基于PDCA循环的新药临床研究中人类遗传资源管理实践

Practice on human genetic resources management using PDCA circle in new drug clinical research

目的旨在通过对医疗机构的临床研究人类遗传资源的管理,确保遗传资源利用的合理合法,维护国家生物安全。方法采用文献阅读和调查法,利用戴明环,从计划、实施、检查、制定对策4个环节对本院的人类遗传资源管理进行持续的质量改进。结果医院人类遗传资源管理理念得到认可,管理质量显著提升。结论PDCA循环管理方法对于医疗机构新药临床研究中的人类遗传资源管理有着积极意义,是现行制度下提升管理水平的有效途径。

Objective The paper aims to ensure the rational and legal utilization of genetic resources and maintain the national biosafety through the management of human genetic resources in clinical research carried out by medical institutions.Methods Literature review and survey methods were adopted.Deming Circle,with focus on the four stages from planning,implementation,inspection,and countermeasures,was used to continuously improve the quality of human genetic resources management in the hospital.Results The concept of hospital human genetic resources management was recognized and the management quality was significantly improved.Conclusions The PDCA cycle management method is of positive significance to the management of human genetic resources in the clinical research of new drugs in medical institutions,and it is an effective way to improve the management level under current system.