{
"description": "Initiate a Study Questionnaire",
"_filename": "Questionnaire-sirb-initiate-study-questionnaire-populate.json",
"package_name": "hl7.fhir.us.sirb",
"subjectType": [ "ResearchStudy" ],
"date": "2023-04-20T13:44:05+00:00",
"meta": {
"tag": [ {
"code": "lformsVersion: 29.0.3",
"system": "http://lhncbc.github.io/lforms/"
} ]
},
"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": "SIRBInitiateAStudyQuestionnaire",
"item": [ {
"item": [ {
"item": [ {
"text": "The official title of a protocol used to identify a clinical study.Include phase (e.g. pilot proof of concept study, phase I, phase II, etc.), design (e.g. randomized, double blind, placebo controlled, etc.), if the study is multi-center, the investigational agent (drug, device, biologic, vaccine, procedural and/or behavioral etc., and target disease(s)",
"type": "display",
"linkId": "in1.1_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Study Title",
"type": "string",
"linkId": "in1.1",
"required": true
}, {
"item": [ {
"text": "A short study title written in language intended for the lay public.",
"type": "display",
"linkId": "in1.2_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": "Study Title (Short)",
"type": "string",
"linkId": "in1.2",
"required": true
}, {
"item": [ {
"text": "The Protocol Number assigned by the sIRB",
"type": "display",
"linkId": "in1.3_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "IRB Protocol Number",
"type": "string",
"linkId": "in1.3",
"required": true
}, {
"item": [ {
"text": "Select the study type, either Interventional (Clinical Trial) or Observational (Non-Interventional)",
"type": "display",
"linkId": "in1.4_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": "Study Type",
"type": "choice",
"linkId": "in1.4",
"required": true,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "INT",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Interventional"
}
}, {
"valueCoding": {
"code": "OBS",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Observational"
}
} ]
} ],
"text": "Research Study Details",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 160%"
} ]
},
"linkId": "in1",
"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"
} ]
}
} ]
}, {
"type": "display",
"linkId": "DIVIDER1"
}, {
"item": [ {
"item": [ {
"text": "Select the organization's type of involvement in the study",
"type": "display",
"linkId": "in5.1_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": "Relationship Type",
"type": "choice",
"linkId": "in5.1",
"required": true,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "SFS",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Sponsor or Funding Source"
}
}, {
"valueCoding": {
"code": "CRO",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Contract Research Organization (CRO)"
}
} ]
}, {
"item": [ {
"text": "e.g. NIH or company name",
"type": "display",
"linkId": "in5.2_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": "Organization Name",
"type": "string",
"linkId": "in5.2",
"required": true
}, {
"item": [ {
"text": "10 digit phone number, including area code",
"type": "display",
"linkId": "in5.3_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": "Phone",
"type": "string",
"linkId": "in5.3",
"required": false
}, {
"item": [ {
"text": "Unique Protocol Identification Number used by the sponsor, if applicable",
"type": "display",
"linkId": "in5.4_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": "Sponsor or Funding Source Protocol Number, if applicable",
"type": "string",
"linkId": "in5.4",
"required": false
}, {
"text": "Other Organization Name, Relationship Type, Phone and Protocol Number (read-only)",
"type": "string",
"linkId": "in5.5",
"readOnly": true,
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
"valueBoolean": true
}, {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%combinedOtherOrgUniqueOneRepetition"
}
} ]
}, {
"text": "Protocol Number with Organization Name (read-only)",
"type": "string",
"linkId": "in5.6",
"readOnly": true,
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
"valueBoolean": true
}, {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%otherOrgProtocolWithNameOneRepetition"
}
} ]
} ],
"text": "Other Organization(s) Involved",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 160%"
} ]
},
"linkId": "in5",
"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"
} ]
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/variable",
"valueExpression": {
"name": "otherOrgRelTypeOneRepetition",
"language": "text/fhirpath",
"expression": "iif(item.where(linkId = 'in5.1').answer.valueCoding.display.exists(), item.where(linkId = 'in5.1').answer.valueCoding.display, ' ')",
"description": "Other Org Relationship Type"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/variable",
"valueExpression": {
"name": "otherOrgNameOneRepetition",
"language": "text/fhirpath",
"expression": "iif(item.where(linkId = 'in5.2').answer.valueString.exists(), item.where(linkId = 'in5.2').answer.valueString, ' ')",
"description": "Other Org Name"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/variable",
"valueExpression": {
"name": "otherOrgPhoneOneRepetition",
"language": "text/fhirpath",
"expression": "iif(item.where(linkId = 'in5.3').answer.valueString.exists(), item.where(linkId = 'in5.3').answer.valueString, ' ')",
"description": "Other Org Phone"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/variable",
"valueExpression": {
"name": "otherOrgProtocolOneRepetition",
"language": "text/fhirpath",
"expression": "iif(item.where(linkId = 'in5.4').answer.valueString.exists(), item.where(linkId = 'in5.4').answer.valueString, ' ')",
"description": "Other Org Protocol"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/variable",
"valueExpression": {
"name": "combinedOtherOrgUniqueOneRepetition",
"language": "text/fhirpath",
"expression": "%otherOrgNameOneRepetition + ' | ' + %otherOrgPhoneOneRepetition + ' | ' + %otherOrgProtocolOneRepetition + ' | ' + %otherOrgRelTypeOneRepetition",
"description": "combination of Other Org fields to make unique identifier"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/variable",
"valueExpression": {
"name": "otherOrgProtocolWithNameOneRepetition",
"language": "text/fhirpath",
"expression": "%otherOrgProtocolOneRepetition + ' (' + %otherOrgNameOneRepetition + ')'",
"description": "Funding Source/Sponsor Protocol and Funding Source/Sponsor Name"
}
} ]
}, {
"type": "display",
"linkId": "DIVIDER2"
}, {
"item": [ {
"item": [ {
"text": "Name of the sIRB (Reviewing Institution)",
"type": "display",
"linkId": "in6.1_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": "sIRB (Reviewing Institution) Name",
"type": "string",
"linkId": "in6.1",
"required": true
}, {
"item": [ {
"text": "The department name or division of the sIRB, if applicable",
"type": "display",
"linkId": "in6.10_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": "Department Name or Division",
"type": "string",
"linkId": "in6.10",
"required": false
}, {
"item": [ {
"text": "Physical address of the sIRB (Reviewing Institution)",
"type": "display",
"linkId": "in6.3_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": "Institution Street Address",
"type": "string",
"linkId": "in6.3",
"required": true
}, {
"text": "Institution City",
"type": "string",
"linkId": "in6.4",
"required": true
}, {
"text": "Institution State",
"type": "string",
"linkId": "in6.5",
"required": true
}, {
"text": "Institution Zip Code",
"type": "string",
"linkId": "in6.6",
"required": true
}, {
"text": "Institution Country",
"type": "string",
"linkId": "in6.7",
"initial": [ {
"valueString": "United States"
} ],
"required": false
}, {
"item": [ {
"text": "DHHS assigned number indicating Assurance of Compliance with the Office of Human Research Protections. The only type of assurance of compliance accepted and approved by OHRP for institutions engaged in non-exempt human subjects research conducted or supported by HHS. Under a FWA, an institution commits to HHS that it will comply with the requirements set forth in 45 CFR 46, as well as the terms of assurance. If the user believes that there is a FWA number assigned but needs to confirm this, select \"temporarily unavailable\". If the user does not know if there is a FWA number assigned, select \"No Information\".",
"type": "display",
"linkId": "in6.8_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": "Is a Federal Wide Assurance (FWA) Number assigned?",
"type": "choice",
"linkId": "in6.8",
"required": true,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "Yes"
}
}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No"
}
}, {
"valueCoding": {
"code": "NI",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No Information"
}
}, {
"valueCoding": {
"code": "NAV",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "temporarily unavailable"
}
} ]
}, {
"item": [ {
"text": "If assigned, enter just numeric value of FWA.",
"type": "display",
"linkId": "in6.9_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": "Federal Wide Assurance Number (if assigned)",
"type": "integer",
"linkId": "in6.9",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "in6.8",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
}, {
"item": [ {
"text": "Is the sIRB an external 3rd party institution, outside of the lead Principal Investigator institution?",
"type": "display",
"linkId": "in6.11_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": "Is the sIRB a 3rd party institution?",
"type": "choice",
"linkId": "in6.11",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "Yes"
}
}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No"
},
"initialSelected": true
} ]
} ],
"text": "sIRB (Reviewing Institution)",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 160%"
} ]
},
"linkId": "in6"
}, {
"type": "display",
"linkId": "DIVIDER3"
}, {
"item": [ {
"item": [ {
"item": [ {
"text": "Name of institution for the lead principal investigator",
"type": "display",
"linkId": "in7.1.1_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": "Lead Principal Investigator Institution Name",
"type": "string",
"linkId": "in7.1.1",
"required": true
}, {
"item": [ {
"text": "The department name or division of the lead principal investigator",
"type": "display",
"linkId": "in7.1.10_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": "Department Name or Division",
"type": "string",
"linkId": "in7.1.10",
"required": false
}, {
"item": [ {
"text": "10-digit phone number, including area code, for the institution of the lead principal investigator",
"type": "display",
"linkId": "in7.1.3_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": "Institution Phone",
"type": "string",
"linkId": "in7.1.3",
"required": false
}, {
"item": [ {
"text": "DHHS assigned number indicating Assurance of Compliance with the Office of Human Research Protections. The only type of assurance of compliance accepted and approved by OHRP for institutions engaged in non-exempt human subjects research conducted or supported by HHS. Under a FWA, an institution commits to HHS that it will comply with the requirements set forth in 45 CFR 46, as well as the terms of assurance. If the user believes that there is a FWA number assigned but needs to confirm this, select \"temporarily unavailable\". If the user does not know if there is a FWA number assigned, select \"No Information\".",
"type": "display",
"linkId": "in7.1.4_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": "Is a Federal Wide Assurance (FWA) Number assigned?",
"type": "choice",
"linkId": "in7.1.4",
"required": true,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "Yes"
}
}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No"
}
}, {
"valueCoding": {
"code": "NI",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No Information"
}
}, {
"valueCoding": {
"code": "NAV",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "temporarily unavailable"
}
} ]
}, {
"item": [ {
"text": "If assigned, enter just numeric value of FWA.",
"type": "display",
"linkId": "in7.1.5_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": "Federal Wide Assurance Number (if assigned)",
"type": "integer",
"linkId": "in7.1.5",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "in7.1.4",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ],
"enableBehavior": "all"
} ],
"text": "Lead Principal Investigator Institution",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#2a623d; font-size: 130%"
} ]
},
"linkId": "in7.1",
"required": false
}, {
"item": [ {
"item": [ {
"text": "First Name or Given Name of the lead PI responsible for the overall study",
"type": "display",
"linkId": "in7.3.1_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": "Lead Principal Investigator First Name",
"type": "string",
"linkId": "in7.3.1",
"required": true
}, {
"item": [ {
"text": "Last name, surname or family name of the lead PI responsible for the overall study",
"type": "display",
"linkId": "in7.3.2_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 Last Name",
"type": "string",
"linkId": "in7.3.2",
"required": true
}, {
"item": [ {
"text": "Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc.",
"type": "display",
"linkId": "in7.3.3_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": "Lead Principal Investigator Suffix",
"type": "string",
"linkId": "in7.3.3",
"required": false
}, {
"item": [ {
"text": "Academic and Professional degrees associated with the lead principal investigator",
"type": "display",
"linkId": "in7.3.4_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Academic and Professional Degrees associated with the Lead Principal Investigator",
"type": "string",
"linkId": "in7.3.4",
"required": true
}, {
"item": [ {
"text": "The department name or division of the lead PI",
"type": "display",
"linkId": "in7.3.10_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Department Name or Division",
"type": "string",
"linkId": "in7.3.10",
"required": false
}, {
"item": [ {
"text": "10-digit phone number, including area code, for the lead principal investigator",
"type": "display",
"linkId": "in7.3.5_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": "Phone",
"type": "string",
"linkId": "in7.3.5",
"required": false
}, {
"item": [ {
"text": "Email address associated with the lead principal investigator",
"type": "display",
"linkId": "in7.3.6_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": "Email address",
"type": "string",
"linkId": "in7.3.6",
"required": false
}, {
"item": [ {
"item": [ {
"text": "Physical address",
"type": "display",
"linkId": "in7.3.7.1_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Street Address",
"type": "string",
"linkId": "in7.3.7.1",
"required": false
}, {
"text": "City",
"type": "string",
"linkId": "in7.3.7.2",
"required": true
}, {
"text": "State",
"type": "string",
"linkId": "in7.3.7.3",
"required": true
}, {
"text": "Zip Code",
"type": "string",
"linkId": "in7.3.7.4",
"required": false
}, {
"text": "Country",
"type": "string",
"linkId": "in7.3.7.5",
"initial": [ {
"valueString": "United States"
} ],
"required": false
} ],
"text": "Address of Lead Principal Investigator",
"type": "group",
"linkId": "in7.3.7",
"required": false
} ],
"text": "Lead Principal Investigator",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#2a623d; font-size: 130%"
} ]
},
"linkId": "in7.3",
"required": false
}, {
"text": "Lead Principal Investigator Unique Site (read-only)",
"type": "string",
"linkId": "in7.9",
"readOnly": true,
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
"valueBoolean": true
}, {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%combinedLeadPIUniqueSite"
}
} ]
}, {
"text": "Lead Principal Investigator Full Name, Suffix and Degrees",
"type": "string",
"linkId": "in7.10",
"readOnly": true,
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
"valueBoolean": true
}, {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%fullNameDSLeadPI"
}
} ]
} ],
"text": "Lead Principal Investigator",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color: #274e90; font-size: 160%"
} ]
},
"linkId": "in7",
"repeats": false,
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/variable",
"valueExpression": {
"name": "leadPIInstitutionName",
"language": "text/fhirpath",
"expression": "iif(%resource.descendants().where(linkId = 'in7.1.1').answer.value.exists(), %resource.descendants().where(linkId = 'in7.1.1').answer.value, ' ')",
"description": "institution for the lead PI"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/variable",
"valueExpression": {
"name": "leadPIDept",
"language": "text/fhirpath",
"expression": "iif(%resource.descendants().where(linkId = 'in7.1.10').answer.value.exists(), %resource.descendants().where(linkId = 'in7.1.10').answer.value, ' ')",
"description": "dept for the lead PI"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/variable",
"valueExpression": {
"name": "leadPIFirstName",
"language": "text/fhirpath",
"expression": "iif(%resource.descendants().where(linkId = 'in7.3.1').answer.value.exists(), %resource.descendants().where(linkId = 'in7.3.1').answer.value, ' ')",
"description": "first name of the lead PI"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/variable",
"valueExpression": {
"name": "leadPILastName",
"language": "text/fhirpath",
"expression": "iif(%resource.descendants().where(linkId = 'in7.3.2').answer.value.exists(), %resource.descendants().where(linkId = 'in7.3.2').answer.value, ' ')",
"description": "last name of the lead PI"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/variable",
"valueExpression": {
"name": "leadPISuffix",
"language": "text/fhirpath",
"expression": "iif(%resource.descendants().where(linkId = 'in7.3.3').answer.value.exists(), %resource.descendants().where(linkId = 'in7.3.3').answer.value, ' ')",
"description": "suffix of the lead PI"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/variable",
"valueExpression": {
"name": "leadPIDegrees",
"language": "text/fhirpath",
"expression": "iif(%resource.descendants().where(linkId = 'in7.3.4').answer.value.exists(), %resource.descendants().where(linkId = 'in7.3.4').answer.value, ' ')",
"description": "degrees of the lead PI"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/variable",
"valueExpression": {
"name": "leadPICity",
"language": "text/fhirpath",
"expression": "iif(%resource.descendants().where(linkId = 'in7.3.7.2').answer.value.exists(), %resource.descendants().where(linkId = 'in7.3.7.2').answer.value, ' ')",
"description": "city of the lead PI"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/variable",
"valueExpression": {
"name": "leadPIState",
"language": "text/fhirpath",
"expression": "iif(%resource.descendants().where(linkId = 'in7.3.7.3').answer.value.exists(), %resource.descendants().where(linkId = 'in7.3.7.3').answer.value, ' ')",
"description": "state of the lead PI"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/variable",
"valueExpression": {
"name": "fullNameDSLeadPI",
"language": "text/fhirpath",
"expression": "%leadPIFirstName + ' ' + %leadPILastName + ', ' + iif(%leadPISuffix = ' ', '', %leadPISuffix+ ', ') + %leadPIDegrees",
"description": "full name, suffix and degrees for the lead PI"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/variable",
"valueExpression": {
"name": "leadPILocation",
"language": "text/fhirpath",
"expression": "iif(%resource.descendants().where(linkId = 'in7.3.7.2').answer.value.exists(), %leadPICity, ' ') + ', ' + iif(%resource.descendants().where(linkId = 'in7.3.7.3').answer.value.exists(), %leadPIState, ' ')",
"description": "city and state of the lead PI"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/variable",
"valueExpression": {
"name": "combinedLeadPIUniqueSite",
"language": "text/fhirpath",
"expression": "%leadPIInstitutionName + ' | ' + %leadPIDept + ' | ' + %fullNameDSLeadPI + ' | ' + %leadPILocation",
"description": "full name, suffix and degrees for the lead PI with the lead PI institution and lead PI dept"
}
} ]
}, {
"type": "display",
"linkId": "DIVIDER4"
}, {
"item": [ {
"item": [ {
"item": [ {
"text": "This question is optional. It can be used to pre-populate the lead principal investigator institution details if this relying site is at the same institution as where the lead principal investigator is conducting the study. If you do not want pre-population to occur, you may leave this question blank.",
"type": "display",
"linkId": "in8.5.1_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": "Is this relying site at the same institution as where the lead principal investigator is conducting the study?",
"type": "choice",
"linkId": "in8.5.1",
"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"
},
"initialSelected": true
} ]
}, {
"item": [ {
"text": "This question is optional. It can be used to pre-populate the lead principal investigator site details if this relying site is at the same site as where the lead principal investigator is conducting the study. If you do not want pre-population to occur, you may leave this question blank.",
"type": "display",
"linkId": "in8.5.2_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": "Is this relying site at the same site as where the lead principal investigator is conducting the study?",
"type": "choice",
"linkId": "in8.5.2",
"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": "in8.5.1",
"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"
},
"initialSelected": true
} ]
}, {
"item": [ {
"text": "This question is optional. It can be used to pre-populate the lead principal investigator details if this relying site PI is the same PI as the lead principal investigator conducting the study. If you do not want pre-population to occur, you may leave this question blank.",
"type": "display",
"linkId": "in8.5.3_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": "Is the relying site PI for this site the same PI as the lead principal investigator conducting the study?",
"type": "choice",
"linkId": "in8.5.3",
"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": "Indicator that the lead PI site where the study is being conducted is also participating as this relying site",
"type": "display",
"linkId": "in8.5.4_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": "Is this relying site also considered to be the lead site for the study?",
"type": "choice",
"linkId": "in8.5.4",
"required": true,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "Yes"
}
}, {
"valueCoding": {
"code": "N",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No"
},
"initialSelected": true
} ]
} ],
"text": "Affiliation with Lead Principal Investigator Institution, Lead Principal Investigator Site or Lead Principal Investigator",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#2a623d; font-size: 130%"
} ]
},
"linkId": "in8.5",
"required": false
}, {
"item": [ {
"item": [ {
"text": "Name of Institution for which their IRB agrees to rely on the decisions of the reviewing IRB at their own institutions.",
"type": "display",
"linkId": "in8.1.1_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": "Relying Institution Name",
"type": "string",
"linkId": "in8.1.1",
"required": true,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "iif(%isSameInstitutionOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.1.1').answer.value)"
}
} ]
}, {
"item": [ {
"text": "The department name or division for the relying site",
"type": "display",
"linkId": "in8.1.10_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": "Department Name or Division",
"type": "string",
"linkId": "in8.1.10",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "iif(%isSameInstitutionOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.1.10').answer.value)"
}
} ]
}, {
"item": [ {
"text": "10-digit phone number, including area code, for the relying institution",
"type": "display",
"linkId": "in8.1.3_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 Institution Phone",
"type": "string",
"linkId": "in8.1.3",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "iif(%isSameInstitutionOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.1.3').answer.value)"
}
} ]
}, {
"item": [ {
"text": "DHHS assigned number indicating Assurance of Compliance with the Office of Human Research Protections. The only type of assurance of compliance accepted and approved by OHRP for institutions engaged in non-exempt human subjects research conducted or supported by HHS. Under a FWA, an institution commits to HHS that it will comply with the requirements set forth in 45 CFR 46, as well as the terms of assurance. If the user believes that there is a FWA number assigned but needs to confirm this, select \"temporarily unavailable\". If the user does not know if there is a FWA number assigned, select \"No Information\".",
"type": "display",
"linkId": "in8.1.4_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": "Is a Federal Wide Assurance (FWA) Number assigned?",
"type": "choice",
"linkId": "in8.1.4",
"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": "iif(%isSameInstitutionOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.1.4').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"
}
}, {
"valueCoding": {
"code": "NI",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "No Information"
}
}, {
"valueCoding": {
"code": "NAV",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532",
"display": "temporarily unavailable"
}
} ]
}, {
"item": [ {
"text": "If assigned, enter just numeric value of FWA.",
"type": "display",
"linkId": "in8.1.5_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": "Federal Wide Assurance Number (if assigned)",
"type": "integer",
"linkId": "in8.1.5",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "iif(%isSameInstitutionOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.1.5').answer.value)"
}
} ],
"enableWhen": [ {
"operator": "=",
"question": "in8.1.4",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ],
"enableBehavior": "all"
}, {
"item": [ {
"text": "Status of the reliance agreement",
"type": "display",
"linkId": "in8.1.6_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": "Reliance Status",
"type": "choice",
"linkId": "in8.1.6",
"required": true,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Drop down",
"coding": [ {
"code": "drop-down",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Drop down"
} ]
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "APPROVED",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Approved for reliance"
}
}, {
"valueCoding": {
"code": "DENIED",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Denied reliance"
}
}, {
"valueCoding": {
"code": "POSSIBLE",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Potential/possible"
}
}, {
"valueCoding": {
"code": "CANCELLED",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Cancelled or not participating"
}
}, {
"valueCoding": {
"code": "ONHOLD",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "Temporarily on hold"
}
} ]
}, {
"text": "Institution whose IRB agrees to rely on oversite by the sIRB (Reviewing IRB)",
"type": "display",
"linkId": "in8.1_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": "Relying Site Institution",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#2a623d; font-size: 130%"
} ]
},
"linkId": "in8.1",
"required": false
}, {
"item": [ {
"item": [ {
"text": "First Name or Given Name of PI at a site conducting the study, responsible for the conduct of the study at his/her relying institution",
"type": "display",
"linkId": "in8.3.1_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": "Relying Site Principal Investigator First Name",
"type": "string",
"linkId": "in8.3.1",
"required": true,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "iif(%isSamePIOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.1').answer.value)"
}
} ]
}, {
"item": [ {
"text": "Last name, surname or family name of PI at a site conducting the study, responsible for the conduct of the study at his/her relying institution",
"type": "display",
"linkId": "in8.3.2_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": "Relying Site Principal Investigator Last Name",
"type": "string",
"linkId": "in8.3.2",
"required": true,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "iif(%isSamePIOneRepetition = 'Y', %resource.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": "in8.3.3_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 Principal Investigator Suffix",
"type": "string",
"linkId": "in8.3.3",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "iif(%isSamePIOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.3').answer.value)"
}
} ]
}, {
"item": [ {
"text": "Academic and Professional degrees associated with the relying site principal investigator",
"type": "display",
"linkId": "in8.3.4_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Academic and Professional Degrees associated with the Relying Site Principal Investigator",
"type": "string",
"linkId": "in8.3.4",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "iif(%isSamePIOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.4').answer.value)"
}
} ]
}, {
"item": [ {
"text": "The department name or division for the relying site PI",
"type": "display",
"linkId": "in8.3.10_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Department Name or Division",
"type": "string",
"linkId": "in8.3.10",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "iif(%isSamePIOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.10').answer.value)"
}
} ]
}, {
"item": [ {
"text": "10-digit phone number, including area code, for the relying site principal investigator",
"type": "display",
"linkId": "in8.3.5_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": "Phone",
"type": "string",
"linkId": "in8.3.5",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "iif(%isSamePIOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.5').answer.value)"
}
} ]
}, {
"item": [ {
"text": "Email address associated with the relying site principal investigator",
"type": "display",
"linkId": "in8.3.6_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": "Email address",
"type": "string",
"linkId": "in8.3.6",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "iif(%isSamePIOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.6').answer.value)"
}
} ]
}, {
"item": [ {
"item": [ {
"text": "Physical address",
"type": "display",
"linkId": "in8.3.7.1_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Street Address",
"type": "string",
"linkId": "in8.3.7.1",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "iif(%isSameSiteOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.7.1').answer.value)"
}
} ]
}, {
"text": "City",
"type": "string",
"linkId": "in8.3.7.2",
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "iif(%isSameSiteOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.7.2').answer.value)"
}
} ]
}, {
"text": "State",
"type": "string",
"linkId": "in8.3.7.3",
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "iif(%isSameSiteOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.7.3').answer.value)"
}
} ]
}, {
"text": "Zip Code",
"type": "string",
"linkId": "in8.3.7.4",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "iif(%isSameSiteOneRepetition = 'Y', %resource.descendants().where(linkId = 'in7.3.7.4').answer.value)"
}
} ]
}, {
"text": "Country",
"type": "string",
"linkId": "in8.3.7.5",
"initial": [ {
"valueString": "United States"
} ],
"required": false
} ],
"text": "Address of Relying Site Principal Investigator",
"type": "group",
"linkId": "in8.3.7",
"required": false
}, {
"text": "Principal Investigator responsible for the conduct of the study at a specific relying site research location.",
"type": "display",
"linkId": "in8.3_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 Principal Investigator",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#2a623d; font-size: 130%"
} ]
},
"linkId": "in8.3",
"required": false
}, {
"text": "Relying Site Principal Investigator Name, Institution, Dept, City and State (read-only)",
"type": "string",
"linkId": "in8.9",
"readOnly": true,
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
"valueBoolean": true
}, {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%combinedSitePIUniqueSiteOneRepetition"
}
} ]
}, {
"text": "Relying Site Principal Investigator Full Name, Suffix and Degrees (read-only)",
"type": "string",
"linkId": "in8.10",
"readOnly": true,
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
"valueBoolean": true
}, {
"url": "http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression",
"valueExpression": {
"language": "text/fhirpath",
"expression": "%fullNameDSSitePIOneRepetition"
}
} ]
}, {
"text": "The research site(s) where the Lead Principal Investigator is conducting research should also be entered as relying site(s) here, even if at the same institution as entered above for the Lead Principal Investigator. If the Lead Principal Investigator is only managing a coordinating center or other administrative office for the study, do not enter the site again here.",
"type": "display",
"linkId": "in8_help",
"extension": [ {
"url": "http://hl7.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(s)",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color: #274e90; font-size: 160%"
} ]
},
"linkId": "in8",
"repeats": true,
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/variable",
"valueExpression": {
"name": "isSameInstitutionOneRepetition",
"language": "text/fhirpath",
"expression": "item.descendants().where(linkId = 'in8.5.1').answer.valueCoding.code",
"description": "is this relying site at the lead PI institution"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/variable",
"valueExpression": {
"name": "isSameSiteOneRepetition",
"language": "text/fhirpath",
"expression": "item.descendants().where(linkId = 'in8.5.2').answer.valueCoding.code",
"description": "is this relying site the same as the lead PI site"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/variable",
"valueExpression": {
"name": "isSamePIOneRepetition",
"language": "text/fhirpath",
"expression": "item.descendants().where(linkId = 'in8.5.3').answer.valueCoding.code",
"description": "is this relying site PI the same as the lead PI"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/variable",
"valueExpression": {
"name": "isFunctioningAsLeadOneRepetition",
"language": "text/fhirpath",
"expression": "item.descendants().where(linkId='in8.5.4').answer.valueCoding.code",
"description": "is the site functioning as a lead site"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/variable",
"valueExpression": {
"name": "sitePIInstitutionNameOneRepetition",
"language": "text/fhirpath",
"expression": "iif(item.descendants().where(linkId = 'in8.1.1').answer.valueString.exists(), item.descendants().where(linkId = 'in8.1.1').answer.valueString, ' ')",
"description": "institution for this relying site PI"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/variable",
"valueExpression": {
"name": "sitePIDeptOneRepetition",
"language": "text/fhirpath",
"expression": "iif(item.descendants().where(linkId = 'in8.1.10').answer.valueString.exists(), item.descendants().where(linkId = 'in8.1.10').answer.valueString, ' ')",
"description": "dept for this relying site PI"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/variable",
"valueExpression": {
"name": "sitePIFirstNameOneRepetition",
"language": "text/fhirpath",
"expression": "iif(item.descendants().where(linkId = 'in8.3.1').answer.valueString.exists(), item.descendants().where(linkId = 'in8.3.1').answer.valueString, ' ')",
"description": "first name of this relying site PI"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/variable",
"valueExpression": {
"name": "sitePILastNameOneRepetition",
"language": "text/fhirpath",
"expression": "iif(item.descendants().where(linkId = 'in8.3.2').answer.valueString.exists(), item.descendants().where(linkId = 'in8.3.2').answer.valueString, ' ')",
"description": "last name of this relying site PI"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/variable",
"valueExpression": {
"name": "sitePISuffixOneRepetition",
"language": "text/fhirpath",
"expression": "iif(item.descendants().where(linkId = 'in8.3.3').answer.valueString.exists(), item.descendants().where(linkId = 'in8.3.3').answer.valueString, ' ')",
"description": "suffix of this relying site PI"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/variable",
"valueExpression": {
"name": "sitePIDegreesOneRepetition",
"language": "text/fhirpath",
"expression": "iif(item.descendants().where(linkId = 'in8.3.4').answer.valueString.exists(), item.descendants().where(linkId = 'in8.3.4').answer.valueString, ' ')",
"description": "degrees of this relying site PI"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/variable",
"valueExpression": {
"name": "sitePICityOneRepetition",
"language": "text/fhirpath",
"expression": "iif(item.descendants().where(linkId = 'in8.3.7.2').answer.valueString.exists(), item.descendants().where(linkId = 'in8.3.7.2').answer.valueString, ' ')",
"description": "city of the relying site PI"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/variable",
"valueExpression": {
"name": "sitePIStateOneRepetition",
"language": "text/fhirpath",
"expression": "iif(item.descendants().where(linkId = 'in8.3.7.3').answer.valueString.exists(), item.descendants().where(linkId = 'in8.3.7.3').answer.valueString, ' ')",
"description": "state of the relying site PI"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/variable",
"valueExpression": {
"name": "fullNameDSSitePIOneRepetition",
"language": "text/fhirpath",
"expression": "%sitePIFirstNameOneRepetition + ' ' + %sitePILastNameOneRepetition + ', ' + iif(%sitePISuffixOneRepetition = ' ', '', %sitePISuffixOneRepetition + ', ') + %sitePIDegreesOneRepetition",
"description": "full name, suffix and degrees for this relying site PI"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/variable",
"valueExpression": {
"name": "sitePILocationOneRepetition",
"language": "text/fhirpath",
"expression": "%sitePICityOneRepetition + ', ' + %sitePIStateOneRepetition",
"description": "city and state of the relying site PI"
}
}, {
"url": "http://hl7.org/fhir/StructureDefinition/variable",
"valueExpression": {
"name": "combinedSitePIUniqueSiteOneRepetition",
"language": "text/fhirpath",
"expression": "%sitePIInstitutionNameOneRepetition + ' | ' + %sitePIDeptOneRepetition + ' | ' + %fullNameDSSitePIOneRepetition + ' | ' + %sitePILocationOneRepetition",
"description": "full name, suffix and degrees for this relying site PI and the relying site PI institution and dept"
}
} ]
}, {
"type": "display",
"linkId": "DIVIDER5"
}, {
"item": [ {
"item": [ {
"text": "Indicator for use of FDA regulated product",
"type": "display",
"linkId": "in9.1_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": "Does this study require a FDA exemption?",
"type": "choice",
"linkId": "in9.1",
"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": "Is an Investigational New Drug (IND) or Investigational Device Exemption (IDE) being used?",
"type": "display",
"linkId": "in9.2_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 an IND or IDE being used in this study?",
"type": "choice",
"linkId": "in9.2",
"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": "Select IND for Investigational New Drug or IDE for Investigational Device Exemption",
"type": "display",
"linkId": "in9.4_help",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
"valueCodeableConcept": {
"text": "Help-Button",
"coding": [ {
"code": "help",
"system": "http://hl7.org/fhir/questionnaire-item-control",
"display": "Help-Button"
} ]
}
} ]
} ],
"text": "Please select IND or IDE:",
"type": "choice",
"linkId": "in9.4",
"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": "in9.2",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ],
"answerOption": [ {
"valueCoding": {
"code": "IND",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "IND"
}
}, {
"valueCoding": {
"code": "IDE",
"system": "http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes",
"display": "IDE"
}
} ]
}, {
"text": "IND/IDE Number",
"type": "string",
"linkId": "in9.3",
"required": false,
"enableWhen": [ {
"operator": "=",
"question": "in9.2",
"answerCoding": {
"code": "Y",
"system": "http://terminology.hl7.org/CodeSystem/v2-0532"
}
} ]
} ],
"text": "FDA exemption and IDE/IND Number",
"type": "group",
"_text": {
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
"valueString": "color:#274e90; font-size: 160%"
} ]
},
"linkId": "in9"
}, {
"type": "display",
"linkId": "DIVIDER6"
}, {
"item": [ {
"text": "Questionnaire Version",
"type": "string",
"linkId": "in10.1",
"initial": [ {
"valueString": "2"
} ],
"readOnly": true,
"required": true,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
"valueBoolean": false
} ]
}, {
"text": "Questionnaire Version Date",
"type": "date",
"linkId": "in10.2",
"initial": [ {
"valueDate": "2021-10-18"
} ],
"readOnly": true,
"required": true,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
"valueBoolean": false
} ]
} ],
"text": "Questionnaire Version Details",
"type": "group",
"linkId": "in10",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
"valueBoolean": false
} ]
}, {
"type": "display",
"linkId": "DIVIDER7"
}, {
"item": [ {
"text": "Link ID prefix",
"type": "string",
"linkId": "ADMIN01",
"initial": [ {
"valueString": "in"
} ],
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
"valueBoolean": true
} ]
}, {
"text": "Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any",
"type": "string",
"linkId": "ADMIN02",
"initial": [ {
"valueString": "temporarily unavailable"
} ],
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
"valueBoolean": true
} ]
}, {
"text": "ID of the Research Study FHIR Resource associated with the study Questionnaire Responses",
"type": "string",
"linkId": "ADMIN03",
"initial": [ {
"valueString": "temporarily unavailable"
} ],
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
"valueBoolean": true
} ]
}, {
"text": "Questionnaire Response ID of the local considerations Questionnaire Response, if any",
"type": "string",
"linkId": "ADMIN04",
"required": false,
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
"valueBoolean": true
} ]
} ],
"text": "Administrative Use Only (will be hidden in the future)",
"type": "group",
"linkId": "ADMIN00",
"extension": [ {
"url": "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
"valueBoolean": true
} ]
} ],
"type": null,
"experimental": null,
"resourceType": "Questionnaire",
"title": "Initiate a Study Questionnaire",
"package_version": "1.0.0",
"status": "draft",
"id": "4ccab206-4b29-4531-a1ba-1a03e4e8ed14",
"kind": null,
"url": "http://hl7.org/fhir/us/sirb/Questionnaire/sirb-initiate-study-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"
} ]
} ]
}