Response to Regulatory Questions (RTQ), published by HL7 International. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/rtq-ig/ and changes regularly. See the Directory of published versions

• Narrative Content
• XML
• JSON
• TTL

: QuestionnaireResponse - JSON Representation

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{
  "resourceType" : "QuestionnaireResponse",
  "id" : "QuestionnaireResponse",
  "meta" : {
    "versionId" : "1",
    "lastUpdated" : "2025-11-20T22:30:00Z",
    "profile" : [
      🔗 "http://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-questionnaireresponse"
    ]
  },
  "identifier" : [
    {
      "system" : "http://hl7.org/fhir/uv/brr/identifier/qa-request",
      "value" : "ID001"
    },
    {
      "system" : "https://ema.europa.eu/procedure-number",
      "value" : "EMEA/H/C/005432/II/0023"
    }
  ],
  "text" : {
    "status" : "generated",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">\n      <p>Dear Assessment Team,</p>\n      <p>Please find below the structured responses to the List of Questions issued on 2025-05-20\n        for the Type II variation (EMEA/H/C/005432/II/0023) concerning ExampleDrug 10 mg Tablets.</p>\n      <p>Yours sincerely,<br/>Dr. John Doe<br/>Head of Regulatory Affairs<br/>SynthPharma AG</p>\n    </div>"
  },
  "questionnaire" : "questionnaire_ID001",
  "status" : "completed",
  "subject" : {
    "reference" : "MedicinalProductDefinition/MedicinalProduct-ExampleDrug",
    "display" : "ExampleDrug 10 mg Tablets"
  },
  "author" : //  Author = Regulatory Authority (EMA) – full inline Organization 
  {
    "type" : "Organization",
    "identifier" : {
      "system" : "https://ema.europa.eu/organization-id",
      "value" : "EMA"
    }
  },
  "source" : //  Source = Marketing Authorisation Holder (SynthPharma AG) – full inline Organization 
  {
    "type" : "Organization",
    "identifier" : {
      "system" : "https://www.zefix.ch/en/SwissCompanyRegistry/UID",
      "value" : "CHE-123.456.789"
    }
  },
  "authored" : "2025-06-25T14:00:00+02:00",
  "item" : [
    {
      "linkId" : "1",
      "extension" : [
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"
        }
      ],
      "answer" : [
        {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"
            }
          ]
        }
      ]
    },
    {
      "linkId" : "2",
      "extension" : [
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"
        }
      ],
      "answer" : [
        {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"
            }
          ]
        }
      ]
    },
    {
      "linkId" : "3",
      "extension" : [
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"
        }
      ],
      "answer" : [
        {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"
            }
          ]
        }
      ]
    },
    {
      "linkId" : "4",
      "extension" : [
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"
        }
      ],
      "answer" : [
        {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"
            }
          ]
        }
      ]
    },
    {
      "linkId" : "5",
      "extension" : [
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"
        }
      ],
      "answer" : [
        {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"
            }
          ]
        }
      ]
    },
    {
      "linkId" : "6",
      "extension" : [
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"
        }
      ],
      "answer" : [
        {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"
            }
          ]
        }
      ]
    },
    {
      "linkId" : "7",
      "extension" : [
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"
        }
      ],
      "answer" : [
        {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"
            }
          ]
        }
      ]
    },
    {
      "linkId" : "8",
      "extension" : [
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"
        }
      ],
      "answer" : [
        {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"
            }
          ]
        }
      ]
    },
    {
      "linkId" : "9",
      "extension" : [
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"
        }
      ],
      "answer" : [
        {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"
            }
          ]
        }
      ]
    },
    {
      "linkId" : "10",
      "extension" : [
        {
          "url" : "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"
        }
      ],
      "answer" : [
        {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/rendering-xhtml"
            }
          ]
        }
      ]
    }
  ]
}