{"id":619355,"date":"2025-10-03T11:49:15","date_gmt":"2025-10-03T03:49:15","guid":{"rendered":"https:\/\/law.asia\/?p=619355"},"modified":"2025-10-13T14:41:11","modified_gmt":"2025-10-13T06:41:11","slug":"drug-clinical-trials-compliance-obligations","status":"publish","type":"post","link":"https:\/\/law.asia\/zh-hans\/drug-clinical-trials-compliance-obligations\/","title":{"rendered":"\u836f\u7269\u7814\u53d1\u4e34\u5e8a\u8bd5\u9a8c\u5408\u89c4\u8981\u70b9"},"content":{"rendered":"<p class=\"Correspondent_Correspondent-Body-DropCap-Chi\" style=\"text-align: justify;\"><span class=\"Corresp-DropCaps-Red-Chi custom-dropcap-red 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class=\"CharOverride-1\">\u6570\u636e\u771f\u5b9e\u6027\u3002<\/span><\/strong>\u4e34\u5e8a\u8bd5\u9a8c\u5e94\u4fdd\u969c\u6240\u91c7\u96c6\u7684\u6e90\u6570\u636e\u53ef\u4ee5\u6eaf\u6e90\uff0c\u786e\u4fdd\u6570\u636e\u7684\u771f\u5b9e\u6027\u3002\u8bd5\u9a8c\u539f\u59cb\u6570\u636e\u7684\u4fee\u6539\u5e94\u7559\u75d5\u4e14\u7406\u7531\u660e\u786e\uff0c\u56e0\u4e3a\u539f\u59cb\u8bb0\u5f55\u7684\u4efb\u610f\u4fee\u6539\u5177\u6709\u53d1\u751f\u4e25\u91cd\u7f3a\u9677\u7684\u53ef\u80fd\u6027\u3002\u4f8b\u5982\uff0c\u67d0\u80bf\u7624\u533b\u9662\u5728\u75c5\u4f8b\u62a5\u544a\u8868\u4e2d\u4fee\u6539\u53d7\u8bd5\u8005\u7684\u836f\u7269\u7528\u91cf\uff0c\u5c06\u4e0d\u7b26\u5408\u8bd5\u9a8c\u65b9\u6848\u8981\u6c42\u7684\u60a3\u8005\u7eb3\u5165\u7b26\u5408\u65b9\u6848\u96c6\u5e76\u7ed9\u4e88\u8bd5\u9a8c\u7528\u836f\uff0c\u6700\u7ec8\u88ab\u5224\u5b9a\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u4e0d\u771f\u5b9e\uff0c\u5bf9\u5e94\u836f\u54c1\u7684\u6ce8\u518c\u7533\u8bf7\u4e0d\u83b7\u6279\u51c6\u3002<\/p>\n<p 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class=\"CharOverride-1\">\u6570\u636e\u53ef\u9760\u6027\u4e0e\u4e00\u81f4\u6027\u3002<\/span><\/strong>\u5b9e\u52a1\u4e2d\u5e94\u91cd\u89c6\u4e34\u5e8a\u7814\u7a76\u8fc7\u7a0b\u8bb0\u5f55\u8868\u683c\u4e0e\u539f\u59cb\u533b\u5b66\u8bb0\u5f55\u7684\u4e00\u81f4\u6027\u3002\u4ee5II\u671f\u3001III\u671f\u4e34\u5e8a\u8bd5\u9a8c\u73b0\u573a\u6838\u67e5\u4e3a\u4f8b\uff0c\u5f53\u836f\u7269\u8f93\u6ce8\u65f6\u95f4\u4e0e\u533b\u5631\u3001\u75c5\u5386\u8bbf\u89c6\u5c31\u8bca\u65f6\u95f4\u3001\u751f\u547d\u4f53\u5f81\u6d4b\u91cf\u7b49\u8868\u683c\u8bb0\u5f55\u65f6\u95f4\u5747\u4e0d\u4e00\u81f4\u65f6\uff0c\u53ef\u80fd\u4f1a\u88ab\u5224\u5b9a\u4e3a\u5f71\u54cd\u4e34\u5e8a\u8bd5\u9a8c\u8d28\u91cf\u3002\u5728\u53d7\u8bd5\u8005\u4eba\u6570\u6781\u5c11\u7684\u60c5\u51b5\u4e0b\uff0c\u82e5\u53d1\u751f\u5f02\u5e38\u591a\u4f8b\u6b21\u7ed9\u836f\u8d85\u7a97\u3001\u968f\u8bbf\u68c0\u67e5\u8d85\u7a97\u7b49\u8fdd\u80cc\u65b9\u6848\u7684\u73b0\u8c61\uff0c\u4e14\u8d85\u7a97\u65f6\u95f4\u660e\u663e\u4e0d\u5408\u7406\uff0c\u5219\u4e0a\u8ff0\u5927\u91cf\u8fdd\u80cc\u8bd5\u9a8c\u65b9\u6848\u7684\u60c5\u51b5\u53ef\u80fd\u88ab\u8ba4\u5b9a\u4e3a\u5f71\u54cd\u4e34\u5e8a\u8bd5\u9a8c\u8d28\u91cf\u3002<\/p>\n<figure id=\"attachment_619344\" aria-describedby=\"caption-attachment-619344\" style=\"width: 200px\" class=\"wp-caption alignright\"><img class=\"size-full wp-image-619344\" src=\"https:\/\/law.asia\/wp-content\/uploads\/2025\/10\/Gao-Yi-Blossom-Credit-Law-Firm.jpg\" alt=\"Gao Yi, Blossom &amp; Credit Law Firm\" width=\"200\" height=\"250\" \/><figcaption id=\"caption-attachment-619344\" class=\"wp-caption-text\"><strong>\u9ad8\u6613<\/strong><br \/>\u5f8b\u5e08<br \/>\u90a6\u76db\u5f8b\u5e08\u4e8b\u52a1\u6240<\/figcaption><\/figure>\n<p class=\"Correspondent_Correspondent-Body-Chi-no-indent ParaOverride-2\" style=\"text-align: justify;\"><strong><span class=\"CharOverride-1\">\u6570\u636e\u5145\u5206\u6027\u3002<\/span><\/strong>\u4e34\u5e8a\u8bd5\u9a8c\u8fc7\u7a0b\u4e2d\u5e94\u5b8c\u6574\u8bb0\u5f55\u8bd5\u9a8c\u7528\u836f\u54c1\u4f7f\u7528\u8fc7\u7a0b\u3002\u4ee5\u6ce8\u5c04\u5242\u4e3a\u4f8b\uff0c\u73b0\u573a\u4f7f\u7528\u8bb0\u5f55\u5e94\u5305\u62ec\u53d7\u8bd5\u8005\u57fa\u672c\u4fe1\u606f\u3001\u533b\u5631\u3001\u6cbb\u7597\u5355\u3001\u6ce8\u5c04\u6267\u884c\u8bb0\u5f55\u3001\u6ce8\u5c04\u5242\u91cf\u3001\u90e8\u4f4d\u3001\u6ce8\u5c04\u540e\u89c2\u5bdf\u7b49\u3002<\/p>\n<h3 class=\"Correspondent_Correspondent-Body-Chi-no-indent ParaOverride-2\" style=\"text-align: justify;\"><strong><span class=\"CharOverride-1\">\uff08\u4e8c\uff09\u6570\u636e\u5408\u89c4<\/span><\/strong><\/h3>\n<p class=\"Correspondent_Correspondent-Body-Chi-no-indent ParaOverride-2\" style=\"text-align: justify;\"><strong><span 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