SCTR Research Support Services SUCCESS Center & Research Nexus Royce Sampson, MSN, RN, CRA SCTR Chief Operations Officer Research Assistant Professor

South Carolina Clinical and Translational Research Institute SCTR Research Nexus

SUCCESS Center Stephanie Gentilin, MA, CCRA, Director Free Consultations and Research Training: Research Navigation Research Toolkit Regulatory consults MAP-R Grants & Contracts Budget Development Consults Epic Research Team SPARC Request Study Tracker Recruitment SCresearch.org eIRB Statewide PM REDCap Consults

Research Toolkit

MAP-R

 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 Request is a web-based research management system  Research service and resource catalog  Provider/core facility service request management system  Investigator Dashboard  Administrative Portal Focus on one stop shop research service catalog and request, budget development and billing compliance, audits, and reporting

Search and Find Research Services and Resources for your Proposal in One Easy to Use Location © 2011, 2012, 2013, 2014 Medical University of South Carolina.

Obtain Research Service Pricing for Better Budgeting © 2011, 2012, 2013,2014 Medical University of South Carolina.

Push Study Calendar into EHR

© 2011, 2012, Medical University of South Carolina. User Dashboard – Protocol, Service Request, User Management

2012 SUCCESS Center Satisfaction Survey Results Service Utilization The survey was sent to 567 faculty and staff members who had utilized SUCCESS Center services from January 2012 to December There was an 15% response rate with 84 responders.

SCTR R ESEARCH N EXUS – S TANDARD OF C ARE (SOC) P ATRICK F LUME, MD, M EDICAL D IRECTOR ; K AREN P ACKARD, MSN, N URSE A DMINISTRATOR Became Provider Based Clinic for the Medical University Hospital Authority on January 13, 2014 Ability to bill third party payers (insurance companies) for SOC services provided during research study visits Increased Investigator and Participant satisfaction Provide care in one location

SCTR Research Nexus: Research Coordination and Management (1Program Manager, 2 Research Nurses, 5 Research Coordinators, 1 Intern) Services include: Study Coordination Project Management Regulatory Management Budget Development Data Entry Quality Assurance Reviews Recruitment Inpatient, Outpatient and Outlying MUSC Clinics Services are available for full, partial, or gap (fill in) Support Experienced Research Coordinators and Nurses; VA credentialed

SCTR Research Nexus: Research Coordination & Management: College/Department Utilization Data (121 Total, 46 Active, 2 Pending)

SCTR Research Nexus: Research Opportunities & Collaborations (Signe Denmark, Program Manager) Services include: Matching Study Opportunities with Investigator Interest Quintiles Partnership Management Feasibility Assessment Site Selection Support Site Initiation Visit Support Budget Development Support Contract Negotiation Guidance in collaboration with ORSP Navigation to Research Support Services Voucher Management

Research Opportunities and Collaborations Protocols matched across the College of Medicine All phases of trials

$$ Vouchers $$ Who: The Principal Investigator (PI) with a MUSC faculty appointment can apply for a voucher for his or her research protocol. The voucher program is open to basic, translational, and clinical researchers along with community research projects affiliated with MUSC. What : A Voucher can be approved for up to $1,000 for research services and supplies (ex. laboratory services, clinical procedures, pregnancy testing supplies, core facilities, or off campus labs). Vouchers cannot be used to fund food, parking, travel, computers, or SCTR services. When : One voucher per protocol, once a year. Vouchers expire one year from the approval date. Where : To apply for a voucher, enter a request through the Services, Pricing & Applications for Research Center (SPARC) system. Services, Pricing & Applications for Research Center (SPARC) system How : Requests are reviewed by SUCCESS Center staff within 2 business day pending all information is complete and accurate. Follow up: You will be expected to complete a survey regarding project outcomes to date. You are required toacknowledge NIH/NCRR Grant Number UL1 TR and provide information on publications, extramural funding and intellectual property related to this funding. Compliance with the NIH Public Access Policy is required. Publications must be submitted to Pubmed Central & receive a PMCID within 3 months of release.acknowledge NIH/NCRR Grant Number UL1 TR000062

SCTR Pilot Projects  New RFA released on May 22, 2014  3 Categories  Discovery - $25K – LOI due on June 13 th  Fast-Forward - $5K SCTR and $5K PI match – July 11 th  High Innovation - $10K – July 11 th  New collaborations, extramural grant focused

SCTR Biostatistics  Provide methodological expertise to translational researchers  Stimulate methodological development in the areas of study design and biostatistics.  Examples of requests: Sample size / power estimation Analyses of preliminary data for a grant Developing analysis plans Assistance with manuscript preparation Grant review Survey design 1 on 1 didactic teaching

SCTR Science Consults Comparative Effectiveness Research Consult – PCOR Novel Technologies & Mobile Apps Consult Drug & Device Development Consults Intellectual Property, Records of Invention & Patents Center for Innovation & Entrepreneurship - Faculty Startups, Commercial Market Analysis NIH Public Access Policy (publications)

CCRT: Core Clinical Research Training Purpose: – Prepare research team members to coordinate cost effective healthcare research – Protect the rights and safety of human subjects – Understand & implement a research protocol – Achieve recruitment and retention goals – Contribute to the science of health care in compliance with the Good Clinical Practice Guidelines and federal regulations – Manage regulatory files Rolling Online Course: – 20 hours of recorded lecture, seminar and workshop – 24/7 course access for 8 weeks – Content provided in 15 different topic areas – Bonus materials & downloadable resources – Certificate of completion with a 75% passing rate – Useful preparation for coordinator certification Live Course (Spring and Fall Session): – contact hours of training over 6 days on MUSC campus – Content provided in 15 different topic areas – Printed materials and resources binder – Certificate of completion with a 75% passing rate – Useful preparation for coordinator certification Continuing Education Credit is offered through MUSC’s Office of Continuing Medical Education: – 13.5 CME or – 1.35 CEU credits

MSCR Program Specifics: Part time – 2 years, Full time – 1 year Course examples include ethics, epidemiology, biostatistics, design and conduct of clinical trials Required item: development of a grant proposal with the goal of being ready for submission by the end of the MSCR program

Society of Clinical Research and Translational Early Scientists (SOCRATES) For Junior Faculty to Present Research Projects in Front of Peers, Senior Researchers, Statisticians and Epidemiologists To Meet Researchers in Other Departments & Foster Collaboration Across Multiple Subspecialties at MUSC To Discuss Ways to Enhance Clinical and Translational Research Across the Campus To Provide Information on Research Opportunities (e.g., grant announcements)

SCTR KL2 & K12 Clinical Scholars Program Post-doctoral K12 Research Scholars Training Program 2 years with potential 3 rd -year extension 75% salary support (subject to NIH cap)/40% clinical scholar $25,000 annual research project budget/$20,000 $1,000 annual travel budget Next slots: upon CTSA renewal in summer 2015

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

Questions?