{"id":207,"date":"2024-06-04T15:03:09","date_gmt":"2024-06-04T07:03:09","guid":{"rendered":"http:\/\/localhost\/wordpress4\/?page_id=207"},"modified":"2025-06-19T15:15:21","modified_gmt":"2025-06-19T07:15:21","slug":"%e8%b3%87%e6%96%99%e7%b5%b1%e8%a8%88%e5%88%86%e6%9e%90","status":"publish","type":"page","link":"https:\/\/www.vcro.com.tw\/cn\/?page_id=207","title":{"rendered":"\u8d44\u6599\u7edf\u8ba1\u5206\u6790"},"content":{"rendered":"\n
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\u8d44\u6599\u7edf\u8ba1\u5206\u6790<\/h2>\n\n\n\n
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VCRO<\/span> \u8d44\u6599\u7edf\u8ba1\u5206\u6790\u56e2\u961f\u62e5\u670928\u5e74\u7684\u751f\u7edf\u4e0e\u8d44\u6599\u9886\u57df\u7ecf\u9a8c<\/p>\n\u6210\u5458\u6709\u8d44\u6df1\u90e8\u95e8\u7ecf\u7406\u4ee5\u53ca\u65d7\u4e0b4\u9879\u4e13\u4e1a\u7ec4\u522b<\/cite><\/blockquote>\n\n\n\n

\u5206\u522b\u4e3a Biostatistician\uff0cProgrammers\uff0cData managers\uff0c \u548c Database developers \uff0c\u5168\u5458\u7686\u4e3a SAS \u7a0b\u5e8f\u5de5\u7a0b\u5e08\u3002\u6211\u4eec\u7684\u56e2\u961f\u4f9d\u7167 ICH GCP\u3001CDISC\u3001\u5f53\u5730\u6cd5\u89c4\u53ca SOP\uff0c\u4ee5\u6570\u767e\u4f59\u4ef6\u6570\u636e\u5904\u7406\u4e0e\u7edf\u8ba1\u5206\u6790\u7684\u7eaf\u719f\u4e13\u4e1a\u7ecf\u9a8c\uff0c\u4e25\u8c28\u7684\u6267\u884c\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u7684\u751f\u7269\u7edf\u8ba1\u8bbe\u8ba1\u4e0e\u6267\u884c\u3001SAS \u7edf\u8ba1\u7f16\u7a0b\u8bbe\u8ba1\u4e0e\u64b0\u5199\u3001\u4e34\u5e8a\u8bd5\u9a8c EDC \u5efa \u7f6e\u3001\u6570\u636e\u5e93\u5efa\u7acb\u4e0e\u4f7f\u7528\u3001\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u6e05\u7406\u6574\u7406\u4e0e\u7ba1\u7406\u3002<\/p>\n\n\n\n

\u4e3a\u786e\u4fdd\u4e34\u5e8a\u6570\u636e\u4e0e\u7edf\u8ba1\u7ed3\u679c\u7684\u51c6\u786e\u6027\u548c\u4e00\u81f4\u6027\uff0cVCRO \u7684 BDMD \u683c\u5916\u91cd\u89c6\u4e0e\u524d\u7aef\u4e34\u5e8a\u6267\u884c\u8005\u548c\u540e\u7aef\u62a5\u544a\u64b0\u5199\u8005\u8fdb\u884c\u5145\u5206\u4e14\u9ad8\u6548\u7684\u6c9f\u901a\u3002EDC \u7cfb\u7edf VCRO \u63d0\u4f9b\u5ba2\u6237\u8f7b\u76c8\u7b80\u4fbf\u7684VCRO EDC Lite \u53ca\u5168\u7403\u77e5\u540d\u7684\u7532\u9aa8\u6587\u7cfb\u7edf Oracle Life Sciences Clinical One Cloud \u6765\u534f\u52a9\u4e34\u5e8a\u6570\u636e\u7684\u6536\u96c6\u3001\u9a8c\u8bc1\u4e0e\u7ba1\u7406\uff0c\u4ece\u800c\u63d0\u4f9b\u5b8c\u6574\u4e14\u53ef\u4fe1\u8d56\u7684\u4e34\u5e8a\u6570\u636e\u670d\u52a1\u3002<\/p>\n\n\n\n

\u6211\u4eec\u81f4\u529b\u4e8e\u786e\u4fdd\u6bcf\u4e2a\u6b65\u9aa4\u90fd\u7b26\u5408\u6700\u9ad8\u6807\u51c6\uff0c\u4e3a\u5ba2\u6237\u63d0\u4f9b\u6700\u4e13\u4e1a\u7684\u652f\u6301\u548c\u4fdd\u969c\u3002<\/p>\n\n\n\n

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\u6211\u4eec\u80fd\u505a\u4ec0\u4e48<\/strong><\/strong><\/p>\n\u4e00\u4e2a\u6210\u529f\u7684\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u5fc5\u987b\u5177\u5907\u5b8c\u6574\u7684\u6570\u636e\u7ba1\u7406\u548c\u53ef\u4fe1\u8d56\u7684\u7edf\u8ba1\u5206\u6790\u7ed3\u679c<\/cite><\/blockquote>\n\n\n\n

VCRO \u8d44\u6599\u7edf\u8ba1\u5206\u6790\u56e2\u961f\u80fd\u591f\u63d0\u4f9b\u8fd9\u4e9b\u5fc5\u8981\u7684\u670d\u52a1\uff0c\u786e\u4fdd\u8bd5\u9a8c\u7ed3\u679c\u7b26\u5408\u5ba2\u6237\u7684\u4ea4\u4ed8\u3001\u7ecf\u6d4e\u6548\u76ca\u5e76\u63d0\u4f9b\u575a\u5b9e\u7684\u4fdd\u969c\u3002<\/p>\n\n\n\n

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\u4e34\u5e8a\u8bd5\u9a8c\u7814\u7a76\u8bbe\u8ba1\u4e0e\u968f\u673a\u5904\u7406<\/strong><\/p>\n<\/div>\n<\/div>\n\n\n\n

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\u6211\u4eec\u63d0\u4f9b\u5b8c\u6574\u7684\u4e34\u5e8a\u8bd5\u9a8c\u7814\u7a76\u8bbe\u8ba1\uff0c\u786e\u4fdd\u8bd5\u9a8c\u7684\u79d1\u5b66\u6027\u548c\u6709\u6548\u6027\uff0c\u5305\u62ec: \u8ba1\u7b97\u6837\u672c\u6570 (\u4f7f\u7528 nQuery Advisor\uff0cSAS )\u3001\u7edf\u8ba1\u65b9\u6cd5\u7814\u7a76\u3001\u5236\u4f5c\u968f\u673a\u5904\u7406\u5217\u8868\u3001\u5236\u4f5c\u4e2a\u6848\u62a5\u544a\u4e66\u53ca\u5176\u4f7f\u7528\u624b\u518c\u3001\u53d7\u8bd5\u8005\u65e5\u5fd7\u8bbe\u8ba1\u3002<\/p>\n<\/div>\n<\/div>\n\n\n\n

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\u6570\u636e\u5904\u7406\u4e0e\u9a8c\u8bc1<\/p>\n<\/div>\n<\/div>\n\n\n\n

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VCRO \u4f7f\u7528 Oracle Life Sciences Clinical One Cloud \u8fdb\u884c\u6570\u636e\u6536\u96c6\u4e0e\u7ba1\u7406\uff0c\u6839\u636e\u8ba1\u5212\u4e66\u64b0\u5199\u9a8c\u8bc1\u89c4\u5219\uff0c\u5e76\u900f\u8fc7 SAS \u7edf\u8ba1\u7f16\u7a0b\u8fdb\u884c\u6570\u636e\u7ec6\u90e8\u6e05\u7406\uff0c\u5305\u62ec: \u6570\u636e\u5904\u7406\u8ba1\u5212\/\u62a5\u544a\u64b0\u5199\u3001\u6570\u636e\u9a8c\u8bc1\u89c4\u5219\u64b0\u5199\u3001SAS \u7edf\u8ba1\u7f16\u7a0b\u64b0\u5199\u6570\u636e\u9a8c\u8bc1\u89c4\u5219\u3001\u6570\u636e\u63d0\u95ee\u3001\u6570\u636e\u5e93\u9501\u5b9a\/\u89e3\u9664\/\u518d\u9501\u5b9a\u3001\u5916\u90e8\u6570\u636e\u7684\u4f20\u8f93\u6574\u5408\u3001\u8ba1\u5212\u4e66\u504f\u79bb\u5217\u8868\u7b49\u2026\u2026\u3002<\/strong>\u7ef4\u5dde\u4ea6\u63d0\u4f9b\u8f7b\u76c8\u7b80\u4fbf\u7684 VCRO EDC Lite\uff0c\u8ba9\u4e34\u5e8a\u8bd5\u9a8c\u7535\u5b50\u5316\u66f4\u52a0\u4eb2\u6c11\u6613\u4e0a\u624b\u3002<\/p>\n<\/div>\n<\/div>\n\n\n\n

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\u6570\u636e\u6807\u51c6\u4e0e\u7f16\u7801<\/p>\n<\/div>\n<\/div>\n\n\n\n

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\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\u683c\u5f0f\u53ef\u4f9d\u5ba2\u6237\u9700\u6c42\u6216\u5b8c\u5168\u7b26\u5408 FDA \u6240\u8981\u6c42\u7684 CDISC \u9001\u4ef6\u6807\u51c6\u3002\u300c\u4e8b\u4ef6\u300d\u4e0e\u300c\u4ecb\u5165\u300d\u53ef\u4f7f\u7528 MedDRA (\u836f\u4e8b\u7ba1\u7406\u7684\u533b\u5b66\u5b57\u5178\uff0cMedical Dictionary for Regulatory Activities )\u3001WHODRUG (\u4e16\u754c\u536b\u751f\u7ec4\u7ec7\u836f\u7269\u5b57\u5178\uff0cWorld Health Organization Drug) \u7b49\u5b57\u5178\u8fdb\u884c\u7f16\u7801\u3002<\/p>\n<\/div>\n<\/div>\n\n\n\n

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SAS\u7edf\u8ba1\u7f16\u7a0b<\/p>\n<\/div>\n<\/div>\n\n\n\n

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\u900f\u8fc7\u4e16\u754c\u516c\u8ba4\u4e00\u6d41\u7684 SAS \u7cfb\u7edf\u8fdb\u884c\u7edf\u8ba1\u7f16\u7a0b\uff0c\u4ee5\u8fbe\u5230\u6570\u636e\u7ed3\u679c\u7684\u5b8c\u6574\u6027\u4e0e\u53ef\u9760\u6027\u8d44\uff0c\u5305\u62ec: \u4e34\u5e8a\u8bd5\u9a8c\u8d44\u6599\u683c\u5f0f\u6807\u51c6\u5316\u3001\u53d7\u8bd5\u8005\u8d44\u6599\u5217\u8868\u3001\u7edf\u8ba1\u5206\u6790\u7ed3\u679c (\u8868\u3001\u56fe\uff0c\u8d44\u6599\u5217\u8868) \u8f93\u51fa\u3002<\/p>\n<\/div>\n<\/div>\n\n\n\n

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\u7edf\u8ba1\u5206\u6790\u4e0e\u62a5\u544a<\/p>\n<\/div>\n<\/div>\n\n\n\n

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\u7edf\u8ba1\u7ed3\u679c\u900f\u8fc7\u7edf\u8ba1\u5e08\u4e0e\u7edf\u8ba1\u987e\u95ee\u7684\u628a\u5173\uff0c\u4e3a\u4e34\u5e8a\u8bd5\u9a8c\u7684\u7ed3\u679c\u5960\u5b9a\u4e86\u826f\u597d\u7684\u57fa\u7840\uff0c\u5305\u62ec: \u8fdb\u884c\u76f2\u6027\u68c0\u9605\u4e0e\u5206\u6790\u524d\u4f1a\u8bae\u3001\u7edf\u8ba1\u5206\u6790\u8ba1\u5212\u64b0\u5199\u3001\u7edf\u8ba1\u5206\u6790\u7ed3\u679c\u54a8\u8be2\u3001\u7edf\u8ba1\u62a5\u544a\u64b0\u5199\u3002<\/p>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n

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\u6211\u4eec\u7684\u7279\u8272\u7279\u8d28<\/strong><\/strong><\/strong><\/p>\n<\/blockquote>\n\n\n\n

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VCRO<\/span> \u751f\u7269\u7edf\u8ba1\u4e0e\u6570\u636e\u5904\u7406\u56e2\u961f\u7406\u89e3\u6240\u6709\u7684\u4e34\u5e8a\u8bd5\u9a8c\u8d44\u6599\u90fd\u662f\u91d1\u94b1\u4e0e\u65f6\u95f4\u6dec\u70bc\u800c\u6765\u7684\uff0c\u56e0\u6b64\u6211\u4eec\u5bf9\u5f85\u6bcf\u4e2a\u6570\u636e\u90fd\u7279\u522b\u5f3a\u8c03\u7ec6\u5fc3\u4e0e\u8010\u5fc3<\/p>\n\n\n\n

\u900f\u8fc7 VCRO \u751f\u7269\u7edf\u8ba1\u4e0e\u6570\u636e\u5904\u7406\u56e2\u961f\u591a\u4f4d\u8d44\u6df1\u8015\u8018\u4e8e\u4e34\u5e8a\u8bd5\u9a8c\u7684\u6210\u5458\u7ecf\u9a8c\u4e2d\uff0c\u6211\u4eec\u5efa\u7acb\u4e86\u4e00\u5957\u7b26\u5408\u56fd\u9645\u6cd5\u89c4\u7684\u5b8c\u6574\u6d41\u7a0b\uff0c\u80fd\u6709\u6548\u5904\u7406\u5404\u79cd\u4e34\u5e8a\u8bd5\u9a8c\u6570\u636e\uff1b\u9664\u6b64\u4e4b\u5916\uff0c\u6211\u4eec\u4e5f\u91cd\u89c6\u9ad8\u6548\u7684\u90e8\u95e8\u95f4\u6c9f\u901a\u4e0e\u7ef4\u62a4\u826f\u597d\u8bad\u7ec3\u7684\u56e2\u961f\uff0c\u786e\u4fdd\u6bcf\u4e2a\u6210\u5458\u90fd\u80fd\u5b9e\u65f6\u638c\u63e1\u6700\u65b0\u4fe1\u606f\u548c\u7814\u7a76\u8fdb\u5c55\u3002<\/p>\n\n\n\n

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\u5b8c\u5584\u7684 SOP<\/h3>\n\n\n\n

SOP \u662f\u8d28\u91cf\u786e\u4fdd\u7684\u57fa\u77f3\uff0c\u57fa\u4e8e\u5b8c\u6210\u6570\u767e\u6b21\u7684\u4e34\u5e8a\u6267\u884c\uff0cVCRO \u62e5\u6709\u5b8c\u6574\u7684\u7edf\u8ba1\u4e0e\u6570\u636e\u5904\u7406 SOP\uff0c\u5e76\u4e14\u4ee5\u5b9a\u671f\u5ba1\u6838\u6539\u7248\u6765\u786e\u4fdd\u4e0e\u6700\u65b0\u6cd5\u89c4\u548c\u6267\u884c\u9762\u7684\u4e00\u81f4\u6027<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n

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\u5185\u90e8\u4e0e\u5916\u90e8\u8bad\u7ec3<\/h3>\n\n\n\n

VCRO \u56e2\u961f\u5b9a\u671f\u7684\u5185\u5916\u90e8\u7684\u8bad\u7ec3\u662f\u4f7f\u4e13\u4e1a\u4eba\u5458\u968f\u65f6\u4fdd\u6301\u4e0e\u65f6\u4ff1\u8fdb\u7684\u91cd\u8981\u653f\u7b56\uff0c\u8bad\u7ec3\u5185\u5bb9\u5305\u62ec\u7eb5\u5411\u7684\u4e13\u9879\u8bad\u7ec3\u4e0e\u6a2a\u5411\u7684\u6c9f\u901a\u8bad\u7ec3\uff0c\u8ba9\u6211\u4eec\u5728\u9762\u5bf9\u4efb\u4f55\u6311\u6218\u90fd\u80fd\u4ee5\u4e13\u4e1a\u7684\u65b9\u5f0f\u63d0\u4f9b\u6700\u597d\u7684\u89e3\u51b3\u65b9\u6848\u3002<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n

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\u4e2d\u592e\u7ba1\u7406\u7684 SAS \u7edf\u8ba1\u7f16\u6210\u5de5\u5177<\/h3>\n\n\n\n

VCRO \u4ee5\u5e9e\u5927\u6709\u7ec4\u7ec7\u7684 SAS \u7edf\u8ba1\u7f16\u6210\u5de5\u5177\uff0c\u53ef\u4ee5\u8fc5\u901f\u4e14\u7cbe\u786e\u5730\u63d0\u9ad8\u5de5\u4f5c\u6548\u7387\u4e0e\u6b63\u786e\u6027\uff0c\u4e0d\u4ec5\u4e3a\u5ba2\u6237\u7f29\u77ed\u8bd5\u9a8c\u65f6\u7a0b\uff0c\u8fd8\u53ef\u5927\u5e45\u8282\u7701\u7814\u53d1\u6210\u672c\u3002<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n

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\u5ba2\u5236\u5316\u7684\u6d41\u7a0b<\/h3>\n\n\n\n

\u968f\u7740\u65e5\u65b0\u6708\u5f02\u7684\u4e34\u5e8a\u8bd5\u9a8c\u8bbe\u8ba1\uff0c\u7ef4\u5dde\u53ef\u4ee5\u6839\u636e\u5ba2\u6237\u7684\u9700\u6c42\u5ba2\u5236\u5316\u7279\u6b8a\u9700\u6c42\u6d41\u7a0b\uff0c\u5728\u9075\u5faa\u6cd5\u89c4\u7684\u539f\u5219\u4e0b\uff0c\u534f\u52a9\u5ba2\u6237\u4ee5\u6ee1\u8db3\u5176\u4e0d\u540c\u9762\u5411\u7684\u9700\u6c42\u3002<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n

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\u6211\u4eec\u4f7f\u547d\u5fc5\u8fbe<\/strong><\/strong><\/p>\n\u4e34\u5e8a\u8bd5\u9a8c\u662f\u4e00\u4e2a\u591a\u6b65\u9aa4\u4e14\u591a\u89c2\u70b9\u7684\u590d\u6742\u8fc7\u7a0b\uff0c\u9700\u8981\u9ad8\u5ea6\u4e13\u4e1a\u7684\u77e5\u8bc6\u548c\u4e30\u5bcc\u7684\u7ecf\u9a8c\u6765\u7ba1\u7406\u5e76\u652f\u6301\u6bcf\u4e2a\u73af\u8282<\/cite><\/blockquote>\n\n\n\n

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