cdisc · Schema

CDISC Dataset (Domain)

Schema representing a CDISC SDTM or ADaM dataset domain specification including all variables.

Properties

Name Type Description
name string Dataset/domain abbreviation (e.g., AE, CM, DM)
label string Human-readable label for the dataset
description string Detailed description of the dataset purpose and content
datasetClass string SDTM general observation class
structure string Dataset structure (one record per subject, one record per visit, etc.)
purpose string Dataset purpose: Tabulation or Analysis
keys array Key variables that uniquely identify a record
variables array List of variables (columns) in the dataset
_links object HAL hypermedia links
View JSON Schema on GitHub

JSON Schema

cdisc-dataset-schema.json Raw ↑
{
  "$schema": "https://json-schema.org/draft/2020-12/schema",
  "$id": "https://library.cdisc.org/api/schemas/dataset",
  "title": "CDISC Dataset (Domain)",
  "description": "Schema representing a CDISC SDTM or ADaM dataset domain specification including all variables.",
  "type": "object",
  "required": ["name", "label"],
  "properties": {
    "name": {
      "type": "string",
      "description": "Dataset/domain abbreviation (e.g., AE, CM, DM)",
      "pattern": "^[A-Z]{2,4}$",
      "examples": ["AE", "CM", "DM", "EX", "LB"]
    },
    "label": {
      "type": "string",
      "description": "Human-readable label for the dataset",
      "examples": ["Adverse Events", "Concomitant/Prior Medications", "Demographics"]
    },
    "description": {
      "type": "string",
      "description": "Detailed description of the dataset purpose and content"
    },
    "datasetClass": {
      "type": "string",
      "description": "SDTM general observation class",
      "enum": ["Events", "Findings", "Interventions", "Special Purpose", "Relationship", "Trial Design"]
    },
    "structure": {
      "type": "string",
      "description": "Dataset structure (one record per subject, one record per visit, etc.)"
    },
    "purpose": {
      "type": "string",
      "description": "Dataset purpose: Tabulation or Analysis",
      "enum": ["Tabulation", "Analysis"]
    },
    "keys": {
      "type": "array",
      "description": "Key variables that uniquely identify a record",
      "items": {
        "type": "string"
      },
      "examples": [["STUDYID", "USUBJID", "AESEQ"]]
    },
    "variables": {
      "type": "array",
      "description": "List of variables (columns) in the dataset",
      "items": {
        "$ref": "#/$defs/Variable"
      }
    },
    "_links": {
      "type": "object",
      "description": "HAL hypermedia links",
      "properties": {
        "self": {
          "$ref": "#/$defs/Link"
        },
        "parentClass": {
          "$ref": "#/$defs/Link"
        },
        "parentProduct": {
          "$ref": "#/$defs/Link"
        }
      }
    }
  },
  "$defs": {
    "Variable": {
      "type": "object",
      "required": ["name", "label", "dataType", "core"],
      "properties": {
        "name": {
          "type": "string",
          "description": "Variable name (e.g., AETERM)",
          "pattern": "^[A-Z][A-Z0-9]{1,7}$"
        },
        "label": {
          "type": "string",
          "description": "Variable label (40 char max)",
          "maxLength": 40
        },
        "description": {
          "type": "string",
          "description": "Detailed variable description"
        },
        "dataType": {
          "type": "string",
          "description": "SAS data type",
          "enum": ["Char", "Num", "date", "datetime", "partialDate", "partialDatetime", "time", "partialTime", "integer", "float", "text", "uri"]
        },
        "length": {
          "type": "integer",
          "description": "Maximum length for character variables",
          "minimum": 1
        },
        "significantDigits": {
          "type": "integer",
          "description": "Number of significant digits for numeric variables"
        },
        "format": {
          "type": "string",
          "description": "SAS format for display",
          "examples": ["DATE9.", "TIME5.", "DATETIME19."]
        },
        "role": {
          "type": "string",
          "description": "Variable role within the SDTM general observation class",
          "enum": [
            "Identifier",
            "Topic",
            "Record Qualifier",
            "Result Qualifier",
            "Synonym Qualifier",
            "Variable Qualifier",
            "Timing",
            "Rule",
            "Grouping Qualifier"
          ]
        },
        "core": {
          "type": "string",
          "description": "Variable core status indicating requirement level",
          "enum": ["Required", "Expected", "Permissible", "Conditionally Required", "Conditionally Expected"]
        },
        "codelistSubmissionValues": {
          "type": "array",
          "description": "Applicable CDISC controlled terminology codelist submission values",
          "items": {
            "type": "string"
          }
        },
        "valueList": {
          "type": "array",
          "description": "Enumerated list of allowed values",
          "items": {
            "type": "string"
          }
        },
        "ordinal": {
          "type": "integer",
          "description": "Variable ordering position within the dataset"
        },
        "simpleDatatype": {
          "type": "string",
          "description": "Simplified datatype",
          "enum": ["text", "integer", "float", "date", "datetime", "time"]
        }
      }
    },
    "Link": {
      "type": "object",
      "properties": {
        "href": {
          "type": "string",
          "format": "uri"
        },
        "title": {
          "type": "string"
        }
      }
    }
  }
}