Transcript Poster Presented at the 2012 Meeting of the CTSA

UC BRAID: Co-creating and evaluating performance in a
regional laboratory for conducting translational science
From Science to knowledge to practice
UC BRAID Executive Committee: Steven Dubinett (UCLA), S. Claiborne Johnston (UCSF), Lars Berglund (UC Davis), Gary Firestein (UCSD), Dan Cooper (UCI)
UC CTSA Evaluation Directors: Pamela Davidson (UCLA), Julie Rainwater (UCD), Fabrice Beretta (UCSF), Margaret Schneider (UCI), Daniel Bouland (UCSD)
UC BRAID: University of California, Biomedical Research, Acceleration, Integration & Development
(5) Institutional Review Board
Introduction
(2) Contracting
(4) UC Research eXchange (UC ReX)
In 2010 the University of California (UC) system wide CTSA
collaboration was launched to enhance clinical and
translational science. The UC Biomedical Research
Acceleration, Integration, and Development (UC BRAID) is
currently conducting activities in 6 majors areas:
(1) Biospecimen Banking
(2) Contracting
(3) Drug and Device Discovery and Development
(4) Informatics/UC Research eXchange (UC ReX)
(5) Institutional Review Board
(6) Metrics
The UC BRAID Contracting Working Group is tasked with
identifying policy changes, new infrastructure, standardized
procedures or processes that will reduce the barriers to clinical
research contracting for the institution, individual researchers,
and external partners. The following are areas of focus: master
Clinical Trials Agreements (CTAs), sharing contract language
(terms and clauses), UC System-wide Training Program for
staff in contract negotiations, Material Transfer Agreements
(MTAs), UC-wide metrics
The UC-Research eXchange (UC-ReX) Informatics Consortium is
building the first cross-campus clinical query system capable of
exchanging patient-level data. Currently we are conducting cohort
feasibility studies using i2b2 to obtain patient counts from the 5
UC medical centers.
UC-BRAID
Proposed outcomes:
Accelerate research contracting in the UC system through:
Increased Master Agreements for industry-sponsored clinical
trials
Develop a shared database of accepted contract terms
Develop a shared clause library
Develop a system-wide training program for contracting
Adopt common processes, procedures and templates for
Material Transfer Agreements (MTAs)
Establish and track contracting metrics
Proposed outcomes:
Governance
Develop fiscally sustainable model and Market Data Explorer
Engage and leverage partners and stakeholders
Align with existing UC and partner capabilities and resources
Data and Quality
Implement semantic life cycle process, Improve data quality
Technology
Ensure site readiness for planned implementations
Develop meaningful capabilities that enable research
collaboration
DATA
REFERENCE
MAINTENANCE
(3) Drug and Device Discovery and
Development (D4)
TECHNOLOGY
(1) Biospecimen Banking
“UC-recognized” Biobanks will adopt standardized operating
procedures, quality control measures and staff training
appropriate to their specific biosample collections so that:
The biobanks conform to NIH, CAP, ISBER standards
The biosamples are of the highest possible quality
The biobanks meet the ethical operating standards of all
campus IRBs
Proposed outcomes:
Develop, vet and obtain stakeholder input on SOPs for all
operations areas
Determine best method to assist biobanks to achieve “UCrecognized” biobank standards educational component
Address governance recommendations
Discuss governance issues for sample sharing across UC
Regional Research Network
Institute global informed consent for use of remnant
biosamples in research
The overall goal of BRAID D4 is to:
Leverage existing shared resources across the UC system
with the uniquely creative and innovative basic and clinical
research at individual campuses
Enable individual research and create value in the broad field
of drug and device discovery.
Proposed outcomes:
Creation of a comprehensive list of integrating the cores
RELIABILITY
The IRB Working Group is tasked with identifying policy
changes, new infrastructure, or processes that will reduce
the barriers to IRB approval for the Institution, individual
researchers, and external partners.
Proposed Outcomes:
•Create IRB Harmonization so that the IRB at one site can
serve as the IRB of record
•Standardize IRB application forms and consent forms
•Implement electronic IRB systems
•Agree to a set of universal IRB metrics and exchange best
practices and experiences
•UC Office of the President will fund efforts to improve
utilization
GOVERNANCE
COLLABORATE
(6) Metrics and Emerging CTSA Evaluation Collaborative
The mission of the metrics subcommittee is to catalyze the harmonization and transparency of metrics and align execution processes
between centers across the UC. In addition to the Metrics Workgroup, we propose to develop a UC CTSA Evaluation Collaborative to
work closely with the UC BRAID PIs on high priority initiatives. The UC Evaluators offer substantial expertise in evaluation design and
methods, quality and process improvement, strategic planning, and organizational transformation and change management.
Regional Context:
All 5 UC CTSAs are governed by the same policies
The time is ripe for transforming the UC CTSAs to create a super structure for accelerating innovation
Sharing resources and expertise will enable us to achieve greater effectiveness and efficiency
Our Challenges and Opportunities:
Creating the national laboratory and system alignment among 60 NCATS-funded CTSAs may take years or decades
Alignment may be accelerated through smaller regional network collaborations and integration
UC CTSA Evaluators can pool resources and expertise to support and advance the UC BRAID agenda
Evaluators collect and analyze quantitative and qualitative data to: (1) inform regional restructuring through needs assessments and
surveys, (2) suggest data driven solutions for solving system challenges, and (3) conceptualize, measure, monitor, and work with
leadership and operations teams to transform and achieve metrics for success
Our challenge is to harmonize measures and to centralize data collection and analysis methods among the 5 UC CTSAs
Conflict is inherent in harmonization processes, and in integrating, and aligning systems
Evaluators can provide unbiased assessments and identify evidence-based best practices for emulating throughout the System
As a UC Evaluation Collaborative we are better positioned to inform the National Consortium and to incorporate national standards