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Copyright © 2019, Oracle and/or its affiliates. All rights reserved. |
Addressing the Gap in Data Standards: Introducing the Aggregation LayerDH11 – Data Handling streamPHUSE EU Connect 2019
Claudio Garutti, Principal Solutions ConsultantMarko Bomyer, Senior Consulting Practice ManagerAmsterdam, 12 November 2019
Copyright © 2019, Oracle and/or its affiliates. All rights reserved. |
Outline
Introduction
Identifying the Gap
Case Study
Best Practices
Conclusion
1
2
3
4
5
3
Copyright © 2019, Oracle and/or its affiliates. All rights reserved. |
Introduction
CDASH
SDTM ADaM?
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Identifying the GapData Models
tablenames
columnnames
columnformats
constraints(e.g. key)
code lists allowedranges
Data Collection
MH (CDASH)
VS (CDASH)
….
EDC raw data
MHIST
VS_1, VS_2, …
….
Lab data SDTM
MH (SDTM)
VS (SDTM)
….
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Identifying the Gap – Gap #1CDASH is the standard for how data is to be collected, not for raw data output
CDASH • EG
Form Design
• EG1
• EG2
EDC Database
• Black box
EDC Extract
• EG1_R
• EG1_NR
• EG2
SDTM • EG
UnionJoin
EGEG1
EG1_R
EG1_NREG2
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Stats
uses
SDTM (ADaM)
Data Manager
uses
something?
Identifying the Gap (#2)Lack of a standard for data cleaning
DB designer
uses
CDASH
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Identifying the Gap (#2)Lack of a standard for data cleaning
Data Manager
uses
something?
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Identifying the Gap (#3)Lack of a deliberate data architecture
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Identifying the Gap (#3)Lack of a deliberate data architecture
Direct Linear
Lab 01
Lab 02
EDC
ePRO
devs
Safety
DMRM
SDTM
ADS
Lab 01
Lab 02
EDC
ePRO
devs
Safety DMRM SDTM ADS
SOURCE CONSUMER SOURCE CONSUMER
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Identifying the Gap (#3)Lack of a deliberate data architecture
Aggregation Layer
Lab 01
Lab 02
EDC
ePRO
devs
Data Model(s)
DMRM
SDTM
ADS
Safety
SOURCE AGGREGATION CONSUMER
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Outline
Introduction
Identifying the Gap
Case Study
Best Practices
Conclusion
1
2
3
4
5
12
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Case StudyLinear architecture vs Aggregation Layer architecture
Aggregation
Linear Source Safety DMRM SDTM ADS
Source Aggregation
DMRM
SDTM
ADS
Safety
High variability
Varies according to the source
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Case StudyLimiting the impact of errors
Aggregation
Linear Source Safety DMRM SDTM ADS
Source Aggregation
DMRM
SDTM
ADS
Safety
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Case StudyLimiting the impact of errors
Aggregation
Linear Source Safety DMRM SDTM ADS
Source Aggregation
DMRM
SDTM
ADS
Safety
Work CONTINUES
Work STOPS
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Case StudyReducing Redundancy To Simplify Maintenance
Aggregation
Linear Source Safety DMRM SDTM ADS
Source Aggregation
DMRM
SDTM
ADS
Safety
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Case StudyReducing Redundancy To Simplify Maintenance
Aggregation
Linear Source ADS
Source Aggregation
DMRM
SDTM
ADS
Safety
Safety+
DMRM+
SDTM+
ADS
DMRM+
SDTM+
ADS
SDTM+
ADS
Redundancy
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Case StudyAvoiding Unnecessary Transformations
Aggregation
Linear Source Safety DMRM SDTM ADS
Source Aggregation
DMRM
SDTM
ADS
Safety
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Case StudyKeeping Control Of Blinding
Aggregation
Linear Source Safety DMRM SDTM ADS
Source Aggregation
DMRM
SDTM
ADS
Safety
Black box
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Case StudySDTM "plug-n-play"
Aggregation
Linear Source Safety DMRM SDTM ADS
Source Aggregation
DMRM
SDTM
ADS
Safety
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Case StudySDTM "plug-n-play"
Aggregation
Linear Source Safety DMRMSDTM
ADS
Source Aggregation
DMRM
SDTM
ADS
Safety
SDTMNEW
SDTMNEW
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Contains All
Derivations
(e.g. calculate BMI once,
serve multiple models)
Standardize
Structure
for re-usability
across studies
Best PracticesAggregation Layer
Internal
Hidden to
end-users
Copyright © 2019, Oracle and/or its affiliates. All rights reserved. |
Outline
Introduction
Identifying the Gap
Case Study
Best Practices
Conclusion
1
2
3
4
5
23
Copyright © 2019, Oracle and/or its affiliates. All rights reserved. |
Conclusion
(1) CDASH ≠ EDC extract
(2) Data managers need
to use something
(3) Deliberate data architecture
CDASH
SDTM ADaM?
Copyright © 2019, Oracle and/or its affiliates. All rights reserved. |
Conclusion
(1) CDASH ≠ EDC extract
(2) Data managers need
to use something
(3) Deliberate data architecture
CDASH
SDTM ADaM?
CDASH
SDTM ADaMAggregation
(+DMRM)
Copyright © 2019, Oracle and/or its affiliates. All rights reserved. |
Claudio Garutti
claudio.garutti@oracle.com
Marko Bomyer
marko.bomyer@oracle.com
Thank you! Questions?
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