SOUTH CAROLINA CLINICAL & TRANSLATIONAL RESEARCH INSTITUTE
Research Toolkit: Design Study
South Carolina Clinical & Translational Research Institute (SCTR) - SCTR Institute provides free consulting and fee-based services to all faculty, staff and students of the Medical University of South Carolina and its affiliated healthcare partners. To request a consultation with a specialist regarding your research needs, including study development, implementation and close out, please visit SPARCRequest©.
SCTR SUCCESS Center - Free Consults - The Support Center for Clinical & Translational Science (SUCCESS) support spans across the entire research spectrum, from inception of ideas through technology transfer and dissemination of best practice models. Support services include: guidance, training, and resources for investigators and study teams at any point in the research process. A SUCCESS Center Research Navigator is available to meet with you and guide you through the process for setting up a study. Submit a request for assistance through SPARCRequest© or contact the SUCCESS Center at 843-792-8300 or email email@example.com.
Research Nexus - The specialized staff of the SCTR Research Nexus consist of project managers, research nurses, research coordinators, laboratory personnel, nutritionists, IT specialists, and professional/administrative personnel. Services available include budget development, regulatory management, data management, study coordination, quality assurance, as well as nursing related clinical assessments and interventions. Facilities available include a core laboratory, fully-equipped outpatient clinic, and imaging suite comprised of highly-technical physical facilities that are on hand to support your research. For more information contact the SUCCESS Center at 843-792-8300 or email firstname.lastname@example.org.
SPARCRequest© - SPARC (Services, Pricing, & Application for Research Centers) is a web-based research management system that provides a central portal (one-stop shop) to researchers and their study teams to browse for research services and resources, as well as submit service and pricing requests with a focus on billing compliance and proposal/budget development. SPARCRequest© does not require a separate registration beyond having a NetID. For non-MUSC users, you can request access on the SPARCRequest© website.
MAP-R - Based on your responses to a series of questions, this web program will provide you with information on the necessary regulatory and institutional approvals required for your specific study. For detailed instructions on how to complete a MAP-R, click here.
Charleston VAMC Research - This information will assist in accessing forms, determining deadlines and instructions for conducting VAMC research.
Library Liaisons - Every college and program has a designated liaison librarian. Liaisons are subject specialists who provide support for students, staff and faculty in the areas of education, research, clinical work, and scholarly communication.
- Palmetto Profiles
- Palmetto Profiles enables the discovery of research expertise within the Health Sciences South Carolina (HSSC) consortium, allowing for new ways to network and collaborate between researchers, between mentors and mentees, between research community and industry partners, and much more.
- Office of Research Development
- ORD helps MUSC faculty members prepare competitive proposals, with an emphasis on strategic research areas prioritized by the colleges and university administration as well as institutional research resources and infrastructure. ORD provides access to a network of detailed professional information for more than 480,000 scientists and scholars worldwide in order to provide potential collaborators.
- Society Of Clinical Research And Translational Early Scientists (SOCRATES) & B&BS Club
- SOCRATES and B&BS Club offer opportunities for junior faculty to present their research projects in front of their peers, members of MUSC's Leadership Counsel, Mentoring Champions, and statisticians & epidemiologists who are part of the SCTR Biostatistics & Ethics Program in order to get constructive feedback for improving and enhancing research studies and grant proposals.
- National Institutes of Health (NIH) Key Dates & Forms
- Office of Research Development
- ORD helps MUSC faculty members prepare competitive proposals, with an emphasis on strategic research areas prioritized by the colleges and university administration as well as institutional research resources and infrastructure. Grantsmanship workshops and Research Project Retreats are also offered through this office.
- Resources and Scientific Environment
- Formerly known as the "institutional boilerplate", this comprehensive list includes descriptions of institutional resources and initiatives relevant to the conduct of research at MUSC. This information may be useful in the development of the resources and facilities portion of a proposal.
- NIH ERA Commons Accounts
- The ERA Commons site is a web-based system that supports the full life cycle of grants administration functions for the NIH as well as the Agency for Healthcare Research and Quality (AHRQ), Centers for Disease Control (CDC), Food and Drug Administration (FDA), the Substance Abuse and Mental Health Services Administration (SAMHSA), and the Veterans Health Administration (VHA). The user name identifies you in the Commons and, along with your password, allows access and provides functionality according to your assigned role.
- Library of Funded Grant Applications
- ORD Online library of successfully funded extramural grant applications, available to MUSC faculty upon request. Contact the Office of Research Development to request access. The library can be found here.
- Grant Review Resources
Limited to MUSC Faculty; Internal SCTR/MUSC scientific review of an extramural grant application (NIH K-series, R-series, U-series, NSF applications)
Limited to MUSC Faculty; $500 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*, PCORI, or AHRQ applications)
* SCTR will make decisions whether to send these applications for external expert reviews based on the needs of the application.
Contact the SUCCESS Center for more information: 843-792-8300 or email@example.com
Science Experts Network Curriculum Vitae (SciENcv) is a new electronic system that helps researchers assemble the professional information needed for participation in federally funded research. SciENcv gathers and compiles information on expertise, employment, education and professional accomplishments. Researchers can use SciENcv to create and maintain biosketches that are submitted with grant applications and annual reports. SciENcv allows researchers to describe and highlight their scientific contributions in their own words.
The Writing Center is a resource for students, faculty, and staff for the development of good writing skills. The Center has developed a quick reference guide to inform you about how it works. From individual consultations to specially tailored workshops, the Writing Center is happy to help.
SCTR SUCCESS Center - Individualized assistance with grant application forms and budget development. Types of services offered include the following examples: budget development and analysis consultation, hands-on grant application and form preparation training, and guidance in navigating the pre- and post-award grant process at MUSC. Request through SPARCRequest©!
- SCTR SUCCESS Center Individualized assistance with grant application forms and budget development. Types of services offered include the following examples: budget development and analysis consultation, education on and access to financial tools and templates, hands-on grant application and form preparation training, and guidance in navigating the pre- and post-award grant process at MUSC.
- Preparing a Proposal Budget for a Sponsored Project
- Determining Allowable and Unallowable Costs on Sponsored Agreements
- Determining Direct vs. Facilities & Administrative (F&A) Costs on Sponsored Agreements
Request through SPARCRequest©!
The Office of Research and Sponsored Programs has central responsibility and institutional signatory authority for proposal submission of sponsored research, scholarship, instruction and other related activities to support and facilitate sponsored research at MUSC. Important information for the preparation of your budget can be found on their Proposal Preparation page. This information includes current fringe benefit rates and facilities & administrative (F&A) cost rates.
As a unit of the Division of Finance and Administration, Grants and Contracts Accounting (GCA) is responsible for post-award administration of sponsored grants and contracts awarded to the University. GCA can assist with budgeting questions related to:
Review the NIH's Types of Grant Programs page for information regarding the specific budget components and restrictions relative to individual NIH funding mechanisms.
When developing a NIH budget, use these NIH tips and reminders. However, remember that these suggestions do not supersede the instructions and guidance found in the relevant Funding Opportunity Announcement.
The NIH administers a legislatively-mandated provision limiting the direct salary (also known as salary or institutional base salary, but excluding any fringe benefits and F&A costs) for individuals working on NIH grants, cooperative agreement awards, and extramural research and development contracts.
- The Collaborative Unit
- An MUSC University Research Resource Facility (URRF). As a URRF, the unit is committed to assisting MUSC investigators in meeting biostatistical, epidemiological, and bioinformatics needs related to research and grant development. Services include initial consultations, grant application assistance, data analysis and interpretation, and manuscript preparation/review.
- The Data Coordination Unit (DCU)
- Provides data management services and coordination for clinical research. The DCU team is highly experienced with all aspects of multicenter clinical trials and outcomes research and offers full service statistical consulting ranging from protocol development to final analysis and report writing. DCU services include study design/protocol development, central registration and randomization, data management, web-based database system development, reporting and publications.
- SCTR Biostatistics, Epidemiology & Research Design (BERD)
- The BERD program provides methodological expertise to translational researchers. They assist SCTR pilot project investigators and K awardees, help investigators with Research Nexus protocol submissions, assist with grant submissions (e.g. sample size estimation, statistical analysis planning), and collaborate on manuscripts.
- SCTR Biomedical Informatics Program
- The Biomedical Informatics Center provides investigators with ready access to a variety of software tools, databases, and support systems that will greatly facilitate the performance of clinical and translational research.
Effective utilization of informatics resources will increase as we expand and refine the data available to researchers within an integrated knowledge and data environment that maximizes the unique collaborative research portal. This integrated environment will permit researcher information and collaborative knowledge to be appropriately and creatively shared by many investigators.
Request a free consultation with Biostatistics or Biomedical Informatics through SPARCRequest©.
MUSC Human Research Protection Program Guide - All human research studies operate under the auspices of a campus-wide Human Research Protection Program (HRPP).
Quality Improvement (QI)
Quality Improvement vs. Research - This resource offers guidance to determine quality improvement activities versus research when developing a project.
MUSC Approval Plan for Research (MAP-R) - this tool can assist investigators in identifying all the steps required for their specific project. Through a series of questions, it determines where you are in the research process and what needs to be completed moving forward.
Hospital Patient Data Requests for Research - Includes information about how to gain access to patient data for research purposes via the MUSC Clinical Data Warehouse.
- Recruitment Planning Feasibility
- MUSC Clinical Data Warehouse (CDW) - The MUSC CDW is a single, secure, integrated database extracted from the MUSC Clinical Data Repository, which includes patient demographics, visit information, ICD-coded diagnoses, ICD-coded procedures, medications, laboratory test results since 1993, and Epic results since July 1, 2014.
- ResearchMatch - A recruitment tool connecting willing volunteers with researchers who are searching for study participants.
Has a feasibility component to see how many registered volunteers in the online matching system meet your study criteria. To register as a ResearchMatch researcher, click here.
- Recruitment Consultation Services - SCTR SUCCESS Center - Free Recruitment Consultation: Based on your needs and target population, you will be matched with the appropriate person (or team of people) who can help you strategically plan for short or long term recruitment. Request service through SPARCRequest©.
- Recruitment "Funnel" Benchmarking Guide - If study-specific, evidence-based recruitment goals cannot be developed in planning, utilize the recruitment scorecard for forecasting calculations and key performance indicators.
- Charleston VAMC Research - This information will assist in accessing forms, determining deadlines and instructions for conducting VAMC research.
- Partnerships for Effective Recruitment
- Center for Community Health Partnerships - The vision of the Center for Community Health Partnerships is to transform health care by mobilizing and engaging communities. it builds on four interacting elements: partnership, participation, prevention and power. The mission of the Center is to engage the communities in activities that promote health, reduce the risks of illness and disease, manage adaptation to chronic conditions, and build community resilience.
- SCTR Community Engagement Core - has training opportunities, funding opportunities, and more to provide researchers and research staff with the opportunity to partner and collaborate with various groups and members of the community. Submit a SPARCRequest© to request a Community Engagement consultation.
- MUSC Center for Health Disparities Research is dedicated to engaging community members and academic partners in all aspects of the research process to promote health, reduce the risk of illness and disease, and build community resilience to help transform health care and eliminate health disparities.Patient Safety
- NIH Data Safety Monitoring Plan (DSMP) / Data Safety Monitoring Board (DSMB)The IRB requires review and approval of data and safety monitoring plans for greater than minimal risk research, clinical research, or clinical investigations funded by the National Institutes of Health (NIH) or regulated by the Food and Drug Administration (FDA).
- MUSC Policy on Data and Safety Monitoring Plans - This policy specifies requirements for appropriate use and establishment of a data and safety monitoring plan for clinical research protocols to ensure the safety of subjects, the accuracy of data, and the appropriate termination of the study.
- DHHS Protection of Human Subjects Regulations - Basic HHS Policy for Protection of Human Research Subjects
- FDA Clinical Trials and Human Subjects Protection Regulation Information - this site includes links to other sites relevant to the conduct of clinical trials, both nationally and internationally.
- ICH E6 Good Clinical Practice Consolidated Guidance - Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects.
- Investigational Drugs and Devices
- Development & Approval Process (Drugs) – Link to FDA resources describing the development and approval process for new drugs.
- FDA Guidance for Investigational New Drugs – This link directs to the FDA’s guidance documents on investigational new drugs and IND applications.
- FDA Guidance on IDE Policies and Procedures - Investigators are encouraged to contact the FDA directly for assistance in determining the need for an IDE.
SCTR Self-Service Research Data & Feasibility Consult - SCTR's Research Data Access & Feasibility team can help you navigate the process of accessing clinical data to evaluate your study's feasibility. The team will also work to discuss a myriad of other feasibility considerations and facilitate matching to other service providers, as needed for successful implementation of your study. Request service through SPARCRequest©.
Office of Research and Sponsored Programs
ORSP has central review responsibility and official signatory authority for proposal submission for sponsored research, including federal, corporate, and foundation sponsorship. Contact the appropriate Grants Administrator prior to submitting your grant application to ensure use of the most current forms and instructions, including the electronic Proposal Data Sheet (ePDS) for internal review and approval. Important information for the preparation of your budget can be found on their Proposal Preparation page. This information includes current fringe benefit rates and facilities & administrative (F&A) cost rates. PLEASE REVIEW AND BE AWARE OF INSTITUTIONAL SUBMISSION DEADLINES.
MUSC's internal electronic Proposal Data Sheet (ePDS) is utilized to route grant proposals for internal review and approval. Fully approved ePDS documents are required for submission to ORSP and prior to proposal submission to an external sponsor.
In accordance with PHS Financial Conflict of Interest Regulations, all significant contributors to federally sponsored award applications, must comply with MUSC’s FCOI Policy. Failure to comply with FCOI regulations can halt application submission. Contact ORSP for more information - 792-3838.
Cayuse is a platform independent software solution for submission of applications via Grants.gov. Cayuse is a web application that can be accessed directly from a PC or Mac desktop. The system supports the creation and submission of error-free grant applications to NIH, DOD, NSF, CDC and AHRQ. If you need to set up a Cayuse account or need additional information about Cayuse, click here. If you want to link directly to the Cayuse site to begin or modify a grant proposal, click here.
The ERA Commons site is a web-based system that supports the full life cycle of grants administration functions for the NIH as well as the Agency for Healthcare Research and Quality (AHRQ), Centers for Disease Control (CDC), Food and Drug Administration (FDA), the Substance Abuse and Mental Health Services Administration (SAMHSA), and the Veterans Health Administration (VHA). The user name identifies you in the Commons and, along with your password, allows access and provides functionality according to your assigned role.
NIH ASSIST - Application Submission System & Interface for Submission Tracking (ASSIST) is NIH's online system for the preparation, submission and tracking of grant applications through Grants.gov to NIH. In 2013-2014, NIH opened up ASSIST for all multi-project grant programs. In 2015, NIH will expand ASSIST support to most competing single-project programs, as well (NOT-OD-15-044; single-project ASSIST timeline).
Identifying funding opportunities is a critical part of the planning process. Funding opportunities can be found from both internal and external sponsors. External sponsors include federal, industry, foundations, and organizations. Internal sources include South Carolina Clinical & Translational Research Institute (SCTR) and Hollings Cancer Center pilot project opportunities, departmental funding and bridge funding. These opportunities can be found through the Office of Research Development
Tips for Research Funding:
- Discuss project with mentor or senior faculty.
- Look for a sponsor that fits your project.
- Contact the funding entity's program officer prior to submission.
- Read Parent Announcements, Request for Applications (RFA) and Program Announcements (PA) carefully to ensure compatibility.
- Review previously funded projects.
- Keep current on funding opportunities by looking at internal funding opportunities and sponsor websites, signing up for listservs, and applying to professional societies for funding opportunities.
Internal Funding ResourcesOffice of Research Development – the Guide to MUSC Internal Funding Opportunities
- MUSC Internal Funding Opportunities – Training and Career Development, and Pilot Project Programs (e.g., SCTR, Hollings, COBREs)
- Bridge Funding for MUSC Faculty – Training and Career Development, and Pilot Project Programs (e.g., SCTR, Hollings, COBREs)
- MUSC ORD Funding Alerts – Sign up to receive funding alerts, as new opportunities are posted, or just browse the catalog of available opportunities.
- To apply for a Voucher, enter a request through SPARCRequest©.
- All voucher awardees will be expected to complete a survey regarding project outcomes to date, in addition to acknowledging NIH Grant Number UL1 TR001450 and provide information on publications, extramural funding and intellectual property related to this funding.
External Funding ResourcesOffice of Research Development
- MUSC ORD Funding Center – consolidated resource for most extramural funding opportunities from federal to community/foundation RFPs
- MUSC ORD-managed Limited Submission Opportunities (e.g., NIH Shared Instrumentation, certain Center Grants, certain NSF Grants, Blue Cross Foundation)
- MUSC ORD Funding Alerts – Sign up to receive funding alerts, as new opportunities are posted, or just browse the catalog of available opportunities.
SCTR Research Opportunities & Collaborations Core
The ROC focuses on pairing investigators with newly available industry opportunities – in part via a partnership with Quintiles. ROC also can assist with the research site selection process, feasibility assessment, site visits, budgets and agreements, research support service matching, and finding collaborative opportunities with other investigators and/or institutions.
Grant Scoop is a web-based resource for scientists seeking private and government funding opportunities for basic and clinical researchers focused on human health. Scientists, for scientists, at all career stages from graduate student to senior PI, have compiled this resource.
Search GrantsNet to find current opportunities for funding your investigations in the biomedical, life, physical, and social sciences, as well as mathematics and engineering.
Grants.gov As an online system, Grants.gov is focused on improving access to services via the Internet. It is currently the single access point for over 900 grant programs offered by the 26 federal grant-making agencies, allowing organizations to electronically find and apply for competitive grant opportunities.
NIH Research Portfolio Online Reporting Tools (RePORT) The NIH Research Portfolio Online Reporting Tools website provides access to reports, data, and analyses of NIH research activities, including information on NIH expenditures and the results of NIH-supported research.
South Carolina EPSCoR/IDeA Program The EPSCoR and IDeA programs are merit-based federal/state/institutional partnerships designed to build the research infrastructure in South Carolina primarily through funding new hires of top-tier faculty and start-up equipment purchases. These improvements enhance research quality, thereby making the institutions and their faculty more competitive in securing federal, state, and private sector research dollars. These activities are ensuring South Carolina's role in the national move toward increased global competitiveness, as called for in the American Competitiveness Initiative (ACI).
South Carolina Research Authority - SCRA is a non-stock, tax-exempt applied research and commercialization services company that builds teams with industry academic institutions, and other organizations to advance research and technology in the state.
This tool is meant to ensure that MUSC study teams working on regulatory submissions and budget negotiations in parallel have their time and effort compensated for those activities and IRB fees covered in the event a final contract agreement is not executed. The tool encourages research team efficiency by enabling parallel processing.
LOI: Regulatory Review Fees and Regulatory Document Submission Preparation Fees
LOI: Authorization for Regulatory Review Fee and Research Team Preparation of Regulatory Submission Documents Fee Payments
SCTR Research Opportunities & Collaborations Core - The ROC focuses on pairing investigators with newly available industry opportunities – in part via a partnership with Quintiles. ROC also can assist with the research site selection process, feasibility assessment, site visits, budgets and agreements, research support service matching, and finding collaborative opportunities with other investigators and/or institutions. Submit a request through SPARCRequest© for a Free Consultation through the Office of Clinical Research.
Confidentiality Agreements - Office of Research and Sponsored Programs
Often the first step in securing corporate-sponsored research. Industry sponsors have an interest in maintaining the confidentiality of their proprietary information. Similarly, the university has great interest in protecting its proprietary intellectual property. A Confidentiality Agreement requires the company and/or the university to keep the information secret for a period of time. ORSP must review and approve these agreements before an investigator can sign them. Review the areas of responsibility for corporate grant and contract administrators and contact Cindy Brown (firstname.lastname@example.org).
A 501(c)3 not-for-profit technology transfer office that acts as the resource for entrepreneurs wishing to commercialize intellectual property from the Medical University of South Carolina (MUSC).
- Office of Research and Sponsored Programs (ORSP)
- ORSP is MUSC's Authorized Representative for sponsored contracts and subcontracts including subcontracts with other institutions for the conduct of research and contracts for industry trials. ORSP will work with the investigator and research staff to develop, review, negotiate, and obtain authorized signatures for contracts & subcontracts.
- MUSC Centers, Cores & Institutes
- MUSC provides for the University's research community access to Research Shared Facilities which offer new and diverse technologies, instrumentation and services within the resources of single laboratories. Many of these facilities are managed directly by investigators or departments. Some are maintained with support and oversight from the Office of the Associate Provost for Research.
The request for an External Affiliate NetID can be made through the SPARCRequest© system at https://sparc.musc.edu. In addition, a REDCap form linked to the request in SPARCRequest© must also be completed and submitted.
There is no cost or background check required for the External Affiliate NetID to be processed. NetIDs will be issued by the SCTR SUCCESS Center and emailed directly to the affiliate within 2 business days.