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CDISC Library try-out: from implementation to evaluation of the API Roman Radelicki – Team Manager Data Programming, SGS PHUSE US Connect 2020 - Orlando | 8-11 March 2020
CDISC Library try-out: from implementation to evaluation of the APIRoman Radelicki – Team Manager Data Programming, SGS
PHUSE US Connect 2020 - Orlando | 8-11 March 2020
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n Metadata Centric Approach
n CDISC 360 – CDISC Library
n Trial Summary
n CDISC Library - API calls
n Conclusion
AGENDA
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Metadata Centric ApproachOur current way of working
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METADATA CENTRIC APPROACH
Client A – Trial ASGS IG v5.0
CLIENT X IG v1.0
CLIENT Y IG v1.0
CLIENT Z IG v3.2
CLIENT Y IG v2.0
CLIENT Z IG v3.3
MDR
SGS IG v5.0Client B – Trial B
SGS IG v5.0
Client Y – Trial Y CLIENT Y IG v2.0
Trials
Annotation Tool
MDR Driven ToolsMappingTool
MetadataCenter
DEA – TS tool
Define.xml
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CDISC 360 – CDISC Library
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n Biomedical concepts: create meaning between data
n Standards as linked metadata
n metadata-driven end-to-end automation
n Non-standard experts use the CDISC standards
n CDISC Library REST API
CDISC 360 – CDISC LIBRARY
EXPERTISE
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API? n Application programming interfacen Key building blocks in service digitalization and integrationn The restaurant analogy
§ As a customer à not allowed in the kitchen§ To know what’s available à menu§ Make your order to a waiter§ The waiter passes it to the kitchen and will deliver what you have
asked for
§ Waiter = API§ Menu = documentation§ Kitchen = server/database
CDISC 360 – CDISC LIBRARY
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Trial SummaryCase study
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n TS§ Part of the Trial Design datasets § describe the characteristics of the trial§ such as trial phase, protocol title, and trial objectives
n In house developed tool to create the TS dataset§ Created manually§ Values controlled by terminology
n Ideal case study candidate§ Try out CDISC Library API§ Linked metadata
TRIAL SUMMARY
SAFETY
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Trial SummaryDemonstration
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Demonstration
TRIAL SUMMARY
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Demonstration
TRIAL SUMMARY
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Demonstration
TRIAL SUMMARY
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Demonstration
TRIAL SUMMARY
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Demonstration
TRIAL SUMMARY
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Demonstration
TRIAL SUMMARY
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Demonstration
TRIAL SUMMARY
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Demonstration
TRIAL SUMMARY
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Demonstration
TRIAL SUMMARY
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Demonstration
TRIAL SUMMARY
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Demonstration
TRIAL SUMMARY
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Demonstration
TRIAL SUMMARY
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Demonstration
TRIAL SUMMARY
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Demonstration
TRIAL SUMMARY
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CDISC LIBRARYAPI calls
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Can we use API requests in stead of our MDR?
n Are the standards we need available in CDISC Library?
n How do I create an CDISC Library Account?
n Can we retrieve the information needed for the TS tool?
n Is more linked metadata available?
CDISC LIBRARY - API CALLS
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CDISC LIBRARY - API CALLS
Can we use API requests in stead of our MDR?
n Are the standards we need available in CDISC Library?
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CDISC LIBRARY - API CALLS
Can we use API requests in stead of our MDR?
n How do I create an CDISC Library Account?
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• https://www.cdisc.org/cdisc-library• Request an account• CDISC Library API Account Request• License Agreement
• Welcome package: information to get you started
• Account details to access the CDISC Library API
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CDISC LIBRARY - API CALLS
Can we use API requests in stead of our MDR?
n Can we retrieve the information needed for the TS tool?
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Demonstration
TRIAL SUMMARY
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Demonstration
TRIAL SUMMARY
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Create API request to get more info about the TSPARMCD from the SDTM Implementation Guide
n From the CDISC Library documentation:
n API Call:
CDISC LIBRARY - API CALLS
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XML?n Extensible Markup Language
n format for representing data that is both human-readable and machine-readable
CDISC LIBRARY - API CALLS
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XML result:
CDISC LIBRARY - API CALLS
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Next API call: TSPARMCD codelist:
n From the CDISC Library documentation:
n API Call:
CDISC LIBRARY - API CALLS
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XML result:
CDISC LIBRARY - API CALLS
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Next API call: term “adaptive Study Design Indicator”:
n API Call:
CDISC LIBRARY - API CALLS
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XML result:
CDISC LIBRARY - API CALLS
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CDISC LIBRARY - API CALLS
Can we use API requests in stead of our MDR?
n Can we retrieve the information needed for the TS tool?
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CDISC LIBRARY - API CALLS
Can we use API requests in stead of our MDR?
n Is more linked metadata available?
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• TSVAL variable: may be subject to controlled terminology
• Additional information from the PDF version of the SDTMIG
• Codetable mapping files from the CDISC website
• FDA SDTCG TS parameters list
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Conclusion
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n By only making use of the CDISC Library API in our TS tool, we can’t provide same functionalities
n Codetable mapping file implementation still needed in the TS tool
n CDISC SHARE vs CDISC Library API§ Versioning traceability § Additional linked metadata missing
CONCLUSION
This case study only touches a fraction of the CDISC 360 concept and its focus is on this level of SDTM and Controlled Terminology for the TS domain
n CDISC Library API vs in-house MDR§ Availability, dependency§ API: most recent information
n I believe CDISC has laid the foundations§ Automatized standards-based processes§ The more linked metadata becomes
available, the better software it will deliver
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