{
"description": null,
"_filename": "Questionnaire-sirb-nonmedicalevent-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": "NonMedical_events",
"item": [ {
"item": [ {
"item": [ {
"text": "Study Title from the Informed Consent",
"type": "display",
"linkId": "nme1.1_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": "nme1.1",
"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": "nme1.3_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": "IRB Protocol Number",
"type": "string",
"linkId": "nme1.3",
"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": "Status of study research activities",
"type": "display",
"linkId": "nme1.4_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": "Status",
"type": "choice",
"linkId": "nme1.4",
"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": "nochange",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "No change in research activities"
}
}, {
"valueCoding": {
"code": "stopped",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "All research activities temporarily and voluntarily stopped for all participants"
}
}, {
"valueCoding": {
"code": "partial",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Partial voluntary hold on some research activities for all participants (explain below)"
}
}, {
"valueCoding": {
"code": "hold",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Voluntary hold on new participant enrollment only"
}
} ]
}, {
"item": [ {
"text": "Explanation for voluntary hold on new participant enrollment.",
"type": "display",
"linkId": "nme1.5_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": "If partial, please explain:",
"type": "text",
"linkId": "nme1.5",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "nme1.4",
"answerCoding": {
"code": "partial",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"
}
} ]
} ],
"text": "Research Study",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 150%"
} ]
},
"linkId": "nme1",
"required": false
}, {
"item": [ {
"item": [ {
"item": [ {
"text": "Select \"Yes\" if the Adverse Non-Medical Event occurred at the lead principal investigator site, the study coordinating center or other administrative unit for the overall study.",
"type": "display",
"linkId": "nme7.1.8_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": "Did the Adverse Non-Medical Event occur at the lead principal investigator site?",
"type": "choice",
"linkId": "nme7.1.8",
"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": "Did the Adverse Non-Medical Event occur at one of the relying sites?",
"type": "choice",
"linkId": "nme7.1.11",
"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": "nme7.1.8",
"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"
}
} ]
}, {
"text": "External Data For linkId nme7.1.9",
"type": "open-choice",
"linkId": "ExternalDataFor_nme7.1.9",
"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 Non-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": "nme7.1.9_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": "If the Adverse Non-Medical Event occurred at one of the relying sites, select the relying site in order to pre-populate the relying institution and relying site principal investigator details below.",
"type": "choice",
"linkId": "nme7.1.9",
"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_nme7.1.9').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": "nme7.1.8",
"answerCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
}, {
"operator": "=",
"question": "nme7.1.11",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ],
"enableBehavior": "all"
}, {
"text": "If the Adverse Non-Medical Event occurred at another organization (unrelated to the lead principal investigator organization/site or relying sites), fill in the details below.",
"type": "display",
"linkId": "nme7.1.12",
"enableWhen": [ {
"operator": "=",
"question": "nme7.1.8",
"answerCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
}, {
"operator": "=",
"question": "nme7.1.11",
"answerCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ],
"enableBehavior": "all"
}, {
"text": "Name of organization/site where the Adverse Non-Medical Event occurred",
"type": "string",
"linkId": "nme7.1.1",
"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 = 'in7.1.1').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": "=",
"question": "nme7.1.8",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
}, {
"operator": "exists",
"question": "nme7.1.11",
"answerBoolean": true
} ],
"enableBehavior": "any"
}, {
"text": "City",
"type": "string",
"linkId": "nme7.1.2",
"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 = 'in7.3.7.2').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.2').answer.value)"
}
} ],
"enableWhen": [ {
"operator": "=",
"question": "nme7.1.8",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
}, {
"operator": "exists",
"question": "nme7.1.11",
"answerBoolean": true
} ],
"enableBehavior": "any"
}, {
"text": "State",
"type": "string",
"linkId": "nme7.1.3",
"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 = 'in7.3.7.3').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.3').answer.value)"
}
} ],
"enableWhen": [ {
"operator": "=",
"question": "nme7.1.8",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
}, {
"operator": "exists",
"question": "nme7.1.11",
"answerBoolean": true
} ],
"enableBehavior": "any"
}, {
"text": "Country",
"type": "string",
"linkId": "nme7.1.4",
"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 = 'in7.3.7.5').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.5').answer.value)"
}
} ],
"enableWhen": [ {
"operator": "=",
"question": "nme7.1.8",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
}, {
"operator": "exists",
"question": "nme7.1.11",
"answerBoolean": true
} ],
"enableBehavior": "any"
} ],
"text": "Where Adverse Non-Medical Event Occurred",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#2a623d; font-size: 125%"
} ]
},
"linkId": "nme7.1",
"repeats": false,
"required": false
}, {
"enableBehavior": "any",
"linkId": "nme7.2",
"repeats": false,
"item": [ {
"item": [ {
"text": "Select \"Yes\" if the Adverse Non-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": "nme7.2.8_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": "If the Adverse Non-Medical Event occurred at a relying site or at another organization (unrelated to the lead principal investigator organization/site or relying sites), will the lead principal investigator site be recording the Adverse Non-Medical Event?",
"type": "choice",
"linkId": "nme7.2.8",
"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": "nme7.1.8",
"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"
}
} ]
}, {
"text": "Name of organization/site which is recording the Adverse Non-Medical Event",
"type": "string",
"linkId": "nme7.2.1",
"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) )"
}
} ]
}, {
"text": "City",
"type": "string",
"linkId": "nme7.2.2",
"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 = 'in7.3.7.2').answer.value, iif(%relyingSiteEventReportedByLeadPISite = 'N', %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.2').answer.value) )"
}
} ]
}, {
"text": "State",
"type": "string",
"linkId": "nme7.2.3",
"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 = 'in7.3.7.3').answer.value, iif(%relyingSiteEventReportedByLeadPISite = 'N', %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.3').answer.value) )"
}
} ]
}, {
"text": "Country",
"type": "string",
"linkId": "nme7.2.4",
"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 = 'in7.3.7.5').answer.value, iif(%relyingSiteEventReportedByLeadPISite = 'N', %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.5').answer.value) )"
}
} ]
} ],
"type": "group",
"enableWhen": [ {
"operator": "=",
"question": "nme7.1.8",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
}, {
"operator": "exists",
"question": "nme7.1.11",
"answerBoolean": true
} ],
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#2a623d; font-size: 125%"
} ]
},
"required": false,
"text": "Responsibility for Adverse Non-Medical Event Reporting"
}, {
"text": "Location where Adverse Non-Medical Event occurred. Adverse non-medical events are: unexpected, related or possibly related to participation in the research, and place the participants or others at a greater risk of harm than was previously known or recognized.",
"type": "display",
"linkId": "nme7_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": "Organization/Site",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 150%"
} ]
},
"linkId": "nme7",
"required": false
}, {
"item": [ {
"item": [ {
"text": "First or given name of the site PI",
"type": "display",
"linkId": "nme8.1_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": "nme8.1",
"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": "nme8.4_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": "Last Name",
"type": "string",
"linkId": "nme8.4",
"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 = 'in7.3.2').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": "nme8.5_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": "nme8.5",
"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 site principal investigator",
"type": "display",
"linkId": "nme8.6_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": "nme8.6",
"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": "nme8.2_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": "Phone",
"type": "string",
"linkId": "nme8.2",
"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 = 'in7.3.5').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": "nme8.3",
"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 = 'in7.3.6').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 Relying Site conducting the study",
"type": "display",
"linkId": "nme8_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 for the site where Adverse Non-Medical Event occurred",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 150%"
} ]
},
"linkId": "nme8",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "nme7.1.8",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
}, {
"operator": "exists",
"question": "nme7.1.11",
"answerBoolean": true
} ],
"enableBehavior": "any"
}, {
"item": [ {
"text": "Non-medical adverse event report",
"type": "display",
"linkId": "nme3_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": "Date report is created",
"type": "display",
"linkId": "nme3.1_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": "Report Date",
"type": "date",
"linkId": "nme3.1",
"required": false
}, {
"linkId": "nme3.2",
"repeats": false,
"item": [ {
"text": "Indicator if report is the Initial report or follow-up report",
"type": "display",
"linkId": "nme3.2_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"
} ]
}
} ]
} ],
"type": "choice",
"answerOption": [ {
"valueCoding": {
"code": "init",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Initial"
}
}, {
"valueCoding": {
"code": "followup",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Follow-up"
}
} ],
"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": "Report Status"
}, {
"item": [ {
"text": "Details about adverse non-medical event",
"type": "display",
"linkId": "nme3.3_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"
} ]
}
} ]
}, {
"item": [ {
"text": "Indicator if new information resulted in unexpected change in risks of research",
"type": "display",
"linkId": "nme3.3.4_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": "New information resulted in unexpected change in risks of the research",
"type": "boolean",
"linkId": "nme3.3.4",
"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"
} ]
}
} ]
}, {
"item": [ {
"item": [ {
"text": "Date new or increased risk first documented",
"type": "display",
"linkId": "nme3.3.5.1_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": "Date:",
"type": "date",
"linkId": "nme3.3.5.1",
"required": false
}, {
"item": [ {
"text": "Date new or increased risk discovered",
"type": "display",
"linkId": "nme3.3.5.2_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": "Date discovered:",
"type": "date",
"linkId": "nme3.3.5.2",
"required": false
}, {
"item": [ {
"text": "Description of new or increased risk",
"type": "display",
"linkId": "nme3.3.5.3_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": "Description:",
"type": "text",
"linkId": "nme3.3.5.3",
"required": false
} ],
"text": "New or increased risk",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#425caf; font-size: 115%; font-weight:bold"
} ]
},
"linkId": "nme3.3.5",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "nme3.3.4",
"answerBoolean": true
} ]
}, {
"item": [ {
"text": "Indicator if problem Involved risk to participants or others",
"type": "display",
"linkId": "nme3.3.6_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": "Unanticipated Problem Involving Risk to Participants or Others",
"type": "boolean",
"linkId": "nme3.3.6",
"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"
} ]
}
} ]
}, {
"item": [ {
"item": [ {
"text": "Date event occurred",
"type": "display",
"linkId": "nme3.3.7.1_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": "Event date:",
"type": "date",
"linkId": "nme3.3.7.1",
"required": false
}, {
"item": [ {
"text": "Date site research team first became aware of unanticipated problem",
"type": "display",
"linkId": "nme3.3.7.2_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": "Date event became aware to study team:",
"type": "date",
"linkId": "nme3.3.7.2",
"required": false
}, {
"item": [ {
"text": "Summary description of unanticipated problem",
"type": "display",
"linkId": "nme3.3.7.3_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": "Event Summary:",
"type": "text",
"linkId": "nme3.3.7.3",
"required": false
}, {
"item": [ {
"text": "Indicator if unanticipated problem was unexpected",
"type": "display",
"linkId": "nme3.3.7.4_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": "Was this event Unexpected?",
"type": "choice",
"linkId": "nme3.3.7.4",
"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": "Explanation for why unanticipated problem was unexpected",
"type": "display",
"linkId": "nme3.3.7.5_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": "If yes, please explain:",
"type": "text",
"linkId": "nme3.3.7.5",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "nme3.3.7.4",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
}, {
"item": [ {
"text": "Unanticipated problem associated with participation in the research study",
"type": "display",
"linkId": "nme3.3.7.6_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": "Was this event Related or Possibly Related to participation in the research?",
"type": "choice",
"linkId": "nme3.3.7.6",
"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": "Explanation for why unanticipated problem is associated with participation in this research",
"type": "display",
"linkId": "nme3.3.7.7_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": "If yes, please explain:",
"type": "text",
"linkId": "nme3.3.7.7",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "nme3.3.7.6",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
}, {
"item": [ {
"text": "Indicator if unanticipated problem increased risk of harm to participants",
"type": "display",
"linkId": "nme3.3.7.8_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": "Does this event suggest that the research places participant(s) or others at a greater Risk of harm than was previously known?",
"type": "choice",
"linkId": "nme3.3.7.8",
"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/v2-0532",
"display": "Yes"
}
}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No"
}
} ]
}, {
"item": [ {
"text": "Explanation for why unanticipated problem is associated with increased risk of harm for research participants",
"type": "display",
"linkId": "nme3.3.7.9_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": "If yes, please explain:",
"type": "text",
"linkId": "nme3.3.7.9",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "nme3.3.7.8",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
} ],
"text": "Unanticipated Problem",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#425caf; font-size: 115%; font-weight:bold"
} ]
},
"linkId": "nme3.3.7",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "nme3.3.6",
"answerBoolean": true
} ]
}, {
"item": [ {
"text": "Indicator protocol deviation was accidental or unintentional",
"type": "display",
"linkId": "nme3.3.8_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": "Protocol Deviation (accidental or unintentional)",
"type": "boolean",
"linkId": "nme3.3.8",
"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"
} ]
}
} ]
}, {
"item": [ {
"item": [ {
"text": "Date non-compliance first identified",
"type": "display",
"linkId": "nme3.3.9.1_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": "Date:",
"type": "date",
"linkId": "nme3.3.9.1",
"required": false
}, {
"item": [ {
"text": "Date site research team first discovered non-compliance protocol deviation",
"type": "display",
"linkId": "nme3.3.9.2_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": "Date discovered:",
"type": "date",
"linkId": "nme3.3.9.2",
"required": false
}, {
"item": [ {
"text": "Description of non-compliance protocol deviation",
"type": "display",
"linkId": "nme3.3.9.3_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": "Description:",
"type": "text",
"linkId": "nme3.3.9.3",
"required": false
}, {
"item": [ {
"item": [ {
"text": "Informed consent not obtained when required by IRB",
"type": "display",
"linkId": "nme3.3.9.4.1_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": "Failure to obtain informed consent when IRB deemed required",
"type": "boolean",
"linkId": "nme3.3.9.4.1",
"required": false
}, {
"item": [ {
"text": "Protocol modified without IRB approval",
"type": "display",
"linkId": "nme3.3.9.4.2_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": "Modifying the protocol without IRB approval, except to avoid hazard to participants",
"type": "boolean",
"linkId": "nme3.3.9.4.2",
"required": false
}, {
"item": [ {
"text": "Conducting research without IRB approval",
"type": "display",
"linkId": "nme3.3.9.4.3_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": "Conducting research prior to IRB approval, during an IRB suspension or after IRB approval ends",
"type": "boolean",
"linkId": "nme3.3.9.4.3",
"required": false
}, {
"item": [ {
"text": "Explanation for why protocol deviation category checked",
"type": "display",
"linkId": "nme3.3.9.4.4_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": "Explain any Checked items",
"type": "text",
"linkId": "nme3.3.9.4.4",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "nme3.3.9.4.1",
"answerBoolean": true
}, {
"operator": "=",
"question": "nme3.3.9.4.2",
"answerBoolean": true
}, {
"operator": "=",
"question": "nme3.3.9.4.3",
"answerBoolean": true
} ],
"enableBehavior": "any"
} ],
"text": "Does the deviation involve any of the following? (Select all that apply)",
"type": "group",
"linkId": "nme3.3.9.4",
"required": false
}, {
"item": [ {
"text": "The rights, welfare, or safety of the participants",
"type": "boolean",
"linkId": "nme3.3.9.5.1",
"required": false
}, {
"text": "The integrity of the research area",
"type": "boolean",
"linkId": "nme3.3.9.5.2",
"required": false
}, {
"text": "The participants' willingness to continue participation",
"type": "boolean",
"linkId": "nme3.3.9.5.3",
"required": false
}, {
"text": "Explain any Checked items",
"type": "text",
"linkId": "nme3.3.9.5.4",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "nme3.3.9.5.1",
"answerBoolean": true
}, {
"operator": "=",
"question": "nme3.3.9.5.2",
"answerBoolean": true
}, {
"operator": "=",
"question": "nme3.3.9.5.3",
"answerBoolean": true
} ],
"enableBehavior": "any"
} ],
"text": "Was the deviation a substantive change from the protocol adversely affecting any of the following? (Select all that apply)",
"type": "group",
"linkId": "nme3.3.9.5",
"required": false
} ],
"text": "Protocol Deviation (Non-Compliance)",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#425caf; font-size: 115%; font-weight:bold"
} ]
},
"linkId": "nme3.3.9",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "nme3.3.8",
"answerBoolean": true
} ]
}, {
"item": [ {
"text": "Indicator of breach of confidentiality",
"type": "display",
"linkId": "nme3.3.10_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": "A breach of Confidentiality",
"type": "boolean",
"linkId": "nme3.3.10",
"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"
} ]
}
} ]
}, {
"item": [ {
"item": [ {
"text": "Date breach of confidentiality first documented",
"type": "display",
"linkId": "nme3.3.11.1_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": "Date breach occurred",
"type": "date",
"linkId": "nme3.3.11.1",
"required": false
}, {
"item": [ {
"text": "Date site study team discovered breach of confidentiality",
"type": "display",
"linkId": "nme3.3.11.2_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": "Date discovered:",
"type": "date",
"linkId": "nme3.3.11.2",
"required": false
}, {
"item": [ {
"text": "Breach of confidentiality description",
"type": "display",
"linkId": "nme3.3.11.3_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": "Description:",
"type": "text",
"linkId": "nme3.3.11.3",
"required": false
} ],
"text": "Breach of Confidentiality",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#425caf; font-size: 115%; font-weight:bold"
} ]
},
"linkId": "nme3.3.11",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "nme3.3.10",
"answerBoolean": true
} ]
}, {
"item": [ {
"text": "Indicator of a study participant incarcerated when the protocol is not approved for prisoner enrollment",
"type": "display",
"linkId": "nme3.3.12_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": "Incarceration of a participant in a protocol not approved to enroll prisoners",
"type": "boolean",
"linkId": "nme3.3.12",
"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"
} ]
}
} ]
}, {
"item": [ {
"item": [ {
"text": "Date site first documented participant incarceration.",
"type": "display",
"linkId": "nme3.3.13.1_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": "Date:",
"type": "date",
"linkId": "nme3.3.13.1",
"required": false
}, {
"item": [ {
"text": "Data site study team discovered patient incarceration",
"type": "display",
"linkId": "nme3.3.13.2_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": "Date incarceration was discovered:",
"type": "date",
"linkId": "nme3.3.13.2",
"required": false
}, {
"item": [ {
"text": "Description of patient incarceration",
"type": "display",
"linkId": "nme3.3.13.3_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": "Description:",
"type": "text",
"linkId": "nme3.3.13.3",
"required": false
} ],
"text": "Incarceration",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#425caf; font-size: 115%; font-weight:bold"
} ]
},
"linkId": "nme3.3.13",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "nme3.3.12",
"answerBoolean": true
} ]
}, {
"item": [ {
"text": "Indicator if participant complaint of unexpected risks was not resolved by study team. Complaint information is related to study site.",
"type": "display",
"linkId": "nme3.3.14_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": "Complaint of a participant indicating unexpected risks or the compliant cannot be resolved by team",
"type": "boolean",
"linkId": "nme3.3.14",
"repeats": false,
"readOnly": false,
"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"
} ]
}
} ]
}, {
"item": [ {
"item": [ {
"text": "Date a participant complaint was first documented",
"type": "display",
"linkId": "nme3.3.15.1_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": "Complaint Date:",
"type": "date",
"linkId": "nme3.3.15.1",
"repeats": false,
"readOnly": false,
"required": false
}, {
"item": [ {
"text": "Date site personnel first received a participant complaint",
"type": "display",
"linkId": "nme3.3.15.2_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": "Date received:",
"type": "date",
"linkId": "nme3.3.15.2",
"required": false
}, {
"item": [ {
"text": "Description of participant unexpected risk complaint",
"type": "display",
"linkId": "nme3.3.15.3_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": "Description:",
"type": "text",
"linkId": "nme3.3.15.3",
"required": false
} ],
"text": "Participant Complaint",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#425caf; font-size: 115%; font-weight:bold"
} ]
},
"linkId": "nme3.3.15",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "nme3.3.14",
"answerBoolean": true
} ]
}, {
"item": [ {
"text": "Indicator for other type of Adverse Non-Medical Event",
"type": "display",
"linkId": "nme3.3.16_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": "Other Type of Adverse Non-Medical Event",
"type": "boolean",
"linkId": "nme3.3.16",
"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"
} ]
}
} ]
}, {
"item": [ {
"item": [ {
"text": "Date event occurred",
"type": "display",
"linkId": "nme3.3.17.1_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": "Event date:",
"type": "date",
"linkId": "nme3.3.17.1",
"required": false
}, {
"item": [ {
"text": "Date site research team first became aware of the event",
"type": "display",
"linkId": "nme3.3.17.2_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": "Date study team became aware of event:",
"type": "date",
"linkId": "nme3.3.17.2",
"required": false
}, {
"item": [ {
"text": "Summary description of the event",
"type": "display",
"linkId": "nme3.3.17.3_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": "Event Summary:",
"type": "text",
"linkId": "nme3.3.17.3",
"required": false
}, {
"item": [ {
"text": "Indicator if event was unexpected",
"type": "display",
"linkId": "nme3.3.17.4_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": "Was this Adverse Non-Medical Event Unexpected?",
"type": "choice",
"linkId": "nme3.3.17.4",
"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": "Explanation for why event was unexpected",
"type": "display",
"linkId": "nme3.3.17.5_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": "If yes, please explain:",
"type": "text",
"linkId": "nme3.3.17.5",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "nme3.3.17.4",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
}, {
"item": [ {
"text": "Adverse Non-Medical Event association with participation in the research study",
"type": "display",
"linkId": "nme3.3.17.6_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": "Was this event Related or Possibly Related to participation in the research?",
"type": "choice",
"linkId": "nme3.3.17.6",
"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": "Explanation for why the event is associated with participation in this research",
"type": "display",
"linkId": "nme3.3.17.7_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": "If yes, please explain:",
"type": "text",
"linkId": "nme3.3.17.7",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "nme3.3.17.6",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
} ],
"text": "Other Type",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#425caf; font-size: 115%; font-weight:bold"
} ]
},
"linkId": "nme3.3.17",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "nme3.3.16",
"answerBoolean": true
} ]
} ],
"text": "Select at least one of the following criteria:",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#2a623d; font-size: 125%"
} ]
},
"linkId": "nme3.3",
"required": false
} ],
"text": "Report",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 150%"
} ]
},
"linkId": "nme3",
"required": false
}, {
"item": [ {
"text": "Reporting information to Sponsor and both relying and reviewing IRBs",
"type": "display",
"linkId": "nme4_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": "Indicator if Sponsor was notified of non-medical adverse event",
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"code": "help",
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}
} ]
} ],
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}, {
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"code": "help",
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}
} ]
} ],
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}, {
"item": [ {
"text": "Indicator if study site IRB notified of non-medical adverse event",
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"code": "help",
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"display": "Help-Button"
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}
} ]
} ],
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"code": "help",
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} ]
} ],
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} ]
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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"
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}
} ]
} ],
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"display": "Yes"
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}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No"
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} ],
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"valueCodeableConcept": {
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"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
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}
} ],
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"required": false,
"text": "Were any Other Parties notified?"
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"text": "List other notified parties",
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"linkId": "nme4.6",
"repeats": false,
"required": false,
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"question": "nme4.5",
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"code": "Y",
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} ],
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}, {
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"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"
} ]
}
} ]
} ],
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"required": false,
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"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
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"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
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} ],
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"valueCoding": {
"code": "completed",
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}, {
"valueCoding": {
"code": "pending",
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"display": "Pending - Currently under development"
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}, {
"valueCoding": {
"code": "notundertaken",
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}
} ]
}, {
"item": [ {
"text": "Description of what the root cause analysis determined the adverse event was caused by",
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"linkId": "nme5.2a_help",
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"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"
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}
} ]
} ],
"text": "If yes, provide determination:",
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"linkId": "nme5.2a",
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"question": "nme5.1",
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}
} ]
}, {
"item": [ {
"text": "Describe status and any interim findings of the root cause analysis",
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"linkId": "nme5.2b_help",
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"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",
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}
} ]
} ],
"text": "If pending, describe status and interim findings, if any:",
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"linkId": "nme5.2b",
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"operator": "=",
"question": "nme5.1",
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"code": "pending",
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}
} ]
}, {
"item": [ {
"text": "Indicator if corrective action is implemented for non-medical adverse event",
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"linkId": "nme5.3_help",
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"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": "Was Corrective Action implemented?",
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"linkId": "nme5.3",
"required": false,
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"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
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}
} ],
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}, {
"valueCoding": {
"code": "pending",
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}, {
"valueCoding": {
"code": "notundertaken",
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} ]
}, {
"item": [ {
"text": "Summary of corrective action implemented for non-medical adverse event. If still pending, provide a status of the corrective action plan",
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"linkId": "nme5.4_help",
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"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 Corrective Action was implemented or is pending, provide a summary:",
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"linkId": "nme5.4",
"required": false,
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"operator": "=",
"question": "nme5.3",
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"code": "completed",
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}, {
"operator": "=",
"question": "nme5.3",
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"code": "pending",
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}
} ],
"enableBehavior": "any"
}, {
"item": [ {
"text": "Indicator if preventative action for non-medical adverse event is implemented",
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"linkId": "nme5.5_help",
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"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"
} ]
}
} ]
} ],
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"linkId": "nme5.5",
"required": false,
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"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
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"system": "http://hl7.org/fhir/questionnaire-item-control",
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}
} ],
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}, {
"valueCoding": {
"code": "notundertaken",
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}, {
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"code": "pending",
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} ]
}, {
"item": [ {
"text": "Summary of preventative action implemented for non-medical adverse event. If still pending, provide status.",
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"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
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"code": "help",
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} ]
} ],
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"operator": "=",
"question": "nme5.5",
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}, {
"operator": "=",
"question": "nme5.5",
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"code": "pending",
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} ],
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} ],
"text": "Corrective and Preventative Action Plan",
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"valueString": "color:#274e90; font-size: 150%"
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},
"linkId": "nme5",
"required": false
}, {
"item": [ {
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"linkId": "nme6_help",
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"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",
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}
} ]
}, {
"item": [ {
"text": "Indicator if changes are required in study protocol resulting from the non-medical adverse event report",
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"linkId": "nme6.1a_help",
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"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
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"text": "Help-Button",
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"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Are changes required to the Study Protocol as a result of this report?",
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"linkId": "nme6.1a",
"required": false,
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"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
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"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
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} ],
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"code": "Y",
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}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No"
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} ]
}, {
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"repeats": true,
"required": true,
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"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Check-box",
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"code": "check-box",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Check-box"
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}
}, {
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"valueCode": "vertical"
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} ],
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}
}, {
"valueCoding": {
"code": "mtd",
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}
}, {
"valueCoding": {
"code": "otherreason",
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} ]
}, {
"item": [ {
"text": "Justification for decision not to change study protocol based upon non-medical adverse event report",
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"linkId": "nme6.2_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"
} ]
}
} ]
} ],
"text": "Justify your decision to not change the Study Protocol (for reasons other than Adverse Non-Medical Event consisted of a missed lab/assessment or missed treatment/dose):",
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"linkId": "nme6.2",
"required": false,
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"question": "nme6.1a",
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}, {
"operator": "=",
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}
} ],
"enableBehavior": "all"
}, {
"item": [ {
"text": "Indicator if changes are required to the informed consent as a result of the non-medical adverse event report",
"type": "display",
"linkId": "nme6.3a_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"
} ]
}
} ]
} ],
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"linkId": "nme6.3a",
"required": false,
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"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
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"system": "http://hl7.org/fhir/questionnaire-item-control",
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}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No"
}
} ]
}, {
"text": "Reason(s) why changes are not required in the Informed Consent:",
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"repeats": true,
"required": true,
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"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
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"code": "check-box",
"system": "http://hl7.org/fhir/questionnaire-item-control",
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"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-choiceOrientation",
"valueCode": "vertical"
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"enableWhen": [ {
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"question": "nme6.3a",
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"code": "N",
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} ],
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"valueCoding": {
"code": "mla",
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}
}, {
"valueCoding": {
"code": "mtd",
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}, {
"valueCoding": {
"code": "otherreason",
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} ]
}, {
"item": [ {
"text": "Justification for decision not to change informed consent based upon non-medical adverse event report",
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"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": "Justify your decision to not change the Informed Consent (for reasons other than Adverse Non-Medical Event consisted of a missed lab/assessment or missed treatment/dose):",
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"linkId": "nme6.4",
"required": false,
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"question": "nme6.3a",
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}, {
"operator": "=",
"question": "nme6.3b",
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"code": "otherreason",
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}
} ],
"enableBehavior": "all"
}, {
"enableBehavior": "any",
"linkId": "nme6.5",
"item": [ {
"text": "Indicator if notification or reconsenting of participants is required due to changes in Study Protocol or Informed Consent",
"type": "display",
"linkId": "nme6.5_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",
"enableWhen": [ {
"operator": "=",
"question": "nme6.1a",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
}, {
"operator": "=",
"question": "nme6.3a",
"answerCoding": {
"code": "Y",
"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"
}
} ],
"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": "Are notifications or re-consenting of participants required as a result of changes in Study Protocol or Informed Consent?"
}, {
"item": [ {
"text": "Description of how notification or re-consent will occur",
"type": "display",
"linkId": "nme6.6_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": "If yes, detail how the notification and/or re-consent will occur:",
"type": "text",
"linkId": "nme6.6",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "nme6.5",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ],
"enableBehavior": "all"
}, {
"item": [ {
"text": "Rationale for not notifying (re-consenting) study participants",
"type": "display",
"linkId": "nme6.7_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": "If no, justify your decision to not notify (re-consent) participants:",
"type": "text",
"linkId": "nme6.7",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "nme6.5",
"answerCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ],
"enableBehavior": "all"
} ],
"text": "Study Protocol and Informed Consent",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 150%"
} ]
},
"linkId": "nme6",
"required": false
}, {
"item": [ {
"text": "Describe the file that is being attached (optional)",
"type": "string",
"linkId": "nme11.1"
}, {
"text": "Attachment",
"type": "attachment",
"linkId": "nme11.2"
}, {
"text": "Attachments related to the Adverse Non-Medical Event can be included here.",
"type": "display",
"linkId": "nme11_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": "nme11",
"repeats": true,
"required": false
}, {
"item": [ {
"text": "Link ID prefix",
"type": "string",
"linkId": "ADMIN01",
"initial": [ {
"valueString": "nme"
} ],
"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": "false",
"resourceType": "Questionnaire",
"title": "Unanticipated Problems Involving Risk to Subjects or Others (UPIRTSO)/Adverse Non-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 = 'nme7.1.8').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 = 'nme7.1.9').answer.value.display",
"description": "relying site where NME occurred"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/variable",
"valueExpression": {
"name": "relyingSiteEventReportedByLeadPISite",
"language": "text/fhirpath",
"expression": "%resource.descendants().where(linkId = 'nme7.2.8').answer.valueCoding.code",
"description": "being reported by lead PI site"
}
} ],
"status": "draft",
"id": "5185bfeb-06a1-4947-a257-b1187ae526b5",
"kind": null,
"url": "http://hl7.org/fhir/us/sirb/Questionnaire/sirb-nonmedicalevent-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"
} ]
} ]
}