{
"description": null,
"_filename": "example/Questionnaire-sirb-consent-questionnaire.json",
"package_name": "hl7.fhir.us.sirb",
"subjectType": [ "ResearchStudy" ],
"date": "2021-08-10T13:15:03+00:00",
"meta": {
"source": "#jpicEga4TSW9nuqD",
"versionId": "34",
"lastUpdated": "2021-07-28T23:23:05.246+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
}, {
"text": "IRB Protocol Number",
"type": "string",
"linkId": "c1.2",
"required": false
} ],
"text": "Research Study",
"type": "group",
"linkId": "c1",
"required": false
}, {
"item": [ {
"item": [ {
"text": "First or given name associated with the site primary responsibility holder",
"type": "display",
"linkId": "c2.2-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": "c2.2",
"required": false
}, {
"item": [ {
"text": "Surname or family name associated with the site primary responsibility holder",
"type": "display",
"linkId": "c2.1-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": "c2.1",
"required": false
}, {
"item": [ {
"text": "Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc. associated with the site principal investigator's name",
"type": "display",
"linkId": "c2.6-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": "c2.6",
"required": false
}, {
"item": [ {
"text": "Professional and Academic degrees associated with the site primary responsibility holder",
"type": "display",
"linkId": "c2.3-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": "c2.3",
"required": false
}, {
"item": [ {
"text": "Academic or Profressional Institution associated with the site primary responsibility holder",
"type": "display",
"linkId": "c2.4-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": "c2.4",
"required": false
}, {
"item": [ {
"text": "Information on how to contact the Site PI. Can include both email/phone number",
"type": "display",
"linkId": "c2.5-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": "text",
"linkId": "c2.5",
"required": false
}, {
"text": "PI at a site conducting the study, responsible for the conduct of the study at his/her relying institution",
"type": "display",
"linkId": "c2-help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Site Principal Investigator",
"type": "group",
"linkId": "c2",
"required": false
}, {
"item": [ {
"item": [ {
"text": "Public or private entity conducting the study- where the participant will go or call",
"type": "display",
"linkId": "c3.1-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": "c3.1",
"required": false
}, {
"item": [ {
"text": "Physical address",
"type": "display",
"linkId": "c3.2-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": "Address",
"type": "text",
"linkId": "c3.2",
"required": false
}, {
"text": "Information about Lead or Site Institution where study will be conducted",
"type": "display",
"linkId": "c3-help",
"extension": [ {
"url": "http://hl7.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 Institution",
"type": "group",
"linkId": "c3",
"required": false
}, {
"item": [ {
"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": "string",
"linkId": "c4.1",
"required": false
} ],
"text": "Sponsor or Funding Source",
"type": "group",
"linkId": "c4",
"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": "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": "Mandated paragraph that 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",
"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. You may take this consent form home to think about and discuss with family or friends."
} ],
"required": false
}, {
"text": "Introductory Paragraph to the participant. Includes statement of research and explanation of the consent process: 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. You may take this consent form home to think about and discuss with family or friends",
"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",
"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 who the participant can anticipate interacting with during their 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 participantr",
"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 number of people targeted for enrollment for 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",
"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",
"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"
} ]
}
} ]
}, {
"item": [ {
"text": "Additional text if needed 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
} ],
"text": "Assessments",
"type": "group",
"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": "text",
"linkId": "c11.2.3",
"required": false
}, {
"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",
"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"
} ]
}
} ]
}, {
"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"
}
} ]
}, {
"text": "Frequency of Procedures",
"type": "decimal",
"linkId": "c11.3.6",
"required": false
}, {
"text": "Procedure Duration (minutes)",
"type": "decimal",
"linkId": "c11.3.7",
"required": false
} ],
"text": "Procedure List",
"type": "group",
"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"
} ]
}
} ]
}, {
"item": [ {
"text": "Additional Text to include after the procedure table to provide the participant 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
}, {
"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",
"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",
"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"
} ]
}
} ]
}, {
"item": [ {
"text": "Additional text for description of other costs not directly associated with a risk",
"type": "display",
"linkId": "c12.2_help"
} ],
"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"
} ]
}
} ],
"definition": "9.4",
"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",
"linkId": "c12",
"required": false
}, {
"item": [ {
"text": "Alternative Procedure Text",
"type": "text",
"linkId": "c13.1",
"required": false
} ],
"text": "Alternative Procedures",
"type": "group",
"linkId": "c13",
"required": false
}, {
"item": [ {
"text": "Name of Benefit",
"type": "string",
"linkId": "c14.1",
"required": false
}, {
"text": "Description of Benefit",
"type": "text",
"linkId": "c14.2",
"required": false
}, {
"text": "Benefit to you",
"type": "choice",
"linkId": "c14.3",
"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": "c14.4",
"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",
"type": "group",
"linkId": "c14",
"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": [ {
"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"
} ]
}
} ],
"definition": "12.1",
"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"
} ],
"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"
}
} ]
}, {
"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
} ],
"text": "Compensation List",
"type": "group",
"linkId": "c15.3",
"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"
} ]
}
} ],
"enableWhen": [ {
"operator": "=",
"question": "c15.1",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
} ],
"text": "Compensation",
"type": "group",
"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": "Who will pay 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",
"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": "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": "text",
"linkId": "c17.2",
"required": false
}, {
"item": [ {
"text": "Contact information for the site IRB contact.",
"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": "text",
"linkId": "c17.3",
"required": false
}, {
"item": [ {
"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": "text",
"linkId": "c17.4",
"required": false
} ],
"text": "Participant Rights and whom to contact for answers",
"type": "group",
"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",
"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"
} ]
}
} ],
"definition": "18.1",
"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",
"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"
} ]
}
} ],
"definition": "19.2a",
"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": "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"
} ]
}
} ],
"definition": "19.2",
"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"
} ]
}
} ],
"definition": "19.3",
"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",
"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"
} ]
}
} ],
"definition": "19.5",
"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"
}
} ]
}, {
"definition": "19.5.1",
"linkId": "c20.9",
"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"
} ]
}
} ]
} ],
"type": "choice",
"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"
}
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"required": false,
"text": "Will the future use data be deidentified?"
}, {
"item": [ {
"text": "Description of deidentification details for future use datasets. Two standardized statements, can be modified.",
"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": "Required Text disclosure surrounding future use of participant's data",
"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",
"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"
} ]
}
} ],
"definition": "20.1",
"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"
}
} ]
}, {
"definition": "20.1.4",
"linkId": "c21.3",
"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"
} ]
}
} ]
} ],
"type": "choice",
"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"
}
} ],
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"required": false,
"text": "Sharing or no Sharing of samples."
}, {
"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,
"enableWhen": [ {
"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,
"enableWhen": [ {
"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",
"linkId": "c21",
"required": false
}, {
"item": [ {
"text": "If selected, 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.",
"type": "display",
"linkId": "c22.1",
"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"
} ]
}
} ],
"definition": "21",
"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"
} ]
}
} ],
"definition": "22",
"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"
} ]
}
} ],
"definition": "23",
"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",
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"linkId": "c26.1",
"required": false,
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"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"
} ]
}
} ],
"definition": "25",
"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"
}
} ]
}, {
"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)",
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"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"
} ]
}
} ],
"definition": "26",
"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",
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"required": false,
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"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"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",
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"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",
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"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",
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"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",
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"display": "Yes"
}
}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No"
}
} ]
} ],
"text": "Signature",
"type": "group",
"linkId": "c31",
"required": false
}, {
"item": [ {
"text": "IRB 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": "string",
"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": "string",
"linkId": "c32.3",
"required": false
}, {
"text": "Expiration Date of Consent",
"type": "dateTime",
"linkId": "c32.6",
"required": false
} ],
"text": "Protocol or Study Number",
"type": "group",
"linkId": "c32",
"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
} ]
}, {
"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
} ]
}, {
"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"
} ],
"type": null,
"experimental": null,
"resourceType": "Questionnaire",
"title": "Consent Questionnaire",
"package_version": "0.1.0",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/variable",
"valueExpression": {
"name": "lookupInitiateStudy",
"language": "application/x-fhir-query",
"expression": "https://docr-fhir.dev.cloud.duke.edu/hapi-fhir-jpaserver/fhir/QuestionnaireResponse/QRIDInitiateStudy",
"description": "response to get the data from"
}
} ],
"status": "draft",
"id": "0e95fcea-14cb-414d-a4cc-3657e60777ae",
"kind": null,
"url": "http://hl7.org/fhir/us/sirb/Questionnaire/sirb-consent-questionnaire",
"version": "0.1.0",
"contact": [ {
"name": "HL7 International - Biomedical Research and Regulation",
"telecom": [ {
"value": "http://www.hl7.org/Special/committees/rcrim",
"system": "url"
} ]
} ]
}