The Tennessee Clinical and Translational Science Institute (TN-CTSI) is committed to providing high quality resources to support researchers. Resources include support with research design and biostatistics, informatics, project management, and clinical research coordinators.
Biostatistics and Study Design Support
The TN-CTSI operates the BERD clinic in partnership with the Department of Preventive Medicine to provide assistance with biostatistics, epidemiology, and study design. Expertise and research interests of the TN-CTSI and the Department of Preventive Medicine include clinical trials, observational studies, statistical genetics, health services research, and statistical computing. Faculty members teach biostatistics courses in the College of Graduate Health Sciences in the Masters of Epidemiology program and Biomedical Sciences program. The BERD Clinic provides faculty and residents consultations on topics ranging from study design, analytical approaches, sample size estimation, programming solutions, epidemiology, biomedical informatics, and manuscript preparation.
Center for Biomedical Informatics (CBMI)
The Center for Biomedical Informatics provides customized biomedical and clinical informatics applications to help manage complex translational and clinical research needs. CBMI specializes in data management, data storage, and project management. Through these key areas the CBMI bridges technology, computation, clinical/public health research to develop high quality deliverables aimed at improving population health in Memphis and its surrounding areas.
The goals and objectives of the CBMI reflect the growing needs of the UTHSC research community as well as the growing Memphis research space. The CBMI is equipped to handle multiple projects, and has expanded capabilities in regard to tools, techniques and available storage space for researchers. To learn more visit the CBMI website or call 901-287-5834.
Center for Leading Innovation and Collaboration (CLIC)
Housed at the University of Rochester, CLIC is the coordinating center for the Clinical and Translational Science Awards (CTSA) Program, which supports a network of more than 50 of the nation’s top biomedical research institutions.
Its purpose is to serve the CTSA Program through coordination, transparent communication, actionable metrics, network analytics and innovative collaboration tools for use around the consortium, and to make the work and accomplishments of the CTSA Program vibrantly visible to all stakeholders. CLIC provides:
-
- Data coordination services to collect, analyze and transform CTSA Program data into actionable insights that accelerate patient impacts.
- A dynamic ecosystem that supports collaboration and team science across the CTSA Program community.
- Communications to support internal CTSA Program activities and to make the progress and impact of translational science visible to internal and external stakeholders.
CLIC has assumed the role of Tufts University to implement the Common Metrics Initiative and builds upon the foundation laid by Vanderbilt University’s CTSA Consortium Coordinating Center (C4). CLIC strives to support the goals of the CTSA Program and to be a central resource for researchers across the network of hubs.
Fundamentals of the NIH Grant Process and Need to Know Resources
NIH Presentations
- Including Diverse Populations in NIH-funded Clinical Research
- An Overview of NIH Policies on Human Subjects
- 2020 NIH Virtual Seminar Presentation Materials
Clinical Research Policy
The Clinical Research Policy Program focuses on the regulatory and policy issues related to research involving human subjects, biospecimens, participant data, and the integration of bioethical considerations across the NIH research portfolio. This program focuses on improving the efficiency, organization, and advancement of clinical research. It serves as a nexus for ongoing harmonization, streamlining, and optimization of policies and requirements concerning the conduct and oversight of clinical research, and addresses a wide range of topics.
Application resources
- Application Process
- Biosketch Formatting
- Budget
- Formatting your Application
- Preparation
- Reference Letters
- Submitting the Application
- Writing your application
NIH Clinical Research and Bioethics Training
- https://clinicalcenter.nih.gov/training/index.html
- https://bioethics.nih.gov/courses/ethical-regulatory-aspects.shtml
NCI Presentations/Resources
- Diversity-Focused Cancer Research Training
- NCI Resources for Researchers
- NCI Research Training and Career Development Awards
- NIH Review: Life as an Established Investigator and Reviewer
- Post-Award Administration An Overview for New Investigators
- NCI Budget Process
Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD)
Affiliates comprised of regulatory affairs specialists and experts from North and South Carolina institutions that receive funding from the NIH Clinical and Translational Science Awards (CTSA) Program. Currently these institutions are the University of North Carolina at Chapel Hill, Duke University, Wake Forest School of Medicine, and RTI International, and the Medical University of South Carolina.
Combining the regulatory talents from the North and South Carolina Clinical and Translational Science Awards (CTSA) programs and the research triangle park area enables sharing of ideas, lessons learned, historical information, and the development of successful strategies to assist the academic researcher in navigating an increasingly complex regulatory environment.
A collaborative effort by the University of Michigan, University of Rochester, Ohio State University, and Tufts University to provide competency-based education and training to clinical research professionals. The primary objectives are to develop an online educational portal for shared competency-based educational offerings and assessments, demonstrate the utility of an e-portfolio system for individualized professional development planning, and to disseminate these educational offerings to broader audiences at research institutions across the United States.
Northwestern University Team Science
Solutions to complex scientific problems require teams of diverse specialists working across the boundaries of disciplinary silos. Teamscience.net aims to create, evaluate, and disseminate durable, readily accessible online learning resources to enhance skills needed to perform transdisciplinary, team-based translational research. The tools on teamscience.net are designed to help learners envision how transdisciplinary collaboration can work and overcome the inevitable communication challenges that arise when working in multidisciplinary teams. Users are able to move freely throughout the site’s learning modules, identifying topics of interest and viewing expert and research-based information on those topics at will.
ClinicalTrials.gov is a database of privately and publicly funded clinical studies conducted around the world.
