th april 2011 rhonda facile (nci-evs) -...
TRANSCRIPT
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26th April 2011 Rhonda Facile (NCI-EVS)
Slides courtesy Dave Iberson-Hurst with some tweaking by Rhonda and Erin.
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CDISC SHARE • Vision • Background • Project Plan
– Where we are today
– Next Steps • Acknowledgements
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A global, accessible electronic library, which through advanced technology, enables precise and standardized data
element definiLons (and richer metadata) that can be used in applicaLons and
studies to improve biomedical research and its link with healthcare.
CDISC SHARE VISION
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Background: The World Today
CDISC Standards now encompass the enLre drug development process – protocol, collecLon, analysis, submission, controlled terminology, – but there is more to be done ….
• some elements don’t fit in exisLng standards • standards are not completely aligned or linked
• standards development takes Lme • Paper/pdf orientated
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Why do we need beZer metadata?
• To enhance Data Quality and Compliance • To decrease the Lme taken to aggregate and review results
• Machine readable standards can lead to beZer “enforcement”
• Illustrate inherent relaLonships between metadata
• Speed up standards development
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Compliance Issues Slide By: Ellen Pinnow, MS Health Programs Coordinator FDA, Office of Women’s Health, Slide from 2006 CDISC US Interchange
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Current 2D World
Relationship
Relationship
Relationship
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CDISC SHARE Aims To: • Provide an environment within which exisLng content is easily maintained
• Accelerate new clinical research content development • Encourage the widest possible parLcipaLon in the development of new clinical research content (asynchronous contribuLon 24/7)
• Deliver all of CDISC’s exisLng and all new content in both human and machine-‐readable forms
• Enable beZer automated handling of clinical research data through the use of machine-‐readable content
• Assist in enabling the use of healthcare data in clinical research
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How do we achieve this?
• Focus on developing rigorous & unambiguous definiLons (semanLc interoperability)
• Build scienLfic concepts on BRIDG • Link all CDISC Standards:
– Controlled terminology – SDTM variables
– CDASH variables
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CDASH
SDTM
One DefiniLon
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ScienLfic Concepts – which model?
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BRIDG • A domain analysis informaLon model represenLng protocol-‐driven biomedical/clinical research
• Provides a basis for harmonizaLon among standards within the clinical research domain and between biomedical/clinical research and healthcare. – ISO 21090 compliant, HL7 alignment, RIM alignment
hZp://www.cdisc.org/bridg
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ScienLfic Concept Mind map -‐ 3D View
SDTM Variables
CDASH Variables
Controlled Terminology
BRIDG Classes
Terminology (Ccodes) comes from the NCIt
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ScienLfic Concept in template Spreadsheet
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SHARE Scien+fic Concepts
(BRIDG, Terminology, Data Types...)
XML V3 Message(s)
ProtecLon of the Content
SDTM ADaM CDASH
XML Format(s) Tabular Form
View View
BRIDG
View View
Transport
CONTENT
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Summary • Richer content • Machine readable
• Layered / structured • One definiLon used many Lmes
• Structured using BRIDG constructs to reflect the nature of the data
• EvoluLon of where we are today
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Project Plan
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Where We Are Today CDASH & SDTM content reviewed and definiLons aligned
ImplementaLon rules extracted from published standards
Metadata model approach agreed
Model tested on SDTM observaLon classes
ScienLfic concepts and their aZributes idenLfied and (mind) mapped for each type of SDTM domain
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CDISC Share Phase 1 – Content Content team to map metadata into model based
Spreadsheets that include:
• All SDTM CDASH domains
• BRIDG • Controlled terminology
• Data types
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CDISC Share Phase 1 – Content Content Template Spreadsheets
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CDISC Share Phase 1 -‐ Governance
• Basic governance in place through mapping of simple scenarios
• Basic administraLve and parLcipant roles defined
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Work Item
Work Item ExisLng Domain
New Domain
Governance Use Cases Under Development
Work Item ScienLfic Concept
ScienLfic Concept
ScienLfic Concept ScienLfic Concept ScienLfic Concept ScienLfic Concept
A simple addiLon to a code list
Code List
AddiLon of a ScienLfic Concept to a Domain
ScienLfic Concept ScienLfic Concept ScienLfic Concept
New Domain
Code List Item
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CDISC Share Phase 1 – Key FuncLonality Requirements
• Users should be able to import & export content.
• Users should be able manipulate data.
• Users should be able access an electronic equivalent of a subset in PDF of SDTMIGv3.1.2, CDASH v 1.1, Terminology. Export a Word equivalent.
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CDASH & SDTM
Requirements
Governance
MD Model
R1
- MindMaps & xls.
Content Sub-team 1
Content Sub-team 2
Study Construction Concepts
External User Interface
Software
CDISC Share Project Plan 2011
Gov Sub-team
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Longer Term CDISC Share Development Plan
Phase 1
Phase 2
Phase 3
Phase 4
Phase 5
SDTM
CDASH
Oncology, Devices, TA (current)
SEND and new TA
ADaM and new TA
new TA
Major Development Phases
ConLnuous smaller
increments in content
ConLnuing SW Releases (do not need to be aligned with Phases)
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MeeLng Schedule
3 calls per week a fourth to start in April. Project progress report calls q 6 weeks
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CDISC Share -‐ Conclusion • Precise definiLons • Rich metadata
• 24/7 access • Linked to NCIt • Dashboard views (by funcLon)
• Links Clinical Research to Healthcare.
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AcLve ParLcipants • Clyde Ulmer -‐ FDA
• Erin Muhlbradt NCI-‐EVS
• Fred Wood -‐ Octagon
• Gary Walker -‐ QuinLles • Hanming Tu -‐ Octagon
• Madhavi Vemuri – J & J
• Mary Lenzen -‐ Octagon
• Melissa Cook -‐ Octagon
• Mike Riben – MD Anderson • Diane Wold -‐ GSK
• Simon Bishop -‐ GSK
• Terry Hardin -‐ Parexel
• Tsai Yiying -‐ FDA
• Michael Morozewicz
• Shannen McGinnis -‐ Amgen
• Barry Cohen -‐ Octagon
• Dave Iberson-‐Hurst -‐ Assero • Rhonda Facile – NCI-‐EVS
• Chris Tolk -‐ CDISC
• Dianne Reeves – NCI-‐CBIIT
• Barrie Nelson -‐ Amgen
• Julie Evans -‐ CDISC • Jian Chen -‐ Edetek
CDISC acknowledges all volunteers, their affiliated companies and the NCI-EVS for support of the CDISC Share project.
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QuesLons about CDISC Share? Interested in joining a team?
Contact
Or visit: cdisc.org
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Strength through collaboration.
As a catalyst for productive collaboration, CDISC brings together individuals spanning the healthcare continuum to develop
global, open, consensus-based medical research data standards.
...and sharing