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目的:分析药物临床试验质量管理问题,并探究其解决措施。方法:通过文献查阅、药物临床试验项目检查和调查问卷的方式进行。通过查阅反映我国药物临床试验机构在临床试验实施过程中存在的问题文献,分析在临床试验过程中存在的问题,并提出相应的建议。结果:药物临床试验质量管理的关键在于加强药物临床试验质量管理,建立健全的管理体系。结论:加强药物临床试验质量管理有助于提高药物临床试验质量。
Objective: To analyze the quality management of drug clinical trials and explore its solutions. Methods: Through literature review, drug clinical trial project inspection and questionnaire. By referring to the literature reflecting the problems existing in clinical trial implementation in our country, the problems existing in clinical trials are analyzed and the corresponding suggestions are put forward. Results: The key to the quality control of drug clinical trials lies in strengthening the quality management of drug clinical trials and establishing a sound management system. Conclusion: Enhancing the quality management of drug clinical trials will help to improve the quality of drug clinical trials.