Establishing a quality management system for a biomedical academic institution that performs clinical research in compliance with Good Clinical Practices
Winn, Kelly Anne
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The focus of this research was to establish a Quality Management System for a biomedical academic institution that performs clinical research in compliance with Good Clinical Practices. The research incorporated a retrospective review of FDA warning letters to establish the most common deficiencies among academic biomedical clinical research institutions and compared these results against a survey used as verification in order to answer the following research questions: What are the challenges of implementing a GCP/Quality Management System? What are the most common GCP violations issued by the FDA? What areas of GCPs should be concentrated on the most in developing a GCP Quality Management System? It was from this qualitative comparative analysis results that a comprehensive process based quality management system standard operating procedure was established.