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药物临床试验档案资料是药物临床试验全过程的真实记录和体现,药品监督管理部门主要据此进行新药审批,相关档案资料应该准确、完整、可靠。分析了药物临床试验档案资料管理在研究者、监查员和药物临床试验基地3个层面存在的一些问题,就药物临床试验档案资料规范化管理探讨了相关解决办法和注意事项,提出研究者及时规范完成记录、监查员认真细致核查、专业档案管理人员时时跟进归整是药物临床试验档案资料完整的重要保证。
Drug clinical trial file information is the true record of the clinical trial of drugs and reflect the whole process, drug supervision and administration department mainly for new drug approval, the relevant file information should be accurate, complete and reliable. This paper analyzes some problems existing in the three aspects of investigators, inspectors and drug clinical trial bases in the management of archives and materials of drug clinical trials. The related solutions and precautions are discussed on the standardized management of archives and materials of drug clinical trials, Complete records, auditors carefully detailed verification, professional records management staff to keep track of the clinical trial is a complete archive of important information guarantee.