crfgen - JSON CRF Library

{
  "form": {
    "formoid": "consents",
    "title": "Consent Withdrawls",
    "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_ds_fields.txt",
    "notes": "[crfdb=db1, domain=DS]"
  },
  "sdtm": {
    "primary_domain": "DS",
    "domains": [
      "DS"
    ],
    "annotation_style": "legacy_text",
    "global_notes": "Converted from legacy TSV: db1_ds_fields.txt"
  },
  "ui": [],
  "fields": [
    {
      "fieldoid": "field_001",
      "fieldordinal": 1,
      "question": "Type of Consent",
      "response": {
        "type": "radio",
        "options": [
          {
            "value": "Study Informed Consent",
            "label": "Study Informed Consent"
          }
        ]
      },
      "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": "Date of Consent Withdrawal",
      "response": {
        "type": "textbox"
      },
      "sdtm_annotation": [
        {
          "domain": "DS",
          "variable": "DSSTDTC",
          "notes": "DS.DSSTDTC"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    }
  ]
}

Example Case Report Forms for DS domain

Sources: DB1 | Forms loaded: 5

Form: Consent Withdrawls

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Primary Domain

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#	Question	Response
1	Type of Consent field_001	Study Informed Consent
2	Date of Consent Withdrawal field_002	DS.DSSTDTC

{
 "form": {
 "formoid": "ds_screen_fail",
 "title": "Screen Fail Status",
 "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_ds_fields.txt",
 "notes": "[crfdb=db1, domain=DS]"
 },
 "sdtm": {
 "primary_domain": "DS",
 "domains": [
 "DS"
 ],
 "annotation_style": "legacy_text",
 "global_notes": "Converted from legacy TSV: db1_ds_fields.txt"
 },
 "ui": [],
 "fields": [
 {
 "fieldoid": "field_001",
 "fieldordinal": 1,
 "question": "Is the subject a screen fa",
 "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": "field_002",
 "fieldordinal": 2,
 "question": "Primary Screen Failure Rea",
 "response": {
 "type": "radio",
 "options": [
 {
 "value": "ADVERSE EVENT",
 "label": "ADVERSE EVENT"
 },
 {
 "value": "LOST TO FOLLOW-UP",
 "label": "LOST TO FOLLOW-UP"
 },
 {
 "value": "WITHDRAWAL BY SUBJECT",
 "label": "WITHDRAWAL BY SUBJECT"
 },
 {
 "value": "OTHER",
 "label": "OTHER"
 }
 ]
 },
 "sdtm_annotation": [
 {
 "notes": "DS.EPOCH=\"SCREENING\" DS.DSSCAT=\"SCREEN FAILURE\" DS.DSCAT=\"DISPOSITION EVENT\" DS.DSDECOD DS.DSTERM when response is not 'OTHER'",
 "raw": "DS.EPOCH=\"SCREENING\" DS.DSSCAT=\"SCREEN FAILURE\" DS.DSCAT=\"DISPOSITION EVENT\" DS.DSDECOD DS.DSTERM when response is not 'OTHER'"
 }
 ],
 "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 Primary Screen Failure",
 "response": {
 "type": "textbox"
 },
 "sdtm_annotation": [
 {
 "domain": "DS",
 "variable": "DSTERM",
 "notes": "when DS.DSDECOD='OTHER'",
 "raw": "DS.DSTERM when DS.DSDECOD='OTHER'"
 }
 ],
 "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": "",
 "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 DS domain

Sources: DB1 | Forms loaded: 5

Form: Screen Fail Status

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Primary Domain

All Domains

#	Question	Response
1	Is the subject a screen fa field_001	NO YES
2	Primary Screen Failure Rea field_002	ADVERSE EVENT LOST TO FOLLOW-UP WITHDRAWAL BY SUBJECT OTHER DS.EPOCH="SCREENING"</br> DS.DSSCAT="SCREEN FAILURE" </br> DS.DSCAT="DISPOSITION EVENT" </br>DS.DSDECOD</br> DS.DSTERM when response is not 'OTHER'
3	If Primary Screen Failure field_003	DS.DSTERM when DS.DSDECOD='OTHER'
4	field_004

{
  "form": {
    "formoid": "enrlment",
    "title": "Enrollment",
    "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_dm_fields.txt",
    "notes": "[crfdb=db1, domain=DM]"
  },
  "sdtm": {
    "primary_domain": "DM",
    "domains": [
      "DM",
      "DS"
    ],
    "annotation_style": "legacy_text",
    "global_notes": "Converted from legacy TSV: db1_dm_fields.txt"
  },
  "ui": [],
  "fields": [
    {
      "fieldoid": "enrlment.ICDT_RAW",
      "fieldordinal": 1,
      "question": "Date Consent Form Signed",
      "response": {
        "type": "textbox"
      },
      "sdtm_annotation": [
        {
          "domain": "DM",
          "variable": "RFICDTC",
          "notes": "DM.RFICDTC"
        },
        {
          "notes": "DS.DSSTDTC when DS.DSDECOD=\"INFORMED CONSENT OBTAINED\"",
          "raw": "DS.DSSTDTC when DS.DSDECOD=\"INFORMED CONSENT OBTAINED\""
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T13:26:22+00:00"
      }
    },
    {
      "fieldoid": "enrlment.ICVERS",
      "fieldordinal": 2,
      "question": "Consent Version Number",
      "response": {
        "type": "textbox"
      },
      "sdtm_annotation": [
        {
          "notes": "SUPPDS.QNAM.ICVERS when DS.DSDECOD=\"INFORMED CONSENT OBTAINED\"",
          "raw": "SUPPDS.QNAM.ICVERS when DS.DSDECOD=\"INFORMED CONSENT OBTAINED\""
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "enrlment.PRTVERS",
      "fieldordinal": 3,
      "question": "Protocol Version",
      "response": {
        "type": "textbox"
      },
      "sdtm_annotation": [
        {
          "notes": "SUPPDS.QNAM.PRTVERS when DS.DSDECOD=\"INFORMED CONSENT OBTAINED\"",
          "raw": "SUPPDS.QNAM.PRTVERS when DS.DSDECOD=\"INFORMED CONSENT OBTAINED\""
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "enrlment.ENRLDT_RAW",
      "fieldordinal": 4,
      "question": "Date of Enrollment",
      "response": {
        "type": "textbox"
      },
      "sdtm_annotation": [
        {
          "domain": "DS",
          "variable": "DSSTDTC",
          "notes": "when DS.DSDECOD=\"ENROLLED\"",
          "raw": "DS.DSSTDTC when DS.DSDECOD=\"ENROLLED\""
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "enrlment.RANDDT_RAW",
      "fieldordinal": 5,
      "question": "Date of Randomization",
      "response": {
        "type": "textbox"
      },
      "sdtm_annotation": [
        {
          "domain": "DS",
          "variable": "DSSTDTC",
          "notes": "when DS.DSDECOD=\"RANDOMIZED\"",
          "raw": "DS.DSSTDTC when DS.DSDECOD=\"RANDOMIZED\""
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "enrlment.RANDNO",
      "fieldordinal": 6,
      "question": "Randomization number",
      "response": {
        "type": "textbox"
      },
      "sdtm_annotation": [
        {
          "domain": "DS",
          "variable": "DSREFID",
          "notes": "when DS.DSDECOD=\"RANDOMIZED\"",
          "raw": "DS.DSREFID when DS.DSDECOD=\"RANDOMIZED\""
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    }
  ]
}

Example Case Report Forms for DS domain

Sources: DB1 | Forms loaded: 5

Form: Enrollment

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Primary Domain

All Domains

DM, DS

#	Question	Response
1	Date Consent Form Signed enrlment.ICDT_RAW	DM.RFICDTC DS.DSSTDTC when DS.DSDECOD="INFORMED CONSENT OBTAINED"
2	Consent Version Number enrlment.ICVERS	SUPPDS.QNAM.ICVERS when DS.DSDECOD="INFORMED CONSENT OBTAINED"
3	Protocol Version enrlment.PRTVERS	SUPPDS.QNAM.PRTVERS when DS.DSDECOD="INFORMED CONSENT OBTAINED"
4	Date of Enrollment enrlment.ENRLDT_RAW	DS.DSSTDTC when DS.DSDECOD="ENROLLED"
5	Date of Randomization enrlment.RANDDT_RAW	DS.DSSTDTC when DS.DSDECOD="RANDOMIZED"
6	Randomization number enrlment.RANDNO	DS.DSREFID when DS.DSDECOD="RANDOMIZED"

{
  "form": {
    "formoid": "eoip",
    "title": "End of Treatment",
    "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_ds_fields.txt",
    "notes": "[crfdb=db1, domain=DS]"
  },
  "sdtm": {
    "primary_domain": "DS",
    "domains": [
      "DS"
    ],
    "annotation_style": "legacy_text",
    "global_notes": "Converted from legacy TSV: db1_ds_fields.txt"
  },
  "ui": [],
  "fields": [
    {
      "fieldoid": "field_001",
      "fieldordinal": 1,
      "question": "Did the subject complete t",
      "response": {
        "type": "radio",
        "options": [
          {
            "value": "Yes",
            "label": "Yes"
          }
        ]
      },
      "sdtm_annotation": [
        {
          "notes": "Not submitted",
          "raw": "Not submitted"
        }
      ],
      "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": "Did the subject complete t",
      "response": {
        "type": "radio",
        "options": [
          {
            "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": "eos.EOSTDT_RAW",
      "fieldordinal": 3,
      "question": "Date of completion/discont",
      "response": {
        "type": "textbox"
      },
      "sdtm_annotation": [
        {
          "domain": "DS",
          "variable": "DSSTDTC",
          "notes": "DS.DSSTDTC"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    },
    {
      "fieldoid": "eos.EOTERM",
      "fieldordinal": 4,
      "question": "Primary reason for ending",
      "response": {
        "type": "radio",
        "options": [
          {
            "value": "Completed",
            "label": "Completed"
          },
          {
            "value": "Decision by Sponsor",
            "label": "Decision by Sponsor"
          },
          {
            "value": "Lost to follow-up",
            "label": "Lost to follow-up"
          },
          {
            "value": "Death",
            "label": "Death"
          },
          {
            "value": "Adverse event",
            "label": "Adverse event"
          },
          {
            "value": "Subject Request",
            "label": "Subject Request"
          }
        ]
      },
      "sdtm_annotation": [
        {
          "domain": "DS",
          "variable": "DSTERM",
          "notes": "DS.DSTERM"
        }
      ],
      "audit": {
        "created_at": "2026-02-22T11:45:57+00:00",
        "updated_at": "2026-02-22T11:45:57+00:00"
      }
    }
  ]
}

Example Case Report Forms for DS domain

Sources: DB1 | Forms loaded: 5

Form: End of Treatment

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Primary Domain

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#	Question	Response
1	Did the subject complete t field_001	Yes Not submitted
2	Did the subject complete t field_002	No
3	Date of completion/discont eos.EOSTDT_RAW	DS.DSSTDTC
4	Primary reason for ending eos.EOTERM	Completed Decision by Sponsor Lost to follow-up Death Adverse event Subject Request DS.DSTERM

{
 "form": {
 "formoid": "eos",
 "title": "End of Study",
 "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_ds_fields.txt",
 "notes": "[crfdb=db1, domain=DS]"
 },
 "sdtm": {
 "primary_domain": "DS",
 "domains": [
 "DS"
 ],
 "annotation_style": "legacy_text",
 "global_notes": "Converted from legacy TSV: db1_ds_fields.txt"
 },
 "ui": [],
 "fields": [
 {
 "fieldoid": "field_001",
 "fieldordinal": 1,
 "question": "Did the subject complete t",
 "response": {
 "type": "radio",
 "options": [
 {
 "value": "Yes",
 "label": "Yes"
 },
 {
 "value": "No",
 "label": "No"
 }
 ]
 },
 "sdtm_annotation": [
 {
 "notes": "Not submitted",
 "raw": "Not submitted"
 }
 ],
 "audit": {
 "created_at": "2026-02-22T11:45:57+00:00",
 "updated_at": "2026-02-22T11:45:57+00:00"
 }
 },
 {
 "fieldoid": "eos.EOSTDT_RAW",
 "fieldordinal": 2,
 "question": "Date of completion/discont",
 "response": {
 "type": "textbox"
 },
 "sdtm_annotation": [
 {
 "domain": "DS",
 "variable": "DSSTDTC",
 "notes": "DS.DSSTDTC"
 }
 ],
 "audit": {
 "created_at": "2026-02-22T11:45:57+00:00",
 "updated_at": "2026-02-22T11:45:57+00:00"
 }
 },
 {
 "fieldoid": "eos.EOTERM",
 "fieldordinal": 3,
 "question": "Primary reason for ending",
 "response": {
 "type": "radio",
 "options": [
 {
 "value": "Completed",
 "label": "Completed"
 },
 {
 "value": "Decision by Sponsor",
 "label": "Decision by Sponsor"
 },
 {
 "value": "Lost to follow-up",
 "label": "Lost to follow-up"
 },
 {
 "value": "Death",
 "label": "Death"
 },
 {
 "value": "Adverse event",
 "label": "Adverse event"
 },
 {
 "value": "Subject Request",
 "label": "Subject Request"
 },
 {
 "value": "Other",
 "label": "Other"
 }
 ]
 },
 "sdtm_annotation": [
 {
 "notes": "DS.DSCAT=\"DISPOSITION EVENT\"DS.DSSCAT=\"END OF STUDY\"DS.DSTERM DS.DSDECOD",
 "raw": "DS.DSCAT=\"DISPOSITION EVENT\"DS.DSSCAT=\"END OF STUDY\"DS.DSTERM DS.DSDECOD"
 }
 ],
 "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": "If other, specify",
 "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 DS domain

Sources: DB1 | Forms loaded: 5

Form: End of Study

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Primary Domain

All Domains

#	Question	Response
1	Did the subject complete t field_001	Yes No Not submitted
2	Date of completion/discont eos.EOSTDT_RAW	DS.DSSTDTC
3	Primary reason for ending eos.EOTERM	Completed Decision by Sponsor Lost to follow-up Death Adverse event Subject Request Other DS.DSCAT="DISPOSITION EVENT"</br>DS.DSSCAT="END OF STUDY"</br>DS.DSTERM</br> DS.DSDECOD
4	If other, specify field_004