share 2.0 and other cdisc innovation 2017 china interchange becnel share2...innovation 2017 china...
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SHARE 2.0 and Other CDISC Innovation
2017 China InterchangeLauren Becnel, Ph.D.
CDISC VP, Strategy & Innovation21 September 2017
IT/Stats
External
MDRs
Clinical Research
Apps Clinical Care
Apps
Other
Systems
End
Users
SHARE &
Ecosystem
Tools
Versioned
CDISC
Standards Foundational Stds
Therapeutic Areas & Biomedical Concepts
Controlled Terms
Patients
Becnel, L. (2017). SHARE-ing CDISC Standards through a Cloud-BasedMetadata Repository. Appl Clin Trials.
Benefits of CDISC SHARE
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System re-validation
planning, resourcing
Data-based decisions Change management
With or…
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Without an MDR
Standards Components in CDISC SHARE
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Classes, Domains and Variables
Controlled Terminologies
Examples RulesAssumptions
Norm. IG
Draft Domains/Variables in “Rolling Copy”
In SHARE MDR In SHARE Ecosystem
*Including Supplements such as Medical Devices & Pharmacogenomics/Genetics
Coming to SHARE MDR
Licensed Access for Members: CDISC SHARE Exports
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https://www.cdisc.org/share/exports-user-documentation
Licensed Access for Member Subscribers: CDISC SHARE’s RESTful API
License includes access to:• Standards (e.g. SDTM 3.2, CDASH 1.1)
• Controlled Terminology packages (e.g. SDTM 2014-03-28)
• Package codelists
• Codelist (e.g. ACN)
• Classes
• Standard domains
• Class domains
• Class model variables
• Domain variables
• Variables
• Mappings
Lexical searching supported
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https://www.cdisc.org/share/api-user-documentation
Visualizing CDISC Standards from the API
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Trace-XML
Hume, S., Sarnikar, S., Becnel, L., Bennett, D. (2017). Visualizing and validating metadatatraceability within the CDISC standards. Proc AMIA Summit Clin Res Inf. AMIA, 2017:158-165.
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New Features in CDISC SHARE 2.0
Adapted from Frederik Malfait, 20 April 2017 SHARE 2.0 Webinar
Linked, Versioned Standards Data
Rules Biomedical Concepts
Coming in 2018!
CDISC SHARE 2.0: A Global Content Repository
10Some content adapted from Johannes Ulander, SDTM, Graph databases and Biomedical Concepts, EU Interchange 2017 & Nuventra.com
XMLRDFJSON
Coming in 2018!
CDISC Data Transport & Sharing Standards
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Study Design Model (SDM-XML) allows organizations to provide rigorous, machine-readable, interchangeable descriptions of the designs of their clinical studies, including treatment plans, eligibility and times and events.
Operational Data Model (ODM-XML) is a platform-independent format for exchanging and archiving clinical and translational research data, along with their associated metadata, administrative data, reference data, and audit information.
Dataset-XML supports the exchange of dataset data based on Define-XML metadata.
Define-XML provides the metadata for human and animal model datasets using the SDTM and/or SEND standards and analysis datasets using ADaM.
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Clinical Trial Registry (CTR-XML)a single XML file that holds the information needed to generate submissions for clinical trial registry submissions primarily to the WHO, EMA EudraCT Registry and United States ClinicalTrials.gov.
Analysis Results Metadata (ARM) Define-XML extension that describes key analysis results and provides traceability back to ADaM.
Controlled Terminology (CT-XML) provides an ODM-based standard for publishing and exchanging the CDISC Controlled Terminology as provided by the NCI/EVS.
CDISC Data Transport & Sharing Standards
Bridging Research & Healthcare – HL7 FHIR, ODM2 & CDISC SHARE
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Protocol
XML plus…
Coming in 2018!
Acknowledgements
CDISC SHARE Team• Anthony Chow
• Julie Chason
• Dr. Sam Hume
• Darcy Wold
• Ann White (Communications)
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TransCelerateBiopharma, Inc.• Brooke Hinkson
SHARE/TCB
• Frederik Malfait