1. UC BRAID: Co-creating and evaluating performance in a regional laboratory for conducting translational science 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 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 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 Introduction (1) Biospecimen Banking (2) Contracting (3) Drug and Device Discovery and Development (D4) (5) Institutional Review Board 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 (6) Metrics and Emerging CTSA Evaluation Collaborative From Science to knowledge to practice 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. 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 (4) UC Research eXchange (UC ReX) UC-BRAID DATA REFERENCE MAINTENANCE RELIABILITY TECHNOLOGY COLLABORATE GOVERNANCE “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 “UC- recognized” 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 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 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