+ OnCore Roll Out April 8, 2011. + Project Purpose Deploy a clinical management system leveraging...
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Transcript of + OnCore Roll Out April 8, 2011. + Project Purpose Deploy a clinical management system leveraging...
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OnCore Roll Out
April 8, 2011
2+Project Purpose
Deploy a clinical management system leveraging existing technology and resources
3+Project Scope In Scope for Phase I
Licensing costs Implementation of OnCore for new users/programs Training for new users Clinical and Technical Support Assessment /audit conducted for programs implementing
OnCore
Out of Scope Phase I Integration with EPIC, CHR (iMedRis), IDR, APEX, CoPath Migration of legacy trials
4+Roll Out: Phase I
Communicate to broad community OnCore/UCSF Open House events Service anyone can use
Supportive approach Consultative
Team in place to support investigators Facilitated roll out
Potential identified early adopters Immune Tolerance Network - 12 studies Neurology - 100 studies Cardiovascular Research Institute (CVRI) - 150 studies CTSA/CTSI
+Initial Investment - 12 months
Year 1 Project Costs: $583,000
Licensing
Non-cancer trials (150-200) $130,000
Project Oversight
Program IT Director 25% $75,000
Project Manager (1FTE) 100% $150,000
Support & Training
Clinical Support/Training (1 FTE) 100% $125,000
Technical Support (1 FTE) 50% $50,000
Contingency (10%) $53,000
Total $583,000
6+Projected Costs
7+OnCore Investment
+ 8
Appendices
9+Assumptions Project Assumptions
Governance - TBD Cost Assumptions
No hardware or software is needed to roll out to non-cancer trials Upfront staffing needs = 3 FTEs 10% increase in licensing costs per year Year 3 assumes new licensing costs of $440,000, based on 500
trials 500 trials is based on Cancer Center and non-Cancer Center
trials Cancer Center annual cost contribution will be a constant
$190,000 Applied towards licensing fees
Assume ongoing costs after year one will be covered through a recharge model
FTE's are fully loaded costs Years 3 and 5 assumes 1 additional FTE (Clinical support)
1 additional FTE for every additional 100 users Year 3 assumes Technical support increase from 50% to 100%
Science Services
Regulatory and
Compliance Services
Clinical Services
Financial and
Administrative
Services
STUDY
• Patient Recruitment/Retention• Feasibility Analysis• Statistical Support• Scientific Protocol Review• IND/IDE Tracking• Bioinformatics• Data Analysis• Data Management Support
• Medicare Coverage Analysis• ClinicalTrials.gov• IRB• DSMB
• Research Pharmacy• Clinical Labs• CRS Services
• Feasibility Analysis• Budget• Study Billing• Sponsor Invoicing• EMF• Pre/Postaward
iMedris IRB
Clinical Research
Management System
Med Center APEX
Integrated Data
Repository
My Research – Data
Management
Specimen
Repositories
Charge
Master
Patient Relationsh
ip Database
Framework for Clinical Research At UCSF
+Clinical Research Infrastructure
Services•Science•Clinical•Regulatory/Compliance
•Financial/Administrative
Systems•iMedris IRB
•CTMS•IDR
•My Research•APEX
•Patient Relationship DB
Cores • Tissue Banks• Specimen
Repositories
Study
12+Organizational Chart - OnCore Support