{"id":207,"date":"2024-06-04T15:03:09","date_gmt":"2024-06-04T07:03:09","guid":{"rendered":"http:\/\/localhost\/wordpress4\/?page_id=207"},"modified":"2024-08-16T14:04:08","modified_gmt":"2024-08-16T06:04:08","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\/tw\/?page_id=207","title":{"rendered":"\u8cc7\u6599\u7d71\u8a08\u5206\u6790"},"content":{"rendered":"\n

\u8cc7\u6599\u7d71\u8a08\u5206\u6790<\/h1>\n\n\n\n

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VCRO<\/span> \u751f\u7269\u7d71\u8a08\u8207\u8cc7\u6599\u8655\u7406\u5718\u968a\u64c1\u670927\u5e74\u7684\u751f\u7d71\u8207
\u8cc7\u6599\u9818\u57df\u7d93\u9a57<\/p>\n\u6210\u54e1\u6709\u8cc7\u6df1\u90e8\u9580\u7d93\u7406\u4ee5\u53ca\u65d7\u4e0b4\u9805\u5c08\u696d\u7d44\u5225<\/cite><\/blockquote>\n\n\n\n

\u5206\u5225\u70ba Biostatisticians\u3001Programmers\u3001Data managers \u548c Database developers\uff0c\u5168\u54e1\u7686\u70ba SAS \u7a0b\u5f0f\u5de5\u7a0b\u5e2b\u3002\u6211\u5011\u7684\u5718\u968a\u4f9d\u7167 ICH GCP\u3001CDISC\u3001\u7576\u5730\u6cd5\u898f\u53ca SOP\uff0c\u4ee5\u53ca\u6578\u767e\u9918\u4ef6\u8cc7\u6599\u8655\u7406\u8207\u7d71\u8a08\u5206\u6790\u7684\u7d14\u719f\u5c08\u696d\u7d93\u9a57\uff0c\u56b4\u8b39\u7684\u57f7\u884c\u81e8\u5e8a\u8a66\u9a57\u751f\u7269\u7d71\u8a08\u3001SAS \u7d71\u8a08\u7de8\u7a0b\u8a2d\u8a08\u8207\u64b0\u5beb\u3001\u81e8\u5e8a\u8a66\u9a57\u8cc7\u6599\u5eab (EDC) \u7cfb\u7d71\u5efa\u7f6e\u8207\u4f7f\u7528\u3001\u81e8\u5e8a\u8a66\u9a57\u6578\u64da\u6e05\u7406\u6574\u7406\u8207\u7ba1\u7406\u3002<\/p>\n\n\n\n

\u70ba\u78ba\u4fdd\u81e8\u5e8a\u6578\u64da\u8207\u7d71\u8a08\u7d50\u679c\u7684\u6e96\u78ba\u6027\u548c\u4e00\u81f4\u6027\uff0cVCRO \u7684 \u751f\u7269\u7d71\u8a08\u8207\u8cc7\u6599\u8655\u7406\u5718\u968a\u683c\u5916\u91cd\u8996\u8207\u524d\u7aef\u81e8\u5e8a\u57f7\u884c\u8005\u548c\u5f8c\u7aef\u5831\u544a\u64b0\u5beb\u8005\u9032\u884c\u5145\u5206\u4e14\u9ad8\u6548\u7684\u6e9d\u901a\u3002EDC\u7cfb\u7d71 \u63d0\u4f9b\u5ba2\u6236\u8f15\u76c8\u7c21\u4fbf\u7684 VCRO EDC Lite \u53ca\u5168\u7403\u77e5\u540d\u7684\u7532\u9aa8\u6587\u7cfb\u7d71 Oracle Life Sciences Clinical One Cloud \u4f86\u5354\u52a9\u81e8\u5e8a\u8cc7\u6599\u7684\u6536\u96c6\u3001\u9a57\u8b49\u8207\u7ba1\u7406\uff0c\u5f9e\u800c\u63d0\u4f9b\u5b8c\u6574\u4e14\u53ef\u4fe1\u8cf4\u7684\u81e8\u5e8a\u6578\u64da\u670d\u52d9\u3002<\/p>\n\n\n\n

\u6211\u5011\u81f4\u529b\u65bc\u78ba\u4fdd\u6bcf\u500b\u6b65\u9a5f\u90fd\u7b26\u5408\u6700\u9ad8\u6a19\u6e96\uff0c\u70ba\u5ba2\u6236\u63d0\u4f9b\u6700\u5c08\u696d\u7684\u652f\u6301\u548c\u4fdd\u969c\u3002<\/p>\n\n\n\n

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\u6211\u5011\u80fd\u505a\u4ec0\u9ebc<\/strong><\/strong><\/p>\n\u4e00\u500b\u6210\u529f\u7684\u81e8\u5e8a\u8a66\u9a57\uff0c\u5fc5\u9808\u5177\u5099\u5b8c\u6574\u7684\u8cc7\u6599\u7ba1\u7406\u548c\u53ef\u4fe1\u8cf4\u7684\u7d71\u8a08\u5206\u6790\u7d50\u679c<\/cite><\/blockquote>\n\n\n\n

VCRO \u751f\u7269\u7d71\u8a08\u8207\u8cc7\u6599\u8655\u7406\u5718\u968a\u80fd\u5920\u63d0\u4f9b\u9019\u4e9b\u5fc5\u8981\u7684\u670d\u52d9\uff0c\u78ba\u4fdd\u8a66\u9a57\u7d50\u679c\u7b26\u5408\u5ba2\u6236\u7684\u4ea4\u4ed8\u3001\u7d93\u6fdf\u6548\u76ca\u4e26\u63d0\u4f9b\u5805\u5be6\u7684\u4fdd\u969c\u3002<\/p>\n\n\n\n

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\u81e8\u5e8a\u8a66\u9a57\u7814\u7a76\u8a2d\u8a08\u8207\u96a8\u6a5f\u8655\u7406<\/p>\n<\/div>\n<\/div>\n\n\n\n

\n

\u6211\u5011\u63d0\u4f9b\u5b8c\u6574\u7684\u81e8\u5e8a\u8a66\u9a57\u7814\u7a76\u8a2d\u8a08\uff0c\u78ba\u4fdd\u8a66\u9a57\u7684\u79d1\u5b78\u6027\u548c\u6709\u6548\u6027\uff0c\u5305\u62ec: \u8a08\u7b97\u6a23\u672c\u6578 (\u4f7f\u7528 nQuery Advisor\uff0cSAS )\u3001\u7d71\u8a08\u65b9\u6cd5\u7814\u7a76\u3001\u88fd\u4f5c\u96a8\u6a5f\u8655\u7406\u5217\u8868\u3001\u88fd\u4f5c\u500b\u6848\u5831\u544a\u66f8\u53ca\u5176\u4f7f\u7528\u624b\u518a\u3001\u53d7\u8a66\u8005\u65e5\u8a8c\u8a2d\u8a08\u3002<\/p>\n<\/div>\n<\/div>\n\n\n\n

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\u8cc7\u6599\u8655\u7406\u8207\u9a57\u8b49<\/p>\n<\/div>\n<\/div>\n\n\n\n

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VCRO \u4f7f\u7528 Oracle Life Sciences Clinical One Cloud \u9032\u884c\u8cc7\u6599\u6536\u96c6\u8207\u7ba1\u7406\uff0c\u6839\u64da\u8a08\u5283\u66f8\u64b0\u5beb\u9a57\u8b49\u898f\u5247\uff0c\u4e26\u900f\u904e SAS \u7d71\u8a08\u7de8\u7a0b\u9032\u884c\u8cc7\u6599\u7d30\u90e8\u6e05\u7406\uff0c\u5305\u62ec: \u8cc7\u6599\u8655\u7406\u8a08\u756b\/\u5831\u544a\u64b0\u5beb\u3001\u8cc7\u6599\u9a57\u8b49\u898f\u5247\u64b0\u5beb\u3001SAS \u7d71\u8a08\u7de8\u7a0b\u64b0\u5beb\u8cc7\u6599\u9a57\u8b49\u898f\u5247\u3001\u8cc7\u6599\u63d0\u554f\u3001\u8cc7\u6599\u5eab\u9396\u5b9a\/\u89e3\u9664\/\u518d\u9396\u5b9a\u3001\u5916\u90e8\u8cc7\u6599\u7684\u50b3\u8f38\u6574\u5408\u3001\u8a08\u5283\u66f8\u504f\u96e2\u5217\u8868\u7b49\u2026\u2026\u3002<\/strong>\u7dad\u5dde\u4ea6\u63d0\u4f9b\u8f15\u76c8\u7c21\u4fbf\u7684 VCRO EDC Lite\uff0c\u8b93\u81e8\u5e8a\u8a66\u9a57\u96fb\u5b50\u5316\u66f4\u52a0\u89aa\u6c11\u6613\u4e0a\u624b\u3002<\/p>\n<\/div>\n<\/div>\n\n\n\n

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\u8cc7\u6599\u6a19\u6e96\u8207\u7de8\u78bc<\/p>\n<\/div>\n<\/div>\n\n\n\n

\n

\u81e8\u5e8a\u8a66\u9a57\u8cc7\u6599\u683c\u5f0f\u53ef\u4f9d\u5ba2\u6236\u9700\u6c42\u6216\u5b8c\u5168\u7b26\u5408 FDA \u6240\u8981\u6c42\u7684 CDISC \u9001\u4ef6\u6a19\u6e96\u3002\u300c\u4e8b\u4ef6\u300d\u8207\u300c\u4ecb\u5165\u300d\u53ef\u4f7f\u7528 MedDRA (\u85e5\u4e8b\u7ba1\u7406\u7684\u91ab\u5b78\u5b57\u5178\uff0cMedical Dictionary for Regulatory Activities )\u3001WHODRUG (\u4e16\u754c\u885b\u751f\u7d44\u7e54\u85e5\u7269\u5b57\u5178\uff0cWorld Health Organization Drug) \u7b49\u5b57\u5178\u9032\u884c\u7de8\u78bc\u3002<\/p>\n<\/div>\n<\/div>\n\n\n\n

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SAS\u7d71\u8a08\u7de8\u7a0b<\/p>\n<\/div>\n<\/div>\n\n\n\n

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\u900f\u904e\u4e16\u754c\u516c\u8a8d\u4e00\u6d41\u7684 SAS \u7cfb\u7d71\u9032\u884c\u7d71\u8a08\u7de8\u7a0b\uff0c\u4ee5\u9054\u5230\u6578\u64da\u7d50\u679c\u7684\u5b8c\u6574\u6027\u8207\u53ef\u9760\u6027\u8cc7\uff0c\u5305\u62ec: \u81e8\u5e8a\u8a66\u9a57\u8cc7\u6599\u683c\u5f0f\u6a19\u6e96\u5316\u3001\u53d7\u8a66\u8005\u8cc7\u6599\u5217\u8868\u3001\u7d71\u8a08\u5206\u6790\u7d50\u679c (\u8868\u3001\u5716\uff0c\u8cc7\u6599\u5217\u8868) \u8f38\u51fa\u3002<\/p>\n<\/div>\n<\/div>\n\n\n\n

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\u7d71\u8a08\u5206\u6790\u8207\u5831\u544a<\/p>\n<\/div>\n<\/div>\n\n\n\n

\n

\u7d71\u8a08\u7d50\u679c\u900f\u904e\u7d71\u8a08\u5e2b\u8207\u7d71\u8a08\u9867\u554f\u7684\u628a\u95dc\uff0c\u70ba\u81e8\u5e8a\u8a66\u9a57\u7684\u7d50\u679c\u5960\u5b9a\u4e86\u826f\u597d\u7684\u57fa\u790e\uff0c\u5305\u62ec: \u9032\u884c\u76f2\u6027\u6aa2\u95b1\u8207\u5206\u6790\u524d\u6703\u8b70\u3001\u7d71\u8a08\u5206\u6790\u8a08\u756b\u64b0\u5beb\u3001\u7d71\u8a08\u5206\u6790\u7d50\u679c\u8aee\u8a62\u3001\u7d71\u8a08\u5831\u544a\u64b0\u5beb\u3002<\/p>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n

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<\/span>\"\u8cc7\u6599\u8655\u7406,\u7dad\u5dde,\u7dad\u5dde\u751f\u7269,\u7dad\u5dde\u751f\u7269\u79d1\u6280,\u7dad\u5dde\u751f\u6280,VCRO,CRO,\u53f0\u7063
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<\/p>\n<\/div><\/div>\n<\/div>\n\n\n\n

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\u6211\u5011\u7684\u7279\u8272\u7279\u8cea<\/strong><\/strong><\/p>\n<\/blockquote>\n\n\n\n

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VCRO<\/span> \u751f\u7269\u7d71\u8a08\u8207\u8cc7\u6599\u8655\u7406\u5718\u968a\u7406\u89e3\u6240\u6709\u7684\u81e8\u5e8a\u8a66\u9a57\u8cc7\u6599\u90fd\u662f\u91d1\u9322\u8207\u6642\u9593\u6dec\u934a\u800c\u4f86\u7684\uff0c\u56e0\u6b64\u6211\u5011\u5c0d\u5f85\u6bcf\u500b\u8cc7\u6599\u90fd\u7279\u5225\u5f37\u8abf\u7d30\u5fc3\u8207\u8010\u5fc3<\/p>\n\n\n\n

\u900f\u904e VCRO \u751f\u7269\u7d71\u8a08\u8207\u8cc7\u6599\u8655\u7406\u5718\u968a\u591a\u4f4d\u8cc7\u6df1\u8015\u8018\u65bc\u81e8\u5e8a\u8a66\u9a57\u7684\u6210\u54e1\u7d93\u9a57\u4e2d\uff0c\u6211\u5011\u5efa\u7acb\u4e86\u4e00\u5957\u7b26\u5408\u570b\u969b\u6cd5\u898f\u7684\u5b8c\u6574\u6d41\u7a0b\uff0c\u80fd\u6709\u6548\u8655\u7406\u5404\u7a2e\u81e8\u5e8a\u8a66\u9a57\u8cc7\u6599\uff1b\u9664\u6b64\u4e4b\u5916\uff0c\u6211\u5011\u4e5f\u91cd\u8996\u9ad8\u6548\u7684\u90e8\u9580\u9593\u6e9d\u901a\u8207\u7dad\u8b77\u826f\u597d\u8a13\u7df4\u7684\u5718\u968a\uff0c\u78ba\u4fdd\u6bcf\u500b\u6210\u54e1\u90fd\u80fd\u5373\u6642\u638c\u63e1\u6700\u65b0\u8cc7\u8a0a\u548c\u7814\u7a76\u9032\u5c55\u3002<\/p>\n\n\n\n

\n<\/div>\n<\/div>\n<\/div>\n\n\n\n

<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n

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

SOP \u662f\u54c1\u8cea\u78ba\u4fdd\u7684\u57fa\u77f3\uff0c\u57fa\u65bc\u5b8c\u6210\u6578\u767e\u6b21\u7684\u81e8\u5e8a\u57f7\u884c\uff0cVCRO \u64c1\u6709\u5b8c\u6574\u7684\u7d71\u8a08\u8207\u8cc7\u6599\u8655\u7406 SOP\uff0c\u4e26\u4e14\u4ee5\u5b9a\u671f\u5be9\u6838\u6539\u7248\u4f86\u78ba\u4fdd\u8207\u6700\u65b0\u6cd5\u898f\u548c\u57f7\u884c\u9762\u7684\u4e00\u81f4\u6027<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n

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\u5167\u90e8\u8207\u5916\u90e8\u8a13\u7df4<\/h3>\n\n\n\n

VCRO \u5718\u968a\u5b9a\u671f\u7684\u5167\u5916\u90e8\u7684\u8a13\u7df4\u662f\u4f7f\u5c08\u696d\u4eba\u54e1\u96a8\u6642\u4fdd\u6301\u8207\u6642\u4ff1\u9032\u7684\u91cd\u8981\u653f\u7b56\uff0c\u8a13\u7df4\u5167\u5bb9\u5305\u62ec\u7e31\u5411\u7684\u5c08\u9805\u8a13\u7df4\u8207\u6a6b\u5411\u7684\u6e9d\u901a\u8a13\u7df4\uff0c\u8b93\u6211\u5011\u5728\u9762\u5c0d\u4efb\u4f55\u6311\u6230\u90fd\u80fd\u4ee5\u5c08\u696d\u7684\u65b9\u5f0f\u63d0\u4f9b\u6700\u597d\u7684\u89e3\u6c7a\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 \u7d71\u8a08\u7de8\u6210\u5de5\u5177<\/h3>\n\n\n\n

VCRO \u4ee5\u9f90\u5927\u6709\u7d44\u7e54\u7684 SAS \u7d71\u8a08\u7de8\u6210\u5de5\u5177\uff0c\u53ef\u4ee5\u8fc5\u901f\u4e14\u7cbe\u78ba\u5730\u63d0\u9ad8\u5de5\u4f5c\u6548\u7387\u8207\u6b63\u78ba\u6027\uff0c\u4e0d\u50c5\u70ba\u5ba2\u6236\u7e2e\u77ed\u8a66\u9a57\u6642\u7a0b\uff0c\u9084\u53ef\u5927\u5e45\u7bc0\u7701\u7814\u767c\u6210\u672c\u3002<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n

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\u5ba2\u88fd\u5316\u7684\u6d41\u7a0b<\/h3>\n\n\n\n

\u96a8\u8457\u65e5\u65b0\u6708\u7570\u7684\u81e8\u5e8a\u8a66\u9a57\u8a2d\u8a08\uff0c\u7dad\u5dde\u53ef\u4ee5\u6839\u64da\u5ba2\u6236\u7684\u9700\u6c42\u5ba2\u88fd\u5316\u7279\u6b8a\u9700\u6c42\u6d41\u7a0b\uff0c\u5728\u9075\u5faa\u6cd5\u898f\u7684\u539f\u5247\u4e0b\uff0c\u5354\u52a9\u5ba2\u6236\u4ee5\u6eff\u8db3\u5176\u4e0d\u540c\u9762\u5411\u7684\u9700\u6c42\u3002<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n

\n

\u6211\u5011\u4f7f\u547d\u5fc5\u9054<\/strong><\/p>\n\u81e8\u5e8a\u8a66\u9a57\u662f\u4e00\u500b\u591a\u6b65\u9a5f\u4e14\u591a\u89c0\u9ede\u7684\u8907\u96dc\u904e\u7a0b\uff0c\u9700\u8981\u9ad8\u5ea6\u5c08\u696d\u7684\u77e5\u8b58\u548c\u8c50\u5bcc\u7684\u7d93\u9a57\u4f86\u7ba1\u7406\u4e26\u652f\u6301\u6bcf\u500b\u74b0\u7bc0<\/cite><\/blockquote>\n\n\n\n

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