South Carolina Clinical & Translational Research Institute (SCTR) Royce R. Sampson, MSN, RN, CRA, SCTR Chief Operations Officer Stephanie Gentilin, MA, CCRA, SCTR SUCCESS Center Director

SCTR.MUSC.edu

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SCTR SUCCESS Center The Support Center for Clinical & Translational Science (SUCCESS) Support spans the entire research spectrum, from inception of ideas through technology transfer and dissemination of best practice models. Provide Linkages to existing research resources Offer consultation services Educate, Train, Mentor and Teach Develop of tools and resources Here to help you answer any research question or help you locate the best resource available AT NO CHARGE.

SUCCESS Consultations Research Navigation Recruitment, Retention & Special Populations Grants, Contracts & Budget Development Regulatory & Quality Assurance State-wide eIRB Project Management Informatics Tool Development and Support (eIRB, SPARCRequest, SCresearch.org) Research Electronic Data Capture (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

SCTR Biostatistics Program Provide methodological expertise to translational researchers Assist with design of multicenter clinical trials Biostatistical education Examples of requests Sample size / power estimation Pilot project and grant development Basic biostatistics “how-to” lectures Priority given to KL2 & TL1, PP applicants, and extramural grant applicants

Feasibility Consultation Service New self-service research data & feasibility consultation service Research teams across campus; industry, federal funding & pilots Self-service tools for de-identified patient counts

Additional SCTR Consultations NIH Public Access Policy & Compliance (publications) Community Engagement & Cultural Competency Research Ethics Novel Device & Technology Development Intellectual Property & Commercialization Research Dissemination Strategies

Extramural Grant Review Assistance for Faculty SCTR Internal Scientific Review of Extramural Grant Application Limited to MUSC Faculty; Internal SCTR/MUSC scientific review of an extramural grant application (NIH K-series, R-series, U-series, NSF applications) External Review of Extramural Grant Application Limited to MUSC Faculty; To engage an external expert to review an extramural grant application following SCTR internal approval* (NIH R-series, K-series, P- series, U-series, NSF applications) * SCTR will make decisions whether to send these applications for external expert reviews based on the needs of the application. Application Due Dates: Minimum 6 weeks before the extramural grant application due to MUSC ORSP

SCTR Research Nexus & Hospital Provider Based Clinic 6 Examination Rooms, 5 Procedure Rooms, 3 Specialty Suites Body Composition Suite Pulmonary Function Testing Suite SCTR Research Nexus & Hospital Provider Based Clinic

Clinical Nursing Services Conduct study protocol procedures Secure specimens Administer medication Gather critical data at bedside Ability to bill 3 rd party payers (insurance companies) for SOC services Nutrition Services Collect and assess macro and micro nutrient intake Provide nutrition education in individual or group sessions Coordinate nutrient specific meals and/or snacks Pulmonary Function Testing Body Composition Testing (BodPod) SCTR Research Nexus Clinic and Laboratory

SCTR Research Nexus Laboratory Qiagen Autopure for Large Volume Automated DNA Extraction Fume Hood for Hazardous Chemical Handling and Stool Preps Six -80°C Freezers, One - 20°C Freezer and Two 2-8°C Refrigerators Laminar Flow Hood for PBMC Processing and Aseptic Methods

Laboratory Services Biological Specimen Processing serum, plasma, PBMCs, urine, stool, milk, saliva, other fluids and tissues as lab can accommodate, aseptic and complex processing capabilities Sample Storage ambient, 2-8°C, -20°C, -80°C Sample Packaging and Shipping to Central Laboratories ambient, refrigerated and frozen on dry ice (IATA certified) Nucleic acid extraction DNA and RNA Immunoassay Protocols ELISAs, salivary luminescence Develop/customize new laboratory protocols microbiome stool extraction, RNA extraction from PBMCs SCTR Research Nexus Clinic and Laboratory

Research Coordination & Management Wide range of research coordination and management services for MUSC investigators Hourly rate Experienced, trained and VA-credentialed personnel, as well as licensed nurse coordinators Project Management Services for Multi-site trials or day-to-day oversight of research programs

Research Coordination & Management Services: Study management & coordination Project management Regulatory management Data management Recruitment Budget development Invoicing & billing compliance Quality assurance reviews Study record and drug storage Conduct study assessments (Psychometric testing) Deliver social-behavioral interventions (group and individual therapy)

Research Opportunities & Collaborations Centralized research liaison for multi-site clinical study opportunities Identify new clinical trial opportunities Pair opportunities with Investigators Assist in navigating the site selection process Confidential Disclosure Agreement (CDA) facilitation with ORSP Support development and negotiation of study budget Clinical Trial Agreement (CTA) facilitation with ORSP Periodic post-award communication, consultation, and research resource needs assessments

Voucher Program o One per rolling 12-month year o Up to $1,000 Pilot Projects o 3 categories o High Innovation category ($10K) and Translational Roadblock category ($25K) are open NOW! Technology Development Grants (SCTR & FRD) o Pre-apps due September 1 st (2 pages) o Supports continued development of reported inventions in the MUSC portfolio MUSC Library of Funded Grant Proposals o Contains successfully funded grant applications – new apps always being added Early Career Investigator Training Programs SCTR Funding Opportunities

Multidisciplinary Scholars Program – NIH KL2 (K12) – Next Slots in Early 2019 o Junior Faculty less than 10 years out of sub-specialty training o 75% effort dedicated to research for 2 years (optional 3 rd ) o US Citizen or permanent resident o $25,000 in research project and training funds o Sample Benefits: K-to-R, Grant Writing Workshop, Individual Development Plan, Research Navigation, All SCTR consult services College of Medicine Clinician Scientist Scholars (K12-type) – Next Slots in Late 2018 o 40% effort dedicated to research o $20,000 in research project funds ($5K from COM, $15K from Dept.) o Same benefits as above Early Career Investigator Training Programs Early Career Investigator Training Programs

Core Clinical Research Training (CCRT) o Online (8 weeks to complete) or Live (Sept – MWF, 8:30a,-12:30pm) o 15 research topic areas covered o 13.5 CME’s or 1.35 CEU’s SCTR Education & Training Resources o Lunch-n-Learns (including archived library of past sessions) o Tools for Mentors & Mentees Series (including archive) o B&BS and SOCRATES (Society of Clinical Research and Translational Early Scholars) o Scientific Retreats biannually o ACRP eLearning Platform Research Toolkit Early Career Investigator Training Programs Training Resources

Questions?