ODM extract for meta data

get

/ec-datahub-svc/rest/v9.0/studies/{studyId}/{mode}/odm/metadata

This API is used to extract meta data in the CDISC ODM-XML format. This version introduces new Clinical One extension attribute 'DataClassification': Specifies the data classifications applied to hidden items and logic change for the attribute 'OrderNumber' of StudyEventRef to maintain the sequence as defined in the Clinical One.

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.

Back to Top

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.
Show Source
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.
Show Source
Nested Schema : Study
Type: object
ODM Study object
Show Source
Nested Schema : BasicDefinitions10
Type: object
Root-level definitions for basic units and reference types in the ODM Study.
Show Source
Nested Schema : GlobalVariables10
Type: object
ODM GlobalVariables for a Study, providing human-readable study description and identifiers.
Show Source
Nested Schema : MetaDataVersion
Type: object
Represents the metadata about the study
Show Source
Nested Schema : MeasurementUnit
Type: object
A measurement unit reference used in study forms, such as mg/dL.
Show Source
Nested Schema : Alias
Type: object
A synonym, translation, or locale-specific label for a MeasurementUnit.
Show Source
  • 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.
Show Source
Nested Schema : TranslatedText
Type: object
A localizable or translated representation of a symbol, label, or similar text element.
Show Source
Nested Schema : ProtocolName10
Type: object
Protocol identifier/name for the ODM Study.
Show Source
Nested Schema : StudyDescription10
Type: object
Free-text description of the ODM Study.
Show Source
  • 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.
Show Source
Nested Schema : codeList
Type: object
Code list definition including items or external mappings.
Show Source
Nested Schema : conditionDef
Type: object
Condition definition containing formal expressions and metadata.
Show Source
Nested Schema : formDef
Type: object
Form definition containing item group references, archive layouts and metadata.
Show Source
Nested Schema : imputationMethod
Type: object
Imputation method definition with value and identifier.
Show Source
  • 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
Show Source
Nested Schema : itemDef
Type: object
Item definition including question, code list, range checks and metadata.
Show Source
Nested Schema : itemGroupDef
Type: object
ItemGroup definition containing item references and metadata.
Show Source
Nested Schema : methodDef
Type: object
Method definition containing formal expressions and metadata.
Show Source
Nested Schema : presentation
Type: object
Presentation metadata including value, identifier and language.
Show Source
Nested Schema : Protocol10
Type: object
Protocol metadata
Show Source
Nested Schema : studyEventDef
Type: object
Study Event Def data
Show Source
Nested Schema : alias
Type: object
A synonym, translation, or locale-specific label for a MeasurementUnit.
Show Source
  • 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.
Show Source
Nested Schema : Description10
Type: object
Description DTO having information on the translated text
Show Source
Nested Schema : enumeratedItem
Type: object
Enumerated item value with optional ordering and aliases.
Show Source
Nested Schema : ExternalCodeList1
Type: object
Reference to an external dictionary-based code list.
Show Source
Nested Schema : alias
Type: object
A synonym, translation, or locale-specific label for a MeasurementUnit.
Show Source
  • 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.
Show Source
Nested Schema : translatedText
Type: object
A localizable or translated representation of a symbol, label, or similar text element.
Show Source
Nested Schema : translatedText
Type: object
A localizable or translated representation of a symbol, label, or similar text element.
Show Source
Nested Schema : alias
Type: object
A synonym, translation, or locale-specific label for a MeasurementUnit.
Show Source
  • 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.
Show Source
  • 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.
Show Source
Nested Schema : alias
Type: array
Aliases for the form
Show Source
Nested Schema : archiveLayout
Type: array
Archive layouts defined for this form
Show Source
Nested Schema : itemGroupRef
Type: array
Item group references for this form
Show Source
Nested Schema : Alias1
Type: object
A synonym, translation, or locale-specific label for a MeasurementUnit.
Show Source
  • 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.
Show Source
Nested Schema : ItemGroupRef1
Type: object
Reference to an ItemGroup within a form.
Show Source
Nested Schema : alias
Type: object
A synonym, translation, or locale-specific label for a MeasurementUnit.
Show Source
  • 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.
Show Source
  • 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.
Show Source
Nested Schema : itemRef
Type: object
Reference to an Item within an ItemGroup.
Show Source
Nested Schema : measurementUnitRef
Type: object
Data captured for a Measurement Unit
Show Source
Nested Schema : Question1
Type: object
Question containing translated display text.
Show Source
Nested Schema : rangeCheck
Type: object
Range check configuration for item validation.
Show Source
Nested Schema : role
Type: object
Represents the role associated with an item or definition.
Show Source
Nested Schema : translatedText
Type: object
A localizable or translated representation of a symbol, label, or similar text element.
Show Source
Nested Schema : checkValue
Type: object
A value used within a range validation.
Show Source
Nested Schema : ErrorMessage1
Type: object
Error message details for validation failures.
Show Source
Nested Schema : formalExpression
Type: object
Formal expression used for validation.
Show Source
Nested Schema : MeasurementUnitRef1
Type: object
Data captured for a Measurement Unit
Show Source
Nested Schema : translatedText
Type: object
A localizable or translated representation of a symbol, label, or similar text element.
Show Source
Nested Schema : alias
Type: array
Aliases for the ItemGroup
Show Source
Nested Schema : itemRef
Type: array
References to Items within this ItemGroup
Show Source
Nested Schema : ItemRef1
Type: object
Reference to an Item within an ItemGroup.
Show Source
Nested Schema : alias
Type: object
A synonym, translation, or locale-specific label for a MeasurementUnit.
Show Source
  • 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.
Show Source
Nested Schema : alias
Type: object
A synonym, translation, or locale-specific label for a MeasurementUnit.
Show Source
  • 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
Show Source
Example:
[
    {
        "eventOID":"SE1"
    }
]
Nested Schema : alias
Type: object
A synonym, translation, or locale-specific label for a MeasurementUnit.
Show Source
  • 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
Show Source

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.
Show Source
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

Back to Top