《药物临床试验质量管理规范》培训的思考

Thinking about the GCP training

医务人员是临床试验的主要设计者和参与者，普及《药物临床试验质量管理规范》（GCP）有助于提高医务人员临床试验的水平规范临床试验的管理，保护受试者的合法权益及健康安全，提高临床试验结果可靠性，从而提升我国医疗机构进行临床试验的能力，促进医药相关产业的发展。从建立临床试验职业资格准人制度和监督管理机制、将《药物临床试验管理规范》（0CP）培训纳入继续教育体系2个方面进行了探讨，提出了加强医务人员GCP培训的途径和建议。

Medical workers are the main designers and participants of clinical trials. In this consideration, popularization of good clinical practice（GCP）knowledge among them can improve their execution of trials, standardize basic clinical trial requirements, protect legitimate rights and health/safety of the subjects, and make the trial results more reliable. These objectives, if accomplished, will upgrade the clinical trials competency of medical institutions in China, and encourage healthy growth of the medical and pharmaceutical industry. The paper probed into the occupation qualification system of clinical trial workers and their supervision mechanism, inclusion of GCP into the continuing education system.