Quality and safety are fundamental principles that must be adhered to in clinical research. Medical institutions conducting stem cell clinical research are the primary entities responsible for the quality management of stem cell products and clinical research. They must implement strict quality control and management throughout the entire process of stem cell clinical research. This includes project initiation review,registration,process supervision,stem cell product preparation management,and risk control. Establishing a comprehensive quality management system for the entire process of stem cell clinical research is a crucial measure to ensure that stem cell clinical research projects are conducted scientifically and in accordance with regulations. Based on the national regulations for stem cell clinical research management the necessity of improving research quality,combined with the practical experiences of building a quality management system for the entire process of stem cell clinical research at the Third Affiliated Hospital,Sun Yat-sen University. The authors of this paper deeply consider the key points of quality management in stem cell clinical research and proposes relevant suggestions and strategies to provide a reference for medical institutions to standardize stem cell clinical research and improve research quality.
关键词
干细胞/临床医学/研究/质量控制
Key words
Stem cell/Clinical medcine/Research/Quality control
维普
万方数据