{
"description": null,
"_filename": "Questionnaire-sirb-consent-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": "Consent_Questionnaire",
"item": [ {
"item": [ {
"item": [ {
"text": "Short Title of the Research Study",
"type": "display",
"linkId": "c1.1_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": "text",
"linkId": "c1.1",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.item.item.where(linkId = 'in1.2').answer.value"
}
} ]
}, {
"text": "IRB Protocol Number",
"type": "string",
"linkId": "c1.2",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.item.item.where(linkId = 'in1.3').answer.value"
}
} ]
} ],
"text": "Research Study",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 150%"
} ]
},
"linkId": "c1",
"required": false
}, {
"item": [ {
"text": "External Data For linkId c38.1",
"type": "open-choice",
"linkId": "ExternalDataFor_c38.1",
"repeats": true,
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.repeat(item).where(linkId = 'in8.9').answer.value"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
"valueBoolean": true
}, {
"url": "http://hl7.org/fhir/StructureDefinition/designNote",
"valueMarkdown": "See FHIR Specification Feedback Jira ticket FHIR-36338. Information obtained from other types of external sources (e.g. launch context, fhir-x-query, etc.) SHOULD only be used for initialExpression and calculatedExpression logic. Other behavior such as enableWhen or answerExpression should always be driven off of answers within the Questionnaire (even if they are hidden answers that are populated from an initialExpression)."
} ]
}, {
"item": [ {
"text": "This question and its answer will not print on the Consent 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": "c38.1_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": "Select the relying site that this consent form pertains to, in order to pre-populate the relying institution and relying site principal investigator details below.",
"type": "choice",
"linkId": "c38.1",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
}, {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-answerExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%resource.repeat(item).where(linkId = 'ExternalDataFor_c38.1').answer.value"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/designNote",
"valueMarkdown": "See FHIR Specification Feedback Jira ticket FHIR-36338. Information obtained from other types of external sources (e.g. launch context, fhir-x-query, etc.) SHOULD only be used for initialExpression and calculatedExpression logic. Other behavior such as enableWhen or answerExpression should always be driven off of answers within the Questionnaire (even if they are hidden answers that are populated from an initialExpression)."
} ]
}, {
"item": [ {
"text": "This question and its answer will not print on the Consent Form but are necessary for the form logic.",
"type": "display",
"linkId": "c38.2_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": "Is this relying site also functioning as the lead site for the overall study with the lead PI for the overall study as the site PI?",
"type": "choice",
"linkId": "c38.2",
"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"
} ]
}
}, {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.5.4').answer.valueCoding"
}
} ],
"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": "Study Site",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 150%"
} ]
},
"linkId": "c38",
"required": false
}, {
"item": [ {
"text": "Multi-site statement",
"type": "text",
"linkId": "c40.1",
"initial": [ {
"valueString": "This research study is part of a multi-site research study. There are other institutions with participants this study. Later in this consent form, more details about the number of participants and sites will be discussed."
} ],
"required": false
}, {
"text": "Statement for Consent Form at Lead PI Site",
"type": "text",
"linkId": "c40.2",
"initial": [ {
"valueString": "In multi-site studies, there is a lead institution that is responsible for the overall coordination of the study. The lead institution has a lead Principal Investigator who is responsible for the overall conduct of the study. The site where you are participating in the study is the lead or main site. The lead study site is responsible for all study activities for the overall study. The principal investigator(PI) is responsible for the conduct of the study. The PI for your study is the lead principal investigator, responsible for the overall study."
} ],
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "c38.2",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
}, {
"text": "Statement for Consent Form at Relying Site (not Lead PI Site)",
"type": "text",
"linkId": "c40.3",
"initial": [ {
"valueString": "This consent form describes your involvement in research at the study site listed below. The site principal investigator (PI) is responsible for the conduct of the study at this site."
} ],
"required": false,
"enableWhen": [ {
"operator": "!=",
"question": "c38.2",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
}, {
"item": [ {
"item": [ {
"text": "First or given name of the relying site PI",
"type": "display",
"linkId": "c40.5.2_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": "First Name",
"type": "string",
"linkId": "c40.5.2",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.item.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 of the relying site PI",
"type": "display",
"linkId": "c40.5.1_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": "Last Name",
"type": "string",
"linkId": "c40.5.1",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.item.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": "c40.5.6_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": "Suffix",
"type": "string",
"linkId": "c40.5.6",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.item.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 relying site PI",
"type": "display",
"linkId": "c40.5.3_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": "Degree(s)",
"type": "string",
"linkId": "c40.5.3",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.4').answer.value"
}
} ]
}, {
"item": [ {
"text": "Relying site PI's Academic or Professional Institution",
"type": "display",
"linkId": "c40.5.4_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": "Associated Institution",
"type": "string",
"linkId": "c40.5.4",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.1.1').answer.value"
}
} ]
}, {
"item": [ {
"item": [ {
"text": "10-digit phone number, including area code",
"type": "display",
"linkId": "c40.5.8.20_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Phone",
"type": "string",
"linkId": "c40.5.8.20",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.5').answer.value"
}
} ]
}, {
"text": "Email",
"type": "string",
"linkId": "c40.5.8.21",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.6').answer.value"
}
} ]
}, {
"text": "Information on how to contact the Site PI.",
"type": "display",
"linkId": "c40.5.8_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": "Contact Information",
"type": "group",
"linkId": "c40.5.8",
"required": false
}, {
"text": "Principal Investigator at Relying Site conducting the study, responsible for the conduct of the study at the relying site",
"type": "display",
"linkId": "c40.5_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": "Principal Investigator at Study Site",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#2a623d; font-size: 125%"
} ]
},
"linkId": "c40.5",
"required": false
}, {
"item": [ {
"item": [ {
"text": "Public or private entity conducting the study- where the participant will go or call",
"type": "display",
"linkId": "c40.9.1_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": "Institution Name",
"type": "string",
"linkId": "c40.9.1",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.1.1').answer.value"
}
} ]
}, {
"item": [ {
"text": "Street Address",
"type": "string",
"linkId": "c40.9.2.10",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.1').answer.value"
}
} ]
}, {
"text": "City",
"type": "string",
"linkId": "c40.9.2.11",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.item.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": "c40.9.2.12",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.3').answer.value"
}
} ]
}, {
"text": "Zip Code",
"type": "string",
"linkId": "c40.9.2.13",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.4').answer.value"
}
} ]
}, {
"text": "Country",
"type": "string",
"linkId": "c40.9.2.14",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.5').answer.value"
}
} ]
} ],
"text": "Address",
"type": "group",
"linkId": "c40.9.2",
"required": false
}, {
"text": "Information about institution for the site where study will be conducted",
"type": "display",
"linkId": "c40.9_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": "Study Site Institution",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#2a623d; font-size: 125%"
} ]
},
"linkId": "c40.9",
"required": false
} ],
"text": "Study Site Principal Investigator and Study Site",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 150%"
} ]
},
"linkId": "c40",
"required": false
}, {
"item": [ {
"text": "Statement about Lead PI and Lead PI Site for Consent Form at Relying Site",
"type": "text",
"linkId": "c49.1",
"initial": [ {
"valueString": "In multi-site studies, there is a lead institution that is responsible for the overall coordination of the study. The lead institution has a lead Principal Investigator who is responsible for the overall conduct of the study. The lead site and lead Principal Investigator are listed here for your information."
} ],
"required": false,
"enableWhen": [ {
"operator": "!=",
"question": "c38.2",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
}, {
"item": [ {
"item": [ {
"text": "First or given name of the lead PI",
"type": "display",
"linkId": "c49.2.2_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": "First Name",
"type": "string",
"linkId": "c49.2.2",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.descendants().where(linkId = 'in7.3.1').answer.value"
}
} ]
}, {
"item": [ {
"text": "Surname or family name of the lead PI",
"type": "display",
"linkId": "c49.2.1_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": "Last Name",
"type": "string",
"linkId": "c49.2.1",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.descendants().where(linkId = 'in7.3.2').answer.value"
}
} ]
}, {
"item": [ {
"text": "Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc.",
"type": "display",
"linkId": "c49.2.6_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": "Suffix",
"type": "string",
"linkId": "c49.2.6",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.descendants().where(linkId = 'in7.3.3').answer.value"
}
} ]
}, {
"item": [ {
"text": "Professional and Academic degrees of the lead PI",
"type": "display",
"linkId": "c49.2.3_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": "Degree(s)",
"type": "string",
"linkId": "c49.2.3",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.descendants().where(linkId = 'in7.3.4').answer.value"
}
} ]
}, {
"item": [ {
"item": [ {
"text": "10-digit phone number, including area code",
"type": "display",
"linkId": "c49.2.5.20_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Phone",
"type": "string",
"linkId": "c49.2.5.20",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.descendants().where(linkId = 'in7.3.5').answer.value"
}
} ]
}, {
"text": "Email",
"type": "string",
"linkId": "c49.2.5.21",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.descendants().where(linkId = 'in7.3.6').answer.value"
}
} ]
}, {
"text": "Information on how to contact the Lead PI.",
"type": "display",
"linkId": "c49.2.5_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": "Contact Information",
"type": "group",
"linkId": "c49.2.5",
"required": false
}, {
"text": "Person(s) designated as the lead PI(s) for the multisite clinical trial; has the appropriate level of authority and responsibility to direct the research being conducted at all sites participating in the clinical trial.",
"type": "display",
"linkId": "c49.2_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": "Lead Principal Investigator",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#2a623d; font-size: 125%"
} ]
},
"linkId": "c49.2",
"required": false
}, {
"item": [ {
"item": [ {
"text": "Public or private entity associated with the lead principal investigator conducting the overall study.",
"type": "display",
"linkId": "c49.5.1_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": "Name",
"type": "string",
"linkId": "c49.5.1",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.descendants().where(linkId = 'in7.1.1').answer.value"
}
} ]
}, {
"item": [ {
"text": "Street Address",
"type": "string",
"linkId": "c49.5.2.10",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.descendants().where(linkId = 'in7.3.7.1').answer.value"
}
} ]
}, {
"text": "City",
"type": "string",
"linkId": "c49.5.2.11",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.descendants().where(linkId = 'in7.3.7.2').answer.value"
}
} ]
}, {
"text": "State",
"type": "string",
"linkId": "c49.5.2.12",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.descendants().where(linkId = 'in7.3.7.3').answer.value"
}
} ]
}, {
"text": "Zip Code",
"type": "string",
"linkId": "c49.5.2.13",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.descendants().where(linkId = 'in7.3.7.4').answer.value"
}
} ]
}, {
"text": "Country",
"type": "string",
"linkId": "c49.5.2.14",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.descendants().where(linkId = 'in7.3.7.5').answer.value"
}
} ]
} ],
"text": "Address",
"type": "group",
"linkId": "c49.5.2",
"required": false
}, {
"text": "Information about Lead Institution",
"type": "display",
"linkId": "c49.5_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": "Lead Principal Investigator Institution",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#2a623d; font-size: 125%"
} ]
},
"linkId": "c49.5",
"required": false,
"enableWhen": [ {
"operator": "!=",
"question": "c38.2",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
} ],
"text": "Lead Principal Investigator and Lead Principal Investigator Site",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 150%"
} ]
},
"linkId": "c49",
"required": false,
"enableWhen": [ {
"operator": "!=",
"question": "c38.2",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
}, {
"item": [ {
"text": "External Data For linkId c4.1",
"type": "open-choice",
"linkId": "ExternalDataFor_c4.1",
"repeats": true,
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.item.where(repeat(item).where(linkId = 'in5.1' and answer.value.code = 'SFS')).repeat(item).where(linkId = 'in5.2').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": "Entity financially supporting the research",
"type": "display",
"linkId": "c4.1_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": "Sponsor Name",
"type": "open-choice",
"linkId": "c4.1",
"repeats": true,
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
}, {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-answerExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%resource.repeat(item).where(linkId = 'ExternalDataFor_c4.1').answer.value"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/designNote",
"valueMarkdown": "See FHIR Specification Feedback Jira ticket FHIR-36338. Information obtained from other types of external sources (e.g. launch context, fhir-x-query, etc.) SHOULD only be used for initialExpression and calculatedExpression logic. Other behavior such as enableWhen or answerExpression should always be driven off of answers within the Questionnaire (even if they are hidden answers that are populated from an initialExpression)."
} ]
} ],
"text": "Sponsor or Funding Source",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 150%"
} ]
},
"linkId": "c4",
"repeats": false,
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Group Table",
"coding": [ {
"code": "gtable",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Group Table"
} ]
}
} ]
}, {
"item": [ {
"text": "Any additional relevant information about the sponsor(s)",
"type": "display",
"linkId": "c5_help",
"extension": [ {
"url": "http://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": "Sponsor Detail",
"type": "text",
"linkId": "c5",
"required": false
}, {
"item": [ {
"text": "Consent that is obtained electronically",
"type": "display",
"linkId": "c6_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Is this consent an eConsent?",
"type": "choice",
"linkId": "c6",
"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": [ {
"item": [ {
"text": "Describes the basic purpose, procedures and reasons behind the research in easily understood prose",
"type": "display",
"linkId": "c7.1_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": "Summary Text Statement",
"type": "text",
"linkId": "c7.1",
"required": true
}, {
"text": "Section header for the mandated text describing the basic purpose, procedures and reasons for the study.",
"type": "display",
"linkId": "c7_help",
"extension": [ {
"url": "http://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": "Summary Text",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 150%"
} ]
},
"linkId": "c7",
"required": false
}, {
"item": [ {
"text": "About Consent Form",
"type": "text",
"linkId": "c8.1",
"initial": [ {
"valueString": "This consent form describes a research study, what you may expect if you decide to take part and important information to help you make your decision. Please read this form carefully and ask questions about anything that is not clear before you agree to participate. We encourage you to discuss this research with family or friends before consenting to participate."
} ],
"required": false
}, {
"text": "Introductory Paragraph to the participant. Includes statement of research and explanation of the consent process.",
"type": "display",
"linkId": "c8_help",
"extension": [ {
"url": "http://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": "Introduction and Statement of Research",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 150%"
} ]
},
"linkId": "c8",
"required": false
}, {
"item": [ {
"item": [ {
"text": "Explanation about why the study is being conducted",
"type": "display",
"linkId": "c9.1_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": "Reason for Research",
"type": "text",
"linkId": "c9.1",
"required": false
}, {
"item": [ {
"text": "Statement of whom the participant can anticipate interacting with during study participation",
"type": "display",
"linkId": "c9.2_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": "Interactions with others",
"type": "text",
"linkId": "c9.2",
"required": false
}, {
"item": [ {
"text": "High level information about what participating in the study will entail for the participant",
"type": "display",
"linkId": "c9.3_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": "Invited Participants",
"type": "text",
"linkId": "c9.3",
"required": false
}, {
"item": [ {
"text": "The total number of people targeted for enrollment in the multi-site study",
"type": "display",
"linkId": "c9.4_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": "Total expected study enrollment",
"type": "integer",
"linkId": "c9.4",
"required": false
}, {
"item": [ {
"text": "Additional field for including miscellaneous enrollment information. May include information about total enrollment from the relying site",
"type": "display",
"linkId": "c9.5_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": "Additional Enrollment Text",
"type": "text",
"linkId": "c9.5",
"required": false
}, {
"item": [ {
"text": "High level information about what participating in the study will entail for the participant.",
"type": "display",
"linkId": "c9.6_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": "What is involved in the study?",
"type": "text",
"linkId": "c9.6",
"required": false
} ],
"text": "Purpose",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 150%"
} ]
},
"linkId": "c9",
"required": false
}, {
"item": [ {
"item": [ {
"item": [ {
"text": "Short name of the assessment",
"type": "display",
"linkId": "c10.1.1_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Name of the Assessment",
"type": "string",
"linkId": "c10.1.1",
"required": false
}, {
"item": [ {
"text": "Short description of the assessment",
"type": "display",
"linkId": "c10.1.2_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": "Description of Assessment",
"type": "text",
"linkId": "c10.1.2",
"required": false
} ],
"text": "Assessment List",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#2a623d; font-size: 125%"
} ]
},
"linkId": "c10.1",
"repeats": true,
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Group Table",
"coding": [ {
"code": "gtable",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Group Table"
} ]
}
} ]
}, {
"type": "display",
"linkId": "c10.31"
}, {
"item": [ {
"text": "Additional text to provide additional context about the assessments collected",
"type": "display",
"linkId": "c10.2_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": "Assessment Supplemental Text",
"type": "text",
"linkId": "c10.2",
"required": false
}, {
"type": "display",
"linkId": "c10.32"
}, {
"item": [ {
"text": "If you upload a table, it must be in .csv format or .xlsx format and it must have the same columns in the same order as in the \"Assessment List\" table in the questionnaire.",
"type": "display",
"linkId": "c10.3_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": "Do you want to upload the \"Assessment List\" table instead of typing the assessments directly into this questionnaire?",
"type": "choice",
"linkId": "c10.3",
"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"
},
"initialSelected": true
} ]
}, {
"item": [ {
"text": "Describe the file that is being attached (optional)",
"type": "string",
"linkId": "c10.4.1",
"required": false
}, {
"text": "Upload attachment(s) here.",
"type": "attachment",
"linkId": "c10.4.2"
} ],
"text": "Assessment List Attachment(s)",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#2a623d; font-size: 125%"
} ]
},
"linkId": "c10.4",
"repeats": true,
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "c10.3",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
}, {
"type": "display",
"linkId": "c10.33"
} ],
"text": "Assessments",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 150%"
} ]
},
"linkId": "c10",
"required": false
}, {
"item": [ {
"item": [ {
"text": "Introductory Text to include prior to the visit table to introduce what the tables contain and explain any additional detail or information about the visit schedule.",
"type": "display",
"linkId": "c11.1_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": "Visit Introductory Text",
"type": "text",
"linkId": "c11.1",
"required": false
}, {
"item": [ {
"item": [ {
"text": "Unique visit type, defined by the procedures which are completed within that visit. E.g. Screening, Baseline, Followup, Final",
"type": "display",
"linkId": "c11.2.1_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": "Visit Type",
"type": "string",
"linkId": "c11.2.1",
"required": false
}, {
"item": [ {
"text": "Description of Visit types, including what procedures it contains",
"type": "display",
"linkId": "c11.2.2_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": "Visit Description",
"type": "text",
"linkId": "c11.2.2",
"required": false
}, {
"text": "Visit Duration",
"type": "decimal",
"linkId": "c11.2.3",
"required": false
}, {
"item": [ {
"text": "Choices for visit duration units are minutes (min), hours (h) or days (d).",
"type": "display",
"linkId": "c11.2.4_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": "Visit Duration Units",
"type": "choice",
"linkId": "c11.2.4",
"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": "min",
"system": "http://unitsofmeasure.org",
"display": "min"
}
}, {
"valueCoding": {
"code": "h",
"system": "http://unitsofmeasure.org",
"display": "h"
}
}, {
"valueCoding": {
"code": "d",
"system": "http://unitsofmeasure.org",
"display": "d"
}
} ]
}, {
"text": "Number of Visits",
"type": "integer",
"linkId": "c11.2.5",
"required": false
} ],
"text": "Visit List",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#2a623d; font-size: 125%"
} ]
},
"linkId": "c11.2",
"repeats": true,
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Group Table",
"coding": [ {
"code": "gtable",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Group Table"
} ]
}
} ]
}, {
"type": "display",
"linkId": "c11.31"
}, {
"item": [ {
"text": "If you upload a table, it must be in .csv format or .xlsx format and it must have the same columns in the same order as in the \"Visit List\" table in the questionnaire.",
"type": "display",
"linkId": "c11.6_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": "Do you want to upload the \"Visit List\" table instead of typing the visits directly into this questionnaire?",
"type": "choice",
"linkId": "c11.6",
"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"
},
"initialSelected": true
} ]
}, {
"item": [ {
"text": "Describe the file that is being attached (optional)",
"type": "string",
"linkId": "c11.7.1",
"required": false
}, {
"text": "Upload attachment(s) here.",
"type": "attachment",
"linkId": "c11.7.2"
} ],
"text": "Visit List Attachment(s)",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#2a623d; font-size: 125%"
} ]
},
"linkId": "c11.7",
"repeats": true,
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "c11.6",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
}, {
"type": "display",
"linkId": "c11.32"
}, {
"item": [ {
"text": "Name of Procedure",
"type": "string",
"linkId": "c11.3.1",
"required": false
}, {
"text": "Common Term of Procedure",
"type": "string",
"linkId": "c11.3.2",
"required": false
}, {
"text": "Description of a Procedure",
"type": "text",
"linkId": "c11.3.3",
"required": false
}, {
"text": "Experimental Procedure Indicator",
"type": "choice",
"linkId": "c11.3.4",
"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"
}
} ]
}, {
"text": "Research Indicator",
"type": "choice",
"linkId": "c11.3.5",
"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": "RES",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Research"
}
}, {
"valueCoding": {
"code": "STDCR",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Standard of Care"
}
} ]
}, {
"item": [ {
"text": "Specify the procedure frequency and the applicable frequency units. For example, 4 times per year or 2 times per week.",
"type": "display",
"linkId": "c11.3.6_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": "Frequency",
"type": "string",
"linkId": "c11.3.6",
"required": false
}, {
"item": [ {
"text": "Specify the procedure duration in minutes",
"type": "display",
"linkId": "c11.3.9_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": "Procedure Duration (minutes)",
"type": "integer",
"linkId": "c11.3.9",
"required": false
} ],
"text": "Procedure List",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#2a623d; font-size: 125%"
} ]
},
"linkId": "c11.3",
"repeats": true,
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Group Table",
"coding": [ {
"code": "gtable",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Group Table"
} ]
}
} ]
}, {
"type": "display",
"linkId": "c11.33"
}, {
"item": [ {
"text": "Additional Text to include after the procedure table to provide the participant with any additional information needed about procedure schedule",
"type": "display",
"linkId": "c11.4_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": "Procedure Supplemental Text",
"type": "text",
"linkId": "c11.4",
"required": false
}, {
"type": "display",
"linkId": "c11.34"
}, {
"item": [ {
"text": "If you upload a table, it must be in .csv format or .xlsx format and it must have the same columns in the same order as in the \"Procedure List\" table in the questionnaire.",
"type": "display",
"linkId": "c11.9_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": "Do you want to upload the \"Procedure List\" table instead of typing the procedures directly into this questionnaire?",
"type": "choice",
"linkId": "c11.9",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "Yes"
}
}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No"
},
"initialSelected": true
} ]
}, {
"item": [ {
"text": "Describe the file that is being attached (optional)",
"type": "string",
"linkId": "c11.10.1",
"required": false
}, {
"text": "Upload attachment(s) here.",
"type": "attachment",
"linkId": "c11.10.2"
} ],
"text": "Procedure List Attachment(s)",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#2a623d; font-size: 125%"
} ]
},
"linkId": "c11.10",
"repeats": true,
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "c11.9",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
}, {
"type": "display",
"linkId": "c11.35"
}, {
"item": [ {
"text": "Time elapsed for a participant to be part of the study from initial enrollment to final discharge or completion",
"type": "display",
"linkId": "c11.5_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": "Total Duration of Study Participation",
"type": "string",
"linkId": "c11.5",
"required": false
} ],
"text": "Visits and Procedures",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 150%"
} ]
},
"linkId": "c11",
"required": false
}, {
"item": [ {
"item": [ {
"text": "Name of the risk",
"type": "string",
"linkId": "c12.1.1",
"required": false
}, {
"text": "Description of Risk",
"type": "text",
"linkId": "c12.1.2",
"required": false
}, {
"text": "Risk Category",
"type": "choice",
"linkId": "c12.1.3",
"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": "PHYS",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Physical"
}
}, {
"valueCoding": {
"code": "NONPHYS",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Non-Physical"
}
} ]
} ],
"text": "Risk List",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#2a623d; font-size: 125%"
} ]
},
"linkId": "c12.1",
"repeats": true,
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Group Table",
"coding": [ {
"code": "gtable",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Group Table"
} ]
}
} ]
}, {
"type": "display",
"linkId": "c12.33"
}, {
"item": [ {
"text": "If you upload a table, it must be in .csv format or .xlsx format and it must have the same columns in the same order as in the \"Risk List\" table in the questionnaire.",
"type": "display",
"linkId": "c12.9_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": "Do you want to upload the \"Risk List\" table instead of typing the risks directly into this questionnaire?",
"type": "choice",
"linkId": "c12.9",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "Yes"
}
}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No"
},
"initialSelected": true
} ]
}, {
"item": [ {
"text": "Describe the file that is being attached (optional)",
"type": "string",
"linkId": "c12.10.1",
"required": false
}, {
"text": "Upload attachment(s) here.",
"type": "attachment",
"linkId": "c12.10.2"
} ],
"text": "Risk List Attachment(s)",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#2a623d; font-size: 125%"
} ]
},
"linkId": "c12.10",
"repeats": true,
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "c12.9",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
}, {
"type": "display",
"linkId": "c12.37"
}, {
"item": [ {
"text": "Additional text for description of other risks",
"type": "display",
"linkId": "c12.2_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": "Risk Supplemental Text",
"type": "text",
"linkId": "c12.2",
"required": false
}, {
"item": [ {
"text": "Indicates whether risks to the fetus are possible",
"type": "display",
"linkId": "c12.3_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": "Fetal Risks",
"type": "choice",
"linkId": "c12.3",
"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": "Textual description of risks to the fetus",
"type": "display",
"linkId": "c12.4_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": "Fetal Risk Details",
"type": "text",
"linkId": "c12.4",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "c12.3",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
} ],
"text": "Risks",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 150%"
} ]
},
"linkId": "c12",
"required": false
}, {
"item": [ {
"item": [ {
"text": "Describe any other treatment/procedure that may be used other than those described for study participation.",
"type": "display",
"linkId": "c13.1_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": "Alternative Procedure Text",
"type": "text",
"linkId": "c13.1",
"required": false
} ],
"text": "Alternative Procedures",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 150%"
} ]
},
"linkId": "c13",
"required": false
}, {
"item": [ {
"item": [ {
"text": "Name of Benefit",
"type": "string",
"linkId": "c14.1.1",
"required": false
}, {
"text": "Description of Benefit",
"type": "text",
"linkId": "c14.1.2",
"required": false
}, {
"text": "Benefit to you",
"type": "choice",
"linkId": "c14.1.3",
"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"
}
} ]
}, {
"text": "Benefit to society",
"type": "choice",
"linkId": "c14.1.4",
"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"
}
} ]
} ],
"text": "Benefits List",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#2a623d; font-size: 125%"
} ]
},
"linkId": "c14.1",
"repeats": true,
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Group Table",
"coding": [ {
"code": "gtable",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Group Table"
} ]
}
} ]
}, {
"type": "display",
"linkId": "c14.31"
}, {
"item": [ {
"text": "If you upload a table, it must be in .csv format or .xlsx format and it must have the same columns in the same order as in the \"Procedure List\" table in the questionnaire.",
"type": "display",
"linkId": "c14.9_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": "Do you want to upload the \"Benefits List\" table instead of typing the benefits directly into this questionnaire?",
"type": "choice",
"linkId": "c14.9",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "Yes"
}
}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No"
},
"initialSelected": true
} ]
}, {
"item": [ {
"text": "Describe the file that is being attached (optional)",
"type": "string",
"linkId": "c14.10.1",
"required": false
}, {
"text": "Upload attachment(s) here.",
"type": "attachment",
"linkId": "c14.10.2"
} ],
"text": "Benefits List Attachment(s)",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#2a623d; font-size: 125%"
} ]
},
"linkId": "c14.10",
"repeats": true,
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "c14.9",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
}, {
"type": "display",
"linkId": "c14.33"
} ],
"text": "Benefits",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 150%"
} ]
},
"linkId": "c14",
"repeats": false,
"required": false
}, {
"item": [ {
"item": [ {
"text": "Indicates whether compensation will be offered or not for the study",
"type": "display",
"linkId": "c15.1_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": "Will there be compensation for participation?",
"type": "choice",
"linkId": "c15.1",
"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": "Additional text about compensation not captured in the compensation table",
"type": "display",
"linkId": "c15.2_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": "Compensation Supplemental Text",
"type": "text",
"linkId": "c15.2",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "c15.1",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
}, {
"linkId": "c15.3",
"repeats": true,
"item": [ {
"text": "What types of visits or milestones will I be compensated for?",
"type": "text",
"linkId": "c15.3.1",
"required": false
}, {
"text": "How many visits or milestones of this type will there be compensation for?",
"type": "integer",
"linkId": "c15.3.2",
"required": false
}, {
"text": "How much will be paid per that type of visit?",
"type": "text",
"linkId": "c15.3.3",
"required": false
} ],
"type": "group",
"enableWhen": [ {
"operator": "=",
"question": "c15.1",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Group Table",
"coding": [ {
"code": "gtable",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Group Table"
} ]
}
} ],
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#2a623d; font-size: 125%"
} ]
},
"required": false,
"text": "Compensation List"
}, {
"type": "display",
"linkId": "c15.33"
}, {
"item": [ {
"text": "If you upload a table, it must be in .csv format or .xlsx format and it must have the same columns in the same order as in the \"Compensation List\" table in the questionnaire.",
"type": "display",
"linkId": "c15.5_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": "Do you want to upload the \"Compensation List\" table instead of typing the risks directly into this questionnaire?",
"type": "choice",
"linkId": "c15.5",
"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": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "Yes"
}
}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No"
},
"initialSelected": true
} ]
}, {
"item": [ {
"text": "Describe the file that is being attached (optional)",
"type": "string",
"linkId": "c15.7.1",
"required": false
}, {
"text": "Upload attachment(s) here.",
"type": "attachment",
"linkId": "c15.7.2"
} ],
"text": "Compensation List Attachment(s)",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#2a623d; font-size: 125%"
} ]
},
"linkId": "c15.7",
"repeats": true,
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "c15.5",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
}, {
"type": "display",
"linkId": "c15.35"
} ],
"text": "Compensation",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 150%"
} ]
},
"linkId": "c15",
"required": false
}, {
"item": [ {
"item": [ {
"text": "Explanation informing participant if any additional costs will occur to the participant as a result of taking part in the study",
"type": "display",
"linkId": "c16.1_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": "What are the costs of participation, if any?",
"type": "text",
"linkId": "c16.1",
"required": false
}, {
"item": [ {
"text": "Reimbursement to participant for other study visit costs not directly associated with a visit",
"type": "display",
"linkId": "c16.2_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": "Will there be reimbursement for other study visit costs incurred?",
"type": "choice",
"linkId": "c16.2",
"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": "Indicates if participant or the participant's insurance will be responsible for any injury which occurs or if the sponsor will cover any treatment costs for injury",
"type": "display",
"linkId": "c16.3_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": "Will costs be covered for medical treatment if research related injury occurs?",
"type": "choice",
"linkId": "c16.3",
"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": "TRTNOTCOV",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Treatment not covered"
}
}, {
"valueCoding": {
"code": "RRICOV",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Research Related injury covered"
}
}, {
"valueCoding": {
"code": "ACNOTCICOV",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Acute but not chronic injury covered"
}
} ]
}, {
"item": [ {
"text": "Description of other costs not directly associated with a visit",
"type": "display",
"linkId": "c16.4_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": "Additional description of treatment coverage",
"type": "text",
"linkId": "c16.4",
"required": false
} ],
"text": "Costs",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 150%"
} ]
},
"linkId": "c16",
"required": false
}, {
"item": [ {
"item": [ {
"text": "Statement of particpant rights",
"type": "display",
"linkId": "c17.1_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": "What are the rights of a participant?",
"type": "text",
"linkId": "c17.1",
"required": false
}, {
"item": [ {
"text": "IRB Contact Name",
"type": "string",
"linkId": "c17.2.1",
"required": false
}, {
"text": "IRB Name",
"type": "string",
"linkId": "c17.2.8",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.descendants().where(linkId = 'in6.1').answer.value"
}
} ]
}, {
"text": "Department Name or Division",
"type": "string",
"linkId": "c17.2.9",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.descendants().where(linkId = 'in6.10').answer.value"
}
} ]
}, {
"text": "Street Address",
"type": "string",
"linkId": "c17.2.10",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.descendants().where(linkId = 'in6.3').answer.value"
}
} ]
}, {
"text": "City",
"type": "string",
"linkId": "c17.2.11",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.descendants().where(linkId = 'in6.4').answer.value"
}
} ]
}, {
"text": "State",
"type": "string",
"linkId": "c17.2.12",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.descendants().where(linkId = 'in6.5').answer.value"
}
} ]
}, {
"text": "Zip Code",
"type": "string",
"linkId": "c17.2.13",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.descendants().where(linkId = 'in6.6').answer.value"
}
} ]
}, {
"text": "Country",
"type": "string",
"linkId": "c17.2.14",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.descendants().where(linkId = 'in6.7').answer.value"
}
} ]
}, {
"item": [ {
"text": "10-digit phone number, including area code",
"type": "display",
"linkId": "c17.2.20_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Phone",
"type": "string",
"linkId": "c17.2.20",
"required": false
}, {
"text": "Email",
"type": "string",
"linkId": "c17.2.21",
"required": false
}, {
"text": "Contact information for the site IRB contact.",
"type": "display",
"linkId": "c17.2_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": "Site IRB Contact Information",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#2a623d; font-size: 125%"
} ]
},
"linkId": "c17.2",
"repeats": false,
"required": false
}, {
"item": [ {
"text": "Study Coordinator Name",
"type": "string",
"linkId": "c17.3.1",
"required": false
}, {
"text": "Study Coordinator Institution or Organization",
"type": "string",
"linkId": "c17.3.8",
"required": false
}, {
"text": "Department Name or Division",
"type": "string",
"linkId": "c17.3.9",
"required": false
}, {
"text": "Street Address",
"type": "string",
"linkId": "c17.3.10",
"required": false
}, {
"text": "City",
"type": "string",
"linkId": "c17.3.11",
"required": false
}, {
"text": "State",
"type": "string",
"linkId": "c17.3.12",
"required": false
}, {
"text": "Zip Code",
"type": "string",
"linkId": "c17.3.13",
"required": false
}, {
"text": "Country",
"type": "string",
"linkId": "c17.3.14",
"required": false
}, {
"item": [ {
"text": "10-digit phone number, including area code",
"type": "display",
"linkId": "c17.3.20_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Phone",
"type": "string",
"linkId": "c17.3.20",
"required": false
}, {
"text": "Email",
"type": "string",
"linkId": "c17.3.21",
"required": false
}, {
"text": "Contact information for the study coordinator",
"type": "display",
"linkId": "c17.3_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Study Coordinator Contact Information",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#2a623d; font-size: 125%"
} ]
},
"linkId": "c17.3",
"required": false
}, {
"item": [ {
"text": "Site Principal Investigator Name",
"type": "string",
"linkId": "c17.4.1",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.where(linkId = 'in8.10').answer.value"
}
} ]
}, {
"text": "Site Principal Investigator Institution",
"type": "string",
"linkId": "c17.4.8",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.1.1').answer.value"
}
} ]
}, {
"text": "Department Name or Division",
"type": "string",
"linkId": "c17.4.9",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.1.10').answer.value"
}
} ]
}, {
"text": "Street Address",
"type": "string",
"linkId": "c17.4.10",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.1').answer.value"
}
} ]
}, {
"text": "City",
"type": "string",
"linkId": "c17.4.11",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.item.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": "c17.4.12",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.3').answer.value"
}
} ]
}, {
"text": "Zip Code",
"type": "string",
"linkId": "c17.4.13",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.4').answer.value"
}
} ]
}, {
"text": "Country",
"type": "string",
"linkId": "c17.4.14",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.7.5').answer.value"
}
} ]
}, {
"item": [ {
"text": "10-digit phone number, including area code",
"type": "display",
"linkId": "c17.4.20_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Phone",
"type": "string",
"linkId": "c17.4.20",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.5').answer.value"
}
} ]
}, {
"text": "Email",
"type": "string",
"linkId": "c17.4.21",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.item.where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.6').answer.value"
}
} ]
}, {
"text": "Contact information for the PI. May be replicated from above.",
"type": "display",
"linkId": "c17.4_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": "Site Principal Investigator Contact Information",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#2a623d; font-size: 125%"
} ]
},
"linkId": "c17.4",
"repeats": false,
"required": false
} ],
"text": "Participant Rights and whom to contact for answers",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 150%"
} ]
},
"linkId": "c17",
"required": false
}, {
"item": [ {
"item": [ {
"text": "Standard prepopulated statement, can be edited.",
"type": "display",
"linkId": "c18.1_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": "Voluntary Permission Statement",
"type": "text",
"linkId": "c18.1",
"initial": [ {
"valueString": "Participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled."
} ],
"required": false
}, {
"item": [ {
"text": "Anticipated circumstances under which subject's participation may be terminated by investigator without regard to subject's or legally authorized representative's consent",
"type": "display",
"linkId": "c18.2_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": "What are the anticipated circumstances under which participant's participation may be terminated by the investigator without regard to the participant's or the legally authorized representative's consent.",
"type": "text",
"linkId": "c18.2",
"required": false
} ],
"text": "Participation",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 150%"
} ]
},
"linkId": "c18",
"required": false
}, {
"item": [ {
"text": "Are there consequences to participant for early withdrawal?",
"type": "choice",
"linkId": "c19.1",
"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"
}
} ]
}, {
"text": "Are there Emotional Consequences of Withdrawal",
"type": "choice",
"linkId": "c19.2",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"enableWhen": [ {
"operator": "=",
"question": "c19.1",
"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"
}
} ]
}, {
"text": "Are there Physical Consequences of Withdrawal",
"type": "choice",
"linkId": "c19.3",
"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"
} ]
}
} ],
"enableWhen": [ {
"operator": "=",
"question": "c19.1",
"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"
}
} ]
}, {
"item": [ {
"text": "Description of the withdrawal consequences, will depend and vary based on type of study.",
"type": "display",
"linkId": "c19.4_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": "What are the consequences of withdrawal?",
"type": "text",
"linkId": "c19.4",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "c19.1",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
} ],
"text": "Early Withdrawal",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 150%"
} ]
},
"linkId": "c19",
"required": false
}, {
"item": [ {
"text": "Will HIPAA content be included within this document?",
"type": "choice",
"linkId": "c20.1",
"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": "If template information required for your state differs from text provided, reword to satisfy state requirements.",
"type": "display",
"linkId": "c20.2_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": "Medical information and billing statement",
"type": "text",
"linkId": "c20.2",
"initial": [ {
"valueString": "Medical information and billing records are protected by the privacy regulations of the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA). This type of information is called protected health information (PHI). PHI about you may be obtained from any hospital, doctor, and other health care provider involved in your care."
} ],
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "c20.1",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
}, {
"item": [ {
"text": "Indicates if records identifying a subject will be maintained.",
"type": "display",
"linkId": "c20.3_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": "Will confidentiality be protected?",
"type": "choice",
"linkId": "c20.3",
"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": "Explanation about processes and procedures to support maintaining privacy and confidentiality",
"type": "display",
"linkId": "c20.4_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": "How will confidentiality be protected?",
"type": "text",
"linkId": "c20.4",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "c20.3",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
}, {
"item": [ {
"text": "Indicates if any data security policy applies to this consent, including device use.",
"type": "display",
"linkId": "c20.5_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": "Are there data security or policies that need to be included in the consent, particularly around device use (optional)",
"type": "choice",
"linkId": "c20.5",
"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": "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": "Optional field for capturing information on IT related data security policies. Example, use of encryption when utilizing mobile data collection",
"type": "display",
"linkId": "c20.6_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": "Describe any data security policies and processes protecting the data",
"type": "text",
"linkId": "c20.6",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "c20.5",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
}, {
"item": [ {
"text": "Role or group who will have access to data",
"type": "open-choice",
"linkId": "c20.7.1",
"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": "OTHINSTRES",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Researchers at other institutions"
}
}, {
"valueCoding": {
"code": "THISINSTRES",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Researchers outside the study team at this institution"
}
}, {
"valueCoding": {
"code": "EXTREGAUTH",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "External Regulatory Authorities"
}
} ]
}, {
"text": "Description of Information Disclosed",
"type": "text",
"linkId": "c20.7.2",
"required": false
} ],
"text": "Who can use or see participant information?",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#2a623d; font-size: 125%"
} ]
},
"linkId": "c20.7",
"repeats": true,
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Group Table",
"coding": [ {
"code": "gtable",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Group Table"
} ]
}
} ]
}, {
"item": [ {
"text": "Indicates whether these data will be used beyond the study window",
"type": "display",
"linkId": "c20.8_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": "Will the data be released for future use?",
"type": "choice",
"linkId": "c20.8",
"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": "Indicates if shared data will retain any identifiers.",
"type": "display",
"linkId": "c20.9_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": "Will the future use data be deidentified?",
"type": "choice",
"linkId": "c20.9",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"enableWhen": [ {
"operator": "=",
"question": "c20.8",
"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"
}
} ]
}, {
"item": [ {
"text": "Description of deidentification details for future use datasets.",
"type": "display",
"linkId": "c20.10_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": "Deidentification detail",
"type": "text",
"linkId": "c20.10",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "c20.9",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
}, {
"item": [ {
"text": "Select the appropriate required text statement about disclosure surrounding future use of participant's data from the two standardized statements.",
"type": "display",
"linkId": "c20.11_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": "Required text disclosure surrounding future use.",
"type": "choice",
"linkId": "c20.11",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"enableWhen": [ {
"operator": "=",
"question": "c20.8",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "DEIDUSED",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Identifiers might be removed from private information or biospecimens, and this information could then be used for future research studies or distributed to another investigator for future research studies without additional informed consent."
}
}, {
"valueCoding": {
"code": "DEIDNOTUSED",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Information or biospecimens collected will not be used or distributed for future research studies, even if deidentified."
}
} ]
} ],
"text": "Confidentiality of Records",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 150%"
} ]
},
"linkId": "c20",
"required": false
}, {
"item": [ {
"text": "Were specimens collected as part of this study?",
"type": "choice",
"linkId": "c21.1",
"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": "Indicator of if genome sequencing is being conducted in conjunction with study",
"type": "display",
"linkId": "c21.2_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": "Is whole genome sequencing being conducted?",
"type": "choice",
"linkId": "c21.2",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"enableWhen": [ {
"operator": "=",
"question": "c21.1",
"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"
}
} ]
}, {
"item": [ {
"text": "Indicator of whether biospecimens will be shared outside of the immediate study team or institution.",
"type": "display",
"linkId": "c21.3_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": "Sharing or no Sharing of samples.",
"type": "choice",
"linkId": "c21.3",
"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"
} ]
}
} ],
"enableWhen": [ {
"operator": "=",
"question": "c21.1",
"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"
}
} ]
}, {
"item": [ {
"text": "Textual description of sharing conditions including, type, when, etc.",
"type": "display",
"linkId": "c21.4_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": "Conditions of sharing",
"type": "text",
"linkId": "c21.4",
"required": false,
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"operator": "=",
"question": "c21.3",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
}, {
"item": [ {
"text": "Indicator of any plans to profit share any funds received as a result of commercial use of those samples.",
"type": "display",
"linkId": "c21.5_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": "Will participant share in profit with commerical use?",
"type": "choice",
"linkId": "c21.5",
"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"
} ]
}
} ],
"enableWhen": [ {
"operator": "=",
"question": "c21.1",
"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"
}
} ]
}, {
"item": [ {
"text": "Textual description of collection and storage procedures and policies for the study.",
"type": "display",
"linkId": "c21.6_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": "Description of Collection and Storage",
"type": "text",
"linkId": "c21.6",
"required": false,
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"operator": "=",
"question": "c21.1",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
}, {
"item": [ {
"text": "Indicator of revocation of sample consent is an option",
"type": "display",
"linkId": "c21.7_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": "Can consent for sample use be revoked?",
"type": "choice",
"linkId": "c21.7",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"enableWhen": [ {
"operator": "=",
"question": "c21.1",
"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"
}
} ]
} ],
"text": "Specimen Management",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 150%"
} ]
},
"linkId": "c21",
"required": false
}, {
"item": [ {
"text": "Statement of Broad Consent for Storage, maintenance and secondary research use",
"type": "text",
"linkId": "c22.1",
"initial": [ {
"valueString": "Participant identifiable information and identifiable biospecimens will be stored, used and shared for the kinds of future research described in this broad consent form, without anyone asking your permission for each new study. Identifying information may also be removed from your information and biospecimens, allowing them to be used for any future research or other purpose."
} ],
"enableWhen": [ {
"operator": "=",
"question": "c22",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
} ],
"text": "Will there be Broad Consent for Storage, maintenance and secondary research use?",
"type": "choice",
"linkId": "c22",
"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": [ {
"item": [ {
"text": "Description of the details for which the participant could be contacted",
"type": "display",
"linkId": "c23.1_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": "Conditions about contact for additional sample use, information not currently described or future research",
"type": "text",
"linkId": "c23.1",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "c23",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
}, {
"text": "Indicator if the participant contact information can be used for future questions or recuitment for this or other studies",
"type": "display",
"linkId": "c23_help",
"extension": [ {
"url": "http://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": "Can the study team contact you for future research?",
"type": "choice",
"linkId": "c23",
"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": "Details about any profit sharing agreements or why profits will not be shared.",
"type": "text",
"linkId": "c24.1",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "c24",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
}, {
"text": "Indicator of participants will receive any commercial profits resulting from their participation in study",
"type": "display",
"linkId": "c24_help",
"extension": [ {
"url": "http://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": "Will participants share in commercial profit?",
"type": "choice",
"linkId": "c24",
"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": "Indicator if study team will provide updates that may affect willingness to remain in study",
"type": "display",
"linkId": "c25_help",
"extension": [ {
"url": "http://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": "Will the study team contact you with new information that may affect your willingness to remain in the study",
"type": "choice",
"linkId": "c25",
"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": [ {
"item": [ {
"text": "Textual description of which results and when will be disclosed to you.",
"type": "display",
"linkId": "c26.1_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": "Condtions under which the study results will be disclosed to you",
"type": "text",
"linkId": "c26.1",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "c26",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
}, {
"text": "Indicator of study team will provide results of lab tests or other feedback of results to you at any time.",
"type": "display",
"linkId": "c26_help",
"extension": [ {
"url": "http://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": "Will the study team disclose clinically relevant study results to you?",
"type": "choice",
"linkId": "c26",
"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": "Clinical Trials.gov statement",
"type": "text",
"linkId": "c27",
"initial": [ {
"valueString": "A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time."
} ],
"readOnly": true,
"required": false
}, {
"item": [ {
"item": [ {
"text": "Indicator if study is covered under a certificate of confidentiality (automatially issued for NIH studies)",
"type": "display",
"linkId": "c28.1_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": "Certificate of Confidentiality Statement",
"type": "text",
"linkId": "c28.1",
"initial": [ {
"valueString": "The Department of Health and Human Services (HHS) has issued a Certificate of Confidentiality to further protect your privacy. With this Certificate, the investigators may not disclose research information that may identify you in any Federal, State, or local civil, criminal, administrative, legislative, or other proceedings, unless you have consented for this use.[trunc]"
} ],
"readOnly": true,
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "c28",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
}, {
"item": [ {
"text": "Add any required text per your state laws.",
"type": "display",
"linkId": "c28.2_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": "Required Disclosures based on state law",
"type": "text",
"linkId": "c28.2",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "c28",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
} ],
"text": "Is this study covered under a Certificate of Confidentiality? (default Y in NIH)",
"type": "choice",
"linkId": "c28",
"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": "PHI authorization expiration. Might be never, a certain date, or a period after a study milestone, such as 6 months after study closure.",
"type": "display",
"linkId": "c29_help",
"extension": [ {
"url": "http://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": "When will the PHI Authorization Expire based on date or time past an event",
"type": "text",
"linkId": "c29",
"required": false
}, {
"text": "Statement of PHI Authorization Revocation",
"type": "text",
"linkId": "c30",
"initial": [ {
"valueString": "Participants have the ability to revoke their consent to share PHI at any time but that there are limitations on what restrictions can apply to data that has already been shared."
} ],
"required": false
}, {
"item": [ {
"text": "Indicator to include Participant Signature and Date/Time",
"type": "choice",
"linkId": "c31.1",
"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"
}
} ]
}, {
"text": "Indicator to include Assent Signature and Date/Time",
"type": "choice",
"linkId": "c31.2",
"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": "Indicator to include Legally Authorized Representative Signature and Date/Time",
"type": "choice",
"linkId": "c31.3",
"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"
}
} ]
}, {
"text": "Relationship of Legally Authorized Representative",
"type": "choice",
"linkId": "c31.4",
"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": "PAR",
"system": "http://terminology.hl7.org/CodeSystem/v2-0063",
"display": "Parent"
}
}, {
"valueCoding": {
"code": "SPO",
"system": "http://terminology.hl7.org/CodeSystem/v2-0063",
"display": "Spouse"
}
}, {
"valueCoding": {
"code": "CHD",
"system": "http://terminology.hl7.org/CodeSystem/v2-0063",
"display": "Child"
}
}, {
"valueCoding": {
"code": "SIB",
"system": "http://terminology.hl7.org/CodeSystem/v2-0063",
"display": "Sibling"
}
}, {
"valueCoding": {
"code": "GRD",
"system": "http://terminology.hl7.org/CodeSystem/v2-0063",
"display": "Guardian"
}
}, {
"valueCoding": {
"code": "OTH",
"system": "http://terminology.hl7.org/CodeSystem/v2-0063",
"display": "Other"
}
} ]
}, {
"text": "Indicator to include a Witness Signature and Date/Time",
"type": "choice",
"linkId": "c31.5",
"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": "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": "Indicator to include Parent 1 Signature and Date/Time",
"type": "choice",
"linkId": "c31.6",
"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"
}
} ]
}, {
"text": "Indicator to include Parent 2 Signature and Date/Time",
"type": "choice",
"linkId": "c31.7",
"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": "Signature",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 150%"
} ]
},
"linkId": "c31",
"required": false
}, {
"item": [ {
"text": "Consent Version Number",
"type": "string",
"linkId": "c32.1",
"required": false
}, {
"item": [ {
"text": "Date that changes whenever a change is made to the consent. It is the versioning system of the sIRB institution, and is updated in accordance with the institution's policy.",
"type": "display",
"linkId": "c32.2_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": "sIRB Version Date of Consent",
"type": "date",
"linkId": "c32.2",
"required": false
}, {
"item": [ {
"text": "A number that changes whenever a change is made to the consent. It is the versioning system of the relying institution, and is updated in accordance with the institution's policy.",
"type": "display",
"linkId": "c32.3_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": "Relying Site Version Date of Consent",
"type": "date",
"linkId": "c32.3",
"required": false
}, {
"text": "Expiration Date of Consent",
"type": "dateTime",
"linkId": "c32.6",
"required": false
} ],
"text": "Consent Version",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 150%"
} ]
},
"linkId": "c32",
"required": false
}, {
"item": [ {
"text": "Describe the file that is being attached (optional)",
"type": "string",
"linkId": "c80.1"
}, {
"text": "Attachment",
"type": "attachment",
"linkId": "c80.2"
}, {
"text": "Other attachments that will be included in the Consent Form that will be provided to the participants should be included here.",
"type": "display",
"linkId": "c80_help",
"extension": [ {
"url": "http://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 Attachments",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 150%"
} ]
},
"linkId": "c80",
"repeats": true,
"required": false
}, {
"item": [ {
"text": "Link ID prefix",
"type": "string",
"linkId": "ADMIN01",
"initial": [ {
"valueString": "c"
} ],
"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, if any",
"type": "string",
"linkId": "ADMIN03",
"initial": [ {
"valueString": "temporarily unavailable"
} ],
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
"valueBoolean": true
}, {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%lookupInitiateStudy.descendants().where(linkId = 'ADMIN03').answer.value"
}
} ]
}, {
"text": "Questionnaire Response ID of the local considerations Questionnaire Response, if any",
"type": "string",
"linkId": "ADMIN04",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
"valueBoolean": true
} ]
} ],
"text": "Administrative Use Only",
"type": "group",
"linkId": "ADMIN00",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
"valueBoolean": true
} ]
} ],
"type": null,
"experimental": null,
"resourceType": "Questionnaire",
"title": "Consent 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": "relyingSiteForForm",
"language": "text/fhirpath",
"expression": "%resource.descendants().where(linkId = 'c38.1').answer.valueCoding.display",
"description": "site that the consent form pertains to"
}
} ],
"status": "draft",
"id": "3fea26ac-76ad-4994-9e41-c2be93535a15",
"kind": null,
"url": "http://hl7.org/fhir/us/sirb/Questionnaire/sirb-consent-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"
} ]
} ]
}