Management system of evaluation processes and treatment of patients in clinical trials

Abstract

The "Arnaldo Milian Castro" Surgical Hospital has an important tradition in the conduct of clinical research wirh products from Molecular Immunology Center and the Center for Genetic Engineering and Biotechnology. So far the work has been based on the standards of Good Clinical Practice and Quality System Elements Promoter Center. However, to achieve conducting clinical trials with quality and meet the needs of internal and external customers is necessary to have a Quality System itself. System of management processes of Evaluation and Treatment of patients in clinical trials developed; Documentary system of these processes are developed, the documents were reviewed, approved and implemented in the areas of research involved in the process, thereby increasing quality standards for clinical site and the standards of Good Clinical Practices are met.

Keywords

• ensayo clínico
• prácticas clínicas/normas