1. REST API for Clinical One Cloud Service
  2. Tasks
  3. Data Hub
  4. ODM
  5. ODM extract for meta data

[Deprecated]: V4.0
get

/ec-datahub-svc/rest/v4.0/studies/{studyId}/{mode}/odm/metadata

Deprecated: Use latest version instead.

This API is used to extract meta data in CDISC ODM-XML format.

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.
  • 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.
  • 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.
  • 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.
  • The version of the study to extract data from in the ODM Extract.
  • 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.

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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  • Study
    ODM Study container with global variables, optional basic definitions and one or more metadata versions describing the study structure.
Nested Schema : Study
Type: object
ODM Study container with global variables, optional basic definitions and one or more metadata versions describing the study structure.
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Nested Schema : BasicDefinitions
Type: object
Collection of units of measurement defined for this study.
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Nested Schema : GlobalVariables
Type: object
Global attributes of a study including human readable name, description and protocol identifier.
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Example:
<GlobalVariables><StudyName>STUDY01</StudyName><StudyDescription>Study01</StudyDescription><ProtocolName>STUDY01</ProtocolName></GlobalVariables>
Nested Schema : metaDataVersion
Type: array
One or more metadata versions that define the study design and data structures.
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Nested Schema : MeasurementUnit
Type: array
Units of measurement defined for this study.
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Nested Schema : MeasurementUnit
Type: object
Definition of a measurement unit including symbol and optional aliases.
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Example:
<MeasurementUnit OID="mg" Name="mg"><Symbol><TranslatedText>mg</TranslatedText></Symbol></MeasurementUnit>
Nested Schema : Alias
Type: array
Zero or more aliases for this unit.
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Nested Schema : Symbol
Type: object
Symbol for a measurement unit represented as a list of translated text entries.
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Example:
<Symbol><TranslatedText>mg</TranslatedText></Symbol>
Nested Schema : Alias
Type: object
Alternative naming context and value for an ODM element.
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Example:
<Alias Context="CDISC" Name="MG"/>
Nested Schema : TranslatedText
Type: array
Translated symbol values with language codes.
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Nested Schema : TranslatedText
Type: object
Localized text value with associated language code.
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Example:
<TranslatedText>mg</TranslatedText>
Nested Schema : ProtocolName
Type: object
Protocol identifier or shorthand title container.
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Example:
<ProtocolName>STUDY01</ProtocolName>
Nested Schema : StudyDescription
Type: object
Description of the study.
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  • Free text description content.
    Example: Randomized double-blind trial across 25 sites
Example:
<StudyDescription>Randomized double-blind trial across 25 sites</StudyDescription>
Nested Schema : StudyName
Type: object
Official study name.
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Example:
<StudyName>STUDY01</StudyName>
Nested Schema : MetaDataVersion
Type: object
Defines the study design and data structures including events, forms, items, code lists and methods.
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Example:
<MetaDataVersionOID="STUDY01v1.0.0.3"Name="STUDY01"co:StudyWid="25"co:GUID="0C7CBA3F70034C47947E2FAB086BFBF5"co:VersionStart="2025-10-29T14:37:54.638Z"><Protocol><StudyEventRefStudyEventOID="AE_DBB3A65B0A97454DAFEAEDDAB37395A1"OrderNumber="1"Mandatory="No"></StudyEventRef><StudyEventRefStudyEventOID="SCR_FD227430BECA4DECA5EA8B0E4DBE18CA"OrderNumber="2"Mandatory="Yes"></StudyEventRef><StudyEventRefStudyEventOID="Baseline_5DF278EB00F24820B9CEFE7BFD7A3078"OrderNumber="3"Mandatory="Yes"></StudyEventRef></Protocol><StudyEventDefOID="CBVisit2_AD5ACD1ED5E346129C6FABE4FA2E7DBE"Name="CBVISIT2"Repeating="No"Type="Scheduled"Category="ScheduleAbleVisit"co:StudyEventWid="248"co:GUID="AD5ACD1ED5E346129C6FABE4FA2E7DBE"co:VersionStart="2025-10-29T14:37:55.423Z"co:DelayDays="4"co:DelayHours="0"co:DelayWindowBeforeDays="2"co:DelayWindowBeforeHours="0"co:DelayWindowAfterDays="2"co:DelayWindowAfterHours="0"><FormRefFormOID="VITAL_SIGNS_FORM_TO_COLLECT_MEASUREMENT_3ADB1375C6714B8C97CA14AFA175D739"OrderNumber="1"Mandatory="Yes"></FormRef><FormRefFormOID="TWOSECTIONF1_19E7EE6903814132A9427E3E7A297107"OrderNumber="2"Mandatory="Yes"></FormRef></StudyEventDef><FormDefOID="DECISION_FORM_FOR_BRANCH_026521949ED24C69B0A82084832A3262"Name="DecisionFrom For Branch"Repeating="No"><ItemGroupRefOrderNumber="1"Mandatory="No"ItemGroupOID="IG_DATE_TIME_6ED56EC23ADD4841B8AC22ECB6205774"></ItemGroupRef><ItemGroupRefOrderNumber="2"Mandatory="Yes"ItemGroupOID="IG_ENABLE_DYNAMIC_VISIT_18936986318C4B00AAF89CDA492E6876"></ItemGroupRef></FormDef><ItemGroupDefOID="IG_LAB_FORM_XRAY_E98F15D6F16F425A8F0EC3B92C8B718F"Name="Lab Form - XRAY"Repeating="Yes"><ItemRefOrderNumber="1"Mandatory="No"ItemOID="LB_TEST_0267AEECE55441088516DA2C0E1B2EDC"></ItemRef><ItemRefOrderNumber="2"Mandatory="Yes"ItemOID="LB_RESULT_DE498EE22C884D55A50D285580AB674D"></ItemRef><ItemRefOrderNumber="3"Mandatory="No"ItemOID="LB_UNIT_00C6D2BF3F8B4178AAB25EBD3304E39E"></ItemRef><ItemRefOrderNumber="4"Mandatory="No"ItemOID="LB_LOW_RANGE_C8B8EEFE75F543299542C222ED94C28F"></ItemRef><ItemRefOrderNumber="5"Mandatory="No"ItemOID="LB_HIGH_RANGE_5CE74A4A9E97435B933B6C28645342AA"></ItemRef><ItemRefOrderNumber="6"Mandatory="No"ItemOID="NORMAL_TEXT_RESULT_746B6577A50C4D0A9DB53E1CD6B60551"></ItemRef></ItemGroupDef><ItemDefOID="SUBJECT_INITIALS_CF149710CBE24A6BB9266E52B5F5BA0F"Name="Subject_Initials"DataType="string"Length="3"co:ItemWid="618"co:GUID="CF149710CBE24A6BB9266E52B5F5BA0F"co:ItemVersionStart="2025-10-29T14:37:55.044Z"co:Precision="0"co:AllowFutureDate="No"><Question><TranslatedText>SubjectInitials</TranslatedText></Question></ItemDef><CodeListOID="GENDER_LAB_GENDER_0056B65135E24D8B960E3E9C4B68E280"Name="Gender"DataType="string"><CodeListItemCodedValue="C46"co:SelectionOID="GENDER_LAB_GENDER_0056B65135E24D8B960E3E9C4B68E280_GENDER_LA2"><Decode><TranslatedText>Female</TranslatedText></Decode></CodeListItem></CodeList></MetaDataVersion>
Nested Schema : CodeList
Type: array
Code lists used by item definitions.
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  • CodeList
    CodeList defining permissible values via CodeListItem/EnumeratedItem or referencing an external catalog.
Nested Schema : ConditionDef
Type: array
Conditional logic definitions used in the study.
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Nested Schema : formDef
Type: array
Form definitions contained in events.
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Nested Schema : ImputationMethod
Type: array
Imputation methods available to handle missing data.
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Nested Schema : Include
Type: object
Reference to another study and metadata version within ODM.
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Example:
{
    "studyOID":"S_0001",
    "metaDataVersionOID":"MDV_0001"
}
Nested Schema : itemDef
Type: array
Item definitions used across the study.
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  • ItemDef
    Item definition including data type, question text, range checks, code list reference, and metadata.
Nested Schema : itemGroupDef
Type: array
Item group definitions within forms.
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Nested Schema : MethodDef
Type: array
Method definitions for derivations or calculations.
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  • MethodDef
    Definition of a computation or derivation used within the ODM metadata, including description, formal expressions, aliases, and attributes.
Nested Schema : Presentation
Type: array
Presentation configurations for items and forms.
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Nested Schema : Protocol
Type: object
Study protocol definition including description and references to study events.
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Example:
{
    "description":{
        "translatedText":[
            {
                "value":"Protocol overview",
                "lang":"en"
            }
        ]
    },
    "studyEventRef":[
        {
            "studyEventOID":"SE_VISIT1",
            "orderNumber":1,
            "mandatory":"Yes",
            "collectionExceptionConditionOID":"COND_001"
        }
    ],
    "alias":[
        {
            "context":"SPONSOR",
            "name":"PROTO-001"
        }
    ]
}
Nested Schema : studyEventDef
Type: array
Definitions of study events or visits.
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Nested Schema : CodeList
Type: object
CodeList defining permissible values via CodeListItem/EnumeratedItem or referencing an external catalog.
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Example:
<CodeList OID="CL.AGE" Name="AgeUnits" DataType="text" SASFormatName="AGEFMT"><Description>Age units used for subject age</Description><CodeListItem CodedValue="YEARS"><Decode><TranslatedText xml:lang="en">Years</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="MONTHS"><Decode><TranslatedText xml:lang="en">Months</TranslatedText></Decode></CodeListItem><Alias Context="SDTM" Name="AGEU"/></CodeList>
Nested Schema : Alias
Type: array
Aliases that provide cross-references (e.g., SDTM variable names).
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Nested Schema : codeListItem
Type: array
Permissible values as coded items. Use when values are explicitly enumerated.
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Nested Schema : Description
Type: object
Localized description containing one or more translated text entries.
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Example:
<Description>
  <TranslatedText xml:lang="en">Protocol overview</TranslatedText>
</Description>
Nested Schema : EnumeratedItem
Type: array
Alternate representation of permissible values as enumerated items.
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Nested Schema : ExternalCodeList
Type: object
Reference to an external catalog-based code list.
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Nested Schema : CodeListItem
Type: object
Permissible values as coded items. Use when values are explicitly enumerated.
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Nested Schema : Alias
Type: array
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Nested Schema : Decode
Type: object
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Nested Schema : TranslatedText
Type: array
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Nested Schema : TranslatedText
Type: array
Localized description text entries.
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Nested Schema : EnumeratedItem
Type: object
Alternate representation of permissible values as enumerated items.
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Nested Schema : Alias
Type: array
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Nested Schema : ConditionDef
Type: object
Definition of a condition used within ODM to control logic, exceptions, or method execution.
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Example:
<ConditionDef OID="COND.WEIGHT_CHECK" Name="Weight Check">
  <Description>
    <TranslatedText xml:lang="en">Check weight-based dosing</TranslatedText>
  </Description>
  <FormalExpression Context="SAS">if (WEIGHT GT 0) then DOSE=WEIGHT*CONC; else DOSE=.;</FormalExpression>
  <Alias Context="bookmark" Name="WeightCheck"/>
</ConditionDef>
Nested Schema : Alias
Type: array
Optional aliases for the condition.
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Nested Schema : FormalExpression
Type: array
One or more formal expressions defining the condition logic.
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Nested Schema : FormalExpression
Type: object
Expression representing method logic in a specific execution context or language.
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  • Execution context or language for the expression.
    Example: SAS
  • Formal expression text.
    Example: if (WEIGHT GT 0) then DOSE=WEIGHT*CONC; else DOSE=.;
Example:
<FormalExpression Context="SAS">if (WEIGHT GT 0) then DOSE=WEIGHT*CONC; else DOSE=.;</FormalExpression>
Nested Schema : FormDef
Type: object
Form definition containing item group references, archive layout, and metadata.
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Example:
<FormDef OID="FRM.DEMO" Name="Demographics Form" Repeating="No"><Description>Form capturing demographic information</Description><ItemGroupRef ItemGroupOID="IG.DEMO" Mandatory="Yes" OrderNumber="1"/><ArchiveLayout Name="DefaultLayout"/><Alias Context="SDTM" Name="DM"/></FormDef>
Nested Schema : Alias
Type: array
Aliases providing cross-references, e.g., SDTM mapping.
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Nested Schema : ArchiveLayout
Type: array
Archive layout definitions for this form.
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Nested Schema : ItemGroupRef
Type: array
References to item groups included in this form.
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Nested Schema : ArchiveLayout
Type: object
Archive layout definitions for this form.
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Nested Schema : ItemGroupRef
Type: object
References to item groups included in this form.
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Nested Schema : ImputationMethod
Type: object
ImputationMethod element describing how missing values are imputed.
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  • Object identifier for the ImputationMethod element.
    Example: IMP001
  • Imputation method text content.
    Example: Mean Imputation
Example:
<ImputationMethod OID="IMP001">Mean Imputation</ImputationMethod>
Nested Schema : ItemDef
Type: object
Item definition including data type, question text, range checks, code list reference, and metadata.
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Example:
<ItemDef OID="IT.AGE" Name="Age" DataType="integer" Length="3" SignificantDigits="0" SASFieldName="AGE" SDSVarName="AGE" Origin="Collected" Comment="Age of subject"><Description>Subject age in years</Description><Question>What is the subject's age?</Question><MeasurementUnitRef MeasurementUnitOID="MU.YEARS"/><RangeCheck Comparator="GE" SoftHard="Soft"><CheckValue>0</CheckValue></RangeCheck><RangeCheck Comparator="LE" SoftHard="Soft"><CheckValue>130</CheckValue></RangeCheck><CodeListRef CodeListOID="CL.AGEU"/><Role>Demographics</Role><Alias Context="SDTM" Name="AGE"/></ItemDef>
Nested Schema : Alias
Type: array
Aliases providing cross-references, e.g., to SDTM.
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Nested Schema : CodeListRef
Type: object
Reference to a CodeList that constrains values for this item.
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Nested Schema : ExternalQuestion
Type: object
Optional external question metadata reference.
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Nested Schema : MeasurementUnitRef
Type: array
List of measurement units referenced by this item.
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Nested Schema : Question
Type: object
Primary question text associated with the ItemDef.
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Nested Schema : RangeCheck
Type: array
Validation constraints for values of this item.
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Nested Schema : Role
Type: array
Roles associated with this item.
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Nested Schema : MeasurementUnitRef
Type: object
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Nested Schema : TranslatedText
Type: array
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Nested Schema : RangeCheck
Type: object
Validation constraints for values of this item.
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Nested Schema : CheckValue
Type: array
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Nested Schema : ErrorMessage
Type: object
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Nested Schema : FormalExpression
Type: array
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Nested Schema : CheckValue
Type: object
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Nested Schema : TranslatedText
Type: array
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Nested Schema : Role
Type: object
Roles associated with this item.
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Nested Schema : ItemGroupDef
Type: object
Item group definition aggregating item references, attributes, and metadata.
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Example:
<ItemGroupDef OID="IG.DEMO" Name="Demographics" Repeating="No" IsReferenceData="No" SASDatasetName="DM" Domain="DM" Origin="Collected" Role="Form" Purpose="CRF" Comment="Demographics group"><Description>Demographics item group</Description><ItemRef ItemOID="IT.AGE" Mandatory="Yes" OrderNumber="1"/><ItemRef ItemOID="IT.SEX" Mandatory="Yes" OrderNumber="2"/><Alias Context="SDTM" Name="DMIG"/></ItemGroupDef>
Nested Schema : Alias
Type: array
Aliases providing cross-references, e.g., to SDTM.
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Nested Schema : ItemRef
Type: array
References to items included in this group.
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Nested Schema : ITEMREF
Type: object
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Nested Schema : CONTROLREF
Type: object
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Nested Schema : MethodDef
Type: object
Definition of a computation or derivation used within the ODM metadata, including description, formal expressions, aliases, and attributes.
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Example:
<MethodDef OID="MD.METH001" Name="DoseComputation" Type="Computation">
  <Description>
    <TranslatedText xml:lang="en">Compute derived dose based on weight and concentration</TranslatedText>
  </Description>
  <FormalExpression Context="SAS">if (WEIGHT GT 0) then DOSE=WEIGHT*CONC; else DOSE=.;</FormalExpression>
 <Alias Context="CDISC" Name="DRVDose"/>
</MethodDef>
Nested Schema : Alias
Type: array
Aliases providing alternative names in different contexts.
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Nested Schema : FormalExpression
Type: array
One or more formal expressions describing the method logic and its execution context.
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Nested Schema : Presentation
Type: object
Presentation element containing display text and metadata.
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Example:
<Presentation OID="PRES001" xml:lang="en">Tablet, 50 mg</Presentation>
Nested Schema : Alias
Type: array
Optional aliases for the protocol.
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Nested Schema : StudyEventRef
Type: array
References to study events that constitute the schedule of assessments.
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Nested Schema : StudyEventRef
Type: object
Reference to a study event within the protocol schedule, including ordering and mandatory collection attributes.
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Example:
{
    "studyEventOID":"SE_VISIT1",
    "orderNumber":1,
    "mandatory":"Yes",
    "collectionExceptionConditionOID":"COND_001"
}
Nested Schema : StudyEventDef
Type: object
Study event definition containing form references, scheduling attributes, and metadata.
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Example:
<StudyEventDef OID="SE.VISIT1" Name="Visit 1" Repeating="No" Type="Scheduled" Category="Screening"><Description>Initial screening visit</Description><FormRef FormOID="FRM.DEMO" Mandatory="Yes" OrderNumber="1"/><Alias Context="SDTM" Name="SV"/></StudyEventDef>
Nested Schema : Alias
Type: array
Aliases providing cross-references (e.g., SDTM).
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Nested Schema : FormRef
Type: array
References to forms associated with this study event.
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Nested Schema : FORMREF
Type: object
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Nested Schema : SECTIONREF
Type: object
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Nested Schema : ITEMSETREF
Type: object
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400 Response

'Missing / invalid data'
Body ()
Root Schema : DataHubResponse
Type: object

Standard Data Hub response envelope.

Successful responses return status as "success" and populate result. Failed responses return status as "failed" and populate errorData.

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Nested Schema : errorData
Type: object

Machine-readable error payload when status is "failed".

This field is null when status is "success".

Example:
{
    "errorCode":"VALIDATION_ERROR",
    "errorMessage":"Invalid column name specified in the select columns: SITE_ID1",
    "details":{
        "field":"selectColumns"
    }
}
Nested Schema : result
Type: object

Payload returned by the API when status is "success".

This field is null when status is "failed".

Example:
{
    "message":"Operation succeeded"
}
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