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• Request
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V5.0

post

/ec-designer-svc/rest/v5.0/studies/{studyId}/versions/{version}/randomizations

Creates a randomization design in the specified study version. The request defines the randomization details, treatment arms, visits, and settings. The response returns the saved randomization design with its generated identifier and configured details.

Request

Path Parameters

• studyId(required): string(uuid)
  Study ID (UUID, 32-character uppercase hexadecimal string). Required.

  Example:

  F054C951EB74443C93716CA714AB686E

• version(required): string
  Study version path segment. Required. Example: "1.0.0.1".

  Example:

  1.0.0.1

Supported Media Types

• application/json

Request Body - application/json ()

Root Schema : RandomizationDto v5.0

Type: object

Title: RandomizationDto v5.0

Randomization Design Info

Show Source

• arms: array arms
• details(required): object RandomizationDetails v5.0
  Title: RandomizationDetails v5.0

  Details of the randomization design.
• id: string (uuid)
  Randomization GUID
• settings(required): object RandomizationSettings v5.0
  Title: RandomizationSettings v5.0

  The settings for the randomization design.
• versionStart: string (date-time)
  Version Start date

  Example: 2018-11-23T08:43:01.7Z
• visits: array visits

{
    "title":"RandomizationDto v5.0",
    "required":[
        "details",
        "settings"
    ],
    "type":"object",
    "properties":{
        "id":{
            "type":"string",
            "description":"Randomization GUID",
            "format":"uuid"
        },
        "versionStart":{
            "type":"string",
            "description":"Version Start date",
            "format":"date-time",
            "example":"2018-11-23T08:43:01.7Z"
        },
        "details":{
            "$ref":"#/components/schemas/RandomizationDetailsV5"
        },
        "arms":{
            "type":"array",
            "items":{
                "$ref":"#/components/schemas/RandomizationArmV5"
            }
        },
        "visits":{
            "type":"array",
            "items":{
                "$ref":"#/components/schemas/RandomizationVisitV5"
            }
        },
        "settings":{
            "$ref":"#/components/schemas/RandomizationSettingsV5"
        }
    },
    "description":"Randomization Design Info"
}

Nested Schema : arms

Type: array

Show Source

• Array of: object RandomizationArm v5.0
  Title: RandomizationArm v5.0

  Randomization Design Treatment Arm Ratio

{
    "type":"array",
    "items":{
        "$ref":"#/components/schemas/RandomizationArmV5"
    }
}

Nested Schema : RandomizationDetails v5.0

Type: object

Title: RandomizationDetails v5.0

Details of the randomization design.

Show Source

• algorithm(required): string
  Allowed Values: [ "NONE", "CENTRAL", "CENTRAL_STRATIFIED", "SITE_BLOCKED_FIXED", "SITE_BLOCKED_FIXED_STRATIFIED", "SITE_BLOCKED_DYNAMIC", "SITE_BLOCKED_DYNAMIC_STRATIFIED", "COUNTRY_BLOCKED_FIXED", "COUNTRY_BLOCKED_FIXED_STRATIFIED", "COUNTRY_BLOCKED_DYNAMIC", "COUNTRY_BLOCKED_DYNAMIC_STRATIFIED", "REGION_BLOCKED_FIXED", "REGION_BLOCKED_FIXED_STRATIFIED", "REGION_BLOCKED_DYNAMIC", "REGION_BLOCKED_DYNAMIC_STRATIFIED", "MINIMIZATION" ]

  The algorithm of the randomization design

  Example: Central
• cohortType(required): string
  Allowed Values: [ "NoCohort", "Adaptive", "Demography", "invalid" ]

  The cohort type of the randomization design

  Example: None
• description: string
  Minimum Length: 0

  Maximum Length: 4000

  Randomization Design Description

  Example: Method to assign study participants to a treatment group.
• randomizationType(required): string
  Allowed Values: [ "Blinded", "Unblinded", "invalid" ]

  Type of the randomization design

  Example: Blinded
• reRandomization: boolean
  Whether to use re-randomization on the randomization design

  Example: true
• title(required): string
  Minimum Length: 1

  Maximum Length: 64

  Randomization Title

  Example: Rand 001
• treatmentArms: string
  Allowed Values: [ "Randomized", "Mapped", "None", "invalid" ]

  Whether to use randomized or mapped on the randomization design

  Example: Randomized

{
    "title":"RandomizationDetails v5.0",
    "required":[
        "algorithm",
        "cohortType",
        "randomizationType",
        "title"
    ],
    "type":"object",
    "properties":{
        "title":{
            "maxLength":64,
            "minLength":1,
            "type":"string",
            "description":"Randomization Title",
            "example":"Rand 001"
        },
        "description":{
            "maxLength":4000,
            "minLength":0,
            "type":"string",
            "description":"Randomization Design Description",
            "example":"Method to assign study participants to a treatment group."
        },
        "algorithm":{
            "type":"string",
            "description":"The algorithm of the randomization design",
            "example":"Central",
            "enum":[
                "NONE",
                "CENTRAL",
                "CENTRAL_STRATIFIED",
                "SITE_BLOCKED_FIXED",
                "SITE_BLOCKED_FIXED_STRATIFIED",
                "SITE_BLOCKED_DYNAMIC",
                "SITE_BLOCKED_DYNAMIC_STRATIFIED",
                "COUNTRY_BLOCKED_FIXED",
                "COUNTRY_BLOCKED_FIXED_STRATIFIED",
                "COUNTRY_BLOCKED_DYNAMIC",
                "COUNTRY_BLOCKED_DYNAMIC_STRATIFIED",
                "REGION_BLOCKED_FIXED",
                "REGION_BLOCKED_FIXED_STRATIFIED",
                "REGION_BLOCKED_DYNAMIC",
                "REGION_BLOCKED_DYNAMIC_STRATIFIED",
                "MINIMIZATION"
            ]
        },
        "cohortType":{
            "type":"string",
            "description":"The cohort type of the randomization design",
            "example":"None",
            "enum":[
                "NoCohort",
                "Adaptive",
                "Demography",
                "invalid"
            ]
        },
        "randomizationType":{
            "type":"string",
            "description":"Type of the randomization design",
            "example":"Blinded",
            "enum":[
                "Blinded",
                "Unblinded",
                "invalid"
            ]
        },
        "reRandomization":{
            "type":"boolean",
            "description":"Whether to use re-randomization on the randomization design",
            "example":true
        },
        "treatmentArms":{
            "type":"string",
            "description":"Whether to use randomized or mapped on the randomization design",
            "example":"Randomized",
            "enum":[
                "Randomized",
                "Mapped",
                "None",
                "invalid"
            ]
        }
    },
    "description":"Details of the randomization design."
}

Nested Schema : RandomizationSettings v5.0

Type: object

Title: RandomizationSettings v5.0

The settings for the randomization design.

Show Source

• allowOutsideWindow: boolean
  Whether to allow randomization outside schedule window

  Example: false
• assignNewRandomizeNumbers: boolean
  Whether to assign new randomization numbers to all subjects

  Example: false
• assignSkippedRandomizationNumbers: boolean
  Whether to assign skipped randomization numbers

  Example: false
• randomizeLimitsToCountEarlyTerminated: boolean
  Whether limits include withdrawn subjects

  Example: false
• randomizeNumberBlinded: boolean
  Whether to use blinded randomization numbers

  Example: false
• randomizeSubjectsIfSitesOutOfKits: boolean
  Whether to restrict randomization numbers to available kit types

  Example: false

{
    "title":"RandomizationSettings v5.0",
    "type":"object",
    "properties":{
        "randomizeSubjectsIfSitesOutOfKits":{
            "type":"boolean",
            "description":"Whether to restrict randomization numbers to available kit types",
            "example":false
        },
        "assignSkippedRandomizationNumbers":{
            "type":"boolean",
            "description":"Whether to assign skipped randomization numbers",
            "example":false
        },
        "randomizeNumberBlinded":{
            "type":"boolean",
            "description":"Whether to use blinded randomization numbers",
            "example":false
        },
        "randomizeLimitsToCountEarlyTerminated":{
            "type":"boolean",
            "description":"Whether limits include withdrawn subjects",
            "example":false
        },
        "assignNewRandomizeNumbers":{
            "type":"boolean",
            "description":"Whether to assign new randomization numbers to all subjects",
            "example":false
        },
        "allowOutsideWindow":{
            "type":"boolean",
            "description":"Whether to allow randomization outside schedule window",
            "example":false
        }
    },
    "description":"The settings for the randomization design."
}

Nested Schema : visits

Type: array

Show Source

• Array of: object RandomizationVisit v5.0
  Title: RandomizationVisit v5.0

  Randomization Visit

{
    "type":"array",
    "items":{
        "$ref":"#/components/schemas/RandomizationVisitV5"
    }
}

Nested Schema : RandomizationArm v5.0

Type: object

Title: RandomizationArm v5.0

Randomization Design Treatment Arm Ratio

Show Source

• id(required): string (uuid)
  Treatment Arm GUID
• name: string
  Treatment Arm Name

  Example: Arm1
• ratio(required): integer (int32)
  Minimum Value: 1

  Maximum Value: 99

  Allowed Values: [ null ]

  The ratio defined for the treatment arm

  Example: 2

{
    "title":"RandomizationArm v5.0",
    "required":[
        "id",
        "ratio"
    ],
    "type":"object",
    "properties":{
        "id":{
            "type":"string",
            "description":"Treatment Arm GUID",
            "format":"uuid"
        },
        "name":{
            "type":"string",
            "description":"Treatment Arm Name",
            "example":"Arm1"
        },
        "ratio":{
            "maximum":99,
            "minimum":1,
            "type":"integer",
            "description":"The ratio defined for the treatment arm",
            "format":"int32",
            "example":2,
            "enum":[
                null
            ]
        }
    },
    "description":"Randomization Design Treatment Arm Ratio"
}

Nested Schema : RandomizationVisit v5.0

Type: object

Title: RandomizationVisit v5.0

Randomization Visit

Show Source

• branchId: string (uuid)
  The id of the branch
• visitId(required): string (uuid)
  Visit GUID
• visitName: string
  Visit name

  Example: Week 3

{
    "title":"RandomizationVisit v5.0",
    "required":[
        "visitId"
    ],
    "type":"object",
    "properties":{
        "visitId":{
            "type":"string",
            "description":"Visit GUID",
            "format":"uuid"
        },
        "visitName":{
            "type":"string",
            "description":"Visit name",
            "example":"Week 3"
        },
        "branchId":{
            "type":"string",
            "description":"The id of the branch",
            "format":"uuid"
        }
    },
    "description":"Randomization Visit"
}

Examples

Select an example requestExample

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Response

Supported Media Types

• application/json

200 Response

Successful operation.

Body ()

Root Schema : RandomizationDto v5.0

Type: object

Title: RandomizationDto v5.0

Randomization Design Info

Show Source

• arms: array arms
• details(required): object RandomizationDetails v5.0
  Title: RandomizationDetails v5.0

  Details of the randomization design.
• id: string (uuid)
  Randomization GUID
• settings(required): object RandomizationSettings v5.0
  Title: RandomizationSettings v5.0

  The settings for the randomization design.
• versionStart: string (date-time)
  Version Start date

  Example: 2018-11-23T08:43:01.7Z
• visits: array visits

{
    "title":"RandomizationDto v5.0",
    "required":[
        "details",
        "settings"
    ],
    "type":"object",
    "properties":{
        "id":{
            "type":"string",
            "description":"Randomization GUID",
            "format":"uuid"
        },
        "versionStart":{
            "type":"string",
            "description":"Version Start date",
            "format":"date-time",
            "example":"2018-11-23T08:43:01.7Z"
        },
        "details":{
            "$ref":"#/components/schemas/RandomizationDetailsV5"
        },
        "arms":{
            "type":"array",
            "items":{
                "$ref":"#/components/schemas/RandomizationArmV5"
            }
        },
        "visits":{
            "type":"array",
            "items":{
                "$ref":"#/components/schemas/RandomizationVisitV5"
            }
        },
        "settings":{
            "$ref":"#/components/schemas/RandomizationSettingsV5"
        }
    },
    "description":"Randomization Design Info"
}

Nested Schema : arms

Type: array

Show Source

• Array of: object RandomizationArm v5.0
  Title: RandomizationArm v5.0

  Randomization Design Treatment Arm Ratio

{
    "type":"array",
    "items":{
        "$ref":"#/components/schemas/RandomizationArmV5"
    }
}

Nested Schema : RandomizationDetails v5.0

Type: object

Title: RandomizationDetails v5.0

Details of the randomization design.

Show Source

• algorithm(required): string
  Allowed Values: [ "NONE", "CENTRAL", "CENTRAL_STRATIFIED", "SITE_BLOCKED_FIXED", "SITE_BLOCKED_FIXED_STRATIFIED", "SITE_BLOCKED_DYNAMIC", "SITE_BLOCKED_DYNAMIC_STRATIFIED", "COUNTRY_BLOCKED_FIXED", "COUNTRY_BLOCKED_FIXED_STRATIFIED", "COUNTRY_BLOCKED_DYNAMIC", "COUNTRY_BLOCKED_DYNAMIC_STRATIFIED", "REGION_BLOCKED_FIXED", "REGION_BLOCKED_FIXED_STRATIFIED", "REGION_BLOCKED_DYNAMIC", "REGION_BLOCKED_DYNAMIC_STRATIFIED", "MINIMIZATION" ]

  The algorithm of the randomization design

  Example: Central
• cohortType(required): string
  Allowed Values: [ "NoCohort", "Adaptive", "Demography", "invalid" ]

  The cohort type of the randomization design

  Example: None
• description: string
  Minimum Length: 0

  Maximum Length: 4000

  Randomization Design Description

  Example: Method to assign study participants to a treatment group.
• randomizationType(required): string
  Allowed Values: [ "Blinded", "Unblinded", "invalid" ]

  Type of the randomization design

  Example: Blinded
• reRandomization: boolean
  Whether to use re-randomization on the randomization design

  Example: true
• title(required): string
  Minimum Length: 1

  Maximum Length: 64

  Randomization Title

  Example: Rand 001
• treatmentArms: string
  Allowed Values: [ "Randomized", "Mapped", "None", "invalid" ]

  Whether to use randomized or mapped on the randomization design

  Example: Randomized

{
    "title":"RandomizationDetails v5.0",
    "required":[
        "algorithm",
        "cohortType",
        "randomizationType",
        "title"
    ],
    "type":"object",
    "properties":{
        "title":{
            "maxLength":64,
            "minLength":1,
            "type":"string",
            "description":"Randomization Title",
            "example":"Rand 001"
        },
        "description":{
            "maxLength":4000,
            "minLength":0,
            "type":"string",
            "description":"Randomization Design Description",
            "example":"Method to assign study participants to a treatment group."
        },
        "algorithm":{
            "type":"string",
            "description":"The algorithm of the randomization design",
            "example":"Central",
            "enum":[
                "NONE",
                "CENTRAL",
                "CENTRAL_STRATIFIED",
                "SITE_BLOCKED_FIXED",
                "SITE_BLOCKED_FIXED_STRATIFIED",
                "SITE_BLOCKED_DYNAMIC",
                "SITE_BLOCKED_DYNAMIC_STRATIFIED",
                "COUNTRY_BLOCKED_FIXED",
                "COUNTRY_BLOCKED_FIXED_STRATIFIED",
                "COUNTRY_BLOCKED_DYNAMIC",
                "COUNTRY_BLOCKED_DYNAMIC_STRATIFIED",
                "REGION_BLOCKED_FIXED",
                "REGION_BLOCKED_FIXED_STRATIFIED",
                "REGION_BLOCKED_DYNAMIC",
                "REGION_BLOCKED_DYNAMIC_STRATIFIED",
                "MINIMIZATION"
            ]
        },
        "cohortType":{
            "type":"string",
            "description":"The cohort type of the randomization design",
            "example":"None",
            "enum":[
                "NoCohort",
                "Adaptive",
                "Demography",
                "invalid"
            ]
        },
        "randomizationType":{
            "type":"string",
            "description":"Type of the randomization design",
            "example":"Blinded",
            "enum":[
                "Blinded",
                "Unblinded",
                "invalid"
            ]
        },
        "reRandomization":{
            "type":"boolean",
            "description":"Whether to use re-randomization on the randomization design",
            "example":true
        },
        "treatmentArms":{
            "type":"string",
            "description":"Whether to use randomized or mapped on the randomization design",
            "example":"Randomized",
            "enum":[
                "Randomized",
                "Mapped",
                "None",
                "invalid"
            ]
        }
    },
    "description":"Details of the randomization design."
}

Nested Schema : RandomizationSettings v5.0

Type: object

Title: RandomizationSettings v5.0

The settings for the randomization design.

Show Source

• allowOutsideWindow: boolean
  Whether to allow randomization outside schedule window

  Example: false
• assignNewRandomizeNumbers: boolean
  Whether to assign new randomization numbers to all subjects

  Example: false
• assignSkippedRandomizationNumbers: boolean
  Whether to assign skipped randomization numbers

  Example: false
• randomizeLimitsToCountEarlyTerminated: boolean
  Whether limits include withdrawn subjects

  Example: false
• randomizeNumberBlinded: boolean
  Whether to use blinded randomization numbers

  Example: false
• randomizeSubjectsIfSitesOutOfKits: boolean
  Whether to restrict randomization numbers to available kit types

  Example: false

{
    "title":"RandomizationSettings v5.0",
    "type":"object",
    "properties":{
        "randomizeSubjectsIfSitesOutOfKits":{
            "type":"boolean",
            "description":"Whether to restrict randomization numbers to available kit types",
            "example":false
        },
        "assignSkippedRandomizationNumbers":{
            "type":"boolean",
            "description":"Whether to assign skipped randomization numbers",
            "example":false
        },
        "randomizeNumberBlinded":{
            "type":"boolean",
            "description":"Whether to use blinded randomization numbers",
            "example":false
        },
        "randomizeLimitsToCountEarlyTerminated":{
            "type":"boolean",
            "description":"Whether limits include withdrawn subjects",
            "example":false
        },
        "assignNewRandomizeNumbers":{
            "type":"boolean",
            "description":"Whether to assign new randomization numbers to all subjects",
            "example":false
        },
        "allowOutsideWindow":{
            "type":"boolean",
            "description":"Whether to allow randomization outside schedule window",
            "example":false
        }
    },
    "description":"The settings for the randomization design."
}

Nested Schema : visits

Type: array

Show Source

• Array of: object RandomizationVisit v5.0
  Title: RandomizationVisit v5.0

  Randomization Visit

{
    "type":"array",
    "items":{
        "$ref":"#/components/schemas/RandomizationVisitV5"
    }
}

Nested Schema : RandomizationArm v5.0

Type: object

Title: RandomizationArm v5.0

Randomization Design Treatment Arm Ratio

Show Source

• id(required): string (uuid)
  Treatment Arm GUID
• name: string
  Treatment Arm Name

  Example: Arm1
• ratio(required): integer (int32)
  Minimum Value: 1

  Maximum Value: 99

  Allowed Values: [ null ]

  The ratio defined for the treatment arm

  Example: 2

{
    "title":"RandomizationArm v5.0",
    "required":[
        "id",
        "ratio"
    ],
    "type":"object",
    "properties":{
        "id":{
            "type":"string",
            "description":"Treatment Arm GUID",
            "format":"uuid"
        },
        "name":{
            "type":"string",
            "description":"Treatment Arm Name",
            "example":"Arm1"
        },
        "ratio":{
            "maximum":99,
            "minimum":1,
            "type":"integer",
            "description":"The ratio defined for the treatment arm",
            "format":"int32",
            "example":2,
            "enum":[
                null
            ]
        }
    },
    "description":"Randomization Design Treatment Arm Ratio"
}

Nested Schema : RandomizationVisit v5.0

Type: object

Title: RandomizationVisit v5.0

Randomization Visit

Show Source

• branchId: string (uuid)
  The id of the branch
• visitId(required): string (uuid)
  Visit GUID
• visitName: string
  Visit name

  Example: Week 3

{
    "title":"RandomizationVisit v5.0",
    "required":[
        "visitId"
    ],
    "type":"object",
    "properties":{
        "visitId":{
            "type":"string",
            "description":"Visit GUID",
            "format":"uuid"
        },
        "visitName":{
            "type":"string",
            "description":"Visit name",
            "example":"Week 3"
        },
        "branchId":{
            "type":"string",
            "description":"The id of the branch",
            "format":"uuid"
        }
    },
    "description":"Randomization Visit"
}

Examples

Select an example successResponse

500 Response

Returned when the request cannot be completed due to validation failure, authorization failure, or an unexpected server-side condition.

Body ()

Root 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.",
            "example":{
                "field":"studyId",
                "reason":"Invalid value"
            }
        }
    },
    "description":"Error Response Details Information"
}

Nested Schema : Object

Type: object

Title: Object

Object with error details information.

Example:

{
    "field":"studyId",
    "reason":"Invalid value"
}

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