1. REST API for Clinical One Platform
  2. Tasks
  3. Data Hub
  4. v8.0

ODM extract for meta data

get

/ec-datahub-svc/rest/v8.0/studies/{studyId}/{mode}/odm/metadata

This API is used to extract meta data in the CDISC ODM-XML format. This version introduces a new clinical one extension attributes 'MandatoryScreening' if an item is required for Screening, 'MandatoryRandomize' if an item is required for Randomization, 'MandatoryDispense' if an item is required for Dispensation and 'SafetyIntegrationEnabled' if study is enabled for Safety Integration.

Request

Path Parameters
Query Parameters
  • Extract study versions that were created after this timestamp only in the ODM Extract. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format.
    Example:
    2024-01-01T00:00:00Z
  • If the value is true, the data extract will include both the CDISC standard elements and Clinical One extension elements in the extract. If the value is false, the extracted data will only consist of the CDISC standard elements. It accepts true or false, or y or n. The default value is true.
    Example:
    true
  • Minimum Value: 1
    The number of study versions, beginning with the offset, that you want to retrieve. Offset must be provided to use this parameter. For example, if you want to retrieve study versions in multiple batches of 10, you can start with an offset of 0 and limit of 10, then repeat calls to this endpoint and increase the offset value by 10 each time.
    Example:
    100
  • Minimum Value: 0
    An order number that specifies which study version you want to start retrieving meta data from. If provided, you also need to specify a value for the limit parameter.
    Example:
    0
  • The version of the study to extract data from in the ODM Extract.
    Example:
    1.0.0.1
  • If the value is true, only summary data is displayed for the study version in the ODM extract. If the value is false, both summary data and complete design data is displayed for the study version in the ODM Extract. It accepts true or false, or y or n. The default value is false.
    Example:
    false

There's no request body for this operation.

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Response

Supported Media Types

200 Response

Successful operation
Body ()
Root Schema : ODM
Type: object
Clinical One ODM 1.3.2 study metadata container including pagination and export attributes.
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Example:
<ODM
	xmlns="http://www.cdisc.org/ns/odm/v1.3"
	xmlns:co="https://docs.oracle.com/en/industries/life-sciences/clinical-one/odm/extensions/v1"
	xmlns:ns0="http://www.w3.org/2000/09/xmldsig#" Description="STUDY01" FileType="Transactional" FileOID="oracle/STUDY01/BF400E2655C4493799A17C7B947557F0" CreationDateTime="2025-11-03T18:14:02.559Z" ODMVersion="1.3.2" Originator="system" SourceSystem="Oracle Life Sciences Clinical One" SourceSystemVersion="MetaData API v8.0" co:studyMode="test" co:includeCOExtensions="true" co:fromTimestamp="2024-01-01T00:00:00Z" co:studyVersion="1.0.0.3" co:studyVersionSummary="false" co:hasMore="false" co:totalResults="1" co:count="1" co:limit="1" co:offset="0">
	<Study OID="STUDY01" co:SafetyIntegrationEnabled="false">
		<GlobalVariables>
			<StudyName>STUDY01</StudyName>
			<StudyDescription>Study01</StudyDescription>
			<ProtocolName>STUDY01</ProtocolName>
		</GlobalVariables>
		<BasicDefinitions>
			<MeasurementUnit OID="Kilogram" Name="Kilogram">
				<Symbol>
					<TranslatedText>Kilogram</TranslatedText>
				</Symbol>
			</MeasurementUnit>
		</BasicDefinitions>
		<MetaDataVersion OID="STUDY01v1.0.0.3" Name="STUDY01" co:StudyWid="25" co:GUID="0C7CBA3F70034C47947E2FAB086BFBF5" co:VersionStart="2025-10-29T14:37:54.638Z">
			<Protocol>
				<StudyEventRef StudyEventOID="Baseline_5DF278EB00F24820B9CEFE7BFD7A3078" OrderNumber="3" Mandatory="Yes"></StudyEventRef>
			</Protocol>
			<StudyEventDef OID="Baseline_5DF278EB00F24820B9CEFE7BFD7A3078" Name="BASELINE" Repeating="No" Type="Scheduled" Category="ScheduleAbleVisit" co:StudyEventWid="42" co:GUID="5DF278EB00F24820B9CEFE7BFD7A3078" co:VersionStart="2025-10-29T14:37:55.423Z" co:DelayDays="1" co:DelayHours="0" co:DelayWindowBeforeDays="1" co:DelayWindowBeforeHours="0" co:DelayWindowAfterDays="1" co:DelayWindowAfterHours="0">
				<FormRef FormOID="DEMOG_3DC0796D51654FEBA0F1ED98EBE8A73B" OrderNumber="1" Mandatory="Yes"></FormRef>
				<FormRef FormOID="PREGNANCY_E243611973104C1CB86F4EE3207F74CD" OrderNumber="2" Mandatory="Yes"></FormRef>
				<FormRef FormOID="VITAL_SIGNS_FORM_TO_COLLECT_MEASUREMENT_3ADB1375C6714B8C97CA14AFA175D739" OrderNumber="3" Mandatory="Yes"></FormRef>
				<FormRef FormOID="VITAL_SIGNS_FORM_TO_COLLECT_MEASUREMENT1_E3D08DDF23CA4BD3B89C1232F107CE03" OrderNumber="4" Mandatory="Yes"></FormRef>
				<FormRef FormOID="TWOSECTIONF1_19E7EE6903814132A9427E3E7A297107" OrderNumber="5" Mandatory="Yes"></FormRef>
				<FormRef FormOID="CONCOMITANT_MEDICATIONS_FORM_234478166C0D4394BA6FF6E4378D6AEF" OrderNumber="6" Mandatory="Yes"></FormRef>
			</StudyEventDef>
			<FormDef OID="AE_REPEATINGFORM_FB76018539144E6C9B0C0655A2770C70" Name="AE(Repeating Form)" Repeating="Yes">
				<ItemGroupRef OrderNumber="1" Mandatory="No" ItemGroupOID="IG_DROPDOWN_03_4C9BA8F0C71C4D97B1A8C4F570E375DF"></ItemGroupRef>
				<ItemGroupRef OrderNumber="2" Mandatory="No" ItemGroupOID="IG_DROPDOWN_04_B9C2862780944AC59ACD64C89E82FB57"></ItemGroupRef>
				<ItemGroupRef OrderNumber="3" Mandatory="No" ItemGroupOID="IG_COMMENTS_4EF72907BB594060A23894AC1992A409"></ItemGroupRef>
				<ItemGroupRef OrderNumber="4" Mandatory="No" ItemGroupOID="IG_FORM_ASSOCIATION_QUES_35766308CA2F465FB6CE7AFDF1B484AC"></ItemGroupRef>
			</FormDef>
			<ItemGroupDef OID="IG_LAB_FORM_XRAY_E98F15D6F16F425A8F0EC3B92C8B718F" Name="Lab Form - XRAY" Repeating="Yes">
				<ItemRef OrderNumber="1" Mandatory="No" ItemOID="LB_TEST_0267AEECE55441088516DA2C0E1B2EDC"></ItemRef>
				<ItemRef OrderNumber="2" Mandatory="Yes" ItemOID="LB_RESULT_DE498EE22C884D55A50D285580AB674D"></ItemRef>
				<ItemRef OrderNumber="3" Mandatory="No" ItemOID="LB_UNIT_00C6D2BF3F8B4178AAB25EBD3304E39E"></ItemRef>
				<ItemRef OrderNumber="4" Mandatory="No" ItemOID="LB_LOW_RANGE_C8B8EEFE75F543299542C222ED94C28F"></ItemRef>
				<ItemRef OrderNumber="5" Mandatory="No" ItemOID="LB_HIGH_RANGE_5CE74A4A9E97435B933B6C28645342AA"></ItemRef>
				<ItemRef OrderNumber="6" Mandatory="No" ItemOID="NORMAL_TEXT_RESULT_746B6577A50C4D0A9DB53E1CD6B60551"></ItemRef>
			</ItemGroupDef>
			<ItemGroupDef OID="IG_DATE_TIME_078905CDD6ED4654A5FEF583F83BB0DF" Name="Date and Time" Repeating="No">
				<ItemRef OrderNumber="1" Mandatory="No" ItemOID="DATE_TIME_078905CDD6ED4654A5FEF583F83BB0DF"></ItemRef>
			</ItemGroupDef>
			<ItemDef OID="SMARTITEM_06_DOB_5EED4980C8A6431697432F0915219916" Name="SMARTITEM_06_DOB" DataType="date" co:ItemWid="871" co:GUID="5EED4980C8A6431697432F0915219916" co:ItemVersionStart="2025-10-29T14:37:54.941Z" co:Precision="0" co:AllowFutureDate="No">
				<Question>
					<TranslatedText>Age_SMARTITEM_06_DOB</TranslatedText>
				</Question>
			</ItemDef>
			<ItemDef OID="RACE_LAB_F0AD42619DE14BCABD6EF726EC7C1BFD" Name="RACE_LAB" DataType="string" co:ItemWid="886" co:GUID="F0AD42619DE14BCABD6EF726EC7C1BFD" co:ItemVersionStart="2025-10-29T14:37:54.941Z" co:Precision="1" co:AllowFutureDate="No">
				<Question>
					<TranslatedText>Race Lab</TranslatedText>
				</Question>
				<CodeListRef CodeListOID="RACE_LAB_RACE_7F07A4A380AF40C790FA695DC656CB67"></CodeListRef>
			</ItemDef>
			<ItemDef OID="WEIGHT_A62588FFAAB24EFFBA0E1064CE21B5DE" Name="WEIGHT" DataType="float" co:ItemWid="111" co:GUID="A62588FFAAB24EFFBA0E1064CE21B5DE" co:ItemVersionStart="2025-10-29T14:37:54.979Z" co:Precision="1" co:AllowFutureDate="No">
				<Question>
					<TranslatedText>Weight</TranslatedText>
				</Question>
				<MeasurementUnitRef MeasurementUnitOID="kg"></MeasurementUnitRef>
			</ItemDef>
			<CodeList OID="ANY_COVID_EFFECTS_ANY_COVID_EFFECTS_92363094B1D245E3A52289ACF37F953B" Name="ANY_COVID_EFFECTS" DataType="string">
				<CodeListItem co:SelectionOID="ANY_COVID_EFFECTS_ANY_COVID_EFFECTS_92363094B1D245E3A52289ACF37F953B_ANY_COVID_EFFECT6">
					<Decode>
						<TranslatedText>Tiredness</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem co:SelectionOID="ANY_COVID_EFFECTS_ANY_COVID_EFFECTS_92363094B1D245E3A52289ACF37F953B_ANY_COVID_EFFECT4">
					<Decode>
						<TranslatedText>Fever</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem co:SelectionOID="ANY_COVID_EFFECTS_ANY_COVID_EFFECTS_92363094B1D245E3A52289ACF37F953B_ANY_COVID_EFFECT5">
					<Decode>
						<TranslatedText>Body Pain</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem co:SelectionOID="ANY_COVID_EFFECTS_ANY_COVID_EFFECTS_92363094B1D245E3A52289ACF37F953B_ANY_COVID_EFFECT7">
					<Decode>
						<TranslatedText>Sleepless</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem co:SelectionOID="ANY_COVID_EFFECTS_ANY_COVID_EFFECTS_92363094B1D245E3A52289ACF37F953B_ANY_COVID_EFFECT8">
					<Decode>
						<TranslatedText>Breathing Problem</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem co:SelectionOID="ANY_COVID_EFFECTS_ANY_COVID_EFFECTS_92363094B1D245E3A52289ACF37F953B_ANY_COVID_EFFECT2">
					<Decode>
						<TranslatedText>Cold</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem co:SelectionOID="ANY_COVID_EFFECTS_ANY_COVID_EFFECTS_92363094B1D245E3A52289ACF37F953B_ANY_COVID_EFFECT1">
					<Decode>
						<TranslatedText>Cough</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem co:SelectionOID="ANY_COVID_EFFECTS_ANY_COVID_EFFECTS_92363094B1D245E3A52289ACF37F953B_ANY_COVID_EFFECT3">
					<Decode>
						<TranslatedText>Throat Infection</TranslatedText>
					</Decode>
				</CodeListItem>
			</CodeList>
		</MetaDataVersion>
	</Study>
</ODM>
Nested Schema : Study
Type: array
List of ODM Study elements.
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Nested Schema : Study
Type: object
ODM Study object
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Nested Schema : BasicDefinitions10
Type: object
Root-level definitions for basic units and reference types in the ODM Study.
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Nested Schema : GlobalVariables10
Type: object
ODM GlobalVariables for a Study, providing human-readable study description and identifiers.
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Nested Schema : MetaDataVersion
Type: object
Represents the metadata about the study
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Nested Schema : MeasurementUnit
Type: object
A measurement unit reference used in study forms, such as mg/dL.
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Nested Schema : Alias
Type: object
A synonym, translation, or locale-specific label for a MeasurementUnit.
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  • Locale, region, or terminology context.
    Example: US
  • Alternative or alias name for the unit in this context.
    Example: mg per deciliter
Nested Schema : Symbol10
Type: object
Symbol element for a MeasurementUnit.
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Nested Schema : TranslatedText
Type: object
A localizable or translated representation of a symbol, label, or similar text element.
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Nested Schema : ProtocolName10
Type: object
Protocol identifier/name for the ODM Study.
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Nested Schema : StudyDescription10
Type: object
Free-text description of the ODM Study.
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  • Free-text description of the Study.
    Example: Phase 3, double blind, randomized clinical study in Diabetes.
Nested Schema : StudyName10
Type: object
Human-readable display name for the ODM Study.
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Nested Schema : codeList
Type: object
Code list definition including items or external mappings.
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Nested Schema : conditionDef
Type: object
Condition definition containing formal expressions and metadata.
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Nested Schema : formDef
Type: object
Form definition containing item group references, archive layouts and metadata.
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Nested Schema : imputationMethod
Type: object
Imputation method definition with value and identifier.
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  • Imputation method object identifier
    Example: a4a7124a-0056-4fb5-9a7e-4a1b0068a966.1_8_0_29
  • Imputation method value
    Example: MeanImputation
Nested Schema : Include10
Type: object
Includes the metadata about the study version
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Nested Schema : itemDef
Type: object
Item definition including question, code list, range checks and metadata.
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Nested Schema : itemGroupDef
Type: object
ItemGroup definition containing item references and metadata.
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Nested Schema : methodDef
Type: object
Method definition containing formal expressions and metadata.
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Nested Schema : presentation
Type: object
Presentation metadata including value, identifier and language.
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Nested Schema : Protocol10
Type: object
Protocol metadata
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Nested Schema : studyEventDef
Type: object
Study Event Def data
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Nested Schema : alias
Type: object
A synonym, translation, or locale-specific label for a MeasurementUnit.
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  • Locale, region, or terminology context.
    Example: US
  • Alternative or alias name for the unit in this context.
    Example: mg per deciliter
Nested Schema : codeListItem
Type: object
Represents a single code list item with decode and metadata.
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Nested Schema : Description10
Type: object
Description DTO having information on the translated text
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Nested Schema : enumeratedItem
Type: object
Enumerated item value with optional ordering and aliases.
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Nested Schema : ExternalCodeList1
Type: object
Reference to an external dictionary-based code list.
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Nested Schema : alias
Type: object
A synonym, translation, or locale-specific label for a MeasurementUnit.
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  • Locale, region, or terminology context.
    Example: US
  • Alternative or alias name for the unit in this context.
    Example: mg per deciliter
Nested Schema : Decode1
Type: object
Decoded text for a code list item with translations.
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Nested Schema : translatedText
Type: object
A localizable or translated representation of a symbol, label, or similar text element.
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Nested Schema : translatedText
Type: object
A localizable or translated representation of a symbol, label, or similar text element.
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Nested Schema : alias
Type: object
A synonym, translation, or locale-specific label for a MeasurementUnit.
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  • Locale, region, or terminology context.
    Example: US
  • Alternative or alias name for the unit in this context.
    Example: mg per deciliter
Nested Schema : alias
Type: object
A synonym, translation, or locale-specific label for a MeasurementUnit.
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  • Locale, region, or terminology context.
    Example: US
  • Alternative or alias name for the unit in this context.
    Example: mg per deciliter
Nested Schema : formalExpression
Type: object
Formal expression used for validation.
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Nested Schema : alias
Type: array
Aliases for the form
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Nested Schema : archiveLayout
Type: array
Archive layouts defined for this form
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Nested Schema : itemGroupRef
Type: array
Item group references for this form
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Nested Schema : Alias1
Type: object
A synonym, translation, or locale-specific label for a MeasurementUnit.
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  • Locale, region, or terminology context.
    Example: US
  • Alternative or alias name for the unit in this context.
    Example: mg per deciliter
Nested Schema : ArchiveLayout1
Type: object
Archive layout metadata for a form.
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Nested Schema : ItemGroupRef1
Type: object
Reference to an ItemGroup within a form.
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Nested Schema : alias
Type: object
A synonym, translation, or locale-specific label for a MeasurementUnit.
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  • Locale, region, or terminology context.
    Example: US
  • Alternative or alias name for the unit in this context.
    Example: mg per deciliter
Nested Schema : CodeListRef1
Type: object
Reference to a CodeList by its OID.
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  • OID of the referenced code list
    Example: c419c414-a0de-4ee4-a138-3b072aa1a00f.1_8_0_29
Nested Schema : ExternalQuestion1
Type: object
External question reference details.
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Nested Schema : itemRef
Type: object
Reference to an Item within an ItemGroup.
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Nested Schema : measurementUnitRef
Type: object
Data captured for a Measurement Unit
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Nested Schema : Question1
Type: object
Question containing translated display text.
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Nested Schema : rangeCheck
Type: object
Range check configuration for item validation.
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Nested Schema : role
Type: object
Represents the role associated with an item or definition.
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Nested Schema : translatedText
Type: object
A localizable or translated representation of a symbol, label, or similar text element.
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Nested Schema : checkValue
Type: object
A value used within a range validation.
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Nested Schema : ErrorMessage1
Type: object
Error message details for validation failures.
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Nested Schema : formalExpression
Type: object
Formal expression used for validation.
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Nested Schema : MeasurementUnitRef1
Type: object
Data captured for a Measurement Unit
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Nested Schema : translatedText
Type: object
A localizable or translated representation of a symbol, label, or similar text element.
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Nested Schema : alias
Type: array
Aliases for the ItemGroup
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Nested Schema : itemRef
Type: array
References to Items within this ItemGroup
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Nested Schema : ItemRef1
Type: object
Reference to an Item within an ItemGroup.
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Nested Schema : alias
Type: object
A synonym, translation, or locale-specific label for a MeasurementUnit.
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  • Locale, region, or terminology context.
    Example: US
  • Alternative or alias name for the unit in this context.
    Example: mg per deciliter
Nested Schema : formalExpression
Type: object
Formal expression used for validation.
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Nested Schema : alias
Type: object
A synonym, translation, or locale-specific label for a MeasurementUnit.
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  • Locale, region, or terminology context.
    Example: US
  • Alternative or alias name for the unit in this context.
    Example: mg per deciliter
Example:
[
    {
        "context":"CDASH",
        "name":"PROTID"
    }
]
Nested Schema : studyEventRef
Type: object
Study Event Ref data
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Example:
[
    {
        "eventOID":"SE1"
    }
]
Nested Schema : alias
Type: object
A synonym, translation, or locale-specific label for a MeasurementUnit.
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  • Locale, region, or terminology context.
    Example: US
  • Alternative or alias name for the unit in this context.
    Example: mg per deciliter
Nested Schema : formRef
Type: object
FormRef metadata
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400 Response

'Missing / invalid data'
Body ()
Root Schema : DataHubResponse
Type: object
Standard response envelope containing status, optional result payload, optional error information and a version number.
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Nested Schema : errorData
Type: object
Error details when status is error.
Example:
{
    "errorCode":"C1-003",
    "errorMessage":"Validation failed",
    "details":{
        "field":"limit",
        "message":"limit must be >= 1"
    }
}
Nested Schema : result
Type: object
Payload returned by the API when status is success.
Example:
{
    "message":"Operation succeeded"
}
Examples

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