• arms: array arms
• details(required): object RandomizationDetails v4.0
  Title: RandomizationDetails v4.0

  Details of the randomization design.
• id: string (uuid)
  Randomization GUID
• settings(required): object RandomizationSettings v4.0
  Title: RandomizationSettings v4.0

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

  Example: 2021-01-17T15:41:10.733Z
• visits: array visits

{
    "title":"RandomizationDto v4.0",
    "required":[
        "details",
        "settings"
    ],
    "type":"object",
    "properties":{
        "id":{
            "type":"string",
            "description":"Randomization GUID",
            "format":"uuid"
        },
        "versionStart":{
            "type":"string",
            "description":"Randomization VersionStart",
            "format":"date-time",
            "example":"2021-01-17T15:41:10.733Z"
        },
        "details":{
            "$ref":"#/components/schemas/RandomizationDetailsV4"
        },
        "arms":{
            "type":"array",
            "items":{
                "$ref":"#/components/schemas/RandomizationArmV4"
            }
        },
        "visits":{
            "type":"array",
            "items":{
                "$ref":"#/components/schemas/RandomizationVisitV4"
            }
        },
        "settings":{
            "$ref":"#/components/schemas/RandomizationSettingsV4"
        }
    },
    "description":"Randomization Design Info"
}

• Array of: object RandomizationArm v4.0
  Title: RandomizationArm v4.0

  Randomization Design Treatment Arm Ratio

{
    "type":"array",
    "items":{
        "$ref":"#/components/schemas/RandomizationArmV4"
    }
}

• 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 v4.0",
    "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."
}

• 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 v4.0",
    "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
        }
    },
    "description":"The settings for the randomization design."
}

• Array of: object RandomizationVisit v4.0
  Title: RandomizationVisit v4.0

  Randomization Visit

{
    "type":"array",
    "items":{
        "$ref":"#/components/schemas/RandomizationVisitV4"
    }
}

• 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 v4.0",
    "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"
}

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

  Example: Week 3

{
    "title":"RandomizationVisit v4.0",
    "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"
}

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

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