{
"description": null,
"_filename": "example/Questionnaire-sirb-nonmedicalevent-questionnaire.json",
"package_name": "hl7.fhir.us.sirb",
"subjectType": [ "ResearchStudy" ],
"date": "2021-08-10T13:15:03+00:00",
"meta": {
"source": "#GxnTt2MWvknGBINg",
"versionId": "9",
"lastUpdated": "2021-07-27T02:22:44.671+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
}, {
"item": [ {
"text": "IRB Number from the Informed Consent",
"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
}, {
"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"
}
} ],
"enableBehavior": "all"
} ],
"text": "Research Study",
"type": "group",
"linkId": "nme1",
"required": false
}, {
"item": [ {
"text": "Location of Adverse Non-Medical Event",
"type": "display",
"linkId": "nme2a_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 organization/site where the Adverse Non-Medical Event occurred",
"type": "string",
"linkId": "nme2a.1.1",
"repeats": false,
"required": false
}, {
"text": "City",
"type": "string",
"linkId": "nme2a.1.2",
"repeats": false,
"required": false
}, {
"text": "State",
"type": "string",
"linkId": "nme2a.1.3",
"repeats": false,
"required": false
}, {
"text": "Country",
"type": "string",
"linkId": "nme2a.1.4",
"repeats": false,
"required": false
} ],
"text": "Organization/site where the Adverse Non-Medical Event occurred",
"type": "group",
"linkId": "nme2a.1",
"repeats": false,
"required": false
}, {
"item": [ {
"text": "Name of organization/site which is recording the Adverse Non-Medical Event",
"type": "string",
"linkId": "nme2a.2.1",
"repeats": false,
"required": false
}, {
"text": "City",
"type": "string",
"linkId": "nme2a.2.2",
"repeats": false,
"required": false
}, {
"text": "State",
"type": "string",
"linkId": "nme2a.2.3",
"repeats": false,
"required": false
}, {
"text": "Country",
"type": "string",
"linkId": "nme2a.2.4",
"repeats": false,
"required": false
} ],
"text": "Organization/site which is recording the Adverse Non-Medical Event",
"type": "group",
"linkId": "nme2a.2",
"repeats": false,
"required": false
} ],
"text": "Site/Organization",
"type": "group",
"linkId": "nme2a",
"required": false
}, {
"item": [ {
"text": "Site Principal Investigator responsible for the research study at the site where Adverse Non-Medical Event occurred",
"type": "display",
"linkId": "nme2b_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
}, {
"item": [ {
"text": "First or given name associated with the site PI",
"type": "display",
"linkId": "nme2b.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": "nme2b.1",
"required": false
}, {
"item": [ {
"text": "Surname or family name associated with the principal investigator",
"type": "display",
"linkId": "nme2b.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": "nme2b.4",
"repeats": false,
"readOnly": false,
"required": false
}, {
"item": [ {
"text": "Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc. associated with the principal investigator's name",
"type": "display",
"linkId": "nme2b.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": "nme2b.5",
"repeats": false,
"readOnly": false,
"required": false
}, {
"item": [ {
"text": "Professional and Academic degrees associated with the principal investigator",
"type": "display",
"linkId": "nme2b.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": "nme2b.6",
"repeats": false,
"readOnly": false,
"required": false
}, {
"item": [ {
"text": "Phone number for site PI",
"type": "display",
"linkId": "nme2b.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": "nme2b.2",
"required": false
}, {
"item": [ {
"text": "Email address for site PI",
"type": "display",
"linkId": "nme2b.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": "Email:",
"type": "string",
"linkId": "nme2b.3",
"required": false
} ],
"text": "Site Principal Investigator for the site where Adverse Non-Medical Event occurred",
"type": "group",
"linkId": "nme2b",
"required": false
}, {
"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
}, {
"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"
} ]
}
} ]
} ],
"text": "Report Status",
"type": "choice",
"linkId": "nme3.2",
"repeats": false,
"readOnly": false,
"required": false,
"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"
}
} ]
}, {
"item": [ {
"text": "Reason for uanticipated problem reporting",
"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"
} ]
}
} ]
} ],
"text": "Check at least one of the following criteria:",
"type": "group",
"linkId": "nme3.3",
"required": false
}, {
"item": [ {
"text": "Indicator if new information resulted in unexpected change in risks of research",
"type": "display",
"linkId": "nme3.4_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": "nme3.4",
"required": false
}, {
"item": [ {
"item": [ {
"text": "Date new or increased risk first documented",
"type": "display",
"linkId": "nme3.5.1_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": "nme3.5.1",
"required": false
}, {
"item": [ {
"text": "Date new or increased risk discovered",
"type": "display",
"linkId": "nme3.5.2_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": "nme3.5.2",
"required": false
}, {
"item": [ {
"text": "Description of new or increased risk",
"type": "display",
"linkId": "nme3.5.3_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": "nme3.5.3",
"required": false
} ],
"text": "New or increased risk",
"type": "group",
"linkId": "nme3.5",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "nme3.4",
"answerBoolean": true
} ],
"enableBehavior": "all"
}, {
"item": [ {
"text": "Indicator if problem Involved risk to participants or others",
"type": "display",
"linkId": "nme3.6_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": "nme3.6",
"required": false
}, {
"item": [ {
"item": [ {
"text": "Date event occurred",
"type": "display",
"linkId": "nme3.7.1_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": "nme3.7.1",
"required": false
}, {
"item": [ {
"text": "Date site research team first became aware of unanticipated problem",
"type": "display",
"linkId": "nme3.7.2_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": "nme3.7.2",
"required": false
}, {
"item": [ {
"text": "Summary description of unanticipated problem",
"type": "display",
"linkId": "nme3.7.3_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": "nme3.7.3",
"required": false
}, {
"item": [ {
"text": "Indicator if unanticipated problem was unexpected",
"type": "display",
"linkId": "nme3.7.4_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": "nme3.7.4",
"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": "nme3.7.5_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": "nme3.7.5",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "nme3.7.4",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ],
"enableBehavior": "all"
}, {
"item": [ {
"text": "Unanticipated problem associated with participation in the research study",
"type": "display",
"linkId": "nme3.7.6_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": "nme3.7.6",
"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": "nme3.7.7_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": "nme3.7.7",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "nme3.7.6",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ],
"enableBehavior": "all"
}, {
"item": [ {
"text": "Indicator if unanticipated problem increased risk of harm to participants",
"type": "display",
"linkId": "nme3.7.8_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": "nme3.7.8",
"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": "nme3.7.9_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": "nme3.7.9",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "nme3.7.8",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ],
"enableBehavior": "all"
} ],
"text": "Unanticipated Problem",
"type": "group",
"linkId": "nme3.7",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "nme3.6",
"answerBoolean": true
} ],
"enableBehavior": "all"
}, {
"item": [ {
"text": "Indicator protocol deviation was accidental or unintentional",
"type": "display",
"linkId": "nme3.8_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": "nme3.8",
"required": false
}, {
"item": [ {
"item": [ {
"text": "Date non-compliance first identified",
"type": "display",
"linkId": "nme3.9.1_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": "nme3.9.1",
"required": false
}, {
"item": [ {
"text": "Date site research team first discovered non-compliance protocol deviation",
"type": "display",
"linkId": "nme3.9.2_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": "nme3.9.2",
"required": false
}, {
"item": [ {
"text": "Description of non-compliance protocol deviation",
"type": "display",
"linkId": "nme3.9.3_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": "nme3.9.3",
"required": false
}, {
"item": [ {
"text": "Reason for protocol deviation",
"type": "display",
"linkId": "nme3.9.4_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"
} ]
}
} ]
}, {
"item": [ {
"text": "Informed consent not obtained when required by IRB",
"type": "display",
"linkId": "nme3.9.4.1_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": "nme3.9.4.1",
"required": false
}, {
"item": [ {
"text": "Protocol modified without IRB approval",
"type": "display",
"linkId": "nme3.9.4.2_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": "nme3.9.4.2",
"required": false
}, {
"item": [ {
"text": "Conducting research without IRB approval",
"type": "display",
"linkId": "nme3.9.4.3_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": "nme3.9.4.3",
"required": false
}, {
"item": [ {
"text": "Explanation for why protocol deviation category checked",
"type": "display",
"linkId": "nme3.9.9.4_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": "Please explain any Checked items:",
"type": "text",
"linkId": "nme3.9.4.4",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "nme3.9.4.1",
"answerBoolean": true
}, {
"operator": "=",
"question": "nme3.9.4.2",
"answerBoolean": true
}, {
"operator": "=",
"question": "nme3.9.4.3",
"answerBoolean": true
} ],
"enableBehavior": "any"
} ],
"text": "Does the deviation involve any of the following? (Check all that apply)",
"type": "group",
"linkId": "nme3.9.4",
"required": false
}, {
"item": [ {
"text": "The rights, welfare, or safety of the participants",
"type": "boolean",
"linkId": "nme3.9.5.1",
"required": false
}, {
"text": "The integrity of the research area",
"type": "boolean",
"linkId": "nme3.9.5.2",
"required": false
}, {
"text": "The participants' willingness to continue participation",
"type": "boolean",
"linkId": "nme3.9.5.3",
"required": false
}, {
"text": "Please explain any Checked items:",
"type": "text",
"linkId": "nme3.9.5.4",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "nme3.9.5.1",
"answerBoolean": true
}, {
"operator": "=",
"question": "nme3.9.5.2",
"answerBoolean": true
}, {
"operator": "=",
"question": "nme3.9.5.3",
"answerBoolean": true
} ],
"enableBehavior": "any"
} ],
"text": "Was the deviation a substantive change from the protocol adversely affecting any of the following? (Check all that apply)",
"type": "group",
"linkId": "nme3.9.5",
"required": false
} ],
"text": "Protocol Deviation (Non-Compliance)",
"type": "group",
"linkId": "nme3.9",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "nme3.8",
"answerBoolean": true
} ],
"enableBehavior": "all"
}, {
"item": [ {
"text": "Indicator of breach of confidentiality",
"type": "display",
"linkId": "nme3.10_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": "nme3.10",
"required": false
}, {
"item": [ {
"item": [ {
"text": "Date breach of confidentiality first documented",
"type": "display",
"linkId": "nme3.11.1_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": "nme3.11.1",
"required": false
}, {
"item": [ {
"text": "Date site study team discovered breach of confidentiality",
"type": "display",
"linkId": "nme3.11.2_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": "nme3.11.2",
"required": false
}, {
"item": [ {
"text": "Breach of confidentiality description",
"type": "display",
"linkId": "nme3.11.3_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": "nme3.11.3",
"required": false
}, {
"text": "Indicator of breach of confidentiality",
"type": "display",
"linkId": "nme3.11_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": "Breach of Confidentiality",
"type": "group",
"linkId": "nme3.11",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "nme3.10",
"answerBoolean": true
} ],
"enableBehavior": "all"
}, {
"item": [ {
"text": "Indicator of a study participant incarcerated when the protocol is not approved for prisoner enrollment",
"type": "display",
"linkId": "nme3.12_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": "nme3.12",
"required": false
}, {
"item": [ {
"item": [ {
"text": "Date site first documented participant incarceration.",
"type": "display",
"linkId": "nme3.13.1_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": "nme3.13.1",
"required": false
}, {
"item": [ {
"text": "Data site study team discovered patient incarceration",
"type": "display",
"linkId": "nme3.13.2_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": "nme3.13.2",
"required": false
}, {
"item": [ {
"text": "Description of patient incarceration",
"type": "display",
"linkId": "nme3.13.3_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": "nme3.13.3",
"required": false
} ],
"text": "Incarceration",
"type": "group",
"linkId": "nme3.13",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "nme3.12",
"answerBoolean": true
} ],
"enableBehavior": "all"
}, {
"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": "nme3.14_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": "nme3.14",
"repeats": false,
"readOnly": false,
"required": false
}, {
"item": [ {
"item": [ {
"text": "Date site first documented participant unexpected risk complaint",
"type": "display",
"linkId": "nme3.15.1_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": "nme3.15.1",
"repeats": false,
"readOnly": false,
"required": false
}, {
"item": [ {
"text": "Date site personnel first received participant unexpected risk complaint",
"type": "display",
"linkId": "nme3.15.2_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": "nme3.15.2",
"required": false
}, {
"item": [ {
"text": "Description of participant unexpected risk complaint",
"type": "display",
"linkId": "nme3.15.3_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": "nme3.15.3",
"required": false
} ],
"text": "Participant Complaint",
"type": "group",
"linkId": "nme3.15",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "nme3.14",
"answerBoolean": true
} ]
}, {
"item": [ {
"text": "Indicator for other type of Adverse Non-Medical Event",
"type": "display",
"linkId": "nme3.16_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": "nme3.16",
"required": false
}, {
"item": [ {
"item": [ {
"text": "Date event occurred",
"type": "display",
"linkId": "nme3.17.1_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": "nme3.17.1",
"required": false
}, {
"item": [ {
"text": "Date site research team first became aware of the event",
"type": "display",
"linkId": "nme3.17.2_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": "nme3.17.2",
"required": false
}, {
"item": [ {
"text": "Summary description of the event",
"type": "display",
"linkId": "nme3.17.3_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": "nme3.17.3",
"required": false
}, {
"item": [ {
"text": "Indicator if event was unexpected",
"type": "display",
"linkId": "nme3.17.4_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": "nme3.17.4",
"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": "nme3.17.5_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": "nme3.17.5",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "nme3.17.4",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ],
"enableBehavior": "all"
}, {
"item": [ {
"text": "Adverse Non-Medical Event association with participation in the research study",
"type": "display",
"linkId": "nme3.17.6_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": "nme3.17.6",
"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": "nme3.17.7_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": "nme3.17.7",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "nme3.17.6",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ],
"enableBehavior": "all"
} ],
"text": "Other Type",
"type": "group",
"linkId": "nme3.17",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "nme3.16",
"answerBoolean": true
} ],
"enableBehavior": "all"
} ],
"text": "Report",
"type": "group",
"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",
"type": "display",
"linkId": "nme4.1_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": "Was the Sponsor notified?",
"type": "choice",
"linkId": "nme4.1",
"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": "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 sponsor notified of non-medical adverse event",
"type": "display",
"linkId": "nme4.2_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": "Notification date:",
"type": "date",
"linkId": "nme4.2",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "nme4.1",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ],
"enableBehavior": "all"
}, {
"item": [ {
"text": "Indicator if study site IRB notified of non-medical adverse event",
"type": "display",
"linkId": "nme4.3_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": "Was the IRB notified?",
"type": "choice",
"linkId": "nme4.3",
"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": "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 study site IRB notified of non-medical adverse event",
"type": "display",
"linkId": "nme4.4_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": "Notification date:",
"type": "date",
"linkId": "nme4.4",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "nme4.3",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ],
"enableBehavior": "all"
}, {
"item": [ {
"text": "Other parties notified of non-medical adverse event (such as coordinating center, other study sites, FDA)",
"type": "display",
"linkId": "nme4.5_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": "Were any Other Parties notified?",
"type": "choice",
"linkId": "nme4.5",
"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": "Please list other notified parties",
"type": "text",
"linkId": "nme4.6",
"repeats": false,
"readOnly": false,
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "nme4.5",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ],
"enableBehavior": "all"
} ],
"text": "Reporting",
"type": "group",
"linkId": "nme4",
"required": false
}, {
"item": [ {
"text": "Description of corrective and preventative action plan",
"type": "display",
"linkId": "nme5_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": "Indicataor if analysis of underlying causes or problems that led to the non-medical adverse event was performed",
"type": "display",
"linkId": "nme5.1_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": "Was a Root Cause analysis performed?",
"type": "choice",
"linkId": "nme5.1",
"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": "completed",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Done, performed or completed"
}
}, {
"valueCoding": {
"code": "pending",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Pending - Currently under development"
}
}, {
"valueCoding": {
"code": "notundertaken",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Not done or undertaken"
}
} ]
}, {
"item": [ {
"text": "Description of what the root cause analysis determined the adverse event was caused by",
"type": "display",
"linkId": "nme5.2a_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, provide determination:",
"type": "text",
"linkId": "nme5.2a",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "nme5.1",
"answerCoding": {
"code": "completed",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"
}
} ],
"enableBehavior": "all"
}, {
"item": [ {
"text": "Describe status and any interim findings of the root cause analysis",
"type": "display",
"linkId": "nme5.2b_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 pending, describe status and interim findings, if any:",
"type": "text",
"linkId": "nme5.2b",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "nme5.1",
"answerCoding": {
"code": "pending",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"
}
} ],
"enableBehavior": "all"
}, {
"item": [ {
"text": "Indicator if corrective action is implemented for non-medical adverse event",
"type": "display",
"linkId": "nme5.3_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": "Was Corrective Action implemented?",
"type": "choice",
"linkId": "nme5.3",
"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": "completed",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Done, performed or completed"
}
}, {
"valueCoding": {
"code": "pending",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Pending - Currently under development"
}
}, {
"valueCoding": {
"code": "notundertaken",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Not done or undertaken"
}
} ]
}, {
"item": [ {
"text": "Summary of corrective action implemented for non-medical adverse event. If still pending, provide a status of the corrective action plan",
"type": "display",
"linkId": "nme5.4_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": "If Corrective Action was implemented or is pending, provide a summary:",
"type": "text",
"linkId": "nme5.4",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "nme5.3",
"answerCoding": {
"code": "completed",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"
}
}, {
"operator": "=",
"question": "nme5.3",
"answerCoding": {
"code": "pending",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"
}
} ],
"enableBehavior": "any"
}, {
"item": [ {
"text": "Indicator if preventative action for non-medical adverse event is implemented",
"type": "display",
"linkId": "nme5.5_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": "Was Preventitive Action implemented?",
"type": "choice",
"linkId": "nme5.5",
"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": "completed",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Done, performed or completed"
}
}, {
"valueCoding": {
"code": "notundertaken",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Not done or undertaken"
}
}, {
"valueCoding": {
"code": "pending",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Pending - Currently under development"
}
} ]
}, {
"item": [ {
"text": "Summary of preventative action implemented for non-medical adverse event. If still pending, provide status.",
"type": "display",
"linkId": "nme5.6_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 Preventitive Action was implemented or is pending, provide a summary:",
"type": "text",
"linkId": "nme5.6",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "nme5.5",
"answerCoding": {
"code": "completed",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"
}
}, {
"operator": "=",
"question": "nme5.5",
"answerCoding": {
"code": "pending",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"
}
} ],
"enableBehavior": "any"
} ],
"text": "Corrective and Preventative Action Plan",
"type": "group",
"linkId": "nme5",
"required": false
}, {
"item": [ {
"text": "Description of protocol and informed consent changes",
"type": "display",
"linkId": "nme6_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 changes are required in study protocol resulting from the non-medical adverse event report",
"type": "display",
"linkId": "nme6.1a_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": "Are changes required to the Study Protocol as a result of this report?",
"type": "choice",
"linkId": "nme6.1a",
"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"
}
} ]
}, {
"text": "Reason(s) why changes are not required in the Study Protocol:",
"type": "choice",
"linkId": "nme6.1b",
"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"
} ]
}
} ],
"enableWhen": [ {
"operator": "=",
"question": "nme6.1a",
"answerCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "mla",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Adverse Non-Medical Event consisted of a missed lab or assessment by a participant (which does not jeopardize the study or increase risks to other participants)"
}
}, {
"valueCoding": {
"code": "mtd",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Adverse Non-Medical Event consisted of a missed treatment or dose by a participant (which does not jeopardize the study or increase risks to other participants"
}
}, {
"valueCoding": {
"code": "otherreason",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Other reason"
}
} ],
"enableBehavior": "all"
}, {
"item": [ {
"text": "Justification for decision not to change study protocol based upon non-medical adverse event report",
"type": "display",
"linkId": "nme6.2_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": "Justify your decision to not change the study protocol:",
"type": "text",
"linkId": "nme6.2",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "nme6.1a",
"answerCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
}, {
"operator": "=",
"question": "nme6.1b",
"answerCoding": {
"code": "otherreason",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"
}
} ],
"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",
"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": "Are changes required to the Informed Consent as a result of this report?",
"type": "choice",
"linkId": "nme6.3a",
"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"
}
} ]
}, {
"text": "Reason(s) why changes are not required in the Informed Consent:",
"type": "choice",
"linkId": "nme6.3b",
"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"
} ]
}
} ],
"enableWhen": [ {
"operator": "=",
"question": "nme6.3a",
"answerCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "mla",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Adverse Non-Medical Event consisted of a missed lab or assessment by a participant (which does not jeopardize the study or increase risks to other participants)"
}
}, {
"valueCoding": {
"code": "mtd",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Adverse Non-Medical Event consisted of a missed treatment or dose by a participant (which does not jeopardize the study or increase risks to other participants"
}
}, {
"valueCoding": {
"code": "otherreason",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Other reason"
}
} ],
"enableBehavior": "all"
}, {
"item": [ {
"text": "Justification for decision not to change informed consent based upon non-medical adverse event report",
"type": "display",
"linkId": "nme6.4_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": "Justify your decision to not change the Informed Consent:",
"type": "text",
"linkId": "nme6.4",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "nme6.3a",
"answerCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
}, {
"operator": "=",
"question": "nme6.3b",
"answerCoding": {
"code": "otherreason",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"
}
} ],
"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 this change?"
}, {
"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",
"linkId": "nme6",
"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
} ]
}, {
"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": "false",
"resourceType": "Questionnaire",
"title": "Adverse Non-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": "c40f29fe-9617-49e0-a508-331092d42f34",
"kind": null,
"url": "https://hl7.org/fhir/us/sirb/Questionnaire/sirb-nonmedicalevents-questionnaire",
"version": "0.1.0",
"contact": [ {
"name": "HL7 International - Biomedical Research and Regulation",
"telecom": [ {
"value": "http://www.hl7.org/Special/committees/rcrim",
"system": "url"
} ]
} ]
}