{"id":159436,"date":"2021-02-18T14:42:27","date_gmt":"2021-02-18T21:42:27","guid":{"rendered":"https:\/\/lifesciences.csoftintl.com\/blog\/%e5%a6%82%e4%bd%95%e6%8f%90%e5%8d%87%e4%b8%b4%e5%ba%8a%e8%af%95%e9%aa%8ctmf%e7%9a%84%e8%bf%87%e5%ae%a1%e7%8e%87%ef%bc%9f\/"},"modified":"2021-03-04T20:37:49","modified_gmt":"2021-03-05T03:37:49","slug":"%e5%a6%82%e4%bd%95%e6%8f%90%e5%8d%87%e4%b8%b4%e5%ba%8a%e8%af%95%e9%aa%8ctmf%e7%9a%84%e8%bf%87%e5%ae%a1%e7%8e%87%ef%bc%9f","status":"publish","type":"post","link":"https:\/\/lifesciences.csoftintl.com\/zh-hans\/blog\/%e5%a6%82%e4%bd%95%e6%8f%90%e5%8d%87%e4%b8%b4%e5%ba%8a%e8%af%95%e9%aa%8ctmf%e7%9a%84%e8%bf%87%e5%ae%a1%e7%8e%87%ef%bc%9f\/","title":{"rendered":"\u5982\u4f55\u63d0\u5347\u4e34\u5e8a\u8bd5\u9a8cTMF\u7684\u8fc7\u5ba1\u7387\uff1f"},"content":{"rendered":"

[et_pb_section admin_label=”section”]
\n\t\t[et_pb_row admin_label=”row”]
\n\t\t\t[et_pb_column type=”4_4″][et_pb_text admin_label=”Text”]<\/p>\n\n

\u4e34\u5e8a\u8bd5\u9a8c\u662f\u836f\u7269\u5f00\u53d1\u8fc7\u7a0b\u4e2d\u4e0d\u53ef\u7f3a\u5c11\u7684\u4e00\u73af\u3002\u8d8a\u6765\u8d8a\u591a\u7684\u4e34\u5e8a\u8bd5\u9a8c\u5728\u4e16\u754c\u5404\u5730\u8fdb\u884c\uff0c\u751a\u81f3\u6709\u8bb8\u591a\u5355\u9879\u8bd5\u9a8c\u5728\u4e0d\u540c\u5730\u533a\u540c\u65f6\u8fdb\u884c\u7684\u60c5\u51b5\uff0c\u56e0\u6b64\uff0c\u6df1\u5165\u4e86\u89e3\u76d1\u7ba1\u6761\u6b3e\uff0c\u5efa\u7acb\u4e00\u4e2a\u5b89\u5168\u7684\u6570\u636e\u7ba1\u7406\u7cfb\u7edf\uff0c\u66f4\u6709\u52a9\u4e8e\u533b\u836f\u516c\u53f8\u83b7\u5f97\u5e02\u573a\u51c6\u5165\u3002\u4e3a\u4e86\u4f7f\u7533\u529e\u8005\u548c\u4e34\u5e8a\u7814\u7a76\u7684\u5de5\u4f5c\u4fdd\u6301\u6709\u5e8f\u5e76\u7b26\u5408\u76d1\u7ba1\u8981\u6c42\uff0c\u4e34\u5e8a\u8bd5\u9a8c\u4e3b\u6587\u6863\uff08Trial Master File\uff0cTMF\uff09\u5e94\u8fd0\u800c\u751f\u3002<\/p>\n\n

TMF<\/a>\u662f\u76d1\u7ba1\u673a\u6784\u4e3a\u76d1\u6d4b\u548c\u8bc4\u4f30\u4e34\u5e8a\u7814\u7a76\u662f\u5426\u9075\u5faa\u7ecf\u6279\u51c6\u7684\u65b9\u6848\u4ee5\u53ca\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u8d28\u91cf\u7ba1\u7406\u89c4\u8303\uff08GCP\uff09\u539f\u5219\u6240\u9700\u7684\u6587\u4ef6\u5e93\u30021996\u5e74<\/a>\uff0c\u4eba\u7528\u836f\u54c1\u6ce8\u518c\u6280\u672f\u56fd\u9645\u534f\u8c03\u4f1a\u8bae(ICH)\u53d1\u5e03\u4e86GCP\u6307\u5357\uff0c\u786e\u5b9a\u4e86\u4e34\u5e8a\u6587\u4ef6\u7684\u6807\u51c6\u3002\u65e0\u8bba\u4e34\u5e8a\u8bd5\u9a8c\u5728\u54ea\u4e2a\u5730\u533a\u8fdb\u884c\uff0cTMF\u90fd\u662f\u836f\u7269\u5f00\u53d1\u8fc7\u7a0b\u4e2d\u83b7\u5f97\u76d1\u7ba1\u90e8\u95e8\u6279\u51c6\u7684\u91cd\u8981\u7ec4\u6210\u90e8\u5206\u3002\u4e0d\u8fc7\uff0c\u6839\u636e\u4e0d\u540c\u5730\u533a\u7ba1\u7406\u673a\u6784\u7684\u5dee\u5f02\uff0cTMF\u6240\u9700\u7684\u6587\u4ef6\u7c7b\u578b\u53ef\u80fd\u6709\u6240\u4e0d\u540c\u3002<\/p><\/p>\n\n

\"翻译<\/figure>\n

\u4e34\u5e8a\u8bd5\u9a8c\u4e3b\u529e\u65b9\u6709\u8d23\u4efb\u4e86\u89e3\u76d1\u7ba1\u673a\u6784\u5728\u5ba1\u67e5\u65f6\u9700\u8981\u7684\u6587\u4ef6\u53ca\u4e0d\u540c\u8981\u6c42\u3002\u4e3a\u4e86\u65b9\u4fbf\u76d1\u7ba1\u673a\u6784\u7684\u5ba1\u6838\uff0cTMF\u9700\u8981\u7531\u5370\u5237\u7248\u672c\u6216\u7535\u5b50\u7248\uff08eTMF\uff09\u8fdb\u884c\u5f52\u6863\uff0c\u5e76\u786e\u4fdd\u5176\u4e2d\u7684\u6570\u636e\u6b63\u786e\u65e0\u8bef\u3002TMF\u53ef\u4ee5\u8ba9\u76d1\u7ba1\u673a\u6784\u6df1\u5165\u4e86\u89e3\u4e34\u5e8a\u8bd5\u9a8c\u7684\u5f00\u5c55\u65b9\u5f0f\uff0c\u59a5\u5584\u4fdd\u62a4\u60a3\u8005\u7684\u6570\u636e\u548c\u9690\u79c1\uff0c\u540c\u65f6\u4e5f\u80fd\u6839\u636e\u62a5\u544a\u516c\u6b63\u91cd\u590d\u9a8c\u8bc1\u7814\u7a76\u3002\u56e0\u6b64\uff0c\u8ba9\u836f\u7269\u5f00\u53d1\u4eba\u5458\u6b63\u786e\u638c\u63e1\u6536\u96c6\u548c\u5b58\u50a8\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u7684\u65b9\u6cd5 \uff0c\u662f\u4fdd\u8bc1TMF\u5728\u8bd5\u9a8c\u671f\u95f4\u4ee5\u53ca\u8bd5\u9a8c\u7ed3\u675f\u540e\u5f97\u5230\u59a5\u5584\u7ba1\u7406\u548c\u7ef4\u62a4\u7684\u5173\u952e\u3002<\/p>\n\n

\u53e6\u4e00\u65b9\u9762\uff0c\u968f\u7740\u4e34\u5e8a\u8bd5\u9a8c\u5728\u5168\u7403\u8303\u56f4\u5f00\u5c55\uff0cTMF\u7684\u7ec4\u7ec7\u5de5\u4f5c\u53ef\u80fd\u53d8\u5f97\u590d\u6742\u3002\u4e3a\u4e86\u6ee1\u8db3\u4e0d\u540c\u5730\u533a\u7684\u76d1\u7ba1\u8981\u6c42\uff0cTMF\/eTMF\u5fc5\u987b\u5728\u63d0\u4f9b\u7ed9\u5ba1\u67e5\u5458\u4e4b\u524d\u51c6\u786e\u7ffb\u8bd1\u6210\u6240\u5728\u5730\u533a\u7684\u5f53\u5730\u8bed\u8a00\uff0c\u5426\u5219\u53ef\u80fd\u4f1a\u5ef6\u8fdf\u76d1\u7ba1\u5ba1\u6279\uff0c\u4ece\u800c\u63a8\u8fdf\u836f\u7269\u6cbb\u7597\u6216\u533b\u7597\u5668\u68b0\u7684\u4e0a\u5e02\u65f6\u95f4\uff0c\u4f7f\u6210\u672c\u589e\u52a0\u3002\u7531\u4e8e\u4e00\u4e9b\u56fd\u5bb6\u5bf9\u73b0\u573a\u5ba1\u6838\u8981\u6c42\u4e0d\u540c\uff0c\u7533\u529e\u8005\u548cTMF\u7ecf\u7406\u5fc5\u987b\u719f\u6089\u5404\u4e2a\u5730\u65b9\u7684\u6cd5\u89c4\u6761\u6b3e\uff0c\u5305\u62ec\u4e00\u4e9b\u9ad8\u96be\u5ea6\u6280\u672f\u6587\u4ef6\u7684\u7ffb\u8bd1\uff0c\u624d\u80fd\u83b7\u5f97\u76d1\u7ba1\u90e8\u95e8\u7684\u6279\u51c6\u3002\u4e0e\u8bed\u8a00\u670d\u52a1\u63d0\u4f9b\u5546\u5408\u4f5c\uff0c\u4e0d\u4ec5\u53ef\u4ee5\u7ffb\u8bd1\u91cd\u8981\u7684\u76d1\u7ba1\u6587\u4ef6\uff0c\u8fd8\u53ef\u4ee5\u57f9\u8bad\u4e0d\u540c\u80cc\u666f\u7684\u5458\u5de5\uff0c\u4ece\u800c\u5e2e\u52a9\u59d4\u6258\u673a\u6784\u8fbe\u5230\u76d1\u7ba1\u6807\u51c6\u3002<\/p> \n

\u00a0<\/p><\/p>\n\n

\u4f5c\u4e3a\u5f00\u5c55\u5168\u7403\u4e34\u5e8a\u8bd5\u9a8c\u548c\u7ef4\u62a4GCP\u7684\u4e00\u90e8\u5206\uff0c\u6bcf\u4e2a\u7814\u7a76\u673a\u6784\u90fd\u9700\u8981\u5bf9\u4e34\u5e8a\u8bd5\u9a8c\u4eba\u5458\u8fdb\u884c\u57f9\u8bad<\/a>\uff0c\u7136\u800c\uff0c\u9488\u5bf9\u5168\u7403\u4e0d\u65ad\u53d8\u5316\u7684TMF\u6cd5\u89c4\uff0c\u5bf9\u591a\u8bed\u79cd\u5458\u5de5<\/a>\u8fdb\u884c\u57f9\u8bad\u662f\u4e00\u9879\u6311\u6218\u3002\u5408\u683c\u7684\u8bed\u8a00\u670d\u52a1\u63d0\u4f9b\u5546\u5728\u4e3a\u4e34\u5e8a\u8bd5\u9a8c\u4eba\u5458\u63d0\u4f9b\u6709\u6548\u7684\u591a\u8bed\u79cdTMF\u7535\u5b50\u5b66\u4e60\u548c\u57f9\u8bad\u6750\u6599\u65b9\u9762\u5177\u6709\u4e30\u5bcc\u7684\u7ecf\u9a8c\uff0c\u53ef\u4ee5\u5e2e\u52a9\u63d0\u9ad8\u5de5\u4f5c\u6548\u7387\uff0c\u51cf\u5c11\u6f5c\u5728\u7684\u9519\u8bef\uff0c\u5e76\u4f7f\u7533\u529e\u8005\u7ec4\u7ec7\u4fdd\u6301\u8d28\u91cf\u7684\u4e00\u81f4\u6027\uff0c\u4ece\u800c\u589e\u52a0\u6574\u4f53\u6536\u5165\u3002<\/p><\/p>\n\n

\u968f\u7740\u6570\u5b57\u5316\u6280\u672f\u7684\u65e5\u76ca\u5b8c\u5584\uff0ceTMF\u56e0\u5728\u521b\u4f5c\u3001\u7f16\u8f91\u548c\u5ba1\u67e5\u76d1\u7ba1\u6587\u4ef6\u65b9\u9762\u66f4\u52a0\u65b9\u4fbf\u534f\u4f5c\u548c\u7ba1\u7406\u800c\u5927\u53d7\u6b22\u8fce\u3002\u5c24\u5176\u662f\uff0c\u81ea2020\u5e74\u4ee5\u6765\uff0c\u968f\u7740COVID-19\u5bfc\u81f4\u5927\u90e8\u5206\u4e34\u5e8a\u8bd5\u9a8c\u6682\u505c\u6216\u8f6c\u4e3a\u8fdc\u7a0b\u8fdb\u884c\uff0ceTMF\u6253\u7834\u4e86\u65f6\u95f4\u4e0e\u7a7a\u95f4\u7684\u9650\u5236\uff0c\u4f7f\u5168\u7403\u5404\u5730\u7684\u4e34\u5e8a\u8bd5\u9a8c\u80fd\u591f\u540c\u6b65\u5206\u4eab\u6570\u636e\uff0c\u5927\u5927\u63d0\u9ad8\u4e86\u8bd5\u9a8c\u7684\u900f\u660e\u5ea6\u548c\u65f6\u6548\u6027\uff0c\u4e5f\u4e3a\u76d1\u7ba1\u5ba1\u6279\u63d0\u4f9b\u4e86\u4fbf\u5229\u3002\u968f\u7740\u6280\u672f\u7684\u4e0d\u65ad\u8fdb\u6b65\uff0cTMF\u8981\u6c42\u7684\u4e0d\u65ad\u53d8\u5316\uff0c\u5bf9\u4e8e\u5f00\u5c55\u5168\u7403\u4e34\u5e8a\u8bd5\u9a8c\u7684\u7533\u529e\u8005\u7ec4\u7ec7\u6765\u8bf4\uff0c\u65e0\u8bba\u4e34\u5e8a\u8bd5\u9a8c\u5728\u54ea\u91cc\u8fdb\u884c\uff0c\u4e0e\u4e13\u4e1a\u7684\u8bed\u8a00\u670d\u52a1\u63d0\u4f9b\u5546\u5408\u4f5c\uff0c\u9488\u5bf9\u6cd5\u89c4\u53d8\u5316\u5bf9\u5de5\u4f5c\u4eba\u5458\u8fdb\u884c\u57f9\u8bad\uff0c\u80fd\u591f\u5927\u5927\u63d0\u9ad8\u76d1\u7ba1\u5ba1\u6838\u5408\u683c\u7387\u3002<\/p>\n

[\/et_pb_text][\/et_pb_column]
\n\t\t[\/et_pb_row]
\n\t[\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"

[et_pb_section admin_label=”section”] [et_p […]<\/p>\n","protected":false},"author":19,"featured_media":156464,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","inline_featured_image":false},"categories":[917,368,467,780,781],"tags":[20,921,825,823,920,824,918],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/lifesciences.csoftintl.com\/zh-hans\/wp-json\/wp\/v2\/posts\/159436"}],"collection":[{"href":"https:\/\/lifesciences.csoftintl.com\/zh-hans\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/lifesciences.csoftintl.com\/zh-hans\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/lifesciences.csoftintl.com\/zh-hans\/wp-json\/wp\/v2\/users\/19"}],"replies":[{"embeddable":true,"href":"https:\/\/lifesciences.csoftintl.com\/zh-hans\/wp-json\/wp\/v2\/comments?post=159436"}],"version-history":[{"count":0,"href":"https:\/\/lifesciences.csoftintl.com\/zh-hans\/wp-json\/wp\/v2\/posts\/159436\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/lifesciences.csoftintl.com\/zh-hans\/wp-json\/wp\/v2\/media\/156464"}],"wp:attachment":[{"href":"https:\/\/lifesciences.csoftintl.com\/zh-hans\/wp-json\/wp\/v2\/media?parent=159436"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/lifesciences.csoftintl.com\/zh-hans\/wp-json\/wp\/v2\/categories?post=159436"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/lifesciences.csoftintl.com\/zh-hans\/wp-json\/wp\/v2\/tags?post=159436"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}