Abstract

This application is submitted in response to NOT-TR-20-014 as a supplement to Parent Award UL1TR002489, the North Carolina Translational and Clinical Sciences Institute (NC TraCS). This CTSA Administrative Supplement will add a dedicated quality assurance/quality control position to the NC TraCS Regulatory Knowledge and Support Program to perform quality reviews of CTSA-related submissions to NCATS, submissions to the eRA Human Subjects System, and management of the overall prior approval process. The following specific aims will be addressed by this supplement:
Aim 1 ? Create a dedicated position to oversee and manage internal processes for prior approval requests to NCATS.
Aim 2 ? Implement a comprehensive evaluation strategy to guide decision-making and ensure continuous improvement in processes.

Public Health Relevance

/Relevance The regulatory processes involved in translating biomedical discoveries into clinical applications are complex and evolve rapidly, often creating barriers that hinder the translation of discoveries into products to improve human health. The goal of the CTSA program is to tackle system-wide scientific and operational changes that solve the outstanding problems limiting the efficiency, effectiveness and reach of translational science. This application supports the CTSA goal by improving the accuracy, efficiency, and effectiveness of the regulatory process.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Advancing Translational Sciences (NCATS)
Type
Linked Specialized Center Cooperative Agreement (UL1)
Project #
3UL1TR002489-03S3
Application #
10158836
Study Section
Program Officer
Chang, Soju
Project Start
2018-03-30
Project End
2023-02-28
Budget Start
2020-07-01
Budget End
2021-02-28
Support Year
3
Fiscal Year
2020
Total Cost
Indirect Cost

  Institution

Name
University of North Carolina Chapel Hill
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
608195277
City
Chapel Hill
State
NC
Country
United States
Zip Code
27599

  Publications

Halladay, Jacqueline R; Lenhart, Kaitlin C; Robasky, Kimberly et al. (2018) Applicability of Precision Medicine Approaches to Managing Hypertension in Rural Populations. J Pers Med 8:
Dhatariya, Ketan; Bain, Stephen C; Buse, John B et al. (2018) The Impact of Liraglutide on Diabetes-Related Foot Ulceration and Associated Complications in Patients With Type 2 Diabetes at High Risk for Cardiovascular Events: Results From the LEADER Trial. Diabetes Care 41:2229-2235
Ayrapetyan, Mesrop; Googe, Paul B; Jolly, Puneet et al. (2018) A 61-year-old man with erythematous forearm papules three months after liver transplantation. Transpl Infect Dis 20:e12869
Andrews, Joseph E; Moore, J Brian; Weinberg, Richard B et al. (2018) Ensuring respect for persons in COMPASS: a cluster randomised pragmatic clinical trial. J Med Ethics 44:560-566
Kirk, Jessime M; Kim, Susan O; Inoue, Kaoru et al. (2018) Functional classification of long non-coding RNAs by k-mer content. Nat Genet 50:1474-1482
Pasquale, Dana K; Doherty, Irene A; Sampson, Lynne A et al. (2018) Leveraging Phylogenetics to Understand HIV Transmission and Partner Notification Networks. J Acquir Immune Defic Syndr 78:367-375
Turner, Kea; Trogdon, Justin G; Weinberger, Morris et al. (2018) Testing the organizational theory of innovation implementation effectiveness in a community pharmacy medication management program: a hurdle regression analysis. Implement Sci 13:105
Qiao, Mu; Feld, Jody A; Franz, Jason R (2018) Aging effects on leg joint variability during walking with balance perturbations. Gait Posture 62:27-33
Anderson, Chelsea; Smitherman, Andrew B; Nichols, Hazel B (2018) Conditional relative survival among long-term survivors of adolescent and young adult cancers. Cancer 124:3037-3043
Philippi, Carissa L; Cornejo, M Daniela; Frost, Carlton P et al. (2018) Neural and behavioral correlates of negative self-focused thought associated with depression. Hum Brain Mapp 39:2246-2257

Showing the most recent 10 out of 76 publications