Establishing a quality management system for a biomedical academic institution that performs clinical research in compliance with Good Clinical Practices

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.