{
  "entities": [
    {
      "columns": [
        {
          "classes": [],
          "data_type": "VARCHAR(12)",
          "description": "Study id (synthetic ZST-...)",
          "name": "study_id",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [],
          "data_type": "VARCHAR(16)",
          "description": "Protocol number (synthetic ZP-...)",
          "name": "protocol_number",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [],
          "data_type": "VARCHAR(16)",
          "description": "Sponsor (invented ZZ-SPONSOR-...)",
          "name": "sponsor_code",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [],
          "data_type": "VARCHAR(8)",
          "description": "PHASE_1 / PHASE_2 / PHASE_3",
          "name": "phase",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [],
          "data_type": "VARCHAR(24)",
          "description": "Therapeutic area (invented)",
          "name": "therapeutic_area",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [],
          "data_type": "VARCHAR(16)",
          "description": "DOUBLE_BLIND / SINGLE_BLIND / OPEN_LABEL",
          "name": "blinding",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [],
          "data_type": "VARCHAR(20)",
          "description": "RECRUITING / ACTIVE / CLOSED_TO_ENROLMENT / COMPLETED",
          "name": "status",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [],
          "data_type": "INT",
          "description": "Planned number of subjects",
          "name": "planned_enrolment",
          "nullable": false,
          "sensitive": false
        }
      ],
      "description": "A (fictional) interventional study run under one protocol by a sponsor.",
      "name": "Study",
      "primary_key": [
        "study_id"
      ],
      "system": "ctms",
      "table": "studies"
    },
    {
      "columns": [
        {
          "classes": [],
          "data_type": "VARCHAR(10)",
          "description": "Site id (synthetic ZSI-...)",
          "name": "site_id",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [],
          "data_type": "VARCHAR(12)",
          "description": "Study",
          "name": "study_id",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [],
          "data_type": "INT",
          "description": "Site number used inside subject numbers",
          "name": "site_number",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [],
          "data_type": "VARCHAR(2)",
          "description": "Country (private-use ZZ / XA / XB)",
          "name": "country_code",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [],
          "data_type": "VARCHAR(10)",
          "description": "ACTIVE / ON_HOLD / CLOSED",
          "name": "status",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [],
          "data_type": "DATE",
          "description": "Site activation date",
          "name": "activated_on",
          "nullable": false,
          "sensitive": false
        }
      ],
      "description": "An investigational site taking part in a study.",
      "name": "Site",
      "primary_key": [
        "site_id"
      ],
      "system": "ctms",
      "table": "sites"
    },
    {
      "columns": [
        {
          "classes": [],
          "data_type": "BIGINT",
          "description": "Investigator record id",
          "name": "investigator_id",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [],
          "data_type": "VARCHAR(10)",
          "description": "Site",
          "name": "site_id",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [
            "PII",
            "DIRECT_IDENTIFIER"
          ],
          "data_type": "VARCHAR(64)",
          "description": "Given name",
          "name": "given_name",
          "nullable": false,
          "sensitive": true
        },
        {
          "classes": [
            "PII",
            "DIRECT_IDENTIFIER"
          ],
          "data_type": "VARCHAR(64)",
          "description": "Family name",
          "name": "family_name",
          "nullable": false,
          "sensitive": true
        },
        {
          "classes": [
            "PII",
            "DIRECT_IDENTIFIER"
          ],
          "data_type": "VARCHAR(128)",
          "description": "Work e-mail",
          "name": "email",
          "nullable": true,
          "sensitive": true
        },
        {
          "classes": [
            "PII",
            "DIRECT_IDENTIFIER"
          ],
          "data_type": "VARCHAR(32)",
          "description": "Work phone",
          "name": "phone",
          "nullable": true,
          "sensitive": true
        },
        {
          "classes": [
            "PII",
            "DIRECT_IDENTIFIER"
          ],
          "data_type": "VARCHAR(16)",
          "description": "Professional registry number (ZREG-...)",
          "name": "registry_number",
          "nullable": true,
          "sensitive": true
        },
        {
          "classes": [],
          "data_type": "VARCHAR(24)",
          "description": "PRINCIPAL_INVESTIGATOR / SUB_INVESTIGATOR / ...",
          "name": "role",
          "nullable": false,
          "sensitive": false
        }
      ],
      "description": "A principal investigator, sub-investigator or coordinator at a site (personal data too).",
      "name": "Investigator",
      "primary_key": [
        "investigator_id"
      ],
      "system": "ctms",
      "table": "investigators"
    },
    {
      "columns": [
        {
          "classes": [
            "DIRECT_IDENTIFIER"
          ],
          "data_type": "VARCHAR(12)",
          "description": "Subject number Z<site>-<nnnn>",
          "name": "subject_id",
          "nullable": false,
          "sensitive": true
        },
        {
          "classes": [],
          "data_type": "VARCHAR(10)",
          "description": "CTMS site (cross-system)",
          "name": "site_ref",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [],
          "data_type": "BIGINT",
          "description": "Enrolling investigator (cross-system)",
          "name": "investigator_ref",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [
            "DIRECT_IDENTIFIER"
          ],
          "data_type": "VARCHAR(12)",
          "description": "Screening number (SCR-...)",
          "name": "screening_number",
          "nullable": false,
          "sensitive": true
        },
        {
          "classes": [
            "PII",
            "DIRECT_IDENTIFIER"
          ],
          "data_type": "VARCHAR(3)",
          "description": "Subject initials",
          "name": "initials",
          "nullable": true,
          "sensitive": true
        },
        {
          "classes": [
            "QUASI_IDENTIFIER"
          ],
          "data_type": "INT",
          "description": "Year of birth",
          "name": "birth_year",
          "nullable": true,
          "sensitive": true
        },
        {
          "classes": [
            "QUASI_IDENTIFIER"
          ],
          "data_type": "VARCHAR(1)",
          "description": "F / M / U",
          "name": "sex",
          "nullable": true,
          "sensitive": true
        },
        {
          "classes": [
            "SENSITIVE"
          ],
          "data_type": "VARCHAR(16)",
          "description": "Self-reported group (invented codes)",
          "name": "ethnicity",
          "nullable": true,
          "sensitive": true
        },
        {
          "classes": [
            "PHI",
            "QUASI_IDENTIFIER"
          ],
          "data_type": "DATE",
          "description": "Informed consent date",
          "name": "consent_date",
          "nullable": false,
          "sensitive": true
        },
        {
          "classes": [],
          "data_type": "VARCHAR(20)",
          "description": "SCREENED / SCREEN_FAILED / ... / LOST_TO_FOLLOW_UP",
          "name": "status",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [],
          "data_type": "VARCHAR(20)",
          "description": "Why screening failed",
          "name": "screen_failure_reason",
          "nullable": true,
          "sensitive": false
        },
        {
          "classes": [],
          "data_type": "VARCHAR(20)",
          "description": "Why the subject left the study",
          "name": "withdrawal_reason",
          "nullable": true,
          "sensitive": false
        }
      ],
      "description": "A study participant known by a per-study subject number (the natural subset root).",
      "name": "Subject",
      "primary_key": [
        "subject_id"
      ],
      "system": "edc",
      "table": "subjects"
    },
    {
      "columns": [
        {
          "classes": [],
          "data_type": "BIGINT",
          "description": "Check id",
          "name": "check_id",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [
            "DIRECT_IDENTIFIER"
          ],
          "data_type": "VARCHAR(12)",
          "description": "Subject",
          "name": "subject_id",
          "nullable": false,
          "sensitive": true
        },
        {
          "classes": [],
          "data_type": "VARCHAR(4)",
          "description": "IN01... / EX01...",
          "name": "criterion_code",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [],
          "data_type": "VARCHAR(10)",
          "description": "INCLUSION / EXCLUSION",
          "name": "criterion_type",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [],
          "data_type": "BOOLEAN",
          "description": "Whether the criterion is met",
          "name": "met",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [
            "PHI",
            "QUASI_IDENTIFIER"
          ],
          "data_type": "DATE",
          "description": "Assessment date",
          "name": "assessed_on",
          "nullable": false,
          "sensitive": true
        }
      ],
      "description": "One inclusion or exclusion criterion assessed at screening.",
      "name": "EligibilityCheck",
      "primary_key": [
        "check_id"
      ],
      "system": "edc",
      "table": "eligibility_checks"
    },
    {
      "columns": [
        {
          "classes": [],
          "data_type": "BIGINT",
          "description": "Visit id",
          "name": "visit_id",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [
            "DIRECT_IDENTIFIER"
          ],
          "data_type": "VARCHAR(12)",
          "description": "Subject",
          "name": "subject_id",
          "nullable": false,
          "sensitive": true
        },
        {
          "classes": [],
          "data_type": "VARCHAR(16)",
          "description": "SCREENING / BASELINE / WEEK_04 / ...",
          "name": "visit_code",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [],
          "data_type": "INT",
          "description": "Planned study day",
          "name": "planned_day",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [],
          "data_type": "INT",
          "description": "Actual study day (NULL when missed)",
          "name": "actual_day",
          "nullable": true,
          "sensitive": false
        },
        {
          "classes": [
            "PHI",
            "QUASI_IDENTIFIER"
          ],
          "data_type": "DATE",
          "description": "Visit date (NULL when missed)",
          "name": "visit_date",
          "nullable": true,
          "sensitive": true
        },
        {
          "classes": [],
          "data_type": "VARCHAR(16)",
          "description": "COMPLETED / MISSED / OUT_OF_WINDOW / SCHEDULED",
          "name": "status",
          "nullable": false,
          "sensitive": false
        }
      ],
      "description": "A protocol visit of a subject (planned on a study day, done within a window or not).",
      "name": "Visit",
      "primary_key": [
        "visit_id"
      ],
      "system": "edc",
      "table": "visits"
    },
    {
      "columns": [
        {
          "classes": [],
          "data_type": "BIGINT",
          "description": "Form id",
          "name": "form_id",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [],
          "data_type": "BIGINT",
          "description": "Visit",
          "name": "visit_id",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [],
          "data_type": "VARCHAR(16)",
          "description": "VITALS / DEMOGRAPHY / ECG / ...",
          "name": "form_code",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [],
          "data_type": "INT",
          "description": "Systolic blood pressure (mmHg)",
          "name": "systolic_bp",
          "nullable": true,
          "sensitive": false
        },
        {
          "classes": [],
          "data_type": "INT",
          "description": "Diastolic blood pressure (mmHg)",
          "name": "diastolic_bp",
          "nullable": true,
          "sensitive": false
        },
        {
          "classes": [],
          "data_type": "VARCHAR(14)",
          "description": "Source data verification status",
          "name": "sdv_status",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [],
          "data_type": "INT",
          "description": "Open data queries",
          "name": "open_queries",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [],
          "data_type": "BOOLEAN",
          "description": "Form locked",
          "name": "locked",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [
            "PHI",
            "SENSITIVE"
          ],
          "data_type": "VARCHAR(300)",
          "description": "Free-text site comment",
          "name": "site_comment",
          "nullable": true,
          "sensitive": true
        }
      ],
      "description": "A case report form page completed for a visit.",
      "name": "CrfForm",
      "primary_key": [
        "form_id"
      ],
      "system": "edc",
      "table": "crf_forms"
    },
    {
      "columns": [
        {
          "classes": [],
          "data_type": "BIGINT",
          "description": "Adverse event id",
          "name": "ae_id",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [
            "DIRECT_IDENTIFIER"
          ],
          "data_type": "VARCHAR(12)",
          "description": "Subject",
          "name": "subject_id",
          "nullable": false,
          "sensitive": true
        },
        {
          "classes": [],
          "data_type": "VARCHAR(10)",
          "description": "Coded term (invented ZAE-...)",
          "name": "ae_term_code",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [
            "PHI",
            "SENSITIVE"
          ],
          "data_type": "VARCHAR(200)",
          "description": "Verbatim term as reported",
          "name": "verbatim_term",
          "nullable": true,
          "sensitive": true
        },
        {
          "classes": [
            "PHI",
            "QUASI_IDENTIFIER"
          ],
          "data_type": "DATE",
          "description": "Onset date",
          "name": "onset_date",
          "nullable": false,
          "sensitive": true
        },
        {
          "classes": [
            "PHI",
            "QUASI_IDENTIFIER"
          ],
          "data_type": "DATE",
          "description": "Resolution date",
          "name": "resolved_date",
          "nullable": true,
          "sensitive": true
        },
        {
          "classes": [],
          "data_type": "VARCHAR(10)",
          "description": "MILD / MODERATE / SEVERE",
          "name": "severity",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [],
          "data_type": "BOOLEAN",
          "description": "Serious adverse event",
          "name": "serious",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [],
          "data_type": "VARCHAR(12)",
          "description": "Relationship to study drug",
          "name": "causality",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [],
          "data_type": "VARCHAR(14)",
          "description": "RECOVERED / ... / FATAL / UNKNOWN",
          "name": "outcome",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [],
          "data_type": "VARCHAR(18)",
          "description": "Action with study drug",
          "name": "action_taken",
          "nullable": false,
          "sensitive": false
        }
      ],
      "description": "An adverse event recorded on the CRF (serious ones also become safety cases).",
      "name": "AdverseEvent",
      "primary_key": [
        "ae_id"
      ],
      "system": "edc",
      "table": "adverse_events"
    },
    {
      "columns": [
        {
          "classes": [],
          "data_type": "BIGINT",
          "description": "Medication record id",
          "name": "cm_id",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [
            "DIRECT_IDENTIFIER"
          ],
          "data_type": "VARCHAR(12)",
          "description": "Subject",
          "name": "subject_id",
          "nullable": false,
          "sensitive": true
        },
        {
          "classes": [],
          "data_type": "VARCHAR(10)",
          "description": "Drug (invented ZDRUG-...)",
          "name": "drug_code",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [
            "PHI",
            "SENSITIVE"
          ],
          "data_type": "VARCHAR(120)",
          "description": "Why it is taken (free text)",
          "name": "indication",
          "nullable": true,
          "sensitive": true
        },
        {
          "classes": [],
          "data_type": "DOUBLE",
          "description": "Dose",
          "name": "dose_amount",
          "nullable": true,
          "sensitive": false
        },
        {
          "classes": [],
          "data_type": "VARCHAR(6)",
          "description": "MG / ML / UG / IU",
          "name": "dose_unit",
          "nullable": true,
          "sensitive": false
        },
        {
          "classes": [
            "PHI",
            "QUASI_IDENTIFIER"
          ],
          "data_type": "DATE",
          "description": "Start date",
          "name": "start_date",
          "nullable": false,
          "sensitive": true
        },
        {
          "classes": [
            "PHI",
            "QUASI_IDENTIFIER"
          ],
          "data_type": "DATE",
          "description": "End date",
          "name": "end_date",
          "nullable": true,
          "sensitive": true
        },
        {
          "classes": [],
          "data_type": "BOOLEAN",
          "description": "Still taken",
          "name": "ongoing",
          "nullable": false,
          "sensitive": false
        }
      ],
      "description": "A medication the subject takes alongside the study treatment.",
      "name": "ConcomitantMedication",
      "primary_key": [
        "cm_id"
      ],
      "system": "edc",
      "table": "concomitant_medications"
    },
    {
      "columns": [
        {
          "classes": [],
          "data_type": "BIGINT",
          "description": "Randomisation record id",
          "name": "randomisation_id",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [
            "DIRECT_IDENTIFIER"
          ],
          "data_type": "VARCHAR(12)",
          "description": "EDC subject number (cross-system)",
          "name": "subject_ref",
          "nullable": false,
          "sensitive": true
        },
        {
          "classes": [
            "DIRECT_IDENTIFIER"
          ],
          "data_type": "VARCHAR(10)",
          "description": "Randomisation number (R...)",
          "name": "randomisation_number",
          "nullable": false,
          "sensitive": true
        },
        {
          "classes": [],
          "data_type": "VARCHAR(10)",
          "description": "Stratification factor level",
          "name": "stratum",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [
            "SENSITIVE"
          ],
          "data_type": "VARCHAR(8)",
          "description": "Treatment arm (blinded)",
          "name": "treatment_arm",
          "nullable": false,
          "sensitive": true
        },
        {
          "classes": [
            "PHI",
            "QUASI_IDENTIFIER"
          ],
          "data_type": "TIMESTAMP",
          "description": "Randomisation time",
          "name": "randomised_at",
          "nullable": false,
          "sensitive": true
        },
        {
          "classes": [],
          "data_type": "VARCHAR(10)",
          "description": "BLINDED / UNBLINDED",
          "name": "unblinding_status",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [
            "SENSITIVE"
          ],
          "data_type": "TIMESTAMP",
          "description": "Emergency unblinding time",
          "name": "unblinded_at",
          "nullable": true,
          "sensitive": true
        },
        {
          "classes": [
            "SENSITIVE"
          ],
          "data_type": "VARCHAR(20)",
          "description": "Why the arm was revealed",
          "name": "unblinding_reason",
          "nullable": true,
          "sensitive": true
        }
      ],
      "description": "Randomisation of a subject to a (blinded) treatment arm, with any emergency unblinding.",
      "name": "Randomisation",
      "primary_key": [
        "randomisation_id"
      ],
      "system": "irt",
      "table": "randomisations"
    },
    {
      "columns": [
        {
          "classes": [],
          "data_type": "BIGINT",
          "description": "Dispensation id",
          "name": "dispensation_id",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [
            "DIRECT_IDENTIFIER"
          ],
          "data_type": "VARCHAR(12)",
          "description": "EDC subject number (cross-system)",
          "name": "subject_ref",
          "nullable": false,
          "sensitive": true
        },
        {
          "classes": [
            "SENSITIVE",
            "DIRECT_IDENTIFIER"
          ],
          "data_type": "VARCHAR(12)",
          "description": "Kit number (ZK...; can reveal the arm)",
          "name": "kit_number",
          "nullable": false,
          "sensitive": true
        },
        {
          "classes": [],
          "data_type": "VARCHAR(16)",
          "description": "Visit at which it was dispensed",
          "name": "visit_code",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [
            "PHI",
            "QUASI_IDENTIFIER"
          ],
          "data_type": "DATE",
          "description": "Dispensation date",
          "name": "dispensed_on",
          "nullable": false,
          "sensitive": true
        },
        {
          "classes": [],
          "data_type": "INT",
          "description": "Units dispensed",
          "name": "units_dispensed",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [],
          "data_type": "INT",
          "description": "Units returned (drug accountability)",
          "name": "units_returned",
          "nullable": true,
          "sensitive": false
        }
      ],
      "description": "An investigational-product kit dispensed to a subject at a visit.",
      "name": "KitDispensation",
      "primary_key": [
        "dispensation_id"
      ],
      "system": "irt",
      "table": "kit_dispensations"
    },
    {
      "columns": [
        {
          "classes": [],
          "data_type": "BIGINT",
          "description": "Case record id",
          "name": "case_id",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [
            "DIRECT_IDENTIFIER"
          ],
          "data_type": "VARCHAR(14)",
          "description": "Safety case number (ZSC-...)",
          "name": "case_number",
          "nullable": false,
          "sensitive": true
        },
        {
          "classes": [
            "DIRECT_IDENTIFIER"
          ],
          "data_type": "VARCHAR(12)",
          "description": "EDC subject number (cross-system)",
          "name": "subject_ref",
          "nullable": false,
          "sensitive": true
        },
        {
          "classes": [],
          "data_type": "BIGINT",
          "description": "EDC adverse event (cross-system)",
          "name": "ae_ref",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [
            "PHI",
            "QUASI_IDENTIFIER"
          ],
          "data_type": "DATE",
          "description": "Date the sponsor received the report",
          "name": "received_on",
          "nullable": false,
          "sensitive": true
        },
        {
          "classes": [],
          "data_type": "VARCHAR(20)",
          "description": "Seriousness criterion",
          "name": "seriousness",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [],
          "data_type": "VARCHAR(10)",
          "description": "EXPECTED / UNEXPECTED",
          "name": "expectedness",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [
            "PII",
            "DIRECT_IDENTIFIER"
          ],
          "data_type": "VARCHAR(96)",
          "description": "Reporting investigator",
          "name": "reporter_name",
          "nullable": true,
          "sensitive": true
        },
        {
          "classes": [
            "PHI",
            "SENSITIVE"
          ],
          "data_type": "VARCHAR(600)",
          "description": "Case narrative (free text)",
          "name": "narrative",
          "nullable": true,
          "sensitive": true
        },
        {
          "classes": [],
          "data_type": "VARCHAR(10)",
          "description": "INITIAL / FOLLOW_UP / CLOSED",
          "name": "report_status",
          "nullable": false,
          "sensitive": false
        }
      ],
      "description": "An individual case safety report raised for a serious adverse event.",
      "name": "SafetyCase",
      "primary_key": [
        "case_id"
      ],
      "system": "safety",
      "table": "safety_cases"
    },
    {
      "columns": [
        {
          "classes": [],
          "data_type": "BIGINT",
          "description": "Sample id",
          "name": "sample_id",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [
            "DIRECT_IDENTIFIER"
          ],
          "data_type": "VARCHAR(12)",
          "description": "Lab accession number (ZA...)",
          "name": "accession_number",
          "nullable": false,
          "sensitive": true
        },
        {
          "classes": [
            "DIRECT_IDENTIFIER"
          ],
          "data_type": "VARCHAR(12)",
          "description": "EDC subject number on the tube label",
          "name": "subject_ref",
          "nullable": false,
          "sensitive": true
        },
        {
          "classes": [],
          "data_type": "BIGINT",
          "description": "EDC visit (cross-system)",
          "name": "visit_ref",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [],
          "data_type": "VARCHAR(12)",
          "description": "SERUM / PLASMA / WHOLE_BLOOD / URINE",
          "name": "specimen_type",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [
            "PHI",
            "QUASI_IDENTIFIER"
          ],
          "data_type": "TIMESTAMP",
          "description": "Collection time",
          "name": "collected_at",
          "nullable": false,
          "sensitive": true
        },
        {
          "classes": [
            "PHI",
            "QUASI_IDENTIFIER"
          ],
          "data_type": "TIMESTAMP",
          "description": "Receipt time at the lab",
          "name": "received_at",
          "nullable": true,
          "sensitive": true
        },
        {
          "classes": [],
          "data_type": "VARCHAR(20)",
          "description": "RECEIVED / ANALYSED / HAEMOLYSED / LOST / ...",
          "name": "status",
          "nullable": false,
          "sensitive": false
        }
      ],
      "description": "A specimen collected at a visit and shipped to the central laboratory.",
      "name": "LabSample",
      "primary_key": [
        "sample_id"
      ],
      "system": "central_lab",
      "table": "lab_samples"
    },
    {
      "columns": [
        {
          "classes": [],
          "data_type": "BIGINT",
          "description": "Result id",
          "name": "result_id",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [],
          "data_type": "BIGINT",
          "description": "Sample",
          "name": "sample_id",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [],
          "data_type": "VARCHAR(8)",
          "description": "Analyte",
          "name": "analyte_code",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [],
          "data_type": "DOUBLE",
          "description": "Numeric result",
          "name": "result_value",
          "nullable": true,
          "sensitive": false
        },
        {
          "classes": [],
          "data_type": "VARCHAR(8)",
          "description": "Unit",
          "name": "unit",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [],
          "data_type": "DOUBLE",
          "description": "Reference range low",
          "name": "reference_low",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [],
          "data_type": "DOUBLE",
          "description": "Reference range high",
          "name": "reference_high",
          "nullable": false,
          "sensitive": false
        },
        {
          "classes": [],
          "data_type": "VARCHAR(2)",
          "description": "N / L / H / LL / HH",
          "name": "flag",
          "nullable": false,
          "sensitive": false
        }
      ],
      "description": "One analyte result of a sample (invented ZLB-... analytes).",
      "name": "LabResult",
      "primary_key": [
        "result_id"
      ],
      "system": "central_lab",
      "table": "lab_results"
    }
  ],
  "relationships": [
    {
      "child": "Site",
      "child_columns": [
        "study_id"
      ],
      "code": "FK_SITES_STUDY_ID",
      "cross_system": false,
      "description": "Site references Study",
      "kind": "FOREIGN_KEY",
      "parent": "Study",
      "parent_columns": [
        "study_id"
      ]
    },
    {
      "child": "Investigator",
      "child_columns": [
        "site_id"
      ],
      "code": "FK_INVESTIGATORS_SITE_ID",
      "cross_system": false,
      "description": "Investigator references Site",
      "kind": "FOREIGN_KEY",
      "parent": "Site",
      "parent_columns": [
        "site_id"
      ]
    },
    {
      "child": "EligibilityCheck",
      "child_columns": [
        "subject_id"
      ],
      "code": "FK_ELIGIBILITY_CHECKS_SUBJECT_ID",
      "cross_system": false,
      "description": "EligibilityCheck references Subject",
      "kind": "FOREIGN_KEY",
      "parent": "Subject",
      "parent_columns": [
        "subject_id"
      ]
    },
    {
      "child": "Visit",
      "child_columns": [
        "subject_id"
      ],
      "code": "FK_VISITS_SUBJECT_ID",
      "cross_system": false,
      "description": "Visit references Subject",
      "kind": "FOREIGN_KEY",
      "parent": "Subject",
      "parent_columns": [
        "subject_id"
      ]
    },
    {
      "child": "CrfForm",
      "child_columns": [
        "visit_id"
      ],
      "code": "FK_CRF_FORMS_VISIT_ID",
      "cross_system": false,
      "description": "CrfForm references Visit",
      "kind": "FOREIGN_KEY",
      "parent": "Visit",
      "parent_columns": [
        "visit_id"
      ]
    },
    {
      "child": "AdverseEvent",
      "child_columns": [
        "subject_id"
      ],
      "code": "FK_ADVERSE_EVENTS_SUBJECT_ID",
      "cross_system": false,
      "description": "AdverseEvent references Subject",
      "kind": "FOREIGN_KEY",
      "parent": "Subject",
      "parent_columns": [
        "subject_id"
      ]
    },
    {
      "child": "ConcomitantMedication",
      "child_columns": [
        "subject_id"
      ],
      "code": "FK_CONCOMITANT_MEDICATIONS_SUBJECT_ID",
      "cross_system": false,
      "description": "ConcomitantMedication references Subject",
      "kind": "FOREIGN_KEY",
      "parent": "Subject",
      "parent_columns": [
        "subject_id"
      ]
    },
    {
      "child": "LabResult",
      "child_columns": [
        "sample_id"
      ],
      "code": "FK_LAB_RESULTS_SAMPLE_ID",
      "cross_system": false,
      "description": "LabResult references LabSample",
      "kind": "FOREIGN_KEY",
      "parent": "LabSample",
      "parent_columns": [
        "sample_id"
      ]
    },
    {
      "child": "Subject",
      "child_columns": [
        "site_ref"
      ],
      "code": "CT_SUBJECT_SITE",
      "cross_system": true,
      "description": "EDC subjects are enrolled at CTMS sites",
      "kind": "RELATIONSHIP_TEMPLATE",
      "parent": "Site",
      "parent_columns": [
        "site_id"
      ]
    },
    {
      "child": "Subject",
      "child_columns": [
        "investigator_ref"
      ],
      "code": "CT_SUBJECT_INVESTIGATOR",
      "cross_system": true,
      "description": "EDC subjects are enrolled by a CTMS investigator",
      "kind": "RELATIONSHIP_TEMPLATE",
      "parent": "Investigator",
      "parent_columns": [
        "investigator_id"
      ]
    },
    {
      "child": "Randomisation",
      "child_columns": [
        "subject_ref"
      ],
      "code": "CT_RANDOMISATION_SUBJECT",
      "cross_system": true,
      "description": "IRT randomises EDC subjects by subject number",
      "kind": "RELATIONSHIP_TEMPLATE",
      "parent": "Subject",
      "parent_columns": [
        "subject_id"
      ]
    },
    {
      "child": "KitDispensation",
      "child_columns": [
        "subject_ref"
      ],
      "code": "CT_KIT_SUBJECT",
      "cross_system": true,
      "description": "IRT dispenses kits to EDC subjects by subject number",
      "kind": "RELATIONSHIP_TEMPLATE",
      "parent": "Subject",
      "parent_columns": [
        "subject_id"
      ]
    },
    {
      "child": "SafetyCase",
      "child_columns": [
        "subject_ref"
      ],
      "code": "CT_CASE_SUBJECT",
      "cross_system": true,
      "description": "Safety cases name the subject number",
      "kind": "RELATIONSHIP_TEMPLATE",
      "parent": "Subject",
      "parent_columns": [
        "subject_id"
      ]
    },
    {
      "child": "SafetyCase",
      "child_columns": [
        "ae_ref"
      ],
      "code": "CT_CASE_ADVERSE_EVENT",
      "cross_system": true,
      "description": "Safety cases are raised for an EDC adverse event",
      "kind": "RELATIONSHIP_TEMPLATE",
      "parent": "AdverseEvent",
      "parent_columns": [
        "ae_id"
      ]
    },
    {
      "child": "LabSample",
      "child_columns": [
        "subject_ref"
      ],
      "code": "CT_SAMPLE_SUBJECT",
      "cross_system": true,
      "description": "Central-lab samples carry the subject number on the tube label",
      "kind": "RELATIONSHIP_TEMPLATE",
      "parent": "Subject",
      "parent_columns": [
        "subject_id"
      ]
    },
    {
      "child": "LabSample",
      "child_columns": [
        "visit_ref"
      ],
      "code": "CT_SAMPLE_VISIT",
      "cross_system": true,
      "description": "Central-lab samples are collected at an EDC visit",
      "kind": "RELATIONSHIP_TEMPLATE",
      "parent": "Visit",
      "parent_columns": [
        "visit_id"
      ]
    }
  ]
}