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.
/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.
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