1. 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 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

4. 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 studies
Cardiovascular Research Institute (CVRI) studies
CTSA/CTSI

5. Initial Investment - 12 months
Year 1 Project Costs: $583,000
Licensing
Non-cancer trials ( )
$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

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%

10. 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

11. 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

12. Organizational Chart - OnCore Support