机构质控员加强对药物临床试验质量控制的探讨

Improvement of Quality Control by Institution Quality Controller for Clinical Drug Trials

目的为各医院药物临床试验机构质控员如何加强临床试验质控提供参考。方法以本院机构质控员近2年在各临床试验项目质控发现的问题,并结合针对这些问题采取的质量控制措施探讨机构质控员如何加强对药物临床试验的质量控制。结果与结论机构质控员通过加强对各药物临床试验的质控管理措施,保证了药物临床试验过程的规范、结果的科学可靠与受试者的权益与安全,并为三级质控制度的有效实施起到了一定的作用。

Objective To provide reference for the improvement of quality control for hospital＇ s clinical drug trials. Methods Based on the problems we have found and the measures we have taken in clinical trial in recent two years, how to enhance quality control in clinical drug trials were studied. Results and Conclusion We ensured that the standardization of drug clinical trials process, scientificness and reliability of results, the rights and safety of participants, and play a role in the three grade quality control.