crfgen - JSON CRF Library

Forms in CM (5)

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{
  "form": {
    "formoid": "adverse",
    "title": "Adverse Events2",
    "description": "",
    "version": "1.0",
    "created_at": "2026-02-24T09:22:48+00:00",
    "updated_at": "2026-02-25T06:47:11+00:00",
    "source": "paste:db1_aetest"
  },
  "sdtm": {
    "primary_domain": "AE",
    "domains": [
      "AE",
      "CM"
    ],
    "domain_name_annotations": [
      "AE (ADVERSE EVENTS)",
      "CM (CONCOMITANT MEDICATIONS)"
    ],
    "form_specific_annotations": [
      "AECAT=GENERAL"
    ]
  },
  "ui": [],
  "fields": [
    {
      "fieldoid": "AE_TERM",
      "fieldordinal": 1,
      "question": "Adverse Event Verbatim",
      "response": {
        "type": "textbox"
      },
      "sdtm_annotation": [
        {
          "variable": "AETERM2",
          "notes": "AETERM2"
        },
        {
          "domain": "CM",
          "variable": "CMTRT",
          "notes": "CM.CMTRT"
        }
      ],
      "audit": {
        "created_at": "2026-02-24T09:22:48+00:00",
        "updated_at": "2026-02-25T06:46:31+00:00"
      }
    },
    {
      "fieldoid": "AE_CAT",
      "fieldordinal": 2,
      "question": "Event Category",
      "response": {
        "type": "radio",
        "options": [
          {
            "value": "General Adverse Event",
            "label": "General Adverse Event",
            "sdtm_annotation": [
              {
                "notes": "NOT SUBMITTED",
                "raw": "NOT SUBMITTED"
              }
            ]
          },
          {
            "value": "Event of Interest",
            "label": "Event of Interest",
            "sdtm_annotation": []
          }
        ]
      },
      "sdtm_annotation": [
        {
          "variable": "AECAT",
          "notes": "AECAT"
        }
      ],
      "audit": {
        "created_at": "2026-02-24T09:22:48+00:00",
        "updated_at": "2026-02-25T06:46:31+00:00"
      }
    },
    {
      "fieldoid": "AE_START",
      "fieldordinal": 3,
      "question": "Start Date",
      "response": {
        "type": "date"
      },
      "sdtm_annotation": [
        {
          "variable": "AESTDTC",
          "notes": "AESTDTC"
        }
      ],
      "audit": {
        "created_at": "2026-02-24T09:22:48+00:00",
        "updated_at": "2026-02-25T06:46:31+00:00"
      }
    }
  ]
}

Example Case Report Forms for CM domain

Sources: DB1, MANUAL | Forms loaded: 5

Form: Adverse Events2

Annotations

Domain name annotations

AE (ADVERSE EVENTS)

CM (CONCOMITANT MEDICATIONS)

Form specific annotations

AECAT=GENERAL

Show domain info

Primary Domain

All Domains

AE, CM

#	Question	Response
1	Adverse Event Verbatim AE_TERM	AETERM2 CM.CMTRT
2	Event Category AE_CAT	General Adverse Event NOT SUBMITTED Event of Interest AECAT
3	Start Date AE_START	AESTDTC

{
  "form": {
    "formoid": "cm801_1",
    "title": "Anti-hyperglycemic agents",
    "description": "",
    "version": "1.0",
    "created_at": "2026-02-22T11:45:57+00:00",
    "updated_at": "2026-02-22T11:45:57+00:00",
    "source": "crfs\\db1_cm_fields.txt",
    "notes": "[crfdb=db1, domain=CM]"
  },
  "sdtm": {
    "primary_domain": "CM",
    "domains": [
      "CM"
    ],
    "annotation_style": "legacy_text",
    "global_notes": "Converted from legacy TSV: db1_cm_fields.txt"
  },
  "ui": [],
  "fields": [
    {
      "fieldoid": "cm801_1.CMDAT",
      "fieldordinal": 1,
      "question": "Collection Date",
      "response": {
        "type": "textbox"
      },
      "sdtm_annotation": [
        {
          "domain": "CM",
          "variable": "CMDTC",
          "notes": "CM.CMDTC"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "cm801_1.CMOCCUR",
      "fieldordinal": 2,
      "question": "Did the subject take any anti-hyperglycemic agent in the last 10 years?",
      "response": {
        "type": "radio",
        "options": [
          {
            "value": "Yes",
            "label": "Yes"
          },
          {
            "value": "No",
            "label": "No"
          }
        ]
      },
      "sdtm_annotation": [
        {
          "notes": "CMTRT=\"ANTI-HYPERGLYCEMIC\"",
          "raw": "CMTRT=\"ANTI-HYPERGLYCEMIC\""
        },
        {
          "domain": "CM",
          "variable": "CMOCCUR",
          "notes": "CM.CMOCCUR"
        },
        {
          "notes": "CM.CMPRESP=\"Y\"",
          "raw": "CM.CMPRESP=\"Y\""
        },
        {
          "notes": "CM.CMEVLINT=\"-P10Y\"",
          "raw": "CM.CMEVLINT=\"-P10Y\""
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "field_003",
      "fieldordinal": 3,
      "question": "If yes, List the Treatments received",
      "response": {
        "type": "textbox"
      },
      "sdtm_annotation": [],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "cm801_1.CMTRT",
      "fieldordinal": 4,
      "question": "Treatment Name",
      "response": {
        "type": "textbox"
      },
      "sdtm_annotation": [
        {
          "domain": "CM",
          "variable": "CMTRT",
          "notes": "CM.CMTRT"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "cm801_1.CMSTDAT",
      "fieldordinal": 5,
      "question": "Start Date",
      "response": {
        "type": "textbox"
      },
      "sdtm_annotation": [
        {
          "domain": "CM",
          "variable": "CMSTDTC",
          "notes": "CM.CMSTDTC"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "cm801_1.CMONGO",
      "fieldordinal": 6,
      "question": "Ongoing?",
      "response": {
        "type": "radio",
        "options": [
          {
            "value": "Yes",
            "label": "Yes"
          },
          {
            "value": "No",
            "label": "No"
          }
        ]
      },
      "sdtm_annotation": [
        {
          "domain": "CM",
          "variable": "CMENRTPT",
          "notes": "CM.CMENRTPT"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "cm801_1.CMENDAT",
      "fieldordinal": 7,
      "question": "End Date",
      "response": {
        "type": "textbox"
      },
      "sdtm_annotation": [
        {
          "domain": "CM",
          "variable": "CMENDTC",
          "notes": "CM.CMENDTC"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "cm801_1.CMDOSE",
      "fieldordinal": 8,
      "question": "Dose",
      "response": {
        "type": "textbox"
      },
      "sdtm_annotation": [
        {
          "domain": "CM",
          "variable": "CMDOSE",
          "notes": "CM.CMDOSE"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "cm801_1.CMDOSU",
      "fieldordinal": 9,
      "question": "Dose Unit",
      "response": {
        "type": "radio",
        "options": [
          {
            "value": "mg",
            "label": "mg"
          },
          {
            "value": "ug",
            "label": "ug"
          },
          {
            "value": "mL",
            "label": "mL"
          },
          {
            "value": "g",
            "label": "g"
          },
          {
            "value": "IU",
            "label": "IU"
          }
        ]
      },
      "sdtm_annotation": [
        {
          "domain": "CM",
          "variable": "CMDOSU",
          "notes": "CM.CMDOSU"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "cm801_1.CMDOSFRQ",
      "fieldordinal": 10,
      "question": "Frequency",
      "response": {
        "type": "radio",
        "options": [
          {
            "value": "BID",
            "label": "BID"
          },
          {
            "value": "TID",
            "label": "TID"
          },
          {
            "value": "QID",
            "label": "QID"
          },
          {
            "value": "QOD",
            "label": "QOD"
          },
          {
            "value": "QM",
            "label": "QM"
          },
          {
            "value": "PRN",
            "label": "PRN"
          },
          {
            "value": "UNKNOWN",
            "label": "UNKNOWN"
          }
        ]
      },
      "sdtm_annotation": [
        {
          "domain": "CM",
          "variable": "CMDOSFRQ",
          "notes": "CM.CMDOSFRQ"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "cm801_1.CMROUTE",
      "fieldordinal": 11,
      "question": "Route",
      "response": {
        "type": "radio",
        "options": [
          {
            "value": "ORAL",
            "label": "ORAL"
          },
          {
            "value": "TOPICAL",
            "label": "TOPICAL"
          },
          {
            "value": "SUBCUTANEOUS",
            "label": "SUBCUTANEOUS"
          },
          {
            "value": "TRANSDERMAL",
            "label": "TRANSDERMAL"
          },
          {
            "value": "INTRAOCULAR",
            "label": "INTRAOCULAR"
          },
          {
            "value": "INTRAMUSCULAR",
            "label": "INTRAMUSCULAR"
          },
          {
            "value": "RESPIRATORY (INHALATION)",
            "label": "RESPIRATORY (INHALATION)"
          },
          {
            "value": "INTRAPERITONIAL",
            "label": "INTRAPERITONIAL"
          },
          {
            "value": "NASAL",
            "label": "NASAL"
          },
          {
            "value": "RECTAL",
            "label": "RECTAL"
          }
        ]
      },
      "sdtm_annotation": [
        {
          "domain": "CM",
          "variable": "CMROUTE",
          "notes": "CM.CMROUTE"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "field_012",
      "fieldordinal": 12,
      "question": "",
      "response": {
        "type": "textbox"
      },
      "sdtm_annotation": [],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    }
  ]
}

Example Case Report Forms for CM domain

Sources: DB1, MANUAL | Forms loaded: 5

Form: Anti-hyperglycemic agents

Show domain info

Primary Domain

All Domains

#	Question	Response
1	Collection Date cm801_1.CMDAT	CM.CMDTC
2	Did the subject take any anti-hyperglycemic agent in the last 10 years? cm801_1.CMOCCUR	Yes No CMTRT="ANTI-HYPERGLYCEMIC" CM.CMOCCUR CM.CMPRESP="Y" CM.CMEVLINT="-P10Y"
3	If yes, List the Treatments received field_003
4	Treatment Name cm801_1.CMTRT	CM.CMTRT
5	Start Date cm801_1.CMSTDAT	CM.CMSTDTC
6	Ongoing? cm801_1.CMONGO	Yes No CM.CMENRTPT
7	End Date cm801_1.CMENDAT	CM.CMENDTC
8	Dose cm801_1.CMDOSE	CM.CMDOSE
9	Dose Unit cm801_1.CMDOSU	mg ug mL g IU CM.CMDOSU
10	Frequency cm801_1.CMDOSFRQ	BID TID QID QOD QM PRN UNKNOWN CM.CMDOSFRQ
11	Route cm801_1.CMROUTE	ORAL TOPICAL SUBCUTANEOUS TRANSDERMAL INTRAOCULAR INTRAMUSCULAR RESPIRATORY (INHALATION) INTRAPERITONIAL NASAL RECTAL CM.CMROUTE
12	field_012

{
  "form": {
    "formoid": "cm801_2",
    "title": "General Concomitant Medications",
    "description": "",
    "version": "1.0",
    "created_at": "2026-02-22T11:45:57+00:00",
    "updated_at": "2026-02-22T11:45:57+00:00",
    "source": "crfs\\db1_cm_fields.txt",
    "notes": "[crfdb=db1, domain=CM]"
  },
  "sdtm": {
    "primary_domain": "CM",
    "domains": [
      "CM"
    ],
    "annotation_style": "legacy_text",
    "global_notes": "Converted from legacy TSV: db1_cm_fields.txt"
  },
  "ui": [],
  "fields": [
    {
      "fieldoid": "cm801_2.CMTRT",
      "fieldordinal": 1,
      "question": "Treatment Name",
      "response": {
        "type": "textbox"
      },
      "sdtm_annotation": [
        {
          "domain": "CM",
          "variable": "CMTRT",
          "notes": "CM.CMTRT"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "cm801_2.CMPRIOR",
      "fieldordinal": 2,
      "question": "Taken prior to the study?",
      "response": {
        "type": "radio",
        "options": [
          {
            "value": "Yes",
            "label": "Yes"
          },
          {
            "value": "No",
            "label": "No"
          }
        ]
      },
      "sdtm_annotation": [
        {
          "domain": "SUPPCM",
          "variable": "CMPRIOR",
          "notes": "SUPPCM.CMPRIOR"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "cm801_2.CMINDC",
      "fieldordinal": 3,
      "question": "Indication",
      "response": {
        "type": "textbox"
      },
      "sdtm_annotation": [
        {
          "domain": "CM",
          "variable": "CMINDC",
          "notes": "CM.CMINDC"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "cm801_2.CMSTDAT",
      "fieldordinal": 4,
      "question": "Start Date",
      "response": {
        "type": "textbox"
      },
      "sdtm_annotation": [
        {
          "domain": "CM",
          "variable": "CMSTDTC",
          "notes": "CM.CMSTDTC"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "cm801_2.CMONGO",
      "fieldordinal": 5,
      "question": "Ongoing?",
      "response": {
        "type": "radio",
        "options": [
          {
            "value": "Yes",
            "label": "Yes"
          },
          {
            "value": "No",
            "label": "No"
          }
        ]
      },
      "sdtm_annotation": [
        {
          "domain": "CM",
          "variable": "CMENRTPT",
          "notes": "CM.CMENRTPT"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "cm801_2.CMENDAT",
      "fieldordinal": 6,
      "question": "End Date",
      "response": {
        "type": "textbox"
      },
      "sdtm_annotation": [
        {
          "domain": "CM",
          "variable": "CMENDTC",
          "notes": "CM.CMENDTC"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "cm801_2.CMDOSE",
      "fieldordinal": 7,
      "question": "Dose",
      "response": {
        "type": "textbox"
      },
      "sdtm_annotation": [
        {
          "domain": "CM",
          "variable": "CMDOSE",
          "notes": "CM.CMDOSE"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "cm801_2.CMDOSU",
      "fieldordinal": 8,
      "question": "Dose Unit",
      "response": {
        "type": "radio",
        "options": [
          {
            "value": "mg",
            "label": "mg"
          },
          {
            "value": "ug",
            "label": "ug"
          },
          {
            "value": "mL",
            "label": "mL"
          },
          {
            "value": "g",
            "label": "g"
          },
          {
            "value": "IU",
            "label": "IU"
          }
        ]
      },
      "sdtm_annotation": [
        {
          "domain": "CM",
          "variable": "CMDOSU",
          "notes": "CM.CMDOSU"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "cm801_2.CMDOSFRQ",
      "fieldordinal": 9,
      "question": "Frequency",
      "response": {
        "type": "radio",
        "options": [
          {
            "value": "BID",
            "label": "BID"
          },
          {
            "value": "TID",
            "label": "TID"
          },
          {
            "value": "QID",
            "label": "QID"
          },
          {
            "value": "QOD",
            "label": "QOD"
          },
          {
            "value": "QM",
            "label": "QM"
          },
          {
            "value": "PRN",
            "label": "PRN"
          },
          {
            "value": "UNKNOWN",
            "label": "UNKNOWN"
          }
        ]
      },
      "sdtm_annotation": [
        {
          "domain": "CM",
          "variable": "CMDOSFRQ",
          "notes": "CM.CMDOSFRQ"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "cm801_2.CMROUTE",
      "fieldordinal": 10,
      "question": "Route",
      "response": {
        "type": "radio",
        "options": [
          {
            "value": "ORAL",
            "label": "ORAL"
          },
          {
            "value": "TOPICAL",
            "label": "TOPICAL"
          },
          {
            "value": "SUBCUTANEOUS",
            "label": "SUBCUTANEOUS"
          },
          {
            "value": "TRANSDERMAL",
            "label": "TRANSDERMAL"
          },
          {
            "value": "INTRAOCULAR",
            "label": "INTRAOCULAR"
          },
          {
            "value": "INTRAMUSCULAR",
            "label": "INTRAMUSCULAR"
          },
          {
            "value": "RESPIRATORY (INHALATION)",
            "label": "RESPIRATORY (INHALATION)"
          },
          {
            "value": "INTRAPERITONIAL",
            "label": "INTRAPERITONIAL"
          },
          {
            "value": "NASAL",
            "label": "NASAL"
          },
          {
            "value": "RECTAL",
            "label": "RECTAL"
          }
        ]
      },
      "sdtm_annotation": [
        {
          "domain": "CM",
          "variable": "CMROUTE",
          "notes": "CM.CMROUTE"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    }
  ]
}

Example Case Report Forms for CM domain

Sources: DB1, MANUAL | Forms loaded: 5

Form: General Concomitant Medications

Show domain info

Primary Domain

All Domains

#	Question	Response
1	Treatment Name cm801_2.CMTRT	CM.CMTRT
2	Taken prior to the study? cm801_2.CMPRIOR	Yes No SUPPCM.CMPRIOR
3	Indication cm801_2.CMINDC	CM.CMINDC
4	Start Date cm801_2.CMSTDAT	CM.CMSTDTC
5	Ongoing? cm801_2.CMONGO	Yes No CM.CMENRTPT
6	End Date cm801_2.CMENDAT	CM.CMENDTC
7	Dose cm801_2.CMDOSE	CM.CMDOSE
8	Dose Unit cm801_2.CMDOSU	mg ug mL g IU CM.CMDOSU
9	Frequency cm801_2.CMDOSFRQ	BID TID QID QOD QM PRN UNKNOWN CM.CMDOSFRQ
10	Route cm801_2.CMROUTE	ORAL TOPICAL SUBCUTANEOUS TRANSDERMAL INTRAOCULAR INTRAMUSCULAR RESPIRATORY (INHALATION) INTRAPERITONIAL NASAL RECTAL CM.CMROUTE

{
  "form": {
    "formoid": "cmpc1",
    "title": "Prior Systemic Anti-Cancer Therapy Regimen",
    "description": "",
    "version": "1.0",
    "created_at": "2026-02-25T10:57:17+00:00",
    "updated_at": "2026-02-25T11:21:01+00:00",
    "source": "paste:manual_fields.txt"
  },
  "sdtm": {
    "primary_domain": "CM",
    "domains": [
      "CM",
      "RS"
    ],
    "domain_name_annotations": [
      "CM (Concomitant/Prior Medications)",
      "RS (Disease Response and Clin Classification)"
    ]
  },
  "ui": [],
  "fields": [
    {
      "fieldoid": "CMCAT",
      "fieldordinal": 1,
      "question": "Category for Medication",
      "response": {
        "type": "textbox"
      },
      "sdtm_annotation": [
        {
          "notes": "CMCAT=PRIOR SYSTEMIC ANTI-CANCER THERAPY",
          "raw": "CMCAT=PRIOR SYSTEMIC ANTI-CANCER THERAPY"
        },
        {
          "notes": "RS.RSCAT=PRIOR SYSTEMIC ANTI-CANCER THERAPY",
          "raw": "RS.RSCAT=PRIOR SYSTEMIC ANTI-CANCER THERAPY"
        }
      ],
      "audit": {
        "created_at": "2026-02-25T10:57:17+00:00",
        "updated_at": "2026-02-25T11:21:01+00:00"
      }
    },
    {
      "fieldoid": "CMSCAT",
      "fieldordinal": 2,
      "question": "Type of Therapy",
      "response": {
        "type": "checkbox",
        "options": [
          {
            "value": "Chemotherapy",
            "label": "Chemotherapy"
          },
          {
            "value": "Hormonal Therapy",
            "label": "Hormonal Therapy"
          },
          {
            "value": "Biologic Therapy",
            "label": "Biologic Therapy"
          },
          {
            "value": "Targeted Therapy",
            "label": "Targeted Therapy"
          },
          {
            "value": "Other",
            "label": "Other"
          }
        ]
      },
      "sdtm_annotation": [
        {
          "variable": "CMSCAT",
          "notes": "CMSCAT"
        }
      ],
      "audit": {
        "created_at": "2026-02-25T10:57:17+00:00",
        "updated_at": "2026-02-25T11:21:01+00:00"
      }
    },
    {
      "fieldoid": "TRTSTT",
      "fieldordinal": 3,
      "question": "Therapy Setting",
      "response": {
        "type": "checkbox",
        "options": [
          {
            "value": "Adjuvant",
            "label": "Adjuvant"
          },
          {
            "value": "Conditioning",
            "label": "Conditioning"
          },
          {
            "value": "Consolidation",
            "label": "Consolidation"
          },
          {
            "value": "Induction",
            "label": "Induction"
          },
          {
            "value": "Locally Advanced",
            "label": "Locally Advanced"
          },
          {
            "value": "Maintenance",
            "label": "Maintenance"
          },
          {
            "value": "Metastatic",
            "label": "Metastatic"
          },
          {
            "value": "Mobilization",
            "label": "Mobilization"
          },
          {
            "value": "Neo-Adjuvant",
            "label": "Neo-Adjuvant"
          },
          {
            "value": "Preventative",
            "label": "Preventative"
          },
          {
            "value": "Radiosensitization",
            "label": "Radiosensitization"
          },
          {
            "value": "Salvage",
            "label": "Salvage"
          }
        ]
      },
      "sdtm_annotation": [
        {
          "domain": "SUPPCM",
          "variable": "TRTSTT",
          "notes": "TRTSTT in SUPPCM"
        }
      ],
      "audit": {
        "created_at": "2026-02-25T10:57:17+00:00",
        "updated_at": "2026-02-25T11:21:01+00:00"
      }
    },
    {
      "fieldoid": "CMGRPID",
      "fieldordinal": 4,
      "question": "Regimen Number",
      "response": {
        "type": "radio",
        "options": [
          {
            "value": "Regimen 1",
            "label": "Regimen 1"
          },
          {
            "value": "Regimen 2",
            "label": "Regimen 2"
          },
          {
            "value": "Regimen 3",
            "label": "Regimen 3"
          },
          {
            "value": "Regimen 4",
            "label": "Regimen 4"
          }
        ]
      },
      "sdtm_annotation": [
        {
          "variable": "CMGRPID",
          "notes": "CMGRPID"
        },
        {
          "notes": "RELREC when RSLNKID=CMGRPID",
          "raw": "RELREC when RSLNKID=CMGRPID"
        }
      ],
      "audit": {
        "created_at": "2026-02-25T10:57:17+00:00",
        "updated_at": "2026-02-25T11:21:01+00:00"
      }
    },
    {
      "fieldoid": "RSORRES_BESTRESP",
      "fieldordinal": 5,
      "question": "Best Overall Response",
      "response": {
        "type": "radio",
        "options": [
          {
            "value": "Complete Response (CR)",
            "label": "Complete Response (CR)"
          },
          {
            "value": "Partial Response (PR)",
            "label": "Partial Response (PR)"
          },
          {
            "value": "Stable Disease (SD)",
            "label": "Stable Disease (SD)"
          },
          {
            "value": "Progressive Disease (PD)",
            "label": "Progressive Disease (PD)"
          },
          {
            "value": "Not Evaluable (NE)",
            "label": "Not Evaluable (NE)"
          },
          {
            "value": "Unknown",
            "label": "Unknown"
          }
        ]
      },
      "sdtm_annotation": [
        {
          "notes": "RSORRES when RSTESTCD=BESTRESP",
          "raw": "RSORRES when RSTESTCD=BESTRESP"
        }
      ],
      "audit": {
        "created_at": "2026-02-25T10:57:17+00:00",
        "updated_at": "2026-02-25T11:21:01+00:00"
      }
    },
    {
      "fieldoid": "RSDAT",
      "fieldordinal": 6,
      "question": "Date of Best Overall Response",
      "response": {
        "type": "date"
      },
      "sdtm_annotation": [
        {
          "variable": "RSDTC",
          "notes": "RSDTC"
        }
      ],
      "audit": {
        "created_at": "2026-02-25T10:57:17+00:00",
        "updated_at": "2026-02-25T11:21:01+00:00"
      }
    },
    {
      "fieldoid": "RSDAT_PD",
      "fieldordinal": 7,
      "question": "Date of Progressive Disease",
      "response": {
        "type": "date"
      },
      "sdtm_annotation": [
        {
          "variable": "RSDTC",
          "notes": "RSDTC"
        },
        {
          "notes": "RSORRES=PD when RSTESTCD=OVRLRESP",
          "raw": "RSORRES=PD when RSTESTCD=OVRLRESP"
        }
      ],
      "audit": {
        "created_at": "2026-02-25T10:57:17+00:00",
        "updated_at": "2026-02-25T11:21:01+00:00"
      }
    },
    {
      "fieldoid": "CMSPID",
      "fieldordinal": 8,
      "question": "Line Number",
      "response": {
        "type": "textbox"
      },
      "sdtm_annotation": [
        {
          "variable": "CMSPID",
          "notes": "CMSPID"
        }
      ],
      "audit": {
        "created_at": "2026-02-25T10:57:17+00:00",
        "updated_at": "2026-02-25T11:21:01+00:00"
      }
    },
    {
      "fieldoid": "CMTRT",
      "fieldordinal": 9,
      "question": "Agent (one agent or therapy per line)",
      "response": {
        "type": "textbox"
      },
      "sdtm_annotation": [
        {
          "variable": "CMTRT",
          "notes": "CMTRT"
        }
      ],
      "audit": {
        "created_at": "2026-02-25T10:57:17+00:00",
        "updated_at": "2026-02-25T11:21:01+00:00"
      }
    },
    {
      "fieldoid": "CMSTDAT",
      "fieldordinal": 10,
      "question": "Start Date",
      "response": {
        "type": "date"
      },
      "sdtm_annotation": [
        {
          "variable": "CMSTDTC",
          "notes": "CMSTDTC"
        }
      ],
      "audit": {
        "created_at": "2026-02-25T10:57:17+00:00",
        "updated_at": "2026-02-25T11:21:01+00:00"
      }
    },
    {
      "fieldoid": "CMENDAT",
      "fieldordinal": 11,
      "question": "End Date",
      "response": {
        "type": "date"
      },
      "sdtm_annotation": [
        {
          "variable": "CMENDTC",
          "notes": "CMENDTC"
        }
      ],
      "audit": {
        "created_at": "2026-02-25T10:57:17+00:00",
        "updated_at": "2026-02-25T11:21:01+00:00"
      }
    },
    {
      "fieldoid": "CMDOSE",
      "fieldordinal": 12,
      "question": "Dose",
      "response": {
        "type": "number"
      },
      "sdtm_annotation": [
        {
          "variable": "CMDOSE",
          "notes": "CMDOSE"
        }
      ],
      "audit": {
        "created_at": "2026-02-25T10:57:17+00:00",
        "updated_at": "2026-02-25T11:21:01+00:00"
      }
    },
    {
      "fieldoid": "CMDOSTXT",
      "fieldordinal": 13,
      "question": "Dose (text)",
      "response": {
        "type": "textarea"
      },
      "sdtm_annotation": [
        {
          "variable": "CMDOSTXT",
          "notes": "CMDOSTXT"
        }
      ],
      "audit": {
        "created_at": "2026-02-25T10:57:17+00:00",
        "updated_at": "2026-02-25T11:21:01+00:00"
      }
    },
    {
      "fieldoid": "CMDOSU",
      "fieldordinal": 14,
      "question": "Dose Unit",
      "response": {
        "type": "textarea"
      },
      "sdtm_annotation": [
        {
          "variable": "CMDOSU",
          "notes": "CMDOSU"
        }
      ],
      "audit": {
        "created_at": "2026-02-25T10:57:17+00:00",
        "updated_at": "2026-02-25T11:21:01+00:00"
      }
    },
    {
      "fieldoid": "CMDOSU_OTH",
      "fieldordinal": 15,
      "question": "If Other, specify",
      "response": {
        "type": "textbox"
      },
      "sdtm_annotation": [
        {
          "variable": "CMDOSU",
          "notes": "CMDOSU"
        }
      ],
      "audit": {
        "created_at": "2026-02-25T10:57:17+00:00",
        "updated_at": "2026-02-25T11:21:01+00:00"
      }
    },
    {
      "fieldoid": "CMDOSFRQ",
      "fieldordinal": 16,
      "question": "Frequency",
      "response": {
        "type": "textbox"
      },
      "sdtm_annotation": [
        {
          "variable": "CMDOSFRQ",
          "notes": "CMDOSFRQ"
        }
      ],
      "audit": {
        "created_at": "2026-02-25T10:57:17+00:00",
        "updated_at": "2026-02-25T11:21:01+00:00"
      }
    },
    {
      "fieldoid": "CMDOSFRQ_OTH",
      "fieldordinal": 17,
      "question": "If Other, specify",
      "response": {
        "type": "textbox"
      },
      "sdtm_annotation": [
        {
          "variable": "CMDOSFRQ",
          "notes": "CMDOSFRQ"
        }
      ],
      "audit": {
        "created_at": "2026-02-25T10:57:17+00:00",
        "updated_at": "2026-02-25T11:21:01+00:00"
      }
    },
    {
      "fieldoid": "CMNCYC",
      "fieldordinal": 18,
      "question": "Number of Cycles",
      "response": {
        "type": "number"
      },
      "sdtm_annotation": [
        {
          "notes": "CM.CMNCYC in SUPPCM",
          "raw": "CM.CMNCYC in SUPPCM"
        }
      ],
      "audit": {
        "created_at": "2026-02-25T10:57:17+00:00",
        "updated_at": "2026-02-25T11:21:01+00:00"
      }
    }
  ]
}

Example Case Report Forms for CM domain

Sources: DB1, MANUAL | Forms loaded: 5

Form: Prior Systemic Anti-Cancer Therapy Regimen

Annotations

Domain name annotations

CM (Concomitant/Prior Medications)

RS (Disease Response and Clin Classification)

Show domain info

Primary Domain

All Domains

CM, RS

#	Question	Response
1	Category for Medication CMCAT	CMCAT=PRIOR SYSTEMIC ANTI-CANCER THERAPY RS.RSCAT=PRIOR SYSTEMIC ANTI-CANCER THERAPY
2	Type of Therapy CMSCAT	Chemotherapy Hormonal Therapy Biologic Therapy Targeted Therapy Other CMSCAT
3	Therapy Setting TRTSTT	Adjuvant Conditioning Consolidation Induction Locally Advanced Maintenance Metastatic Mobilization Neo-Adjuvant Preventative Radiosensitization Salvage TRTSTT in SUPPCM
4	Regimen Number CMGRPID	Regimen 1 Regimen 2 Regimen 3 Regimen 4 CMGRPID RELREC when RSLNKID=CMGRPID
5	Best Overall Response RSORRES_BESTRESP	Complete Response (CR) Partial Response (PR) Stable Disease (SD) Progressive Disease (PD) Not Evaluable (NE) Unknown RSORRES when RSTESTCD=BESTRESP
6	Date of Best Overall Response RSDAT	RSDTC
7	Date of Progressive Disease RSDAT_PD	RSDTC RSORRES=PD when RSTESTCD=OVRLRESP
8	Line Number CMSPID	CMSPID
9	Agent (one agent or therapy per line) CMTRT	CMTRT
10	Start Date CMSTDAT	CMSTDTC
11	End Date CMENDAT	CMENDTC
12	Dose CMDOSE	CMDOSE
13	Dose (text) CMDOSTXT	CMDOSTXT
14	Dose Unit CMDOSU	CMDOSU
15	If Other, specify CMDOSU_OTH	CMDOSU
16	Frequency CMDOSFRQ	CMDOSFRQ
17	If Other, specify CMDOSFRQ_OTH	CMDOSFRQ
18	Number of Cycles CMNCYC	CM.CMNCYC in SUPPCM

{
  "form": {
    "formoid": "conmeds",
    "title": "Concomitant Medications",
    "description": "",
    "version": "1.0",
    "created_at": "2026-02-22T11:45:57+00:00",
    "updated_at": "2026-02-22T11:45:57+00:00",
    "source": "crfs\\db1_cm_fields.txt",
    "notes": "[crfdb=db1, domain=CM]"
  },
  "sdtm": {
    "primary_domain": "CM",
    "domains": [
      "CM"
    ],
    "annotation_style": "legacy_text",
    "global_notes": "Converted from legacy TSV: db1_cm_fields.txt"
  },
  "ui": [],
  "fields": [
    {
      "fieldoid": "conmeds.CMCAT",
      "fieldordinal": 1,
      "question": "Medication category",
      "response": {
        "type": "textbox"
      },
      "sdtm_annotation": [
        {
          "domain": "CM",
          "variable": "CMCAT",
          "notes": "CM.CMCAT"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "conmeds.CMVT",
      "fieldordinal": 2,
      "question": "Medication",
      "response": {
        "type": "textbox"
      },
      "sdtm_annotation": [
        {
          "domain": "CM",
          "variable": "CMTRT",
          "notes": "CM.CMTRT"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "field_003",
      "fieldordinal": 3,
      "question": "Taken prior to study?",
      "response": {
        "type": "radio",
        "options": [
          {
            "value": "No",
            "label": "No"
          },
          {
            "value": "Yes",
            "label": "Yes"
          }
        ]
      },
      "sdtm_annotation": [],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "conmeds.CMSTDT_RAW",
      "fieldordinal": 4,
      "question": "Date First Taken",
      "response": {
        "type": "textbox"
      },
      "sdtm_annotation": [
        {
          "domain": "CM",
          "variable": "CMSTDTC",
          "notes": "CM.CMSTDTC"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "conmeds.CMENDT_RAW",
      "fieldordinal": 5,
      "question": "Date Last Taken",
      "response": {
        "type": "textbox"
      },
      "sdtm_annotation": [
        {
          "domain": "CM",
          "variable": "CMENDTC",
          "notes": "CM.CMENDTC"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "conmeds.CMINDC",
      "fieldordinal": 6,
      "question": "Indication",
      "response": {
        "type": "textbox"
      },
      "sdtm_annotation": [
        {
          "domain": "CM",
          "variable": "CMINDC",
          "notes": "CM.CMINDC"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "conmeds.CMDOSE_RAW",
      "fieldordinal": 7,
      "question": "Dose",
      "response": {
        "type": "textbox"
      },
      "sdtm_annotation": [
        {
          "domain": "CM",
          "variable": "CMDOSE",
          "notes": "CM.CMDOSE"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "conmeds.CMDOSEU_RAW",
      "fieldordinal": 8,
      "question": "Unit",
      "response": {
        "type": "textbox"
      },
      "sdtm_annotation": [
        {
          "domain": "CM",
          "variable": "CMDOSU",
          "notes": "CM.CMDOSU"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "conmeds.CMDOSFRQ",
      "fieldordinal": 9,
      "question": "Frequency",
      "response": {
        "type": "textbox"
      },
      "sdtm_annotation": [
        {
          "domain": "CM",
          "variable": "CMDOSFRQ",
          "notes": "CM.CMDOSFRQ"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "conmeds.ROUTE",
      "fieldordinal": 10,
      "question": "Route",
      "response": {
        "type": "textbox"
      },
      "sdtm_annotation": [
        {
          "domain": "CM",
          "variable": "CMROUTE",
          "notes": "CM.CMROUTE"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    }
  ]
}

Example Case Report Forms for CM domain

Sources: DB1, MANUAL | Forms loaded: 5

Form: Concomitant Medications

Show domain info

Primary Domain

All Domains

#	Question	Response
1	Medication category conmeds.CMCAT	CM.CMCAT
2	Medication conmeds.CMVT	CM.CMTRT
3	Taken prior to study? field_003	No Yes
4	Date First Taken conmeds.CMSTDT_RAW	CM.CMSTDTC
5	Date Last Taken conmeds.CMENDT_RAW	CM.CMENDTC
6	Indication conmeds.CMINDC	CM.CMINDC
7	Dose conmeds.CMDOSE_RAW	CM.CMDOSE
8	Unit conmeds.CMDOSEU_RAW	CM.CMDOSU
9	Frequency conmeds.CMDOSFRQ	CM.CMDOSFRQ
10	Route conmeds.ROUTE	CM.CMROUTE