{"id":52,"date":"2024-06-27T16:02:02","date_gmt":"2024-06-27T08:02:02","guid":{"rendered":"http:\/\/localhost\/wordpress4\/?p=52"},"modified":"2024-08-26T15:39:19","modified_gmt":"2024-08-26T07:39:19","slug":"%e7%b6%ad%e5%b7%9e%e7%94%9f%e6%8a%80%e5%8f%97%e9%82%80%e6%93%94%e4%bb%bb%e7%94%9f%e7%89%a9%e8%97%a5cmc%e5%b9%b3%e5%8f%b0%e3%80%8c4-2%e5%9c%8b%e9%9a%9b%e8%a8%bb%e5%86%8a%e7%b3%bb%e5%88%97%e5%b0%88","status":"publish","type":"post","link":"https:\/\/www.vcro.com.tw\/tw\/?p=52","title":{"rendered":"FDA \u63a8\u52d5\u81e8\u5e8a\u8a66\u9a57\u5275\u65b0"},"content":{"rendered":"\n<p><strong>\u7f8e\u570b\u98df\u54c1\u85e5\u54c1\u76e3\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u81f4\u529b\u65bc\u63a8\u52d5\u81e8\u5e8a\u8a66\u9a57\u5275\u65b0\uff0c\u4ee5\u52a0\u901f\u65b0\u85e5\u548c\u6cbb\u7642\u65b9\u6cd5\u7684\u958b\u767c\uff0c\u4e26\u78ba\u4fdd\u9019\u4e9b\u7522\u54c1\u80fd\u5920\u5b89\u5168\u6709\u6548\u5730\u60e0\u53ca\u60a3\u8005\u3002\u4ee5\u4e0b\u662fFDA\u5728\u4fc3\u9032\u81e8\u5e8a\u8a66\u9a57\u5275\u65b0\u65b9\u9762\u7684\u5e7e\u500b\u4e3b\u8981\u8209\u63aa\uff1a<\/strong><\/p>\n\n\n\n<p class=\"has-small-font-size\"><strong>1. \u61c9\u7528\u5148\u9032\u6280\u8853<\/strong><br> \u00b7\u00a0 \u4eba\u5de5\u667a\u6167\u548c\u6a5f\u5668\u5b78\u7fd2\uff1a\u9019\u4e9b\u6280\u8853\u88ab\u7528\u4f86\u5206\u6790\u5927\u898f\u6a21\u8cc7\u6599\u96c6\uff0c\u5f9e\u800c\u8b58\u5225\u6f5b\u5728\u7684\u6cbb\u7642\u9776\u9ede\u548c \u9810\u6e2c\u6cbb\u7642\u6548\u679c\u3002<br> \u00b7\u00a0 \u6578\u4f4d\u5065\u5eb7\u6280\u8853\uff1aFDA\u9f13\u52f5\u4f7f\u7528\u6578\u4f4d\u5065\u5eb7\u5de5\u5177\uff08\u5982\u53ef\u7a7f\u6234\u8a2d\u5099\u548c\u79fb\u52d5\u5065\u5eb7\u61c9\u7528\uff09\u4f86\u6536\u96c6\u81e8\u5e8a\u8cc7\u6599\uff0c\u9019\u4e9b\u5de5\u5177\u53ef\u4ee5\u63d0\u9ad8\u8cc7\u6599\u6536\u96c6\u7684\u6548\u7387\u548c\u7cbe\u78ba\u6027\u3002<\/p>\n\n\n\n<p style=\"line-height:1.5\"><strong>2. \u8a2d\u8a08\u9748\u6d3b\u7684\u8a66\u9a57\u6a21\u5f0f<\/strong><br> \u00b7\u00a0 \u9069\u61c9\u6027\u8a2d\u8a08\u8a66\u9a57\uff1a\u9019\u7a2e\u8a2d\u8a08\u5141\u8a31\u5728\u8a66\u9a57\u9032\u884c\u904e\u7a0b\u4e2d\u6839\u64da\u4e2d\u671f\u8cc7\u6599\u9032\u884c\u4fee\u6539\uff0c\u5f9e\u800c\u63d0\u9ad8\u8a66\u9a57\u6548\u7387\u548c\u8cc7\u6e90\u5229\u7528\u7387\u3002<br> \u00b7\u00a0 \u4e3b\u8a66\u9a57\u548c\u5098\u72c0\u8a66\u9a57\uff1a\u9019\u4e9b\u8a66\u9a57\u8a2d\u8a08\u5141\u8a31\u540c\u6642\u6e2c\u8a66\u591a\u500b\u6cbb\u7642\u65b9\u6cd5\u6216\u85e5\u7269\uff0c\u4e26\u5728\u55ae\u4e00\u7684\u8a66\u9a57\u57fa\u790e\u4e0a\u8a55\u4f30\u5176\u6548\u679c\uff0c\u5f9e\u800c\u52a0\u901f\u65b0\u85e5\u7684\u958b\u767c\u9032\u7a0b\u3002<\/p>\n\n\n\n<p><strong>3. \u52a0\u5f37\u60a3\u8005\u53c3\u8207<\/strong><br> \u00b7\u00a0 \u60a3\u8005\u5831\u544a\u7d50\u679c\uff08PROs\uff09\uff1aFDA\u9f13\u52f5\u5728\u81e8\u5e8a\u8a66\u9a57\u4e2d\u4f7f\u7528\u60a3\u8005\u5831\u544a\u7d50\u679c\uff0c\u9019\u4e9b\u7d50\u679c\u80fd\u5920\u66f4\u6e96\u78ba\u5730\u53cd\u6620\u60a3\u8005\u7684\u6cbb\u7642\u9ad4\u9a57\u548c\u751f\u6d3b\u54c1\u8cea\u3002<br> \u00b7\u00a0 \u60a3\u8005\u53c3\u8207\u8a08\u756b\uff1aFDA\u7a4d\u6975\u63a8\u52d5\u60a3\u8005\u53c3\u8207\u81e8\u5e8a\u8a66\u9a57\u8a2d\u8a08\u548c\u6c7a\u7b56\u904e\u7a0b\uff0c\u4ee5\u78ba\u4fdd\u8a66\u9a57\u7d50\u679c\u66f4\u5177\u76f8\u95dc\u6027\u548c\u5be6\u7528\u6027\u3002<\/p>\n\n\n\n<p><strong>4. \u52a0\u901f\u5be9\u8a55\u904e\u7a0b<\/strong><br> \u00b7\u00a0 \u7a81\u7834\u6027\u7642\u6cd5\u8a8d\u5b9a\uff1a\u91dd\u5c0d\u5177\u6709\u986f\u8457\u81e8\u5e8a\u512a\u52e2\u7684\u65b0\u85e5\uff0cFDA\u63d0\u4f9b\u52a0\u901f\u5be9\u8a55\u901a\u9053\uff0c\u6e1b\u5c11\u5be9\u6279\u6642\u9593\uff0c\u8b93\u9019\u4e9b\u5275\u65b0\u6cbb\u7642\u65b9\u6cd5\u66f4\u5feb\u5730\u60e0\u53ca\u60a3\u8005\u3002<br> \u00b7\u00a0 \u5feb\u901f\u901a\u9053\u548c\u512a\u5148\u5be9\u8a55\uff1a\u9019\u4e9b\u8a08\u756b\u65e8\u5728\u7e2e\u77ed\u5be9\u6279\u6642\u9593\uff0c\u7279\u5225\u662f\u5c0d\u65bc\u6cbb\u7642\u56b4\u91cd\u75be\u75c5\u548c\u672a\u6eff\u8db3\u91ab\u7642\u9700\u6c42\u7684\u85e5\u7269\u3002<\/p>\n\n\n\n<p><strong>5. \u52a0\u5f37\u8cc7\u6599\u6a19\u6e96\u548c\u6574\u5408<\/strong><br> \u00b7\u00a0 \u6a19\u6e96\u5316\u8cc7\u6599\u683c\u5f0f\uff1aFDA\u63a8\u52d5\u4f7f\u7528\u6a19\u6e96\u5316\u7684\u8cc7\u6599\u683c\u5f0f\uff0c\u4ee5\u4fbf\u65bc\u8cc7\u6599\u7684\u5171\u7528\u548c\u5206\u6790\uff0c\u9019\u6709\u52a9\u65bc\u63d0\u9ad8\u81e8\u5e8a\u8a66\u9a57\u8cc7\u6599\u7684\u54c1\u8cea\u548c\u4e00\u81f4\u6027\u3002<br> \u00b7\u00a0 \u8cc7\u6599\u6574\u5408\u548c\u5206\u6790\u5e73\u81fa\uff1aFDA\u652f\u63f4\u5efa\u7acb\u548c\u4f7f\u7528\u7d9c\u5408\u8cc7\u6599\u5e73\u81fa\uff0c\u9019\u4e9b\u5e73\u81fa\u53ef\u4ee5\u5f59\u96c6\u4f86\u81ea\u4e0d\u540c\u4f86\u6e90\u7684\u8cc7\u6599\uff0c\u5f9e\u800c\u9032\u884c\u66f4\u5168\u9762\u7684\u5206\u6790\u548c\u7814\u7a76\u3002<\/p>\n\n\n\n<p><strong>6. \u5168\u7403\u5354\u4f5c<\/strong><br> \u00b7\u00a0 \u570b\u969b\u5408\u4f5c\uff1aFDA\u7a4d\u6975\u53c3\u8207\u570b\u969b\u5408\u4f5c\uff0c\u8207\u5176\u4ed6\u570b\u5bb6\u7684\u76e3\u7ba1\u6a5f\u69cb\u5171\u7528\u8cc7\u6599\u548c\u77e5\u8b58\uff0c\u4ee5\u4fc3\u9032\u5168\u7403\u7bc4\u570d\u5167\u7684\u81e8\u5e8a\u8a66\u9a57\u5275\u65b0\u3002<br> \u00b7\u00a0 \u8de8\u570b\u81e8\u5e8a\u8a66\u9a57\uff1aFDA\u9f13\u52f5\u548c\u652f\u6301\u8de8\u570b\u81e8\u5e8a\u8a66\u9a57\uff0c\u4ee5\u4fbf\u80fd\u5920\u66f4\u5feb\u901f\u5730\u6536\u96c6\u548c\u5206\u6790\u4f86\u81ea\u4e0d\u540c\u4eba\u7fa4\u7684\u8cc7\u6599\uff0c\u5f9e\u800c\u63a8\u52d5\u65b0\u85e5\u548c\u6cbb\u7642\u65b9\u6cd5\u7684\u5168\u7403\u61c9\u7528\u3002<\/p>\n\n\n\n<p>\u901a\u904e\u9019\u4e9b\u8209\u63aa\uff0cFDA\u6b63\u5728\u63a8\u52d5\u81e8\u5e8a\u8a66\u9a57\u9818\u57df\u7684\u5275\u65b0\uff0c\u65e8\u5728\u52a0\u901f\u65b0\u85e5\u548c\u6cbb\u7642\u65b9\u6cd5\u7684\u958b\u767c\uff0c\u4e26\u78ba\u4fdd\u5b83\u5011\u80fd\u5920\u5b89\u5168\u6709\u6548\u5730\u9020\u798f\u4e8e\u60a3\u8005\u3002<\/p>\n\n\n\n<p><a href=\"https:\/\/www.fda.gov\/news-events\/fda-voices\/fda-promotes-clinical-trial-innovation\">https:\/\/www.fda.gov\/news-events\/fda-voices\/fda-promotes-clinical-trial-innovation<\/a><\/p>\n\n\n<figure class=\"wp-block-post-featured-image\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"1024\" src=\"https:\/\/www.vcro.com.tw\/tw\/wp-content\/uploads\/2024\/07\/5a9f35ed-7702-4a86-bcab-cfad62e90cf9.jpg\" class=\"attachment-post-thumbnail size-post-thumbnail wp-post-image\" alt=\"VCRO \u7dad\u5dde\u751f\u7269\u79d1\u6280 \u7dad\u5dde\u5feb\u8a0a FDA \u63a8\u52d5\u81e8\u5e8a\u8a66\u9a57\u5275\u65b0\" style=\"object-fit:cover;\" srcset=\"https:\/\/www.vcro.com.tw\/tw\/wp-content\/uploads\/2024\/07\/5a9f35ed-7702-4a86-bcab-cfad62e90cf9.jpg 1024w, https:\/\/www.vcro.com.tw\/tw\/wp-content\/uploads\/2024\/07\/5a9f35ed-7702-4a86-bcab-cfad62e90cf9-300x300.jpg 300w, https:\/\/www.vcro.com.tw\/tw\/wp-content\/uploads\/2024\/07\/5a9f35ed-7702-4a86-bcab-cfad62e90cf9-150x150.jpg 150w, https:\/\/www.vcro.com.tw\/tw\/wp-content\/uploads\/2024\/07\/5a9f35ed-7702-4a86-bcab-cfad62e90cf9-768x768.jpg 768w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure>","protected":false},"excerpt":{"rendered":"<p>\u7f8e\u570b\u98df\u54c1\u85e5\u54c1\u76e3\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u81f4\u529b\u65bc\u63a8\u52d5\u81e8\u5e8a\u8a66\u9a57\u5275\u65b0\uff0c\u4ee5\u52a0\u901f\u65b0\u85e5\u548c\u6cbb\u7642\u65b9\u6cd5\u7684\u958b\u767c\uff0c\u4e26\u78ba\u4fdd\u9019\u4e9b\u7522\u54c1\u80fd\u5920\u5b89\u5168\u6709\u6548 [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1297,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7],"tags":[23,22,20,21,19],"class_list":["post-52","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-7","tag-fda","tag-vcro","tag-20","tag-21","tag-19"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.6 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\r\n<title>FDA \u63a8\u52d5\u81e8\u5e8a\u8a66\u9a57\u5275\u65b0 - VCRO \u53f0\u7063 CRO 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