OnCore Roll Out April 8, 2011

Project Purpose Deploy a clinical management system leveraging existing technology and resources

Project Scope In Scope for Phase I Out of Scope 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

Roll Out: Phase I Communicate to broad community Supportive approach 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) $125,000 Technical Support (1 FTE) 50% $50,000 Contingency (10%) $53,000 Total $583,000

Projected Costs

OnCore Investment

Appendices

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%

STUDY Framework for Clinical Research At UCSF Science Services Regulatory and Compliance Services Clinical Services Financial and Administrative Services 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 Feasibility Analysis Budget Study Billing Sponsor Invoicing EMF Pre/Postaward Research Pharmacy Clinical Labs CRS Services STUDY Clinical Research Management System iMedris IRB Charge Master Med Center APEX Specimen Repositories Integrated Data Repository Patient Relationship Database My Research – Data Management

Clinical Research Infrastructure Cores Tissue Banks Specimen Repositories Services Science Clinical Regulatory/Compliance Financial/Administrative Systems iMedris IRB CTMS IDR My Research APEX Patient Relationship DB Study

Organizational Chart - OnCore Support