1. Clinical Research Infrastructure Initiative Status
March, 2012
Susanne Hildebrand-Zanki
AVC, Research

2. STUDY Framework for Clinical Research At UCSF
Science Services
Regulatory and
Compliance Services
Clinical Services
Financial
and
Administrative Services
Statistical Support
IND/IDE Tracking
Bioinformatics
Data Analysis
Data Management Support
ClinicalTrials.gov
IRB
DSMB
Study Billing
Sponsor Invoicing
EMF
Pre/Postaward
Research Pharmacy
Clinical Labs
CRS Services
Medicare Coverage Analysis
Patient Recruitment/Retention
Feasibility Analysis
Scientific Protocol Review
Budgeting
STUDY
iMedris IRB
Charge Master
OnCore-CRM
OnCore-BSM
OnCore-URM
Med Center APeX
Specimen
Repositories
Clinical Integrated Data Repository
Patient Relationship Database
My Research – Data Management

3. In Process – For Discussion and Feedback
Review and revision of protocol initiation processes
Proposal to institute feasibility and scientific review prior to CHR submission (based on recommendations of the Clinical Research Infrastructure Advisory Committee)
Improvement of financial and administrative services
Proposal to consolidate budgeting and coverage analysis (based on recommendations from the Clinical Trial Budgeting and Financial Management work Group Report – July 18, 2011)

5. Proposal to consolidate budgeting and coverage analysis
Consolidate budget development for industry trials in the Clinical Trial Business Support Center (CTBSC) housed in the Industry Contract Division (ICD)
Consolidate all coverage analyses in the CTBSC
The Cancer Center ITR unit would continue to exist as is
Federal and non-profit funded clinical research proposals would route through the Research Management Services, with coverage analysis coordinated with ICD
Streamline workflow so that processes can occur in parallel, i.e, budget development, contract negotiation and IRB review
Use a standard budget template that ensures that all study costs are captured and accurately reflected
Provide additional staff to consolidate research billing and monitoring of research compliance in the Clinical Compliance Office.
Provide consistent training for faculty, clinical research coordinators, and clinical RSCs.

7. Funding
Initial 12 months investment from Medical Center, School of Medicine and EVCP Office to hire staff and start implementation
To the extent possible and practical, capture administrative costs in study budgets
Increase clinical trial indirect cost rate from 26% to 33%, with the marginal new revenue made available to cover costs. Approved December 2011, effective date March 31, 2012
Charge industry 150% of research rate for procedures and labs

8. APPENDIX

9. Goal: efficient, effective, and supportive campus-wide infrastructure for clinical research
Objective: improve the ability of our faculty to do high quality clinical research and to ensure that UCSF is well equipped to support translational research. The goal includes improvements in all aspects of clinical research:
services to our investigators
technology solutions for clinical research management, bio-banking
data storage, retrieval, and data analysis
streamlined pre-and post-award processes
Success will be measured among other things by:
the volume of work managed by the newly formed support units
number of study teams being trained on OnCore and the number of studies being initiated and maintained in the system
number of active users of the IDR/MyResearch environment
the reduction in the number of unproductive trials
increase in research compliance
satisfaction of the clinical research community with the clinical research environment at UCSF

11. 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
Budgeting
Study Billing
Sponsor Invoicing
EMF
Pre/Postaward
Research Pharmacy
Clinical Labs
CRS Services
STUDY
iMedris IRB
Charge Master
OnCore-CRM
OnCore-BSM
OnCore-URM
Med Center APeX
Specimen
Repositories
Clinical Integrated Data Repository
Patient Relationship Database
My Research – Data Management

12. Clinical Research Infrastructure Advisory Committee

14. Progress to Date
Implementation of an electronic clinical study management system
IT Governance Committee endorsed decision to roll out multidisciplinary version of OnCore suite, including Clinical Research, Registry, and Biospecimen Management
Pilot program initiated in August addition of 7 clinical trials, 1 registry study, and 2 biospecimen banking studies
Campus wide launch in April 2012
Improvement of financial and administrative services
Budget Office eliminated negative STIP on cost reimbursement clinical trials, effective July 2011
Office of Research published partial charge master in IRIS in March 2011, full charge master will be published with APeX go live in June 2012
Controller’s Office rolled out Human Study Debit Card Program
Improvement of regulatory processes
Created position for support of clinicaltrials.gov registry within AVC, CECO Office
HRPP initiated effort to improve user interface for IRIS

15. Progress to Date cont’d
Improvement of Clinical Services
Creation of the HUB clinical research resources website through a collaboration of OR, CECO, and CRS/CTSI
CRS instituted Clinical Coordinator pool
CRS developed Research Participant Recruitment Core Service
Creation of a job family for clinical coordinators initiated by the Clinical Coordinator Committee (under review at HR, expected roll out FY 13 )
Medical Center improved Research Pharmacy infrastructure
Improvement of Integrated Data Repository/MyResearch Environment
Completed APeX – IDR integration in February 2012
Ensured that existing research feeds of Medical Center data are accommodated in APeX
Secured funding to upgrade IDR/MyResearch infrastructure and to increase the number of data sources and data elements available to researchers

16. Oncore Project Purpose
Deploy a clinical management system leveraging existing technology and resources, specifically Forte Research’s Multidisciplinary OnCore Clinical Research Management System (OnCore-CRM) Software
Additional applications covered under the agreement with Forte Research are:
OnCore BioSpecimen Management System (OnCore-BSM) Software
OnCore Unified Registries Management System (OnCore-URM) Software

17. 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
CTSI
Dermatology

18. 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
After the initial rollout, OnCore will move to a recharge model for long term sustainability.

19. Clinical Research Hub Implementation Project
The goal of this project is to create a website to provide a single portal to resources, expertise, and best practices for investigators and research staff to facilitate efficient, compliant and ethical study conduct and management.

20. Sharing information to promote Clinical Research
Information to researchers on regulatory issues, management, training resources (completed, rollout Q1 2012)
Collaboration between multiple departments

21. Clinical Research Financial Management Work Group
Charge:
To develop a best practices document for the campus for clinical trial budgeting and financial management. The resulting toolkit would be used by departments to prepare trial budgets and for getting the appropriate reviews and approvals prior to submission to the sponsor as well as to conduct appropriate financial management of awards during implementation and after closeout
Deliverable due June 2011
Members: Christine Razler (Radiology); Lynda Jacobsen (CRS); Jennifer Kellen (Neurology), Nicole Lama (Cancer Center); Suzanne Sutton (Medicine,

22. Charge Master
In order to meet the immediate need of clinical coordinators and staff who prepare clinical trial budgets, we have published a partial charge master in the iMedRIS Help section. The charge master has the current retail and research pricing for about 80% of the CPT codes, and hopefully all of the most frequently ones used in trials. 
This is an interim solution until June 2012, when the charge master will become available in the Medical Center’s electronic medical record management system, APeX. For assessments or tests not currently listed in the spreadsheet, study staff still need to contact the Medical Center for the appropriate charge.

23. APeX Information Flow- Clinicians to Researchers
Shadow Server
Staging
Server
(Microsoft
SQL Server)
Patient care
Epic
Production Server (Chronicles Caché)
Clarity
(Microsoft
SQL Server)
IDR
(Limited
Data Set)
MyResearch
(Data Marts / Ontologies)
Medical Center Network
MyResearch Network
Operational and financial reports
Government-mandated reporting
Research

24. IDR and Clarity Environments
Operational, financial and government mandated reporting out of Epic’s Operational Data Store ‘Clarity’
Limited Data Set (LDS), i.e. no PHI except dates of service, brought over to IDR for Cohort Selection
Any PHI data extract for research purposes:
Requires CHR approval
Comes from Medical Center, not IDR
Done via separate secure interfaces provided by IDR