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新药临床试验质量是药品上市后安全有效的保障。加强新药临床试验监督管理,对提高新药临床试验质量具有重大意义。“三级质控”管理模式可有效解决目前新药临床试验监查中存在的问题,使药物临床试验质量得到进一步提高。
The quality of clinical trials of new drugs is safe and effective after the drug market protection. Strengthening the supervision and administration of new drug clinical trials is of great significance to improving the quality of clinical trials of new drugs. “Three quality control ” management mode can effectively solve the problems existing in the current clinical trial monitoring of new drugs, and further improve the quality of clinical trials of drugs.