addressing the gap in data standards: introducing the ...introducing the aggregation layer dh11 ......
TRANSCRIPT
![Page 1: Addressing the Gap in Data Standards: Introducing the ...Introducing the Aggregation Layer DH11 ... PowerPoint Presentation Author: b Created Date: 11/19/2019 8:03:20 PM](https://reader036.vdocuments.site/reader036/viewer/2022071411/61069e0f934ec721522528fc/html5/thumbnails/1.jpg)
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
![Page 2: Addressing the Gap in Data Standards: Introducing the ...Introducing the Aggregation Layer DH11 ... PowerPoint Presentation Author: b Created Date: 11/19/2019 8:03:20 PM](https://reader036.vdocuments.site/reader036/viewer/2022071411/61069e0f934ec721522528fc/html5/thumbnails/2.jpg)
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
![Page 3: Addressing the Gap in Data Standards: Introducing the ...Introducing the Aggregation Layer DH11 ... PowerPoint Presentation Author: b Created Date: 11/19/2019 8:03:20 PM](https://reader036.vdocuments.site/reader036/viewer/2022071411/61069e0f934ec721522528fc/html5/thumbnails/3.jpg)
Copyright © 2019, Oracle and/or its affiliates. All rights reserved. |
Introduction
CDASH
SDTM ADaM?
![Page 4: Addressing the Gap in Data Standards: Introducing the ...Introducing the Aggregation Layer DH11 ... PowerPoint Presentation Author: b Created Date: 11/19/2019 8:03:20 PM](https://reader036.vdocuments.site/reader036/viewer/2022071411/61069e0f934ec721522528fc/html5/thumbnails/4.jpg)
Copyright © 2019, Oracle and/or its affiliates. All rights reserved. |
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)
….
![Page 5: Addressing the Gap in Data Standards: Introducing the ...Introducing the Aggregation Layer DH11 ... PowerPoint Presentation Author: b Created Date: 11/19/2019 8:03:20 PM](https://reader036.vdocuments.site/reader036/viewer/2022071411/61069e0f934ec721522528fc/html5/thumbnails/5.jpg)
Copyright © 2019, Oracle and/or its affiliates. All rights reserved. |
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
![Page 6: Addressing the Gap in Data Standards: Introducing the ...Introducing the Aggregation Layer DH11 ... PowerPoint Presentation Author: b Created Date: 11/19/2019 8:03:20 PM](https://reader036.vdocuments.site/reader036/viewer/2022071411/61069e0f934ec721522528fc/html5/thumbnails/6.jpg)
Copyright © 2019, Oracle and/or its affiliates. All rights reserved. |
Stats
uses
SDTM (ADaM)
Data Manager
uses
something?
Identifying the Gap (#2)Lack of a standard for data cleaning
DB designer
uses
CDASH
![Page 7: Addressing the Gap in Data Standards: Introducing the ...Introducing the Aggregation Layer DH11 ... PowerPoint Presentation Author: b Created Date: 11/19/2019 8:03:20 PM](https://reader036.vdocuments.site/reader036/viewer/2022071411/61069e0f934ec721522528fc/html5/thumbnails/7.jpg)
Copyright © 2019, Oracle and/or its affiliates. All rights reserved. |
Identifying the Gap (#2)Lack of a standard for data cleaning
Data Manager
uses
something?
![Page 8: Addressing the Gap in Data Standards: Introducing the ...Introducing the Aggregation Layer DH11 ... PowerPoint Presentation Author: b Created Date: 11/19/2019 8:03:20 PM](https://reader036.vdocuments.site/reader036/viewer/2022071411/61069e0f934ec721522528fc/html5/thumbnails/8.jpg)
Copyright © 2019, Oracle and/or its affiliates. All rights reserved. |
Identifying the Gap (#3)Lack of a deliberate data architecture
![Page 9: Addressing the Gap in Data Standards: Introducing the ...Introducing the Aggregation Layer DH11 ... PowerPoint Presentation Author: b Created Date: 11/19/2019 8:03:20 PM](https://reader036.vdocuments.site/reader036/viewer/2022071411/61069e0f934ec721522528fc/html5/thumbnails/9.jpg)
Copyright © 2019, Oracle and/or its affiliates. All rights reserved. |
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
![Page 10: Addressing the Gap in Data Standards: Introducing the ...Introducing the Aggregation Layer DH11 ... PowerPoint Presentation Author: b Created Date: 11/19/2019 8:03:20 PM](https://reader036.vdocuments.site/reader036/viewer/2022071411/61069e0f934ec721522528fc/html5/thumbnails/10.jpg)
Copyright © 2019, Oracle and/or its affiliates. All rights reserved. |
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
![Page 11: Addressing the Gap in Data Standards: Introducing the ...Introducing the Aggregation Layer DH11 ... PowerPoint Presentation Author: b Created Date: 11/19/2019 8:03:20 PM](https://reader036.vdocuments.site/reader036/viewer/2022071411/61069e0f934ec721522528fc/html5/thumbnails/11.jpg)
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
12
![Page 12: Addressing the Gap in Data Standards: Introducing the ...Introducing the Aggregation Layer DH11 ... PowerPoint Presentation Author: b Created Date: 11/19/2019 8:03:20 PM](https://reader036.vdocuments.site/reader036/viewer/2022071411/61069e0f934ec721522528fc/html5/thumbnails/12.jpg)
Copyright © 2019, Oracle and/or its affiliates. All rights reserved. |
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
![Page 13: Addressing the Gap in Data Standards: Introducing the ...Introducing the Aggregation Layer DH11 ... PowerPoint Presentation Author: b Created Date: 11/19/2019 8:03:20 PM](https://reader036.vdocuments.site/reader036/viewer/2022071411/61069e0f934ec721522528fc/html5/thumbnails/13.jpg)
Copyright © 2019, Oracle and/or its affiliates. All rights reserved. |
Case StudyLimiting the impact of errors
Aggregation
Linear Source Safety DMRM SDTM ADS
Source Aggregation
DMRM
SDTM
ADS
Safety
![Page 14: Addressing the Gap in Data Standards: Introducing the ...Introducing the Aggregation Layer DH11 ... PowerPoint Presentation Author: b Created Date: 11/19/2019 8:03:20 PM](https://reader036.vdocuments.site/reader036/viewer/2022071411/61069e0f934ec721522528fc/html5/thumbnails/14.jpg)
Copyright © 2019, Oracle and/or its affiliates. All rights reserved. |
Case StudyLimiting the impact of errors
Aggregation
Linear Source Safety DMRM SDTM ADS
Source Aggregation
DMRM
SDTM
ADS
Safety
Work CONTINUES
Work STOPS
![Page 15: Addressing the Gap in Data Standards: Introducing the ...Introducing the Aggregation Layer DH11 ... PowerPoint Presentation Author: b Created Date: 11/19/2019 8:03:20 PM](https://reader036.vdocuments.site/reader036/viewer/2022071411/61069e0f934ec721522528fc/html5/thumbnails/15.jpg)
Copyright © 2019, Oracle and/or its affiliates. All rights reserved. |
Case StudyReducing Redundancy To Simplify Maintenance
Aggregation
Linear Source Safety DMRM SDTM ADS
Source Aggregation
DMRM
SDTM
ADS
Safety
![Page 16: Addressing the Gap in Data Standards: Introducing the ...Introducing the Aggregation Layer DH11 ... PowerPoint Presentation Author: b Created Date: 11/19/2019 8:03:20 PM](https://reader036.vdocuments.site/reader036/viewer/2022071411/61069e0f934ec721522528fc/html5/thumbnails/16.jpg)
Copyright © 2019, Oracle and/or its affiliates. All rights reserved. |
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
![Page 17: Addressing the Gap in Data Standards: Introducing the ...Introducing the Aggregation Layer DH11 ... PowerPoint Presentation Author: b Created Date: 11/19/2019 8:03:20 PM](https://reader036.vdocuments.site/reader036/viewer/2022071411/61069e0f934ec721522528fc/html5/thumbnails/17.jpg)
Copyright © 2019, Oracle and/or its affiliates. All rights reserved. |
Case StudyAvoiding Unnecessary Transformations
Aggregation
Linear Source Safety DMRM SDTM ADS
Source Aggregation
DMRM
SDTM
ADS
Safety
![Page 18: Addressing the Gap in Data Standards: Introducing the ...Introducing the Aggregation Layer DH11 ... PowerPoint Presentation Author: b Created Date: 11/19/2019 8:03:20 PM](https://reader036.vdocuments.site/reader036/viewer/2022071411/61069e0f934ec721522528fc/html5/thumbnails/18.jpg)
Copyright © 2019, Oracle and/or its affiliates. All rights reserved. |
Case StudyKeeping Control Of Blinding
Aggregation
Linear Source Safety DMRM SDTM ADS
Source Aggregation
DMRM
SDTM
ADS
Safety
Black box
![Page 19: Addressing the Gap in Data Standards: Introducing the ...Introducing the Aggregation Layer DH11 ... PowerPoint Presentation Author: b Created Date: 11/19/2019 8:03:20 PM](https://reader036.vdocuments.site/reader036/viewer/2022071411/61069e0f934ec721522528fc/html5/thumbnails/19.jpg)
Copyright © 2019, Oracle and/or its affiliates. All rights reserved. |
Case StudySDTM "plug-n-play"
Aggregation
Linear Source Safety DMRM SDTM ADS
Source Aggregation
DMRM
SDTM
ADS
Safety
![Page 20: Addressing the Gap in Data Standards: Introducing the ...Introducing the Aggregation Layer DH11 ... PowerPoint Presentation Author: b Created Date: 11/19/2019 8:03:20 PM](https://reader036.vdocuments.site/reader036/viewer/2022071411/61069e0f934ec721522528fc/html5/thumbnails/20.jpg)
Copyright © 2019, Oracle and/or its affiliates. All rights reserved. |
Case StudySDTM "plug-n-play"
Aggregation
Linear Source Safety DMRMSDTM
ADS
Source Aggregation
DMRM
SDTM
ADS
Safety
SDTMNEW
SDTMNEW
![Page 21: Addressing the Gap in Data Standards: Introducing the ...Introducing the Aggregation Layer DH11 ... PowerPoint Presentation Author: b Created Date: 11/19/2019 8:03:20 PM](https://reader036.vdocuments.site/reader036/viewer/2022071411/61069e0f934ec721522528fc/html5/thumbnails/21.jpg)
Copyright © 2019, Oracle and/or its affiliates. All rights reserved. |
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
![Page 22: Addressing the Gap in Data Standards: Introducing the ...Introducing the Aggregation Layer DH11 ... PowerPoint Presentation Author: b Created Date: 11/19/2019 8:03:20 PM](https://reader036.vdocuments.site/reader036/viewer/2022071411/61069e0f934ec721522528fc/html5/thumbnails/22.jpg)
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
![Page 23: Addressing the Gap in Data Standards: Introducing the ...Introducing the Aggregation Layer DH11 ... PowerPoint Presentation Author: b Created Date: 11/19/2019 8:03:20 PM](https://reader036.vdocuments.site/reader036/viewer/2022071411/61069e0f934ec721522528fc/html5/thumbnails/23.jpg)
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?
![Page 24: Addressing the Gap in Data Standards: Introducing the ...Introducing the Aggregation Layer DH11 ... PowerPoint Presentation Author: b Created Date: 11/19/2019 8:03:20 PM](https://reader036.vdocuments.site/reader036/viewer/2022071411/61069e0f934ec721522528fc/html5/thumbnails/24.jpg)
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)
![Page 25: Addressing the Gap in Data Standards: Introducing the ...Introducing the Aggregation Layer DH11 ... PowerPoint Presentation Author: b Created Date: 11/19/2019 8:03:20 PM](https://reader036.vdocuments.site/reader036/viewer/2022071411/61069e0f934ec721522528fc/html5/thumbnails/25.jpg)
Copyright © 2019, Oracle and/or its affiliates. All rights reserved. |
Claudio Garutti
Marko Bomyer
Thank you! Questions?