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EMA总结2024年度GCP检查,分享缺陷实例
*仅作示意用近日,EMA发布了《药物临床试验质量管理规范(GCP)检查员工作组(IWG)2024年度报告》,该报告涵盖67次检查(52次常规、15次有因检查),涉及临床研究者(62.7%)、申办者(26.9%)和合同研究组织(CRO)(7.5%)等参与方,主要分布在亚洲(32.8%)、北美(25.4%)和欧盟/欧洲经济区(22.4%)。检查发现335项主 ...
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