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临床试验研究质量和数据真实完整性是对试验药物有效性和安全性进行科学和公正评价的基础。临床试验过程的规范化和标准化,可以保证临床试验及其数据的质量,而规范化和标准化的实践反过来又可推动和提高实际工作的效率和可靠性。目前,国际上针对临床试验及其数据管理的标准规范较为完备,欧美国家对试验数据管理规程指南或条例,以及执行力度都较为成熟。我国在临床试验及其数据管理方面的经验和监管规范尚有待完善。本文从良好临床数据管理的角度,对全球临床试验数据管理的法规和标准作出介绍,期待能对完善我国临床试验数据监管体系有所借鉴。
The quality of the clinical trial research and the true integrity of the data are the basis for a scientific and fair evaluation of the efficacy and safety of the test drug. The standardization and standardization of the clinical trial process can guarantee the quality of clinical trials and their data, and standardization and standardization practices in turn can promote and enhance the efficiency and reliability of practical work. At present, the international standards for clinical trials and data management are more complete, and the guidelines and regulations for test data management procedures and the enforcement of the test data in European and American countries are relatively mature. Our experience and regulatory norms in clinical trials and data management have yet to be improved. This article from the perspective of good clinical data management, the global clinical trial data management regulations and standards are introduced, looking forward to improve our clinical trial data monitoring system to learn from.