Research FRANCE Stephane AUGER A Coherent and Practical EndtoEnd M etadata S trategy using Existing S tandards and Tools for Clinical Research CONTEXT Clinical studies performed in 4 divisions ID: 380257
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Slide1
Danone Research, FRANCE
Stephane AUGER
A
Coherent
and
Practical End-to-End
M
etadata
S
trategy
using
Existing
S
tandards
and
Tools
for Clinical ResearchSlide2
CONTEXT
Clinical studies performed in 4 divisions
Dairy
,
Waters,
Baby and Medical Nutrition
Historically
Mostly paper-based studies until very recently
DM Outsourced to CROs
Few internal data / metadata standards
Result
Few controls
on data / metadata received from CROs
Lack
of homogeneity between
studies
Resource intensive to pool for meta analysis or
format for a DR/DWSlide3
CONTEXT
2010
Upper management request for a “Data Warehouse”
“First, we need to get
more
control over
our clinical
study metadata”
Thought process to address the end goal:
Use existing tools/software as much as possible
Standardize up front… CDISC SDTM, CDASH, ODM
A bonus if we could make metadata management and study set-up more efficientSlide4
Key Decision #1
:Metadata Standards Management (1)
Manage Study Metadata Standards
CRF Forms, Item Groups, Items,
Codelists
Item Characteristics (type, formats, range values etc.)
CRF
completion
guidelines / help text
Database structure
Based on SDTM/CDASH
Implementation of a
Study Metadata Modeler
(SMM) … with a duel useSlide5
Key Decision #1
:Metadata Standards Management (2)
Create
Study-Specific
Metadata
Use Metadata Library to create a study-specific “CRF”
Export study-specific “CRF” in
ODM
format to an EDC system
→
Requires ODM-compatible EDC system
Implementation
of
a
Study Metadata Modeler
(SMM
) … with a duel useSlide6
SMM Functionality
SMM
EDC
ODM
ODM
Visit Layout
Simple
Edit Checks
DB Structure
CRF
Custom Attributes
IWRS
Coding
TSDV
Database Admin.
Workflow
C
onfig
.
Complex
Edit Checks
Custom ConfigurationSlide7
Key Decision #1
:Metadata Standards Management (3)
SMM
-
Implementation Experience
Define
company standard
CRF forms and variablesWorkgroups representing Clin Ops, QA, Statistics, Data Management1 year –
80 man/days
Resulted
in a Data Standards Committee and change management processDefine standard DB structure in the SMMEach EDC has different production database specificities
One library for multiple EDC systems
SMM provider an essential resource
3 months –
60 man/daysSlide8
Key Decision #2
:ODM-Compliant EDC (1)
ODM-in
Import Study-Specific CRF metadata - ODM file
ODM-out
Export study metadata & study data in ODM
Implementation
of
ODM-compliant
EDC tool(s)Slide9
Study Set-up: What’s left to do?
SMM
EDC
ODM
ODM
Medical
Coding
Database Admin.
Workflow
C
onfig
.
Complex
Edit Checks
Visit Layout
Simple
Edit Checks
DB Structure
CRF
TSDV
Custom AttributesSlide10
Key Decision #2:
ODM-Compliant EDC (2)
Implementation Experience
Many challenges to overcome and details
to solve
SMM & EDC implementation at the same time
Requires
tech-savy personnel
60-80%
of the EDC study build is done automatically in this process
Main differences between our two EDC tools
Two-step ODM import process
Visit configuration
Complex
e
dit checks need to be re-configured Slide11
Implementation Experience (2)
Impact on EDC budget?75%
decrease in professional
service
costs
62%
decrease in overall EDC budgetImpact on Data Management Resources?No Change in Study Build FTEs (but more tasks performed internally)
≈50 decrease
in study set-up time (Protocol
to EDC Go-Live) ≈ 20% increase in overall DM study budget (vs. Paper-based)
Database &
EDC
Set-up
CRF = EDC Set-up
Reduced Programing
Reduced
Validation
Key Decision
#2
:
ODM-Compliant EDC (3)
Metadata ControlStandardization
EfficiencyWarehouse-ready dataSlide12
Roles and Responsibilities
CRO
EDC Vendor
SMM
EDC
ODM In
Workflow
Config
.
Database Admin.
Complex
Edit Checks
CRF &
Study Build
Danone
(
Data Manager)
In-Study
DM
Hosting & Support
Validation
Custom
Config
.
/
Reports
Database
LockSlide13
Key Decision #3:
ODM-Compliant Mapping Tool
SMM
EDC
ODM
Study Metadata Standards
Study Build ODM
ODM
??Slide14
Key Decision #3
:ODM-Compliant Mapping Tool
Maps ODM (from the EDC) to produce:
SAS transport datasets (SDTM format)
Define.xml
Standardized ODM
Standard Mapping Metadata
Re-Usable mapping scripts
Validation =
only once
Implementation
of
ODM-compliant
Mapping (ETL) toolSlide15
Data Repository?
Key Decision
#3
:
ODM-Compliant
Mapping Tool
ETL
Mapping
Tool
EDC a
ODM
Define.xml
SAS Datasets
ODM
EDC b
ODMSlide16
Clinical Study Data & Metadata Flow: Tools
Mapping
(XML4Pharma)
Metadata
Standards &
Study Set-up
(
Formedix
)
Data Collection (EDC)
(
Medidata
RAVE
OpenClinica
)
METADATA
METADATA + STUDY DATA
Data RepositorySlide17
Clinical Study Data & Metadata Flow:Management
METADATA
METADATA + STUDY DATA
Metadata Standards & Management
Metadata
Standards &
Study Set-up
(
Formedix
)
Mapping
(XML4Pharma)
Data Collection (EDC)
(
Medidata
RAVE
OpenClinica
)
Data RepositorySlide18
Clinical Study Data & Metadata Flow: Standards
METADATA
METADATA + STUDY DATA
Metadata
Standards &
Study Set-up
(
Formedix
)
Mapping
(XML4Pharma)
Data Collection (EDC)
(
Medidata
RAVE
OpenClinica
)
Data Repository
ODM
SDTM
SDTM/CDASH
Define.xmlSlide19
Conclusion
End-to-End metadata standardization and control is possible
There
are significant cost and time savings to be had!
The
tools and standards are
ready and available NOWSlide20
Thank You!