Document¶

Referenced schema · Source · Dereferenced version

A source document. At present every document is a regulatory approval.

Fields¶

Field	Type	Required	Description
`id`	string matching `^doc:(fda\|ema\|hse\|hc\|hpra):.+$`	yes
`type`	always `Document`	yes
`documentType`	one of `Regulatory approval`	yes
`name`	string	yes
`title`	string or null	yes
`aliases`	array of string	yes
`description`	string	yes
`urls`	array of string matching `^url:(fda\|ema\|hse\|hc\|hpra):.+$`	yes
`doi`	string or null	yes
`pmid`	string or null	yes
`agent_id`	string matching `^agent:(org\|user):[a-z0-9]+$`	yes	Foreign key to `agents.id`.
`company`	string	yes
`drug_name_brand`	string or null	yes
`drug_name_generic`	string or null	yes
`first_publication_date`	iso_date_or_null	yes
`publication_date`	iso_date_or_null	yes
`regulatory_identifier`	string or null	yes	Identifier assigned by the regulatory agency. FDA documents use the application type and six-digit application number (e.g. NDA208716, BLA125427); EMA documents use the product number (e.g. EMEA/H/C/006184).
`status`	one of `Active`, `Deprecated`	yes

Definitions¶

iso_date_or_null¶

An ISO 8601 date (YYYY-MM-DD) or null.

Type: null or string format date

Additional rules¶

These rules also apply to every record:

When id matches ^doc:fda:: regulatory_identifier is string matching ^(BLA|NDA)[0-9]{6}$.

JSON Schema¶

Full JSON Schema

{
  "$schema": "https://json-schema.org/draft/2020-12/schema",
  "$id": "https://moalmanac.org/schemas/referenced/documents.schema.json",
  "title": "Document",
  "description": "A source document. At present every document is a regulatory approval.",
  "type": "object",
  "properties": {
    "id": {
      "type": "string",
      "pattern": "^doc:(fda|ema|hse|hc|hpra):.+$"
    },
    "type": {
      "const": "Document"
    },
    "documentType": {
      "enum": [
        "Regulatory approval"
      ]
    },
    "name": {
      "type": "string"
    },
    "title": {
      "type": [
        "string",
        "null"
      ]
    },
    "aliases": {
      "type": "array",
      "items": {
        "type": "string"
      }
    },
    "description": {
      "type": "string"
    },
    "urls": {
      "type": "array",
      "items": {
        "type": "string",
        "pattern": "^url:(fda|ema|hse|hc|hpra):.+$",
        "description": "Foreign key to `urls.id`."
      }
    },
    "doi": {
      "type": [
        "string",
        "null"
      ]
    },
    "pmid": {
      "type": [
        "string",
        "null"
      ]
    },
    "agent_id": {
      "type": "string",
      "pattern": "^agent:(org|user):[a-z0-9]+$",
      "description": "Foreign key to `agents.id`."
    },
    "company": {
      "type": "string"
    },
    "drug_name_brand": {
      "type": [
        "string",
        "null"
      ]
    },
    "drug_name_generic": {
      "type": [
        "string",
        "null"
      ]
    },
    "first_publication_date": {
      "$ref": "#/$defs/iso_date_or_null"
    },
    "publication_date": {
      "$ref": "#/$defs/iso_date_or_null"
    },
    "regulatory_identifier": {
      "type": [
        "string",
        "null"
      ],
      "description": "Identifier assigned by the regulatory agency. FDA documents use the application type and six-digit application number (e.g. NDA208716, BLA125427); EMA documents use the product number (e.g. EMEA/H/C/006184)."
    },
    "status": {
      "enum": [
        "Active",
        "Deprecated"
      ]
    }
  },
  "required": [
    "id",
    "type",
    "documentType",
    "name",
    "title",
    "aliases",
    "description",
    "urls",
    "doi",
    "pmid",
    "agent_id",
    "company",
    "drug_name_brand",
    "drug_name_generic",
    "first_publication_date",
    "publication_date",
    "regulatory_identifier",
    "status"
  ],
  "additionalProperties": false,
  "allOf": [
    {
      "if": {
        "required": [
          "id"
        ],
        "properties": {
          "id": {
            "pattern": "^doc:fda:"
          }
        }
      },
      "then": {
        "properties": {
          "regulatory_identifier": {
            "type": "string",
            "pattern": "^(BLA|NDA)[0-9]{6}$"
          }
        }
      }
    }
  ],
  "$defs": {
    "iso_date_or_null": {
      "description": "An ISO 8601 date (YYYY-MM-DD) or null.",
      "oneOf": [
        {
          "type": "null"
        },
        {
          "type": "string",
          "format": "date"
        }
      ]
    }
  }
}