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目的:探索药物临床试验机构药品零库存管理模式和临床试验用药品管理的工作流程。方法:依照《中华人民共和国药品管理法》、《药品经营质量管理规范》、《药物临床试验质量管理规范》等相关法规,探索药物临床试验机构药品零库存管理模式和临床试验用药品管理的工作流程。结果:采用临床试验用药品零库存管理模式确保了临床试验用药及其质量控制。结论:结合医院实际状况,确保临床及时供药、提高工作效率,充分保护受试者的权益和用药安全。
OBJECTIVE: To explore the zero inventory management model of drug clinical trials and the work flow of drug management in clinical trial. Methods: In accordance with relevant laws and regulations such as Drug Administration Law of the People’s Republic of China, Code of Practice for Quality Control of Pharmaceutical Products, Code of Practice for Quality Control of Clinical Drugs and other relevant laws and regulations, the Company sought to explore the mode of zero inventory management of drug clinical trial institutions and the work of drug management in clinical trials Process. Results: The zero-inventory management model for clinical trials ensured clinical trial medication and quality control. Conclusion: Combined with the actual condition of the hospital, to ensure timely clinical drug supply and improve work efficiency, fully protect the rights and safety of the subjects.