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V6.0

post

/ec-designer-ors-svc/rest/v6.0/studies/{studyId}/versions/{version}/randomizations

Creates a new randomization design in a study version.

Request

Path Parameters

• studyId(required): string(uuid)
  Study unique identifier.
• version(required): string
  Study version identifier.

Supported Media Types

• application/json

Request Body - application/json ()

Root Schema : schema

Type: object

Randomization design payload used by the v6 create and update randomization endpoints.

Show Source

• arms: array arms
  Treatment arms configured for the randomization design.
• details: object RandomizationDetailsV6Doc
  Details for the randomization design.
• id: string (uuid)
  Minimum Length: 32

  Maximum Length: 32

  Randomization unique identifier.
• settings: object RandomizationSettingsV6Doc
  Settings that control randomization number handling and visit-window behavior.
• versionStart: string (date-time)
  Minimum Length: 20

  Maximum Length: 40

  Version start timestamp for the randomization design.

  Example: 2025-01-17T15:41:10.733Z
• visits: array visits
  Visits that participate in randomization.

{
    "type":"object",
    "properties":{
        "id":{
            "maxLength":32,
            "minLength":32,
            "type":"string",
            "description":"Randomization unique identifier.",
            "format":"uuid"
        },
        "versionStart":{
            "maxLength":40,
            "minLength":20,
            "type":"string",
            "description":"Version start timestamp for the randomization design.",
            "format":"date-time",
            "example":"2025-01-17T15:41:10.733Z"
        },
        "details":{
            "$ref":"#/components/schemas/RandomizationDetailsV6Doc"
        },
        "arms":{
            "type":"array",
            "description":"Treatment arms configured for the randomization design.",
            "example":[
                {
                    "id":"C1B8327AFAA6412287106192AB5984EF",
                    "name":"Arm A",
                    "ratio":2
                }
            ],
            "items":{
                "$ref":"#/components/schemas/RandomizationArmV6Doc"
            }
        },
        "visits":{
            "type":"array",
            "description":"Visits that participate in randomization.",
            "example":[
                {
                    "visitId":"E1B8327AFAA6412287106192AB5984EF",
                    "visitName":"Week 1",
                    "branchId":"F1B8327AFAA6412287106192AB5984EF"
                }
            ],
            "items":{
                "$ref":"#/components/schemas/RandomizationVisitV6Doc"
            }
        },
        "settings":{
            "$ref":"#/components/schemas/RandomizationSettingsV6Doc"
        }
    },
    "description":"Randomization design payload used by the v6 create and update randomization endpoints."
}

Nested Schema : arms

Type: array

Treatment arms configured for the randomization design.

Show Source

• Array of: object RandomizationArmV6Doc
  Treatment arm ratio configured for the randomization design.

{
    "type":"array",
    "description":"Treatment arms configured for the randomization design.",
    "example":[
        {
            "id":"C1B8327AFAA6412287106192AB5984EF",
            "name":"Arm A",
            "ratio":2
        }
    ],
    "items":{
        "$ref":"#/components/schemas/RandomizationArmV6Doc"
    }
}

Example:

[
    {
        "id":"C1B8327AFAA6412287106192AB5984EF",
        "name":"Arm A",
        "ratio":2
    }
]

Nested Schema : RandomizationDetailsV6Doc

Type: object

Details for the randomization design.

Show Source

• algorithm: string
  Minimum Length: 4

  Maximum Length: 31

  Allowed Values: [ "None", "Central", "CentralStratified", "SiteBlockedFixed", "SiteBlockedFixedStratified", "SiteBlockedDynamic", "SiteBlockedDynamicStratified", "CountryBlockedFixed", "CountryBlockedFixedStratified", "CountryBlockedDynamic", "CountryBlockedDynamicStratified", "RegionBlockedFixed", "RegionBlockedFixedStratified", "RegionBlockedDynamic", "RegionBlockedDynamicStratified", "Minimization" ]

  Randomization algorithm. Allowed values: None = no randomization algorithm configured, Central = centrally managed randomization without stratification, CentralStratified = central stratified randomization, SiteBlockedFixed = site-blocked fixed randomization, SiteBlockedFixedStratified = site-blocked fixed stratified randomization, SiteBlockedDynamic = site-blocked dynamic randomization, SiteBlockedDynamicStratified = site-blocked dynamic stratified randomization, CountryBlockedFixed = country-blocked fixed randomization, CountryBlockedFixedStratified = country-blocked fixed stratified randomization, CountryBlockedDynamic = country-blocked dynamic randomization, CountryBlockedDynamicStratified = country-blocked dynamic stratified randomization, RegionBlockedFixed = region-blocked fixed randomization, RegionBlockedFixedStratified = region-blocked fixed stratified randomization, RegionBlockedDynamic = region-blocked dynamic randomization, RegionBlockedDynamicStratified = region-blocked dynamic stratified randomization, Minimization = minimization algorithm.

  Example: Central
• cohortType: string
  Minimum Length: 7

  Maximum Length: 10

  Allowed Values: [ "NoCohort", "Adaptive", "Demography", "invalid" ]

  Cohort behavior for the randomization design. Allowed values: NoCohort = no cohorting is applied, Adaptive = adaptive cohorts are used, Demography = demographic cohorts are used, invalid = unrecognized persisted value.

  Example: NoCohort
• description: string
  Minimum Length: 1

  Maximum Length: 4000

  Randomization design description.

  Example: Method to assign study participants to a treatment group.
• randomizationType: string
  Minimum Length: 7

  Maximum Length: 9

  Allowed Values: [ "Blinded", "Unblinded", "invalid" ]

  Randomization blinding type. Allowed values: Blinded = subject assignments remain blinded, Unblinded = subject assignments are visible, invalid = unrecognized persisted value.

  Example: Blinded
• reRandomization: boolean
  Indicates whether re-randomization is enabled.

  Example: true
• title: string
  Minimum Length: 1

  Maximum Length: 64

  Randomization title.

  Example: Rand 001
• treatmentArms: string
  Minimum Length: 4

  Maximum Length: 10

  Allowed Values: [ "Randomized", "Mapped", "None", "invalid" ]

  Treatment arm assignment mode. Allowed values: Randomized = arms are assigned by the randomization algorithm, Mapped = arms are mapped explicitly, None = no treatment arms are configured, invalid = unrecognized persisted value.

  Example: Randomized

{
    "type":"object",
    "properties":{
        "title":{
            "maxLength":64,
            "minLength":1,
            "type":"string",
            "description":"Randomization title.",
            "example":"Rand 001"
        },
        "description":{
            "maxLength":4000,
            "minLength":1,
            "type":"string",
            "description":"Randomization design description.",
            "example":"Method to assign study participants to a treatment group."
        },
        "algorithm":{
            "maxLength":31,
            "minLength":4,
            "type":"string",
            "description":"Randomization algorithm. Allowed values: None = no randomization algorithm configured, Central = centrally managed randomization without stratification, CentralStratified = central stratified randomization, SiteBlockedFixed = site-blocked fixed randomization, SiteBlockedFixedStratified = site-blocked fixed stratified randomization, SiteBlockedDynamic = site-blocked dynamic randomization, SiteBlockedDynamicStratified = site-blocked dynamic stratified randomization, CountryBlockedFixed = country-blocked fixed randomization, CountryBlockedFixedStratified = country-blocked fixed stratified randomization, CountryBlockedDynamic = country-blocked dynamic randomization, CountryBlockedDynamicStratified = country-blocked dynamic stratified randomization, RegionBlockedFixed = region-blocked fixed randomization, RegionBlockedFixedStratified = region-blocked fixed stratified randomization, RegionBlockedDynamic = region-blocked dynamic randomization, RegionBlockedDynamicStratified = region-blocked dynamic stratified randomization, Minimization = minimization algorithm.",
            "example":"Central",
            "enum":[
                "None",
                "Central",
                "CentralStratified",
                "SiteBlockedFixed",
                "SiteBlockedFixedStratified",
                "SiteBlockedDynamic",
                "SiteBlockedDynamicStratified",
                "CountryBlockedFixed",
                "CountryBlockedFixedStratified",
                "CountryBlockedDynamic",
                "CountryBlockedDynamicStratified",
                "RegionBlockedFixed",
                "RegionBlockedFixedStratified",
                "RegionBlockedDynamic",
                "RegionBlockedDynamicStratified",
                "Minimization"
            ]
        },
        "cohortType":{
            "maxLength":10,
            "minLength":7,
            "type":"string",
            "description":"Cohort behavior for the randomization design. Allowed values: NoCohort = no cohorting is applied, Adaptive = adaptive cohorts are used, Demography = demographic cohorts are used, invalid = unrecognized persisted value.",
            "example":"NoCohort",
            "enum":[
                "NoCohort",
                "Adaptive",
                "Demography",
                "invalid"
            ]
        },
        "randomizationType":{
            "maxLength":9,
            "minLength":7,
            "type":"string",
            "description":"Randomization blinding type. Allowed values: Blinded = subject assignments remain blinded, Unblinded = subject assignments are visible, invalid = unrecognized persisted value.",
            "example":"Blinded",
            "enum":[
                "Blinded",
                "Unblinded",
                "invalid"
            ]
        },
        "reRandomization":{
            "type":"boolean",
            "description":"Indicates whether re-randomization is enabled.",
            "example":true
        },
        "treatmentArms":{
            "maxLength":10,
            "minLength":4,
            "type":"string",
            "description":"Treatment arm assignment mode. Allowed values: Randomized = arms are assigned by the randomization algorithm, Mapped = arms are mapped explicitly, None = no treatment arms are configured, invalid = unrecognized persisted value.",
            "example":"Randomized",
            "enum":[
                "Randomized",
                "Mapped",
                "None",
                "invalid"
            ]
        }
    },
    "description":"Details for the randomization design.",
    "example":{
        "title":"Rand 001",
        "description":"Method to assign study participants to a treatment group.",
        "algorithm":"Central",
        "cohortType":"NoCohort",
        "randomizationType":"Blinded",
        "reRandomization":true,
        "treatmentArms":"Randomized"
    }
}

Example:

{
    "title":"Rand 001",
    "description":"Method to assign study participants to a treatment group.",
    "algorithm":"Central",
    "cohortType":"NoCohort",
    "randomizationType":"Blinded",
    "reRandomization":true,
    "treatmentArms":"Randomized"
}

Nested Schema : RandomizationSettingsV6Doc

Type: object

Settings that control randomization number handling and visit-window behavior.

Show Source

• allowOutsideWindow: boolean
  Indicates whether randomization is allowed outside the schedule window.

  Example: false
• assignNewRandomizeNumbers: boolean
  Indicates whether new randomization numbers are assigned to all subjects.

  Example: true
• assignSkippedRandomizationNumbers: boolean
  Indicates whether skipped randomization numbers should be assigned.

  Example: false
• randomizeLimitsToCountEarlyTerminated: boolean
  Indicates whether early terminated subjects count toward randomization limits.

  Example: false
• randomizeNumberBlinded: boolean
  Indicates whether randomization numbers are blinded.

  Example: true
• randomizeSubjectsIfSitesOutOfKits: boolean
  Indicates whether randomization should continue when sites are out of kits.

  Example: false

{
    "type":"object",
    "properties":{
        "randomizeSubjectsIfSitesOutOfKits":{
            "type":"boolean",
            "description":"Indicates whether randomization should continue when sites are out of kits.",
            "example":false
        },
        "assignSkippedRandomizationNumbers":{
            "type":"boolean",
            "description":"Indicates whether skipped randomization numbers should be assigned.",
            "example":false
        },
        "randomizeNumberBlinded":{
            "type":"boolean",
            "description":"Indicates whether randomization numbers are blinded.",
            "example":true
        },
        "randomizeLimitsToCountEarlyTerminated":{
            "type":"boolean",
            "description":"Indicates whether early terminated subjects count toward randomization limits.",
            "example":false
        },
        "assignNewRandomizeNumbers":{
            "type":"boolean",
            "description":"Indicates whether new randomization numbers are assigned to all subjects.",
            "example":true
        },
        "allowOutsideWindow":{
            "type":"boolean",
            "description":"Indicates whether randomization is allowed outside the schedule window.",
            "example":false
        }
    },
    "description":"Settings that control randomization number handling and visit-window behavior.",
    "example":{
        "randomizeSubjectsIfSitesOutOfKits":false,
        "assignSkippedRandomizationNumbers":false,
        "randomizeNumberBlinded":true,
        "randomizeLimitsToCountEarlyTerminated":false,
        "assignNewRandomizeNumbers":true,
        "allowOutsideWindow":false
    }
}

Example:

{
    "randomizeSubjectsIfSitesOutOfKits":false,
    "assignSkippedRandomizationNumbers":false,
    "randomizeNumberBlinded":true,
    "randomizeLimitsToCountEarlyTerminated":false,
    "assignNewRandomizeNumbers":true,
    "allowOutsideWindow":false
}

Nested Schema : visits

Type: array

Visits that participate in randomization.

Show Source

• Array of: object RandomizationVisitV6Doc
  Visit included in the randomization design.

{
    "type":"array",
    "description":"Visits that participate in randomization.",
    "example":[
        {
            "visitId":"E1B8327AFAA6412287106192AB5984EF",
            "visitName":"Week 1",
            "branchId":"F1B8327AFAA6412287106192AB5984EF"
        }
    ],
    "items":{
        "$ref":"#/components/schemas/RandomizationVisitV6Doc"
    }
}

Example:

[
    {
        "visitId":"E1B8327AFAA6412287106192AB5984EF",
        "visitName":"Week 1",
        "branchId":"F1B8327AFAA6412287106192AB5984EF"
    }
]

Nested Schema : RandomizationArmV6Doc

Type: object

Treatment arm ratio configured for the randomization design.

Show Source

• id: string (uuid)
  Minimum Length: 32

  Maximum Length: 32

  Treatment arm unique identifier.
• name: string
  Minimum Length: 1

  Maximum Length: 64

  Treatment arm name.

  Example: Arm A
• ratio: integer (int32)
  Minimum Value: 1

  Maximum Value: 99

  Treatment arm allocation ratio. Allowed numeric range is 1 through 99. Zero and negative values are not allowed.

  Example: 2

{
    "type":"object",
    "properties":{
        "id":{
            "maxLength":32,
            "minLength":32,
            "type":"string",
            "description":"Treatment arm unique identifier.",
            "format":"uuid"
        },
        "name":{
            "maxLength":64,
            "minLength":1,
            "type":"string",
            "description":"Treatment arm name.",
            "example":"Arm A"
        },
        "ratio":{
            "maximum":99,
            "minimum":1,
            "type":"integer",
            "description":"Treatment arm allocation ratio. Allowed numeric range is 1 through 99. Zero and negative values are not allowed.",
            "format":"int32",
            "example":2
        }
    },
    "description":"Treatment arm ratio configured for the randomization design."
}

Nested Schema : RandomizationVisitV6Doc

Type: object

Visit included in the randomization design.

Show Source

• branchId: string (uuid)
  Minimum Length: 32

  Maximum Length: 32

  Branch unique identifier for the visit path.
• visitId: string (uuid)
  Minimum Length: 32

  Maximum Length: 32

  Visit unique identifier.
• visitName: string
  Minimum Length: 1

  Maximum Length: 64

  Visit name.

  Example: Week 1

{
    "type":"object",
    "properties":{
        "visitId":{
            "maxLength":32,
            "minLength":32,
            "type":"string",
            "description":"Visit unique identifier.",
            "format":"uuid"
        },
        "visitName":{
            "maxLength":64,
            "minLength":1,
            "type":"string",
            "description":"Visit name.",
            "example":"Week 1"
        },
        "branchId":{
            "maxLength":32,
            "minLength":32,
            "type":"string",
            "description":"Branch unique identifier for the visit path.",
            "format":"uuid"
        }
    },
    "description":"Visit included in the randomization design."
}

Examples

Select an example AddRandomizationRequest

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Response

Supported Media Types

• application/json

200 Response

Successful operation.

Body ()

Root Schema : RandomizationResponseV6

Type: object

Designer response envelope returned by the v6 randomization create and update endpoints.

Show Source

• errorData: object RandomizationErrorV6
  Error payload returned by the v6 randomization endpoints.
• result: object schema
  Randomization design payload used by the v6 create and update randomization endpoints.
• status: string
  Minimum Length: 7

  Maximum Length: 7

  Allowed Values: [ "success" ]

  Envelope status returned by the endpoint. Allowed value: success.

  Example: success
• version: integer (int32)
  Minimum Value: 1

  Envelope version for the shared Designer response wrapper.

  Example: 1

{
    "type":"object",
    "properties":{
        "status":{
            "maxLength":7,
            "minLength":7,
            "type":"string",
            "description":"Envelope status returned by the endpoint. Allowed value: success.",
            "example":"success",
            "enum":[
                "success"
            ]
        },
        "result":{
            "$ref":"#/components/schemas/RandomizationPayloadV6"
        },
        "errorData":{
            "$ref":"#/components/schemas/RandomizationErrorV6"
        },
        "version":{
            "minimum":1,
            "type":"integer",
            "description":"Envelope version for the shared Designer response wrapper.",
            "format":"int32",
            "example":1
        }
    },
    "description":"Designer response envelope returned by the v6 randomization create and update endpoints."
}

Nested Schema : RandomizationErrorV6

Type: object

Error payload returned by the v6 randomization endpoints.

Show Source

• details: object details
  Request-specific error details object.
• errorCode: string
  Minimum Length: 1

  Maximum Length: 32

  Application error code.

  Example: C1-400
• errorMessage: string
  Minimum Length: 1

  Maximum Length: 1024

  Human-readable error message.

  Example: Randomization details are invalid

{
    "type":"object",
    "properties":{
        "errorCode":{
            "maxLength":32,
            "minLength":1,
            "type":"string",
            "description":"Application error code.",
            "example":"C1-400"
        },
        "errorMessage":{
            "maxLength":1024,
            "minLength":1,
            "type":"string",
            "description":"Human-readable error message.",
            "example":"Randomization details are invalid"
        },
        "details":{
            "type":"object",
            "description":"Request-specific error details object.",
            "example":{
                "field":"details.title",
                "message":"must not be blank"
            }
        }
    },
    "description":"Error payload returned by the v6 randomization endpoints.",
    "nullable":true,
    "example":{
        "errorCode":"C1-400",
        "errorMessage":"Randomization details are invalid",
        "details":{
            "field":"details.title",
            "message":"must not be blank"
        }
    }
}

Example:

{
    "errorCode":"C1-400",
    "errorMessage":"Randomization details are invalid",
    "details":{
        "field":"details.title",
        "message":"must not be blank"
    }
}

Nested Schema : schema

Type: object

Randomization design payload used by the v6 create and update randomization endpoints.

Show Source

• arms: array arms
  Treatment arms configured for the randomization design.
• details: object RandomizationDetailsV6Doc
  Details for the randomization design.
• id: string (uuid)
  Minimum Length: 32

  Maximum Length: 32

  Randomization unique identifier.
• settings: object RandomizationSettingsV6Doc
  Settings that control randomization number handling and visit-window behavior.
• versionStart: string (date-time)
  Minimum Length: 20

  Maximum Length: 40

  Version start timestamp for the randomization design.

  Example: 2025-01-17T15:41:10.733Z
• visits: array visits
  Visits that participate in randomization.

{
    "type":"object",
    "properties":{
        "id":{
            "maxLength":32,
            "minLength":32,
            "type":"string",
            "description":"Randomization unique identifier.",
            "format":"uuid"
        },
        "versionStart":{
            "maxLength":40,
            "minLength":20,
            "type":"string",
            "description":"Version start timestamp for the randomization design.",
            "format":"date-time",
            "example":"2025-01-17T15:41:10.733Z"
        },
        "details":{
            "$ref":"#/components/schemas/RandomizationDetailsV6Doc"
        },
        "arms":{
            "type":"array",
            "description":"Treatment arms configured for the randomization design.",
            "example":[
                {
                    "id":"C1B8327AFAA6412287106192AB5984EF",
                    "name":"Arm A",
                    "ratio":2
                }
            ],
            "items":{
                "$ref":"#/components/schemas/RandomizationArmV6Doc"
            }
        },
        "visits":{
            "type":"array",
            "description":"Visits that participate in randomization.",
            "example":[
                {
                    "visitId":"E1B8327AFAA6412287106192AB5984EF",
                    "visitName":"Week 1",
                    "branchId":"F1B8327AFAA6412287106192AB5984EF"
                }
            ],
            "items":{
                "$ref":"#/components/schemas/RandomizationVisitV6Doc"
            }
        },
        "settings":{
            "$ref":"#/components/schemas/RandomizationSettingsV6Doc"
        }
    },
    "description":"Randomization design payload used by the v6 create and update randomization endpoints."
}

Nested Schema : details

Type: object

Request-specific error details object.

Example:

{
    "field":"details.title",
    "message":"must not be blank"
}

Nested Schema : arms

Type: array

Treatment arms configured for the randomization design.

Show Source

• Array of: object RandomizationArmV6Doc
  Treatment arm ratio configured for the randomization design.

{
    "type":"array",
    "description":"Treatment arms configured for the randomization design.",
    "example":[
        {
            "id":"C1B8327AFAA6412287106192AB5984EF",
            "name":"Arm A",
            "ratio":2
        }
    ],
    "items":{
        "$ref":"#/components/schemas/RandomizationArmV6Doc"
    }
}

Example:

[
    {
        "id":"C1B8327AFAA6412287106192AB5984EF",
        "name":"Arm A",
        "ratio":2
    }
]

Nested Schema : RandomizationDetailsV6Doc

Type: object

Details for the randomization design.

Show Source

• algorithm: string
  Minimum Length: 4

  Maximum Length: 31

  Allowed Values: [ "None", "Central", "CentralStratified", "SiteBlockedFixed", "SiteBlockedFixedStratified", "SiteBlockedDynamic", "SiteBlockedDynamicStratified", "CountryBlockedFixed", "CountryBlockedFixedStratified", "CountryBlockedDynamic", "CountryBlockedDynamicStratified", "RegionBlockedFixed", "RegionBlockedFixedStratified", "RegionBlockedDynamic", "RegionBlockedDynamicStratified", "Minimization" ]

  Randomization algorithm. Allowed values: None = no randomization algorithm configured, Central = centrally managed randomization without stratification, CentralStratified = central stratified randomization, SiteBlockedFixed = site-blocked fixed randomization, SiteBlockedFixedStratified = site-blocked fixed stratified randomization, SiteBlockedDynamic = site-blocked dynamic randomization, SiteBlockedDynamicStratified = site-blocked dynamic stratified randomization, CountryBlockedFixed = country-blocked fixed randomization, CountryBlockedFixedStratified = country-blocked fixed stratified randomization, CountryBlockedDynamic = country-blocked dynamic randomization, CountryBlockedDynamicStratified = country-blocked dynamic stratified randomization, RegionBlockedFixed = region-blocked fixed randomization, RegionBlockedFixedStratified = region-blocked fixed stratified randomization, RegionBlockedDynamic = region-blocked dynamic randomization, RegionBlockedDynamicStratified = region-blocked dynamic stratified randomization, Minimization = minimization algorithm.

  Example: Central
• cohortType: string
  Minimum Length: 7

  Maximum Length: 10

  Allowed Values: [ "NoCohort", "Adaptive", "Demography", "invalid" ]

  Cohort behavior for the randomization design. Allowed values: NoCohort = no cohorting is applied, Adaptive = adaptive cohorts are used, Demography = demographic cohorts are used, invalid = unrecognized persisted value.

  Example: NoCohort
• description: string
  Minimum Length: 1

  Maximum Length: 4000

  Randomization design description.

  Example: Method to assign study participants to a treatment group.
• randomizationType: string
  Minimum Length: 7

  Maximum Length: 9

  Allowed Values: [ "Blinded", "Unblinded", "invalid" ]

  Randomization blinding type. Allowed values: Blinded = subject assignments remain blinded, Unblinded = subject assignments are visible, invalid = unrecognized persisted value.

  Example: Blinded
• reRandomization: boolean
  Indicates whether re-randomization is enabled.

  Example: true
• title: string
  Minimum Length: 1

  Maximum Length: 64

  Randomization title.

  Example: Rand 001
• treatmentArms: string
  Minimum Length: 4

  Maximum Length: 10

  Allowed Values: [ "Randomized", "Mapped", "None", "invalid" ]

  Treatment arm assignment mode. Allowed values: Randomized = arms are assigned by the randomization algorithm, Mapped = arms are mapped explicitly, None = no treatment arms are configured, invalid = unrecognized persisted value.

  Example: Randomized

{
    "type":"object",
    "properties":{
        "title":{
            "maxLength":64,
            "minLength":1,
            "type":"string",
            "description":"Randomization title.",
            "example":"Rand 001"
        },
        "description":{
            "maxLength":4000,
            "minLength":1,
            "type":"string",
            "description":"Randomization design description.",
            "example":"Method to assign study participants to a treatment group."
        },
        "algorithm":{
            "maxLength":31,
            "minLength":4,
            "type":"string",
            "description":"Randomization algorithm. Allowed values: None = no randomization algorithm configured, Central = centrally managed randomization without stratification, CentralStratified = central stratified randomization, SiteBlockedFixed = site-blocked fixed randomization, SiteBlockedFixedStratified = site-blocked fixed stratified randomization, SiteBlockedDynamic = site-blocked dynamic randomization, SiteBlockedDynamicStratified = site-blocked dynamic stratified randomization, CountryBlockedFixed = country-blocked fixed randomization, CountryBlockedFixedStratified = country-blocked fixed stratified randomization, CountryBlockedDynamic = country-blocked dynamic randomization, CountryBlockedDynamicStratified = country-blocked dynamic stratified randomization, RegionBlockedFixed = region-blocked fixed randomization, RegionBlockedFixedStratified = region-blocked fixed stratified randomization, RegionBlockedDynamic = region-blocked dynamic randomization, RegionBlockedDynamicStratified = region-blocked dynamic stratified randomization, Minimization = minimization algorithm.",
            "example":"Central",
            "enum":[
                "None",
                "Central",
                "CentralStratified",
                "SiteBlockedFixed",
                "SiteBlockedFixedStratified",
                "SiteBlockedDynamic",
                "SiteBlockedDynamicStratified",
                "CountryBlockedFixed",
                "CountryBlockedFixedStratified",
                "CountryBlockedDynamic",
                "CountryBlockedDynamicStratified",
                "RegionBlockedFixed",
                "RegionBlockedFixedStratified",
                "RegionBlockedDynamic",
                "RegionBlockedDynamicStratified",
                "Minimization"
            ]
        },
        "cohortType":{
            "maxLength":10,
            "minLength":7,
            "type":"string",
            "description":"Cohort behavior for the randomization design. Allowed values: NoCohort = no cohorting is applied, Adaptive = adaptive cohorts are used, Demography = demographic cohorts are used, invalid = unrecognized persisted value.",
            "example":"NoCohort",
            "enum":[
                "NoCohort",
                "Adaptive",
                "Demography",
                "invalid"
            ]
        },
        "randomizationType":{
            "maxLength":9,
            "minLength":7,
            "type":"string",
            "description":"Randomization blinding type. Allowed values: Blinded = subject assignments remain blinded, Unblinded = subject assignments are visible, invalid = unrecognized persisted value.",
            "example":"Blinded",
            "enum":[
                "Blinded",
                "Unblinded",
                "invalid"
            ]
        },
        "reRandomization":{
            "type":"boolean",
            "description":"Indicates whether re-randomization is enabled.",
            "example":true
        },
        "treatmentArms":{
            "maxLength":10,
            "minLength":4,
            "type":"string",
            "description":"Treatment arm assignment mode. Allowed values: Randomized = arms are assigned by the randomization algorithm, Mapped = arms are mapped explicitly, None = no treatment arms are configured, invalid = unrecognized persisted value.",
            "example":"Randomized",
            "enum":[
                "Randomized",
                "Mapped",
                "None",
                "invalid"
            ]
        }
    },
    "description":"Details for the randomization design.",
    "example":{
        "title":"Rand 001",
        "description":"Method to assign study participants to a treatment group.",
        "algorithm":"Central",
        "cohortType":"NoCohort",
        "randomizationType":"Blinded",
        "reRandomization":true,
        "treatmentArms":"Randomized"
    }
}

Example:

{
    "title":"Rand 001",
    "description":"Method to assign study participants to a treatment group.",
    "algorithm":"Central",
    "cohortType":"NoCohort",
    "randomizationType":"Blinded",
    "reRandomization":true,
    "treatmentArms":"Randomized"
}

Nested Schema : RandomizationSettingsV6Doc

Type: object

Settings that control randomization number handling and visit-window behavior.

Show Source

• allowOutsideWindow: boolean
  Indicates whether randomization is allowed outside the schedule window.

  Example: false
• assignNewRandomizeNumbers: boolean
  Indicates whether new randomization numbers are assigned to all subjects.

  Example: true
• assignSkippedRandomizationNumbers: boolean
  Indicates whether skipped randomization numbers should be assigned.

  Example: false
• randomizeLimitsToCountEarlyTerminated: boolean
  Indicates whether early terminated subjects count toward randomization limits.

  Example: false
• randomizeNumberBlinded: boolean
  Indicates whether randomization numbers are blinded.

  Example: true
• randomizeSubjectsIfSitesOutOfKits: boolean
  Indicates whether randomization should continue when sites are out of kits.

  Example: false

{
    "type":"object",
    "properties":{
        "randomizeSubjectsIfSitesOutOfKits":{
            "type":"boolean",
            "description":"Indicates whether randomization should continue when sites are out of kits.",
            "example":false
        },
        "assignSkippedRandomizationNumbers":{
            "type":"boolean",
            "description":"Indicates whether skipped randomization numbers should be assigned.",
            "example":false
        },
        "randomizeNumberBlinded":{
            "type":"boolean",
            "description":"Indicates whether randomization numbers are blinded.",
            "example":true
        },
        "randomizeLimitsToCountEarlyTerminated":{
            "type":"boolean",
            "description":"Indicates whether early terminated subjects count toward randomization limits.",
            "example":false
        },
        "assignNewRandomizeNumbers":{
            "type":"boolean",
            "description":"Indicates whether new randomization numbers are assigned to all subjects.",
            "example":true
        },
        "allowOutsideWindow":{
            "type":"boolean",
            "description":"Indicates whether randomization is allowed outside the schedule window.",
            "example":false
        }
    },
    "description":"Settings that control randomization number handling and visit-window behavior.",
    "example":{
        "randomizeSubjectsIfSitesOutOfKits":false,
        "assignSkippedRandomizationNumbers":false,
        "randomizeNumberBlinded":true,
        "randomizeLimitsToCountEarlyTerminated":false,
        "assignNewRandomizeNumbers":true,
        "allowOutsideWindow":false
    }
}

Example:

{
    "randomizeSubjectsIfSitesOutOfKits":false,
    "assignSkippedRandomizationNumbers":false,
    "randomizeNumberBlinded":true,
    "randomizeLimitsToCountEarlyTerminated":false,
    "assignNewRandomizeNumbers":true,
    "allowOutsideWindow":false
}

Nested Schema : visits

Type: array

Visits that participate in randomization.

Show Source

• Array of: object RandomizationVisitV6Doc
  Visit included in the randomization design.

{
    "type":"array",
    "description":"Visits that participate in randomization.",
    "example":[
        {
            "visitId":"E1B8327AFAA6412287106192AB5984EF",
            "visitName":"Week 1",
            "branchId":"F1B8327AFAA6412287106192AB5984EF"
        }
    ],
    "items":{
        "$ref":"#/components/schemas/RandomizationVisitV6Doc"
    }
}

Example:

[
    {
        "visitId":"E1B8327AFAA6412287106192AB5984EF",
        "visitName":"Week 1",
        "branchId":"F1B8327AFAA6412287106192AB5984EF"
    }
]

Nested Schema : RandomizationArmV6Doc

Type: object

Treatment arm ratio configured for the randomization design.

Show Source

• id: string (uuid)
  Minimum Length: 32

  Maximum Length: 32

  Treatment arm unique identifier.
• name: string
  Minimum Length: 1

  Maximum Length: 64

  Treatment arm name.

  Example: Arm A
• ratio: integer (int32)
  Minimum Value: 1

  Maximum Value: 99

  Treatment arm allocation ratio. Allowed numeric range is 1 through 99. Zero and negative values are not allowed.

  Example: 2

{
    "type":"object",
    "properties":{
        "id":{
            "maxLength":32,
            "minLength":32,
            "type":"string",
            "description":"Treatment arm unique identifier.",
            "format":"uuid"
        },
        "name":{
            "maxLength":64,
            "minLength":1,
            "type":"string",
            "description":"Treatment arm name.",
            "example":"Arm A"
        },
        "ratio":{
            "maximum":99,
            "minimum":1,
            "type":"integer",
            "description":"Treatment arm allocation ratio. Allowed numeric range is 1 through 99. Zero and negative values are not allowed.",
            "format":"int32",
            "example":2
        }
    },
    "description":"Treatment arm ratio configured for the randomization design."
}

Nested Schema : RandomizationVisitV6Doc

Type: object

Visit included in the randomization design.

Show Source

• branchId: string (uuid)
  Minimum Length: 32

  Maximum Length: 32

  Branch unique identifier for the visit path.
• visitId: string (uuid)
  Minimum Length: 32

  Maximum Length: 32

  Visit unique identifier.
• visitName: string
  Minimum Length: 1

  Maximum Length: 64

  Visit name.

  Example: Week 1

{
    "type":"object",
    "properties":{
        "visitId":{
            "maxLength":32,
            "minLength":32,
            "type":"string",
            "description":"Visit unique identifier.",
            "format":"uuid"
        },
        "visitName":{
            "maxLength":64,
            "minLength":1,
            "type":"string",
            "description":"Visit name.",
            "example":"Week 1"
        },
        "branchId":{
            "maxLength":32,
            "minLength":32,
            "type":"string",
            "description":"Branch unique identifier for the visit path.",
            "format":"uuid"
        }
    },
    "description":"Visit included in the randomization design."
}

Examples

Select an example AddRandomizationSuccess

500 Response

Returned when the service cannot create the requested randomization design for the supplied study version because of an unexpected server-side failure.

Body ()

Root 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 : details

Type: object

Examples

Select an example AddRandomizationError

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