药物临床试验机构对试验项目质控要点

Key Points of Quality Control in the Pilot Project of Drug Clinical Trial Institutions

目的机构质控员对药物临床试验过程进行质量控制,保障机构内每个药物临床试验符合药物临床试验质量管理规范。方法规定临床试验质控主要内容。结果通过质控可以发现临床试验中出现的许多问题,项目组采取相应纠正措施。结论质控充分保护受试者权益,保证临床试验数据真实、科学、可靠,更好地保证临床试验质量。

Objective Mechanism of quality control staff to carry on the quality control of drug clinical trial process, clinical trials of each drug security mechanism in accord with the standard of quality management of drug clinical trial. Methods Main content of provisions of clinical trials quality control. Results Through quality control and you can find many problems in clinical trials, The team take appropriate corrective action. Conclusion Quality control can fully protect the rights and interests of subjects, ensure the clinical test data, scientific, reliable, Ensure clinical test data, scientific, reliable, better guarantee the quality of clinical trials.