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Forms in DV (1)

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Protocol Deviations

{
  "form": {
    "formoid": "protdev",
    "title": "Protocol Deviations",
    "description": "",
    "version": "1.0",
    "created_at": "2026-02-26T06:14:29+00:00",
    "updated_at": "2026-02-26T06:14:29+00:00",
    "source": "paste:manual_fields.txt"
  },
  "sdtm": {
    "primary_domain": "DV",
    "domains": [
      "DV"
    ]
  },
  "ui": [],
  "fields": [
    {
      "fieldoid": "DVYN",
      "fieldordinal": 1,
      "question": "Were there any protocol deviations?",
      "response": {
        "type": "radio",
        "options": [
          {
            "value": "Yes",
            "label": "Yes"
          },
          {
            "value": "No",
            "label": "No"
          }
        ]
      },
      "sdtm_annotation": [
        {
          "notes": "NOT SUBMITTED",
          "raw": "NOT SUBMITTED"
        }
      ],
      "audit": {
        "created_at": "2026-02-26T06:14:29+00:00",
        "updated_at": "2026-02-26T06:14:29+00:00"
      }
    },
    {
      "fieldoid": "DVSPID",
      "fieldordinal": 2,
      "question": "What is the protocol deviation identifier?",
      "response": {
        "type": "textbox"
      },
      "sdtm_annotation": [
        {
          "variable": "DVSPID",
          "notes": "DVSPID"
        }
      ],
      "audit": {
        "created_at": "2026-02-26T06:14:29+00:00",
        "updated_at": "2026-02-26T06:14:29+00:00"
      }
    },
    {
      "fieldoid": "DVDECOD",
      "fieldordinal": 3,
      "question": "What was the protocol deviation?",
      "response": {
        "type": "radio",
        "options": [
          {
            "value": "Informed Consent Not Obtained",
            "label": "Informed Consent Not Obtained"
          },
          {
            "value": "Inclusion Criteria Not Met",
            "label": "Inclusion Criteria Not Met"
          },
          {
            "value": "Study Drug Non-Compliance",
            "label": "Study Drug Non-Compliance"
          },
          {
            "value": "Randomization Error",
            "label": "Randomization Error"
          },
          {
            "value": "Other",
            "label": "Other"
          }
        ]
      },
      "sdtm_annotation": [
        {
          "variable": "DVDECOD",
          "notes": "DVDECOD"
        }
      ],
      "audit": {
        "created_at": "2026-02-26T06:14:29+00:00",
        "updated_at": "2026-02-26T06:14:29+00:00"
      }
    },
    {
      "fieldoid": "DVTTERM",
      "fieldordinal": 4,
      "question": "Specify Protocol Deviation",
      "response": {
        "type": "textbox"
      },
      "sdtm_annotation": [
        {
          "variable": "DVTTERM",
          "notes": "DVTTERM"
        }
      ],
      "audit": {
        "created_at": "2026-02-26T06:14:29+00:00",
        "updated_at": "2026-02-26T06:14:29+00:00"
      }
    },
    {
      "fieldoid": "DVSTDAT",
      "fieldordinal": 5,
      "question": "Start Date",
      "response": {
        "type": "date"
      },
      "sdtm_annotation": [
        {
          "variable": "DVSTDTC",
          "notes": "DVSTDTC"
        }
      ],
      "audit": {
        "created_at": "2026-02-26T06:14:29+00:00",
        "updated_at": "2026-02-26T06:14:29+00:00"
      }
    },
    {
      "fieldoid": "DVENDAT",
      "fieldordinal": 6,
      "question": "End Date",
      "response": {
        "type": "date"
      },
      "sdtm_annotation": [
        {
          "variable": "DVENDTC",
          "notes": "DVENDTC"
        }
      ],
      "audit": {
        "created_at": "2026-02-26T06:14:29+00:00",
        "updated_at": "2026-02-26T06:14:29+00:00"
      }
    }
  ]
}

Example Case Report Forms for DV domain

Sources: DB1 | Forms loaded: 1

Form: Protocol Deviations

Show domain info

Primary Domain

All Domains

#	Question	Response
1	Were there any protocol deviations? DVYN	Yes No NOT SUBMITTED
2	What is the protocol deviation identifier? DVSPID	DVSPID
3	What was the protocol deviation? DVDECOD	Informed Consent Not Obtained Inclusion Criteria Not Met Study Drug Non-Compliance Randomization Error Other DVDECOD
4	Specify Protocol Deviation DVTTERM	DVTTERM
5	Start Date DVSTDAT	DVSTDTC
6	End Date DVENDAT	DVENDTC