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• Request
• Response

V3.0

post

/ec-dc-svc/rest/v3.0/studies/{studyId}/{mode}/subjects

Create a subject record in the specified study and mode. The request body must include all subject details and settings. Returns the created subject.

Request

Path Parameters

• mode(required): string
  Indicates the operational mode of the study. Accepted values: active, test, or training.

  Example:

  test

• studyId(required): string
  Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.

  Example:

  3234E620DE2E41D69A36571064E727B2

Supported Media Types

• application/json

Request Body - application/json ()

Root Schema : schema

Type: object

Contains details related to subject

Show Source

• SubjectDto: object SubjectDto1
  Base subject details including identity, demographics, study and site context, and state transitions

{
    "type":"object",
    "properties":{
        "SubjectDto":{
            "$ref":"#/components/schemas/SubjectDto1"
        }
    },
    "description":"Contains details related to subject"
}

Nested Schema : SubjectDto1

Type: object

Base subject details including identity, demographics, study and site context, and state transitions

Show Source

• comment: string
  Minimum Length: 0

  Maximum Length: 2048

  Comment for latest subject update

  Example: Initial enrollment
• description: string
  Minimum Length: 0

  Maximum Length: 500

  Free text description for the subject

  Example: Screened subject
• dob: string (date-time)
  Date of birth
• enrollmentFailure: string
  Minimum Length: 0

  Maximum Length: 255

  Reason for enrollment failure, if any

  Example: Consent withdrawn
• enrollmentOverride: string
  Minimum Length: 0

  Maximum Length: 255

  If subject enrollment is overridden.

  Example: Subject Enrollment Overridden
• gender: string
  Minimum Length: 0

  Maximum Length: 10

  Gender value

  Example: [{"value":"1","label":"male"}]
• id: string
  Unique identifier (UUID, 32-character uppercase hexadecimal string) of the subject

  Example: 1BC29B36F5D64B1B95F4BDBBCEA481BE
• informedConsentDate: string (date-time)
  Informed consent date

  Example: 2025-09-25T09:00:00Z
• reason: string
  Minimum Length: 0

  Maximum Length: 255

  Reason for latest subject update

  Example: Protocol break happened
• screeningDate: string (date-time)
  Screening date if applicable

  Example: 2025-10-01T10:00:00Z
• screeningFailure: string
  Minimum Length: 0

  Maximum Length: 255

  Reason for screening failure, if any

  Example: Inclusion criteria not met
• siteId: string
  Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.

  Example: ABCDEF1234567890ABCDEF1234567890
• state(required): string
  Minimum Length: 0

  Maximum Length: 100

  Lifecycle state of the subject in the study. Reflects the subject???s current status. Common values include:

  • New
  • Active
  • Screening_Initiated
  • Screen_Failed
  • Withdrawn
  • Auto_Screen_Failed
  • Complete
  • Enrolled

  Example: Active
• stateDate: string (date-time)
  Timestamp when the subject transitioned to current state

  Example: 2025-10-16T14:30:31.892Z
• studyId: string
  Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.

  Example: ABCDEF1234567890ABCDEF1234567890
• studyVersion(required): string
  String representing the version of the study. Helps track changes in form or study design.

  Example: 3.0.0.1
• subjectNumber(required): string
  Minimum Length: 0

  Maximum Length: 500

  Unique subject Number representing the patient/participant enrolled in the study.

  Example: SUBJ-0001
• versionStart: string (date-time)
  The timestamp marking the beginning of the validity period for this record version within the system.

  Example: 2025-10-16T14:30:31.892Z

{
    "required":[
        "state",
        "studyVersion",
        "subjectNumber"
    ],
    "type":"object",
    "properties":{
        "screeningDate":{
            "type":"string",
            "description":"Screening date if applicable",
            "format":"date-time",
            "example":"2025-10-01T10:00:00Z"
        },
        "id":{
            "type":"string",
            "description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the subject",
            "example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
        },
        "versionStart":{
            "type":"string",
            "description":"The timestamp marking the beginning of the validity period for this record version within the system.",
            "format":"date-time",
            "example":"2025-10-16T14:30:31.892Z"
        },
        "description":{
            "maxLength":500,
            "minLength":0,
            "type":"string",
            "description":"Free text description for the subject",
            "example":"Screened subject"
        },
        "subjectNumber":{
            "maxLength":500,
            "minLength":0,
            "type":"string",
            "description":"Unique subject Number representing the patient/participant enrolled in the study.",
            "example":"SUBJ-0001"
        },
        "studyId":{
            "type":"string",
            "description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
            "example":"ABCDEF1234567890ABCDEF1234567890"
        },
        "siteId":{
            "type":"string",
            "description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
            "example":"ABCDEF1234567890ABCDEF1234567890"
        },
        "dob":{
            "type":"string",
            "description":"Date of birth",
            "format":"date-time"
        },
        "state":{
            "maxLength":100,
            "minLength":0,
            "type":"string",
            "description":"Lifecycle state of the subject in the study.  Reflects the subject???s current status. Common values include: <ul><li>New</li><li>Active</li><li>Screening_Initiated</li><li>Screen_Failed</li><li>Withdrawn</li><li>Auto_Screen_Failed</li><li>Complete</li><li>Enrolled</li></ul>",
            "example":"Active"
        },
        "stateDate":{
            "type":"string",
            "description":"Timestamp when the subject transitioned to current state",
            "format":"date-time",
            "example":"2025-10-16T14:30:31.892Z"
        },
        "screeningFailure":{
            "maxLength":255,
            "minLength":0,
            "type":"string",
            "description":"Reason for screening failure, if any",
            "example":"Inclusion criteria not met"
        },
        "enrollmentFailure":{
            "maxLength":255,
            "minLength":0,
            "type":"string",
            "description":"Reason for enrollment failure, if any",
            "example":"Consent withdrawn"
        },
        "enrollmentOverride":{
            "maxLength":255,
            "minLength":0,
            "type":"string",
            "description":"If subject enrollment is overridden.",
            "example":"Subject Enrollment Overridden"
        },
        "informedConsentDate":{
            "type":"string",
            "description":"Informed consent date",
            "format":"date-time",
            "example":"2025-09-25T09:00:00Z"
        },
        "gender":{
            "maxLength":10,
            "minLength":0,
            "type":"string",
            "description":"Gender value",
            "example":"[{\"value\":\"1\",\"label\":\"male\"}]"
        },
        "reason":{
            "maxLength":255,
            "minLength":0,
            "type":"string",
            "description":"Reason for latest subject update",
            "example":"Protocol break happened"
        },
        "comment":{
            "maxLength":2048,
            "minLength":0,
            "type":"string",
            "description":"Comment for latest subject update",
            "example":"Initial enrollment"
        },
        "studyVersion":{
            "type":"string",
            "description":"String representing the version of the study. Helps track changes in form or study design.",
            "example":"3.0.0.1"
        }
    },
    "description":"Base subject details including identity, demographics, study and site context, and state transitions"
}

Examples

Select an example Request body for creating a subject

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Response

Supported Media Types

• application/json

200 Response

Success

Body ()

Root Schema : schema

Type: array

Show Source

• Array of: object SubjectDto_3
  Subject details including object version number for optimistic locking

{
    "type":"array",
    "items":{
        "$ref":"#/components/schemas/SubjectDto_3"
    }
}

Nested Schema : SubjectDto_3

Type: object

Subject details including object version number for optimistic locking

Show Source

• comment: string
  Minimum Length: 0

  Maximum Length: 2048

  Comment for latest subject update

  Example: Initial enrollment
• description: string
  Minimum Length: 0

  Maximum Length: 500

  Free text description for the subject

  Example: Screened subject
• dob: string (date-time)
  Date of birth
• enrollmentFailure: string
  Minimum Length: 0

  Maximum Length: 255

  Reason for enrollment failure, if any

  Example: Consent withdrawn
• enrollmentOverride: string
  Minimum Length: 0

  Maximum Length: 255

  If subject enrollment is overridden.

  Example: Subject Enrollment Overridden
• eventType: string
  Event Type for Subject, can have value New, Screened, Randomized, Withdrawn, Undo_Withdrawn, Randomization_Replaced, Transferred, Screen_Failed, Undo_Randomization.

  Example: Screened
• gender: string
  Minimum Length: 0

  Maximum Length: 10

  Gender value

  Example: [{"value":"1","label":"male"}]
• id: string
  Unique identifier (UUID, 32-character uppercase hexadecimal string) of the subject

  Example: 1BC29B36F5D64B1B95F4BDBBCEA481BE
• informedConsentDate: string (date-time)
  Informed consent date

  Example: 2025-09-25T09:00:00Z
• objectVersionNumber: number
  Audit trail field that represents the version number of the data.

  Example: 14
• reason: string
  Minimum Length: 0

  Maximum Length: 255

  Reason for latest subject update

  Example: Protocol break happened
• screeningDate: string (date-time)
  Screening date if applicable

  Example: 2025-10-01T10:00:00Z
• screeningFailure: string
  Minimum Length: 0

  Maximum Length: 255

  Reason for screening failure, if any

  Example: Inclusion criteria not met
• siteId: string
  Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.

  Example: ABCDEF1234567890ABCDEF1234567890
• state(required): string
  Minimum Length: 0

  Maximum Length: 100

  Lifecycle state of the subject in the study. Reflects the subject???s current status. Common values include:

  • New
  • Active
  • Screening_Initiated
  • Screen_Failed
  • Withdrawn
  • Auto_Screen_Failed
  • Complete
  • Enrolled

  Example: Active
• stateDate: string (date-time)
  Timestamp when the subject transitioned to current state

  Example: 2025-10-16T14:30:31.892Z
• studyId: string
  Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.

  Example: ABCDEF1234567890ABCDEF1234567890
• studyVersion(required): string
  String representing the version of the study. Helps track changes in form or study design.

  Example: 3.0.0.1
• subjectNumber(required): string
  Minimum Length: 0

  Maximum Length: 500

  Unique subject Number representing the patient/participant enrolled in the study.

  Example: SUBJ-0001
• subjectTransferId: string
  Unique Identifier(UUID, 32-character uppercase hexadecimal string) of a subject transfer if applicable

  Example: 1BC29B36F5D64B1B95F4BDBBCEA481BE
• versionStart: string (date-time)
  The timestamp marking the beginning of the validity period for this record version within the system.

  Example: 2025-10-16T14:30:31.892Z

{
    "required":[
        "state",
        "studyVersion",
        "subjectNumber"
    ],
    "type":"object",
    "properties":{
        "screeningDate":{
            "type":"string",
            "description":"Screening date if applicable",
            "format":"date-time",
            "example":"2025-10-01T10:00:00Z"
        },
        "eventType":{
            "type":"string",
            "description":"Event Type for Subject, can have value New, Screened, Randomized, Withdrawn, Undo_Withdrawn, Randomization_Replaced, Transferred, Screen_Failed, Undo_Randomization.",
            "example":"Screened"
        },
        "subjectTransferId":{
            "type":"string",
            "description":"Unique Identifier(UUID, 32-character uppercase hexadecimal string) of a subject transfer if applicable",
            "example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
        },
        "objectVersionNumber":{
            "type":"number",
            "description":"Audit trail field that represents the version number of the data.",
            "example":14
        },
        "id":{
            "type":"string",
            "description":"Unique identifier (UUID, 32-character uppercase hexadecimal string) of the subject",
            "example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
        },
        "versionStart":{
            "type":"string",
            "description":"The timestamp marking the beginning of the validity period for this record version within the system.",
            "format":"date-time",
            "example":"2025-10-16T14:30:31.892Z"
        },
        "description":{
            "maxLength":500,
            "minLength":0,
            "type":"string",
            "description":"Free text description for the subject",
            "example":"Screened subject"
        },
        "subjectNumber":{
            "maxLength":500,
            "minLength":0,
            "type":"string",
            "description":"Unique subject Number representing the patient/participant enrolled in the study.",
            "example":"SUBJ-0001"
        },
        "studyId":{
            "type":"string",
            "description":"Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.",
            "example":"ABCDEF1234567890ABCDEF1234567890"
        },
        "siteId":{
            "type":"string",
            "description":"Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.",
            "example":"ABCDEF1234567890ABCDEF1234567890"
        },
        "dob":{
            "type":"string",
            "description":"Date of birth",
            "format":"date-time"
        },
        "state":{
            "maxLength":100,
            "minLength":0,
            "type":"string",
            "description":"Lifecycle state of the subject in the study.  Reflects the subject???s current status. Common values include: <ul><li>New</li><li>Active</li><li>Screening_Initiated</li><li>Screen_Failed</li><li>Withdrawn</li><li>Auto_Screen_Failed</li><li>Complete</li><li>Enrolled</li></ul>",
            "example":"Active"
        },
        "stateDate":{
            "type":"string",
            "description":"Timestamp when the subject transitioned to current state",
            "format":"date-time",
            "example":"2025-10-16T14:30:31.892Z"
        },
        "screeningFailure":{
            "maxLength":255,
            "minLength":0,
            "type":"string",
            "description":"Reason for screening failure, if any",
            "example":"Inclusion criteria not met"
        },
        "enrollmentFailure":{
            "maxLength":255,
            "minLength":0,
            "type":"string",
            "description":"Reason for enrollment failure, if any",
            "example":"Consent withdrawn"
        },
        "enrollmentOverride":{
            "maxLength":255,
            "minLength":0,
            "type":"string",
            "description":"If subject enrollment is overridden.",
            "example":"Subject Enrollment Overridden"
        },
        "informedConsentDate":{
            "type":"string",
            "description":"Informed consent date",
            "format":"date-time",
            "example":"2025-09-25T09:00:00Z"
        },
        "gender":{
            "maxLength":10,
            "minLength":0,
            "type":"string",
            "description":"Gender value",
            "example":"[{\"value\":\"1\",\"label\":\"male\"}]"
        },
        "reason":{
            "maxLength":255,
            "minLength":0,
            "type":"string",
            "description":"Reason for latest subject update",
            "example":"Protocol break happened"
        },
        "comment":{
            "maxLength":2048,
            "minLength":0,
            "type":"string",
            "description":"Comment for latest subject update",
            "example":"Initial enrollment"
        },
        "studyVersion":{
            "type":"string",
            "description":"String representing the version of the study. Helps track changes in form or study design.",
            "example":"3.0.0.1"
        }
    },
    "description":"Subject details including object version number for optimistic locking"
}

Examples

Select an example Response body for successful subject creation

400 Response

Bad request.

Body ()

Root Schema : DcsResponse

Type: object

Show Source

• errorData: object ErrorResponseData
• result: object result
• status: string
• version: integer (int32)

{
    "type":"object",
    "properties":{
        "status":{
            "type":"string"
        },
        "result":{
            "type":"object"
        },
        "version":{
            "type":"integer",
            "format":"int32",
            "writeOnly":true
        },
        "errorData":{
            "$ref":"#/components/schemas/ErrorResponseData"
        }
    }
}

Nested Schema : ErrorResponseData

Type: object

Show Source

• details: object details
• errorCode: string
• errorMessage: string

{
    "type":"object",
    "properties":{
        "errorCode":{
            "type":"string"
        },
        "errorMessage":{
            "type":"string"
        },
        "details":{
            "type":"object"
        }
    }
}

Nested Schema : result

Type: object

Nested Schema : details

Type: object

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