{
  "description": "Initiate a Study Questionnaire",
  "_filename": "example/Questionnaire-sirb-initiate-study-questionnaire.json",
  "package_name": "hl7.fhir.us.sirb",
  "subjectType": [ "ResearchStudy" ],
  "date": "2021-08-10T13:15:03+00:00",
  "meta": {
    "source": "#5wyvVyNxvYAqEcet",
    "versionId": "5",
    "lastUpdated": "2021-07-25T19:43:52.253+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": "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": "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(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"
        } ]
      }
    } ]
  }, {
    "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": "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": true
    }, {
      "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": "DHHS assigned number indicating Assurance of Compliance with the Office of Human Research Protections. Enter just the numeric value of the FWA.",
        "type": "display",
        "linkId": "inin6.9-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"
        }
      } ],
      "enableBehavior": "all"
    } ],
    "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": [ {
        "text": "The first or given name associated with the overall principal investigator",
        "type": "display",
        "linkId": "in7.1-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": "Overall Principal Investigator First Name",
      "type": "string",
      "linkId": "in7.1",
      "required": true
    }, {
      "item": [ {
        "text": "Last name, surname or family name associated with the overall principal investigator",
        "type": "display",
        "linkId": "in7.2-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": "Overall Principal Investigator Last Name",
      "type": "string",
      "linkId": "in7.2",
      "required": true
    }, {
      "item": [ {
        "text": "Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc. associated with the overall principal investigator's name",
        "type": "display",
        "linkId": "in7.3-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": "Overall Principal Investigator Suffix",
      "type": "string",
      "linkId": "in7.3",
      "required": false
    }, {
      "item": [ {
        "text": "Academic and Professional degrees associated with the overall principal investigator",
        "type": "display",
        "linkId": "in7.4-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 Overall Principal Investigator",
      "type": "string",
      "linkId": "in7.4",
      "required": false
    }, {
      "item": [ {
        "text": "The institution of the overall principal investigator",
        "type": "display",
        "linkId": "in7.5-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": "Overall Principal Investigator Institution Name",
      "type": "string",
      "linkId": "in7.5",
      "required": true
    }, {
      "item": [ {
        "text": "The department name or division for the overall principal investigator",
        "type": "display",
        "linkId": "in7.6-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": "Department Name or Division",
      "type": "string",
      "linkId": "in7.6",
      "required": false
    }, {
      "item": [ {
        "text": "Physical address of the overall principal investigator",
        "type": "display",
        "linkId": "in7.7-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": "Street Address",
      "type": "string",
      "linkId": "in7.7",
      "required": true
    }, {
      "text": "City",
      "type": "string",
      "linkId": "in7.8",
      "required": true
    }, {
      "text": "State",
      "type": "string",
      "linkId": "in7.9",
      "required": true
    }, {
      "text": "Zip Code",
      "type": "string",
      "linkId": "in7.10",
      "required": true
    }, {
      "text": "Country",
      "type": "string",
      "linkId": "in7.11",
      "initial": [ {
        "valueString": "United States"
      } ],
      "required": true
    }, {
      "item": [ {
        "text": "Phone number, including area code for the overall principal investigator",
        "type": "display",
        "linkId": "in7.12-help",
        "extension": [ {
          "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
          "valueCodeableConcept": {
            "text": "Help-Button",
            "coding": [ {
              "code": "help",
              "system": "http://hl7.org/fhir/questionnaire-item-control",
              "display": "Help-Button"
            } ]
          }
        } ]
      } ],
      "text": "Overall Principal Investigator Phone",
      "type": "string",
      "linkId": "in7.12",
      "required": true
    }, {
      "item": [ {
        "text": "Email address associated with overall principal investigator",
        "type": "display",
        "linkId": "in7.13-help",
        "extension": [ {
          "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl",
          "valueCodeableConcept": {
            "text": "Help-Button",
            "coding": [ {
              "code": "help",
              "system": "http://hl7.org/fhir/questionnaire-item-control",
              "display": "Help-Button"
            } ]
          }
        } ]
      } ],
      "text": "Overall Principal Investigator Email Address",
      "type": "string",
      "linkId": "in7.13",
      "required": true
    } ],
    "text": "Overall Principal Investigator for the Study",
    "type": "group",
    "_text": {
      "extension": [ {
        "url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
        "valueString": "color:#274e90; font-size: 160%"
      } ]
    },
    "linkId": "in7"
  }, {
    "type": "display",
    "linkId": "DIVIDER4"
  }, {
    "item": [ {
      "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": false
      }, {
        "item": [ {
          "text": "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
      }, {
        "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"
            } ]
          }
        } ],
        "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": "DHHS assigned number indicating Assurance of Compliance with the Office of Human Research Protections. Enter just the numeric value of the 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,
        "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": "Institutions for which their IRB agrees to rely on the decisions of the reviewing IRB at their own institutions.",
        "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"
            } ]
          }
        } ]
      }, {
        "item": [ {
          "item": [ {
            "text": "Physical address",
            "type": "display",
            "linkId": "in8.1.7.1-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": "in8.1.7.1",
          "required": false
        }, {
          "text": "City",
          "type": "string",
          "linkId": "in8.1.7.2",
          "required": false
        }, {
          "text": "State",
          "type": "string",
          "linkId": "in8.1.7.3",
          "required": false
        }, {
          "text": "Zip Code",
          "type": "string",
          "linkId": "in8.1.7.4",
          "required": false
        }, {
          "text": "Country",
          "type": "string",
          "linkId": "in8.1.7.5",
          "initial": [ {
            "valueString": "United States"
          } ],
          "required": false
        } ],
        "text": "Relying Site Address",
        "type": "group",
        "_text": {
          "extension": [ {
            "url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
            "valueString": "color:#2a623d; font-size: 130%"
          } ]
        },
        "linkId": "in8.1.7",
        "required": false
      } ],
      "text": "Confirmed or Potential Relying Site Overview",
      "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 \r\nPI 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": false
      }, {
        "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": false
      }, {
        "item": [ {
          "text": "Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc. associated with the relying site principal investigator",
          "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
      }, {
        "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
      }, {
        "item": [ {
          "text": "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
      }, {
        "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
      }, {
        "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
        }, {
          "text": "City",
          "type": "string",
          "linkId": "in8.3.7.2",
          "required": false
        }, {
          "text": "State",
          "type": "string",
          "linkId": "in8.3.7.3",
          "required": false
        }, {
          "text": "Zip Code",
          "type": "string",
          "linkId": "in8.3.7.4",
          "required": false
        }, {
          "text": "Country",
          "type": "string",
          "linkId": "in8.3.7.5",
          "initial": [ {
            "valueString": "United States"
          } ],
          "required": false
        } ],
        "text": "Address of Relying Site Principal Investigator",
        "type": "group",
        "_text": {
          "extension": [ {
            "url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
            "valueString": "color:#2a623d; font-size: 130%"
          } ]
        },
        "linkId": "in8.3.7",
        "required": false
      } ],
      "text": "Site Principal Investigator at Relying Site",
      "type": "group",
      "_text": {
        "extension": [ {
          "url": "http://hl7.org/fhir/StructureDefinition/rendering-style",
          "valueString": "color:#2a623d; font-size: 130%"
        } ]
      },
      "linkId": "in8.3",
      "required": false
    } ],
    "text": "Confirmed or Potential 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
  }, {
    "type": "display",
    "linkId": "DIVIDER5"
  }, {
    "item": [ {
      "text": "Questionnaire Version",
      "type": "string",
      "linkId": "in9.1",
      "initial": [ {
        "valueString": "1"
      } ],
      "readOnly": true,
      "required": true,
      "extension": [ {
        "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
        "valueBoolean": false
      } ]
    }, {
      "text": "Questionnaire Version Date",
      "type": "date",
      "linkId": "in9.2",
      "initial": [ {
        "valueDate": "2021-06-01"
      } ],
      "readOnly": true,
      "required": true,
      "extension": [ {
        "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
        "valueBoolean": false
      } ]
    } ],
    "text": "Questionnaire Version Details",
    "type": "group",
    "linkId": "in9",
    "extension": [ {
      "url": "http://hl7.org/fhir/StructureDefinition/questionnaire-hidden",
      "valueBoolean": false
    } ]
  }, {
    "type": "display",
    "linkId": "DIVIDER6"
  }, {
    "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": "0.1.0",
  "status": "draft",
  "id": "81dfc261-d28e-4dca-8c64-d37de76a28e0",
  "kind": null,
  "url": "http://hl7.org/fhir/us/sirb/Questionnaire/sirb-initiate-study-questionnaire",
  "version": "0.1.0",
  "contact": [ {
    "name": "HL7 International - Biomedical Research and Regulation",
    "telecom": [ {
      "value": "http://www.hl7.org/Special/committees/rcrim",
      "system": "url"
    } ]
  } ]
}