1. 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

2. 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

3. 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

4. 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)

5. Biostatistics

6. 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

7. Clinical Research Support

8. 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

9. 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
CHLA Contact: Shannen Nelson, RN, MSN

10. Clinical Research Informatics

11. 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

12. 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
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

13. Training and Education

14. 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

15. SC-CTSI Training and Education

16. Team Building and Funding

17. 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

18. SC-CTSI Community Engagement

19. 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

20. Search Tools

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

22. Clinical Studies Directory (clinicaltrials.keckmedicine.org)

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

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

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

26. Thank You SC CTSI | www.sc-ctsi.org Phone: (323) 442-4032