{"id":52,"date":"2024-06-27T16:02:02","date_gmt":"2024-06-27T08:02:02","guid":{"rendered":"http:\/\/localhost\/wordpress4\/?p=52"},"modified":"2024-07-09T09:56:06","modified_gmt":"2024-07-09T01:56:06","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\/cn\/?p=52","title":{"rendered":"FDA \u63a8\u52a8\u4e34\u5e8a\u8bd5\u9a8c\u521b\u65b0"},"content":{"rendered":"\n<p><strong><strong>\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u81f4\u529b\u4e8e\u63a8\u52a8\u4e34\u5e8a\u8bd5\u9a8c\u521b\u65b0\uff0c\u4ee5\u52a0\u901f\u65b0\u836f\u548c\u6cbb\u7597\u65b9\u6cd5\u7684\u5f00\u53d1\uff0c\u5e76\u786e\u4fdd\u8fd9\u4e9b\u4ea7\u54c1\u80fd\u591f\u5b89\u5168\u6709\u6548\u5730\u60e0\u53ca\u60a3\u8005\u3002\u4ee5\u4e0b\u662fFDA\u5728\u4fc3\u8fdb\u4e34\u5e8a\u8bd5\u9a8c\u521b\u65b0\u65b9\u9762\u7684\u51e0\u4e2a\u4e3b\u8981\u4e3e\u63aa\uff1a<\/strong><\/strong><\/p>\n\n\n<figure class=\"wp-block-post-featured-image\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1024\" height=\"1024\" src=\"https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2024\/07\/5a9f35ed-7702-4a86-bcab-cfad62e90cf9.jpg\" class=\"attachment-post-thumbnail size-post-thumbnail wp-post-image\" alt=\"\" style=\"object-fit:cover;\" srcset=\"https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2024\/07\/5a9f35ed-7702-4a86-bcab-cfad62e90cf9.jpg 1024w, https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2024\/07\/5a9f35ed-7702-4a86-bcab-cfad62e90cf9-300x300.jpg 300w, https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2024\/07\/5a9f35ed-7702-4a86-bcab-cfad62e90cf9-150x150.jpg 150w, https:\/\/www.vcro.com.tw\/cn\/wp-content\/uploads\/2024\/07\/5a9f35ed-7702-4a86-bcab-cfad62e90cf9-768x768.jpg 768w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n<p class=\"has-small-font-size\"><strong>1. <strong>&nbsp;\u5e94\u7528\u5148\u8fdb\u6280\u672f<\/strong><\/strong><br> \u00b7&nbsp; \u4eba\u5de5\u667a\u80fd\u548c\u673a\u5668\u5b66\u4e60\uff1a\u8fd9\u4e9b\u6280\u672f\u88ab\u7528\u6765\u5206\u6790\u5927\u89c4\u6a21\u6570\u636e\u96c6\uff0c\u4ece\u800c\u8bc6\u522b\u6f5c\u5728\u7684\u6cbb\u7597\u9776\u70b9\u548c \u9884\u6d4b\u6cbb\u7597\u6548\u679c\u3002<br>\u00b7&nbsp; \u6570\u5b57\u5065\u5eb7\u6280\u672f\uff1aFDA\u9f13\u52b1\u4f7f\u7528\u6570\u5b57\u5065\u5eb7\u5de5\u5177\uff08\u5982\u53ef\u7a7f\u6234\u8bbe\u5907\u548c\u79fb\u52a8\u5065\u5eb7\u5e94\u7528\uff09\u6765\u6536\u96c6\u4e34\u5e8a\u8d44\u6599\uff0c\u8fd9\u4e9b\u5de5\u5177\u53ef\u4ee5\u63d0\u9ad8\u6570\u636e\u6536\u96c6\u7684\u6548\u7387\u548c\u7cbe\u786e\u6027\u3002<\/p>\n\n\n\n<p style=\"line-height:1.5\"><strong>2. <strong>\u8bbe\u8ba1\u7075\u6d3b\u7684\u8bd5\u9a8c\u6a21\u5f0f<\/strong><\/strong><br>\u00b7&nbsp; \u9002\u5e94\u6027\u8bbe\u8ba1\u8bd5\u9a8c\uff1a\u8fd9\u79cd\u8bbe\u8ba1\u5141\u8bb8\u5728\u8bd5\u9a8c\u8fdb\u884c\u8fc7\u7a0b\u4e2d\u6839\u636e\u4e2d\u671f\u6570\u636e\u8fdb\u884c\u4fee\u6539\uff0c\u4ece\u800c\u63d0\u9ad8\u8bd5\u9a8c\u6548\u7387\u548c\u8d44\u6e90\u5229\u7528\u7387\u3002<br>\u00b7&nbsp; \u4e3b\u8bd5\u9a8c\u548c\u4f1e\u72b6\u8bd5\u9a8c\uff1a\u8fd9\u4e9b\u8bd5\u9a8c\u8bbe\u8ba1\u5141\u8bb8\u540c\u65f6\u6d4b\u8bd5\u591a\u4e2a\u6cbb\u7597\u65b9\u6cd5\u6216\u836f\u7269\uff0c\u5e76\u5728\u5355\u4e00\u7684\u8bd5\u9a8c\u57fa\u7840\u4e0a\u8bc4\u4f30\u5176\u6548\u679c\uff0c\u4ece\u800c\u52a0\u901f\u65b0\u836f\u7684\u5f00\u53d1\u8fdb\u7a0b\u3002<\/p>\n\n\n\n<p><strong>3. <strong>\u52a0\u5f3a\u60a3\u8005\u53c2\u4e0e<\/strong><\/strong><br> \u00b7&nbsp; \u60a3\u8005\u62a5\u544a\u7ed3\u679c\uff08PROs\uff09\uff1aFDA\u9f13\u52b1\u5728\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u4f7f\u7528\u60a3\u8005\u62a5\u544a\u7ed3\u679c\uff0c\u8fd9\u4e9b\u7ed3\u679c\u80fd\u591f\u66f4\u51c6\u786e\u5730\u53cd\u6620\u60a3\u8005\u7684\u6cbb\u7597\u4f53\u9a8c\u548c\u751f\u6d3b\u8d28\u91cf\u3002<br>\u00b7&nbsp; \u60a3\u8005\u53c2\u4e0e\u8ba1\u5212\uff1aFDA\u79ef\u6781\u63a8\u52a8\u60a3\u8005\u53c2\u4e0e\u4e34\u5e8a\u8bd5\u9a8c\u8bbe\u8ba1\u548c\u51b3\u7b56\u8fc7\u7a0b\uff0c\u4ee5\u786e\u4fdd\u8bd5\u9a8c\u7ed3\u679c\u66f4\u5177\u76f8\u5173\u6027\u548c\u5b9e\u7528\u6027\u3002<\/p>\n\n\n\n<p><strong>4. <strong>\u52a0\u901f\u5ba1\u8bc4\u8fc7\u7a0b<\/strong><\/strong><br> \u00b7&nbsp; \u7a81\u7834\u6027\u7597\u6cd5\u8ba4\u5b9a\uff1a\u9488\u5bf9\u5177\u6709\u663e\u8457\u4e34\u5e8a\u4f18\u52bf\u7684\u65b0\u836f\uff0cFDA\u63d0\u4f9b\u52a0\u901f\u5ba1\u8bc4\u901a\u9053\uff0c\u51cf\u5c11\u5ba1\u6279\u65f6\u95f4\uff0c\u8ba9\u8fd9\u4e9b\u521b\u65b0\u6cbb\u7597\u65b9\u6cd5\u66f4\u5feb\u5730\u60e0\u53ca\u60a3\u8005\u3002<br>\u00b7&nbsp; \u5feb\u901f\u901a\u9053\u548c\u4f18\u5148\u5ba1\u8bc4\uff1a\u8fd9\u4e9b\u8ba1\u5212\u65e8\u5728\u7f29\u77ed\u5ba1\u6279\u65f6\u95f4\uff0c\u7279\u522b\u662f\u5bf9\u4e8e\u6cbb\u7597\u4e25\u91cd\u75be\u75c5\u548c\u672a\u6ee1\u8db3\u533b\u7597\u9700\u6c42\u7684\u836f\u7269\u3002<\/p>\n\n\n\n<p><strong>5. <strong>\u52a0\u5f3a\u6570\u636e\u6807\u51c6\u548c\u6574\u5408<\/strong><\/strong><br> \u00b7&nbsp; \u6807\u51c6\u5316\u6570\u636e\u683c\u5f0f\uff1aFDA\u63a8\u52a8\u4f7f\u7528\u6807\u51c6\u5316\u7684\u6570\u636e\u683c\u5f0f\uff0c\u4ee5\u4fbf\u4e8e\u6570\u636e\u7684\u5171\u4eab\u548c\u5206\u6790\uff0c\u8fd9\u6709\u52a9\u4e8e\u63d0\u9ad8\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u7684\u8d28\u91cf\u548c\u4e00\u81f4\u6027\u3002<br>\u00b7&nbsp; \u6570\u636e\u6574\u5408\u548c\u5206\u6790\u5e73\u53f0\uff1aFDA\u652f\u6301\u5efa\u7acb\u548c\u4f7f\u7528\u7efc\u5408\u6570\u636e\u5e73\u53f0\uff0c\u8fd9\u4e9b\u5e73\u53f0\u53ef\u4ee5\u6c47\u96c6\u6765\u81ea\u4e0d\u540c\u6765\u6e90\u7684\u8d44\u6599\uff0c\u4ece\u800c\u8fdb\u884c\u66f4\u5168\u9762\u7684\u5206\u6790\u548c\u7814\u7a76\u3002<\/p>\n\n\n\n<p><strong>6. <strong>\u5168\u7403\u534f\u4f5c<\/strong><\/strong><br> \u00b7&nbsp; \u56fd\u9645\u5408\u4f5c\uff1aFDA\u79ef\u6781\u53c2\u4e0e\u56fd\u9645\u5408\u4f5c\uff0c\u4e0e\u5176\u4ed6\u56fd\u5bb6\u7684\u76d1\u7ba1\u673a\u6784\u5171\u4eab\u6570\u636e\u548c\u77e5\u8bc6\uff0c\u4ee5\u4fc3\u8fdb\u5168\u7403\u8303\u56f4\u5185\u7684\u4e34\u5e8a\u8bd5\u9a8c\u521b\u65b0\u3002<br>\u00b7&nbsp; \u8de8\u56fd\u4e34\u5e8a\u8bd5\u9a8c\uff1aFDA\u9f13\u52b1\u548c\u652f\u6301\u8de8\u56fd\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u4ee5\u4fbf\u80fd\u591f\u66f4\u5feb\u901f\u5730\u6536\u96c6\u548c\u5206\u6790\u6765\u81ea\u4e0d\u540c\u4eba\u7fa4\u7684\u8d44\u6599\uff0c\u4ece\u800c\u63a8\u52a8\u65b0\u836f\u548c\u6cbb\u7597\u65b9\u6cd5\u7684\u5168\u7403\u5e94\u7528\u3002<\/p>\n\n\n\n<p>\u901a\u8fc7\u8fd9\u4e9b\u4e3e\u63aa\uff0cFDA\u6b63\u5728\u63a8\u52a8\u4e34\u5e8a\u8bd5\u9a8c\u9886\u57df\u7684\u521b\u65b0\uff0c\u65e8\u5728\u52a0\u901f\u65b0\u836f\u548c\u6cbb\u7597\u65b9\u6cd5\u7684\u5f00\u53d1\uff0c\u5e76\u786e\u4fdd\u5b83\u4eec\u80fd\u591f\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","protected":false},"excerpt":{"rendered":"<p>\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u81f4\u529b\u4e8e\u63a8\u52a8\u4e34\u5e8a\u8bd5\u9a8c\u521b\u65b0\uff0c\u4ee5\u52a0\u901f\u65b0\u836f\u548c\u6cbb\u7597\u65b9\u6cd5\u7684\u5f00\u53d1\uff0c\u5e76\u786e\u4fdd\u8fd9\u4e9b\u4ea7\u54c1\u80fd\u591f\u5b89\u5168\u6709\u6548 [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1341,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[11],"tags":[],"class_list":["post-52","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-11"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.6 - 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