South Carolina Clinical & Translational Research Institute Royce R. Sampson, MSN, RN, CRA SUCCESS Center Director Stephanie Gentilin MA, CCRA SUCCESS Center Associate Director

 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”

 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.

Program Areas:

Intake or Online Request Form The “Front Door” for Research Support  Research Navigation Consults  Regulatory Consults & Training  Recruitment Consultations  Grant Submission/Report Consults  Budget Development Consultations  Research Coordinator/Nurse Core  CTRC Proposal Pricing / Auditing

 Budget Development Core  Regulatory Core  IRB submissions (initial, amendments, & renewals)  Consent Forms  HIPAA Authorization  Certificate of Confidentiality  Research Coordinator Core  Nurse Coordinator Core

 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

 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

Clinical & Translational Research Center Clinical & Translational Research Center

 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 the Request Services button at

Tools and Resources Research Toolkit Cores & Facilites

Regulatory Resources MUSC Approval Plan for Research (MAP-R)

Recruitment Resources

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

What is it?  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! What is it not?  The end-all solution to participant recruitment  A replacement for successful, existing recruitment efforts  A tool that permits ‘cold calling’ volunteers  A final product

Additional Tools Palmetto Profiles REDCap

 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

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

Applications for any SCTR service can be requested through the SCTR Programs Application & Request Kiosk (SPARK) at

Keep in Touch  SCTR-Weekly Research listserv - CALENDAR and Announcements  Monthly Research Lunch-N-Learn 3 rd Wednesday of Month 12pm-1pm

Thank You! Questions?