+

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