{
  "description": "Data standards to move data and documents from clinical research sites to a single ethics review board in support of the \\\"NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research.\\n",
  "_filename": "ImplementationGuide-hl7.fhir.us.sirb.json",
  "package_name": "hl7.fhir.us.sirb",
  "definition": {
    "page": {
      "page": [ {
        "title": "Conformance and Functionality Expectations",
        "nameUrl": "conformance_and_functionality_expectations.html",
        "generation": "markdown"
      }, {
        "title": "Downloads",
        "nameUrl": "downloads.html",
        "generation": "markdown"
      } ],
      "title": "Single IRB (sIRB)",
      "nameUrl": "index.html",
      "generation": "markdown"
    },
    "grouping": [ {
      "id": "new-group1",
      "name": "Questionnaires"
    }, {
      "id": "new-group2",
      "name": "Questionnaire Responses"
    }, {
      "id": "new-group3",
      "name": "Research Study"
    }, {
      "id": "new-group4",
      "name": "Example"
    } ],
    "resource": [ {
      "name": "Initiate a Study Questionnaire",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "Questionnaire"
      } ],
      "reference": {
        "display": "Initiate a Study Questionnaire",
        "reference": "Questionnaire/sirb-initiate-study-questionnaire"
      },
      "groupingId": "new-group1",
      "description": "This questionnaire serves as an initial collection form for recurring data elements that are present in the other forms.  These other forms will then subsequently prepopulate with these data to minimize data entry time and errors.",
      "exampleBoolean": true
    }, {
      "name": "Protocol Questionnaire",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "Questionnaire"
      } ],
      "reference": {
        "display": "Protocol Questionnaire",
        "reference": "Questionnaire/sirb-protocol-questionnaire"
      },
      "groupingId": "new-group1",
      "description": "The Protocol Questionnaire is used by the Principal Investigator and/or the Study Coordinator to justify the study and request the approval for the study.  Contents include a synopsis for non-technical board members and a detailed protocol discussion.  Other important sections of form requesting approval for the protocol include work history of the researchers, risks to university personnel performing the research, risk mitigations being undertaken by the researchers, long discussions of the existing body of knowledge and explanations of how the study can be rationalized in light of the existing knowledge on this study topic.",
      "exampleBoolean": true
    }, {
      "name": "Consent Questionnaire",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "Questionnaire"
      } ],
      "reference": {
        "display": "Consent Questionnaire",
        "reference": "Questionnaire/sirb-consent-questionnaire"
      },
      "groupingId": "new-group1",
      "description": "The Consent Form Questionnaire creates the exact Consent Form content word-for-word that will be shown to the sIRB’s Institutional Review Board to be approved to use during the study.  The rendering and pdf format created by the software are also provided to the sIRB to be approved.",
      "exampleBoolean": true
    }, {
      "name": "Recruitment Materials Questionnaire",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "Questionnaire"
      } ],
      "reference": {
        "display": "Recruitment Materials Questionnaire",
        "reference": "Questionnaire/sirb-recruitment-materials-questionnaire"
      },
      "groupingId": "new-group1",
      "description": "The Recruitment Materials Form is used to seek approval from the sIRB to use the specified recruitment materials (at the requested time, place, duration and medium) during the study and for the methods of communication that are proposed for responding to the study participants",
      "exampleBoolean": true
    }, {
      "name": "Determination Letter Questionnaire",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "Questionnaire"
      } ],
      "reference": {
        "display": "Determination Letter Questionnaire",
        "reference": "Questionnaire/sirb-determination-letter-questionnaire"
      },
      "groupingId": "new-group1",
      "description": "This questionnaire collects information required in the production of a determination letter. These data are used to send a Determination Letter Report to each site when a decision is made regarding the institution’s approval to serve as a relying site.",
      "exampleBoolean": true
    }, {
      "name": "Continuing Review Questionnaire",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "Questionnaire"
      } ],
      "reference": {
        "display": "Continuing Review Questionnaire",
        "reference": "Questionnaire/sirb-continuing-review-questionnaire"
      },
      "groupingId": "new-group1",
      "description": "The Continuing Review Questionnaire collects data used in a report which is then provided to the sIRB on a regular basis so that continued activity on the study can be reviewed.",
      "exampleBoolean": true
    }, {
      "name": "Adverse Medical Event Questionnaire",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "Questionnaire"
      } ],
      "reference": {
        "display": "Adverse Medical Event Questionnaire",
        "reference": "Questionnaire/sirb-adverse-event-questionnaire"
      },
      "groupingId": "new-group1",
      "description": "The Adverse Events Questionnaire is intended to create a Medical Adverse Event Report to the sIRB to notify them of the Medical Adverse Event, the medical description of the event, the resolution of the event, whether there were associated protocol violations and the relationship of the medical event to the study agent.",
      "exampleBoolean": true
    }, {
      "name": "Adverse Non-Medical Event Questionnaire",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "Questionnaire"
      } ],
      "reference": {
        "display": "NonMedical Events",
        "reference": "Questionnaire/sirb-nonmedicalevent-questionnaire"
      },
      "groupingId": "new-group1",
      "description": "The Non-Medical Adverse Questionnaire is intended to create a Non-Medical Adverse Event Report to the sIRB.  An example of a Non-Medical Adverse Event is the inadvertent disclosure to several participants that they are receiving the placebo in a blind study.  The Non-Medical Adverse Questionnaire captures details for the report such as the root cause of the event, the corrective action plan and associated changes to the protocol or consent form as a result of the event.",
      "exampleBoolean": true
    }, {
      "name": "Adverse Non-Medical Event Questionnaire Response",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "QuestionnaireResponse"
      } ],
      "reference": {
        "reference": "QuestionnaireResponse/NME-QR"
      },
      "groupingId": "new-group2",
      "description": "Example of Questionaire Response for Non=Medical Adverse Events",
      "exampleBoolean": true
    }, {
      "name": "Protocol Questionnaire Response",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "QuestionnaireResponse"
      } ],
      "reference": {
        "reference": "QuestionnaireResponse/PROTOCOL-QR"
      },
      "groupingId": "new-group2",
      "description": "Example of a submitted Protocol Questionnaire Response",
      "exampleBoolean": true
    }, {
      "name": "Adverse Medical Event Questionnaire Response",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "QuestionnaireResponse"
      } ],
      "reference": {
        "reference": "QuestionnaireResponse/MEDICAL-AE-QR"
      },
      "groupingId": "new-group2",
      "description": "Example of an Adverse Medical Event Questionnaire Response",
      "exampleBoolean": true
    }, {
      "name": "Initiate a Study Questionnaire Response",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "QuestionnaireResponse"
      } ],
      "reference": {
        "reference": "QuestionnaireResponse/INITIATE-QR"
      },
      "groupingId": "new-group2",
      "description": "Example of a Intiate a Study Questionaire Response",
      "exampleBoolean": true
    }, {
      "name": "Determination Letter Questionnaire Response",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "QuestionnaireResponse"
      } ],
      "reference": {
        "reference": "QuestionnaireResponse/DETERMINATION-QR"
      },
      "groupingId": "new-group2",
      "description": "Example of a Determination Letter Questionaire Response",
      "exampleBoolean": true
    }, {
      "name": "Recruit Questionnaire Response",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "QuestionnaireResponse"
      } ],
      "reference": {
        "reference": "QuestionnaireResponse/RECRUIT-QR"
      },
      "groupingId": "new-group2",
      "description": "Example of a Recruitment Materials Questionnaire Response",
      "exampleBoolean": true
    }, {
      "name": "Temporary Codes",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "CodeSystem"
      } ],
      "reference": {
        "display": "Temporary Codes",
        "reference": "CodeSystem/temporarycodes"
      },
      "description": "This is a temporary codesystem capturing the custom codelists used across the forms.",
      "exampleBoolean": false
    }, {
      "name": "Example of Research Study",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "ResearchStudy"
      } ],
      "reference": {
        "display": "Double blind, placebo-controlled trial of a new class of arthritis medication",
        "reference": "ResearchStudy/ResearchStudy2858"
      },
      "groupingId": "new-group3",
      "description": "Example of Research Study",
      "exampleBoolean": true
    }, {
      "name": "Continuing Review Questionnaire Response",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "QuestionnaireResponse"
      } ],
      "reference": {
        "reference": "QuestionnaireResponse/CONTINUING-REVIEW-QR"
      },
      "groupingId": "new-group2",
      "description": "Description of CR QR",
      "exampleBoolean": false
    }, {
      "name": "Consent QR",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "QuestionnaireResponse"
      } ],
      "reference": {
        "reference": "QuestionnaireResponse/CONSENT-QR"
      },
      "groupingId": "new-group2",
      "description": "Description of Consent QR",
      "exampleBoolean": false
    }, {
      "name": "Determination Questionnaire with pre-population",
      "extension": [ {
        "url": "http://hl7.org/fhir/tools/StructureDefinition/resource-information",
        "valueString": "Questionnaire"
      } ],
      "reference": {
        "display": "sIRB Determination Questionnaire",
        "reference": "Questionnaire/POPULATE-sirb-determination-letter-questionnaire"
      },
      "groupingId": "new-group4",
      "description": "Determination Questionnaire with pre-population",
      "exampleBoolean": true
    } ],
    "extension": [ {
      "url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
      "extension": [ {
        "url": "code",
        "valueString": "copyrightyear"
      }, {
        "url": "value",
        "valueString": "2020+"
      } ]
    }, {
      "url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
      "extension": [ {
        "url": "code",
        "valueString": "releaselabel"
      }, {
        "url": "value",
        "valueString": "STU 1 ballot"
      } ]
    }, {
      "url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
      "extension": [ {
        "url": "code",
        "valueString": "path-liquid"
      }, {
        "url": "value",
        "valueString": "template/liquid"
      } ]
    }, {
      "url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
      "extension": [ {
        "url": "code",
        "valueString": "path-liquid"
      }, {
        "url": "value",
        "valueString": "input/liquid"
      } ]
    }, {
      "url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
      "extension": [ {
        "url": "code",
        "valueString": "path-qa"
      }, {
        "url": "value",
        "valueString": "temp/qa"
      } ]
    }, {
      "url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
      "extension": [ {
        "url": "code",
        "valueString": "path-temp"
      }, {
        "url": "value",
        "valueString": "temp/pages"
      } ]
    }, {
      "url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
      "extension": [ {
        "url": "code",
        "valueString": "path-output"
      }, {
        "url": "value",
        "valueString": "output"
      } ]
    }, {
      "url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
      "extension": [ {
        "url": "code",
        "valueString": "path-suppressed-warnings"
      }, {
        "url": "value",
        "valueString": "input/ignoreWarnings.txt"
      } ]
    }, {
      "url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
      "extension": [ {
        "url": "code",
        "valueString": "path-history"
      }, {
        "url": "value",
        "valueString": "http://hl7.org/fhir/us/sirb/history.html"
      } ]
    }, {
      "url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
      "extension": [ {
        "url": "code",
        "valueString": "template-html"
      }, {
        "url": "value",
        "valueString": "template-page.html"
      } ]
    }, {
      "url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
      "extension": [ {
        "url": "code",
        "valueString": "template-md"
      }, {
        "url": "value",
        "valueString": "template-page-md.html"
      } ]
    }, {
      "url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
      "extension": [ {
        "url": "code",
        "valueString": "apply-contact"
      }, {
        "url": "value",
        "valueString": "true"
      } ]
    }, {
      "url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
      "extension": [ {
        "url": "code",
        "valueString": "apply-context"
      }, {
        "url": "value",
        "valueString": "true"
      } ]
    }, {
      "url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
      "extension": [ {
        "url": "code",
        "valueString": "apply-copyright"
      }, {
        "url": "value",
        "valueString": "true"
      } ]
    }, {
      "url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
      "extension": [ {
        "url": "code",
        "valueString": "apply-jurisdiction"
      }, {
        "url": "value",
        "valueString": "true"
      } ]
    }, {
      "url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
      "extension": [ {
        "url": "code",
        "valueString": "apply-license"
      }, {
        "url": "value",
        "valueString": "true"
      } ]
    }, {
      "url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
      "extension": [ {
        "url": "code",
        "valueString": "apply-publisher"
      }, {
        "url": "value",
        "valueString": "true"
      } ]
    }, {
      "url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
      "extension": [ {
        "url": "code",
        "valueString": "apply-version"
      }, {
        "url": "value",
        "valueString": "true"
      } ]
    }, {
      "url": "http://hl7.org/fhir/tools/StructureDefinition/ig-parameter",
      "extension": [ {
        "url": "code",
        "valueString": "active-tables"
      }, {
        "url": "value",
        "valueString": "true"
      } ]
    } ],
    "parameter": [ {
      "code": "path-resource",
      "value": "input/capabilities"
    }, {
      "code": "path-resource",
      "value": "input/examples"
    }, {
      "code": "path-resource",
      "value": "input/extensions"
    }, {
      "code": "path-resource",
      "value": "input/models"
    }, {
      "code": "path-resource",
      "value": "input/operations"
    }, {
      "code": "path-resource",
      "value": "input/profiles"
    }, {
      "code": "path-resource",
      "value": "input/resources"
    }, {
      "code": "path-resource",
      "value": "input/vocabulary"
    }, {
      "code": "path-resource",
      "value": "input/maps"
    }, {
      "code": "path-resource",
      "value": "input/testing"
    }, {
      "code": "path-resource",
      "value": "input/history"
    }, {
      "code": "path-resource",
      "value": "fsh-generated/resources"
    }, {
      "code": "path-pages",
      "value": "template/config"
    }, {
      "code": "path-pages",
      "value": "input/images"
    }, {
      "code": "path-tx-cache",
      "value": "input-cache/txcache"
    } ]
  },
  "date": "2021-07-23",
  "meta": {
    "source": "#8wsNiuZaaMz8Tbp6",
    "versionId": "333",
    "lastUpdated": "2021-07-29T04:13:05.490+00:00"
  },
  "publisher": "HL7 International - BR&R Work Group",
  "fhirVersion": [ "4.0.1" ],
  "license": "CC0-1.0",
  "jurisdiction": [ {
    "text": "United States of America",
    "coding": [ {
      "code": "US",
      "system": "urn:iso:std:iso:3166",
      "display": "United States of America"
    } ]
  } ],
  "dependsOn": [ {
    "id": "sdc",
    "uri": "http://hl7.org/fhir/uv/sdc/ImplementationGuide/sdc",
    "version": "2.7.0",
    "packageId": "hl7.fhir.uv.sdc"
  } ],
  "name": "SingleInstitutionalReviewBoard",
  "type": null,
  "experimental": null,
  "resourceType": "ImplementationGuide",
  "title": "Single Institutional Review Board (sIRB) Implementation Guide",
  "package_version": "0.1.0",
  "status": "draft",
  "id": "ee9dafec-84df-4358-904b-6c132558aa46",
  "kind": null,
  "url": "http://hl7.org/fhir/us/sirb/ImplementationGuide/hl7.fhir.us.sirb",
  "version": "0.1.0",
  "packageId": "hl7.fhir.us.sirb",
  "contact": [ {
    "name": "HL7 International - Biomedical Research and Regulation",
    "telecom": [ {
      "value": "http://www.hl7.org/Special/committees/rcrim",
      "system": "url"
    } ]
  } ]
}