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Forms in RS (2)

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Prior Systemic Anti-Cancer Therapy Regimen
Investigator Tumor Response Assessment

{
  "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 RS domain

Sources: DB1 | Forms loaded: 2

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": "tumr_resp",
    "title": "Investigator Tumor Response Assessment",
    "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_rs_fields.txt",
    "notes": "[crfdb=db1, domain=RS]"
  },
  "sdtm": {
    "primary_domain": "RS",
    "domains": [
      "RS"
    ],
    "annotation_style": "legacy_text",
    "global_notes": "Converted from legacy TSV: db1_rs_fields.txt"
  },
  "ui": [],
  "fields": [
    {
      "fieldoid": "field_001",
      "fieldordinal": 1,
      "question": "Was the Investigator\u2019s assessment of overall response obtained?",
      "response": {
        "type": "radio",
        "options": [
          {
            "value": "Yes",
            "label": "Yes"
          },
          {
            "value": "No",
            "label": "No"
          }
        ]
      },
      "sdtm_annotation": [],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "field_002",
      "fieldordinal": 2,
      "question": "Investigator\u2019s assessment of overall response",
      "response": {
        "type": "radio",
        "options": [
          {
            "value": "Complete Remission (CR)",
            "label": "Complete Remission (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)"
          }
        ]
      },
      "sdtm_annotation": [
        {
          "domain": "RS",
          "variable": "RSORRES",
          "notes": "RS.RSORRES"
        }
      ],
      "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": "Response Assessment Date",
      "response": {
        "type": "textbox"
      },
      "sdtm_annotation": [
        {
          "domain": "RS",
          "variable": "RSDTC",
          "notes": "RS.RSDTC"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "field_004",
      "fieldordinal": 4,
      "question": "Reason the Investigator\u2019s assessment of overall response not obtained",
      "response": {
        "type": "radio",
        "options": [
          {
            "value": "Not Evaluable (NE)",
            "label": "Not Evaluable (NE)"
          },
          {
            "value": "No Assessment Performed",
            "label": "No Assessment Performed"
          }
        ]
      },
      "sdtm_annotation": [],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "field_005",
      "fieldordinal": 5,
      "question": "Did the patient experience Symptomatic Deterioration?\u00a0",
      "response": {
        "type": "radio",
        "options": [
          {
            "value": "Yes",
            "label": "Yes"
          },
          {
            "value": "No",
            "label": "No"
          }
        ]
      },
      "sdtm_annotation": [],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "field_006",
      "fieldordinal": 6,
      "question": "Date of Symptomatic Deterioration",
      "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 RS domain

Sources: DB1 | Forms loaded: 2

Form: Investigator Tumor Response Assessment

Show domain info

Primary Domain

All Domains

#	Question	Response
1	Was the Investigator’s assessment of overall response obtained? field_001	Yes No
2	Investigator’s assessment of overall response field_002	Complete Remission (CR) Partial Response (PR) Stable Disease (SD) Progressive Disease (PD) RS.RSORRES
3	Response Assessment Date field_003	RS.RSDTC
4	Reason the Investigator’s assessment of overall response not obtained field_004	Not Evaluable (NE) No Assessment Performed
5	Did the patient experience Symptomatic Deterioration? field_005	Yes No
6	Date of Symptomatic Deterioration field_006