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V4.0

post

/ec-dc-svc/rest/v4.0/studies/{studyId}/{mode}/subjects

Adds a subject to a study. If Medical Record Number (mrnNumber) is provided and if the user has Link Subject-Patient rights, subject patient link would also be established.

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

Show Source

• subject: object SubjectDto13
  Subject properties indicating Screening Number

{
    "type":"object",
    "properties":{
        "subject":{
            "$ref":"#/components/schemas/SubjectDto13"
        }
    }
}

Nested Schema : SubjectDto13

Type: object

Subject properties indicating Screening Number

Show Source

• canBeCompleted: boolean
  Indicates if the subject has met conditions to be completed

  Example: true
• 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  Example: Consent withdrawn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  Event Type for Subject, can have value New, Screened, Randomized, Withdrawn, Undo_Withdrawn, Randomization_Replaced, Transferred, Screen_Failed, Undo_Randomization.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
• freezedStatus: string
  Frozen status of the record can have values NOT_APPLICABLE, FROZEN, UNFREEZE.

  Example: FROZEN
• fromStudyId: string
  Origin study identifier (UUID, 32-character uppercase hexadecimal string) from which the subject was transferred

  Example: 5D5F9311C591424F852B99FD902E98A4
• gender: string
  Minimum Length: 0

  Maximum Length: 10

  Gender value

  Example: [{"value":"1","label":"male"}]
• hasLockData: boolean
  Indicates whether lock related data exists for the subject

  Example: false
• 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
• lastSigned: string (date-time)
  Timestamp when the subject was last signed

  Example: 2025-10-16T14:30:31.892Z
• lockedDateTime: string (date-time)
  Timestamp when the subject was locked

  Example: 2025-10-16T14:30:31.892Z
• lockedInStudyVersion: string
  Study version in which the subject is locked

  Example: 3.0.0.4
• lockedStatus: string
  Lock status of the subject,applicable values are LOCKED, UNLOCKED

  Example: UNLOCKED
• mhealthSubjectId: string
  Unique Identifier (UUID, 32-character uppercase hexadecimal string) of the subject in mHealth system.

  Example: 1BC29B36F5D64B1B95F4BDBBCEA481BE
• mrnNumber: string
  Medical record number of subject

  Example: mrn-0001
• objectVersionNumber: number
  Audit trail field that represents the version number of the data.

  Example: 14
• operationType: string
  Operation type on the record, can have values CREATED, MODIFIED or REMOVED

  Example: MODIFIED
• previousSubjectNumber: string
  Previous subject number if renumbered or transferred

  Example: SUBJECT-0001-OLD
• randomizationNumber: string
  Randomization number assigned to the subject if applicable.

  Example: RND-0001
• reason: string
  Minimum Length: 0

  Maximum Length: 255

  Reason for latest subject update

  Example: Protocol break happened
• screenFailureComment: string
  Comment to make Subject fail in screening

  Example: screeing failure
• screenFailureDate: string (date-time)
  Date when the subject was marked as screen failure

  Example: 2025-10-16T14:30:31.892Z
• 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
• screeningNumber: string
  Indicates the number of screened subject

  Example: SCR-0001
• signedStatus: string
  Signed status for workflow, the acceptable values are: NEVER_SIGNED, SIGNED, UNSIGNED, NEVER_SIGNED.

  Example: SIGNED
• siteId: string
  Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.

  Example: ABCDEF1234567890ABCDEF1234567890
• softwareVersionNumber: number
  Software version number associated with the event

  Example: 14
• sourceTimeStamp: string (date-time)
  Source system timestamp for the subject payload

  Example: 2025-10-16T14:30:31.892Z
• 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
• studyCompletionDate: string
  Date at which clinical study completed

  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
• subjectSiteSerialNumber: string
  Site-level serial number assigned to the subject

  Example: SITE-0001-001
• subjectStudySerialNumber: string
  Study-level serial number assigned to the subject

  Example: STUDY-0001-001
• subjectTransferId: string
  Unique Identifier(UUID, 32-character uppercase hexadecimal string) of a subject transfer if applicable

  Example: 1BC29B36F5D64B1B95F4BDBBCEA481BE
• subjNumSiteOrgId: string
  Subject number site organization identifier (UUID, 32-character uppercase hexadecimal string)

  Example: 5D5F9311C591424F852B99FD902E98A4
• verifiedStatus: string
  Verified status for review workflow,the acceptable values are: NEVER_VEIFIED, VERIFIED, UNVERIFIED, NOT_APPLICABLE.

  Example: VERIFIED
• versionEnd: string (date-time)
  End timestamp of the subject version record

  Example: 2025-10-16T14:30:31.892Z
• 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
• withdrawalComment: string
  Comment to withdraw subject

  Example: Subject fails in trial
• withdrawalDate: string (date-time)
  withdrawl Date of subject

  Example: 2025-10-16T14:30:31.892Z
• withdrawalReason: string
  Reason to withdraw subject

  Example: not suitable

{
    "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
        },
        "mhealthSubjectId":{
            "type":"string",
            "description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string)  of the subject in mHealth system.",
            "example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
        },
        "fromStudyId":{
            "type":"string",
            "description":"Origin study identifier (UUID, 32-character uppercase hexadecimal string) from which the subject was transferred",
            "example":"5D5F9311C591424F852B99FD902E98A4"
        },
        "subjNumSiteOrgId":{
            "type":"string",
            "description":"Subject number site organization identifier (UUID, 32-character uppercase hexadecimal string) ",
            "example":"5D5F9311C591424F852B99FD902E98A4"
        },
        "signedStatus":{
            "type":"string",
            "description":"Signed status for workflow, the acceptable values are:  NEVER_SIGNED, SIGNED, UNSIGNED, NEVER_SIGNED.",
            "example":"SIGNED"
        },
        "verifiedStatus":{
            "type":"string",
            "description":"Verified status for review workflow,the acceptable values are: NEVER_VEIFIED, VERIFIED, UNVERIFIED, NOT_APPLICABLE.",
            "example":"VERIFIED"
        },
        "freezedStatus":{
            "type":"string",
            "description":"Frozen status of the record can have values NOT_APPLICABLE, FROZEN, UNFREEZE.",
            "example":"FROZEN"
        },
        "lastSigned":{
            "type":"string",
            "description":"Timestamp when the subject was last signed",
            "format":"date-time",
            "example":"2025-10-16T14:30:31.892Z"
        },
        "softwareVersionNumber":{
            "type":"number",
            "description":"Software version number associated with the event",
            "example":14
        },
        "operationType":{
            "type":"string",
            "description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
            "example":"MODIFIED"
        },
        "subjectStudySerialNumber":{
            "type":"string",
            "description":"Study-level serial number assigned to the subject",
            "example":"STUDY-0001-001"
        },
        "subjectSiteSerialNumber":{
            "type":"string",
            "description":"Site-level serial number assigned to the subject",
            "example":"SITE-0001-001"
        },
        "versionEnd":{
            "type":"string",
            "description":"End timestamp of the subject version record",
            "format":"date-time",
            "example":"2025-10-16T14:30:31.892Z"
        },
        "previousSubjectNumber":{
            "type":"string",
            "description":"Previous subject number if renumbered or transferred",
            "example":"SUBJECT-0001-OLD"
        },
        "screenFailureDate":{
            "type":"string",
            "description":"Date when the subject was marked as screen failure",
            "format":"date-time",
            "example":"2025-10-16T14:30:31.892Z"
        },
        "lockedStatus":{
            "type":"string",
            "description":"Lock status of the subject,applicable values are LOCKED, UNLOCKED",
            "example":"UNLOCKED"
        },
        "hasLockData":{
            "type":"boolean",
            "description":"Indicates whether lock related data exists for the subject",
            "example":false
        },
        "lockedDateTime":{
            "type":"string",
            "description":"Timestamp when the subject was locked",
            "format":"date-time",
            "example":"2025-10-16T14:30:31.892Z"
        },
        "canBeCompleted":{
            "type":"boolean",
            "description":"Indicates if the subject has met conditions to be completed",
            "example":true
        },
        "lockedInStudyVersion":{
            "type":"string",
            "description":"Study version in which the subject is locked",
            "example":"3.0.0.4"
        },
        "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"
        },
        "sourceTimeStamp":{
            "type":"string",
            "description":"Source system timestamp for the subject payload",
            "format":"date-time",
            "example":"2025-10-16T14:30:31.892Z"
        },
        "screeningNumber":{
            "type":"string",
            "description":"Indicates the number of screened subject ",
            "example":"SCR-0001"
        },
        "randomizationNumber":{
            "type":"string",
            "description":"Randomization number assigned to the subject if applicable.",
            "example":"RND-0001"
        },
        "mrnNumber":{
            "type":"string",
            "description":"Medical record number of subject",
            "example":"mrn-0001"
        },
        "withdrawalDate":{
            "type":"string",
            "description":"withdrawl Date of subject",
            "format":"date-time",
            "example":"2025-10-16T14:30:31.892Z"
        },
        "studyCompletionDate":{
            "type":"string",
            "description":"Date at which clinical study completed",
            "example":"2025-10-16T14:30:31.892Z"
        },
        "withdrawalReason":{
            "type":"string",
            "description":"Reason to withdraw subject",
            "example":"not suitable"
        },
        "withdrawalComment":{
            "type":"string",
            "description":"Comment to withdraw subject",
            "example":"Subject fails in trial"
        },
        "screenFailureComment":{
            "type":"string",
            "description":"Comment to make Subject fail in screening",
            "example":"screeing failure"
        }
    },
    "description":"Subject properties indicating Screening Number"
}

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 SubjectRespDto13
  Subject details including screening, randomization, completion status and withdrawal information

{
    "type":"array",
    "items":{
        "$ref":"#/components/schemas/SubjectRespDto13"
    }
}

Nested Schema : SubjectRespDto13

Type: object

Subject details including screening, randomization, completion status and withdrawal information

Show Source

• canBeCompleted: boolean
  Indicates if the subject has met conditions to be completed

  Example: true
• 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
• ehrLinkStatus: number
  EHR link status code for the subject

  Example: 1
• 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
• freezedStatus: string
  Frozen status of the record can have values NOT_APPLICABLE, FROZEN, UNFREEZE.

  Example: FROZEN
• fromStudyId: string
  Origin study identifier (UUID, 32-character uppercase hexadecimal string) from which the subject was transferred

  Example: 5D5F9311C591424F852B99FD902E98A4
• gender: string
  Minimum Length: 0

  Maximum Length: 10

  Gender value

  Example: [{"value":"1","label":"male"}]
• hasLockData: boolean
  Indicates whether lock related data exists for the subject

  Example: false
• 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
• lastSigned: string (date-time)
  Timestamp when the subject was last signed

  Example: 2025-10-16T14:30:31.892Z
• lockedDateTime: string (date-time)
  Timestamp when the subject was locked

  Example: 2025-10-16T14:30:31.892Z
• lockedInStudyVersion: string
  Study version in which the subject is locked

  Example: 3.0.0.4
• lockedStatus: string
  Lock status of the subject,applicable values are LOCKED, UNLOCKED

  Example: UNLOCKED
• mhealthSubjectId: string
  Unique Identifier (UUID, 32-character uppercase hexadecimal string) of the subject in mHealth system.

  Example: 1BC29B36F5D64B1B95F4BDBBCEA481BE
• objectVersionNumber: number
  Audit trail field that represents the version number of the data.

  Example: 14
• operationType: string
  Operation type on the record, can have values CREATED, MODIFIED or REMOVED

  Example: MODIFIED
• previousSubjectNumber: string
  Previous subject number if renumbered or transferred

  Example: SUBJECT-0001-OLD
• randomizationNumber: string
  Randomization number assigned to the subject if applicable.

  Example: RND-001
• reason: string
  Minimum Length: 0

  Maximum Length: 255

  Reason for latest subject update

  Example: Protocol break happened
• screenFailureComment: string
  Additional comment for screen failure

  Example: Subject breached protocols
• screenFailureDate: string (date-time)
  Date when the subject was marked as screen failure

  Example: 2025-10-16T14:30:31.892Z
• 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
• screeningNumber: string
  Screening number assigned to the subject

  Example: SCR-0001
• signedStatus: string
  Signed status for workflow, the acceptable values are: NEVER_SIGNED, SIGNED, UNSIGNED, NEVER_SIGNED.

  Example: SIGNED
• siteId: string
  Unique identifier of the site. Uses UUID in a 32-character uppercase hexadecimal string format.

  Example: ABCDEF1234567890ABCDEF1234567890
• softwareVersionNumber: number
  Software version number associated with the event

  Example: 14
• sourceTimeStamp: string (date-time)
  Source system timestamp for the subject payload

  Example: 2025-10-16T14:30:31.892Z
• 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
• studyCompletionDate: string (date-time)
  Date when the subject completed the study

  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
• subjectSiteSerialNumber: string
  Site-level serial number assigned to the subject

  Example: SITE-0001-001
• subjectStudySerialNumber: string
  Study-level serial number assigned to the subject

  Example: STUDY-0001-001
• subjectTransferId: string
  Unique Identifier(UUID, 32-character uppercase hexadecimal string) of a subject transfer if applicable

  Example: 1BC29B36F5D64B1B95F4BDBBCEA481BE
• subjNumSiteOrgId: string
  Subject number site organization identifier (UUID, 32-character uppercase hexadecimal string)

  Example: 5D5F9311C591424F852B99FD902E98A4
• verifiedStatus: string
  Verified status for review workflow,the acceptable values are: NEVER_VEIFIED, VERIFIED, UNVERIFIED, NOT_APPLICABLE.

  Example: VERIFIED
• versionEnd: string (date-time)
  End timestamp of the subject version record

  Example: 2025-10-16T14:30:31.892Z
• 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
• withdrawalComment: string
  Additional comment provided for withdrawal

  Example: Subject breached protocols
• withdrawalDate: string (date-time)
  Date when the subject was withdrawn

  Example: 2025-10-16T14:30:31.892Z
• withdrawalReason: string
  Reason provided when the subject is withdrawn

  Example: Not applicable

{
    "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
        },
        "mhealthSubjectId":{
            "type":"string",
            "description":"Unique Identifier (UUID, 32-character uppercase hexadecimal string)  of the subject in mHealth system.",
            "example":"1BC29B36F5D64B1B95F4BDBBCEA481BE"
        },
        "fromStudyId":{
            "type":"string",
            "description":"Origin study identifier (UUID, 32-character uppercase hexadecimal string) from which the subject was transferred",
            "example":"5D5F9311C591424F852B99FD902E98A4"
        },
        "subjNumSiteOrgId":{
            "type":"string",
            "description":"Subject number site organization identifier (UUID, 32-character uppercase hexadecimal string) ",
            "example":"5D5F9311C591424F852B99FD902E98A4"
        },
        "signedStatus":{
            "type":"string",
            "description":"Signed status for workflow, the acceptable values are:  NEVER_SIGNED, SIGNED, UNSIGNED, NEVER_SIGNED.",
            "example":"SIGNED"
        },
        "verifiedStatus":{
            "type":"string",
            "description":"Verified status for review workflow,the acceptable values are: NEVER_VEIFIED, VERIFIED, UNVERIFIED, NOT_APPLICABLE.",
            "example":"VERIFIED"
        },
        "freezedStatus":{
            "type":"string",
            "description":"Frozen status of the record can have values NOT_APPLICABLE, FROZEN, UNFREEZE.",
            "example":"FROZEN"
        },
        "lastSigned":{
            "type":"string",
            "description":"Timestamp when the subject was last signed",
            "format":"date-time",
            "example":"2025-10-16T14:30:31.892Z"
        },
        "softwareVersionNumber":{
            "type":"number",
            "description":"Software version number associated with the event",
            "example":14
        },
        "operationType":{
            "type":"string",
            "description":"Operation type on the record, can have values CREATED, MODIFIED or REMOVED",
            "example":"MODIFIED"
        },
        "subjectStudySerialNumber":{
            "type":"string",
            "description":"Study-level serial number assigned to the subject",
            "example":"STUDY-0001-001"
        },
        "subjectSiteSerialNumber":{
            "type":"string",
            "description":"Site-level serial number assigned to the subject",
            "example":"SITE-0001-001"
        },
        "versionEnd":{
            "type":"string",
            "description":"End timestamp of the subject version record",
            "format":"date-time",
            "example":"2025-10-16T14:30:31.892Z"
        },
        "previousSubjectNumber":{
            "type":"string",
            "description":"Previous subject number if renumbered or transferred",
            "example":"SUBJECT-0001-OLD"
        },
        "screenFailureDate":{
            "type":"string",
            "description":"Date when the subject was marked as screen failure",
            "format":"date-time",
            "example":"2025-10-16T14:30:31.892Z"
        },
        "lockedStatus":{
            "type":"string",
            "description":"Lock status of the subject,applicable values are LOCKED, UNLOCKED",
            "example":"UNLOCKED"
        },
        "hasLockData":{
            "type":"boolean",
            "description":"Indicates whether lock related data exists for the subject",
            "example":false
        },
        "lockedDateTime":{
            "type":"string",
            "description":"Timestamp when the subject was locked",
            "format":"date-time",
            "example":"2025-10-16T14:30:31.892Z"
        },
        "canBeCompleted":{
            "type":"boolean",
            "description":"Indicates if the subject has met conditions to be completed",
            "example":true
        },
        "lockedInStudyVersion":{
            "type":"string",
            "description":"Study version in which the subject is locked",
            "example":"3.0.0.4"
        },
        "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"
        },
        "sourceTimeStamp":{
            "type":"string",
            "description":"Source system timestamp for the subject payload",
            "format":"date-time",
            "example":"2025-10-16T14:30:31.892Z"
        },
        "screeningNumber":{
            "type":"string",
            "description":"Screening number assigned to the subject",
            "example":"SCR-0001"
        },
        "randomizationNumber":{
            "type":"string",
            "description":"Randomization number assigned to the subject if applicable.",
            "example":"RND-001"
        },
        "withdrawalReason":{
            "type":"string",
            "description":"Reason provided when the subject is withdrawn",
            "example":"Not applicable"
        },
        "ehrLinkStatus":{
            "type":"number",
            "description":"EHR link status code for the subject",
            "example":1
        },
        "withdrawalDate":{
            "type":"string",
            "description":"Date when the subject was withdrawn",
            "format":"date-time",
            "example":"2025-10-16T14:30:31.892Z"
        },
        "studyCompletionDate":{
            "type":"string",
            "description":"Date when the subject completed the study",
            "format":"date-time",
            "example":"2025-10-16T14:30:31.892Z"
        },
        "withdrawalComment":{
            "type":"string",
            "description":"Additional comment provided for withdrawal",
            "example":"Subject breached protocols"
        },
        "screenFailureComment":{
            "type":"string",
            "description":"Additional comment for screen failure",
            "example":"Subject breached protocols"
        }
    },
    "description":"Subject details including screening, randomization, completion status and withdrawal information"
}

Examples

Select an example CreateSubjectResponse

400 Response

Bad request.

Body ()

Root Schema : DcsResponse

Type: object

Show Source

• errorData: object ErrorResponseData
  Title: ErrorResponseData

  Error Response Details Information
• 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

Title: ErrorResponseData

Error Response Details Information

Show Source

• details: object Object
  Title: Object

  Object with error details information.
• errorCode: string
  Error code which is stored in ErrorCode enum. Example : C1-003

  Example: C1-003
• errorMessage: string
  Error message which is stored in service property file. Example : Cannot modify object after a study version has been approved

  Example: Cannot modify object after a study version has been approved

{
    "title":"ErrorResponseData",
    "type":"object",
    "properties":{
        "errorCode":{
            "type":"string",
            "description":"Error code which is stored in ErrorCode enum. Example : C1-003",
            "example":"C1-003"
        },
        "errorMessage":{
            "type":"string",
            "description":"Error message which is stored in service property file. Example : Cannot modify object after a study version has been approved",
            "example":"Cannot modify object after a study version has been approved"
        },
        "details":{
            "title":"Object",
            "type":"object",
            "description":"Object with error details information."
        }
    },
    "description":"Error Response Details Information"
}

Nested Schema : result

Type: object

Nested Schema : Object

Type: object

Title: Object

Object with error details information.

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