{"id":8453,"date":"2025-01-15T11:42:20","date_gmt":"2025-01-15T11:42:20","guid":{"rendered":"https:\/\/www.ulatus.tw\/academy\/?p=8453"},"modified":"2025-02-10T12:46:52","modified_gmt":"2025-02-10T12:46:52","slug":"understanding-multilingual-documentation-requirements-under-the-eu-clinical-trials-regulation-ctr","status":"publish","type":"post","link":"https:\/\/www.ulatus.tw\/academy\/understanding-multilingual-documentation-requirements-under-the-eu-clinical-trials-regulation-ctr\/","title":{"rendered":"\u4e86\u89e3\u6b50\u76df\u81e8\u5e8a\u8a66\u9a57\u6cd5\u898f (CTR) \u4e0b\u7684\u591a\u8a9e\u8a00\u6587\u4ef6\u8981\u6c42"},"content":{"rendered":"<p>\u6b50\u76df\u81e8\u5e8a\u8a66\u9a57\u6cd5\u898f (CTR) \u65bc 2023 \u5e74 1 \u6708 31 \u65e5\u5168\u9762\u751f\u6548\uff0c\u91cd\u65b0\u5b9a\u7fa9\u4e86\u6574\u500b\u6b50\u6d32\u7684\u81e8\u5e8a\u8a66\u9a57\u6587\u4ef6\u8981\u6c42\u3002\u5728 \u5be6\u65bdCTR \u4e4b\u524d\uff0c\u6bcf\u500b\u6b50\u76df\u570b\u5bb6\u90fd\u6709\u81ea\u5df1\u7684\u81e8\u5e8a\u8a66\u9a57\u5be9\u6279\u548c\u7ba1\u7406\u6d41\u7a0b\uff0c\u9019\u5f80\u5f80\u6703\u5c0e\u81f4\u4e0d\u4e00\u81f4\u3001\u5ef6\u8aa4\u548c\u66f4\u9ad8\u7684\u6210\u672c\u3002CTR \u65e8\u5728\u900f\u904e\u4e00\u500b\u7d71\u4e00\u7684\u7cfb\u7d71\uff0c\u5373\u81e8\u5e8a\u8a66\u9a57\u4fe1\u606f\u7cfb\u7d71 (CTIS)\uff0c\u96c6\u4e2d\u63d0\u4ea4\u3001\u8a55\u4f30\u548c\u76e3\u63a7\u8a66\u9a57\uff0c\u4ee5\u89e3\u6c7a\u9019\u4e9b\u554f\u984c\u3002\u9019\u7a2e\u5305\u62ec\u4e00\u81f4\u7684\u591a\u8a9e\u8a00\u6587\u4ef6\u5728\u5185\u7684\u96c6\u4e2d\u5316\u7cfb\u7d71\u4f7f\u81e8\u5e8a\u8a66\u9a57\u6d41\u7a0b\u5177\u6709\u66f4\u5927\u7684\u900f\u660e\u5ea6\u3001\u66f4\u9ad8\u7684\u6548\u7387\u548c\u5354\u8abf\u6027\u3002<\/p>\n<h2>\u70ba\u4ec0\u9ebc\u591a\u8a9e\u8a00\u6587\u4ef6\u5f88\u91cd\u8981<\/h2>\n<p>\u81e8\u5e8a\u8a66\u9a57\u901a\u5e38\u6d89\u53ca\u4f86\u81ea\u591a\u500b\u570b\u5bb6\u3001\u8b1b\u4e0d\u540c\u8a9e\u8a00\u7684\u53c3\u8207\u8005\u548c\u7814\u7a76\u4eba\u54e1\u3002\u6b50\u76df<a href=\"https:\/\/www.ulatus.tw\/corporate-translation\/medical.htm\">\u81e8\u5e8a\u8a66\u9a57\u6cd5\u898f\u7ffb\u8b6f<\/a>\u898f\u5247\u78ba\u4fdd\u6bcf\u500b\u53c3\u8207\u8005\u3001\u7814\u7a76\u4eba\u54e1\u548c\u76e3\u7ba1\u8005\u90fd\u80fd\u5920\u7372\u53d6\u548c\u7406\u89e3\u91cd\u8981\u7684\u8a66\u9a57\u8cc7\u8a0a\u3002\u9019\u6709\u4ee5\u4e0b\u5e7e\u9ede\u91cd\u8981\u6027\uff1a<\/p>\n<ol>\n<li><strong>\u5e6b\u52a9\u53c3\u8207\u8005\u4e86\u89e3\u8a66\u9a57<\/strong><br \/>\n\u53c3\u8207\u8005\u9700\u8981\u78ba\u5207\u5730\u77e5\u9053\u4ed6\u5011\u8a3b\u518a\u7684\u76ee\u7684\u662f\u4ec0\u9ebc\u3002\u5c07\u8868\u683c\u548c\u8aaa\u660e\u7ffb\u8b6f\u6210\u4ed6\u5011\u7684\u8a9e\u8a00\uff0c\u53ef\u4ee5\u78ba\u4fdd\u4ed6\u5011\u5145\u5206\u4e86\u89e3\u8a66\u9a57\u7684\u98a8\u96aa\u3001\u597d\u8655\u548c\u7a0b\u5e8f\u3002<\/li>\n<li><strong>\u78ba\u4fdd\u76e3\u7ba1\u6a5f\u69cb\u80fd\u5920\u5c65\u884c\u8077\u8cac<\/strong><br \/>\n\u6bcf\u500b\u6b50\u76df\u570b\u5bb6\u7684\u76e3\u7ba1\u6a5f\u69cb\u5fc5\u9808\u5be9\u67e5\u8a66\u9a57\u6587\u4ef6\u4ee5\u5c0d\u7814\u7a76\u9032\u884c\u6279\u51c6\u548c\u76e3\u7763\u3002\u9019\u4e9b\u6587\u4ef6\u5fc5\u9808\u7ffb\u8b6f\u6210\u9032\u884c\u8a66\u9a57\u7684\u570b\u5bb6\u7684\u5b98\u65b9\u8a9e\u8a00\u3002<\/li>\n<li><strong>\u5efa\u7acb\u516c\u773e\u4fe1\u4efb<\/strong><br \/>\n\u6b50\u76df CTR \u5f37\u8abf\u900f\u660e\u5ea6\uff0c\u9019\u610f\u5473\u8457\u8a66\u9a57\u7d50\u679c\u5fc5\u9808\u8207\u516c\u773e\u5206\u4eab\u3002\u4ee5\u6e05\u6670\u3001\u6613\u65bc\u7406\u89e3\u7684\u8a9e\u8a00\u63d0\u4f9b\u9019\u4e9b\u7d50\u679c\uff0c\u6709\u52a9\u65bc\u5efa\u7acb\u5c0d\u91ab\u5b78\u7814\u7a76\u7684\u4fe1\u4efb\u3002<\/li>\n<\/ol>\n<h2>\u54ea\u4e9b\u6587\u4ef6\u9700\u8981\u7ffb\u8b6f\uff1f<\/h2>\n<p>EU CTR \u660e\u78ba\u5217\u51fa\u4e86\u9700\u8981\u7ffb\u8b6f\u7684\u5177\u9ad4\u6587\u4ef6\uff1a<\/p>\n<ul>\n<li><strong>\u5c0d\u65bc\u53c3\u8207\u8005\uff1a<\/strong><br \/>\n\u77e5\u60c5\u540c\u610f\u66f8 (ICF)\u3001\u75c5\u60a3\u8cc7\u8a0a\u5c0f\u518a (PIL) \u548c\u62db\u52df\u8cc7\u6599\u7b49\u6587\u4ef6\u9700\u8981\u4f7f\u7528\u53c3\u8207\u8005\u6240\u4f7f\u7528\u7684\u8a9e\u8a00\u3002\u9019\u6709\u52a9\u65bc\u4ed6\u5011\u5c31\u53c3\u52a0\u8a66\u9a57\u505a\u51fa\u771f\u6b63\u77e5\u60c5\u7684\u6c7a\u5b9a\u3002<\/li>\n<li><strong>\u5c0d\u65bc\u76e3\u7ba1\u6a5f\u69cb\uff1a<\/strong><br \/>\n\u7814\u7a76\u65b9\u6848\u3001\u7814\u7a76\u8005\u624b\u518a\u548c\u5b89\u5168\u5831\u544a\u7b49\u95dc\u9375\u6587\u4ef6\u5fc5\u9808\u7ffb\u8b6f\u6210\u8a66\u9a57\u6240\u5728\u570b\u5bb6\u7684\u5b98\u65b9\u8a9e\u8a00\u3002<\/li>\n<li><strong>\u5c0d\u65bc\u516c\u773e\uff1a<\/strong><br \/>\n\u8a66\u9a57\u7d50\u679c\u5fc5\u9808\u4ee5\u4efb\u4f55\u4eba\u90fd\u80fd\u7406\u89e3\u7684\u7c21\u55ae\u8a9e\u8a00\u5448\u73fe\uff0c\u78ba\u4fdd\u6bcf\u500b\u4eba\uff08\u800c\u4e0d\u50c5\u50c5\u662f\u91ab\u7642\u5c08\u696d\u4eba\u54e1\uff09\u90fd\u80fd\u7372\u53d6\u8cc7\u8a0a\u3002<\/li>\n<\/ul>\n<h3>\u81e8\u5e8a\u8a66\u9a57\u4e2d\u7ffb\u8b6f\u7684\u6311\u6230<\/h3>\n<p>\u7ffb\u8b6f\u81e8\u5e8a\u8a66\u9a57\u6587\u4ef6\u9700\u8981\u4ed4\u7d30\u7684\u898f\u5283\u3001\u6e96\u78ba\u6027\u548c\u5c08\u696d\u77e5\u8b58\u3002\u4ee5\u4e0b\u662f\u4e3b\u8981\u6311\u6230\uff1a<\/p>\n<ol>\n<li><strong>\u622a\u6b62\u65e5\u671f\u7dca\u8feb<\/strong><br \/>\n\u76e3\u7ba1\u6a5f\u69cb\u901a\u5e38\u9700\u8981\u5feb\u901f\u7372\u53d6\u6587\u4ef6\uff0c\u5c24\u5176\u662f\u5b89\u5168\u5831\u544a\u7b49\u7dca\u6025\u66f4\u65b0\u3002\u932f\u904e\u9019\u4e9b\u622a\u6b62\u65e5\u671f\u53ef\u80fd\u6703\u5c0e\u81f4\u5be9\u5224\u5ef6\u9072\u751a\u81f3\u53d6\u6d88\u3002<\/li>\n<li><strong>\u8a9e\u8a00<\/strong><strong>\u9593<\/strong><strong>\u7684\u4e00\u81f4\u6027<\/strong><br \/>\n\u78ba\u4fdd\u591a\u7a2e\u8a9e\u8a00\u4e4b\u9593\u4fdd\u6301\u76f8\u540c\u7684\u542b\u7fa9\u662f\u5177\u6709\u6311\u6230\u6027\u7684\u3002\u932f\u8aa4\u6216\u4e0d\u4e00\u81f4\u53ef\u80fd\u6703\u4f7f\u53c3\u8207\u8005\u611f\u5230\u56f0\u60d1\u6216\u5c0e\u81f4\u6279\u51c6\u554f\u984c\u3002<\/li>\n<li><strong>\u8907\u96dc\u7684\u91ab\u5b78<\/strong><strong>\u8853\u8a9e<\/strong><br \/>\n\u81e8\u5e8a\u8a66\u9a57\u6d89\u53ca\u6280\u8853\u548c\u79d1\u5b78\u8853\u8a9e\u3002\u8b6f\u8005\u5fc5\u9808\u5c0d\u9019\u4e9b\u8853\u8a9e\u9032\u884c\u6e96\u78ba\u50b3\u9054\uff0c\u4f7f\u975e\u5c08\u5bb6\u4e5f\u80fd\u7406\u89e3\u5b83\u5011\u3002<\/li>\n<li><strong>\u4e0d\u65b7\u8b8a\u5316\u7684\u9700\u6c42<\/strong><br \/>\n\u95dc\u65bc\u7ffb\u8b6f\u5167\u5bb9\u53ca\u65b9\u5f0f\u7684\u898f\u5b9a\u7d93\u5e38\u66f4\u65b0\u3002\u8a66\u9a57\u7533\u8fa6\u8005\u5fc5\u9808\u96a8\u6642\u4e86\u89e3\u6700\u65b0\u4fe1\u606f\uff0c\u4ee5\u4fdd\u6301\u5408\u898f\u6027\u3002<\/li>\n<\/ol>\n<h3>\u8a9e\u8a00\u670d\u52d9\u63d0\u4f9b\u8005 (LSP) \u5982\u4f55\u63d0\u4f9b\u5354\u52a9<\/h3>\n<p>\u70ba\u4e86\u61c9\u5c0d\u9019\u4e9b\u6311\u6230\uff0c\u8a31\u591a\u8a66\u9a57\u7533\u8fa6\u8005\u8058\u8acb\u8a9e\u8a00\u670d\u52d9\u63d0\u4f9b\u8005 (LSP)\u3002\u9019\u4e9b\u516c\u53f8\u5c08\u9580<a href=\"https:\/\/www.ulatus.com\/medical-translation-service\/regulatory-submission.htm\">\u7ffb\u8b6f\u91ab\u7642\u548c\u76e3\u7ba1\u6587\u4ef6<\/a>\u3002\u8207LSP\u5408\u4f5c\u53ef\u4ee5\u5728\u4ee5\u4e0b\u5e7e\u65b9\u9762\u5f97\u5230\u5e6b\u52a9\uff1a<\/p>\n<ul>\n<li><strong>\u5c08\u696d\u7ffb\u8b6f\u4eba\u54e1<\/strong><br \/>\nLSP \u4f7f\u7528\u7cbe\u901a\u91ab\u5b78\u548c\u79d1\u5b78\u8853\u8a9e\u7684\u5c08\u696d\u4eba\u54e1\uff0c\u78ba\u4fdd\u7ffb\u8b6f\u6e96\u78ba\u4e14\u7b26\u5408\u6587\u5316\u80cc\u666f\u3002<\/li>\n<li><strong>\u5feb\u901f\u53ef\u9760\u7684\u6d41\u7a0b<\/strong><br \/>\n\u4ed6\u5011\u7d93\u5e38\u4f7f\u7528\u7ffb\u8b6f\u8a18\u61b6\u5eab\u548c\u4eba\u5de5\u667a\u6167 (AI) \u7b49\u5148\u9032\u5de5\u5177\uff0c\u5728\u4fdd\u6301\u9ad8\u8cea\u91cf\u7684\u540c\u6642\uff0c\u52a0\u5feb\u7ffb\u8b6f\u904e\u7a0b\u3002<\/li>\n<li><strong>\u6cd5\u898f\u77e5\u8b58<\/strong><br \/>\nLSP \u59cb\u7d42\u9075\u5b88 EU CTR \u7684\u7ffb\u8b6f\u898f\u5247\uff0c\u5e6b\u52a9\u8d0a\u52a9\u5546\u6eff\u8db3\u6240\u6709\u8981\u6c42\uff0c\u800c\u4e0d\u6703\u907a\u6f0f\u95dc\u9375\u7d30\u7bc0\u3002<\/li>\n<li><strong>\u96c6\u4e2d<\/strong><strong>\u5316<\/strong><strong>\u7cfb\u7d71<\/strong><br \/>\n\u8a31\u591a LSP \u63d0\u4f9b\u5c08\u6848\u7ba1\u7406\u5e73\u53f0\uff0c\u53ef\u4ee5\u5728\u4e00\u500b\u5730\u65b9\u8655\u7406\u6240\u6709\u6587\u4ef6\u7684\u7ffb\u8b6f\uff0c\u5f9e\u800c\u6e1b\u5c11\u932f\u8aa4\u4e26\u78ba\u4fdd\u4e00\u81f4\u6027\u3002<\/li>\n<li><strong>\u6210\u672c\u6548\u76ca<\/strong><br \/>\n\u5f9e\u9577\u9060\u4f86\u770b\uff0c\u8207\u7d93\u9a57\u8c50\u5bcc\u7684 LSP \u5408\u4f5c\u53ef\u80fd\u66f4\u5177\u6210\u672c\u6548\u76ca\u3002\u7ffb\u8b6f\u4e2d\u7684\u932f\u8aa4\u6216\u5ef6\u9072\u53ef\u80fd\u6703\u5c0e\u81f4\u8fd4\u5de5\u3001\u984d\u5916\u7684\u76e3\u7ba1\u67e5\u8a62\u4ee5\u53ca\u8a66\u9a57\u6642\u9593\u8868\u7684\u63a8\u9072\uff0c\u9019\u4e9b\u90fd\u6703\u589e\u52a0\u7e3d\u9ad4\u9810\u7b97\u3002<\/li>\n<\/ul>\n<h3>\u8655\u7406\u7ffb\u8b6f\u7684\u6700\u4f73\u5be6\u8e10<\/h3>\n<p>\u8d0a\u52a9\u5546\u53ef\u4ee5\u63a1\u53d6\u5e7e\u500b\u6b65\u9a5f\u4f86\u6709\u6548\u7ba1\u7406\u7ffb\u8b6f\u5de5\u4f5c\uff1a<\/p>\n<ol>\n<li><strong>\u5118\u65e9\u958b\u59cb<\/strong><br \/>\n\u5f9e\u8a66\u9a57\u4e00\u958b\u59cb\u5c31\u8a08\u5283\u7ffb\u8b6f\u5de5\u4f5c\u3002\u78ba\u5b9a\u54ea\u4e9b\u6587\u4ef6\u9700\u8981\u7ffb\u8b6f\u4ee5\u53ca\u4f55\u6642\u9700\u8981\u7ffb\u8b6f\u3002<\/li>\n<li><strong>\u8207\u5c08\u5bb6\u5408\u4f5c<\/strong><br \/>\n\u4f7f\u7528\u65e2\u4e86\u89e3\u6280\u8853\u8853\u8a9e\u53c8\u719f\u6089\u76ee\u6a19\u8a9e\u8a00\u6587\u5316\u80cc\u666f\u7684\u5c08\u696d\u7ffb\u8b6f\u4eba\u54e1\u3002<\/li>\n<li><strong>\u96c6\u4e2d<\/strong><strong>\u7ba1\u7406<\/strong><strong>\u7ffb\u8b6f<\/strong><br \/>\n\u4f7f\u7528\u55ae\u4e00\u5e73\u53f0\u4f86\u7ba1\u7406\u6240\u6709\u7ffb\u8b6f\u5de5\u4f5c\uff0c\u78ba\u4fdd\u6587\u4ef6\u4fdd\u6301\u4e00\u81f4\u4e14\u6613\u65bc\u66f4\u65b0\u3002<\/li>\n<li><strong>\u9032\u884c<\/strong><strong>\u6e96\u78ba\u6027<\/strong><strong>\u96d9\u91cd\u6aa2\u67e5<\/strong><br \/>\n\u5be6\u65bd\u54c1\u8cea\u6aa2\u67e5\uff0c\u4f8b\u5982\u56de\u8b6f\uff0c\u5c07\u6587\u4ef6\u7ffb\u8b6f\u56de\u539f\u8a9e\u8a00\uff0c\u4ee5\u78ba\u4fdd\u7121\u7d30\u7bc0\u907a\u6f0f\u6216\u6539\u8b8a\u3002<\/li>\n<li><strong>\u89e3\u6c7a\u6587\u5316\u5dee\u7570<\/strong><br \/>\n\u6709\u4e9b\u55ae\u5b57\u6216\u77ed\u8a9e\u53ef\u80fd\u7121\u6cd5\u76f4\u63a5\u7ffb\u8b6f\uff0c\u6216\u8005\u5b83\u5011\u5728\u53e6\u4e00\u7a2e\u6587\u5316\u4e2d\u53ef\u80fd\u5177\u6709\u4e0d\u540c\u7684\u542b\u7fa9\u3002\u8207\u4e86\u89e3\u9019\u4e9b\u7d30\u5fae\u5dee\u5225\u7684\u8b6f\u8005\u5408\u4f5c\uff0c\u4ee5\u9632\u6b62\u8aa4\u89e3\u3002<\/li>\n<li><strong>\u4fdd\u6301\u77e5\u60c5<\/strong><br \/>\n\u96a8\u6642\u4e86\u89e3 CTR \u898f\u5247\u7684\u66f4\u65b0\uff0c\u56e0\u70ba\u8b8a\u66f4\u53ef\u80fd\u6703\u5f71\u97ff\u9700\u8981\u7ffb\u8b6f\u7684\u6587\u4ef6\u53ca\u5176\u683c\u5f0f\u3002<\/li>\n<li>\n<h3><strong>\u4e0b\u4e00\u6b65<\/strong><\/h3>\n<\/li>\n<\/ol>\n<ol>\n<li style=\"list-style-type: none;\">\n<ul>\n<li>\u70ba\u8a66\u9a57\u7684\u6bcf\u500b\u968e\u6bb5\u88fd\u5b9a\u4e00\u4efd\u300c\u7ffb\u8b6f\u6e05\u55ae\u300d\u3002<\/li>\n<li>\u5728\u6700\u7d42\u78ba\u5b9a\u8a66\u9a57\u6587\u4ef6\u4e4b\u524d\u8207 LSP \u5efa\u7acb\u95dc\u4fc2\u3002<\/li>\n<li>\u5728 CTIS\uff08\u81e8\u5e8a\u8a66\u9a57\u8cc7\u8a0a\u7cfb\u7d71\uff09\u4e2d\u8a2d\u5b9a\u6db5\u84cb\u7ffb\u8b6f\u5be9\u67e5\u548c\u6279\u51c6\u7684\u5de5\u4f5c\u6d41\u7a0b\u3002<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n<h3>\u4f7f\u81e8\u5e8a\u8a66\u9a57\u516c\u5e73\u4e14\u53ef\u53ca<\/h3>\n<p>EU CTR 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