Post on 07-Feb-2019
Introduction to the Operational Data Model (ODM)
CDISC European Italian-Speaking User Group MeetingMilano, 16 November 2007
Dr. Philippe VerplanckeXClinical GmbH
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“End-to-end” process (overview)
LABs
Sponsor
Investigator
CRO
Subject
ODM
OD
M
ODM
LAB
LAB
OD
M
Archive
Archive
SDTMADaMODM
Define.XML
“End-to-end” process (detail)
SDTMADaM
EDCCDM
Standard Analysis
Extraction,Transformation,
Loading
Trial Design
ODMExport
ODM
Shared value-level
ODM metadata
OperationalDatabase;Normalized, vertical
Analysis & SubmissionDatabase;Denormalizedpartially horizontal
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What is the ODM?
• ODM is a standard for representing clinical trials data - CRF data as well as data tabulations (SDTM) - to support data interchange and archive.
• Specification of an XML standard for describing clinical trials data that is vendor neutral, platform independent & ensures 21 CFR Part 11 compliance (audit trailing, electronic signatures, etc.)
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Why XML?
• Well suited for clinical data software systems• Vendor neutral• Platform independent, flexible• Designed for interchange of data between
heterogeneous systems• Files can be automatically checked for
syntactical, structural and semantic correctness (with XML schemas)
• Easy to transform in PDF and other formats
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ODM Advantages
• Single format provides all components needed to describe clinical research data with attribution requirements mandated by regulatory agencies.
• Reduces the number of unique file formats a clinical application needs to support.
• The ODM provides features that can improve the integrity and reliability of clinical data interchange.
• Flexibility in design means ODM can be adapted to any clinical research application where clinical data is needed.
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History
1999 2000 2001 2002 2003 2004
ODM V1.0 ODM V1.1 ODM V1.2
200519981997
CDISC Volunteer Group
CDISC Europe
DIA SIACFormed
CDISC Incorporated
CDISC Japan
SDTM into guidance
Define.XML guidance
ODM V1.3
2006
ODMCertification
Program
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• Was introduced by CDISC in September 2006 at the 3rd Interchange Meeting in Bethesda
• Independent testing procedures aimed at eliminating variability in ODM toolsets and at ensuring consistency in interoperability between ODM implementations
• The first official certification logos for full compliance with ODM were received by XClinical (EDC system “MARVIN”) and Datalabs (acquired by Clinphone)
ODM Certification Program
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ODM Use Cases (1/2)
• Data Interchange – Transfer of information between two or more parties than maintains the integrity of the contents of the data.
• Data Archive – Long term storage of files that are no longer in active use
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ODM Use Cases (2/2)
• Automatic set up of EDC / CDM systems• Data Acquisition
– eCRF– ePRO– EHR
• eSource• Submission of CRF raw data (ODM XML files)• Submission of SDTM data (ODM XML files
instead of SAS transport files)
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Use Case: Data Interchange
• One of the original use cases for the model• Ability to interchange Metadata and / or
Clinical Data
ODMXML
MetaData
Data
A BAudit
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ODM: MetaData
Site Details
Site No.:_______
Subject's Characteristics
Number:_______
Sex: M [ ] F [ ]
Height: _________ cm
Weight: _________ kg
ODMXML
MetaData
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ODM Metadata XML elements
StudyEventDef
FormDef
ItemGroupDef
ItemDef
MetaDataVersion
Protocol
Study
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ODM: Data
ODMXMLData
Site Details
Site No.:___5___
Subject's Characteristics
Number:__12___
Sex: M [Y] F [ ]
Height: ___156__ cm
Weight: ___87.2___ kg
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ODM Data XML elements
StudyEventData
FormData
ItemGroupData
ItemData
ClinicalData
SubjectData
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SubjectData
Clinical Data Keys
StudyEventData
FormData
ItemGroupData
ItemData
attributes
ClinicalData
@ ItemGroupRepeatKey
attributes @ FormRepeatKey
attributes @ StudyEventRepeatKey
attributes @ StudyOID
attributes@ SubjectKey
@ StudyEventOID
@ FormOID
@ ItemGroupOID
attributes@ ItemOID
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Example traditional data file
• Traditional Approach
12,5,M,87.2,156
Site Details
Site No.:___5___
Subject's Characteristics
Number:__12___
Sex: M [Y] F [ ]
Height: ___156___ cm
Weight: ___87.2___ kg
Data
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Example ODM data file
• ODM <ItemGroupDef OID="IG_COMMON" Repeating="No" SASDatasetName="COMMON" Name="Common" Domain="DM">
<ItemRef ItemOID="I_SITE" Mandatory="Yes" OrderNumber="1"/>
<ItemRef ItemOID="I_SUBJECTID" Mandatory="Yes" OrderNumber="2"/>
<ItemRef ItemOID="I_SEX" Mandatory="Yes" OrderNumber="3"/>
</ItemGroupDef>
<ItemGroupDef OID="IG_PE" Repeating="No" SASDatasetName="PHYEXBAS" Name="Physical Exam" Domain="VS">
<ItemRef ItemOID="I_HEIGHT" Mandatory="Yes" OrderNumber="1"/>
<ItemRef ItemOID="I_WEIGHT" Mandatory="Yes" OrderNumber="2"/>
</ItemGroupDef>…….<ItemDef OID="I_HEIGHT" Name="Height" DataType="integer" SDSVarName="VSORRES" Length="3" SASFieldName="HEIGHT">
<Question><TranslatedText xml:lang="en">Height</TranslatedText>
</Question><MeasurementUnitRef MeasurementUnitOID="MU_CMS"/>
</ItemDef>……...<SubjectData SubjectKey="SUBJECT_12" TransactionType="Insert">
<StudyEventData StudyEventOID="BASELINE"><FormData FormOID="F_BASELINE">
<AuditRecord><UserRef UserOID="USER_2"/><LocationRef LocationOID="LOCATION_2"/><DateTimeStamp>2005-05-23T07:30:16.000+01:00</DateTimeStamp><ReasonForChange>Initial Entry</ReasonForChange>
</AuditRecord>…<ItemGroupData ItemGroupOID="IG_PE_BASE">
<ItemData ItemOID="I_HEIGHT" Value=“156“/><ItemData ItemOID="I_WEIGHT" Value=“87.2“/>
</ItemGroupData>
Metadata
Data
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Use Case: Audit & Archive
ODMXML
Audit
Site Details
Site No.:___5___
Subject's Characteristics
Number:__12___
Sex: M [Y] F [ ]
Height: ___1560__ cm
Weight: ___87.2___ kg
156ABC
1/1/2005
Data
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ItemData
AuditRecord
ODM elements for Audit & Archive
Signature
MeasurementUnitRef
Annotation
attributes
@ ItemOID
@ TransactionType
@ Value
@ IsNull
attributes
@ EditPoint
@ UsedImputationMethodUserRef
LocationRef
DateTimeStamp
ReasonForChange
SourceID
Archive
What
Why
Who
When
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ODM: Administrative
ODMXMLAdm
in
Doctor Green
Site Yellow
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Use Case: Set up of EDC/CDMS
• Use of the ODM Metadata to configure tools• eCRF systems
– Several vendors using ODM-based mechanisms• eDiary systems
– At least one system uses ODM for configuration purposes
• ODM Version 1.3 developed to include additional support
ODMXML
MetaData
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Practical Experience1. ACRO Standard Form
2. CDISC SDTM Standard
3. ACRO Form + CDISC SDTM Standard = Annotated Form
5. Standard electronicmetadata
configures collection system
4. Annotated Form + ODM Standard = Standard electronicmetadata (XML)
<ODM><Study>
<Meta…</Meta…
</Study></ODM>
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Electronic Configuration (ACRO)
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Electronic Configuration (ACRO)
Courtesy of Assero
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Electronic Configuration (ACRO)
Courtesy of Formedix
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Electronic Configuration (ACRO)
Courtesy of XClinical
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Electronic Configuration (ACRO)
Courtesy of XML4Pharma
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Electronic Configuration (ACRO)
Courtesy of Outcome
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Acquisition
Sponsor
Site A Site B Site C
EDC EHR Paper
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Acquisition
• ODM allows for integration of multiple data sources
Sponsor
Site A Site B Site C
EDC EHR Paper
ODM
ODMXML
Data
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eSource
• Investigator is obliged to– Maintain source data (accurate)– Retain source data– Prevent its destruction– Allow access to inspectors
ElectronicSource
Sponsor
ODMXML
MetaData
Data Audit
ODMXML
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ODM for Submission of CRF data
ODMXML
XSLTTransformation
Audit
ODMXML
XSLTTransformation
MetaData
Data
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FR / Vol. 72, No. 48 / Tuesday, March 13, 2007
Updated
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ODM for Submission of SDTM data
• The FDA is developing an electronic submissions review environment based on CDISC Submission Standards– Current environment based on 1999
eSubmissions Guidance– Define.pdf – Metadata documentation– SAS Transport Files – for CRTs
• Seek to gain efficiencies through use of standard tools & implementation of Janus data warehouse
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Submission components
• Submission MetaData– Currently uses PDF mechanism – Define.PDF– ODM version – Define.XML
• Submission Datasets – Currently SAS XPORT Transport (XPT)– ODM support being developed
• CRF Data and Audit Trail – Currently paper or PDF– CDISC ODM (pilot phase)
• Annotated CRF– Currently PDF– CDISC ODM (pilot phase)
Based on a Slide by Randy Levin, M.D. Director for Health and Regulatory Data Standards, FDA, November 2004, DIA Meeting, Amsterdam
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Submission guidances
http://www.fda.gov/cder/regulatory/ersr/ectd.htm
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Submission guidances
• Study Data Tabulation Model (SDTM)– Referenced in FDA Guidance as of 21 July 04
• Federal Register announcement– Department of Health and Human Services, Semiannual Regulatory
Agenda (26818 Federal Register / Vol. 70, No. 93 / Monday, May 16, 2005 / Unified Agenda)
– “The proposal would revise our regulations to require that CSD [Clinical Study Data] submitted for NDAs, ANDAs, BLAs, and theirsupplements and amendments be provided in electronic format and require the use of standard data structure, terminology, and code sets.”
• Define.XML– Referenced in FDA Guidance as of 18 March 05
• Federal Register announcement– Federal Register / Vol. 70, No. 209 / Monday, October 31, 2005 /
The Regulatory Plan
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Define.XML = SDTM metadata in ODM format
ODM XML
CRF SDTMDefine.XML
MetaData
DataAudit
MetaData
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• Schema -- uses new ODM schema extension methdology– Def namespace
• Extends ItemGroupDef & ItemDef to meet all SDS metadata requirements
• Borrows leaf/xlink mechanism from eCTD to include external files:– Annotated CRF– SAS Transport Files
• Anticipates Analysis file needs – provides measure specific metadata
Define.XML
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SDS Domain MetaData in define.xml
• Dataset Name – ItemGroupDef Domain• Description – ItemGroupDef Name• Location – extended attribute• Structure – extended attribute • Purpose – ItemGroupDef Purpose• Key Fields – extended attribute
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SDS Variable MetaData in define.xml
• Variable Name – ItemDef Name• Variable Description – Extension (def:label)• Type – ItemDef DataType • Format – ItemDef CodeListRef• Origin – ItemgDef Origin• Role – ItemRef Role• Comments – ItemDef Comment
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Float/Derived54Weight in kgWGTCM
Float/Derived20BodyMassIndexBMI
Float/Derived178Height in cmHGTCM
Integer125Weight in poundsWGTLB
Integer65Height in inchesHGTIN
DatatypeVSORRESVSTestVSTestCD
SDS Value Level MetaData
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SDS Value-level MetaData in define.xml
• TESTCD – ItemDef OID• TEST – ItemDef attribute (def:label)• etc.
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The Next Step
ODM XML
CRF SDTMDefine.XML
MetaData
DataAudit
MetaData
SDTM?
Data
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ODM as the Backbone
LABs
Sponsor
Investigator
CRO
Subject
ODM
About the speaker
• XClinical, founded 2002, is an EDC-CDM vendor with offices in Munich, Paris and Cambridge, US.
• Active member of CDISC
• MARVIN is our online, integrated EDC-CDM SystemØ GCP system validated, 21 CFR 11 compliant
Ø ODM certified
• ODM study composer, SDTM tabulator tool
• 44+ studies, 45.300+ patients
Thank you
• Questions?
• Contact– philippe.verplancke@xclinical.com
– Tel. +49 89 4522775100