1. REST API for Clinical One Cloud Service
  2. Tasks
  3. Designer
  4. Randomization APIs
  5. Randomization
  6. Create randomization design

V6.0

post

/ec-designer-ors-svc/rest/v6.0/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
Supported Media Types
Request Body - application/json ()
Root Schema : schema
Type: object
Randomization design payload used by the v6 create and update randomization endpoints.
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Nested Schema : arms
Type: array
Treatment arms configured for the randomization design.
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Example:
[
    {
        "id":"C1B8327AFAA6412287106192AB5984EF",
        "name":"Arm A",
        "ratio":2
    }
]
Nested Schema : RandomizationDetailsV6Doc
Type: object
Details for the randomization design.
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  • 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
  • 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
  • Minimum Length: 1
    Maximum Length: 4000
    Randomization design description.
    Example: Method to assign study participants to a treatment group.
  • 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
  • Indicates whether re-randomization is enabled.
    Example: true
  • Minimum Length: 1
    Maximum Length: 64
    Randomization title.
    Example: Rand 001
  • 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
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.
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Example:
{
    "randomizeSubjectsIfSitesOutOfKits":false,
    "assignSkippedRandomizationNumbers":false,
    "randomizeNumberBlinded":true,
    "randomizeLimitsToCountEarlyTerminated":false,
    "assignNewRandomizeNumbers":true,
    "allowOutsideWindow":false
}
Nested Schema : visits
Type: array
Visits that participate in randomization.
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Example:
[
    {
        "visitId":"E1B8327AFAA6412287106192AB5984EF",
        "visitName":"Week 1",
        "branchId":"F1B8327AFAA6412287106192AB5984EF"
    }
]
Nested Schema : RandomizationArmV6Doc
Type: object
Treatment arm ratio configured for the randomization design.
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  • Minimum Length: 32
    Maximum Length: 32
    Treatment arm unique identifier.
  • Minimum Length: 1
    Maximum Length: 64
    Treatment arm name.
    Example: Arm A
  • 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
Nested Schema : RandomizationVisitV6Doc
Type: object
Visit included in the randomization design.
Show Source
Examples

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Response

Supported Media Types

200 Response

Successful operation.
Body ()
Root Schema : RandomizationResponseV6
Type: object
Designer response envelope returned by the v6 randomization create and update endpoints.
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Nested Schema : RandomizationErrorV6
Type: object
Error payload returned by the v6 randomization endpoints.
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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
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
Example:
[
    {
        "id":"C1B8327AFAA6412287106192AB5984EF",
        "name":"Arm A",
        "ratio":2
    }
]
Nested Schema : RandomizationDetailsV6Doc
Type: object
Details for the randomization design.
Show Source
  • 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
  • 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
  • Minimum Length: 1
    Maximum Length: 4000
    Randomization design description.
    Example: Method to assign study participants to a treatment group.
  • 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
  • Indicates whether re-randomization is enabled.
    Example: true
  • Minimum Length: 1
    Maximum Length: 64
    Randomization title.
    Example: Rand 001
  • 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
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
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
Example:
[
    {
        "visitId":"E1B8327AFAA6412287106192AB5984EF",
        "visitName":"Week 1",
        "branchId":"F1B8327AFAA6412287106192AB5984EF"
    }
]
Nested Schema : RandomizationArmV6Doc
Type: object
Treatment arm ratio configured for the randomization design.
Show Source
  • Minimum Length: 32
    Maximum Length: 32
    Treatment arm unique identifier.
  • Minimum Length: 1
    Maximum Length: 64
    Treatment arm name.
    Example: Arm A
  • 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
Nested Schema : RandomizationVisitV6Doc
Type: object
Visit included in the randomization design.
Show Source
Examples

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
Title: ErrorResponseData
Error Response Details Information
Show Source
  • Object
    Title: Object
    Object with error details information.
  • Error code which is stored in ErrorCode enum. Example : C1-003
    Example: C1-003
  • 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
Nested Schema : Object
Type: object
Title: Object
Object with error details information.
Example:
{
    "field":"studyId",
    "reason":"Invalid value"
}
Examples

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