CTSA Administrative Supplement for Quality Assurance/Quality Control Position

$97,147UL1FY2020TRNIH

Univ Of North Carolina Chapel Hill, Chapel Hill NC

Investigators

Linked publications, trials & patents

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Abstract

Project summary 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.

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