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Packagehl7.fhir.uv.rwi-pharma
Resource TypeCodeSystem
IdCodeSystem-apix-task-input-output-type.json
FHIR VersionR5
Sourcehttps://build.fhir.org/ig/HL7/reg-workflow-pharma/CodeSystem-apix-task-input-output-type.html
URLhttp://hl7.org/fhir/uv/rwi-pharma/CodeSystem/apix-task-input-output-type
Version0.1.0
Statusdraft
Date2026-10-25T20:05:09+00:00
NameAPIXTaskInputOutputTypeCS
TitleAPIX Task Input and Output Types
Realmuv
Authorityhl7
DescriptionTypes of documents and data exchanged as Task inputs and outputs. Inputs come from the requester; outputs come from the owner. This code system holds the types used by the IG's examples; see the Terminology page for a fuller example set.
Contentcomplete

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Narrative

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Generated Narrative: CodeSystem apix-task-input-output-type

This case-sensitive code system http://hl7.org/fhir/uv/rwi-pharma/CodeSystem/apix-task-input-output-type defines the following codes:

CodeDisplayDefinition
cover-letter Cover LetterLetter describing the submission and its contents.
application-form Application FormCompleted regional application form.
validation-report Validation ReportOutcome of technical or administrative validation.
protocol ProtocolClinical trial protocol (or amended protocol).
request-for-information Request for InformationQuestions from the regulator during assessment of a trial.
response-to-questions Response to QuestionsApplicant's response document to a list of questions.
authorisation-decision Authorisation DecisionDecision on a clinical trial application or modification.
icsr-e2b-r2 ICSR (E2B(R2))A single individual case safety report as an ICH E2B(R2) XML message.
icsr-e2b-r3 ICSR (E2B(R3))A single individual case safety report as an ICH E2B(R3) XML message.
susar-e2b-r2 SUSAR (E2B(R2))A single SUSAR report from a clinical trial as an ICH E2B(R2) XML message.
susar-e2b-r3 SUSAR (E2B(R3))A single SUSAR report from a clinical trial as an ICH E2B(R3) XML message.
icsr-e2b-r2-acklog ICSR E2B(R2) Acknowledgment LogICH E2B(R2) acknowledgment message (ichicsrack) returned for an ICSR, with the transmission and report acknowledgment codes and any errors.
icsr-e2b-r3-acklog ICSR E2B(R3) Acknowledgment LogICH E2B(R3) acknowledgment message returned for an ICSR, with the transmission (ACK.A.4) and report (ACK.B.r.6) acknowledgment codes and any errors.
susar-e2b-r2-acklog SUSAR E2B(R2) Acknowledgment LogICH E2B(R2) acknowledgment message (ichicsrack) returned for a SUSAR, with the transmission and report acknowledgment codes and any errors.
susar-e2b-r3-acklog SUSAR E2B(R3) Acknowledgment LogICH E2B(R3) acknowledgment message returned for a SUSAR, with the transmission (ACK.A.4) and report (ACK.B.r.6) acknowledgment codes and any errors.
change-description Change Description and JustificationDescription of the proposed change, with current vs proposed comparison and justification.
epi-bundle ePI BundleElectronic product information as a FHIR document Bundle.
proposed-labelling Proposed LabellingProposed product information (e.g., annotated ePI, annotated PDF or Word).
labelling-comments Labelling CommentsRegulator’s comments on, or revised version of, proposed labelling.
approved-labelling Approved LabellingFinal agreed product information.
approval-letter Approval LetterLetter granting approval or authorization.

Source1

{
  "resourceType": "CodeSystem",
  "id": "apix-task-input-output-type",
  "text": {
    "status": "generated",
    "div": "<!-- snip (see above) -->"
  },
  "extension": [
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
      "valueCode": "brr"
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
      "valueInteger": 1,
      "_valueInteger": {
        "extension": [
          {
            "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
            "valueCanonical": "http://hl7.org/fhir/uv/rwi-pharma/ImplementationGuide/hl7.fhir.uv.rwi-pharma"
          }
        ]
      }
    },
    {
      "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
      "valueCode": "trial-use",
      "_valueCode": {
        "extension": [
          {
            "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
            "valueCanonical": "http://hl7.org/fhir/uv/rwi-pharma/ImplementationGuide/hl7.fhir.uv.rwi-pharma"
          }
        ]
      }
    }
  ],
  "url": "http://hl7.org/fhir/uv/rwi-pharma/CodeSystem/apix-task-input-output-type",
  "version": "0.1.0",
  "name": "APIXTaskInputOutputTypeCS",
  "title": "APIX Task Input and Output Types",
  "status": "draft",
  "experimental": false,
  "date": "2026-10-25T20:05:09+00:00",
  "publisher": "HL7 International / Biomedical Research and Regulation",
  "contact": [
    {
      "name": "HL7 International / Biomedical Research and Regulation",
      "telecom": [
        {
          "system": "url",
          "value": "http://www.hl7.org/Special/committees/rcrim"
        }
      ]
    }
  ],
  "description": "Types of documents and data exchanged as Task inputs and outputs. Inputs come from the requester; outputs come from the owner. This code system holds the types used by the IG's examples; see the Terminology page for a fuller example set.",
  "jurisdiction": [
    {
      "coding": [
        {
          "system": "http://unstats.un.org/unsd/methods/m49/m49.htm",
          "code": "001",
          "display": "World"
        }
      ]
    }
  ],
  "caseSensitive": true,
  "content": "complete",
  "count": 21,
  "concept": [
    {
      "code": "cover-letter",
      "display": "Cover Letter",
      "definition": "Letter describing the submission and its contents."
    },
    {
      "code": "application-form",
      "display": "Application Form",
      "definition": "Completed regional application form."
    },
    {
      "code": "validation-report",
      "display": "Validation Report",
      "definition": "Outcome of technical or administrative validation."
    },
    {
      "code": "protocol",
      "display": "Protocol",
      "definition": "Clinical trial protocol (or amended protocol)."
    },
    {
      "code": "request-for-information",
      "display": "Request for Information",
      "definition": "Questions from the regulator during assessment of a trial."
    },
    {
      "code": "response-to-questions",
      "display": "Response to Questions",
      "definition": "Applicant's response document to a list of questions."
    },
    {
      "code": "authorisation-decision",
      "display": "Authorisation Decision",
      "definition": "Decision on a clinical trial application or modification."
    },
    {
      "code": "icsr-e2b-r2",
      "display": "ICSR (E2B(R2))",
      "definition": "A single individual case safety report as an ICH E2B(R2) XML message."
    },
    {
      "code": "icsr-e2b-r3",
      "display": "ICSR (E2B(R3))",
      "definition": "A single individual case safety report as an ICH E2B(R3) XML message."
    },
    {
      "code": "susar-e2b-r2",
      "display": "SUSAR (E2B(R2))",
      "definition": "A single SUSAR report from a clinical trial as an ICH E2B(R2) XML message."
    },
    {
      "code": "susar-e2b-r3",
      "display": "SUSAR (E2B(R3))",
      "definition": "A single SUSAR report from a clinical trial as an ICH E2B(R3) XML message."
    },
    {
      "code": "icsr-e2b-r2-acklog",
      "display": "ICSR E2B(R2) Acknowledgment Log",
      "definition": "ICH E2B(R2) acknowledgment message (ichicsrack) returned for an ICSR, with the transmission and report acknowledgment codes and any errors."
    },
    {
      "code": "icsr-e2b-r3-acklog",
      "display": "ICSR E2B(R3) Acknowledgment Log",
      "definition": "ICH E2B(R3) acknowledgment message returned for an ICSR, with the transmission (ACK.A.4) and report (ACK.B.r.6) acknowledgment codes and any errors."
    },
    {
      "code": "susar-e2b-r2-acklog",
      "display": "SUSAR E2B(R2) Acknowledgment Log",
      "definition": "ICH E2B(R2) acknowledgment message (ichicsrack) returned for a SUSAR, with the transmission and report acknowledgment codes and any errors."
    },
    {
      "code": "susar-e2b-r3-acklog",
      "display": "SUSAR E2B(R3) Acknowledgment Log",
      "definition": "ICH E2B(R3) acknowledgment message returned for a SUSAR, with the transmission (ACK.A.4) and report (ACK.B.r.6) acknowledgment codes and any errors."
    },
    {
      "code": "change-description",
      "display": "Change Description and Justification",
      "definition": "Description of the proposed change, with current vs proposed comparison and justification."
    },
    {
      "code": "epi-bundle",
      "display": "ePI Bundle",
      "definition": "Electronic product information as a FHIR document Bundle."
    },
    {
      "code": "proposed-labelling",
      "display": "Proposed Labelling",
      "definition": "Proposed product information (e.g., annotated ePI, annotated PDF or Word)."
    },
    {
      "code": "labelling-comments",
      "display": "Labelling Comments",
      "definition": "Regulator’s comments on, or revised version of, proposed labelling."
    },
    {
      "code": "approved-labelling",
      "display": "Approved Labelling",
      "definition": "Final agreed product information."
    },
    {
      "code": "approval-letter",
      "display": "Approval Letter",
      "definition": "Letter granting approval or authorization."
    }
  ]
}