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 Clinical Trials Governance Board (CTGB)
- Center for Biomedical Informatics (CBMI)
- Center for Leading Innovation and Collaboration (CLIC)
- NIH Resources
- Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD)
- The Development, Implementation and Assessment of Novel Training in Domain-based Competencies (Diamond project)
- Northwestern University Team Science
- ClinicalTrials.gov
To learn more about the Clinical Trials Governance Board clinical trials units, please visit the CTGB Clinical Trails Groups webpage.
- Data Management
- Data Storage
- Project Management
Through these key areas of specialty 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 Center for Biomedical Informatics have been developed keeping in mind the growing needs of the UTHSC research community as well as the growing Memphis research space. Not only is the CBMI equipped to handle multiple projects but we have expanded our capabilities in regard to tools, techniques and available storage space for researchers.
To learn more about the Center for Biomedical Informatics, please visit the CBMI website.
Please call the CBMI at 901-287-5834 if you have any questions.
https://clic-ctsa.org/about/clic
The Center for Leading Innovation and Collaboration (CLIC), housed at the University of Rochester, 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.
The purpose of CLIC 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.
https://www.youtube.com/watch?v=czS19f5Di_I&feature=youtu.be
NIH Presentations
Including Diverse Populations in NIH-funded Clinical Research https://www.youtube.com/watch?v=fYoNnIt_f1o
An Overview of NIH Policies on Human Subjects https://www.youtube.com/watch?v=jPWxPgR-vww
2020 NIH Virtual Seminar Presentation Materials https://grants.nih.gov/virtual-seminar-2020/presentations.html
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.
- https://osp.od.nih.gov/clinical-research/clinical-research-policy/
Application resources
- Application Process:https://grants.nih.gov/grants/how-to-apply-application-guide.html
- Biosketch Formatting: https://grants.nih.gov/grants/forms/biosketch.htm
- Budget: https://grants.nih.gov/grants/how-to-apply-application-guide/format-and-write/develop-your-budget.htm
- Formatting your Application: https://grants.nih.gov/grants/how-to-apply-application-guide/format-and-write/format-attachments.htm
- Preparation: https://grants.nih.gov/grants/how-to-apply-application-guide/prepare-to-apply.htm
- Reference Letters: https://grants.nih.gov/grants/how-to-apply-application-guide/submission-process/reference-letters.htm
- Submitting the Application: https://grants.nih.gov/grants/how-to-apply-application-guide/submit.htm
- Writing your application: https://grants.nih.gov/grants/how-to-apply-application-guide/write-application.htm
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: https://vepimg.b8cdn.com/uploads/vjfnew/2182/content/docs/1602095808diversity-focused-cancer-research-training-dr-lin-pptx1602095808.pptx
- NCI Resources for Researchers:https://vepimg.b8cdn.com/uploads/vjfnew/2182/content/docs/1601471080nci-experimental-resources-available-for-researchers-pdf1601471080.pdf
- NCI Research Training and Career Development Awards:https://vepimg.b8cdn.com/uploads/vjfnew/2182/content/docs/1601471105nci-research-training-and-career-development-awards-pdf1601471105.pdf
- NIH Review: Life as an Established Investigator and Reviewer: https://vepimg.b8cdn.com/uploads/vjfnew/2182/content/docs/1601471121nih-peer-review-prepare-your-application-for-review-how-to-participate-in-review-pdf1601471121.pdf
- Post-Award Administration An Overview for New Investigators:https://vepimg.b8cdn.com/uploads/vjfnew/2182/content/docs/1601471132post-award-information-for-new-grant-recipients-pdf1601471132.pdf
- NCI Budget Process:https://vepimg.b8cdn.com/uploads/vjfnew/2182/content/docs/1601471143the-nci-budget-process-pdf1601471143.pdf
NIH Develop Your Budget:
The Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD) affiliates are 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 (RTP) 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.
The Development, Implementation and Assessment of Novel Training in Domain-based Competencies, or “DIAMOND” project, is a collaborative effort by the University of Michigan, University of Rochester, The Ohio State University and Tufts University to provide competency-based education and training to clinical research professionals. The primary objectives of this project 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.
ClinicalTrials.gov is a database of privately and publicly funded clinical studies conducted around the world.