{
  "study_name": "CDISC Pilot Study",
  "study_id": "CDISCPILOT01",
  "sdtmig_version": "SDTMIG 3.4",
  "domains": {
    "DM": {
      "domain": "DM",
      "domain_label": "Demographics",
      "class_name": "Special Purpose",
      "structure": "One record per subject",
      "keys": [
        "STUDYID",
        "USUBJID"
      ],
      "variables": [
        {
          "target_variable": "STUDYID",
          "target_label": "Study Identifier",
          "target_type": "Char",
          "source_dataset": "",
          "source_variable": "",
          "mapping_type": "hardcoded",
          "derivation": "Hardcoded to CDISCPILOT01",
          "decode_map": "",
          "hardcoded_value": "CDISCPILOT01",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "DOMAIN",
          "target_label": "Domain Abbreviation",
          "target_type": "Char",
          "source_dataset": "",
          "source_variable": "",
          "mapping_type": "hardcoded",
          "derivation": "Hardcoded to DM",
          "decode_map": "",
          "hardcoded_value": "DM",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "USUBJID",
          "target_label": "Unique Subject Identifier",
          "target_type": "Char",
          "source_dataset": "dm_raw",
          "source_variable": "USUBJID",
          "mapping_type": "direct",
          "derivation": "Direct copy from raw data",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "SUBJID",
          "target_label": "Subject Identifier for the Study",
          "target_type": "Char",
          "source_dataset": "dm_raw",
          "source_variable": "SUBJID",
          "mapping_type": "direct",
          "derivation": "Direct copy from raw data",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "SITEID",
          "target_label": "Study Site Identifier",
          "target_type": "Char",
          "source_dataset": "dm_raw",
          "source_variable": "SITEID",
          "mapping_type": "direct",
          "derivation": "Direct copy from raw data",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "Site",
          "core": "Required"
        },
        {
          "target_variable": "SITEGR1",
          "target_label": "Site Group 1",
          "target_type": "Char",
          "source_dataset": "dm_raw",
          "source_variable": "SITEGR1",
          "mapping_type": "direct",
          "derivation": "Direct copy from raw data",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "AGE",
          "target_label": "Age",
          "target_type": "Num",
          "source_dataset": "dm_raw",
          "source_variable": "AGE",
          "mapping_type": "direct",
          "derivation": "Direct copy from raw data",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "ISO 8601",
          "core": "Expected"
        },
        {
          "target_variable": "AGEU",
          "target_label": "Age Units",
          "target_type": "Char",
          "source_dataset": "",
          "source_variable": "",
          "mapping_type": "hardcoded",
          "derivation": "Hardcoded to YEARS",
          "decode_map": "",
          "hardcoded_value": "YEARS",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "SEX",
          "target_label": "Sex",
          "target_type": "Char",
          "source_dataset": "dm_raw",
          "source_variable": "SEX",
          "mapping_type": "decode",
          "derivation": "Value-level decode",
          "decode_map": "{\"M\":\"M\",\"F\":\"F\"}",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "Sex",
          "core": "Required"
        },
        {
          "target_variable": "RACE",
          "target_label": "Race",
          "target_type": "Char",
          "source_dataset": "dm_raw",
          "source_variable": "RACE",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "Race",
          "core": "Required"
        },
        {
          "target_variable": "ETHNIC",
          "target_label": "Ethnicity",
          "target_type": "Char",
          "source_dataset": "dm_raw",
          "source_variable": "ETHNIC",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "Ethnicity",
          "core": "Required"
        },
        {
          "target_variable": "ARMCD",
          "target_label": "Planned Arm Code",
          "target_type": "Char",
          "source_dataset": "dm_raw",
          "source_variable": "ARMCD",
          "mapping_type": "decode",
          "derivation": "Value-level decode",
          "decode_map": "{\"TRT\":\"TRT\",\"PBO\":\"PBO\",\"SCRNFAIL\":\"SCRNFAIL\"}",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "ARMCD",
          "core": "Required"
        },
        {
          "target_variable": "ARM",
          "target_label": "Description of Planned Arm",
          "target_type": "Char",
          "source_dataset": "dm_raw",
          "source_variable": "ARM",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "ACTARMCD",
          "target_label": "Actual Arm Code",
          "target_type": "Char",
          "source_dataset": "dm_raw",
          "source_variable": "ACTARMCD",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "ACTARM",
          "target_label": "Description of Actual Arm",
          "target_type": "Char",
          "source_dataset": "dm_raw",
          "source_variable": "ACTARM",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "COUNTRY",
          "target_label": "Country",
          "target_type": "Char",
          "source_dataset": "dm_raw",
          "source_variable": "COUNTRY",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "DMDTC",
          "target_label": "Date/Time of Collection",
          "target_type": "Date",
          "source_dataset": "",
          "source_variable": "",
          "mapping_type": "computed",
          "derivation": "Computed from study reference date",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": false,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "DMDY",
          "target_label": "Study Day of Collection",
          "target_type": "Num",
          "source_dataset": "",
          "source_variable": "",
          "mapping_type": "computed",
          "derivation": "Computed as DMDTC - RFSTDTC + 1",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": false,
          "codelist": "",
          "core": "Required"
        }
      ]
    },
    "AE": {
      "domain": "AE",
      "domain_label": "Adverse Events",
      "class_name": "Events",
      "structure": "One record per adverse event per subject",
      "keys": [
        "STUDYID",
        "USUBJID",
        "AESEQ",
        "AETERM"
      ],
      "variables": [
        {
          "target_variable": "STUDYID",
          "target_label": "Study Identifier",
          "target_type": "Char",
          "source_dataset": "",
          "source_variable": "",
          "mapping_type": "hardcoded",
          "derivation": "Hardcoded",
          "decode_map": "",
          "hardcoded_value": "CDISCPILOT01",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "DOMAIN",
          "target_label": "Domain Abbreviation",
          "target_type": "Char",
          "source_dataset": "",
          "source_variable": "",
          "mapping_type": "hardcoded",
          "derivation": "Hardcoded to AE",
          "decode_map": "",
          "hardcoded_value": "AE",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "USUBJID",
          "target_label": "Unique Subject Identifier",
          "target_type": "Char",
          "source_dataset": "ae_raw",
          "source_variable": "USUBJID",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "AESEQ",
          "target_label": "Sequence Number",
          "target_type": "Num",
          "source_dataset": "",
          "source_variable": "",
          "mapping_type": "computed",
          "derivation": "Sequential within USUBJID",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "AETERM",
          "target_label": "Reported Term for the Adverse Event",
          "target_type": "Char",
          "source_dataset": "ae_raw",
          "source_variable": "AETERM",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "AELLT",
          "target_label": "Lowest Level Term",
          "target_type": "Char",
          "source_dataset": "ae_raw",
          "source_variable": "AELLT",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "AEDECOD",
          "target_label": "Dictionary-Derived Term",
          "target_type": "Char",
          "source_dataset": "ae_raw",
          "source_variable": "AEDECOD",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "AEBODSYS",
          "target_label": "Body System or Organ Class",
          "target_type": "Char",
          "source_dataset": "ae_raw",
          "source_variable": "AEBODSYS",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "AESEV",
          "target_label": "Severity/Intensity",
          "target_type": "Char",
          "source_dataset": "ae_raw",
          "source_variable": "AESEV",
          "mapping_type": "decode",
          "derivation": "Value-level decode",
          "decode_map": "{\"MILD\":\"MILD\",\"MODERATE\":\"MODERATE\",\"SEVERE\":\"SEVERE\"}",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "AESEV",
          "core": "Required"
        },
        {
          "target_variable": "AESER",
          "target_label": "Serious Event",
          "target_type": "Char",
          "source_dataset": "ae_raw",
          "source_variable": "AESER",
          "mapping_type": "decode",
          "derivation": "Value-level decode",
          "decode_map": "{\"Y\":\"Y\",\"N\":\"N\"}",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "NY",
          "core": "Required"
        },
        {
          "target_variable": "AEACN",
          "target_label": "Action Taken with Study Treatment",
          "target_type": "Char",
          "source_dataset": "ae_raw",
          "source_variable": "AEACN",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "AEACN",
          "core": "Required"
        },
        {
          "target_variable": "AEREL",
          "target_label": "Causality",
          "target_type": "Char",
          "source_dataset": "ae_raw",
          "source_variable": "AEREL",
          "mapping_type": "decode",
          "derivation": "Value-level decode",
          "decode_map": "{\"PROBABLE\":\"PROBABLE\",\"POSSIBLE\":\"POSSIBLE\",\"NOT RELATED\":\"NOT RELATED\"}",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "AEREL",
          "core": "Required"
        },
        {
          "target_variable": "AESTDTC",
          "target_label": "Start Date/Time of Adverse Event",
          "target_type": "Char",
          "source_dataset": "ae_raw",
          "source_variable": "AESTDTC",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "AEENDTC",
          "target_label": "End Date/Time of Adverse Event",
          "target_type": "Char",
          "source_dataset": "ae_raw",
          "source_variable": "AEENDTC",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "AESTDY",
          "target_label": "Study Day of Start of Adverse Event",
          "target_type": "Num",
          "source_dataset": "",
          "source_variable": "",
          "mapping_type": "computed",
          "derivation": "Computed from AESTDTC",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "AEENDY",
          "target_label": "Study Day of End of Adverse Event",
          "target_type": "Num",
          "source_dataset": "",
          "source_variable": "",
          "mapping_type": "computed",
          "derivation": "Computed from AEENDTC",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        }
      ]
    },
    "LB": {
      "domain": "LB",
      "domain_label": "Laboratory Test Results",
      "class_name": "Findings",
      "structure": "One record per lab test per timepoint per subject",
      "keys": [
        "STUDYID",
        "USUBJID",
        "LBTESTCD",
        "LBDTC"
      ],
      "variables": [
        {
          "target_variable": "STUDYID",
          "target_label": "Study Identifier",
          "target_type": "Char",
          "source_dataset": "",
          "source_variable": "",
          "mapping_type": "hardcoded",
          "derivation": "Hardcoded",
          "decode_map": "",
          "hardcoded_value": "CDISCPILOT01",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "DOMAIN",
          "target_label": "Domain Abbreviation",
          "target_type": "Char",
          "source_dataset": "",
          "source_variable": "",
          "mapping_type": "hardcoded",
          "derivation": "Hardcoded to LB",
          "decode_map": "",
          "hardcoded_value": "LB",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "USUBJID",
          "target_label": "Unique Subject Identifier",
          "target_type": "Char",
          "source_dataset": "lb_raw",
          "source_variable": "USUBJID",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "LBTESTCD",
          "target_label": "Lab Test Code",
          "target_type": "Char",
          "source_dataset": "lb_raw",
          "source_variable": "LBTESTCD",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "LBTESTCD",
          "core": "Required"
        },
        {
          "target_variable": "LBTEST",
          "target_label": "Lab Test Name",
          "target_type": "Char",
          "source_dataset": "lb_raw",
          "source_variable": "LBTEST",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "LBCAT",
          "target_label": "Lab Category",
          "target_type": "Char",
          "source_dataset": "lb_raw",
          "source_variable": "LBCAT",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "LBORRES",
          "target_label": "Original Result",
          "target_type": "Char",
          "source_dataset": "lb_raw",
          "source_variable": "LBORRES",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "LBORRESU",
          "target_label": "Original Result Unit",
          "target_type": "Char",
          "source_dataset": "lb_raw",
          "source_variable": "LBORRESU",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "LBSTRESC",
          "target_label": "Standardized Result (Char)",
          "target_type": "Char",
          "source_dataset": "lb_raw",
          "source_variable": "LBSTRESC",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "LBSTRESN",
          "target_label": "Standardized Result (Num)",
          "target_type": "Num",
          "source_dataset": "lb_raw",
          "source_variable": "LBSTRESN",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "LBSTRESU",
          "target_label": "Standardized Result Unit",
          "target_type": "Char",
          "source_dataset": "lb_raw",
          "source_variable": "LBSTRESU",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "LBNRIND",
          "target_label": "Normal Range Indicator",
          "target_type": "Char",
          "source_dataset": "lb_raw",
          "source_variable": "LBNRIND",
          "mapping_type": "decode",
          "derivation": "Value-level decode",
          "decode_map": "{\"LOW\":\"LOW\",\"NORMAL\":\"NORMAL\",\"HIGH\":\"HIGH\",\"ABNORMAL\":\"ABNORMAL\"}",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "LBSTNRLO",
          "target_label": "Normal Range Lower Limit",
          "target_type": "Num",
          "source_dataset": "lb_raw",
          "source_variable": "LBSTNRLO",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "LBSTNRHI",
          "target_label": "Normal Range Upper Limit",
          "target_type": "Num",
          "source_dataset": "lb_raw",
          "source_variable": "LBSTNRHI",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "LBDTC",
          "target_label": "Date/Time of Specimen Collection",
          "target_type": "Char",
          "source_dataset": "lb_raw",
          "source_variable": "LBDTC",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "LBDY",
          "target_label": "Study Day of Specimen Collection",
          "target_type": "Num",
          "source_dataset": "",
          "source_variable": "",
          "mapping_type": "computed",
          "derivation": "Computed from LBDTC",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        }
      ]
    },
    "CM": {
      "domain": "CM",
      "domain_label": "Concomitant Medications",
      "class_name": "Interventions",
      "structure": "One record per medication per subject",
      "keys": [
        "STUDYID",
        "USUBJID",
        "CMTRT"
      ],
      "variables": [
        {
          "target_variable": "STUDYID",
          "target_label": "Study Identifier",
          "target_type": "Char",
          "source_dataset": "",
          "source_variable": "",
          "mapping_type": "hardcoded",
          "derivation": "Hardcoded",
          "decode_map": "",
          "hardcoded_value": "CDISCPILOT01",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "DOMAIN",
          "target_label": "Domain Abbreviation",
          "target_type": "Char",
          "source_dataset": "",
          "source_variable": "",
          "mapping_type": "hardcoded",
          "derivation": "Hardcoded to CM",
          "decode_map": "",
          "hardcoded_value": "CM",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "USUBJID",
          "target_label": "Unique Subject Identifier",
          "target_type": "Char",
          "source_dataset": "cm_raw",
          "source_variable": "USUBJID",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "CMTRT",
          "target_label": "Reported Name of Drug, Med, or Therapy",
          "target_type": "Char",
          "source_dataset": "cm_raw",
          "source_variable": "CMTRT",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "CMDECOD",
          "target_label": "Standardized Medication Name",
          "target_type": "Char",
          "source_dataset": "cm_raw",
          "source_variable": "CMDECOD",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "CMCAT",
          "target_label": "Category of Medication",
          "target_type": "Char",
          "source_dataset": "cm_raw",
          "source_variable": "CMCAT",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "CMDOSE",
          "target_label": "Dose",
          "target_type": "Num",
          "source_dataset": "cm_raw",
          "source_variable": "CMDOSE",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "CMDOSU",
          "target_label": "Dose Unit",
          "target_type": "Char",
          "source_dataset": "cm_raw",
          "source_variable": "CMDOSU",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "CMROUTE",
          "target_label": "Route of Administration",
          "target_type": "Char",
          "source_dataset": "cm_raw",
          "source_variable": "CMROUTE",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "CMSTDTC",
          "target_label": "Start Date/Time",
          "target_type": "Char",
          "source_dataset": "cm_raw",
          "source_variable": "CMSTDTC",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "CMENDTC",
          "target_label": "End Date/Time",
          "target_type": "Char",
          "source_dataset": "cm_raw",
          "source_variable": "CMENDTC",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        }
      ]
    },
    "VS": {
      "domain": "VS",
      "domain_label": "Vital Signs",
      "class_name": "Findings",
      "structure": "One record per vital sign measurement per subject",
      "keys": [
        "STUDYID",
        "USUBJID",
        "VSTESTCD",
        "VSDTC"
      ],
      "variables": [
        {
          "target_variable": "STUDYID",
          "target_label": "Study Identifier",
          "target_type": "Char",
          "source_dataset": "",
          "source_variable": "",
          "mapping_type": "hardcoded",
          "derivation": "Hardcoded",
          "decode_map": "",
          "hardcoded_value": "CDISCPILOT01",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "DOMAIN",
          "target_label": "Domain Abbreviation",
          "target_type": "Char",
          "source_dataset": "",
          "source_variable": "",
          "mapping_type": "hardcoded",
          "derivation": "Hardcoded to VS",
          "decode_map": "",
          "hardcoded_value": "VS",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "USUBJID",
          "target_label": "Unique Subject Identifier",
          "target_type": "Char",
          "source_dataset": "vs_raw",
          "source_variable": "USUBJID",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "VSTESTCD",
          "target_label": "Vital Signs Test Code",
          "target_type": "Char",
          "source_dataset": "vs_raw",
          "source_variable": "VSTESTCD",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "VSTEST",
          "target_label": "Vital Signs Test Name",
          "target_type": "Char",
          "source_dataset": "vs_raw",
          "source_variable": "VSTEST",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "VSORRES",
          "target_label": "Original Result",
          "target_type": "Char",
          "source_dataset": "vs_raw",
          "source_variable": "VSORRES",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "VSSTRESC",
          "target_label": "Standardized Result (Char)",
          "target_type": "Char",
          "source_dataset": "vs_raw",
          "source_variable": "VSSTRESC",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "VSSTRESN",
          "target_label": "Standardized Result (Num)",
          "target_type": "Num",
          "source_dataset": "vs_raw",
          "source_variable": "VSSTRESN",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "VSSTRESU",
          "target_label": "Standardized Result Unit",
          "target_type": "Char",
          "source_dataset": "vs_raw",
          "source_variable": "VSSTRESU",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "VSBLFL",
          "target_label": "Baseline Flag",
          "target_type": "Char",
          "source_dataset": "",
          "source_variable": "",
          "mapping_type": "computed",
          "derivation": "First post-dose measurement flagged as Y",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "VSDTC",
          "target_label": "Date/Time of Measurement",
          "target_type": "Char",
          "source_dataset": "vs_raw",
          "source_variable": "VSDTC",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "VSDY",
          "target_label": "Study Day",
          "target_type": "Num",
          "source_dataset": "",
          "source_variable": "",
          "mapping_type": "computed",
          "derivation": "Computed from VSDTC",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        }
      ]
    },
    "EX": {
      "domain": "EX",
      "domain_label": "Exposure",
      "class_name": "Interventions",
      "structure": "One record per dosing occasion per subject",
      "keys": [
        "STUDYID",
        "USUBJID",
        "EXDTC"
      ],
      "variables": [
        {
          "target_variable": "STUDYID",
          "target_label": "Study Identifier",
          "target_type": "Char",
          "source_dataset": "",
          "source_variable": "",
          "mapping_type": "hardcoded",
          "derivation": "Hardcoded",
          "decode_map": "",
          "hardcoded_value": "CDISCPILOT01",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "DOMAIN",
          "target_label": "Domain Abbreviation",
          "target_type": "Char",
          "source_dataset": "",
          "source_variable": "",
          "mapping_type": "hardcoded",
          "derivation": "Hardcoded to EX",
          "decode_map": "",
          "hardcoded_value": "EX",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "USUBJID",
          "target_label": "Unique Subject Identifier",
          "target_type": "Char",
          "source_dataset": "ex_raw",
          "source_variable": "USUBJID",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "EXDOSE",
          "target_label": "Dose",
          "target_type": "Num",
          "source_dataset": "ex_raw",
          "source_variable": "EXDOSE",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "EXDOSU",
          "target_label": "Dose Unit",
          "target_type": "Char",
          "source_dataset": "ex_raw",
          "source_variable": "EXDOSU",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "EXROUTE",
          "target_label": "Route of Administration",
          "target_type": "Char",
          "source_dataset": "ex_raw",
          "source_variable": "EXROUTE",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "EXDTC",
          "target_label": "Date/Time of Dose",
          "target_type": "Char",
          "source_dataset": "ex_raw",
          "source_variable": "EXDTC",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "EXSTDTC",
          "target_label": "Start Date/Time of Treatment",
          "target_type": "Char",
          "source_dataset": "ex_raw",
          "source_variable": "EXSTDTC",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "EXENDTC",
          "target_label": "End Date/Time of Treatment",
          "target_type": "Char",
          "source_dataset": "ex_raw",
          "source_variable": "EXENDTC",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        }
      ]
    },
    "DS": {
      "domain": "DS",
      "domain_label": "Disposition",
      "class_name": "Events",
      "structure": "One record per disposition event per subject",
      "keys": [
        "STUDYID",
        "USUBJID",
        "DSDECOD"
      ],
      "variables": [
        {
          "target_variable": "STUDYID",
          "target_label": "Study Identifier",
          "target_type": "Char",
          "source_dataset": "",
          "source_variable": "",
          "mapping_type": "hardcoded",
          "derivation": "Hardcoded",
          "decode_map": "",
          "hardcoded_value": "CDISCPILOT01",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "DOMAIN",
          "target_label": "Domain Abbreviation",
          "target_type": "Char",
          "source_dataset": "",
          "source_variable": "",
          "mapping_type": "hardcoded",
          "derivation": "Hardcoded to DS",
          "decode_map": "",
          "hardcoded_value": "DS",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "USUBJID",
          "target_label": "Unique Subject Identifier",
          "target_type": "Char",
          "source_dataset": "ds_raw",
          "source_variable": "USUBJID",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "DSDECOD",
          "target_label": "Disposition Event Decoded Term",
          "target_type": "Char",
          "source_dataset": "ds_raw",
          "source_variable": "DSDECOD",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "DSSTDTC",
          "target_label": "Start Date/Time of Disposition Event",
          "target_type": "Char",
          "source_dataset": "ds_raw",
          "source_variable": "DSSTDTC",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        }
      ]
    },
    "MH": {
      "domain": "MH",
      "domain_label": "Medical History",
      "class_name": "Events",
      "structure": "One record per medical history event per subject",
      "keys": [
        "STUDYID",
        "USUBJID",
        "MHTERM"
      ],
      "variables": [
        {
          "target_variable": "STUDYID",
          "target_label": "Study Identifier",
          "target_type": "Char",
          "source_dataset": "",
          "source_variable": "",
          "mapping_type": "hardcoded",
          "derivation": "Hardcoded",
          "decode_map": "",
          "hardcoded_value": "CDISCPILOT01",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "DOMAIN",
          "target_label": "Domain Abbreviation",
          "target_type": "Char",
          "source_dataset": "",
          "source_variable": "",
          "mapping_type": "hardcoded",
          "derivation": "Hardcoded to MH",
          "decode_map": "",
          "hardcoded_value": "MH",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "USUBJID",
          "target_label": "Unique Subject Identifier",
          "target_type": "Char",
          "source_dataset": "mh_raw",
          "source_variable": "USUBJID",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "MHTERM",
          "target_label": "Medical History Term",
          "target_type": "Char",
          "source_dataset": "mh_raw",
          "source_variable": "MHTERM",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        },
        {
          "target_variable": "MHSTDTC",
          "target_label": "Start Date/Time",
          "target_type": "Char",
          "source_dataset": "mh_raw",
          "source_variable": "MHSTDTC",
          "mapping_type": "direct",
          "derivation": "Direct copy",
          "decode_map": "",
          "hardcoded_value": "",
          "is_required": true,
          "codelist": "",
          "core": "Required"
        }
      ]
    }
  }
}