Thomas Buchanan MD, Director Michele Kipke, PhD, Co-Director Southern California Clinical and Translational Science Institute The SC-CTSI Thomas Buchanan MD, Director Michele Kipke, PhD, Co-Director www.sc-ctsi.org

What is the SC-CTSI? It an institute that promotes and supports clinical and translational research to improve health, in particular for diverse populations It a partnership among USC, CHLA, Los Angeles County Department of Health Services, and more than sixty community organizations which work together to define research priorities; develop, support and streamline research; and disseminate results to improve health It a supported by a Clinical and Translational Science Award from NIH and from strong institutional support from USC and CHLA www.sc-ctsi.org

Three Main Areas Supported by the SC-CTSI Clinical Trials and Studies Clinical trials of novel therapeutic approaches Development of novel diagnostics and biomarkers Human mechanistic studies Methods to enhance clinical research processes Community Partnered Research Identify research priorities Engage community members in research Disseminate findings to the community Training and Career Development Mentored career development program (KL2) Courses, seminars, workshops for faculty, staff, trainees, community

Research Services and Tools CONSULTATIONS Biostatistics Community-Engaged Research Human Studies and Trials Managing Data in REDCap Research Ethics Translational Research Team Building CLINICAL RESEARCH SUPPORT Clinical Research Services Navigator Study Design Recruitment Study Coordinators Regulatory Support Budget and Coverage Analysis Scientific Review Voucher Program Clinical Trials Units Orientation to Clinical Research at USC CLINICAL RESEARCH INFORMATICS Overview of Clinical Research Informatics Clinical Data Services Clinical Trial Management System (CTMS) Enterprise Research Data Warehouse (DEWARS) Local Study Participant Discovery Tool (i2b2) Los Angeles Data Resource (LADR) Data Management Tool (REDCap) National Study Participant Discovery Tool TRAINING AND EDUCATION Training and Education Home Training Video Library Institutional Career Development Program (KL2) Digital Scholar Program TEAM BUILDING AND FUNDING Pilot Awards Team Building Vouchers Team Building Toolkit COMMUNITY ENGAGEMENT Community-Engaged Research Services for Researchers Services for Community Members Our Partners SEARCH TOOLS Clinical Studies Directory Research Resource Finder Research Training Finder Research Expert Finder (PROFILES) www.sc-ctsi.org

Biostatistics

SC-CSTI: Biostatistics Expert advice across the life of your study Design a study Choosing a study design Estimation of sample size and power Statistical analysis plans Manage a study Advice on general data management (REDCap) Assist with reporting during a study Statistical analysis Perform statistical analysis Assist with interpretation of results Creation of tables and figures Scientific Writing Manuscript preparation Writing support Responding to reviewers Other biostatistical issues Biostatistics Charge-Back Structure Standard Rate: $125/hr Free Support: Initial consultation: up to 1 hour SC CTSI Pilot Funding Awardees: up to 2 hours Junior Faculty: up to 5 hours/yr K scholars during training: up to 15 hours/yr T trainees during training: up to 15 hours/yr Extramural Grant Planning: up to 3 hours/grant PM516 Volunteers: up to 5 hours/project

Clinical Research Support

SC-CSTI: Clinical Research Support (CRS) Single stop for accessing expertise, services and infrastructure to design and conduct clinical trials (non-cancer; CISO supports cancer trails) Study Coordinator Pool Recruitment Strategies Regulatory Support (INDs, auditing, monitoring) Budgeting and Coverage Analysis Clinical Trials Unit Scientific and Feasibility Review Program Manager: Nicki Karimipour, PhD Nicki.Karimipour@med.uwc.edu 323-442-1280

SC CTSI: Clinical Trials Unit Dedicated unit for medium to high complexity studies High precision (PK/PD, special procedures) High Risk (first in human, intensive monitoring, biopsies) High complexity (infusions, complex processing) Body composition by DEXA, Research-trained staff, including research nurses, phlebotomists, lab technicians One on the HSC, one at CHLA HSC Contact: Yolanda Gutierrez, BS Cerda@med.usc.edu CHLA Contact: Shannen Nelson, RN, MSN shnelson@chla.usc.edu

Clinical Research Informatics

Clinical Research Informatics DEWARS data warehouse: a single and integrated repository of clinical and research data sources to support research and analytic needs across USC & CHLA Clinical Trials Management System: software for managing budgeting, contracting, coverage analysis, enrollment, participant visits, billing and collections for clinical trials Health Research Computing Cloud: a self-service portal for high-performance computing and data archiving in HIPAA compliant environment (under development) Data Development Services: assistance with data collection and management strategies REDCap: free, secure and HIPAA-compliant data capture and storage tool (case report forms, multi-site access, event reporting, data storage and export to analytical tools) Director: Daniella Meeker, PhD cri@usc.edu

DEWARS: What Can You Do Now? Study Planning and Power Analysis: Self-service website to find number of patients at Keck, CHLA, and LA County that meet your study inclusion and exclusion criteria. Request an account at i2b2@usc.edu Screening and Recruiting: With IRB approval, get information for additional screening and/or contact information for recruiting. DEWARS: What’s Next? Health Outcomes and Implementation Research: Access to high-quality clean data sets from health systems. Expansions to Partner Health Systems: Los Angeles Data Resource – Cedars-Sinai, City of Hope, UCLA

Training and Education

SC-CTSI Training and Education Mentored Career Development (KL2) Program (4 new each year) Three years of commitment and support at 75% effort Home department has to pay one year, program pays the rest Didactic training, hands on research, career development Masters degree and certification options Mentor “match-making”; Mentoring and mentee workshops Clinical Research Coursework, Seminars, Workshops for faculty, staff, students and training

SC-CTSI Training and Education

Team Building and Funding

SC CTSI Funding Opportunities $40,000 pilot grants (~10 per year) Clinical or community research projects Methods to improve clinical research methods and processes Next application due date Feb 15, 2018 $75,000 implementation science grants (1 per year) Implementation science projects in LA County Health System Timeline: Planning Workshop: Sept 18, 2017 Letters of Intent: October 23, 2017 Full applications: December 5, 2017 Small Grants and Vouchers $5,000 team building grants (~7 per year) $3,000 clinical research vouchers (~20 per year) Continuous submissions

SC-CTSI Community Engagement

SC-CTSI Community Engagement LA Community Engagement Research Core: One-Stop shop for community engagement Faculty consultations and team building Community Advisory Boards Toolkits and support in creating a CAB to integrate community perspective throughout the research study Training and Capacity Building Community Engaged Research 101 (for investigators) Research 101(for community health workers) Participant Recruitment Research Ambassadors in community settings Strategies and access to hard-to-reach populations

Search Tools

Clinical Studies Directory (clinicaltrials.keckmedicine.org) Ulcerative Colitis

Clinical Studies Directory (clinicaltrials.keckmedicine.org)

USC Health Sciences Profiles (profiles.sc-ctsi.org) Diabetes

USC Health Sciences Profiles (profiles.sc-ctsi.org)

USC Health Sciences Profiles (profiles.sc-ctsi.org)

Thank You SC CTSI | www.sc-ctsi.org Phone: (323) 442-4032 Email: info@sc-ctsi.org Twitter: @SoCalCTSI