Introduction to the

Operational Data Model

(ODM)

CDISC European Italian-Speaking

User Group Meeting
Milano, 16 November 2007

Dr. Philippe Verplancke

XClinical GmbH
 “End-to-end” process (overview)

CRO Sponsor
ODM
Archive
ODM

SDTM
ODM ADaM

B
LA

LA
Investigator ODM
Define.XML
OD
M

Subject LABs
Archive

2
 “End-to-end” process (detail)

EDC
CDM

Operational
Database;
ODM Normalized,
vertical

ODM
Export
Trial Design
Extraction,
Transformation, Standard
Loading Analysis

Shared
value-level SDTM Analysis &
ODM metadata Submission
ADaM
Database;
Denormalized
partially horizontal
 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.)
4
 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
5
 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.
6
 History
ODM
CDISC Volunteer CDISC CDISC SDTM into Certification
Group Europe Japan guidance
Program
DIA SIAC CDISC Define.XML
Formed Incorporated guidance

1997 1998 1999 2000 2001 2002 2003 2004 2005 2006

ODM V1.0 ODM V1.1 ODM V1.2 ODM V1.3

7
 ODM Certification Program

• 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)

8
 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

9
 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)
10
 Use Case: Data Interchange

a it
a t d
D u
ODMA
a
A XML at B
a D
et
M

• One of the original use cases for the model

• Ability to interchange Metadata and / or
Clinical Data

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 ODM: MetaData

Site Details

Site No.:_______

Subject's Characteristics
ta ODM
a
Number:_______
a D
t XML
Sex: M [] F[]
e
Height: _________ cm M
Weight: _________ kg

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 ODM Metadata XML elements

Study

MetaDataVersion

Protocol

StudyEventDef

FormDef

ItemGroupDef

ItemDef
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 ODM: Data

Site Details

Site No.:___5___

Subject's Characteristics

a ODM
Number:__12___
a t
Sex: M [Y] F[] D XML
Height: ___156__ cm

Weight: ___87.2___ kg

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 ODM Data XML elements

ClinicalData

SubjectData

StudyEventData

FormData

ItemGroupData

ItemData
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 Clinical Data Keys
attributes @ StudyOID

ClinicalData
@ SubjectKey
attributes

SubjectData
@ StudyEventOID
attributes @ StudyEventRepeatKey
StudyEventData

@ FormOID
attributes @ FormRepeatKey
FormData

@ ItemGroupOID
attributes
@ ItemGroupRepeatKey
ItemGroupData

@ ItemOID
attributes
ItemData 16
 Example traditional data file

• Traditional Approach
Site Details

Site No.:___5___

Subject's Characteristics

Number:__12___ Data 12,5,M,87.2,156

Sex: M [Y] F[]

Height: ___156___ cm

Weight: ___87.2___ kg

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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"/>

Metadata <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>
…
Data <ItemGroupData ItemGroupOID="IG_PE_BASE">
<ItemData ItemOID="I_HEIGHT" Value=“156“/>
<ItemData ItemOID="I_WEIGHT" Value=“87.2“/>
</ItemGroupData>

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 Use Case: Audit & Archive

Site Details

Site No.:___5___

t a
Subject's Characteristics
a ODM
Number:__12___ D
it XML
Sex: M [Y] F[]
156
u d
Height: ___1560__ cm ABC
1/1/2005 A
Weight: ___87.2___ kg

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 ODM elements for Audit & Archive
ItemData
attributes
Archive @ ItemOID

@ TransactionType
AuditRecord attributes
@ Value

@ EditPoint
@ IsNull
UserRef
@ UsedImputationMethod
LocationRef

DateTimeStamp Who

ReasonForChange What
SourceID When

Signature Why
MeasurementUnitRef

Annotation

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ODM: Administrative

Site Yellow

in ODM
d m XML
A
Doctor Green

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 Use Case: Set up of EDC/CDMS

ODM
XML ata
a D
et
M
• 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
22
Association of CROs

http://www.acrohealth.org/
23
 Practical Experience
1. ACRO
Standard Form

4. Annotated Form +
ODM Standard =
Standard electronic
metadata (XML)

<ODM>
<Study>
<Meta…
</Meta…
</Study>
</ODM>

5. Standard
3. ACRO Form +
electronic
CDISC SDTM
metadata
Standard =
configures
Annotated Form
collection system

2. CDISC SDTM
Standard 24
Electronic Configuration (ACRO)

25
 Electronic Configuration (ACRO)

Courtesy of Assero 26
 Electronic Configuration (ACRO)

Courtesy of Formedix 27
 Electronic Configuration (ACRO)

Courtesy of XClinical 28
 Electronic Configuration (ACRO)

Courtesy of XML4Pharma 29
 Electronic Configuration (ACRO)

Courtesy of Outcome 30
 Acquisition

Sponsor

EDC EHR Paper

Site A Site B Site C

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 Acquisition

Sponsor
• ODM allows for
ta
integration of a
D
ODM
multiple data XML
sources
D M
O

EDC EHR Paper

Site A Site B Site C

32
 eSource

it
ta ud
• Investigator is obliged to a A
D
ODM
– Maintain source data (accurate) t a
XML a
– Retain source data a D
et
– Prevent its destruction M
– Allow access to inspectors
Sponsor

ODM Electronic
XML Source

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 ODM for Submission of CRF data

ODM XSLT
XML t a Transformation
a
a D
e t
M

ta
a
D
ODM XSLT
XML Transformation
it
u d
A

34
FR / Vol. 72, No. 48 / Tuesday, March
13, 2007 a ted
Upd

35
 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
36
 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 37
 Submission guidances

http://www.fda.gov/cder/regulatory/ersr/ectd.htm 38
 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 their
supplements 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
39
 Define.XML = SDTM metadata in ODM
format

t a a
a a t
a D D
e t t a
M
CRF t
M
e
SDTM
a d i Define.XML
t
D
a Au

ODM XML

40
 Define.XML

• 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
41
 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

42
 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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 SDS Value Level MetaData

VSTestCD VSTest VSORRES Datatype

HGTIN Height in inches 65 Integer

WGTLB Weight in pounds 125 Integer

HGTCM Height in cm 178 Float/Derived

WGTCM Weight in kg 54 Float/Derived

BMI BodyMassIndex 20 Float/Derived

44
 SDS Value-level MetaData in define.xml

• TESTCD – ItemDef OID

• TEST – ItemDef attribute (def:label)
• etc.

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 The Next Step

t a
a a ta
a t aD a
aD et D
et M
M
CRF t
SDTM SDTM
a d i Define.XML ?
t
D
a Au

ODM XML

46
 ODM as the Backbone

CRO Sponsor

ODM
Investigator

Subject LABs

47
 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 System
Ø 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