843-792-8300 sctr.musc

1. South Carolina Clinical & Translational Research Institute Royce R. Sampson, MSN, RN, CRA SUCCESS Center Director Stephanie Gentilin MA, CCRA SUCCESS Center Associate Director 843-792-8300 http://sctr.musc.edu

2. What is the CTSA? The largest NIH Initiative of the last decade Provide integrated resources to advance interdisciplinary, translational, innovative research “Advance the health of the nation by transforming patient observations and basic discovery into clinical practice” 843-792-8300 http://sctr.musc.edu

3. Translational Research Two levels Applying discoveries generated in the laboratory and in preclinical studies to the development of studies in humans Research aimed at the adoption of best practices in the community SCTR’s mission is to facilitate clinical and translational research by providing research support services, research training and improving access to research-related resources. 843-792-8300 http://sctr.musc.edu

4. 843-792-8300 http://sctr.musc.edu

5. Program Areas:

6. SUCCESS Center • Research Navigation Consults • Regulatory Consults & Training • Recruitment Consultations • Grant Submission/Report Consults • Budget Development Consultations • Research Coordinator/Nurse Core • CTRC Proposal Pricing / Auditing The “Front Door” for Research Support Intake or Online Request Form 843-792-8300 http://sctr.musc.edu

7. SCTR SUCCESS Center: Fee for Service Programs • Budget Development Core • Regulatory Core • IRB submissions (initial, amendments, & renewals) • Consent Forms • HIPAA Authorization • Certificate of Confidentiality • Research Coordinator Core • Nurse Coordinator Core

8. Biostatistics/Epidemiology Assistance • Study design (e.g. randomized trial, case-control, etc.) • Help with statistics during the process of  manuscript preparation • Sample size / power estimation • Data analysis for pilot projects / preliminary studies sections of grants • Statistical / epidemiological assistance with grant development

9. SCTR Consults • Commercialization/Product Development Consultation • Community Engagement Consultation • Comparative Effectiveness Research Consultation • Intellectual Property Consultation • Novel Technologies Application Consultation • Research Ethics Consultation • SCTR Translational Assistance and Review Program (STAR) • Clinical Data Warehouse (CDW) Consultation

10. Clinical & Translational Research Center

11. SCTR Vouchers • Funding opportunity open to MUSC Principal Investigators • Vouchers up to $1,000 are available for services and supplies for research projects • such as SCTR services, Medical University Hospital (MUH) Laboratory and Radiology, Core Facilities, outside labs and research vendors, research supplies, non-routine CTRC supplies, software and medications. • Only 1 voucher is allowed per protocol (up to 2 protocols) every 6 months • A PI is limited to 2 vouchers in any 6 month period. • To apply for a voucher, enter a request through theRequest Servicesbutton at www.SCTR.MUSC.edu

12. Tools and Resources Research Toolkit Cores & Facilites 843-792-8300 http://sctr.musc.edu

13. Research Toolkit

14. Research Toolkit

15. Cores & Facilities

16. Regulatory Resources MUSC Approval Plan for Research (MAP-R) 843-792-8300 http://sctr.musc.edu

17. MAP-R

18. MAP-R

19. MAP-R

20. MAP-R

21. Recruitment Resources www.SCresearch.org www.ResearchMatch.org 843-792-8300 http://sctr.musc.edu

22. SCresearch.org Publically available, easy to search listing of active, IRB approved research studies within the HSSC consortium Click eIRB platform Must be IRB “Approved” and open for enrollment Primary goal is to promote research opportunities Automated process through the eIRB system

25. What is it? What is it not? • A ‘matching’ tool to help volunteers easily connect with research studies • An innovative national partnership to develop a centralized web-based recruitment registry • A free, complementary recruitment tool • Secure & promotes volunteer choice at all levels • Disease-neutral • Anyone residing in the US can join! • The end-all solution to participant recruitment • A replacement for successful, existing recruitment efforts • A tool that permits ‘cold calling’ volunteers • A final product

27. Additional Tools Palmetto Profiles REDCap 843-792-8300 http://sctr.musc.edu

29. A secure, web-based application designed exclusively to support data capture for research studies • Intuitive interface for data entry (with data validation) • Includes audit trails for tracking data manipulation • Automated export procedures for seamless data downloads to common statistical packages • Other features include branching logic, calculated fields data de-identification, and survey capabilities

30. SPARC (Services, Pricing, Applications & Requests Center) Web-Based Research Management • Budget Development • Request Services • Invoice Sponsor • Track Services

31. Applying for SCTR Services Applications for any SCTR service can be requested through the SCTR Programs Application & Request Kiosk (SPARK) at http://sctr.musc.edu 843-792-8300 http://sctr.musc.edu

32. Create a service request for a new protocol Ask a Question

33. Keep in Touch • SCTR-Weekly Research listserv - CALENDAR and Announcements • Monthly Research Lunch-N-Learn • 3rd Wednesday of Month 12pm-1pm 843.792.8300 http://SCTR.MUSC.edu success@musc.edu 843-792-8300 http://sctr.musc.edu

34. Thank You! Questions? 843-792-8300 http://sctr.musc.edu