crfgen - JSON CRF Library

{
  "form": {
    "formoid": "adverse",
    "title": "Adverse Events",
    "description": "",
    "version": "1.0",
    "created_at": "2026-02-22T11:45:57+00:00",
    "updated_at": "2026-02-24T13:32:42+00:00",
    "source": "crfs\\db1_ae_fields.txt",
    "notes": "[crfdb=db1, domain=AE]"
  },
  "sdtm": {
    "primary_domain": "AE",
    "domains": [
      "AE",
      "FA"
    ],
    "annotation_style": "legacy_text",
    "global_notes": "Converted from legacy TSV: db1_ae_fields.txt"
  },
  "ui": [],
  "fields": [
    {
      "fieldoid": "field_001",
      "fieldordinal": 1,
      "question": "Adverse Event Verbatim",
      "response": {
        "type": "textbox"
      },
      "sdtm_annotation": [
        {
          "variable": "AETERM",
          "notes": "AETERM"
        },
        {
          "domain": "FA",
          "variable": "FAOBJ",
          "notes": "FA.FAOBJ"
        }
      ],
      "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": "Event Category",
      "response": {
        "type": "radio",
        "options": [
          {
            "value": "General Adverse Event",
            "label": "General Adverse Event"
          },
          {
            "value": "Event of Interest",
            "label": "Event of Interest"
          }
        ]
      },
      "sdtm_annotation": [
        {
          "variable": "AECAT",
          "notes": "AECAT"
        }
      ],
      "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": "Did the event start before administering first dose of study medication?",
      "response": {
        "type": "radio",
        "options": [
          {
            "value": "Yes",
            "label": "Yes"
          },
          {
            "value": "No",
            "label": "No"
          }
        ]
      },
      "sdtm_annotation": [
        {
          "domain": "SUPPAE",
          "variable": "PRFDOS",
          "notes": "PRFDOS in SUPPAE"
        }
      ],
      "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": "Date Started",
      "response": {
        "type": "textbox"
      },
      "sdtm_annotation": [
        {
          "variable": "AESTDTC",
          "notes": "AESTDTC"
        }
      ],
      "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": "Event ongoing?",
      "response": {
        "type": "radio",
        "options": [
          {
            "value": "No",
            "label": "No"
          },
          {
            "value": "Yes",
            "label": "Yes"
          }
        ]
      },
      "sdtm_annotation": [
        {
          "notes": "AEENRTPT=ONGOING",
          "raw": "AEENRTPT=ONGOING"
        },
        {
          "notes": "AEENTPT=END OF STUDY",
          "raw": "AEENTPT=END OF STUDY"
        }
      ],
      "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 Ended",
      "response": {
        "type": "textbox"
      },
      "sdtm_annotation": [
        {
          "variable": "AEENDTC",
          "notes": "AEENDTC"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "field_007",
      "fieldordinal": 7,
      "question": "Severity of the Event",
      "response": {
        "type": "radio",
        "options": [
          {
            "value": "Mild",
            "label": "Mild"
          },
          {
            "value": "Moderate",
            "label": "Moderate"
          },
          {
            "value": "Severe",
            "label": "Severe"
          }
        ]
      },
      "sdtm_annotation": [
        {
          "variable": "AESEV",
          "notes": "AESEV"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "field_008",
      "fieldordinal": 8,
      "question": "Event Related to Study Drug",
      "response": {
        "type": "radio",
        "options": [
          {
            "value": "Yes",
            "label": "Yes"
          },
          {
            "value": "No",
            "label": "No"
          }
        ]
      },
      "sdtm_annotation": [
        {
          "variable": "AEREL",
          "notes": "AEREL"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "field_009",
      "fieldordinal": 9,
      "question": "Toxicity Grade of the Event (CTCAE)",
      "response": {
        "type": "radio",
        "options": [
          {
            "value": "1",
            "label": "1"
          },
          {
            "value": "2",
            "label": "2"
          },
          {
            "value": "3",
            "label": "3"
          },
          {
            "value": "4",
            "label": "4"
          },
          {
            "value": "5",
            "label": "5"
          }
        ]
      },
      "sdtm_annotation": [
        {
          "variable": "AETOXGR",
          "notes": "AETOXGR"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "field_010",
      "fieldordinal": 10,
      "question": "Action Taken with Study Drug because of Adverse Event",
      "response": {
        "type": "radio",
        "options": [
          {
            "value": "No action taken",
            "label": "No action taken"
          },
          {
            "value": "Dose increased",
            "label": "Dose increased"
          },
          {
            "value": "Dose reduced",
            "label": "Dose reduced"
          },
          {
            "value": "Drug interrupted",
            "label": "Drug interrupted"
          },
          {
            "value": "Drug withdrawn",
            "label": "Drug withdrawn"
          }
        ]
      },
      "sdtm_annotation": [
        {
          "variable": "AEACN",
          "notes": "AEACN"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "field_011",
      "fieldordinal": 11,
      "question": "Other action taken?",
      "response": {
        "type": "textbox"
      },
      "sdtm_annotation": [
        {
          "variable": "AEACNOTH",
          "notes": "AEACNOTH"
        }
      ],
      "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": "Serious Event?",
      "response": {
        "type": "radio",
        "options": [
          {
            "value": "Yes",
            "label": "Yes"
          },
          {
            "value": "No",
            "label": "No"
          }
        ]
      },
      "sdtm_annotation": [
        {
          "variable": "AESER",
          "notes": "AESER"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "field_013",
      "fieldordinal": 13,
      "question": "Resulted in Death?",
      "response": {
        "type": "radio",
        "options": [
          {
            "value": "Yes",
            "label": "Yes"
          },
          {
            "value": "No",
            "label": "No"
          }
        ]
      },
      "sdtm_annotation": [
        {
          "variable": "AESDTH",
          "notes": "AESDTH"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "field_014",
      "fieldordinal": 14,
      "question": "Immediately Life Threatening?",
      "response": {
        "type": "radio",
        "options": [
          {
            "value": "Yes",
            "label": "Yes"
          },
          {
            "value": "No",
            "label": "No"
          }
        ]
      },
      "sdtm_annotation": [
        {
          "variable": "AESLIFE",
          "notes": "AESLIFE"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "field_015",
      "fieldordinal": 15,
      "question": "Required Hospitalization or Prolonged Hospitalization?",
      "response": {
        "type": "radio",
        "options": [
          {
            "value": "Yes",
            "label": "Yes"
          },
          {
            "value": "No",
            "label": "No"
          }
        ]
      },
      "sdtm_annotation": [
        {
          "variable": "AESHOSP",
          "notes": "AESHOSP"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "field_016",
      "fieldordinal": 16,
      "question": "If hospitalized,\u00a0",
      "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": "field_017",
      "fieldordinal": 17,
      "question": "date of hospitalization",
      "response": {
        "type": "textbox"
      },
      "sdtm_annotation": [
        {
          "variable": "HOSTDTC",
          "notes": "HOSTDTC"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "field_018",
      "fieldordinal": 18,
      "question": "Time of hospitalization",
      "response": {
        "type": "textbox"
      },
      "sdtm_annotation": [
        {
          "variable": "HOSTDTC",
          "notes": "HOSTDTC"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "field_019",
      "fieldordinal": 19,
      "question": "If hospitalized,\u00a0",
      "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": "field_020",
      "fieldordinal": 20,
      "question": "date of discharge",
      "response": {
        "type": "textbox"
      },
      "sdtm_annotation": [
        {
          "variable": "HOENDTC",
          "notes": "HOENDTC"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "field_021",
      "fieldordinal": 21,
      "question": "Time of discharge",
      "response": {
        "type": "textbox"
      },
      "sdtm_annotation": [
        {
          "variable": "HOENDTC",
          "notes": "HOENDTC"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "field_022",
      "fieldordinal": 22,
      "question": "Persistent or Significant Disability?",
      "response": {
        "type": "radio",
        "options": [
          {
            "value": "Yes",
            "label": "Yes"
          },
          {
            "value": "No",
            "label": "No"
          }
        ]
      },
      "sdtm_annotation": [
        {
          "variable": "AESDISAB",
          "notes": "AESDISAB"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "field_023",
      "fieldordinal": 23,
      "question": "Congenital Anomaly/Birth Defect?",
      "response": {
        "type": "radio",
        "options": [
          {
            "value": "Yes",
            "label": "Yes"
          },
          {
            "value": "No",
            "label": "No"
          }
        ]
      },
      "sdtm_annotation": [
        {
          "variable": "AESCONG",
          "notes": "AESCONG"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "field_024",
      "fieldordinal": 24,
      "question": "Other Medically Important Serious Event?",
      "response": {
        "type": "radio",
        "options": [
          {
            "value": "Yes",
            "label": "Yes"
          },
          {
            "value": "No",
            "label": "No"
          }
        ]
      },
      "sdtm_annotation": [
        {
          "variable": "AESMIE",
          "notes": "AESMIE"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "field_025",
      "fieldordinal": 25,
      "question": "Outcome of the Event?",
      "response": {
        "type": "radio",
        "options": [
          {
            "value": "Recovered/Resolved",
            "label": "Recovered/Resolved"
          },
          {
            "value": "Not Recovered/Not Resolved",
            "label": "Not Recovered/Not Resolved"
          },
          {
            "value": "Fatal",
            "label": "Fatal"
          },
          {
            "value": "Unknown",
            "label": "Unknown"
          }
        ]
      },
      "sdtm_annotation": [
        {
          "variable": "AEOUT",
          "notes": "AEOUT"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "field_026",
      "fieldordinal": 26,
      "question": "Was the event adjudicated",
      "response": {
        "type": "radio",
        "options": [
          {
            "value": "Yes",
            "label": "Yes"
          },
          {
            "value": "No",
            "label": "No"
          }
        ]
      },
      "sdtm_annotation": [
        {
          "variable": "FAORRES",
          "notes": "when FATESTCD=ADJUD",
          "raw": "FAORRES when FATESTCD=ADJUD"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "field_027",
      "fieldordinal": 27,
      "question": "Adjudication Result",
      "response": {
        "type": "radio",
        "options": [
          {
            "value": "Positive",
            "label": "Positive"
          },
          {
            "value": "Negative",
            "label": "Negative"
          }
        ]
      },
      "sdtm_annotation": [
        {
          "variable": "FAORRES",
          "notes": "when FATESTCD=ADJRES",
          "raw": "FAORRES when FATESTCD=ADJRES"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "field_028",
      "fieldordinal": 28,
      "question": "Relationship to Non-Study Treatment",
      "response": {
        "type": "radio",
        "options": [
          {
            "value": "Adjunct Therapy",
            "label": "Adjunct Therapy"
          },
          {
            "value": "Study Disease",
            "label": "Study Disease"
          },
          {
            "value": "Other Medical Condition",
            "label": "Other Medical Condition"
          },
          {
            "value": "Study Procedure",
            "label": "Study Procedure"
          },
          {
            "value": "None",
            "label": "None"
          }
        ]
      },
      "sdtm_annotation": [
        {
          "variable": "AERELNST",
          "notes": "AERELNST"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    }
  ]
}

Example Case Report Forms for AE domain

Sources: DB1, MANUAL | Forms loaded: 3

Form: Adverse Events

Show domain info

Primary Domain

All Domains

AE, FA

#	Question	Response
1	Adverse Event Verbatim field_001	AETERM FA.FAOBJ
2	Event Category field_002	General Adverse Event Event of Interest AECAT
3	Did the event start before administering first dose of study medication? field_003	Yes No PRFDOS in SUPPAE
4	Date Started field_004	AESTDTC
5	Event ongoing? field_005	No Yes AEENRTPT=ONGOING AEENTPT=END OF STUDY
6	Date Ended field_006	AEENDTC
7	Severity of the Event field_007	Mild Moderate Severe AESEV
8	Event Related to Study Drug field_008	Yes No AEREL
9	Toxicity Grade of the Event (CTCAE) field_009	1 2 3 4 5 AETOXGR
10	Action Taken with Study Drug because of Adverse Event field_010	No action taken Dose increased Dose reduced Drug interrupted Drug withdrawn AEACN
11	Other action taken? field_011	AEACNOTH
12	Serious Event? field_012	Yes No AESER
13	Resulted in Death? field_013	Yes No AESDTH
14	Immediately Life Threatening? field_014	Yes No AESLIFE
15	Required Hospitalization or Prolonged Hospitalization? field_015	Yes No AESHOSP
16	If hospitalized, field_016
17	date of hospitalization field_017	HOSTDTC
18	Time of hospitalization field_018	HOSTDTC
19	If hospitalized, field_019
20	date of discharge field_020	HOENDTC
21	Time of discharge field_021	HOENDTC
22	Persistent or Significant Disability? field_022	Yes No AESDISAB
23	Congenital Anomaly/Birth Defect? field_023	Yes No AESCONG
24	Other Medically Important Serious Event? field_024	Yes No AESMIE
25	Outcome of the Event? field_025	Recovered/Resolved Not Recovered/Not Resolved Fatal Unknown AEOUT
26	Was the event adjudicated field_026	Yes No FAORRES when FATESTCD=ADJUD
27	Adjudication Result field_027	Positive Negative FAORRES when FATESTCD=ADJRES
28	Relationship to Non-Study Treatment field_028	Adjunct Therapy Study Disease Other Medical Condition Study Procedure None AERELNST

{
  "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 AE domain

Sources: DB1, MANUAL | Forms loaded: 3

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": "adverse1",
    "title": "Adverse Events",
    "description": "",
    "version": "1.0",
    "created_at": "2026-02-24T10:26:57+00:00",
    "updated_at": "2026-02-26T06:47:25+00:00",
    "source": "paste:manual_fields.txt"
  },
  "sdtm": {
    "primary_domain": "AE",
    "domains": [
      "AE"
    ],
    "form_annotation": [
      "AE (Adverse Events)"
    ]
  },
  "ui": [],
  "fields": [
    {
      "fieldoid": "AE_TERM",
      "fieldordinal": 1,
      "question": "Adverse Event Verbatim",
      "response": {
        "type": "textbox"
      },
      "sdtm_annotation": [
        {
          "variable": "AETERM",
          "notes": "AETERM"
        }
      ],
      "audit": {
        "created_at": "2026-02-24T10:26:57+00:00",
        "updated_at": "2026-02-26T06:47:25+00:00"
      }
    },
    {
      "fieldoid": "AE_CAT",
      "fieldordinal": 3,
      "question": "Event Category",
      "response": {
        "type": "radio",
        "options": [
          {
            "value": "General Adverse Event",
            "label": "General Adverse Event"
          },
          {
            "value": "Event of Interest",
            "label": "Event of Interest"
          }
        ]
      },
      "sdtm_annotation": [
        {
          "variable": "AECAT",
          "notes": "AECAT"
        }
      ],
      "audit": {
        "created_at": "2026-02-24T10:26:57+00:00",
        "updated_at": "2026-02-26T06:47:25+00:00"
      }
    }
  ]
}

Example Case Report Forms for AE domain

Sources: DB1, MANUAL | Forms loaded: 3

Form: Adverse Events

Annotations

Form annotations

AE (Adverse Events)

Show domain info

Primary Domain

All Domains

#	Question	Response
1	Adverse Event Verbatim AE_TERM	AETERM
3	Event Category AE_CAT	General Adverse Event Event of Interest AECAT