Clinical Research Infrastructure Initiative Status

March, 2012

Susanne Hildebrand-ZankiAVC, Research

Science ServicesScience Services

Regulatory andCompliance

Services

Regulatory andCompliance

Services

Clinical ServicesClinical Services

Financial and

Administrative Services

Financial and

Administrative Services

STUDYSTUDYSTUDYSTUDY

•Statistical Support• IND/IDE Tracking• Bioinformatics• Data Analysis• Data Management Support

•ClinicalTrials.gov• IRB• DSMB • Research

Pharmacy• Clinical Labs• CRS Services

•Study Billing• Sponsor Invoicing• EMF• Pre/Postaward

iMedris IRBiMedris IRBOnCore-CRMOnCore-BSMOnCore-URM

OnCore-CRMOnCore-BSMOnCore-URM Med Center

APeXMed Center

APeX

Clinical Integrated

Data Repository

Clinical Integrated

Data Repository

My Research – Data

Management

My Research – Data

Management

SpecimenRepositories

SpecimenRepositories

Charge MasterCharge Master

Patient Relationship

Database

Patient Relationship

Database

Framework for Clinical Research At UCSFFramework for Clinical Research At UCSF

•Patient Recruitment/Retention• Feasibility Analysis• Scientific Protocol Review

Medicare Coverage Analysis

•Budgeting

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)

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4

5

Proposal to consolidate budgeting and coverage analysis

1. Consolidate budget development for industry trials in the Clinical Trial Business Support Center (CTBSC) housed in the Industry Contract Division (ICD)

2. Consolidate all coverage analyses in the CTBSC

3. The Cancer Center ITR unit would continue to exist as is

4. Federal and non-profit funded clinical research proposals would route through the Research Management Services, with coverage analysis coordinated with ICD

5. Streamline workflow so that processes can occur in parallel, i.e, budget development, contract negotiation and IRB review

6. Use a standard budget template that ensures that all study costs are captured and accurately reflected

7. Provide additional staff to consolidate research billing and monitoring of research compliance in the Clinical Compliance Office.

8. Provide consistent training for faculty, clinical research coordinators, and clinical RSCs.

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October 10, 2011

Page 4

Clinical Research Pre-Award

Susanne Hildebrand-ZankiASSOCIATE VICE CHANCELLOR

RESEARCH

Contracts and

Grants Division (C&G)

Research Management

Services

Committee on Human

Research (CHR)

Erik LiumASSISTANT VICE CHANCELLOR

Office of Innovation, Technology and Alliances (ITA),

Industry

Contracts Division (ICD)

Bill Balke

CTSIClinical Research

Services (CRS)

Frank McCormickHelen Diller Family

Comprehensive Cancer Center (CC)

Director INVESTIGATIONAL TRIALS RESOURCES

(ITR)

Budget

Development– Industry

Trials

Clinical Billing

QA Analyst

TEAM LEAD

MCA

Analyst – Cancer

Center Trials

QA

Analyst

Clinical

Research Service

Coordinator (CRSC)

ORGANIZATIONAL STRUCTURE

Elizabeth BoydASSOCIATE VICE CHANCELLOR

ETHICS AND COMPLIANCE

Clinical Compliance

Office

Budget

Development – Non-

Industry Trials

Coverage Analysis – ALL Trials

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

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APPENDIX

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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

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Science ServicesScience Services

Regulatory andCompliance

Services

Regulatory andCompliance

Services

Clinical ServicesClinical Services

Financial and

Administrative Services

Financial and

Administrative Services

STUDYSTUDYSTUDYSTUDY

• 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

• Budgeting• Study Billing• Sponsor Invoicing• EMF• Pre/Postaward

iMedris IRBiMedris IRBOnCore-CRMOnCore-BSMOnCore-URM

OnCore-CRMOnCore-BSMOnCore-URM Med Center

APeXMed Center

APeX

Clinical Integrated Data

Repository

Clinical Integrated Data

Repository

My Research – Data

Management

My Research – Data

Management

SpecimenRepositories

SpecimenRepositories

Charge MasterCharge Master

Patient Relationship

Database

Patient Relationship

Database

Framework for Clinical Research At UCSFFramework for Clinical Research At UCSF

Clinical Research Infrastructure Advisory Committee

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First Name Last Name DepartmentBill Balke CRS/CTSIDoug Berman ITS-ARSKirsten Bibbins-Domingo SFGHMichael Blum Med Ctr.Elizabeth Boyd CECOBret Brodowy Med Ctr.Russ Cucina Med Ctr.Jane Czech NeurologyJohn Fahy PulmonaryDixie Horning Ob/GynClay Johnston CTSIJune Lee CTSIAudrey Lyndon NursingSharmila Majumdar RadiologyKalpana Prabhakar SurgeryMark Ryder DentistryPeter Sayre ITNEric Small Cancer CenterWade Smith NeurologySuzanne Sutton MedicineMargaret Tempero (Chair) Cancer CenterAlan Venook Medicine

Paul Volberding Global Health

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8/1/2010 12/31/2012

10/1/2010 1/1/2011 4/1/2011 7/1/2011 10/1/2011 1/1/2012 4/1/2012 7/1/2012 10/1/2012

Convened Clinical Research Infrastructure Taskforce to develop a conceptual framework and to make recommendations for improvements

Task force completed its work and issued report

Implementation plan developed

Apr 2011

Oct 2010

Mar 2011

Clinical Research Infrastructure

Advisory Committee formed, Margaret Tempero,

chair

Partial charge master published in IRIS Eliminated negative

STIP on cost reimbursement clinical trials

Dec 2010

Jul 2011

Sep 2011

Initiated improvements to IRIS user interface

Start of OnCore Pilot

Proposal to create Clinical Coordinator job family submitted to HR – in progress

HUB soft launch

Dec 2011

CRS rolls out Clinical Coordinator pool

CRS launches Patient Recruitment Service

Today

Mar 2012

Improvements to Research Pharmacy underway

OnCore roll out to campus

Apr 2012

Existing research feeds are accommodated from APeX

Jul 2012

IDR/APeX integration complete

IDR/MyResearch infrastructure improvements complete

Clinical Services Technology Regulatory Admin/Financial Planning/Oversight

Hired staff within AVC, CECO to

centrally support clinicaltrials.gov

registration

Science Services

Implement feasibility /scientific review process

Implement Clinical Trial Support Business Service unit

Clinical Research Infrastructure Initiative Project Timeline

Human Study Debit Card Program

Oct 2011

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

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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

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OncoreProject 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

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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– CTSI– Dermatology

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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

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.

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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/

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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 Clarity

(Microsoft SQL Server)

IDR(Limited Data Set)

Epic Production Server (Chronicles Caché)

MyResearch(Data Marts / Ontologies)

• Operational and financial reports• Government-mandated reporting

Research

Patient careStagingServer

(MicrosoftSQL Server)

Medical Center Network MyResearch Network

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