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Indication

Referenced schema · Source · Dereferenced version

Regulatory approval text and its source. Root type Indication with one subtype per organization, selected by the id prefix ind:{org}:. Only HSE indications carry reimbursement_scheme and reimbursement_comment.

Root type shared by every organization. Organization-specific types below extend it; the top-level schema closes the record with unevaluatedProperties.

Fields

Field Type Required Description
id string matching ^ind:(fda|ema|hse|hc|hpra):.+$ yes
type always Indication yes
description string yes Regulatory approval text, verbatim.
contributions array of string matching ^ctrb:[a-z]+:\d{4}-\d{2}-\d{2}:\d+$ yes
reportedIn array of string matching ^doc:(fda|ema|hse|hc|hpra):.+$ yes
status one of Approved, Accelerated, Superseded, Withdrawn yes
statement_description string yes
raw_biomarkers string or null yes
raw_cancer_types string yes
raw_therapeutics string yes
superseded_by array of string matching ^ind:(fda|ema|hse|hc|hpra):.+$ yes

Subtypes

Every record matches exactly one subtype, which adds to the fields above.

Subtype Applies when Description
FDA Indication id matches ^ind:fda: Indication from the organization fda. reportedIn lists the evergreen FDA document (doc:fda:{drug}) first, followed by the dated, Deprecated FDA document (doc:fda:{drug}:{YYYY-MM-DD}) for the label in which the indication was initially approved.
EMA Indication id matches ^ind:ema: Indication from the organization ema.
HC Indication id matches ^ind:hc: Indication from the organization hc.
HPRA Indication id matches ^ind:hpra: Indication from the organization hpra.
HSE Indication id matches ^ind:hse: Indication from the Health Service Executive (HSE). Unlike other organizations, carries reimbursement information.

FDA Indication

Indication from the organization fda. reportedIn lists the evergreen FDA document (doc:fda:{drug}) first, followed by the dated, Deprecated FDA document (doc:fda:{drug}:{YYYY-MM-DD}) for the label in which the indication was initially approved.

Builds on Indication.

Field Type Required Description
id matching ^ind:fda:
reportedIn array of (string matching ^doc:fda:[^:]+$, string matching ^doc:fda:[^:]+:\d{4}-\d{2}-\d{2}$) (exactly 2 items) The evergreen document, then the dated document for the initial approval.

EMA Indication

Indication from the organization ema.

Builds on Indication.

Field Type Required Description
id matching ^ind:ema:

HC Indication

Indication from the organization hc.

Builds on Indication.

Field Type Required Description
id matching ^ind:hc:

HPRA Indication

Indication from the organization hpra.

Builds on Indication.

Field Type Required Description
id matching ^ind:hpra:

HSE Indication

Indication from the Health Service Executive (HSE). Unlike other organizations, carries reimbursement information.

Builds on Indication.

Field Type Required Description
id matching ^ind:hse:
reimbursement_scheme one of CDS, ODMS, Incomplete Reimbursement, Hospital, N/A, Hybrid yes
reimbursement_comment string or null yes

JSON Schema

Full JSON Schema
{
  "$schema": "https://json-schema.org/draft/2020-12/schema",
  "$id": "https://moalmanac.org/schemas/referenced/indications.schema.json",
  "title": "Indication",
  "description": "Regulatory approval text and its source. Root type `Indication` with one subtype per organization, selected by the id prefix `ind:{org}:`. Only HSE indications carry `reimbursement_scheme` and `reimbursement_comment`.",
  "$ref": "#/$defs/Indication",
  "allOf": [
    {
      "if": {
        "required": [
          "id"
        ],
        "properties": {
          "id": {
            "pattern": "^ind:fda:"
          }
        }
      },
      "then": {
        "$ref": "#/$defs/FDA Indication"
      }
    },
    {
      "if": {
        "required": [
          "id"
        ],
        "properties": {
          "id": {
            "pattern": "^ind:ema:"
          }
        }
      },
      "then": {
        "$ref": "#/$defs/EMA Indication"
      }
    },
    {
      "if": {
        "required": [
          "id"
        ],
        "properties": {
          "id": {
            "pattern": "^ind:hc:"
          }
        }
      },
      "then": {
        "$ref": "#/$defs/HC Indication"
      }
    },
    {
      "if": {
        "required": [
          "id"
        ],
        "properties": {
          "id": {
            "pattern": "^ind:hpra:"
          }
        }
      },
      "then": {
        "$ref": "#/$defs/HPRA Indication"
      }
    },
    {
      "if": {
        "required": [
          "id"
        ],
        "properties": {
          "id": {
            "pattern": "^ind:hse:"
          }
        }
      },
      "then": {
        "$ref": "#/$defs/HSE Indication"
      }
    }
  ],
  "unevaluatedProperties": false,
  "$defs": {
    "Indication": {
      "type": "object",
      "properties": {
        "id": {
          "type": "string",
          "pattern": "^ind:(fda|ema|hse|hc|hpra):.+$"
        },
        "type": {
          "const": "Indication"
        },
        "description": {
          "type": "string",
          "description": "Regulatory approval text, verbatim."
        },
        "contributions": {
          "type": "array",
          "items": {
            "type": "string",
            "pattern": "^ctrb:[a-z]+:\\d{4}-\\d{2}-\\d{2}:\\d+$",
            "description": "Foreign key to `contributions.id`."
          }
        },
        "reportedIn": {
          "type": "array",
          "items": {
            "type": "string",
            "pattern": "^doc:(fda|ema|hse|hc|hpra):.+$",
            "description": "Foreign key to `documents.id`."
          }
        },
        "status": {
          "enum": [
            "Approved",
            "Accelerated",
            "Superseded",
            "Withdrawn"
          ]
        },
        "statement_description": {
          "type": "string"
        },
        "raw_biomarkers": {
          "type": [
            "string",
            "null"
          ]
        },
        "raw_cancer_types": {
          "type": "string"
        },
        "raw_therapeutics": {
          "type": "string"
        },
        "superseded_by": {
          "type": "array",
          "items": {
            "type": "string",
            "pattern": "^ind:(fda|ema|hse|hc|hpra):.+$",
            "description": "Foreign key to `indications.id`."
          }
        }
      },
      "required": [
        "id",
        "type",
        "description",
        "contributions",
        "reportedIn",
        "status",
        "statement_description",
        "raw_biomarkers",
        "raw_cancer_types",
        "raw_therapeutics",
        "superseded_by"
      ],
      "description": "Root type shared by every organization. Organization-specific types below extend it; the top-level schema closes the record with unevaluatedProperties."
    },
    "FDA Indication": {
      "description": "Indication from the organization `fda`. `reportedIn` lists the evergreen FDA document (`doc:fda:{drug}`) first, followed by the dated, Deprecated FDA document (`doc:fda:{drug}:{YYYY-MM-DD}`) for the label in which the indication was initially approved.",
      "allOf": [
        {
          "$ref": "#/$defs/Indication"
        },
        {
          "properties": {
            "id": {
              "pattern": "^ind:fda:"
            },
            "reportedIn": {
              "type": "array",
              "minItems": 2,
              "maxItems": 2,
              "prefixItems": [
                {
                  "type": "string",
                  "pattern": "^doc:fda:[^:]+$",
                  "description": "Foreign key to the evergreen `documents.id`."
                },
                {
                  "type": "string",
                  "pattern": "^doc:fda:[^:]+:\\d{4}-\\d{2}-\\d{2}$",
                  "description": "Foreign key to the dated `documents.id` for the initial approval."
                }
              ],
              "description": "The evergreen document, then the dated document for the initial approval."
            }
          }
        }
      ]
    },
    "EMA Indication": {
      "description": "Indication from the organization `ema`.",
      "allOf": [
        {
          "$ref": "#/$defs/Indication"
        },
        {
          "properties": {
            "id": {
              "pattern": "^ind:ema:"
            }
          }
        }
      ]
    },
    "HC Indication": {
      "description": "Indication from the organization `hc`.",
      "allOf": [
        {
          "$ref": "#/$defs/Indication"
        },
        {
          "properties": {
            "id": {
              "pattern": "^ind:hc:"
            }
          }
        }
      ]
    },
    "HPRA Indication": {
      "description": "Indication from the organization `hpra`.",
      "allOf": [
        {
          "$ref": "#/$defs/Indication"
        },
        {
          "properties": {
            "id": {
              "pattern": "^ind:hpra:"
            }
          }
        }
      ]
    },
    "HSE Indication": {
      "description": "Indication from the Health Service Executive (HSE). Unlike other organizations, carries reimbursement information.",
      "allOf": [
        {
          "$ref": "#/$defs/Indication"
        },
        {
          "properties": {
            "id": {
              "pattern": "^ind:hse:"
            },
            "reimbursement_scheme": {
              "enum": [
                "CDS",
                "ODMS",
                "Incomplete Reimbursement",
                "Hospital",
                "N/A",
                "Hybrid"
              ]
            },
            "reimbursement_comment": {
              "type": [
                "string",
                "null"
              ]
            }
          },
          "required": [
            "reimbursement_scheme",
            "reimbursement_comment"
          ]
        }
      ]
    }
  }
}