DAta | National Center for Advancing Translational Sciences

ID	Title	Body	Facebook Description	Facebook Title	Twitter Description	Twitter Title
344	Council Working Group on the IOM Report: The CTSA Program at NIH	At the suggestion of Congress, NIH commissioned an Institute of Medicine (IOM) study in July 2012 to review the Clinical and Translational Science Awards (CTSA) program. On June 25, 2013, the IOM released its report, which provides recommendations to build on the successes of the program and realize its full potential for transforming translational science for the benefit of human health. To provide guidance on these recommendations, NCATS established the Advisory Council Working Group on the IOM Report: The CTSA Program at NIH. This group provided advice on changes to the CTSA program, with a focus on establishing measurable goals and objectives. The working group included both council and non-council members who have extensive expertise in the subject areas addressed in the IOM report. Their insights and perspective were critical to the evolution of the CTSA program and to NCATS, and more broadly, to the biomedical research community. On May 16, 2014, the working group issued a report (PDF - 414KB) in response to the IOM's findings. NCATS released a related statement from the director. Having completed its assigned tasks, this working group now is disbanded. Working Group Members Co-Chairs Ronald J. Bartek President/Director/Co-Founder FARA/Friedreich’s Ataxia Research Alliance Mary L. (Nora) Disis, M.D. Professor, Department of Medicine Division of Oncology University of Washington School of Medicine Scott J. Weir, Pharm.D., Ph.D. Director, Institute for Advancing Medical Innovation University of Kansas Cancer Center Members Ann Bonham, Ph.D. Chief Scientific Officer Association of American Medical Colleges Matthew Davis, M.D., M.P.P. Professor of Pediatrics and Communicable Diseases and Professor of Internal Medicine, Medical School Professor of Public Policy, Gerald R. Ford School of Public Policy University of Michigan Chief Medical Executive, Michigan Department of Community Health David L. DeMets, Ph.D. Professor, Department of Biostatistics & Medical Informatics University of Wisconsin Gary H. Gibbons, M.D. Director, National Heart, Lung, and Blood Institute National Institutes of Health Robert A. Harrington, M.D. Arthur L. Bloomfield Professor of Medicine Chair, Department of Medicine Stanford University Philip L. Lee, J.D., M.P.M. President Results Leadership Group Lynn Marks, M.D. Senior Vice President, Projects, Clinical Platforms & Sciences, GlaxoSmithKline Corporate Secretary & Chair of the Operations Committee, TransCelerate Biopharma Sharon Milgram, Ph.D. Director, Office of Intramural Training and Education National Institutes of Health Louis J. Muglia, M.D., Ph.D. Co-Director, Perinatal Institute, Division of Neonatology Director, Center for Prevention of Preterm Birth Professor, University of Cincinnati Department of Pediatrics Cincinnati Children’s Hospital Fernando Pineda-Reyes CEO and Founder CREA Results Robert I. Tepper, M.D. Partner Third Rock Ventures, LLC
343	About the GRDR®	The NIH/NCATS Global Rare Diseases Patient Registry Data Repository/GRDR® program goal is to build a Web-based resource that integrates, secures and stores de-identified patient information from many different registries for rare diseases, all in one place. A registry is a place to collect and store large amounts of data on a specific topic. A rare disease patient registry might include information about a patient’s disease diagnosis, age, gender and medications. Often, foundations and other groups that advocate for patients create registries to help researchers and health care professionals study a particular disease. Data Collection & Submission Registry owners — usually rare disease advocacy groups or academic-based researchers — will collect and store their own data. GRDR program staff have developed common data elements (CDEs) that will enable registry owners to collect data using common formats and terms. To submit those data for inclusion, registry owners should use a global unique identifier (GUID) for each participant. The GUID is an identifying code that is designed to track patients’ data in a de-identified manner to protect the confidentiality of research subjects. Standardizing data and using GUIDs enable registries to be interoperable with one another and with other national databases. The data will be made broadly available to scientists, who can use the information to conduct analyses across many diseases and spur new research collaborations, studies and clinical trials, as well as find patients to recruit to scientific studies. Background The GRDR program began as a proof-of-concept project following a 2010 workshop sponsored by the NIH Office of Rare Diseases Research (ORDR), “Advancing Rare Disease Research: The Intersection of Patient Registries, Biospecimen Repositories, and Clinical Data” (PDF - 55KB). This project, which concluded in September 2013, included 12 patient advocacy group registries. It involved validating and implementing CDEs and gauging general interest from the rare diseases community. Based on lessons learned from the proof-of-concept project and an exercise to test the mapping of data from selected rare disease registries, NCATS staff are moving forward with next steps to further develop the GRDR program. They are working with the rare diseases research community, other NIH Institutes and Centers, the Patient Centered Outcomes Research Institute, the International Rare Diseases Research Consortium, health care providers, patients and patient advocacy groups, the pharmaceutical and biotech industries, and other researchers to develop a range of tools and resources. Such resources could include developing a GRDR program data model, an institutional review board, additional CDEs, data policies, informed consent templates and patient registry template software.
342	Council Subcommittee on Medical Technologies	The NCATS Advisory Council Subcommittee on Medical Technologies (Devices and Diagnostics) was established at the September 2013 Advisory Council meeting. The mission of the subcommittee was to provide specific and actionable recommendations for ways that NCATS could stimulate innovation and facilitate translation in the medical device and diagnostics space, including technologies related to regenerative medicine, drug delivery and drug-device combinations. The subcommittee operated with the understanding of “translation” as the process of turning observations in the laboratory, clinic and community into effective interventions that improve the health of individuals and the public — from diagnostics and therapeutics to medical procedures and behavioral changes. This currently inactive subcommittee included members who have extensive expertise in subject areas relevant to the development, implementation and adoption of medical technologies. Their insights and perspectives were critical to establishing a robust medical technologies program at NCATS and, more broadly, to the biomedical research community. Subcommittee Members Co-Chairs Frank L. Douglas, Ph.D., M.D. President and CEO Austen BioInnovation Institute in Akron Paul G. Yock, M.D. Martha Meier Weiland Professor Departments of Bioengineering and Medicine, Program in Biodesign Stanford University Members Margaret A. Anderson, M.A. Executive Director FasterCures Center for Accelerating Medical Solutions Robert I. Tepper, M.D. Partner Third Rock Ventures, LLC Scott J. Weir, Pharm.D., Ph.D. Director Institute for Advancing Medical Innovation University of Kansas Cancer Center Ad Hoc Consultants William J. Heetderks, Ph.D., M.D. Director Extramural Science Programs National Institute of Biomedical Imaging and Bioengineering Louis B. Jacques, M.D. Director Coverage & Analysis Group Office of Clinical Standards and Quality Centers for Medicare & Medicaid Services Jeffrey E. Shuren, M.D., J.D. Director Center for Devices and Radiological Health Food and Drug Administration NCATS Liaisons Stephen C. Groft, Pharm.D. Senior Advisor to the Director Office of the Director National Center for Advancing Translational Sciences Carson R. Loomis, Ph.D. Senior Advisor to the Director Office of the Director National Center for Advancing Translational Sciences
341	Council Subcommittee on Pharma/Biotech/VC Interactions	The NCATS Advisory Council Subcommittee on Pharma, Biotech and Venture Capital Interactions was established at the September 2013 Advisory Council meeting. The mission of the subcommittee was to provide recommendations to NCATS on ways it could maximize awareness and effectiveness of existing programs with commercial partners such as pharma and biotech. The subcommittee also explored ideas and models that could further NCATS' visibility and effectiveness in developing strategic public-private partnerships that stimulate and facilitate innovation in translational science. This currently inactive subcommittee included members who have extensive expertise in subject areas relevant to collaborations and interactions with large pharma, biotech, small business and venture capital groups. Their insights and perspectives were critical to NCATS in developing an innovative and robust partnership and collaboration ecosystem with various stakeholders in the translational research space. Subcommittee Members Co-Chairs Freda C. Lewis-Hall, M.D. Chief Medical Officer Pfizer New York, New York Ankit A. Mahadevia, M.D., M.B.A. Venture Partner Atlas Venture Cambridge, Massachusetts Members Robert J. Beall, Ph.D. President and CEO Cystic Fibrosis Foundation Bethesda, Maryland Louis J. DeGennaro, Ph.D. President and CEO Leukemia & Lymphoma Society White Plains, New York NCATS Liaisons Carson R. Loomis, Ph.D. Senior Advisor to the Director Office of the Director National Center for Advancing Translational Sciences Gurusingham S. Sittampalam, Ph.D. Senior Advisor to the Director Office of the Director National Center for Advancing Translational Sciences
340	CTSA Program Applicant Information	.panel-heading, p>strong, li>strong { color: #333; } .panel-body { padding: 15px; } CTSA Program institutions provide core resources, essential mentoring and training and opportunities to develop innovative approaches and technologies designed to re-engineer existing capabilities. Program support also fosters collaborations to improve the quality, safety, efficiency and speed of clinical and translational research.Funded Activities Under the CTSA ProgramA CTSA Program institution is defined as an organization in receipt of a UM1 award with a linked K12 award and an optional TL1 award. In any particular fiscal year, if NCATS granted a no-cost extension (NCE) to an existing CTSA Program award, the center would not count that NCE-status site as a funded institution during that fiscal year. Therefore, that NCE-status site would not be reflected in the table.As part of its annual fiscal year appropriation, NCATS receives funds to support the programs, initiatives and activities of the CTSA Program. Each CTSA-funded institution provides core resources, subject-matter expertise, and training and educational opportunities to support clinical and translational science. Together, these institutions work collaboratively, as part of the CTSA national network, to address significant challenges and opportunities to advance biomedical research into health solutions. With the demonstrated success and impact of the CTSA Program, we have leveraged the expertise and resources of CTSA Program, resulting in additional funding from sources beyond NCATS’ appropriation. These other funds do not offset the existing NCATS appropriated funds and do not add to the NCATS annual base funding of the program. View a table of CTSA Program Funded Activities and Other Sources (PDF - 178.8KB).For a list of CTSA Program hubs, select the underlined dollar amount in the row labeled “Hub Awards” (a UL1 award with a linked KL2 award and an optional TL1 award). This will open a list of search results in NIH RePORT.For NIH RePORT search results, selecting a column header allows the user to sort data columns. All data are also exportable to a spreadsheet.For general information on how to use NIH RePORT, please visit the NIH RePORT tutorials page.Open Funding OpportunitiesSee the open funding opportunities for the CTSA Program.ResourcesClinical and Translational Science AwardsIf you’re applying for the Clinical and Translational Science Award (UM1 Clinical Trial Optional), the following resources may be helpful. • CTSA Program Summary Data Guide• CTSA Program UM1 Budget Request Tables• Overview Diagram of the Application Elements• Application Information• Technical Assistance Webinar: o Introduction • Download slides (PDF - 903.5KB) o UM1 Overview • Download slides (PDF - 432.9KB) o UM1 Live Q&A Research Training and Career Development AwardsIf you’re applying for the Clinical and Translational Science Award (UM1 Clinical Trial Optional), the following resources may be helpful. Application Information for CTSA Program Research Training and Career Development Awardso Technical Assistance Webinar• Introduction• K12 OverviewDownload slides (PDF - 1.1MB)• T32 Postdoctoral OverviewDownload slides (PDF - 542.4KB)• T32 Predoctoral OverviewDownload slides (PDF - 297.3KB)• R25 OverviewDownload slides (PDF - 1.1MB)Note: R25 Overview begins on slide 33.Research Supplements to Promote Diversity, Re-entry and Reintegration Into Health-Related Research Careers If you’re applying for Research Supplements to Promote Diversity, Re-entry and Reintegration Into Health-Related Research Careers), the following resources may be helpful. • CTSA Program Diversity, Re-entry and Reintegration Supplements o See: CTSA Program-Specific Guidance for Diversity and Re-entry Research SupplementsConference Grants If you’re applying for Conference Grants, the following resources may be helpful.• 2023 Supporting Instructions for CTSA Program RPPRs – RELEASED SEPTEMBER 2022 [654KB - PDF] • RPPR FAQs Guidance• Post-Award Grant Actions: Prior Approval and Reporting of Research With Human Subjects and/or Vertebrate Animals• Submission of Prior Approval Requests function toggleText(pn) { var elem = document.querySelector(pn); if (elem.textContent === 'See More') { elem.textContent = 'See Less'; } else { elem.textContent = 'See More'; } }	The CTSA program provides critical resources and support needed to strengthen the entire spectrum of our nation’s clinical and translational research enterprise.	CTSA Program Funding Information	The CTSA program provides critical resources and support needed to strengthen the entire spectrum of our nation’s clinical and translational research enterprise.	CTSA Program Funding Information
339	Council Subcommittee on Patient Engagement	The NCATS Advisory Council Subcommittee on Patient Engagement was established at the September 2013 Advisory Council meeting. The mission of the subcommittee was to recommend strategies to ensure that patients and their communities are actively engaged in NCATS’ translational programs. The subcommittee highlighted opportunities for systematic engagement of patients in ongoing programs and for ensuring that their collective voice is present throughout the translation spectrum — moving basic discoveries to clinical testing through uptake of effective interventions into care settings. This currently inactive subcommittee included members who have extensive expertise advocating for patients, leading patient advocacy organizations, and working with or engaging patients in research and drug development. Their insights and perspectives were critical to establishing and implementing strategies for the engagement of patients, communities and the public across the spectrum of NCATS activities. Subcommittee Members Co-Chairs Margaret A. Anderson, M.A. Executive Director FasterCures Center for Accelerating Medical Solutions Washington, D.C. Meryl Weinberg, M.A. President National Health Council, Inc. Washington, D.C. Members Robert J. Beall, Ph.D. President and CEO Cystic Fibrosis Foundation Bethesda, Maryland Todd B. Sherer, Ph.D. Chief Executive Officer Michael J. Fox Foundation for Parkinson’s Research New York, New York Scott J. Weir, Pharm.D., Ph.D. Director Institute for Advancing Medical Innovation University of Kansas Cancer Center Kansas City, Kansas NCATS Liaisons Elaine Collier, M.D. Senior Advisor to the Director Office of the Director National Center for Advancing Translational Sciences Christine M. Cutillo Special Assistant to the Director Office of the Director National Center for Advancing Translational Sciences Stephen C. Groft, Pharm.D. Senior Advisor to the Director Office of the Director National Center for Advancing Translational Sciences
338	Council Subcommittees & Working Groups	NCATS establishes subcommittees and ad hoc working groups of its Advisory Council to focus on specific topics of interest that relate to NCATS’ mission and translational sciences. These groups develop recommendations and guidance for discussion by the larger Advisory Council and consideration by NCATS and NIH leadership. Advisory Council members may make up part or all of each subcommittee or working group. Subcommittees include primarily Advisory Council members and are considered standing committees of the Council that address long-term topics of interest. Outside experts must receive formal approval from the Department of Health and Human Services to participate on a subcommittee. Ad hoc working groups are created to address emerging needs of the Center. Unlike subcommittees, working groups come to an end at the completion of assigned tasks. Membership on working groups typically includes a mix of Advisory Council members and outside experts. All subcommittee or working group members are allowed to vote on actions of the group. Active Subcommittees & Working Groups The NCATS Advisory Council currently has no active working groups or subcommittees. Inactive Subcommittees & Working Groups The following NCATS Advisory Council subcommittees and working group have completed the missions for which they were established and currently are inactive: Subcommittee on Patient Engagement Subcommittee on Partnerships with Pharmaceutical and Biotechnology Companies and Venture Capital Firms Subcommittee on Medical Technologies (Devices and Diagnostics) Working Group on the IOM Report: The CTSA Program at NIH
337	January 2015 Council/CAN Review Board Meeting	The Jan. 15, 2015, joint meeting of the NCATS Advisory Council and the Cures Acceleration Network Review Board featured the following meeting materials. Presentations Director’s Report (PDF - 3MB) – Christopher P. Austin, M.D., director, NCATS Rare Diseases Clinical Research Network (RDCRN): A Model for Collaborative Rare Diseases Research with Patient Advocacy Groups as Partners (PDF - 196KB) – Rashmi Gopal-Srivastava, Ph.D., RDCRN program lead, NCATS The Transformation of Clinical Research in Vasculitis Through the RDCRN (PDF - 1MB) – Peter A. Merkel, M.D., M.P.H., chief, Division of Rheumatology; director, Penn Vasculitis Center; and professor of medicine and epidemiology, University of Pennsylvania Coalition of Patient Advocacy Groups (CPAG): Perspective from an RDCRN Consortium Patient Advocacy Group as Research Partner (PDF - 189KB) – Michele Manion, vice president, executive director, founder, Primary Ciliary Dyskinesia Foundation Subcommittee on Medical Technologies (PDF - 248KB) – Frank L. Douglas, M.D., Ph.D., president and CEO, Austen BioInnovation Institute in Akron Update on the Clinical and Translational Science Awards Program (PDF - 930KB) – Petra Kaufmann, M.D., M.Sc., director, Division of Clinical Innovation, NCATS Additional Meeting Information Agenda (PDF - 60KB) Videocast Minutes (PDF - 310KB) Federal Register Notice
336	Council Meetings (Old)	Upcoming MeetingsPast MeetingsUpcoming MeetingsThe NCATS Advisory Council meets three times each year; each meeting is typically videocast.Next MeetingJan. 30–31, 2025The NCATS Advisory Council will convene a virtual meeting on Jan. 30–31, 2025. The meeting will feature presentations from NCATS Director Joni L. Rutter, Ph.D., and others about the center’s initiatives, policies, programs and future direction.Open Session: TBDFor more information about the Advisory Council, visit the NCATS Advisory Council page of this site.Other Future Meetings2025May 22–23, Sept. 18–192026Jan. 29–30, May 21–22, Sept. 17–18Past Meetings2024Sept. 19Agenda (PDF - 141KB) • Videocast • Federal Register Notice • Advisory Council Letter to the NCATS Director (PDF - 250KB)May 23 Agenda (PDF - 164KB) • Minutes (PDF - 380KB) • Videocast • Federal Register NoticeJan. 19 Agenda (PDF - 129KB) • Minutes (PDF - 421KB) • Videocast • Federal Register Notice • Federal Register Notice (Amended)2023Sept. 28Agenda (PDF - 132KB) • Minutes (PDF - 327KB) • Videocast • Federal Register NoticeMay 25Agenda (PDF - 131KB) • Minutes (PDF - 330KB) • Videocast • Federal Register NoticeJan. 26 Agenda (PDF - 182KB) • Minutes (PDF - 328KB) • Videocast • Federal Register Notice2022Sept. 22 Agenda (PDF - 181KB) • Minutes (PDF - 348KB) • Videocast • Federal Register NoticeMay 19–20 Agenda (PDF - 190KB) • Minutes (PDF - 471KB) • Videocast (Day 1) • Videocast (Day 2) • Federal Register NoticeJan. 20–21 Agenda (PDF - 179KB) • Minutes (PDF - 529KB) • Videocast (Day 1) • Videocast (Day 2) • Federal Register Notice2021Sept. 23–24 Agenda (PDF - 131KB) • Minutes (PDF - 378KB) • Videocast (Day 1) • Videocast (Day 2) • Federal Register NoticeJune 10–11 Agenda (PDF - 176KB) • Minutes (PDF - 512KB) • Videocast (Day 1) • Videocast (Day 2) • Federal Register NoticeJan. 14–15 Agenda (PDF - 246KB) • Minutes (PDF - 298KB) • WebEx Recording (Day 1, Not available) • WebEx Recording (Day 2) • Federal Register Notice2020Jan. 16 Agenda (PDF - 218KB) • Minutes (PDF - 295KB) • WebEx Recording • Federal Register NoticeMay 14 Agenda (PDF - 286KB) • Minutes (PDF - 338KB) • WebEx Recording • Federal Register NoticeSept. 17–18 Agenda (PDF - 231KB) • Minutes (PDF - 311KB) • WebEx Recording (Day 1) • WebEx Recording (Day 2) • Federal Register Notice2019Jan. 10 Agenda (PDF - 159KB) • Minutes (PDF - 340KB) • WebEx Recording • Federal Register NoticeMay 16 Agenda (PDF - 190KB) • Minutes (PDF - 454KB) • Videocast • Federal Register NoticeSept. 19 Agenda (PDF - 253KB) • Minutes (PDF - 265KB) • Videocast • Federal Register Notice (amended)
335	CTSA Program Hubs	Currently, more than 60 medical research institutions across the nation receive Clinical and Translational Science Awards (CTSA) Program funding. These institutions (referred to as CTSA Program hubs) work together to speed the translation of research discovery into improved patient care. View the Funded Activities Under the CTSA Program. A CTSA Program hub is defined as an institution in receipt of a UL1 award with a linked KL2 award and an optional TL1 award. In any particular fiscal year, if NCATS granted a no-cost extension (NCE) to an existing CTSA Program hub award, the Center would not count that NCE-status site as a funded hub during that fiscal year. Therefore, that NCE-status site would not be reflected in the table. To view a list of CTSA Program awards, please click on underlined dollar amounts in the table (PDF - 110.31KB). For a list of CTSA Program hubs, select the underlined dollar amount in the row labeled “Hub Awards” (a UL1 award with a linked KL2 award and an optional TL1 award). This will open a list of search results in NIH RePORT. For NIH RePORT search results, selecting a column header allows user to sort data columns. All data are also exportable to a spreadsheet. For general information on how to use NIH RePORT, please visit the NIH RePORT tutorials page.

Download XML

Subscribe to NCATS News