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

Puvanesarajah, Samantha; Nyante, Sarah J; Kuzmiak, Cherie M et al. (2018) PAM50 and Risk of Recurrence Scores for Interval Breast Cancers. Cancer Prev Res (Phila) 11:327-336
Philpott, Hamish; Dellon, Evan (2018) Histologic improvement after 6 weeks of dietary elimination for eosinophilic esophagitis may be insufficient to determine efficacy. Asia Pac Allergy 8:e20
Lee, Craig R; Sriramoju, Vindhya B; Cervantes, Alexandra et al. (2018) Clinical Outcomes and Sustainability of Using CYP2C19 Genotype-Guided Antiplatelet Therapy After Percutaneous Coronary Intervention. Circ Genom Precis Med 11:e002069
Hibbard, Jonathan C; Friedstat, Jonathan S; Thomas, Sonia M et al. (2018) LIBERTI: A SMART study in plastic surgery. Clin Trials 15:286-293
Mock, Meredith G; Hirsch, Katie R; Blue, Malia N M et al. (2018) Post-Exercise Ingestion of Low or High Molecular Weight Glucose Polymer Solution Does Not Improve Cycle Performance in Female Athletes. J Strength Cond Res :
Peery, Anne F; Cools, Katherine S; Strassle, Paula D et al. (2018) Increasing Rates of Surgery for Patients With Nonmalignant Colorectal Polyps in the United States. Gastroenterology 154:1352-1360.e3
Buse, John B; Carlson, Anders L; Komatsu, Mitsuhisa et al. (2018) Fast-acting insulin aspart versus insulin aspart in the setting of insulin degludec-treated type 1 diabetes: Efficacy and safety from a randomized double-blind trial. Diabetes Obes Metab 20:2885-2893
Lewek, Michael D; Raiti, Cristina; Doty, Amanda (2018) The Presence of a Paretic Propulsion Reserve During Gait in Individuals Following Stroke. Neurorehabil Neural Repair 32:1011-1019
James, Theodore W; Crockett, Seth D (2018) Management of acute pancreatitis in the first 72 hours. Curr Opin Gastroenterol 34:330-335
Antoniak, Silvio; Tatsumi, Kohei; Schmedes, Clare M et al. (2018) Protease-activated receptor 1 activation enhances doxorubicin-induced cardiotoxicity. J Mol Cell Cardiol 122:80-87

Showing the most recent 10 out of 76 publications