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

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

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)

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.

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

APPENDIX

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

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

Clinical Research Infrastructure Advisory Committee

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 2011- 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

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

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

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 CTSI Dermatology

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

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.

Sharing information to promote Clinical Research Information to researchers on regulatory issues, management, training resources (completed, rollout Q1 2012) Collaboration between multiple departments http://hub.ucsf.edu/

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,

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.

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

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