae6.29_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": "open-choice",
"linkId": "mae6.29",
"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": [ {
"text": "Name of SAE treatment/procedure participant received",
"type": "display",
"linkId": "mae6.30_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"
} ]
}
} ]
}, {
"item": [ {
"text": "Name of SAE treatment/procedure participant received",
"type": "display",
"linkId": "mae6.30.1_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": "mae6.30.1",
"required": false
}, {
"item": [ {
"text": "Start date for SAE treatment/procedure participant received",
"type": "display",
"linkId": "mae6.30.2_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": "mae6.30.2",
"required": false
}, {
"item": [ {
"text": "Stop date for SAE treatment/procedure participant received",
"type": "display",
"linkId": "mae6.30.3_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": "mae6.30.3",
"required": false
}, {
"item": [ {
"text": "Is the SAE treatment/procedure for the participant ongoing",
"type": "display",
"linkId": "mae6.30.4_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": "mae6.30.4",
"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 Treatments/Procedures",
"type": "group",
"linkId": "mae6.30",
"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": "mae6.29",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
} ],
"text": "Adverse Medical Event Information",
"type": "group",
"linkId": "mae6",
"required": false
}, {
"item": [ {
"text": "Were any laboratory or diagnostic tests administered to the participant in response to the SAE?",
"type": "display",
"linkId": "mae7_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": "open-choice",
"linkId": "mae7",
"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": "Laboratory or diagnostic tests obtained in response to AE",
"type": "display",
"linkId": "mae8_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": "Lab/Diagnostic Test",
"type": "string",
"linkId": "mae8.1",
"required": false
}, {
"text": "Date",
"type": "date",
"linkId": "mae8.2",
"required": false
}, {
"text": "Result",
"type": "string",
"linkId": "mae8.3",
"required": false
}, {
"text": "Low Range",
"type": "string",
"linkId": "mae8.4",
"required": false
}, {
"text": "High Range",
"type": "string",
"linkId": "mae8.5",
"required": false
}, {
"text": "Comments",
"type": "string",
"linkId": "mae8.6",
"required": false
} ],
"text": "SAE Laboratory or Diagnostic Tests",
"type": "group",
"linkId": "mae8",
"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": "mae7",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
}, {
"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
} ]
}, {
"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
} ]
}, {
"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": "0.1.0",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/variable",
"valueExpression": {
"name": "lookupInitiateStudy",
"language": "application/x-fhir-query",
"expression": "https://docr-fhir.dev.cloud.duke.edu/hapi-fhir-jpaserver/fhir/QuestionnaireResponse/QRIDInitiateStudy",
"description": "response to get the data from"
}
} ],
"status": "draft",
"id": "2aab1b29-f7dc-4884-a347-ff0e42adf17b",
"kind": null,
"url": "http://hl7.org/fhir/us/sirb/Questionnaire/sirb-adverse-event-questionnaire",
"version": "0.1.0",
"contact": [ {
"name": "HL7 International - Biomedical Research and Regulation",
"telecom": [ {
"value": "http://www.hl7.org/Special/committees/rcrim",
"system": "url"
} ]
} ]
}