{"id":61186,"date":"2018-12-03T01:00:00","date_gmt":"2018-12-07T03:05:07","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/12\/07\/f6122dc8dc\/"},"modified":"2018-12-07T11:05:08","modified_gmt":"2018-12-07T03:05:08","slug":"f6122dc8dc","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/61186\/","title":{"rendered":"\u8f89\u745eGCP\u57f9\u8bad\uff08\u4e8c\uff09"},"content":{"rendered":"
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\"\u8f89\u745eGCP\u57f9\u8bad\uff08\u4e8c\uff09\"<\/span><\/a><\/p>\n


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\u7b2c\u5341\u4e00\u8bb2 <\/span><\/strong>\u8bd5\u9a8c\u65b9\u6848\uff1a\u4e34\u5e8a\u7814\u7a76\u7684\u5de5\u5177<\/span><\/strong><\/p>\n

Dr. Pierre Etienne <\/span><\/p>\n

\u5927\u5bb6\u597d\uff0c\u6211\u662fPierreEtienne\uff0c\u5728\u8f89\u745e\u516c\u53f8\u5de5\u4f5c\u3002\u6211\u662f\u4e00\u4e2a\u533b\u751f\uff0c\u5728\u8f89\u745e\u8d1f\u8d23\u65b0\u836f\u5f00\u53d1\u4e34\u5e8a\u8bd5\u9a8c\u7684\u6267\u884c\u3002<\/span><\/p>\n

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\u7814\u7a76\u8005\u53c2\u52a0\u4e34\u5e8a\u8bd5\u9a8c\u4e5f\u5e94\u8be5\u662f<\/span>\u201c<\/span>\u8d62<\/span>\u201d<\/span>\u7684\u3002\u4ed6\u4eec\u6709\u673a\u4f1a\u63a5\u89e6\u6700\u65b0\u7684\u836f\u7269\uff0c\u4ed6\u4eec\u6709\u673a\u4f1a\u5728\u7b2c\u4e00\u65f6\u95f4\u89c2\u5bdf\u836f\u7269\u7684\u4f5c\u7528\u3002\u4ed6\u4eec\u83b7\u5f97\u58f0\u8a89\u3002\u6211\u60f3\u6307\u51fa\uff0c\u5728\u67d0\u4e9b\u60c5\u51b5\u4e0b\uff0c\u7814\u7a76\u8005\u901a\u8fc7\u4e0e\u5236\u836f\u516c\u53f8\u5408\u4f5c\u8fdb\u884c\u4e34\u5e8a\u7814\u7a76\u53ef\u4ee5\u83b7\u5f97\u4e00\u5b9a\u7684\u8d39\u7528\uff0c\u4ed6\u4eec\u53ef\u4ee5\u5c06\u8fd9\u4e9b\u8d39\u7528\u5e94\u7528\u4e8e\u4e00\u4e9b\u91cd\u8981\u7684\u3001\u5374\u53c8\u96be\u4ee5\u83b7\u5f97\u8d44\u52a9\u7684\u7814\u7a76\u9879\u76ee\u4e2d\u3002<\/span><\/span><\/p>\n

\u76d1\u67e5\u5458\uff0c\u4ed6\u4eec\u901a\u5e38\u662f\u62a4\u58eb\u6216\u4ee5\u5f80\u7684\u7814\u7a76\u534f\u8c03\u5458\uff0c\u4e5f\u53ef\u4ee5\u4ece\u53c2\u52a0\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u53d7\u76ca\u3002\u7533\u529e\u8005\uff0c\u5373\u5236\u836f\u516c\u53f8\uff0c\u5f53\u7136\u4e5f\u662f\u8d62\u5bb6\u3002\u5b83\u9700\u8981\u4e34\u5e8a\u8bd5\u9a8c\u6765\u5145\u5b9e\u6570\u636e\u5e93\uff0c\u652f\u6301\u4ea7\u54c1\u4ee5\u5f97\u5230\u7ba1\u7406\u673a\u6784\u7684\u6279\u51c6\u3002\u5373\u4f7f\u5728\u4ea7\u54c1\u4e0a\u5e02\u540e\uff0c\u7533\u529e\u8005\u540c\u6837\u9700\u8981\u4e34\u5e8a\u6570\u636e\u6765\u652f\u6301\u5b83\u4eec\u7684\u4ea7\u54c1\u3002\u5f53\u5236\u836f\u516c\u53f8\u7684\u9500\u552e\u4ee3\u8868\u4e0e\u533b\u751f\u4eec\u8ba8\u8bba\u5176\u4ea7\u54c1\u65f6\uff0c\u8fd9\u4e9b\u6570\u636e\u5e93\u4e2d\u7684\u4fe1\u606f\u5c06\u6709\u6240\u5e2e\u52a9\u3002\u8fd9\u4e5f\u6709\u52a9\u4e8e\u5236\u836f\u516c\u53f8\u6811\u7acb\u5176\u5f62\u8c61\u3002<\/span><\/p>\n

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\u4ec0\u4e48\u662f\u5931\u8d25\u7684\u4e34\u5e8a\u8bd5\u9a8c\u5462\uff1f\u4e00\u4e2a\u5931\u8d25\u7684\u4e34\u5e8a\u8bd5\u9a8c\u662f\u6307\u5176\u672a\u80fd\u6070\u5f53\u5730\u8bc4\u4ef7\u65b0\u6cbb\u7597\u7684\u5b89\u5168\u6027\u548c\/\u6216\u7597\u6548\u3002\u4f46\u6211\u8981\u6307\u51fa\u7684\u662f\uff0c\u4e00\u9879\u4e34\u5e8a\u8bd5\u9a8c\u4e0d\u53ef\u80fd\u63ed\u793a\u65b0\u6cbb\u7597\u7684\u6240\u6709\u65b9\u9762\u3002\u5bf9\u836f\u7269\u7684\u4e86\u89e3\u5e94\u8be5\u662f\u968f\u7740\u65f6\u95f4\u7684\u63a8\u79fb\u3001\u836f\u7269\u6ce8\u518c\u4e4b\u524d\u4e34\u5e8a\u8bd5\u9a8c\u7684\u5b8c\u6210\u4ee5\u53ca\u4e0a\u5e02\u4ee5\u540e\u7684\u5e94\u7528\u624d\u9010\u6b65\u63ed\u793a\u7684\u3002\u5982\u679c\u8981\u7b49\u5230\u836f\u7269\u7684\u6240\u6709\u771f\u76f8\u90fd\u63ed\u793a\u51fa\u6765\u624d\u4e0a\u5e02\uff0c\u90a3\u4e48\u8fd9\u4e2a\u836f\u7269\u5c31\u5df2\u7ecf\u592a\u9648\u65e7\u4e86\u3002<\/span><\/p>\n

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\u6709\u4e9b\u8bd5\u9a8c\u7684\u5931\u8d25\u662f\u7531\u4e8e\u5165\u9009\u53d7\u8bd5\u8005\u975e\u5e38\u56f0\u96be\u3002\u6211\u4eec\u4ece\u539f\u5148\u7684\u8bbe\u8ba1\u4e2d\u504f\u79bb\uff0c\u5165\u9009\u4e86\u4e00\u4e9b\u4e0d\u591f\u6807\u51c6\u7684\u75c5\u4eba\u3002\u6bcf\u6b21\u6211\u4eec\u504f\u79bb\u4e86\u539f\u59cb\u7684\u5047\u8bbe\u65f6\u90fd\u4f1a\u4ea7\u751f\u5e72\u6270\uff0c\u8fd9\u5c31\u5f71\u54cd\u4e86\u6211\u4eec\u5bf9\u5dee\u5f02\u7684\u8ba4\u8bc6\u3002\u6709\u4e9b\u7814\u7a76\u8005\u6ca1\u6709\u4e25\u683c\u5730\u9075\u5faa\u8bd5\u9a8c\u65b9\u6848\u7684\u8981\u6c42\uff0c\u4e5f\u4f1a\u4ea7\u751f\u5e72\u6270\u3002\u8fd9\u4e9b\u9519\u8bef\u90fd\u4f1a\u4f7f\u5f97\u8d44\u6599\u7684\u8d28\u91cf\u8f83\u5dee\u3002<\/span><\/p>\n

\u4e34\u5e8a\u8bd5\u9a8c\u662f\u4e2a\u6e10\u8fdb\u7684\u8fc7\u7a0b\u3002\u9996\u5148\uff0c\u6211\u4eec\u8981\u5b9a\u4e49\u7814\u7a76\u7684\u76ee\u7684\u5e76\u5728\u8fd9\u4e2a\u9636\u6bb5\u4e0e\u8bb8\u591a\u4f19\u4f34\u5408\u4f5c\u3002\u6211\u4eec\u53ef\u4ee5\u548c\u53d7\u8bd5\u8005\u3001\u75c5\u4eba\u673a\u6784\u7684\u4ee3\u8868\u3001\u533b\u751f\u3001\u4fdd\u9669\u516c\u53f8\u4e00\u8d77\u6765\u786e\u5b9a\u7814\u7a76\u7684\u76ee\u7684\u3002\u4e00\u65e6\u786e\u5b9a\uff0c\u5c31\u53ef\u4ee5\u8fdb\u5165\u7814\u7a76\u7684\u8bbe\u8ba1\u9636\u6bb5\u3002\u7814\u7a76\u8ba1\u5212\u5f97\u5230\u6279\u51c6\u540e\uff0c\u6211\u4eec\u5c31\u53ef\u4ee5\u5f00\u59cb\u5165\u9009\u75c5\u4eba\u3001\u6536\u96c6\u8d44\u6599\u3002\u8fd9\u4e9b\u8d44\u6599\u7531\u8d1f\u8d23\u6570\u636e\u7ba1\u7406\u7684\u4e13\u4e1a\u4eba\u5458\u5904\u7406\uff0c\u4ed6\u4eec\u6c47\u96c6\u548c\u603b\u7ed3\u6570\u636e\uff0c\u5c06\u5176\u6574\u7406\u6210\u6570\u636e\u8868\uff0c\u540e\u8005\u662f\u63d0\u4ea4\u7ed9\u5236\u836f\u516c\u53f8\u7684\u7814\u7a76\u62a5\u544a\u7684\u57fa\u7840\u548c\u6838\u5fc3\u3002\u8fd9\u4e9b\u7ed9\u5236\u836f\u516c\u53f8\u7684\u62a5\u544a\u662f\u5185\u90e8\u62a5\u544a\uff0c\u5b83\u4eec\u53ef\u4ee5\u4e0e\u53c2\u52a0\u4e34\u5e8a\u8bd5\u9a8c\u7684\u7814\u7a76\u8005\u4e00\u8d77\u5206\u4eab\uff0c\u7136\u540e\u53ef\u4ee5\u53d1\u8868\u3002\u6211\u8981\u6307\u51fa\u7684\u662f\uff0c\u5728\u53d1\u8868\u6587\u7ae0\u4e0a\u6709\u65f6\u6709\u4e00\u70b9\u5206\u6b67\uff0c\u7814\u7a76\u8005\u603b\u662f\u5e0c\u671b\u5c3d\u5feb\u5730\u53d1\u8868\uff0c\u800c\u5236\u836f\u516c\u53f8\u603b\u662f\u5e0c\u671b\u6682\u7f13\u53d1\u8868\uff0c\u5c24\u5176\u662f\u90a3\u4e9b\u8fd8\u6ca1\u6709\u4e0a\u5e02\u7684\u836f\u7269\u3002\u8fc7\u65e9\u5730\u53d1\u8868\u8fd9\u4e9b\u7ed3\u679c\u53ef\u80fd\u5bf9\u6211\u4eec\u7684\u7ade\u4e89\u5bf9\u624b\u6709\u5229\u3002<\/span><\/p>\n

\u505a\u7814\u7a76\u8ba1\u5212\u7684\u8981\u70b9\u5217\u5728\u672c\u5f20\u5e7b\u706f\u4e2d\u3002\u76ee\u7684\u8981\u660e\u786e\u3001\u5e76\u5c3d\u53ef\u80fd\u7684\u4e25\u5bc6\u3002\u8d44\u6599\u6536\u96c6\u7684\u6807\u51c6\u8981\u6e05\u695a\uff0c\u6bcf\u4e2a\u6b65\u9aa4\u90fd\u8981\u6709\u8d28\u91cf\u76d1\u67e5\u3002\u524d\u4e00\u5f20\u5e7b\u706f\u4ecb\u7ecd\u4e86\u4e34\u5e8a\u8bd5\u9a8c\u7684\u8fde\u7eed\u8fc7\u7a0b\uff0c\u5728\u6bcf\u4e2a\u6b65\u9aa4\u7ed3\u675f\u65f6\uff0c\u8d44\u6599\u90fd\u5e94\u8be5\u4ece\u7814\u7a76\u8005\u5230\u76d1\u67e5\u5458\u3001\u4ece\u76d1\u67e5\u5458\u5230\u6570\u636e\u7ba1\u7406\u5458\uff0c\u4ece\u6570\u636e\u7ba1\u7406\u5458\u5230\u7edf\u8ba1\u5b66\u5bb6\uff0c\u4ece\u7edf\u8ba1\u5b66\u5bb6\u5230\u62a5\u544a\u4e66\u5199\u8005\u8fd9\u6837\u4e00\u4e2a\u8fc7\u7a0b\u3002\u6bcf\u4e2a\u6b65\u9aa4\u90fd\u5e94\u6709\u8d28\u91cf\u63a7\u5236\u7684\u8981\u6c42\uff0c\u800c\u4e14\u5f88\u91cd\u8981\u7684\u662f\uff0c\u8981\u4e8b\u5148\u660e\u786e\u8fd9\u4e9b\u8981\u6c42\u3002<\/span><\/p>\n

\u8d44\u6e90\u7684\u5206\u914d\u662f\u975e\u5e38\u91cd\u8981\u7684\u3002\u5728\u6ca1\u6709\u8db3\u591f\u8d44\u6e90\u7684\u60c5\u51b5\u4e0b\u5c31\u5f00\u59cb\u4e00\u9879\u4e34\u5e8a\u8bd5\u9a8c\u662f\u4e0d\u9053\u5fb7\u7684\uff0c\u662f\u6d6a\u8d39\u65f6\u95f4\u3002\u53d7\u8bd5\u8005\u63a5\u53d7\u7684\u662f\u4e00\u79cd\u65b0\u7684\u836f\u7269\uff0c\u53ef\u80fd\u4f1a\u6709\u5b89\u5168\u6027\u7684\u95ee\u9898\uff0c\u800c\u6574\u4e2a\u793e\u4f1a\u4e5f\u6ca1\u6709\u4ece\u8bd5\u9a8c\u4e2d\u53d7\u76ca\u3002<\/span><\/p>\n

\u53c2\u52a0\u8bd5\u9a8c\u7684\u4eba\u5458\u5f88\u591a\uff0c\u786e\u5b9a\u6bcf\u4e2a\u4eba\u7684\u804c\u8d23\u662f\u975e\u5e38\u91cd\u8981\u7684\u3002\u6211\u5f88\u559c\u6b22\u8fd9\u4e2a\u7cfb\u7edf\uff0c\u8fd9\u662f\u4ece\u6ce2\u58eb\u987f\u7684\u4e00\u4e2a\u54a8\u8be2\u516c\u53f8\u501f\u9274\u6765\u7684\uff0c\u5c06\u6240\u6709\u7684\u53c2\u52a0\u8005\u5206\u6210\u56db\u5927\u7c7b\u3002\u4e00\u7c7b\u662f\u8d1f\u8d23\u5f00\u59cb\u548c\u7ed3\u675f\u5de5\u4f5c\u7684\u4eba\u5458\uff0c\u4e00\u7c7b\u662f\u6709\u6743\u5206\u914d\u4efb\u52a1\u548c\u7ecf\u8d39\u7684\u4eba\u5458\uff0c\u53e6\u4e00\u7c7b\u662f\u6709\u8d23\u4efb\u652f\u6301\u3001\u57f9\u8bad\u3001\u6559\u80b2\u6216\u63d0\u4f9b\u6750\u6599\u7684\u4eba\u5458\u3002\u6700\u540e\u4e00\u7c7b\u662f\u6709\u6743\u5229\u5728\u5f97\u5230\u67d0\u4e9b\u901a\u77e5\u65f6\u80fd\u505a\u51fa\u53ca\u65f6\u53cd\u5e94\u7684\u4eba\u5458\u3002\u5728\u5236\u836f\u516c\u53f8\u4e2d\u6709\u5f88\u591a\u8fd9\u6837\u7684\u4eba\u5458\u3002\u786e\u5b9a\u5404\u81ea\u7684\u8d23\u4efb\u6709\u52a9\u4e8e\u7814\u7a76\u8ba1\u5212\u7684\u786e\u5b9a\u53ca\u5b9e\u65bd\u3002<\/span><\/p>\n

\u8fd9\u662f\u7b2c\u4e00\u90e8\u5206\uff0c\u7b2c\u4e8c\u90e8\u5206\u5c06\u8c08\u5230\u8bd5\u9a8c\u65b9\u6848\u7684\u7ec6\u8282\u3002<\/span><\/p>\n


<\/span><\/strong><\/p>\n

\u8bd5\u9a8c\u65b9\u6848\uff1a\u4e34\u5e8a\u7814\u7a76\u7684\u5de5\u5177\uff082\uff09<\/span><\/strong><\/p>\n

Dr. Pierre Etienne<\/span><\/strong><\/p>\n

\u8fd9\u662f\u4e34\u5e8a\u8bd5\u9a8c\u65b9\u6848\u4f5c\u4e3a\u4e34\u5e8a\u7814\u7a76\u5de5\u5177\u7684\u7b2c\u4e8c\u90e8\u5206\u3002\u4e0b\u9762\u8be6\u7ec6\u4ecb\u7ecd\u8bd5\u9a8c\u65b9\u6848\u7684\u8981\u6c42\u548c\u683c\u5f0f\u3002<\/span><\/p>\n

\u5728\u6211\u4eec\u8981\u505a\u7684\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\uff0c\u8bd5\u9a8c\u65b9\u6848\u662f\u5236\u836f\u516c\u53f8\u7533\u529e\u8005\u548c\u5176\u4ed6\u8bb8\u591a\u516c\u53f8\u4ee5\u5916\u7684\u4e13\u5bb6\u5171\u540c\u5546\u8ba8\u786e\u5b9a\u7684\uff1a\u533b\u751f\uff0c\u75c5\u4eba\u7684\u652f\u6301\u8005\u4ee5\u53ca\u5b66\u672f\u673a\u6784\u3002\u7533\u529e\u8005\u5c06\u8d44\u6599\u6536\u96c6\u5728\u4e00\u8d77\u6210\u4e3a\u65b9\u6848\uff0c\u9610\u8ff0\u4e3a\u4ec0\u4e48\u8981\u8fdb\u884c\u8bd5\u9a8c\u3001\u8bd5\u9a8c\u7684\u76ee\u7684\u4ee5\u53ca\u600e\u6837\u8fdb\u884c\u8bd5\u9a8c\u3002\u8bd5\u9a8c\u65b9\u6848\u8981\u63cf\u8ff0\u7814\u7a76\u7684\u8fc7\u7a0b\u4ee5\u53ca\u6d4b\u91cf\u65b9\u6cd5\u4ee5\u8bc4\u4ef7\u836f\u7269\u7684\u7597\u6548\u53ca\u5b89\u5168\u6027\uff0c\u9700\u8981\u8fdb\u884c\u7684\u6cbb\u7597\uff0c\u5bf9\u7167\u6cbb\u7597\u548c\u62df\u7814\u7a76\u7684\u65b0\u6cbb\u7597\u3002\u6709\u5173\u7684\u6cd5\u89c4\u8981\u6c42\u4e5f\u5e94\u8be5\u5305\u62ec\u5728\u5185\uff1a\u4e00\u822c\u7684\u6cd5\u89c4\u8981\u6c42\uff0c\u8fd8\u6709\u67d0\u4e9b\u56fd\u5bb6\u7279\u6b8a\u7684\u6cd5\u89c4\u8981\u6c42,\u540e\u8005\u6709\u65f6\u53ef\u80fd\u66f4\u4e25\u683c\u3002<\/span><\/p>\n

\u4e00\u4e9b\u9700\u8981\u8003\u8651\u7684\u91cd\u70b9\uff1a\u7814\u7a76\u8005\u6709\u8d23\u4efb\u5b8c\u5168\u4f9d\u4ece\u8bd5\u9a8c\u65b9\u6848\u3002\u4e5f\u5c31\u662f\u8bf4\uff0c\u4efb\u4f55\u504f\u79bb\u8bd5\u9a8c\u65b9\u6848\u7684\u505a\u6cd5\u90fd\u88ab\u8ba4\u4e3a\u662f\u4e0d\u4f9d\u4ece\u3002\u6216\u8005\u8bf4\uff0c\u7814\u7a76\u8005\u5728\u6ca1\u6709\u901a\u77e5\u7533\u529e\u8005\u548c\u4f26\u7406\u59d4\u5458\u4f1a\u4e4b\u524d\u4e0d\u80fd\u5bf9\u8bd5\u9a8c\u65b9\u6848\u505a\u4efb\u4f55\u6539\u52a8\u3002\u552f\u4e00\u7684\u4f8b\u5916\u662f\u5728\u5fc5\u987b\u4fdd\u62a4\u53d7\u8bd5\u8005\u7684\u6743\u5229\u548c\u5b89\u5168\u6027\u65f6\u3002\u4e0b\u9762\u6211\u8fd8\u4f1a\u8be6\u7ec6\u9610\u8ff0\u8fd9\u70b9\u3002\u5982\u679c\u6709\u4efb\u4f55\u53d8\u52a8\uff0c\u5e94\u8be5\u5411\u7533\u529e\u8005\u3001\u4f26\u7406\u59d4\u5458\u4f1a\u5c3d\u5feb\u5730\u63d0\u4ea4\u8be6\u7ec6\u7684\u62a5\u544a\u3002<\/span><\/p>\n

ICH GCP\u5217\u51fa\u4e86\u8bd5\u9a8c\u65b9\u6848\u7b26\u5408GCP\u7684\u76f8\u5173\u8981\u6c42\uff0c\u5927\u90e8\u5206\u90fd\u662f\u663e\u800c\u6613\u89c1\u7684\u3002\u8bd5\u9a8c\u65b9\u6848\u8981\u6709\u4e00\u4e2a\u9996\u9875\uff0c\u5199\u4e0a\u7814\u7a76\u7684\u9898\u76ee\u548c\u65e5\u671f\uff08\u8fd9\u70b9\u975e\u5e38\u91cd\u8981\uff0c\u56e0\u4e3a\u8bd5\u9a8c\u65b9\u6848\u53ef\u80fd\u4f1a\u6709\u8bb8\u591a\u7248\u672c\uff09\uff0c\u9996\u9875\u8fd8\u5e94\u8be5\u5305\u62ec\u5236\u836f\u516c\u53f8\uff08\u7533\u529e\u8005\uff09\u7684\u540d\u79f0\u548c\u5730\u5740\uff0c\u8d1f\u8d23\u8bd5\u9a8c\u76d1\u67e5\u673a\u6784\u7684\u540d\u79f0\u548c\u5730\u5740\uff08\u5c24\u5176\u662f\u5f53\u76d1\u67e5\u5458\u6240\u5c5e\u7684\u673a\u6784\u4e0d\u662f\u7533\u529e\u8005\u65f6\uff0c\u5982\u7533\u529e\u8005\u4e0e\u5408\u540c\u7814\u7a76\u7ec4\u7ec7\uff08CRO\uff09\u7b7e\u7f72\u5408\u59d4\u6258\u5176\u8fdb\u884c\u76d1\u67e5\uff09\u3002\u5728\u9996\u9875\u4e0a\u8fd8\u9700\u8981\u6709\u4e34\u5e8a\u5b9e\u9a8c\u5ba4\u7684\u540d\u79f0\u548c\u5730\u5740\uff0c\u4ee5\u53ca\u7814\u7a76\u8005\u4ee5\u53ca\u5171\u540c\u7814\u7a76\u8005\u7684\u59d3\u540d\u4ee5\u53ca\u804c\u79f0\u3002\u6700\u540e\uff0c\u8fd8\u6709\u4e00\u4e2a\u4fdd\u5bc6\u58f0\u660e\uff0c\u63d0\u9192\u8bd5\u9a8c\u65b9\u6848\u7684\u4f7f\u7528\u8005\uff0c\u8bd5\u9a8c\u65b9\u6848\u7684\u77e5\u8bc6\u4ea7\u6743\u5f52\u7533\u529e\u8005\u6240\u6709\uff0c\u4e0d\u80fd\u968f\u610f\u5730\u900f\u9732\u7ed9\u4efb\u4f55\u672a\u4e0e\u7533\u529e\u8005\u7b7e\u7f72\u8fc7\u5408\u540c\u7684\u4eba\u5458\u3002<\/span><\/p>\n

ICH-GCP\u5bf9\u8bd5\u9a8c\u65b9\u6848\u7684\u8981\u6c42\u662f\u4ec0\u4e48\u5462?\u8c61\u5927\u5bb6\u6240\u4e86\u89e3\u7684\u90a3\u6837\uff0c\u8bd5\u9a8c\u65b9\u6848\u5e94\u8be5\u6709\u5165\u9009\u548c\u6392\u9664\u6807\u51c6\uff0c\u5e94\u8be5\u6709\u5b89\u5168\u6027\u76d1\u6d4b\u7684\u7279\u5f02\u6027\u63cf\u8ff0\u4ee5\u8bc4\u4ef7\u836f\u7269\u7684\u5b89\u5168\u6027\u548c\u8010\u53d7\u6027\u3002\u5bf9\u7597\u6548\u7684\u7ec8\u70b9\u6216\u8005\u7597\u6548\u6307\u6807\u5e94\u8be5\u6709\u51c6\u786e\u7684\u63cf\u8ff0\uff0c\u5305\u62ec\u8bc4\u4ef7\u7684\u65b9\u6cd5\u548c\u65f6\u95f4\u3002\u5bf9\u7edf\u8ba1\u5b66\u65b9\u6cd5\u4e5f\u5e94\u8be5\u6709\u8be6\u7ec6\u7684\u63cf\u8ff0\uff0c\u4f8b\u5982\u662f\u5426\u6709\u4e2d\u671f\u5206\u6790\u3002<\/span><\/p>\n

\u5b89\u5168\u6027\u62a5\u544a\u4ee5\u53ca\u5b89\u5168\u6027\u62a5\u544a\u7684\u8054\u7cfb\u65b9\u5f0f\u5e94\u8be5\u5728\u8bd5\u9a8c\u65b9\u6848\u4e2d\u8be6\u7ec6\u63cf\u8ff0\u3002\u4e34\u5e8a\u5b9e\u9a8c\u5ba4\u7684\u6307\u6807\u4e5f\u5e94\u8be5\u8be6\u7ec6\u63cf\u8ff0\u3002\u5e76\u5e94\u8be5\u8be6\u7ec6\u8bf4\u660e\u4ec0\u4e48\u662f\u5141\u8bb8\u7684\u3001\u4ec0\u4e48\u662f\u4e0d\u5141\u8bb8\u7684\u5408\u5e76\u7528\u836f\uff0c\u5e94\u8be5\u6709\u9644\u52a0\u7684\u4fe1\u606f\u4e3a\u7814\u7a76\u8005\u63d0\u4f9b\u5e2e\u52a9\u3002\u4f8b\u5982\uff0c\u5bf9\u4e8e\u7279\u5b9a\u7684\u75be\u75c5\u7684\u8bca\u65ad\u6807\u51c6\u6216\u4e00\u4e2a\u6d41\u7a0b\u56fe\u3002\u8fd8\u5e94\u8be5\u63d0\u9192\u7814\u7a76\u8005\u6309\u7167\u8fd0\u8f93\u90e8\u95e8\u7684\u6709\u5173\u89c4\u5b9a\u5904\u7406\u6709\u5bb3\u7269\u8d28\u3002\u8fd9\u662f\u7814\u7a76\u8005\u5e94\u8be5\u8d1f\u8d23\u7684\u90e8\u5206\u3002<\/span><\/p>\n

\u6211\u4eec\u7684\u8d23\u4efb\u662f\u4fdd\u8bc1\u4ed6\u4eec\u719f\u6089\u76f8\u5173\u7684\u6cd5\u89c4\uff0c\u5982\u679c\u4ed6\u4eec\u4e0d\u4e86\u89e3\u76f8\u5173\u89c4\u5b9a\u65f6\u5e94\u63d0\u4f9b\u76f8\u5e94\u7684\u57f9\u8bad\u4fe1\u606f\u3002\u7814\u7a76\u8005\u548c\u53d7\u8bd5\u8005\u5e94\u8be5\u6709\u9014\u5f84\u53ef24\u5c0f\u65f6\u76f4\u63a5\u8054\u7cfb\u5230\u7533\u529e\u8005\u3002\u5e94\u63d0\u4f9b\u7535\u8bdd\u53f7\u7801\u3002\u7406\u60f3\u7684\u662f\uff0c\u4f7f\u7528\u4e00\u4e2a\u7535\u8bdd\u53f7\u7801\u4ee5\u7b80\u5316\u63a5\u53d7\u6765\u81ea\u5404\u65b9\u7684\u7535\u8bdd\u3002\u4ee3\u8868\u5236\u836f\u516c\u53f8\u8d1f\u8d23\u63a5\u6765\u7535\u7684\u7ec4\u7ec7\u6216\u56e2\u4f53\uff0c\u5bf9\u5176\u5e94\u6709\u63cf\u8ff0\u3002\u6709\u5173\u4f26\u7406\u5b66\u7684\u7ae0\u8282\u4e5f\u5e94\u5217\u5728\u8fd9\u91cc\u3002<\/span><\/p>\n

\u7814\u7a76\u8005\u548c\u7533\u529e\u8005\u6709\u5173\u8d44\u91d1\u7684\u5408\u540c\u5e94\u4f5c\u63cf\u8ff0\uff0c\u8fd9\u5bf9\u7814\u7a76\u8005\u6240\u5728\u7684\u673a\u6784\u800c\u8a00\u5e94\u8be5\u662f\u900f\u660e\u7684\u3002\u5bf9\u4f26\u7406\u59d4\u5458\u4f1a\u4e5f\u5e94\u8be5\u662f\u900f\u660e\u7684\u3002\u5728\u8bd5\u9a8c\u65b9\u6848\u4e2d\u5e94\u8be5\u6709\u4fdd\u9669\u7684\u58f0\u660e\u3002\u8fd8\u5e94\u8be5\u6709\u5173\u4e8e\u6587\u7ae0\u53d1\u8868\u89c4\u5219\u7684\u58f0\u660e\uff1a\u4ec0\u4e48\u65f6\u5019\u7814\u7a76\u8005\u53ef\u4ee5\u62ff\u5230\u7814\u7a76\u6570\u636e\uff1b\u7814\u7a76\u5e94\u8be5\u53d1\u8868\u5728\u4ec0\u4e48\u7c7b\u578b\u7684\u6742\u5fd7\u4e0a\uff1b\u8c01\u5c06\u662f\u4f5c\u8005\u3002<\/span><\/p>\n

ICH<\/span>\u5bf9\u4e8e\u8bd5\u9a8c\u65b9\u6848\u7684\u5f62\u5f0f\u6709\u6b63\u89c4\u7684\u63cf\u8ff0\u3002\u8bd5\u9a8c\u65b9\u6848\u7684\u5404\u4e2a\u7ae0\u8282\u5e94\u5982\u4ee5\u4e0b\uff0c\u8fd9\u4e9b\u662f<\/span>ICH<\/span>\u7684\u89c4\u5b9a\u3002\u5e94\u5305\u62ec\uff1a<\/span><\/span><\/p>\n

    \n
  1. \n

    \u63cf\u8ff0\u7814\u7a76\u7684\u7c7b\u578b\u548c\u8bbe\u8ba1\u3001\u662f\u5426\u4e3a\u53cc\u76f2\u3001\u5355\u76f2\u4ee5\u53ca\u5242\u91cf\u6548\u5e94\u7684\u7ae0\u8282\u3002\u4f8b\u5982\uff0c<\/span><\/p>\n<\/li>\n

  2. \n

    \u63cf\u8ff0\u4e3b\u8981\u7814\u7a76\u7ec8\u70b9\u4ee5\u53ca\u6b21\u8981\u6216\u63a2\u7d22\u7814\u7a76\u7ec8\u70b9\u7684\u7ae0\u8282\u3002<\/span><\/p>\n<\/li>\n

  3. \n

    \u63cf\u8ff0\u6cbb\u7597\u7684\u5206\u914d\u65b9\u6cd5\u3001\u968f\u673a\u65b9\u6cd5\u4ee5\u53ca\u9632\u6b62\u7814\u7a76\u8005\u3001\u53d7\u8bd5\u8005\u6216\u8005\u7533\u529e\u8005\u51b3\u5b9a\u8c01\u4f7f\u7528\u65b0\u836f\u3001\u8c01\u4f7f\u7528\u5bf9\u7167\u836f\u7269\u65b9\u6cd5\u7684\u7ae0\u8282\u3002<\/span><\/p>\n<\/li>\n

  4. \n

    \u63cf\u8ff0\u6cbb\u7597\u3001\u7ed9\u836f\u7684\u65b9\u6848\u3001\u5242\u578b\u3001\u836f\u7269\u5305\u88c5\u65b9\u5f0f\u4ee5\u53ca\u6807\u7b7e\u7684\u7ae0\u8282\u3002<\/span><\/p>\n<\/li>\n

  5. \n

    \u5173\u4e8e\u53d7\u8bd5\u8005\u53c2\u52a0\u65f6\u95f4\u7684\u7ae0\u8282<\/span><\/p>\n<\/li>\n

  6. \n

    \u5173\u4e8e\u53d7\u8bd5\u8005\u5728\u4e0d\u80fd\u8010\u53d7\u548c\u5e0c\u671b\u9000\u51fa\u7814\u7a76\u65f6\u7ec8\u6b62\u7814\u7a76\u7684\u6807\u51c6\uff0c\u4ee5\u53ca\u5982\u4f55\u5904\u7406\u76f8\u5173\u8d44\u6599\u7684\u7ae0\u8282\u3002<\/span><\/p>\n<\/li>\n

  7. \n

    \u65b9\u6cd5\u5b66\u7684\u7ae0\u8282\uff0c\u63cf\u8ff0\u4ec0\u4e48\u65f6\u5019\u5e94\u8be5\u9000\u51fa\u8bd5\u9a8c\uff0c\u8fd9\u901a\u5e38\u662f\u5728\u51fa\u73b0\u67d0\u73b0\u5b89\u5168\u6027\u4fe1\u53f7\u65f6\u3002<\/span><\/p>\n<\/li>\n

  8. \n

    \u63cf\u8ff0\u7533\u529e\u8005\u600e\u6837\u76d1\u67e5\u7814\u7a76\u4e2d\u5fc3\u7684\u7ae0\u8282\uff0c\u6709\u4e9b\u7814\u7a76\u9700\u8981\u76d1\u67e5\u7684\u6b21\u6570\u5c11\uff0c\u800c\u53e6\u4e00\u4e9b\u5219\u8f83\u591a\uff0c\uff0d\u8fd9\u4e9b\u90fd\u5e94\u8fdb\u884c\u660e\u786e\u7684\u63cf\u8ff0\u3002<\/span><\/p>\n<\/li>\n

  9. \n

    \u5173\u4e8e\u5982\u4f55\u76d1\u7763\u53d7\u8bd5\u8005\u4f9d\u4ece\u6027\u7684\u7ae0\u8282\u3002<\/span><\/p>\n<\/li>\n<\/ol>\n

    <\/span><\/p>\n

    <\/span><\/p>\n

    <\/span><\/p>\n

    <\/span><\/p>\n

    \u53d7\u8bd5\u8005\u5e94\u670d\u7528\u836f\u7269\u5e76\u6309\u7167\u65b9\u6848\u4e2d\u7684\u65b9\u6cd5\u670d\u4ece\u6cbb\u7597\u3002\u5728\u4e34\u5e8a\u5b9e\u8df5\u4e2d\uff0c\u75c5\u4eba\u5e76\u4e0d\u80fd\u5b8c\u5168\u4f9d\u4ece\u533b\u5631\uff0c\u6240\u4ee5\u6ca1\u6709\u7406\u7531\u8ba4\u4e3a\u53c2\u52a0\u8fd9\u9879\u7814\u7a76\u7684\u53d7\u8bd5\u8005\u7684\u4f9d\u4ece\u6027\u4f1a\u66f4\u597d\u3002\u6211\u4eec\u9700\u8981\u4e00\u5b9a\u7684\u65b9\u6cd5\u6765\u76d1\u7763\u4f9d\u4ece\u6027\u3002<\/span><\/p>\n

    \u6570\u836f\u7247\u6709\u4e00\u5b9a\u7684\u5e2e\u52a9\u3002\u6211\u4eec\u53ef\u4ee5\u8ba1\u7b97\u5728\u4e24\u6b21\u968f\u8bbf\u4e4b\u95f4\u60a3\u8005\u670d\u7528\u4e86\u591a\u5c11\u836f\u7269\u3002\u5176\u4ed6\u7684\u65b9\u6cd5\uff0c\u5982\u5e94\u7528\u836f\u4ee3\u52a8\u529b\u5b66\u7684\u65b9\u6cd5\u3001\u6d4b\u5b9a\u8840\u6d46\u4ee5\u786e\u5b9a\u5bf9\u836f\u7269\u7684\u66b4\u9732\u91cf\u3002\u8fd8\u6709\u4e9b\u65b9\u6cd5\u53ef\u4ee5\u68c0\u6d4b\u60a3\u8005\u6253\u5f00\u836f\u74f6\u7684\u6b21\u6570\u3002\u7136\u800c\uff0c\u91cd\u8981\u7684\u662f\uff0c\u8981\u5bf9\u8fd9\u4e9b\u8fc7\u7a0b\u4e8b\u5148\u8fdb\u884c\u8be6\u7ec6\u7684\u63cf\u8ff0\u3002<\/span><\/p>\n

    \u8fd8\u5e94\u8be5\u4e8b\u5148\u63cf\u8ff0\u5f53\u7533\u529e\u8005\u548c\u7ba1\u7406\u673a\u6784\u6d3e\u51fa\u7684\u7a3d\u67e5\u5458\u5230\u7814\u7a76\u4e2d\u5fc3\u7a3d\u67e5\u65f6\u7814\u7a76\u8005\u8981\u505a\u4ec0\u4e48\u5de5\u4f5c\u3002\u8fd9\u4e9b\u90fd\u5e94\u8be5\u4e8b\u5148\u8fdb\u884c\u63cf\u8ff0\u3002<\/span><\/p>\n

    \u8bd5\u9a8c\u4f1a\u4ea7\u751f\u5927\u91cf\u7684\u6570\u636e\uff0c\u5927\u91cf\u7684\u6587\u5b57\u5de5\u4f5c\uff0c\u5927\u91cf\u7684\u6587\u4ef6\u3002\u6709\u4e9b\u9700\u8981\u4fdd\u5b58\u5f88\u957f\u7684\u65f6\u95f4\uff08\u8fd9\u5728\u6cd5\u89c4\u8981\u6c42\u4e2d\u6709\u63cf\u8ff0\uff09\u3002\u5728\u8bd5\u9a8c\u65b9\u6848\u4e2d\u5e94\u8be5\u63cf\u8ff0\u4ec0\u4e48\u9700\u8981\u957f\u671f\u4fdd\u5b58\uff0c\u4ec0\u4e48\u53ef\u4ee5\u51cf\u5c11\u4fdd\u5b58\u65f6\u95f4\u3002<\/span><\/p>\n

    \u6700\u540e\uff0c\u5bf9\u4e8e\u7814\u7a76\u8005\u548c\u7533\u529e\u8005\u4e4b\u95f4\u7684\u5408\u540c\u5e94\u8be5\u8bb0\u5f55\uff0c\u5373\u6240\u8c13\u7684\u7814\u7a76\u8005\u9875\u6216\u7b7e\u7f72\u9875\u3002\u8fd9\u5c06\u7814\u7a76\u8005\u548c\u7533\u529e\u8005\u8054\u7cfb\u8d77\u6765\u4e86\u3002\u5408\u540c\u89c4\u5b9a\u7814\u7a76\u8005\u5e94\u8be5\u4f9d\u636e\u7533\u529e\u8005\u548c\u4f26\u7406\u59d4\u5458\u4f1a\u6279\u51c6\u7684\u8bd5\u9a8c\u65b9\u6848\u8fdb\u884c\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u7814\u7a76\u8005\u4e0d\u80fd\u5728\u6ca1\u6709\u7533\u529e\u8005\u540c\u610f\u7684\u60c5\u51b5\u4e0b\u504f\u79bb\u8bd5\u9a8c\u65b9\u6848\uff0c\u9664\u975e\u662f\u5728\u7d27\u6025\u60c5\u51b5\u4e0b\u4e3a\u4e86\u907f\u514d\u53d7\u8bd5\u8005\u53d7\u5230\u635f\u5bb3\u3002\u4e0b\u9762\u5c06\u8bb2\u5230\u8fd9\u4e00\u70b9\u3002<\/span><\/p>\n

    \u67d0\u4e9b\u60c5\u51b5\u4e0b\u7814\u7a76\u8005\u4f1a\u89c9\u5f97\u4ed6\u4e0d\u5f97\u4e0d\u504f\u79bb\u8bd5\u9a8c\u65b9\u6848\uff0c\u4f8b\u5982\uff0c\u5fc5\u987b\u8981\u4e2d\u65ad\u7814\u7a76\u56e0\u4e3a\u7814\u7a76\u8005\u9ad8\u5ea6\u6000\u7591\u65b0\u7684\u6cbb\u7597\u5bf9\u53d7\u8bd5\u8005\uff0c\u53ef\u80fd\u662f\u67d0\u4e2a\u7279\u6b8a\u7684\u4e2a\u4f53\u6216\u662f\u53d7\u8bd5\u8005\u6574\u4f53\uff0c\u662f\u5371\u9669\u7684\u3002\u5728\u8fd9\u79cd\u60c5\u51b5\u4e0b\uff0c\u7814\u7a76\u8005\u6ca1\u6709\u522b\u7684\u9009\u62e9\uff0c\u53ea\u80fd\u8fdb\u884c\u8fd9\u79cd\u6539\u53d8\uff0c\u8bb0\u5f55\u4e0b\u539f\u56e0\uff0c\u901a\u77e5\u7533\u529e\u8005\u4ee5\u5f97\u5230\u5176\u540c\u610f\uff0c\u901a\u77e5\u4f26\u7406\u59d4\u5458\u4f1a\u4ee5\u5f97\u5230\u5176\u6279\u51c6\u3002\u8fd9\u79cd\u60c5\u51b5\u5f88\u5c11\u53d1\u751f\uff0c\u5f53\u5e94\u5141\u8bb8\u8fd9\u79cd\u60c5\u51b5\u7684\u53d1\u751f\u3002<\/span><\/p>\n

    \u603b\u7684\u8bf4\u6765\uff0c\u4e34\u5e8a\u8bd5\u9a8c\u65b9\u6848\u8bb0\u5f55\u4e86\u8bd5\u9a8c\u7684\u6240\u6709\u8981\u6c42\uff0c\u5fc5\u987b\u5f97\u5230\u4f26\u7406\u59d4\u5458\u4f1a\u7684\u6279\u51c6\u3002\u504f\u79bb\u8bd5\u9a8c\u65b9\u6848\u5fc5\u987b\u8981\u6709\u7814\u7a76\u8005\u548c\u7533\u529e\u8005\u7684\u540c\u610f\u548c\u76f8\u5173\u7684\u8bb0\u5f55\u5e76\u63d0\u4ea4\u7ed9\u4f26\u7406\u59d4\u5458\u4f1a\u6279\u51c6\uff0c\u5fc5\u987b\u4e25\u683c\u5730\u9075\u5faa\u8fd9\u4e9b\u89c4\u5b9a\u3002\u5982\u679c\u8fd9\u4e9b\u6761\u4ef6\u90fd\u5f97\u5230\u4e86\u6ee1\u8db3\uff0c\u90a3\u4e48\u8f83\u5bb9\u6613\u8fbe\u5230\u7814\u7a76\u7684\u79d1\u5b66\u548c\u5546\u4e1a\u76ee\u7684\uff1b\u6709\u9ad8\u8d28\u91cf\u7684\u8ba1\u5212\uff1b\u53ef\u4ee5\u5728\u8f83\u597d\u7684\u6742\u5fd7\u4e0a\u53d1\u8868\u9ad8\u8d28\u91cf\u7684\u6587\u7ae0\u5e76\u80fd\u5728\u9884\u7b97\u5185\u5b8c\u6210\u4efb\u52a1\u3002\u8fd9\u5bf9\u4e8e\u5236\u836f\u516c\u53f8\u548c\u7814\u7a76\u8005\u800c\u8a00\u90fd\u975e\u5e38\u91cd\u8981\u3002\u5982\u679c\u8fd9\u4e9b\u6761\u4ef6\u90fd\u5f97\u5230\u4e86\u6ee1\u8db3\uff0c\u5c31\u662f\u4e00\u4e2a<\/span>\u201c<\/span>\u53cc\u8d62<\/span>\u201d<\/span>\u7684\u5c40\u9762\uff0c\u4e5f\u662f\u4e34\u5e8a\u8bd5\u9a8c\u7684\u6700\u5927\u76ca\u5904\u3002\u7814\u7a76\u8005\u662f\u8d62\u5bb6\uff0c\u7533\u529e\u8005\u662f\u8d62\u5bb6\uff0c\u53c2\u52a0\u8005\u4e5f\u662f\u8d62\u5bb6\u3002<\/span><\/span><\/p>\n

    \u8c22\u8c22\u3002<\/span><\/p>\n


    <\/p>\n

    \u7b2c\u5341\u4e8c\u8bb2 <\/span><\/strong>\u8bd5\u9a8c\u6587\u4ef6<\/span><\/strong><\/p>\n

    Ms. Lillian Marinovich<\/span><\/strong> <\/span><\/p>\n

    \u5927\u5bb6\u597d\uff0c\u6211\u662fLillianMarinovich\uff0c\u6765\u81ea\u8f89\u745e\u5168\u7403\u7814\u7a76\u548c\u5f00\u53d1\u90e8\u3002\u6211\u8d1f\u8d23\u4e34\u5e8a\u7814\u7a76\u548c\u76d1\u67e5\u7684\u5168\u7403\u8d28\u91cf\u63a7\u5236\u3002\u4eca\u5929\u7684\u8bfe\u7a0b\u4e3b\u8981\u6ce8\u91cd\u4e8e\u4e34\u5e8a\u8bd5\u9a8c\u7684\u6587\u4ef6\u8bb0\u5f55\u3002\u6211\u4eec\u5c06\u8ba8\u8bba\u4e34\u5e8a\u8bd5\u9a8c\u8fdb\u884c\u4e2d\u975e\u5e38\u91cd\u8981\u7684\u4e00\u4e2a\u65b9\u9762\uff1a\u4e0e\u7814\u7a76\u7684\u6279\u51c6\u3001\u8fdb\u884c\u4ee5\u53ca\u8d44\u6599\u7684\u6536\u96c6\u5bc6\u5207\u76f8\u5173\u7684\u6587\u4ef6\u7684\u6536\u96c6\u3001\u4fdd\u5b58\u548c\u5904\u7406\u7684\u6cd5\u89c4\u8981\u6c42\u3002<\/span><\/p>\n

    ICH GCP\u5728\u7b2c8\u8282\u5bf9\u4e8e\u91cd\u8981\u6587\u4ef6\u6709\u975e\u5e38\u660e\u786e\u7684\u5b9a\u4e49\u3002\u91cd\u8981\u6587\u4ef6\u662f\u90a3\u4e9b\u53ef\u4ee5\u4e2a\u522b\u6216\u96c6\u4e2d\u5728\u4e00\u8d77\u8bc4\u4ef7\u8bd5\u9a8c\u7684\u8fdb\u884c\u8fc7\u7a0b\u4ee5\u53ca\u6570\u636e\u8d28\u91cf\u7684\u6587\u4ef6\u3002\u5b83\u4e5f\u8bf4\u660e\u4e86\uff0c\u5728\u8bd5\u9a8c\u5f00\u59cb\u4e4b\u524d\u5fc5\u987b\u7531\u7533\u529e\u8005\u548c\u7814\u7a76\u8005\u5206\u522b\u5efa\u7acb\u8bd5\u9a8c\u603b\u6587\u4ef6\u5939\uff08TMF\uff09\uff0c\u5728\u6574\u4e2a\u8bd5\u9a8c\u8fc7\u7a0b\u4e2d\uff0c\u8fd9\u4e2a\u6587\u4ef6\u5939\u90fd\u5e94\u8be5\u59a5\u5584\u4fdd\u5b58\u3001\u53ca\u65f6\u66f4\u65b0\u3002TMF\u4e2d\u7684\u6587\u4ef6\u5e94\u8be5\u5f88\u597d\u5730\u7ec4\u7ec7\u5e76\u5b89\u5168\u5730\u4fdd\u5b58\uff0c\u4ee5\u5907\u7533\u529e\u8005\u7684\u5b9a\u671f\u76d1\u67e5\u4ee5\u53ca\u7533\u529e\u8005\u6216\u8005\u7ba1\u7406\u673a\u6784\u7684\u7a3d\u67e5\u3002<\/span><\/p>\n

    \u5728\u4e34\u5e8a\u8bd5\u9a8c\u8fdb\u884c\u4e2d\u6700\u91cd\u8981\u7684\u6587\u4ef6\u662f\u4e34\u5e8a\u8bd5\u9a8c\u65b9\u6848\u3002\u8bd5\u9a8c\u65b9\u6848\u9648\u5217\u4e86\u8fdb\u884c\u4e34\u5e8a\u8bd5\u9a8c\u7684\u79d1\u5b66\u4f9d\u636e\uff0c\u8be6\u7ec6\u89e3\u91ca\u4e86\u62df\u7814\u7a76\u65b0\u836f\u7684\u7279\u70b9\uff0c\u6709\u9488\u5bf9\u6027\u5730\u63cf\u8ff0\u4e86\u8bd5\u9a8c\u8fdb\u884c\u7684\u6b65\u9aa4\u4ee5\u53ca\u6570\u636e\u7684\u6536\u96c6\u548c\u5206\u6790\u3002TMF\u5e94\u8be5\u4fdd\u5b58\u539f\u59cb\u7684\u83b7\u5f97\u6279\u51c6\u7684\u8bd5\u9a8c\u65b9\u6848\u6216\u4fee\u6539\u540e\u5f97\u5230\u6279\u51c6\u7684\u65b9\u6848\uff0c\u4f26\u7406\u59d4\u5458\u4f1a\u3001\u7533\u529e\u8005\u6216\u6709\u5173\u7ba1\u7406\u673a\u6784\u7684\u6279\u51c6\u6587\u4ef6\u3002\u7533\u529e\u8005\u548c\u7814\u7a76\u8005\u90fd\u5e94\u8be5\u5728\u6700\u540e\u7684\u8bd5\u9a8c\u65b9\u6848\u4e0a\u7b7e\u5b57\u3002\u67d0\u4e9b\u60c5\u51b5\u4e0b\u5728\u7814\u7a76\u8fdb\u884c\u7684\u8fc7\u7a0b\u4e2d\uff0c\u9700\u8981\u5bf9\u539f\u6765\u7684\u8bd5\u9a8c\u65b9\u6848\u8fdb\u884c\u4fee\u6539\u3002\u5728\u6267\u884c\u8bd5\u9a8c\u65b9\u6848\u7684\u6539\u53d8\u4e4b\u524d\uff0c\u8fd9\u4e9b\u4fee\u6539\u6216\u53d8\u5316\u7684\u5185\u5bb9\u5fc5\u987b\u5f97\u5230\u6279\u51c6\uff0c\u76f8\u5173\u7684\u6279\u51c6\u6587\u4ef6\u4e5f\u5fc5\u987b\u4fdd\u5b58\u5728TMF\u4e2d\u3002<\/span><\/p>\n

    \u77e5\u60c5\u540c\u610f\u4e66\uff08ICF)\u662f\u91cd\u8981\u6587\u4ef6\u4e4b\u4e00\u3002\u672a\u5177\u7b7e\u540d\u7684\u539f\u7248\u77e5\u60c5\u540c\u610f\u4e66\u5e94\u8be5\u5f97\u5230\u4f26\u7406\u59d4\u5458\u4f1a\u7684\u6279\u51c6\uff0c\u5e76\u4fdd\u5b58\u5728TMF\u4e2d\u3002\u5982\u679c\u6587\u4ef6\u88ab\u7ffb\u8bd1\u4e3a\u4e0d\u540c\u7684\u6587\u5b57\uff0c\u5728\u8bb8\u591a\u5168\u7403\u9879\u76ee\u4e2d\u5e38\u5e38\u5982\u6b64\uff0c\u6240\u6709\u88ab\u6279\u51c6\u7684\u7ffb\u8bd1\u4ef6\u4e5f\u5fc5\u987b\u4fdd\u5b58\u5728TMF\u4e2d\u3002\u5982\u679c\u6709\u5173\u4e8e\u8bd5\u9a8c\u7528\u836f\u54c1\u7684\u65b0\u4fe1\u606f\uff0c\u5219\u5e94\u4fee\u8ba2\u77e5\u60c5\u540c\u610f\u4e66\u4ee5\u8865\u5145\u8fd9\u4e9b\u65b0\u4fe1\u606f\u3002\u5bf9\u539f\u59cbICF\u7684\u4efb\u4f55\u4fee\u6539\u7a3f\u7684\u6279\u51c6\u6587\u4ef6\u90fd\u5e94\u8be5\u4fdd\u5b58\u5728TMF\u4e2d\u3002<\/span><\/p>\n

    TMF\u4e5f\u5e94\u8be5\u4fdd\u5b58\u4e0e\u8d1f\u8d23\u6279\u51c6\u8be5\u8bd5\u9a8c\u7684\u4f26\u7406\u59d4\u5458\u4f1a\uff08IRB\/EC\uff09\u6709\u5173\u7684\u6587\u4ef6\u3002\u5305\u62ec\u63cf\u8ff0\u4f26\u7406\u59d4\u5458\u4f1a\u7ec4\u6210\u7684\u6587\u4ef6\u3002\u8be5\u6587\u4ef6\u5217\u6709\u53c2\u52a0\u4f26\u7406\u59d4\u5458\u4f1a\u4f1a\u8bae\u4eba\u5458\u7684\u5b8c\u6574\u540d\u5355\uff0c\u4ed6\u4eec\u4e2d\u5373\u6709\u4e13\u4e1a\u4eba\u5458\u4e5f\u6709\u975e\u4e13\u4e1a\u4eba\u5458\uff0c\u5c06\u8d1f\u8d23\u4fdd\u62a4\u53c2\u4e0e\u8be5\u8bd5\u9a8c\u7684\u4eba\u7c7b\u53d7\u8bd5\u8005\uff0c\u4ee5\u53ca\u4ed6\u4eec\u4e0e\u7814\u7a76\u5355\u4f4d\u7684\u5173\u7cfb\u7b49\u3002\u5176\u4ed6\u9700\u8981\u7684\u6587\u4ef6\u6709\uff1a\u4f26\u7406\u59d4\u5458\u4f1a\u5bf9\u8bd5\u9a8c\u65b9\u6848\u548cICF\u7684\u4e66\u9762\u6279\u51c6\u6587\u4ef6\uff0c\u4efb\u4f55\u8bd5\u9a8c\u65b9\u6848\u6216ICF\u4fee\u6539\u5728\u5b9e\u65bd\u524d\u83b7\u5f97\u7684\u6279\u51c6\u6587\u4ef6\uff0c\u53ea\u6709\u4e00\u4f8b\u5916\uff1a\u5373\u6709\u53ef\u80fd\u5bf9\u53d7\u8bd5\u8005\u4ea7\u751f\u7acb\u5373\u7684\u635f\u5bb3\u65f6\uff0c\u53ef\u4ee5\u5728\u5f97\u5230\u6279\u51c6\u524d\u5c31\u6539\u52a8\u8bd5\u9a8c\u65b9\u6848\u3002\u4efb\u4f55\u4e25\u91cd\u4e0d\u826f\u4e8b\u4ef6\u7684\u8bb0\u5f55\u4ee5\u53ca\u5df2\u63d0\u4ea4\u7ed9\u4f26\u7406\u59d4\u5458\u4f1a\u7684\u76f8\u5173\u6587\u4ef6\u4e5f\u5e94\u8be5\u4fdd\u5b58\u3002\u7814\u7a76\u8005\u624b\u518c\u662f\u6709\u5173\u7814\u7a76\u836f\u7269\u7684\u6240\u6709\u79d1\u5b66\u7279\u70b9\u548c\u6700\u65b0\u5904\u65b9\u4fe1\u606f\u7684\u6587\u4ef6\u3002<\/span><\/p>\n

    \u67d0\u4e9b\u4f26\u7406\u59d4\u5458\u4f1a\u8981\u6c42\u6709\u4e00\u4efd\u7a7a\u767d\u7684\u8bb0\u5f55\u7814\u7a76\u6570\u636e\u7684\u75c5\u4f8b\u8bb0\u5f55\u8868\uff08<\/span>CRF\uff09\u3002\u53e6\u5916\uff0c\u4e3b\u8981\u7814\u7a76\u8005\u548c\u6240\u6709\u7814\u7a76\u8005\u7684\u82f1\u6587\u7b80\u5386\u6216\u8005\u662f\u82f1\u6587\u7684\u7b80\u5386\u5c0f\u7ed3\u4e5f\u90fd\u5e94\u8be5\u4fdd\u5b58\u5728<\/span>TMF\u4e2d\u3002\u5728\u67d0\u4e9b\u60c5\u51b5\u4e0b\uff0c\u4e3a\u4e86\u80fd\u627e\u5230\u8db3\u591f\u7684\u60a3\u8005\u53c2\u52a0\u7814\u7a76\uff0c\u9700\u8981\u505a\u5e7f\u544a\uff0c\u5982\u679c\u662f\u8fd9\u79cd\u60c5\u51b5\uff0c\u4f26\u7406\u59d4\u5458\u4f1a\uff08<\/span>IRB\/EC) \u5e94\u8be5\u6279\u51c6\u8fd9\u4e9b\u5e7f\u544a\u6750\u6599\u3002<\/span><\/span><\/p>\n

    \u7814\u7a76\u4e2d\u5fc3\u548c\u7814\u7a76\u8005\u4e4b\u95f4\u7684\u901a\u4fe1\u5e94\u8be5\u4fdd\u5b58\u5728<\/span>TMF<\/span>\u4e2d\uff0c\u8fd9\u4e9b\u6587\u4ef6\u8bb0\u5f55\u4e86\u7533\u529e\u8005\u548c\u7814\u7a76\u4e2d\u5fc3\u548c\u4f26\u7406\u59d4\u5458\u4f1a\u4e4b\u95f4\u7684\u901a\u4fe1\u3002\u53e6\u5916\uff0c\u5f53\u5730\u7684\u4f26\u7406\u59d4\u5458\u4f1a\u53ef\u80fd\u8981\u6c42\u8fde\u7eed\u5b9a\u671f\u5730\u5bf9\u5df2\u6279\u51c6\u7684\u7814\u7a76\u8fdb\u884c\u5ba1\u67e5\u3002\u6bcf\u5e74\u5e94\u81f3\u5c11\u4e00\u6b21\u3002\u5728\u6bcf\u4e2a\u4e34\u5e8a\u8bd5\u9a8c\u7ed3\u675f\u65f6\u9700\u8981\u5411\u4f26\u7406\u59d4\u5458\u4f1a\u63d0\u4ea4\u603b\u7ed3\u62a5\u544a\u3002<\/span><\/span><\/p>\n

    \u8bd5\u9a8c\u6587\u4ef6\u7684\u7b2c\u4e00\u90e8\u5206\u5c31\u5230\u6b64\u4e3a\u6b62\u3002<\/span><\/p>\n

    \u8bd5\u9a8c\u6587\u4ef6\uff082\uff09<\/span><\/strong><\/p>\n

    Ms. Lillian Marinovich<\/span><\/strong><\/p>\n

    \u8fd9\u662f\u6709\u5173\u4e34\u5e8a\u8bd5\u9a8c\u6587\u4ef6\u7684\u7b2c\u4e8c\u90e8\u5206\u3002\u7f8e\u56fdFDA\u5bf9\u4e8e\u6240\u6709\u7f8e\u56fdIND\u8bd5\u9a8c\u8981\u6c42\u67091572\u8868\u683c\u3002FDA\u8981\u6c42\u6bcf\u4e2a\u7814\u7a76\u8005\u5747\u586b\u5199\u548c\u7b7e\u7f721572\u8868\u3002\u8fd9\u4e5f\u662f\u4e3b\u8981\u7814\u7a76\u8005\u548c\u7f8e\u56fdFDA\u95f4\u6709\u6cd5\u5b9a\u7ea6\u675f\u529b\u7684\u534f\u8bae\u3002\u5982\u679c1572\u8868\u6709\u6240\u6539\u52a8\uff0c\u5e94\u8be5\u518d\u6b21\u63d0\u4ea4\u7ed9\u7533\u529e\u8005\uff0c\u4ee5\u4fbf\u518d\u6b21\u9012\u4ea4FDA\u30021572\u8868\u5305\u62ec\u7814\u7a76\u8005\u5bf9FDA\u7684\u627f\u8bfa\u3002\u70b9\u51fbLIBRARY\u53ef\u4ee5\u4ece\u8fd9\u4e2a\u7f51\u5740\u4e0a\u4e0b\u8f7d\u8be5\u8868\u683c\u7684\u6837\u672c\u3002<\/span><\/p>\n

    \u7b2c9\u8282\u5173\u4e8e\u7814\u7a76\u8005\u7684\u627f\u8bfa\u5982\u4e0b:<\/span><\/p>\n

    \u201c<\/span>\u6211\u540c\u610f\u6309\u7167\u76f8\u5173\u8bd5\u9a8c\u65b9\u6848\u7684\u8981\u6c42\u8fdb\u884c\u7814\u7a76\uff0c\u5e76\u4e14\u540c\u610f\u5728\u6ca1\u6709\u7533\u529e\u8005\u7684\u540c\u610f\u4e4b\u524d\u4e0d\u80fd\u4efb\u610f\u5730\u6539\u52a8\u8bd5\u9a8c\u65b9\u6848\uff0c\u9664\u975e\u662f\u5728\u9700\u8981\u4fdd\u62a4\u53d7\u8bd5\u8005\u7684\u5b89\u5168\u3001\u6743\u5229\u548c\u798f\u7949\u65f6\u3002\u6211\u540c\u610f\u4eb2\u81ea\u505a\u672c\u7814\u7a76\u6216\u8005\u4e3b\u6301\u672c\u9879\u7814\u7a76\u7684\u8fdb\u884c\u3002\u6211\u540c\u610f\u987b\u544a\u77e5\u4f5c\u4e3a\u5bf9\u7167\u7ec4\u7684\u75c5\u4eba\u6216\u4e2a\u4eba\uff0c\u672c\u7814\u7a76\u4e2d\u4f7f\u7528\u7684\u836f\u7269\u6709\u7814\u7a76\u7684\u76ee\u7684\uff0c\u5e76\u4e14\u6211\u4fdd\u8bc1\u6309\u76f8\u5173\u6cd5\u5f8b\u7684\u8981\u6c42\u83b7\u5f97\u77e5\u60c5\u540c\u610f\u3002<\/span>\u201d<\/span><\/span><\/p>\n

    TMF\u7684\u53e6\u4e00\u90e8\u5206\u662f\u901a\u8baf\u90e8\u5206\u3002\u8be5\u90e8\u5206\u5305\u62ec\u4e00\u7cfb\u5217\u8bb0\u5f55\u4e86\u7814\u7a76\u4e2d\u5fc3\u548c\u7533\u529e\u8005\u8054\u7cfb\u7684\u6587\u4ef6\u3002\u8fd9\u4e9b\u6587\u4ef6\u4e3a\uff1a\u7b7e\u540d\u7684\u4fdd\u5bc6\u534f\u8bae\uff1b\u4e0e\u7533\u529e\u8005\u6765\u5f80\u7684\u539f\u59cb\u4fe1\u4ef6\uff1b\u4fe1\u4ef6\u548c\u5907\u5fd8\u5f55\u7684\u590d\u5370\u4ef6\uff1b\u8fd8\u5305\u62ec\u4e0e\u7533\u529e\u8005\u6765\u5f80\u7684\u7535\u5b50\u90ae\u4ef6\u7684\u6253\u5370\u4ef6\uff1b\u4efb\u4f55\u4f20\u771f\u4ef6\u7684\u9996\u9875\u4ee5\u53ca\u9644\u4ef6\uff1b\u4ee5\u53ca\u7533\u529e\u8005\u548c\u7814\u7a76\u4e2d\u5fc3\u7535\u8bdd\u8054\u7cfb\u7684\u67d0\u4e9b\u8bb0\u5f55\u3002<\/span><\/p>\n

    \u5bf9\u4e34\u5e8a\u8bd5\u9a8c\u8fdb\u884c\u76d1\u67e5\u662f\u6cd5\u5f8b\u7684\u8981\u6c42\u3002\u7533\u529e\u8005\u8981\u8fdb\u884c\u76d1\u67e5\u8bbf\u89c6\uff0c\u5e76\u4e14\u8981\u6c42\u7533\u529e\u8005\u5bf9\u8fd9\u4e9b\u76d1\u67e5\u8bbf\u89c6\u8fdb\u884c\u8bb0\u5f55\u3002\u76d1\u67e5\u9632\u89c6\u662f\u4e3a\u4e86\u76d1\u7763\u5bf9\u8bd5\u9a8c\u65b9\u6848\u7684\u4f9d\u4ece\u6027\uff0c\u4ee5\u53ca\u5e38\u89c4\u6536\u96c6\u6587\u4ef6\u3002\u53e6\u5916\uff0c\u5728\u76d1\u67e5\u6587\u4ef6\u90e8\u5206\u8fd8\u5305\u62ec\u7814\u7a76\u8005\u7684\u7b7e\u5b57\u8bb0\u5f55\u5355\uff0c\u8bb0\u5f55\u53c2\u52a0\u76d1\u67e5\u9632\u89c6\u7684\u76f8\u5173\u4eba\u5458\u7684\u59d3\u540d\u3002<\/span><\/p>\n

    TMF\u7684\u53e6\u4e00\u90e8\u5206\u662f\u836f\u7269\u7684\u4f9b\u5e94\u548c\u6e05\u70b9\u8bb0\u5f55\u3002\u8be5\u90e8\u5206\u5305\u62ec\uff1a\u4e3a\u8fdb\u884c\u4e34\u5e8a\u8bd5\u9a8c\u53d1\u9001\u5230\u7814\u7a76\u4e2d\u5fc3\u7684\u836f\u7269\u6536\u8d27\u5355\u636e\uff0c\u5305\u62ec\u8fd0\u8f93\u6536\u636e\uff1b\u50a8\u5b58\u6307\u5357\uff1b\u53d7\u8bd5\u8005\u836f\u7269\u5206\u53d1\u6307\u5357\uff1b\u76f2\u7801\u4ee5\u53ca\u7d27\u6025\u60c5\u51b5\u4e0b\u7834\u76f2\u7684\u7a0b\u5e8f\uff1b\u75c5\u4eba\u7684\u6e05\u70b9\u8bb0\u5f55\uff1b\u4ee5\u53ca\u4efb\u4f55\u836f\u7269\u5206\u53d1\u548c\u5f52\u8fd8\u672a\u4f7f\u7528\u836f\u7269\u7684\u8bb0\u5f55\u3002<\/span><\/p>\n

    \u53e6\u5916\uff0cTMF\u8fd8\u5305\u62ec\u4e86\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u5b9e\u9a8c\u5ba4\u548c\u5176\u5b83\u8f85\u52a9\u68c0\u67e5\u7684\u6240\u6709\u4fe1\u606f\u3002\u6240\u6709\u53c2\u52a0\u7684\u5b9e\u9a8c\u5ba4\u5305\u62ec\u5f53\u5730\u548c\u4e2d\u5fc3\u5b9e\u9a8c\u5ba4\u7684\u6587\u4ef6\u90fd\u5e94\u8be5\u6536\u96c6\u8d77\u6765\u3002\u8fd9\u4e9b\u5b9e\u9a8c\u5ba4\u4ee5\u53ca\u5176\u4ed6\u7684\u68c0\u6d4b\u4e2d\u5fc3\u7684\u8d44\u683c\u8bc1\u4e66\u3001\u8ba4\u53ef\u8bc1\u4e66\u6216\u8005\u5df2\u6709\u7684\u8d28\u91cf\u63a7\u5236\u8bc4\u4ef7\u6587\u4ef6\u5747\u5e94\u6536\u96c6\uff0c\u5728\u6574\u4e2a\u7814\u7a76\u8fc7\u7a0b\u4e2d\u5747\u5e94\u5982\u6b64\u3002\u53e6\u5916\uff0c\u5b9e\u9a8c\u5ba4\u7684\u6b63\u5e38\u503c\u8303\u56f4\u4ee5\u53ca\u53c2\u8003\u503c\u4e5f\u90fd\u5e94\u8be5\u5305\u62ec\u5728\u5176\u4e2d\u3002\u8bd5\u9a8c\u65b9\u6848\u4e2d\u89c4\u5b9a\u7684\u68c0\u6d4b\uff0c\u5176\u624b\u518c\u548c\u53c2\u8003\u503c\u3002\u6bcf\u4e2a\u75c5\u4eba\u7684\u68c0\u67e5\u7ed3\u679c\u8bb0\u5f55\u5728\u5176\u76f8\u5e94\u7684CRF\u4e2d\u6216\u8005\u4e0e\u4ed6\u4eec\u7684\u533b\u7597\u8bb0\u5f55\u4fdd\u5b58\u5728\u4e00\u8d77\u3002\u8bd5\u9a8c\u4e2d\u6536\u96c6\u7684\u6807\u672c\u6570\u91cf\u3001\u6807\u672c\u7684\u4fdd\u5b58\u65b9\u6cd5\u3001\u5728\u54ea\u91cc\u4fdd\u5b58\u6807\u672c\u4ee5\u53ca\u6240\u6709\u7684\u6837\u672c\u6e05\u5355\u90fd\u5e94\u8be5\u6709\u8bb0\u5f55\u5e76\u59a5\u5584\u4fdd\u5b58\u3002<\/span><\/p>\n

    \u4e0b\u9762\u6211\u4eec\u5c06\u8ba8\u8bba\u53d7\u8bd5\u8005\u7684\u6587\u4ef6\u3002\u53d7\u8bd5\u8005\u7684\u75c5\u4f8b\u8bb0\u5f55\u8868\uff08<\/span>CRF\uff09\u8868\u5305\u542b\u4e86\u8bd5\u9a8c\u8fc7\u7a0b\u4e2d\u6536\u96c6\u7684\u4fe1\u606f\u3002\u5b83\u4eec\u5305\u62ec\u968f\u673a\u5316\u4ee5\u540e\u63a5\u53d7\u836f\u7269\u6cbb\u7597\u7684\u75c5\u4eba\u4ee5\u53ca\u7b5b\u9009\u5931\u8d25\u7684\u75c5\u4eba\u3002\u5176\u4ed6\u53d7\u8bd5\u8005\u7684\u6587\u4ef6\u6709\uff1a\u539f\u59cb\u8bb0\u5f55\uff0c\u53ef\u80fd\u662f\u533b\u9662\u7684\u533b\u7597\u8bb0\u5f55\u3001\u95e8\u8bca\u8bb0\u5f55\u3001\u62a4\u58eb\u8bb0\u5f55\u7b49\u7b49\u3002\u53e6\u5916\uff0c\u53d7\u8bd5\u8005\u7684\u6587\u4ef6\u8fd8\u6709\u5df2\u7b7e\u540d\u7684\u77e5\u60c5\u540c\u610f\u4e66\u53ca\u5176\u6240\u6709\u7248\u672c\u7684\u77e5\u60c5\u540c\u610f\u4e66\uff08\u5fc5\u8981\u65f6\uff09\u3002\u53d7\u8bd5\u8005\u6587\u4ef6\u8fd8\u5305\u62ec\u4e2a\u4eba\u7684\u836f\u7269\u6e05\u70b9\u8bb0\u5f55\u3001\u5165\u9009\u8bb0\u5f55\u8868\u3001\u7b5b\u9009\u8bb0\u5f55\u8868\u4ee5\u53ca\u4efb\u4f55\u53d7\u8bd5\u8005\u8bc6\u522b\u7f16\u53f7\u7684\u6e05\u5355\u3002<\/span><\/span><\/p>\n

    \u8d22\u52a1\u65b9\u9762\u7684\u4fe1\u606f\u4e5f\u7531\u7533\u529e\u8005\u4fdd\u5b58\u5728\u7814\u7a76\u4e2d\u5fc3\uff0c\u4f46\u662f\u8be5\u6587\u4ef6\u4e0d\u4fdd\u5b58\u5728<\/span>TMF\u4e2d\uff0c\u800c\u662f\u5355\u72ec\u4fdd\u5b58\u3002\u8fd9\u4e9b\u8d22\u52a1\u4fe1\u606f\u6587\u4ef6\u5305\u62ec<\/span>FDA\u5173\u4e8e\u7f8e\u56fd<\/span>IND\u8bd5\u9a8c\u8981\u7528\u7684<\/span>3454\u6216<\/span>3455\u8868\u683c\u3002<\/span><\/span><\/p>\n

    \u6587\u4ef6\u7684\u4fdd\u7559\u662f\u975e\u5e38\u91cd\u8981\u7684\uff0c\u6839\u636e<\/span>ICH<\/span>\u7684\u8981\u6c42\uff0c\u6240\u6709\u7684\u8bd5\u9a8c\u6587\u4ef6\u90fd\u5e94\u8be5\u5728\u5f00\u53d1\u9879\u76ee\u7ec8\u6b62\u540e\u4fdd\u7559<\/span>2<\/span>\u5e74\uff0c\u6216\u8005\u662f\u5728\u6700\u540e\u4e00\u6b21\u88ab\u6279\u51c6\u4e0a\u5e02\u540e\u4fdd\u5b58<\/span>2<\/span>\u5e74\u3002<\/span>FDA<\/span>\u8981\u6c42\u6240\u6709\u7684\u6587\u4ef6\u5fc5\u987b\u4fdd\u7559\u5230<\/span>IND<\/span>\u7ed3\u675f\u540e<\/span>2<\/span>\u5e74\u6216\u8005\u6700\u540e\u4e00\u4e2a\u9002\u5e94\u75c7\u7684<\/span>NDA<\/span>\u83b7\u5f97\u6279\u51c6\u540e<\/span>2<\/span>\u5e74\u3002\u8bd5\u9a8c\u6587\u4ef6\u5e94\u8be5\u5b89\u5168\u7684\u4fdd\u5b58\uff0c\u5e76\u4e14\u80fd\u5bb9\u6613\u5730\u63d0\u4f9b\uff08\u7533\u529e\u8005\uff09\u8fdb\u884c\u7a3d\u67e5\u6216\uff08\u7ba1\u7406\u673a\u6784\uff09\u89c6\u5bdf\u3002\u53e6\u5916\uff0c\u5982\u679c\u7814\u7a76\u8005\u8981\u9500\u6bc1\u4efb\u4f55\u8bd5\u9a8c\u6587\u4ef6\uff0c\u5e94\u8be5\u7acb\u5373\u901a\u77e5\u7533\u529e\u8005\u3002<\/span><\/span><\/p>\n

    \u603b\u7684\u8bf4\u6765\uff0c\u6587\u4ef6\u7684\u4fdd\u5b58\u5bf9\u4e8e\u4e34\u5e8a\u8bd5\u9a8c\u7684\u8d28\u91cf\u662f\u81f3\u5173\u91cd\u8981\u7684\u3002\u8fd9\u4e0d\u4ec5\u662f\u826f\u597d\u7684\u4e34\u5e8a\u5b9e\u8df5\u548c\u79d1\u5b66\u5b9e\u8df5\u7684\u9700\u8981\uff0c\u4e5f\u662f\u7ba1\u7406\u673a\u6784\u7684\u8981\u6c42\u3002\u5b8c\u6574\u7684\u6587\u4ef6\u662f\u7a3d\u67e5\u7684\u5173\u952e\u3002\u8bf7\u8bb0\u4f4f\uff0c\u5982\u679c\u6ca1\u6709\u6587\u4ef6\u8bb0\u5f55\uff0c\uff08\u5de5\u4f5c\uff09\u5c31\u6ca1\u6709\u53d1\u751f\u3002\u8c22\u8c22\u5927\u5bb6\u3002<\/span><\/p>\n


    <\/p>\n

    \u7b2c\u5341\u4e09\u8bb2 <\/span><\/strong>\u4e34\u5e8a\u8bd5\u9a8c\u7684\u8d23\u4efb<\/span><\/strong><\/p>\n

    Dr. Guillermo Rodr\u00edguez<\/span><\/strong><\/span><\/p>\n

    \u6b22\u8fce\u5927\u5bb6\uff0c\u6211\u662f\u6765\u81ea\u54e5\u65af\u8fbe\u9ece\u52a0\u7684 <\/span>Guillermo Rodriguez<\/span>\u533b\u751f\u3002\u4e0b\u9762\u7684\u8bfe\u7a0b\u6709\u5173\u4e34\u5e8a\u8bd5\u9a8c\u7684\u8d23\u4efb\u3002<\/span><\/span><\/p>\n

    \u8fdb\u884c\u4e00\u9879\u4e34\u5e8a\u8bd5\u9a8c\u9700\u8981\u56e2\u961f\u5408\u4f5c\u3002\u56e2\u961f\u6709\u4e09\u4e2a\u90e8\u5206\u7ec4\u6210\uff1a\u7533\u529e\u8005\u3001\u7814\u7a76\u8005\u548c\u4f26\u7406\u59d4\u5458\u4f1a\u3002\u8fd9\u4e09\u90e8\u5206\u4e2d\u7684\u6bcf\u4e00\u65b9\u90fd\u5e94\u8be5\u975e\u5e38\u6e05\u695a\u5728\u6574\u4e2a\u8fc7\u7a0b\u4e2d\u6700\u91cd\u8981\u7684\u662f\u53d7\u8bd5\u8005\uff1a\u5373\u53c2\u52a0\u7814\u7a76\u7684\u4eba\u3002<\/span><\/p>\n

    \u8fd9\u4e09\u90e8\u5206\u4eba\u5458\u5e94\u8be5\u4e3a\u7814\u7a76\u7684\u6210\u529f\u505a\u51fa\u81ea\u5df1\u7684\u52aa\u529b\u3002\u6765\u81ea\u7533\u529e\u8005\u65b9\u9762\u7684\u8d21\u732e\u5305\u62ec\u63d0\u4f9b\u7814\u7a76\u836f\u7269\u3001\u8bd5\u9a8c\u65b9\u6848\u4ee5\u53ca\u8fdb\u884c\u7814\u7a76\u7684\u8d44\u91d1<\/span>\/<\/span>\u8d44\u6e90\u3002\u7814\u7a76\u8005\u5229\u7528\u5176\u4e13\u4e1a\u77e5\u8bc6\u4e3a\u7814\u7a76\u670d\u52a1\uff0c\u7814\u7a76\u8005\u5728\u6574\u4e2a\u7814\u7a76\u8fc7\u7a0b\u4e2d\u8d1f\u8d23\u7167\u987e\u53d7\u8bd5\u8005\uff0c\u4ed6\u4eec\u9700\u8981\u89e3\u91ca\u7ed3\u679c\u548c\u8bc4\u4ef7\u8bd5\u9a8c\u7684\u540e\u679c\u3002\u6700\u540e\uff0c\u4f26\u7406\u59d4\u5458\u4f1a\u8d1f\u8d23\u4fdd\u62a4\u53d7\u8bd5\u8005\u7684\u6743\u5229\u3002\u4f26\u7406\u59d4\u5458\u4f1a\u5e94\u8be5\u5bf9\u8bd5\u9a8c\u65b9\u6848\u8fdb\u884c\u516c\u6b63\u548c\u72ec\u7acb\u7684\u8bc4\u4ef7\u3002<\/span><\/span><\/p>\n

    \u6211\u4eec\u53ef\u4ee5\u5c06\u8d23\u4efb\u5206\u6210\u4e09\u4e2a\u4e3b\u8981\u90e8\u5206\uff1a<\/span><\/p>\n

    \u2022 \u4f26\u7406\u5b66\u7684\u8d23\u4efb<\/span><\/p>\n

    \u2022 \u79d1\u5b66\u7684\u8d23\u4efb<\/span><\/p>\n

    \u2022 \u7ba1\u7406\u7684\u8d23\u4efb<\/span><\/p>\n

    \u8ba9\u6211\u4eec\u4ece\u7533\u529e\u8005\u8c08\u8d77\u3002\u7533\u529e\u8005\u7684\u4f26\u7406\u5b66\u8d23\u4efb\u662f\u4ec0\u4e48\u5462\uff1f\u6700\u4e3b\u8981\u7684\u662f\u4fdd\u8bc1\u53c2\u52a0\u8bd5\u9a8c\u7684\u53d7\u8bd5\u8005\u7684\u6743\u76ca\u53d7\u5230\u4e86\u4fdd\u62a4\u3002\u5728\u6574\u4e2a\u8bfe\u7a0b\u4e2d\uff0c\u4f60\u4eec\u5c06\u4e0d\u65ad\u542c\u5230\u8fd9\u4e00\u70b9\uff0c\u56e0\u4e3a\u5bf9\u6bcf\u4e2a\u4eba\u800c\u8a00\u8fd9\u90fd\u662f\u6700\u57fa\u672c\u7684\u8d23\u4efb\u3002\u7533\u529e\u8005\u7684\u53e6\u4e00\u4e2a\u8d23\u4efb\u662f\u786e\u8ba4\u5728\u7814\u7a76\u5f00\u59cb\u4e4b\u524d\u7814\u7a76\u5df2\u7ecf\u5f97\u5230\u4e86\u4f26\u7406\u59d4\u5458\u4f1a\u7684\u6279\u51c6\u3002\u7533\u529e\u8005\u7684\u5176\u4ed6\u4f26\u7406\u5b66\u8d23\u4efb\u8fd8\u5305\u62ec\u4fdd\u8bc1\u4f9d\u636e<\/span>GCP<\/span>\u539f\u5219\u8fdb\u884c\u4e34\u5e8a\u7814\u7a76\u4ee5\u53ca\u5728\u7814\u7a76\u8fc7\u7a0b\u4e2d\u4e00\u65e6\u53d1\u751f\u4e86\u5bf9\u53d7\u8bd5\u8005\u7684\u635f\u5bb3\u8981\u8d1f\u8d23\u8865\u507f\u3002<\/span><\/span><\/p>\n

    \u4ece\u79d1\u5b66\u7684\u89d2\u5ea6\u8bb2\uff0c\u7533\u529e\u8005\u6709\u51e0\u9879\u8d23\u4efb\u3002\u4ed6\u6709\u8d23\u4efb\u8d1f\u8d23\u8bd5\u9a8c\u65b9\u6848\u548c\u7814\u7a76\u8005\u624b\u518c\u7684\u51c6\u5907\u3002\u4e5f\u6709\u8d23\u4efb\u5728\u7814\u7a76\u8fc7\u7a0b\u4e2d\u63d0\u4f9b\u6709\u5173\u7814\u7a76\u836f\u7269\u7684\u57fa\u7840\u548c\u4e34\u5e8a\u7684\u4fe1\u606f\u3002\u8fd9\u4e9b\u4fe1\u606f\u5e94\u8be5\u662f\u6700\u65b0\u7684\uff0c\u56e0\u4e3a\u6211\u4eec\u53ef\u80fd\u5728\u7814\u7a76\u8fc7\u7a0b\u4e2d\u5b66\u5230\u8bb8\u591a\u4e1c\u897f\u3002\u6211\u4eec\u5e94\u8be5\u90fd\u77e5\u9053\u6b63\u5728\u53d1\u751f\u7684\u4e8b\u4ee5\u53ca\u5176\u4ed6\u4e2d\u5fc3\u53d1\u751f\u7684\u4e8b\u60c5\u3002<\/span><\/p>\n

    \u9009\u62e9\u7814\u7a76\u8005\u4e5f\u662f\u7533\u529e\u8005\u7684\u53e6\u4e00\u4e2a\u4e3b\u8981\u8d23\u4efb\u3002\u4f18\u79c0\u7684\u7814\u7a76\u8005\u624d\u80fd\u4fdd\u8bc1\u4e34\u5e8a\u8bd5\u9a8c\u7684\u4f18\u79c0\u3002\uff0c\u4e3a\u7814\u7a76\u8005\u63d0\u4f9b\u4e34\u5e8a\u652f\u6301\u5f88\u91cd\u8981\uff0c\u7533\u529e\u8005\u7684\u4eba\u5458\u5e94\u6709\u826f\u597d\u7684\u8d44\u8d28\u5e76\u6709\u80fd\u529b\u56de\u7b54\u7814\u7a76\u8005\u7684\u95ee\u9898\u3002\u5411\u7ba1\u7406\u673a\u6784\u62a5\u544a\u6240\u6709\u7684\u4e0d\u826f\u4e8b\u4ef6\u662f\u53e6\u4e00\u9879\u8d23\u4efb\u3002\u6574\u4f53\u8d1f\u8d23\u8bd5\u9a8c\u4ee5\u53ca\u5728\u7814\u7a76\u7ed3\u675f\u65f6\u505a\u6700\u7ec8\u7684\u603b\u7ed3\u62a5\u544a\u4e5f\u662f\u7533\u529e\u8005\u7684\u79d1\u5b66\u8d23\u4efb\u3002<\/span><\/p>\n

    \u7533\u529e\u8005\u7684\u884c\u653f\u7ba1\u7406\u8d23\u4efb\u5305\u62ec\u4e3a\u8fdb\u884c\u4e34\u5e8a\u8bd5\u9a8c\u5efa\u7acb\u6240\u6709\u7684\u7a0b\u5e8f\u548c\u8d23\u4efb\uff0c\u5305\u62ec\u5236\u5b9a<\/span>QA\/QC\u89c4\u8303\u6216\u8005\u8ba1\u5212\u4ee5\u4fdd\u8bc1\u7814\u7a76\u7684\u8d28\u91cf\u3002\u4e0e\u7814\u7a76\u8005\u7b7e\u7f72\u5408\u540c\u4ee5\u53ca\u8bd5\u9a8c\u65b9\u6848\u4e5f\u662f\u7533\u529e\u8005\u7684\u7ba1\u7406\u8d23\u4efb\u3002\u7533\u529e\u8005\u8fd8\u5e94\u8be5\u5f97\u5230\u7814\u7a76\u8005\u7684\u627f\u8bfa\uff0c\u9075\u5faa<\/span>GCP\u539f\u5219\u3001\u975e\u5e38\u4e25\u683c\u5730\u4f9d\u4ece\u8bd5\u9a8c\u65b9\u6848\u8fdb\u884c\u4e34\u5e8a\u7814\u7a76\u3002\u7533\u529e\u8005\u7684\u53e6\u4e00\u7ba1\u7406\u4e0a\u7684\u8d23\u4efb\u662f\u4efb\u547d\u8bd5\u9a8c\u7684\u76d1\u67e5\u5458\u3002\u786e\u4fdd\u7ba1\u7406\u673a\u6784\u53ef\u4ee5\u63a5\u89e6\u7814\u7a76\u8d44\u6599\u4e5f\u662f\u975e\u5e38\u91cd\u8981\u7684\u8d23\u4efb\u3002\u7ba1\u7406\u673a\u6784\u4e5f\u8bb8\u4f1a\u5728\u51e0\u5e74\u540e\u6765\u68c0\u67e5\u8fd9\u4e9b\u8d44\u6599\u3002\u5e94\u5728\u7a3d\u67e5\u65f6\u80fd\u63d0\u4f9b\u76f8\u5e94\u7684\u8d44\u6599\u3002\u8fd9\u5c31\u662f\u4e3a\u4ec0\u4e48\u7533\u529e\u8005\u9700\u8981\u6839\u636e\u5404\u4e2a\u5730\u533a\u7684\u89c4\u5b9a\u5c06\u7814\u7a76\u8d44\u6599\u4fdd\u5b58\u6570\u5e74\u3002<\/span><\/span><\/p>\n

    \u7533\u529e\u8005\u53ef\u4ee5\u5c06\u4e00\u4e9b\u8d23\u4efb\u59d4\u6258\u7ed9\u7814\u7a76\u7684\u76d1\u67e5\u5458\u3002\u7814\u7a76\u76d1\u67e5\u5458\u5c31\u50cf\u662f\u7533\u529e\u8005\u7684\u5927\u4f7f\u3002\u4ed6\u6216\u5979\u53ef\u4ee5\u5230\u7814\u7a76\u4e2d\u5fc3\uff0c\u5728\u90a3\u91cc\u5b8c\u6210\u4e00\u90e8\u5206\u7684\u5de5\u4f5c\u3002\u76d1\u67e5\u5458\u4e5f\u6709\u4f26\u7406\u5b66\u3001\u79d1\u5b66\u548c\u7ba1\u7406\u7684\u8d23\u4efb\u3002\u4ece\u4f26\u7406\u5b66\u89d2\u5ea6\uff0c\u76d1\u67e5\u5458\u5e94\u8be5\u4fdd\u8bc1\u53d7\u8bd5\u8005\u7684\u6743\u76ca\u5f97\u5230\u4e86\u4fdd\u62a4\u3002\u4ed6\u6216\u5979\u6709\u8d23\u4efb\u6838\u5b9e\u77e5\u60c5\u540c\u610f\u7684\u8fc7\u7a0b\u6b63\u786e\u548c\u53ca\u65f6\u3002\u4ece\u79d1\u5b66\u89d2\u5ea6\u8bb2\uff0c\u76d1\u67e5\u5458\u5e94\u8be5\u76d1\u7763\u5e76\u6838\u5b9e\u7814\u7a76\u662f\u4f9d\u4ece\u8bd5\u9a8c\u65b9\u6848\u6216<\/span>\/<\/span>\u53ca\u5176\u4fee\u6539\u7a3f\u8fdb\u884c\u7684\uff0c\u5e76\u4e14\u6838\u5b9e\u539f\u59cb\u8d44\u6599\u4e0e<\/span>CRF<\/span>\u4e2d\u7684\u76f8\u5173\u8bb0\u5f55\u4e00\u81f4\u3002\u76d1\u67e5\u5458\u5e94\u786e\u5b9a\u6240\u6709\u62a5\u544a\u7ed9\u7533\u529e\u8005\u7684\u8d44\u6599\u90fd\u6b63\u786e\u5730\u53cd\u6620\u4e86\u60a3\u8005\u7684\u6cbb\u7597\u60c5\u51b5\u3002\u6b63\u786e\u5904\u7406\u7814\u7a76\u836f\u7269\u662f\u53e6\u4e00\u9879\u91cd\u8981\u8d23\u4efb\u3002\u7814\u7a76\u836f\u7269\u7684\u4f7f\u7528\u5e94\u8be5\u6309\u7167\u8bd5\u9a8c\u65b9\u6848\u7684\u8981\u6c42\u5e76\u4e14\u53ea\u80fd\u7528\u4e8e\u8be5\u7814\u7a76\u3002\u76d1\u67e5\u5458\u5e94\u6838\u5b9e\u7814\u7a76\u8005\u4e86\u89e3\u4e86\u8bd5\u9a8c\u65b9\u6848\u7684\u6240\u6709\u7ec6\u8282\u4ee5\u53ca\u7814\u7a76\u836f\u7269\u7684\u6240\u6709\u4fe1\u606f\u3002<\/span><\/span><\/p>\n

    \u4e0d\u826f\u4e8b\u4ef6\u7684\u62a5\u544a\u662f\u76d1\u67e5\u5458\u7684\u91cd\u8981\u8d23\u4efb\u3002\u4e34\u5e8a\u8bd5\u9a8c\u7684\u5b89\u5168\u6027\u662f\u81f3\u5173\u91cd\u8981\u7684\uff0c\u6240\u4ee5\u8fd9\u662f\u76d1\u67e5\u5458\u7684\u4e3b\u8981\u8d23\u4efb\u4e4b\u4e00\u3002\u62a5\u544a\u4efb\u4f55\u504f\u79bb\u6216\u8fdd\u53cd\u8bd5\u9a8c\u65b9\u6848\u7684\u505a\u6cd5\u662f\u76d1\u67e5\u5458\u7684\u53e6\u4e00\u8d23\u4efb\u3002\u76d1\u67e5\u8bbf\u89c6\u4e2d\u7684\u53d1\u73b0\u5e94\u5199\u51fa\u62a5\u544a\u63d0\u4ea4\u7ed9\u7533\u529e\u8005\u548c\u7814\u7a76\u8005\u3002\u8be5\u62a5\u544a\u8bf4\u660e\u4e86\u7814\u7a76\u662f\u600e\u6837\u8fdb\u884c\u7684\u3002\u6211\u4eec\u662f\u5426\u5728\u6b63\u786e\u884c\u4e8b\uff1f\u76d1\u67e5\u5458\u8fd8\u5e94\u8be5\u4e0e\u7814\u7a76\u8005\u534f\u8c03\uff0c\u4fdd\u8bc1\u6240\u6709\u9700\u8981\u7684\u6750\u6599\u548c\u4f9b\u5e94\u90fd\u53ca\u65f6\u5730\u9001\u8fbe\u3002<\/span><\/p>\n

    \u6211\u4eec\u53ef\u4ee5\u5c06\u7533\u529e\u8005\u7684\u8d23\u4efb\u5206\u6210<\/span>5<\/span>\u4e2a\u4e3b\u8981\u90e8\u5206\uff1a<\/span><\/p>\n

    \u2022\u63d0\u4f9b\u8bd5\u9a8c\u65b9\u6848\u3001\u7814\u7a76\u836f\u7269\u3001\u7814\u7a76\u7528\u54c1\u548c\u8d44\u91d1\u8d44\u6e90<\/span><\/p>\n

    \u2022\u4e3a\u53d7\u5230\u635f\u5bb3\u7684\u53d7\u8bd5\u8005\u63d0\u4f9b\u6cbb\u7597\u548c\u8865\u507f\u3002<\/span><\/p>\n

    \u2022\u76d1\u7763\u8bd5\u9a8c\u4ee5\u4fdd\u8bc1\u4f9d\u4ece<\/span>GCP<\/span>\u539f\u5219\u8fdb\u884c<\/span><\/p>\n

    \u2022\u5bf9\u7814\u7a76\u8d44\u6599\u8fdb\u884c\u5b58\u6863<\/span><\/p>\n

    \u2022\u5236\u5b9a<\/span> QA\/QC <\/span>\u8ba1\u5212<\/span><\/p>\n

    \u8fd9\u4e00\u90e8\u5206\u5230\u6b64\u4e3a\u6b62\uff0c\u4e0b\u4e00\u90e8\u5206\u6211\u4eec\u5c06\u8ba8\u8bba\u7814\u7a76\u8005\u548c\u4f26\u7406\u59d4\u5458\u4f1a\u7684\u8d23\u4efb\u3002<\/span><\/p>\n

    \u8fdb\u884c\u4e34\u5e8a\u8bd5\u9a8c\u7684\u8d23\u4efb\uff08<\/span>2<\/span>\uff09<\/span><\/strong><\/span><\/p>\n

    Dr. Guillermo Rodr\u00edguez<\/span><\/strong><\/span><\/p>\n

    \u5728\u8fd9\u4e00\u90e8\u5206\uff0c\u6211\u4eec\u5c06\u8ba8\u8bba\u7814\u7a76\u8005\u548c\u4f26\u7406\u59d4\u5458\u4f1a\u7684\u8d23\u4efb\u3002<\/span><\/p>\n

    \u7814\u7a76\u8005\u7684\u4f26\u7406\u5b66\u8d23\u4efb\u5305\u62ec\u4fdd\u62a4\u53d7\u8bd5\u8005\u7684\u6743\u76ca\uff0c\u5e76\u4e14\u4fdd\u8bc1\u5728\u7814\u7a76\u5f00\u59cb\u65f6\u548c\u4ee5\u540e\u8be5\u7814\u7a76\u5f97\u5230\u4e86\u4f26\u7406\u59d4\u5458\u4f1a\u7684\u5ba1\u67e5\u548c\u6279\u51c6\u3002\u4ed6\u6709\u8d23\u4efb\u6b63\u786e\u3001\u53ca\u65f6\u5730\u4ece\u6240\u6709\u53d7\u8bd5\u8005\u90a3\u91cc\u83b7\u5f97\u77e5\u60c5\u540c\u610f\u4e66\uff0c\u5e76\u6309\u7167<\/span>GCP<\/span>\u539f\u5219\u4eb2\u81ea\u6216\u8005\u6307\u5bfc\u7814\u7a76\u7684\u8fdb\u884c\u3002<\/span><\/span><\/p>\n

    \u4ece\u79d1\u5b66\u89d2\u5ea6\u8bb2\uff0c\u7814\u7a76\u8005\u4e5f\u6709\u8d23\u4efb\u8fdb\u884c\u9002\u5f53\u7684\u57f9\u8bad\u548c\u5177\u6709\u76f8\u5173\u7684\u7ecf\u9a8c\u3002\u6211\u4eec\u4e0d\u80fd\u60f3\u8c61\uff0c\u4e00\u4e2a\u7814\u7a76\u8005\u5728\u4ed6\u6ca1\u6709\u4e13\u4e1a\u77e5\u8bc6\u7684\u9886\u57df\u8fdb\u884c\u4e34\u5e8a\u7814\u7a76\u3002\u7814\u7a76\u8005\u4e3a\u7814\u7a76\u63d0\u4f9b\u8d44\u6e90\u3001\u4eba\u5458\u4ee5\u53ca\u8bbe\u5907\u3002\u4e86\u89e3\u7814\u7a76\u8005\u624b\u518c\u4e2d\u7684\u8bd5\u9a8c\u836f\u7269\u3001\u8bd5\u9a8c\u65b9\u6848\u4ee5\u53ca\u6240\u6709\u7684\u76f8\u5173\u4fe1\u606f\u4e5f\u662f\u7814\u7a76\u8005\u7684\u79d1\u5b66\u8d23\u4efb\u3002\u7814\u7a76\u8005\u5e94\u8be5\u5145\u5206\u5730\u7406\u89e3\u8bd5\u9a8c\u65b9\u6848\uff0c\u8bc4\u4ef7\u7ed3\u679c\u548c\u4e0d\u826f\u4e8b\u4ef6\u3002\u4e0b\u9762\u662f\u7814\u7a76\u8005\u7684\u4e3b\u8981\u8d23\u4efb\uff1a\u9488\u5bf9\u4e0d\u826f\u4e8b\u4ef6\u7684\u533b\u5b66\u51b3\u5b9a\u548c\u6cbb\u7597\uff0c\u4e25\u683c\u9075\u5faa\u8bd5\u9a8c\u65b9\u6848\uff0c\u6b63\u786e\u5730\u4f7f\u7528\u7814\u7a76\u836f\u7269\u4ee5\u53ca\u6536\u96c6\u3001\u6ce8\u518c\u548c\u8bb0\u5f55\u76f8\u5173\u7684\u8d44\u6599\u3002<\/span><\/p>\n

    \u4ece\u884c\u653f\u7ba1\u7406\u7684\u89d2\u5ea6\u8bf4\uff0c\u7814\u7a76\u8005\u7684\u8d23\u4efb\u5305\u62ec\u7b7e\u7f72\u4e09\u4e2a\u6587\u4ef6\uff1a\u8bd5\u9a8c\u65b9\u6848\u3001\u7814\u7a76\u8005\u534f\u8bae\u4ee5\u53ca\u7f8e\u56fd<\/span>IND<\/span>\u8bd5\u9a8c\u6240\u8981\u6c42\u7684<\/span>FDA1572<\/span>\u8868\u3002\u5411\u7533\u529e\u8005\u53ca\u4f26\u7406\u59d4\u5458\u4f1a\u62a5\u544a\u4e25\u91cd\u4e0d\u826f\u4e8b\u4ef6\u4e5f\u662f\u7814\u7a76\u8005\u7684\u8d23\u4efb\uff0c\u8fd8\u9700\u8981\u5c06\u91cd\u8981\u6587\u4ef6\u4fdd\u5b58\u5728\u4e3b\u8981\u6587\u4ef6\u5939\uff08<\/span>TMF) <\/span>\u4e2d\uff0c\u5e76\u4e14\u6b63\u786e\u5168\u9762\u5730\u4fdd\u5b58\u7814\u7a76\u8bb0\u5f55\u3002\u5728\u7ba1\u7406\u673a\u6784\u9700\u8981\u5ba1\u9605\u65f6\uff0c\u5e94\u5c06\u7814\u7a76\u8bb0\u5f55\u63d0\u4f9b\u7ed9\u4ed6\u4eec\u3002\u5b9a\u671f\u5730\u5411\u4f26\u7406\u59d4\u5458\u4f1a\u63d0\u4f9b\u7814\u7a76\u8fdb\u5c55\u4ee5\u53ca\u603b\u7ed3\u62a5\u544a\u4e5f\u662f\u7814\u7a76\u8005\u7684\u7ba1\u7406\u8d23\u4efb\u3002<\/span><\/span><\/p>\n

    \u5982\u540c\u7533\u529e\u8005\u4f1a\u901a\u8fc7\u76d1\u67e5\u5458\u5b8c\u6210\u4e00\u90e8\u5206\u5de5\u4f5c\u4e00\u6837\uff0c\u7814\u7a76\u8005\u4e5f\u53ef\u4ee5\u6388\u6743\u7814\u7a76\u534f\u8c03\u5458\u534f\u52a9\u5176\u5de5\u4f5c\u3002\u7814\u7a76\u534f\u8c03\u5458\u5e2e\u52a9\u4e3b\u8981\u7814\u7a76\u8005\u8fdb\u884c\u7814\u7a76\u3002\u6388\u6743\u7684\u8303\u56f4\u56e0\u7814\u7a76\u534f\u8c03\u5458\u7684\u80cc\u666f\u3001\u57f9\u8bad\u4ee5\u53ca\u7ecf\u9a8c\u800c\u6709\u6240\u4e0d\u540c\u3002\u8fd9\u79cd\u6388\u6743\u5e94\u8be5\u5728\u7814\u7a76\u5f00\u59cb\u65f6\u5c31\u6b63\u5f0f\u52a0\u4ee5\u8bf4\u660e\uff0c\u8ba9\u6bcf\u4e2a\u4eba\u90fd\u660e\u767d\u5176\u8d23\u4efb\u3002\u4ece\u8fd9\u5f20\u5e7b\u706f\u4e0a\u53ef\u4ee5\u770b\u5230\uff0c\u7814\u7a76\u534f\u8c03\u5458\u7684\u8d23\u4efb\u662f\u600e\u6837\u968f\u7740\u57f9\u8bad\u7684\u589e\u52a0\u800c\u589e\u52a0\u7684\u3002\u4e00\u4e2a\u6ca1\u6709\u533b\u5b66\u80cc\u666f\u7684\u534f\u8c03\u5458\uff0c\u5982\u79d8\u4e66\u7684\u8d23\u4efb\u5c11\u4e8e\u4e00\u4e2a\u6709\u533b\u5b66\u80cc\u666f\u7684\u534f\u8c03\u5458\u5982\u62a4\u58eb\u6216\u52a9\u7406\u533b\u751f\uff0c\u66f4\u5c11\u4e8e\u4e00\u4e2a\u4f5c\u4e3a\u4e34\u5e8a\u534f\u8c03\u5458\u7684\u533b\u751f\u2015\u2015\u4f8b\u5982\uff0c\u4e00\u4e2a\u5168\u79d1\u533b\u751f\u3002\u8ba9\u6211\u4eec\u4e00\u8d77\u6765\u770b\u4e00\u4e0b\u4e0d\u540c\u7c7b\u578b\u7684\u7814\u7a76\u534f\u8c03\u5458\u7684\u4f5c\u7528\u3002\u6ca1\u6709\u533b\u5b66\u80cc\u666f\u7684\u534f\u8c03\u5458\u901a\u5e38\u8d1f\u8d23\u5b89\u6392\u5404\u7c7b\u7ea6\u4f1a\uff1b\u4ed6\u4eec\u6839\u636e\u539f\u59cb\u8d44\u6599\u7684\u4fe1\u606f\u5b8c\u6210<\/span>CRF<\/span>\uff1b\u4ed6\u4eec\u534f\u8c03\u6240\u6709\u7684\u7814\u7a76\u76f8\u5173\u7684\u6d3b\u52a8\uff0c\u5982\u76d1\u67e5\u9632\u89c6\u3002<\/span><\/span><\/p>\n

    \u6709\u533b\u5b66\u80cc\u666f\u7684\u7814\u7a76\u534f\u8c03\u5458\u80fd\u505a\u66f4\u591a\u7684\u5de5\u4f5c\u3002\u4ed6\u4eec\u4e0e\u7814\u7a76\u7684\u53d7\u8bd5\u8005\u63d0\u4ea4\u3001\u89e3\u91ca\u548c\u8ba8\u8bba\u77e5\u60c5\u540c\u610f\u4e66\u7684\u5185\u5bb9\u3002\u4ed6\u4eec\u53c2\u52a0\u6240\u6709\u8bd5\u9a8c\u65b9\u6848\u8981\u6c42\u7684\u968f\u8bbf\u3002\u4ed6\u4eec\u5c06\u7814\u7a76\u836f\u7269\u53d1\u653e\u7ed9\u53d7\u8bd5\u8005\uff0c\u5e76\u4e14\u5411\u4ed6\u4eec\u89e3\u91ca\u836f\u7269\u7684\u4f7f\u7528\u65b9\u6cd5\u3002\u4ed6\u4eec\u5b89\u6392\u76f8\u5173\u7684\u5c31\u8bca\u65f6\u95f4\uff0c\u6839\u636e\u7814\u7a76\u8005\u5728\u539f\u59cb\u8d44\u6599\u4e0a\u8bb0\u5f55\u4e0b\u7684\u4fe1\u606f\u586b\u5199<\/span>CRF<\/span>\u3002\u4ed6\u4eec\u8fd8\u9700\u8981\u534f\u8c03\u6240\u6709\u7684\u8bd5\u9a8c\u76f8\u5173\u6d3b\u52a8\u3002<\/span><\/span><\/p>\n

    \u4e00\u4e2a\u533b\u751f\u4f5c\u4e3a\u4e34\u5e8a\u534f\u8c03\u5458\u7684\u4f5c\u7528\u751a\u81f3\u66f4\u4e3a\u91cd\u8981\u3002\u4ed6\u4eec\u4e0e\u7814\u7a76\u8005\u4e00\u8d77\u5bf9\u60a3\u8005\u505a\u51fa\u4e34\u5e8a\u8bc4\u4ef7\u3002\u4ed6\u4eec\u6210\u4e3a\u53d7\u8bd5\u8005\u7684\u4e3b\u8981\u533b\u751f\u3002\u4ed6\u4eec\u4fdd\u8bc1\u53d7\u8bd5\u8005\u4f9d\u4ece\u8bd5\u9a8c\u65b9\u6848\u548c<\/span>GCP<\/span>\u7684\u8981\u6c42\u3002\u4ed6\u4eec\u4e5f\u4e0e\u7814\u7a76\u8005\u4e00\u8d77\u5bf9\u4e25\u91cd\u4e0d\u826f\u4e8b\u4ef6\u8fdb\u884c\u8bc4\u4ef7\u3001\u62a5\u544a\u4ee5\u53ca\u968f\u8bbf\u3002<\/span><\/span><\/p>\n

    \u6709\u4e9b\u8d23\u4efb\u7814\u7a76\u8005\u4e0d\u80fd\u6388\u6743\u7ed9\u4efb\u4f55\u4eba\u3002\u8fd9\u5305\u62ec\u5bf9\u7814\u7a76\u4ee5\u53ca\u7814\u7a76\u4eba\u5458\u7684\u5168\u9762\u6307\u5bfc\u76d1\u7763\uff1b\u5c06\u53d7\u8bd5\u8005\u7684\u6743\u76ca\u548c\u5b89\u5168\u6027\u4fdd\u62a4\u5728\u7814\u7a76\u8005\u7684\u5173\u5fc3\u4e4b\u4e0b\uff0c\u4fdd\u8bc1\u7814\u7a76\u9075\u5faa<\/span>GCP<\/span>\u539f\u5219\u5e76\u4e14\u4e25\u683c\u6309\u7167\u8bd5\u9a8c\u65b9\u6848\u8fdb\u884c\u3002\u7b7e\u7f72<\/span>FDA1572<\/span>\u8868\u4e5f\u662f\u5176\u4e0d\u53ef\u66ff\u4ee3\u7684\u8d23\u4efb\u3002\u5f53\u4ed6\u6216\u5979\u7b7e\u7f72\u8fd9\u4e2a\u6587\u4ef6\u65f6\uff0c\u7814\u7a76\u8005\u5c31\u627f\u8bfa\u6309\u7167\u6587\u4ef6\u4e2d\u7684\u7814\u7a76\u8005\u58f0\u660e\u6765\u8fdb\u884c\u7814\u7a76\uff1b\u8bc4\u4ef7\u3001\u62a5\u544a\u548c\u6cbb\u7597\u6240\u6709\u7684\u4e25\u91cd\u4e0d\u826f\u4e8b\u4ef6\u3002\u8bb0\u5f55\u5e76\u59a5\u5584\u5730\u4fdd\u5b58\u8bb0\u5f55\u662f\u7814\u7a76\u8005\u4e0d\u80fd\u66ff\u4ee3\u7684\u8d23\u4efb\u3002\u76d1\u7763\u7814\u7a76\u836f\u7269\u7684\u6070\u5f53\u4f7f\u7528\u53ca\u53d1\u653e\u4e5f\u662f\u7814\u7a76\u8005\u4e0d\u53ef\u66ff\u4ee3\u7684\u8d23\u4efb\u3002<\/span><\/span><\/p>\n

    \u6211\u4eec\u65e0\u8bba\u600e\u6837\u5f3a\u8c03\u4e00\u4e2a\u597d\u7684\u7814\u7a76\u534f\u8c03\u5458\u7684\u91cd\u8981\u6027\u90fd\u4e0d\u8fc7\u5206\u3002\u4e00\u4e2a\u8bad\u7ec3\u6709\u7d20\u3001\u7ecf\u9a8c\u4e30\u5bcc\u4ee5\u53ca\u8d1f\u8d23\u7684\u7814\u7a76\u534f\u8c03\u5458\u662f\u4e00\u4e2a\u4e34\u5e8a\u8bd5\u9a8c\u6210\u529f\u7684\u6700\u91cd\u8981\u7684\u56e0\u7d20\u3002<\/span><\/p>\n

    \u603b\u7684\u8bf4\u6765\uff0c\u7814\u7a76\u8005\u7684\u8d23\u4efb\u5305\u62ec\uff1a\u7b7e\u7f72<\/span>1572<\/span>\u8868\uff1b\u4fdd\u5b58\u8bb0\u5f55\uff1b\u9075\u5faa<\/span>GCP<\/span>\u539f\u5219\uff1b\u76d1\u7763\u77e5\u60c5\u540c\u610f\u7684\u8fc7\u7a0b\uff1b\u76d1\u7763\u4f26\u7406\u59d4\u5458\u4f1a\u53ca\u65f6\u6279\u51c6\u4e86\u8bd5\u9a8c\u65b9\u6848\uff1b\u62a5\u544a\u6240\u6709\u7684\u4e25\u91cd\u4e0d\u826f\u4e8b\u4ef6\uff1b\u4e25\u683c\u9075\u5faa\u8bd5\u9a8c\u65b9\u6848\u3002\u8fd9\u4e9b\u90fd\u662f\u7814\u7a76\u8005\u5fc5\u987b\u505a\u7684\u3002<\/span><\/span><\/p>\n

    \u4e0b\u9762\u6211\u4eec\u8c08\u4e00\u4e0b\u4f26\u7406\u59d4\u5458\u4f1a\u6216\u8005\u673a\u6784\u5ba1\u6838\u59d4\u5458\u4f1a\uff08<\/span>IRB<\/span>\uff09\u3002\u4f26\u7406\u59d4\u5458\u4f1a\u6709\u4f26\u7406\u5b66\u7684\u8d23\u4efb\uff0c\u5305\u62ec\u4fdd\u8bc1\u53d7\u8bd5\u8005\u7684\u6743\u76ca\u5f97\u5230\u4e86\u4fdd\u62a4\u3002\u4f26\u7406\u59d4\u5458\u4f1a\u5e94\u8be5\u6279\u51c6\u77e5\u60c5\u540c\u610f\u4e66\uff0c\u5e76\u4e14\u786e\u5b9a\u5176\u4e2d\u6709\u5173\u4e8e\u53d7\u8bd5\u8005\u635f\u5bb3\u7684\u6761\u6b3e\u3001\u4efb\u4f55\u4ed8\u7ed9\u53d7\u8bd5\u8005\u7684\u8d39\u7528\u90fd\u5f97\u5230\u4e86\u4f26\u7406\u59d4\u5458\u7684\u6279\u51c6\u3002\u5728\u7814\u7a76\u8fc7\u7a0b\u4e2d\u53d1\u73b0\u6709\u672a\u9884\u6599\u5230\u7684\u5371\u9669\u65f6\uff0c\u4f26\u7406\u59d4\u5458\u4f1a\u6709\u8d23\u4efb\u4e2d\u65ad\u6216\u53d6\u6d88\u7814\u7a76\u3002<\/span><\/span><\/p>\n

    \u4f26\u7406\u59d4\u5458\u4f1a\u7684\u79d1\u5b66\u8d23\u4efb\u5305\u62ec\u8bc4\u4ef7\u7814\u7a76\u8005\u7684\u6280\u80fd\u4ee5\u53ca\u7814\u7a76\u4e2d\u5fc3\u7684\u60c5\u51b5\uff1b\u6279\u51c6\u8bd5\u9a8c\u65b9\u6848\u548c\u6240\u6709\u7684\u4fee\u6539\u6587\u4ef6\uff1b\u5ba1\u9605\u7814\u7a76\u671f\u95f4\u6240\u6709\u7684\u5b89\u5168\u6027\u62a5\u544a\u548c\u4e25\u91cd\u4e0d\u826f\u4e8b\u4ef6\u62a5\u544a\u3002\u5ba1\u9605\u7814\u7a76\u8005\u6709\u5173\u7814\u7a76\u8fdb\u5c55\u7684\u62a5\u544a\u548c\u6700\u540e\u7684\u603b\u7ed3\u62a5\u544a\u4e5f\u662f\u4f26\u7406\u59d4\u5458\u4f1a\u7684\u8d23\u4efb\u3002<\/span><\/p>\n

    \u4ece\u884c\u653f\u7ba1\u7406\u7684\u89d2\u5ea6\u800c\u8a00\uff0c\u4f26\u7406\u59d4\u5458\u4f1a\u5e94\u5b9a\u671f\u5730\u4e3e\u884c\u4f1a\u8bae\uff0c\u5b8c\u6574\u4fdd\u5b58\u4f1a\u8bae\u8bb0\u5f55\uff0c\u5e76\u5728\u8bd5\u9a8c\u6587\u4ef6\u5939\u4e2d\u4fdd\u5b58\u5b8c\u6574\u7684\u6587\u4ef6\u3002\u4f26\u7406\u59d4\u5458\u4f1a\u4e5f\u6709\u8d23\u4efb\u4ee5\u4e66\u9762\u5f62\u5f0f\u901a\u77e5\u7814\u7a76\u8005\u662f\u5426\u6279\u51c6\u8bd5\u9a8c\u65b9\u6848\u3002\u603b\u7684\u8bf4\u6765\uff0c\u4f26\u7406\u59d4\u5458\u4f1a\u5e94\u5ba1\u6279\u8bd5\u9a8c\u65b9\u6848\u548c\u77e5\u60c5\u540c\u610f\u4e66\uff1b\u5ba1\u9605\u6240\u6709\u7684\u5b89\u5168\u6027\u62a5\u544a\uff1b\u4fdd\u62a4\u53d7\u8bd5\u8005\u7684\u6743\u76ca\uff1b\u4fdd\u7559\u8bb0\u5f55\uff1b\u5b9a\u671f\u8fdb\u884c\u4f1a\u8bae\u3002<\/span><\/p>\n

    \u6211\u4eec\u53ef\u4ee5\u8bf4\u8fdb\u884c\u4e34\u5e8a\u8bd5\u9a8c\u9700\u8981\u591a\u65b9\u5408\u4f5c\uff0c\u8fd9\u662f\u7533\u529e\u8005\u3001\u7814\u7a76\u8005\u548c\u4f26\u7406\u59d4\u5458\u4f1a\u4e4b\u95f4\u7684\u5408\u4f5c\uff0c\u6bcf\u65b9\u5728\u8fd9\u4e2a\u8fc7\u7a0b\u4e2d\u90fd\u6709\u5404\u81ea\u91cd\u8981\u7684\u8d23\u4efb\u3002\u7533\u529e\u8005\u63d0\u4f9b\u7814\u7a76\u836f\u7269\u3001\u8bd5\u9a8c\u65b9\u6848\u3001\u8d44\u6e90\uff0c\u5e76\u76d1\u7763\u8bd5\u9a8c\u662f\u4e25\u683c\u6309\u7167\u8bd5\u9a8c\u65b9\u6848\u548c<\/span>GCP<\/span>\u539f\u5219\u8fdb\u884c\u7684\u3002\u7814\u7a76\u8005\u5e94\u5bf9\u53d7\u8bd5\u8005\u63d0\u4f9b\u533b\u7597\u7167\u987e\uff0c\u5e76\u4e14\u6309\u7167\u7814\u7a76\u65b9\u6848\u548c<\/span>GCP<\/span>\u539f\u5219\u8fdb\u884c\u7814\u7a76\u3002\u6700\u540e\uff0c\u4f26\u7406\u59d4\u5458\u4f1a\u662f\u4fdd\u62a4\u53d7\u8bd5\u8005\u6743\u5229\u7684\u4e00\u65b9\u3002\u8fd9\u79cd\u5408\u4f5c\u5173\u7cfb\u4ee5\u53ca\u6bcf\u4e00\u65b9\u5bf9\u7814\u7a76\u7684\u8d21\u732e\u51b3\u5b9a\u4e86\u7814\u7a76\u7684\u6210\u529f\u4e0e\u5426\u3002<\/span><\/span><\/p>\n

    \u8fd9\u90e8\u5206\u5230\u6b64\u7ed3\u675f\uff0c\u8c22\u8c22\u5927\u5bb6\u3002<\/span><\/p>\n


    <\/p>\n

    \u7b2c\u5341\u56db\u8bb2 <\/span><\/strong>\u8bd5\u9a8c\u7528\u836f\u54c1\u7684\u7ba1\u7406<\/span><\/strong><\/p>\n

    Mr. Patrick Floody<\/span><\/strong><\/h1>\n

    \u5927\u5bb6\u597d\uff0c\u6211\u662f<\/span>Patrick Floody<\/span>\u3002\u6211\u662f\u8f89\u745e\u516c\u53f8\u7684\u4e34\u5e8a\u8bd5\u9a8c\u56fd\u9645\u534f\u8c03\u5458\uff0c\u4e3b\u8981\u8d1f\u8d23\u5728\u62c9\u4e01\u7f8e\u6d32\u548c\u4e9a\u6d32\u56fd\u5bb6\u7684\u5de5\u4f5c\u3002\u4eca\u5929\u7ed9\u5927\u5bb6\u8bb2\u7684\u662f\u8bd5\u9a8c\u7528\u836f\u54c1\u7684\u7ba1\u7406\u3002\u5206\u6210\u4e24\u4e2a\u4e3b\u8981\u90e8\u5206\uff1a\u7533\u529e\u8005\u7684\u8d23\u4efb\u548c\u7814\u7a76\u8005\u7684\u8d23\u4efb\u3002<\/span><\/span><\/p>\n

    \u7533\u529e\u8005\u7684\u8d23\u4efb\u5305\u62ec\u4e3a\u7814\u7a76\u8005\u63d0\u4f9b\u8bd5\u9a8c\u7528\u836f\u54c1\uff0c\u8fd9\u4e0d\u4ec5\u5305\u62ec\u6240\u7814\u7a76\u7684\u836f\u7269\uff0c\u8fd8\u5305\u62ec\u7814\u7a76\u4e2d\u6240\u9700\u8981\u7684\u5bf9\u7167\u836f\u6216\u5b89\u6170\u5242\u3002\u5728\u5411\u7814\u7a76\u8005\u63d0\u4f9b\u8bd5\u9a8c\u7528\u836f\u4e4b\u524d\uff0c\u7533\u529e\u8005\u5e94\u786e\u5b9a\u8be5\u7814\u7a76\u5df2\u83b7\u5f97\u4f26\u7406\u59d4\u5458\u4f1a\u548c\u7ba1\u7406\u673a\u6784\u7684\u6279\u51c6\u3002\u7533\u529e\u8005\u8fd8\u5e94\u8be5\u5efa\u7acb\u5173\u4e8e\u8bd5\u9a8c\u7528\u836f\u7ba1\u7406\u548c\u5b58\u50a8\u7684\u7ba1\u7406\u7a0b\u5e8f\uff0c\u8be5\u7a0b\u5e8f\u987b\u5305\u62ec\u8bd5\u9a8c\u7528\u836f\u7684\u5b89\u5168\u6536\u8bab\u3001\u5408\u9002\u7684\u5b58\u50a8\u4ee5\u53ca\u53d1\u653e\u8bb0\u5f55\u3001\u4ece\u75c5\u4eba\u5904\u6536\u56de\u672a\u4f7f\u7528\u7684\u836f\u54c1\u4ee5\u53ca\u8bd5\u9a8c\u6700\u7ec8\u7531\u7814\u7a76\u8005\u5411\u7533\u529e\u8005\u5f52\u8fd8\u672a\u4f7f\u7528\u7684\u836f\u54c1\u548c\u5176\u4ed6\u5269\u4f59\u836f\u54c1\u3002<\/span><\/p>\n

    \u7533\u529e\u8005\u5e94\u4fdd\u8bc1\u53ca\u65f6\u5730\u63d0\u4f9b\u8bd5\u9a8c\u7528\u836f\u54c1\uff0c\u5e76\u4e14\u5e94\u4fdd\u8bc1\u5b83\u4eec\u521a\u597d\u5728\u7814\u7a76\u5f00\u59cb\u4e4b\u524d\u4ea4\u7ed9\u7814\u7a76\u8005\u3002\u8fd9\u6837\uff0c\u7814\u7a76\u8005\u53ef\u4ee5\u7acb\u5373\u7b5b\u67e5\u3001\u5165\u7ec4\u75c5\u4eba\u3002\u7533\u529e\u8005\u5fc5\u987b\u4fdd\u5b58\u836f\u54c1\u8fd0\u8f93\u3001\u6536\u8bab\u3001\u53d1\u653e\u3001\u5f52\u8fd8\u4ee5\u53ca\u9500\u6bc1\u7684\u8bb0\u5f55\u3002\u8fd8\u5e94\u8be5\u5efa\u7acb\u53ec\u56de\u7684\u7cfb\u7edf\uff0c\u4ee5\u4fbf\u5728\u53d1\u751f\u836f\u54c1\u53ec\u56de\u3001\u5931\u6548\u53ca\u5728\u7814\u7a76\u7ed3\u675f\u7684\u65f6\u5019\u56de\u6536\u8bd5\u9a8c\u7528\u836f\u3002\u5fc5\u987b\u5efa\u7acb\u836f\u54c1\u9500\u6bc1\u7684\u7a0b\u5e8f\u3002\u6211\u4eec\u5e94\u8be5\u6e05\u70b9\u8fd4\u8fd8\u7684\u6bcf\u4e00\u7247\u836f\u7269\u6216\u5236\u5242\uff0c\u8fd8\u5e94\u8be5\u5bf9\u8fd9\u4e9b\u836f\u54c1\u7684\u9500\u6bc1\u8fdb\u884c\u8bb0\u5f55\u3002<\/span><\/p>\n

    \u7533\u529e\u8005\u8fd8\u5e94\u8be5\u786e\u4fdd\u8bd5\u9a8c\u7528\u836f\u54c1\u5728\u6574\u4e2a\u7814\u7a76\u671f\u95f4\u4fdd\u6301\u7a33\u5b9a\u3002\u53ef\u4ee5\u6709\u51e0\u79cd\u65b9\u6cd5\u3002\u7533\u529e\u8005\u53ef\u4ee5\u5c06\u5931\u6548\u7684\u65e5\u671f\u5199\u5728\u836f\u74f6<\/span>\/<\/span>\u76d2\u4e0a\uff0c\u5e76\u63d0\u4f9b\u4e00\u4e2a\u5199\u6709\u5931\u6548\u65e5\u671f\u7684\u836f\u68c0\u62a5\u544a\u3002\u7533\u529e\u8005\u5e94\u8be5\u4fdd\u5b58\u4e00\u4e9b\u836f\u54c1\u4ee5\u4fbf\u4ee5\u540e\u7684\u5206\u6790\uff0c\u4ee5\u518d\u6b21\u786e\u8ba4\u8d28\u91cf\u6807\u51c6\uff0c\u5e76\u4fdd\u7559\u6bcf\u6279\u836f\u54c1\u7684\u6837\u672c\u3001\u5206\u6790\u7684\u8bb0\u5f55\u4ee5\u53ca\u836f\u54c1\u7279\u70b9\u7684\u8bb0\u5f55\u3002<\/span><\/span><\/p>\n

    \u7814\u7a76\u8005\u6709\u8d23\u4efb\u6e05\u70b9\u836f\u7269\u548c\u4ee5\u5408\u9002\u65b9\u5f0f\u5b58\u50a8\u836f\u7269\u3002\u5982\u679c\u7814\u7a76\u8005\u613f\u610f\uff0c\u4ed6\u6216\u5979\u53ef\u4ee5\u8ba9\u4e00\u4e2a\u836f\u5e08\u6216\u8005\u53e6\u4e00\u4e2a\u5728\u4ed6\u7ba1\u7406\u4e4b\u4e0b\u7684\u4eba\u6765\u505a\u8fd9\u4e24\u4ef6\u4e8b\u3002\u8fd9\u4eba\u53ef\u4ee5\u8d1f\u8d23\u6536\u836f\u3001\u5b58\u50a8\u548c\u6e05\u70b9\u836f\u7269\u4ee5\u53ca\u5411\u53d7\u8bd5\u8005\u53d1\u653e\u836f\u7269\u3002\u7814\u7a76\u8005\u5fc5\u987b\u4fdd\u8bc1\u6240\u6709\u8bd5\u9a8c\u7528\u836f\u7684\u4f7f\u7528\u90fd\u4f9d\u4ece\u8bd5\u9a8c\u65b9\u6848\u3002\u4ed6\u8fd8\u5e94\u8be5\u5411\u6bcf\u4e00\u4e2a\u53d7\u8bd5\u8005\u89e3\u91ca\u8bd5\u9a8c\u7528\u836f\u7684\u4f7f\u7528\u65b9\u6cd5\u3002<\/span><\/p>\n

    \u540c\u6837\uff0c\u7814\u7a76\u8005\u7684\u8d23\u4efb\u8fd8\u5305\u62ec\u4fdd\u5b58\u836f\u7269\u9001\u8fbe\u8be5\u4e2d\u5fc3\u7684\u8bb0\u5f55\u3001\u836f\u7269\u5728\u8be5\u4e2d\u5fc3\u7684\u5e93\u5b58\u8bb0\u5f55\u3001\u6bcf\u4e2a\u53d7\u8bd5\u8005\u4f7f\u7528\u7684\u60c5\u51b5\u8bb0\u5f55\u4ee5\u53ca\u6700\u7ec8\u5c06\u8bd5\u9a8c\u7528\u836f\u5f52\u8fd8\u7ed9\u7533\u529e\u8005\u7684\u8bb0\u5f55\u3002\u8fd9\u4e9b\u8bb0\u5f55\u5fc5\u987b\u5305\u62ec\u65e5\u671f\u3001\u6570\u91cf\u3001\u6279\u53f7\u6216\u7cfb\u5217\u53f7\uff0c\u4ee5\u53ca\u5931\u6548\u671f\uff0c\u8fd8\u6709\u8bd5\u9a8c\u4e2d\u67d0\u53d7\u8bd5\u8005\u4f7f\u7528\u7684\u8bd5\u9a8c\u7528\u836f\u7684\u552f\u4e00\u6027\u7f16\u7801\u3002\u8fd9\u53ef\u4ee5\u901a\u8fc7\u4f7f\u7528\u968f\u673a\u53f7\u6216\u8005\u5165\u9009<\/span>\/\u7b5b\u9009\u53f7\u7801\u6765\u505a\u5230\u3002<\/span><\/span><\/p>\n

    \u603b\u5f97\u8bf4\u6765\uff0c\u7533\u529e\u8005\u5e94\u5efa\u7acb\u76f8\u5173\u7684\u7a0b\u5e8f\u5e76\u5c06\u8fd9\u4e9b\u7a0b\u5e8f\u5199\u4e0b\u6765\u63d0\u4f9b\u7ed9\u7814\u7a76\u8005\u3002\u7814\u7a76\u8005\u5fc5\u987b\u4fdd\u8bc1\u4ed6\u4eec\u9075\u5faa\u4e86\u8bd5\u9a8c\u65b9\u6848\u4ee5\u53ca\u7533\u529e\u8005\u63d0\u4f9b\u7684\u7ba1\u7406\u7a0b\u5e8f\u7684\u8981\u6c42\u3002\u7814\u7a76\u8005\u548c\u7533\u529e\u8005\u90fd\u5e94\u4fdd\u8bc1\u9075\u5b88\u6240\u5728\u56fd\u7684\u6cd5\u89c4\u8981\u6c42\u4ee5\u53ca<\/span>GCP\u7684\u539f\u5219\u8fdb\u884c\u7814\u7a76\u3002<\/span><\/span><\/p>\n

    \u8c22\u8c22\u3002<\/span><\/p>\n


    <\/p>\n

    \u7b2c\u5341\u4e94\u8bb2 <\/span><\/strong>\u5b89\u5168\u6027\u62a5\u544a\u7684\u8d23\u4efb<\/span><\/strong><\/p>\n

    Ms. Noemi Rosa<\/span><\/strong><\/span><\/p>\n

    \u5927\u5bb6\u597d\uff0c\u6211\u662f\u8f89\u745e\u516c\u53f8\u7684 <\/span>Noemi Rosa<\/span>\u3002\u4eca\u5929\u7ed9\u5927\u5bb6\u8bb2\u89e3<\/span>ICH<\/span>\u5b89\u5168\u6027\u62a5\u544a\u7684\u6307\u5357\u3002<\/span>.<\/span><\/span><\/p>\n

    \u4eca\u5929\u4e3b\u8981\u8ba8\u8bba<\/span>ICH GCP<\/span>\u4e2d\u5173\u4e8e\u5b89\u5168\u6027\u7684\u90e8\u5206\u4ee5\u53ca<\/span>ICH E2A <\/span>\u6587\u4ef6\uff0c\u5b83\u6b63\u5f0f\u7684\u9898\u76ee\u662f<\/span>\u201c<\/span>\u4e34\u5e8a\u5b89\u5168\u6027\u6570\u636e\u7ba1\u7406\uff1a\u5feb\u901f\u62a5\u544a\u7684\u5b9a\u4e49\u548c\u6807\u51c6<\/span>\u201d<\/span>\u3002<\/span><\/span><\/p>\n

    \u76ee\u7684<\/span>:<\/span><\/strong>\u5728\u672c\u8282\u7ed3\u675f\u65f6\uff0c\u5927\u5bb6\u5c06\u719f\u6089<\/span>ICH<\/span><\/strong>\u7684\u4e0b\u5217\u5b9a\u4e49\uff1a<\/span><\/span><\/p>\n

    \u2022\u4e0d\u826f\u4e8b\u4ef6\u6216<\/span>AE<\/span><\/p>\n

    \u2022<\/span>\u836f\u7269\u4e0d\u826f\u53cd\u5e94\u6216<\/span>ADR,<\/span><\/p>\n

    \u2022<\/span>\u672a\u9884\u671f\u7684\u836f\u7269\u4e0d\u826f\u53cd\u5e94<\/span><\/p>\n

    \u2022\u4e25\u91cd\u4e0d\u826f\u4e8b\u4ef6<\/span><\/p>\n

    \u6b64\u5916\uff0c\u5927\u5bb6\u8fd8\u4f1a\u719f\u6089\u836f\u7269\u7814\u53d1\u671f\u95f4\u5feb\u901f\u62a5\u544a\u7684<\/span>ICH<\/span>\u6807\u51c6\u4ee5\u53ca<\/span>GCP<\/span>\u5b89\u5168\u6027\u62a5\u544a\u7684\u8981\u6c42\u3002<\/span><\/span><\/p>\n

    ICH<\/span>\u6307\u5357\u4e2d\u6709\u5173\u5b89\u5168\u6027\u7684\u5185\u5bb9\u4e3a\u6211\u4eec\u63d0\u4f9b\u4e86\u6807\u51c6\u7684\u5b9a\u4e49\u548c\u672f\u8bed\u3001\u5728\u7814\u7a76\u671f\u95f4\u8fdb\u884c\u5feb\u901f\u62a5\u544a\u7684\u673a\u5236\u4ee5\u53ca\u5bf9\u7814\u7a76\u8005\u548c\u7533\u529e\u8005\u8fdb\u884c\u5b89\u5168\u6027\u62a5\u544a\u7684\u8981\u6c42\u3002<\/span><\/span><\/p>\n

    \u5b9a\u4e49\u548c\u672f\u8bed<\/span>: <\/span><\/strong><\/span><\/p>\n

    \u9996\u5148\uff0c\u8ba9\u6211\u4eec\u8ba8\u8bba\u4e00\u4e0b\u4e0d\u826f\u4e8b\u4ef6\u7684\u5b9a\u4e49\u3002<\/span><\/p>\n

    \u6839\u636e<\/span>ICH<\/span>\u7684\u5b9a\u4e49\uff0c\u4e00\u4e2a\u4e0d\u826f\u4e8b\u4ef6\uff0c\u662f\u6307\u75c5\u4eba\u6216\u4e34\u5e8a\u8bd5\u9a8c\u53d7\u8bd5\u8005\u63a5\u53d7\u4e00\u79cd\u836f\u54c1\u540e\u51fa\u73b0\u7684\u4e0d\u826f\u533b\u5b66\u8868\u73b0\uff0c\u4f46\u5e76\u4e0d\u4e00\u5b9a\u4e0e\u8be5\u6cbb\u7597\u6709\u56e0\u679c\u5173\u7cfb\u3002<\/span><\/span><\/p>\n

    \u56e0\u6b64\uff0c\u4e0d\u826f\u4e8b\u4ef6\u53ef\u4ee5\u662f\u4efb\u4f55\u672a\u9884\u671f\u6216\u4e0d\u9002\u7684\u75c7\u72b6\u3001\u4f53\u5f81\u6216\u75be\u75c5\uff0c\u6682\u65f6\u5730\u4e0e\u836f\u7269\u6709\u5173\u8054\uff0c\u4f46\u4e0d\u4e00\u5b9a\u4e0e\u836f\u7269\u6709\u56e0\u679c\u5173\u7cfb\u3002\u5173\u4e8e\u836f\u7269\u4e0d\u826f\u53cd\u5e94\u6216\u79f0<\/span>ADR<\/span>\uff0c<\/span>ICH E2A <\/span>\u6307\u5357\u63d0\u4f9b\u4e86\u4e24\u4e2a\u5b9a\u4e49\uff1a<\/span><\/span><\/p>\n

    \u2022 \u7b2c\u4e00\u4e2a\u5b9a\u4e49\u662f\u5bf9\u4e8e\u6279\u51c6\u4e0a\u5e02\u524d\u7684\u4e34\u5e8a\u7814\u7a76\u9636\u6bb5<\/span><\/p>\n

    \u2022 \u7b2c\u4e8c\u4e2a\u5b9a\u4e49\u5e94\u7528\u4e8e\u4e0a\u5e02\u540e\u7684\u836f\u7269<\/span><\/p>\n

    \u5bf9\u4e8e\u6279\u51c6\u4e0a\u5e02\u524d\u7684\u4e34\u5e8a\u7814\u7a76\u9636\u6bb5\uff0c\u836f\u7269\u4e0d\u826f\u53cd\u5e94\u6307\u5728\u4efb\u4f55\u5242\u91cf\u4e0b\u51fa\u73b0\u7684\u4e0d\u9002\u548c\u975e\u9884\u671f\u7684\u53cd\u5e94\u3002<\/span>ICH<\/span>\u4f7f\u7528\u4e86<\/span>\u201c<\/span>\u5bf9\u836f\u7269\u7684\u53cd\u5e94<\/span>\u201c<\/span>\uff0c\u610f\u6307\u56e0\u679c\u5173\u7cfb\u81f3\u5c11\u662f\u4e00\u79cd\u5408\u7406\u7684\u53ef\u80fd\u6027\u3002<\/span><\/span><\/p>\n

    ICH<\/span>\u5bf9\u4e8e\u4e0a\u5e02\u540e\u836f\u54c1\u7684\u836f\u7269\u4e0d\u826f\u53cd\u5e94\u7684\u5b9a\u4e49\u662f\u5728\u5e38\u89c4\u5242\u91cf\u4e0b\u7528\u4e8e\u9884\u9632\u3001\u8bca\u65ad\u6216\u6cbb\u7597\u6216\u8005\u8c03\u6574\u751f\u7406\u673a\u80fd\u65f6\u51fa\u73b0\u7684\u4e0d\u9002\u548c\u975e\u9884\u671f\u7684\u53cd\u5e94\u3002<\/span><\/span><\/p>\n

    \u73b0\u5728\u8ba9\u6211\u4eec\u8ba8\u8bba\u4e00\u4e0b\u672a\u9884\u671f\u7684\u836f\u7269\u4e0d\u826f\u53cd\u5e94\u7684\u5b9a\u4e49\u3002<\/span>ICH\u5c06\u5176\u5b9a\u4e49\u4e3a\u4e00\u79cd\u4e0d\u826f\u53cd\u5e94\uff0c\u5176\u7279\u70b9\u548c\u4e25\u91cd\u5ea6\u4e0e\u73b0\u6709\u7684\u4ea7\u54c1\u4fe1\u606f\u4e0d\u7b26\u3002<\/span>\u201c\u836f\u7269\u7684\u540c\u7c7b\u6548\u5e94<\/span>\u201d \u5728\u6b64\u4e0d\u9002\u7528\uff0c\u56e0\u4e3a\u5b83\u662f\u4e0d\u80fd<\/span>\u4ece\u836f\u54c1\u7684\u836f\u7406\u7279\u70b9\u4e2d\u63a8\u65ad\u51fa\u6765\u7684\u3002<\/span><\/span><\/p>\n

    \u201c\u4e25\u91cd<\/span>\u201d\u548c<\/span>\u201c\u91cd\u5ea6<\/span>\u201d\u6709\u5f88\u91cd\u8981\u7684\u5dee\u522b\u3002\u5bf9\u4e8e\u4e00\u4e2a\u4e0d\u826f\u4e8b\u4ef6\u800c\u8a00\uff0c\u53ef\u4ee5\u6839\u636e\u4e25\u91cd\u7a0b\u5ea6\u5206\u7ea7\uff08\u5373\uff0c\u8f7b\u5ea6\u3001\u4e2d\u5ea6\u6216\u91cd\u5ea6\u7684\u5934\u75db\uff09\u3002\u4e00\u4e2a\u4e0d\u826f\u4e8b\u4ef6\u88ab\u79f0\u4e3a<\/span>\u201c\u4e25\u91cd<\/span>\u201d\u662f\u56e0\u4e3a\u5b83\u7b26\u5408\u6309\u8f6c\u5f52\u6216\u8005\u533b\u5b66\u610f\u4e49\u89c4\u5b9a\u7684\u6807\u51c6\uff0c\u6211\u4eec\u5c06\u5728\u4ee5\u540e\u8be6\u7ec6\u8ba8\u8bba\u8fd9\u4e00\u70b9\u3002\u4e25\u91cd\u6027\uff08\u800c\u4e0d\u662f\u4e25\u91cd\u7a0b\u5ea6\uff09\u88ab\u4f5c\u4e3a<\/span>ICH E2A\u6587\u4ef6\u4e2d\u754c\u5b9a\u5411\u7ba1\u7406\u673a\u6784\u62a5\u544a\u8d23\u4efb\u7684\u6807\u51c6\u3002\u56e0\u6b64\uff0c\u4e86\u89e3\u6709\u5173\u4e25\u91cd\u4e0d\u826f\u4e8b\u4ef6\u7684\u5b9a\u4e49\u662f\u975e\u5e38\u91cd\u8981\u7684\u3002<\/span><\/span><\/p>\n

    \u4e00\u4e2a\u4e25\u91cd\u4e0d\u826f\u4e8b\u4ef6\uff08<\/span>SAE) <\/span>\u662f\u6307\u5728\u4efb\u4f55\u5242\u91cf\u4e0b\u51fa\u73b0\u7684\u4efb\u4f55\u4e0d\u826f\u533b\u5b66\u60c5\u51b5\uff0c\u5b83<\/span>:<\/span><\/span><\/p>\n

    \u2022\u9020\u6210\u6b7b\u4ea1<\/span><\/p>\n

    \u2022\u5a01\u80c1\u751f\u547d<\/span><\/p>\n

    \u2022\u9700\u8981\u4f4f\u9662\u6216\u8005\u4f7f\u5f97\u539f\u6709\u7684\u4f4f\u9662\u65f6\u95f4\u5ef6\u957f<\/span><\/p>\n

    \u2022\u9020\u6210\u6c38\u4e45\u7684\u6216\u663e\u8457\u7684\u6b8b\u75be<\/span>\/<\/span>\u529f\u80fd\u969c\u788d<\/span><\/p>\n

    \u2022\u5148\u5929\u6027\u5f02\u5e38<\/span> \/ <\/span>\u51fa\u751f\u7f3a\u9677<\/span><\/p>\n

    ICH<\/span>\u5bf9\u4e25\u91cd\u4e0d\u826f\u4e8b\u4ef6\u7684\u5b9a\u4e49\u8fd8\u5305\u62ec\uff0c\u5bf9\u4e00\u4e9b\u91cd\u8981\u533b\u5b66\u4e8b\u4ef6\u9700\u8981\u5e94\u7528\u533b\u5b66\u548c\u79d1\u5b66\u7684\u5224\u65ad\u6765\u51b3\u5b9a\u662f\u5426\u8fdb\u884c\u5feb\u901f\u62a5\u544a\uff0c\u8fd9\u4e9b\u91cd\u8981\u533b\u5b66\u4e8b\u4ef6\u867d\u7136\u4e0d\u4f1a\u9a6c\u4e0a\u5a01\u80c1\u751f\u547d\u6216\u5f15\u8d77\u6b7b\u4ea1\u3001\u4f4f\u9662\u4f46\u4ecd\u53ef\u80fd\u5371\u53ca\u75c5\u4eba\u5e76\u9700\u8981\u5e72\u9884\u6765\u9632\u6b62\u5b9a\u4e49\u4e2d\u540e\u679c\u7684\u53d1\u751f\u3002\u901a\u5e38\uff0c\u6839\u636e<\/span>ICH<\/span>\u6307\u5357\uff0c\u8fd9\u4e9b\u60c5\u51b5\u4e5f\u5e94\u88ab\u8ba4\u4e3a\u662f\u4e25\u91cd\u4e0d\u826f\u4e8b\u4ef6\u3002<\/span><\/span><\/p>\n

    ICH E2A<\/span>\u4e2d\u63d0\u53ca\u7684\u4e00\u4e9b\u91cd\u8981\u533b\u5b66\u4e8b\u4ef6\u7684\u4f8b\u5b50\u6709\uff1a\u8fc7\u654f\u6027\u652f\u6c14\u7ba1\u75c9\u631b\uff0c\u9700\u8981\u5728\u6025\u8bca\u5ba4\u6216\u5bb6\u91cc\u884c\u76d1\u62a4\u6cbb\u7597\uff1b\u8840\u6db2\u5371\u8c61\u6216\u62bd\u6410\uff0c\u4f46\u6ca1\u6709\u9020\u6210\u4f4f\u9662\uff1b\u6216\u8005\u51fa\u73b0\u836f\u7269\u4f9d\u8d56\u6216\u836f\u7269\u6ee5\u7528\u3002<\/span><\/span><\/p>\n

    \u5728\u7814\u671f\u95f4\u836f\u7269\u7684\u5feb\u901f\u62a5\u544a<\/span><\/p>\n

    \u9996\u5148\uff0c\u6839\u636e<\/span>ICH<\/span>\u6307\u5357\uff0c\u4ec0\u4e48\u662f\u5e94\u8be5\u5feb\u901f\u62a5\u544a\u7ed9\u7ba1\u7406\u673a\u6784\u7684\u5462\uff1f\u5b83\u4eec\u662f\u4e25\u91cd\u7684\u3001\u672a\u9884\u671f\u7684\u3001\u4ee5\u53ca\u5728\u7814\u7a76\u671f\u95f4\u4e0e\u7814\u7a76\u836f\u7269\u6709\u5408\u7406\u7684\u56e0\u679c\u5173\u7cfb\u7684\u4e0d\u826f\u4e8b\u4ef6\u3002<\/span>ICH<\/span>\u5728<\/span>E2A<\/span>\u6307\u5357\u4e2d\u63d0\u5230\uff0c\u4e0a\u5e02\u540e\u836f\u7269\u7684\u81ea\u53d1\u62a5\u544a\u5f80\u5f80\u610f\u5473\u7740\u6709\u56e0\u679c\u5173\u7cfb\u3002<\/span>. <\/span><\/span><\/p>\n

    \u5176\u4ed6\u53ef\u80fd\u9700\u8981\u8fdb\u884c\u5feb\u901f\u62a5\u544a\u7684\u60c5\u51b5\u662f\uff1a\u4efb\u4f55\u53ef\u80fd\u5f71\u54cd\u836f\u7269\u76ca\u5904\uff0d\u98ce\u9669\u8bc4\u4ef7\u6216\u8005\u5f71\u54cd\u4e34\u5e8a\u7814\u7a76\u8fdb\u884c\u7684\u4fe1\u606f\uff0c\u6307\u5357\u4e2d\u7684\u4e00\u4e9b\u4e8b\u4f8b\u5982\u4e0b<\/span>:<\/span><\/span><\/p>\n

    \u2022<\/span>\u9884\u671f\u4e2d\u7684\u4e25\u91cd\u4e0d\u826f\u53cd\u5e94\uff0c\u4f46\u53d1\u751f\u7684\u9891\u7387\u589e\u52a0\uff0c\u5e76\u88ab\u8ba4\u4e3a\u6709\u4e34\u5e8a\u610f\u4e49<\/span><\/p>\n

    \u2022<\/span>\u5bf9\u60a3\u8005\u4eba\u7fa4\u6709\u663e\u8457\u5371\u5bb3\uff0c\u5982<\/span>,<\/span>\u5c06\u7f3a\u4e4f\u7597\u6548\u7684\u836f\u7269\u7528\u4e8e\u81f4\u6b7b\u6027\u75be\u75c5\u7684\u6cbb\u7597<\/span><\/p>\n

    \u2022<\/span>\u5728\u65b0\u5b8c\u6210\u7684\u52a8\u7269\u5b9e\u9a8c\u4e2d\u6709\u91cd\u8981\u7684\u5b89\u5168\u6027\u53d1\u73b0\uff0c\u5982\u53d1\u73b0\u81f4\u764c\u6027<\/span><\/p>\n

    ICH<\/span>\u6307\u5357\u6307\u51fa\u9700\u8981\u8fdb\u884c\u5feb\u901f\u62a5\u544a\u7684\u6700\u4f4e\u6807\u51c6\u662f\uff1a<\/span><\/span><\/p>\n

    \u2022<\/span><\/span>\u4e00\u4e2a\u53ef\u786e\u5b9a\u7684\u75c5\u4eba<\/span><\/p>\n

    \u2022\u4e00\u4e2a\u6000\u7591\u7684\u836f\u7269<\/span><\/p>\n

    \u2022<\/span><\/span>\u4e00\u4e2a\u53ef\u786e\u5b9a\u7684\u62a5\u544a\u6765\u6e90<\/span><\/p>\n

    \u2022\u4e2a\u4e8b\u4ef6\u6216\u540e\u679c\uff0c\u5b83\u88ab\u786e\u5b9a\u662f\u4e25\u91cd\u7684\u548c\u672a\u9884\u671f\u7684<\/span><\/p>\n

    \u2022<\/span>\u5bf9\u4e8e\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u7684\u75c5\u4f8b\uff0c\u6709\u5408\u7406\u7684\u53ef\u7591\u56e0\u679c\u5173\u7cfb<\/span><\/p>\n

    \u7814\u7a76\u8005\u7684\u8d23\u4efb<\/span><\/p>\n

    \u7814\u7a76\u8005\u7684\u8d23\u4efb\u662f\u7acb\u5373\u5411\u7533\u529e\u8005\u62a5\u544a\u6240\u6709\u7684\u4e25\u91cd\u4e0d\u826f\u4e8b\u4ef6\uff0c\u5728\u7814\u7a76\u65b9\u6848\u6216\u5176\u4ed6\u6587\u4ef6\u4e2d\u786e\u5b9a\u7684\u4e0d\u9700\u8981\u7acb\u5373\u62a5\u544a\u7684\u60c5\u51b5\u9664\u5916\u3002\u7814\u7a76\u8005\u8fd8\u5e94\u8be5\u9075\u4ece\u6709\u5173\u7684\u6cd5\u89c4\u8981\u6c42\u5411\u7ba1\u7406\u90e8\u95e8\u548c<\/span>IRB \/ <\/span>\u4f26\u7406\u59d4\u5458\u4f1a\u62a5\u544a\u672a\u9884\u671f\u7684\u4e25\u91cd\u836f\u7269\u4e0d\u826f\u53cd\u5e94<\/span> (ADRs)<\/span>\u3002<\/span><\/span><\/p>\n

    \u7814\u7a76\u8005\u5e94\u8be5\u5728\u8bd5\u9a8c\u65b9\u6848\u89c4\u5b9a\u7684\u65f6\u95f4\u5185\u5c06\u65b9\u6848\u786e\u5b9a\u7684\u5b89\u5168\u6027\u8bc4\u4ef7\u6240\u9700\u7684\u6240\u6709\u9879\u76ee\u62a5\u544a\u7ed9\u7533\u529e\u8005\uff0c\u4f8b\u5982\uff0c\u4f5c\u4e3a\u836f\u7269\u5b89\u5168\u6027\u8bc4\u4ef7\u7684\u4e00\u90e8\u5206\uff0c\u5e94\u5728\u8bd5\u9a8c\u65b9\u6848\u89c4\u5b9a\u7684\u65f6\u95f4\u5185\u5c06\u4e0d\u826f\u4e8b\u4ef6\u548c<\/span> \/ <\/span>\u6216\u5b9e\u9a8c\u5ba4\u5f02\u5e38\u62a5\u544a\u7ed9\u7533\u529e\u8005\u3002<\/span><\/span><\/p>\n

    \u5bf9\u4e8e\u6b7b\u4ea1\u7684\u62a5\u544a\uff0c\u7814\u7a76\u8005\u5e94\u8be5\u5c06\u6240\u8981\u6c42\u7684\u5176\u4ed6\u4fe1\u606f\u62a5\u544a\u7ed9\u7533\u529e\u8005\u548c<\/span>IRB\/<\/span>\u4f26\u7406\u59d4\u5458\u4f1a\u3002\u8fd9\u4e9b\u6587\u4ef6\u5305\u62ec\u5982\u5c38\u68c0\u62a5\u544a\u6216\u75c5\u5386\u8bb0\u5f55\u3002\u5e94\u6ce8\u610f\uff0c\u4e0d\u540c\u7684\u56fd\u5bb6\u5bf9\u6b64\u8981\u6c42\u53ef\u4ee5\u6709\u6240\u4e0d\u540c\u3002<\/span><\/span><\/p>\n

    \u5411\u7ba1\u7406\u673a\u6784\u62a5\u544a\u7684\u65f6\u95f4\u8981\u6c42\u4e3a\uff0c\u5bf9\u4e8e\u81f4\u6b7b\u6027\u6216\u5a01\u80c1\u751f\u547d\u7684\u672a\u9884\u671f\u7684\u836f\u7269\u4e0d\u826f\u53cd\u5e94\uff0c\u7533\u529e\u8005\u5e94\u5c3d\u5feb\u62a5\u544a\uff0c\u4f46\u6700\u8fdf\u4e0d\u8d85\u8fc7\u5176\u9996\u6b21\u4e86\u89e3\u8be5\u75c5\u4f8b\u7b26\u5408\u5feb\u901f\u62a5\u544a\u6807\u51c6\u540e<\/span>7<\/span>\u5929\uff08\u65e5\u5386\u65e5\uff09\u5185\u3002\u5728\u9996\u6b21\u5feb\u901f\u62a5\u544a\u540e\u7684<\/span>8<\/span>\u5929\u5185\uff08\u65e5\u5386\u65e5\uff09\u8fd8\u5fc5\u987b\u63d0\u4f9b\u4e00\u4efd\u5b8c\u6574\u7684\u62a5\u544a\uff08\u5373\uff0c\u5b8c\u6574\u7684\u62a5\u544a\u5728\u7533\u529e\u8005\u9996\u6b21\u77e5\u9053\u4e8b\u4ef6\u7684\u53d1\u751f\u540e<\/span>15<\/span>\u5929\u5185\u5b8c\u6210\uff09<\/span><\/span><\/p>\n

    \u5bf9\u4e8e\u6240\u6709\u5176\u4ed6\u7684\u4e25\u91cd\u672a\u9884\u671f\u836f\u7269\u4e0d\u826f\u53cd\u5e94\u2015\u2015\u2015\u4e25\u91cd\u7684\u672a\u9884\u671f\u7684\u3001\u76f8\u5173\u7684\u4f46\u4e0d\u662f\u81f4\u6b7b\u6027\u6216\u5a01\u80c1\u751f\u547d\u7684\uff0d\u7533\u529e\u8005\u5e94\u5c3d\u5feb\u62a5\u544a\uff0c\u4f46\u4e0d\u8fdf\u4e8e\u5176\u9996\u6b21\u77e5\u9053\u8be5\u75c5\u4f8b\u7b26\u5408\u5feb\u901f\u62a5\u544a\u6807\u51c6\u7684<\/span>15<\/span>\u5929\u4e4b\u5185\uff08\u65e5\u5386\u65e5\uff09\u3002<\/span><\/span><\/p>\n

    \u7533\u529e\u8005\u8fd8\u5e94\u8be5\u5411\u6240\u6709\u76f8\u5173\u7684\u7814\u7a76\u8005\u548c\u7814\u7a76\u673a\u6784\u5feb\u901f\u62a5\u544a\u6240\u6709\u4e25\u91cd\u7684\u548c\u672a\u9884\u671f\u7684\u836f\u7269\u4e0d\u826f\u53cd\u5e94\uff0c\u9700\u8981\u65f6\u4e5f\u8981\u5411<\/span>IRB\/<\/span>\u4f26\u7406\u59d4\u5458\u4f1a\u8fdb\u884c\u62a5\u544a\u3002\u901a\u5e38\u505a\u6cd5\u662f\uff0c\u7533\u529e\u8005\u4f1a\u5148\u5411\u7814\u7a76\u8005\u62a5\u544a\uff0c\u7136\u540e\u518d\u7531\u7814\u7a76\u8005\u901a\u77e5\u5f53\u5730\u7684<\/span>IRB<\/span>\u6216\u4f26\u7406\u59d4\u5458\u4f1a\u3002<\/span><\/span><\/p>\n

    \u5982\u524d\u6240\u8ff0\uff0c\u7533\u529e\u8005\u4e5f\u5e94\u8be5\u901a\u77e5\u836f\u653f\u7ba1\u7406\u90e8\u95e8\u3002\u5feb\u901f\u62a5\u544a\u5fc5\u987b\u7b26\u5408\u6709\u5173\u7684\u6cd5\u89c4\u8981\u6c42\u4ee5\u53ca<\/span>ICH<\/span>\u6709\u5173\u5b89\u5168\u6027\u7ba1\u7406\u7684\u6307\u5357\u3002\u7533\u529e\u8005\u5e94\u8be5\u6839\u636e\u836f\u653f\u7ba1\u7406\u90e8\u95e8\u7684\u8981\u6c42\u63d0\u4ea4\u6240\u6709\u7684\u6700\u65b0\u5b89\u5168\u6027\u8d44\u6599\u5e76\u505a\u5b9a\u671f\u62a5\u544a\u3002<\/span><\/span><\/p>\n

    \u76f2\u6cd5\u8bd5\u9a8c\u7684\u7ba1\u7406\uff0c\u5176\u4ed6<\/span><\/p>\n

    ICH E2A <\/span>\u6307\u5357\u8ba8\u8bba\u4e86\u5e94\u8be5\u600e\u6837\u7ba1\u7406\u76f2\u6cd5\u8bd5\u9a8c\u7684\u539f\u5219\u3002\u6307\u5357\u6307\u51fa\uff0c\u5982\u679c\u7814\u7a76\u8005\u6ca1\u6709\u7834\u76f2\uff0c\u7533\u529e\u8005\u53ef\u4ee5\u6839\u636e\u8be5\u4e8b\u4ef6\u5c5e\u5feb\u901f\u62a5\u544a\u7684\u75c5\u4f8b\u800c\u9488\u5bf9\u67d0\u7279\u5b9a\u7684\u75c5\u4eba\u7834\u76f2\u3002\u5982\u679c\u53ef\u80fd\uff0c\u5e94\u8be5\u4f7f\u5206\u6790\u548c\u89e3\u91ca\u7ed3\u679c\u7684\u4eba\u5458\u7ee7\u7eed\u4fdd\u6301\u76f2\u6001\u76f4\u5230\u7814\u7a76\u7ed3\u675f\u3002\u6307\u5357\u4e5f\u6307\u51fa\uff0c\u5982\u679c<\/span>\u201c<\/span>\u81f4\u6b7b<\/span>\u201d<\/span>\u6216\u5176\u4ed6<\/span>\u201c<\/span>\u4e25\u91cd<\/span>\u201d<\/span>\u540e\u679c\u662f\u7814\u7a76\u7684\u4e3b\u8981\u7597\u6548\u7ec8\u70b9\uff0c\u7533\u529e\u8005\u5e94\u8be5\u4e8b\u5148\u4e0e\u7ba1\u7406\u90e8\u95e8\u8fbe\u6210\u4e00\u81f4\uff0c\u5c06\u8fd9\u7c7b\u4e25\u91cd\u4e0d\u826f\u4e8b\u4ef6\u5e94\u6309\u7167<\/span>\u201c<\/span>\u4e0e\u75be\u75c5\u76f8\u5173<\/span>\u201d<\/span>\u6765\u5904\u7406\uff0c\u800c\u4e0d\u662f\u6309\u5e38\u89c4\u505a\u5feb\u901f\u62a5\u544a\u3002<\/span><\/span><\/p>\n

    E2A\u6307\u5357\u8fd8\u5305\u62ec\u4e00\u4e9b\u5176\u4ed6\u4e8b\u9879\u7684\u6307\u5bfc\u539f\u5219\uff0c\u5982\u6d3b\u6027\u5bf9\u7167\u7684\u7814\u7a76\u4e2d\u5e94\u600e\u6837\u62a5\u544a\u4e25\u91cd\u4e0d\u826f\u4e8b\u4ef6\u3002\u5982\u679c\u4e00\u4e2a\u4e25\u91cd\u4e0d\u826f\u4e8b\u4ef6\u7b26\u5408\u5feb\u901f\u62a5\u544a\u7684\u6807\u51c6\u800c\u53d7\u8bd5\u8005\u662f\u5728\u6d3b\u6027\u836f\u7269\u5bf9\u7167\u7ec4\uff0c\u7533\u529e\u8005\u5e94\u8be5\u5411\u8be5\u836f\u7269\u7684\u751f\u4ea7\u5546\u6216\u5411\u7ba1\u7406\u90e8\u95e8\u62a5\u544a\u3002<\/span><\/span><\/p>\n

    \u5b89\u6170\u5242\u7ec4\u53d1\u751f\u7684\u4e8b\u4ef6\u901a\u5e38\u4e0d\u6ee1\u8db3\u836f\u7269\u76f8\u5173\u4e8b\u4ef6\u7684\u6807\u51c6\uff0c\u5373\u4e0d\u662f\u4e00\u79cd\u836f\u7269\u4e0d\u826f\u53cd\u5e94\uff0c\uff0c\u6240\u4ee5\u901a\u5e38\u4e0d\u9700\u8981\u5feb\u901f\u62a5\u544a\u3002<\/span><\/p>\n

    \u6709\u4e00\u79cd\u4ee5\u4e0a\u914d\u65b9\u7684\u836f\u54c1\u51fa\u73b0\u4e25\u91cd\u4e0d\u826f\u4e8b\u4ef6\uff0c\u5e94\u63a8\u5ef6\u81f3\u5176\u6240\u6709\u914d\u65b9\u548c\u4f7f\u7528\u4e2d\u7684\u4ea7\u54c1\u3002\u5bf9\u7814\u7a76\u5b8c\u6210\u4ee5\u540e\u51fa\u73b0\u7684\u4e8b\u4ef6\uff0c\u7533\u529e\u8005\u5e94\u8be5\u5411\u5bf9\u5f85\u7814\u7a76\u4e2d\u53d1\u751f\u7684\u4e8b\u4ef6\u4e00\u6837\u8fdb\u884c\u5904\u7406\u3002\u5c31\u662f\u8bf4\uff0c\u7533\u529e\u8005\u5e94\u8be5\u5bf9\u8be5\u4e8b\u4ef6\u7684\u8bc4\u4ef7\u4ee5\u786e\u5b9a\u5176\u662f\u5426\u4e3a\u4e25\u91cd\u7684\u3001\u672a\u9884\u671f\u7684\u3001\u76f8\u5173\u7684\u4ee5\u53ca\u662f\u5426\u4e3a\u81f4\u6b7b\u6027\u7684\u6216\u5a01\u80c1\u751f\u547d\u7684\uff0d\u5982\u679c\u662f\u8fd9\u6837\uff0c\u5219\u987b\u5feb\u901f\u62a5\u544a\u3002<\/span><\/p>\n

    \u8c22\u8c22\u5927\u5bb6\u3002<\/span><\/p>\n


    <\/p>\n

    \u7b2c\u5341\u516d\u8bb2 <\/span><\/strong>\u75c5\u4f8b\u62a5\u544a\u8868\u586b\u5199\u6307\u5357<\/span><\/strong><\/p>\n

    Mr. Brian Peters<\/span><\/strong><\/span><\/p>\n

    \u5927\u5bb6\u597d\uff0c\u6211\u662f <\/span>Brian Peters<\/span>\u3002\u6211\u7684\u5de5\u4f5c\u9886\u57df\u662f\u57f9\u8bad\u548c\u804c\u4e1a\u53d1\u5c55\uff0c\u6211\u53c2\u4e0e\u4e34\u5e8a\u7814\u7a76\u5de5\u4f5c\u5df2\u6709<\/span>10<\/span>\u5e74\u4e86\u3002\u4eca\u5929\u4e3b\u8981\u7ed9\u5927\u5bb6\u4ecb\u7ecd\u5982\u4f55\u5b8c\u6210\u75c5\u4f8b\u62a5\u544a\u8868\u3002\u5185\u5bb9\u5305\u62ec\u75c5\u4f8b\u62a5\u544a\u8868\u7684\u5b9a\u4e49\u3001\u586b\u5199\u548c\u66f4\u6b63\u75c5\u4f8b\u62a5\u544a\u8868\u7684\u8d23\u4efb\u3001\u75c5\u4f8b\u62a5\u544a\u8868\u548c\u8bd5\u9a8c\u65b9\u6848\u7684\u5173\u7cfb\u3001\u75c5\u4f8b\u62a5\u544a\u8868\u4e0e\u539f\u59cb\u6587\u4ef6\u7684\u5173\u7cfb\uff0c\u586b\u5199\u75c5\u4f8b\u62a5\u544a\u8868\u4e2d\u5e38\u89c1\u7684\u9519\u8bef\u4ee5\u53ca\u5982\u4f55\u907f\u514d\u8fd9\u4e9b\u9519\u8bef\uff0c\u7533\u529e\u8005\u7684\u5ba1\u6838\u8fc7\u7a0b\uff0c\u6570\u636e\u6f84\u6e05\u8868\u4ee5\u53ca\u6587\u4ef6\u4fdd\u5b58\u7684\u8981\u6c42\u3002<\/span><\/span><\/p>\n

    ICH<\/span>\u5c06\u75c5\u4f8b\u62a5\u544a\u8868\uff08<\/span>CRF) <\/span>\u5b9a\u4e49\u4e3a\u4e00\u79cd\u5370\u5237\u7684\u3001\u53ef\u89c6\u7684\u6216\u8005\u662f\u7535\u5b50\u7248\u7684\u6587\u4ef6\uff0c\u7528\u4e8e\u8bb0\u5f55\u6bcf\u4e2a\u53d7\u8bd5\u8005\u7684\u6240\u6709\u8bd5\u9a8c\u65b9\u6848\u8981\u6c42\u7684\u4fe1\u606f\uff0c\u5411\u7533\u529e\u8005\u62a5\u544a\u3002\u5728\u8fd9\u91cc\u6211\u8981\u6307\u51fa\u7684\u662f\u7535\u5b50\u7248\u8fd9\u4e2a\u8bcd\uff0c\u4f60\u4eec\u4e2d\u7684\u8bb8\u591a\u4eba\u53ef\u80fd\u8fd8\u6ca1\u6709\u673a\u4f1a\u63a5\u89e6\u7535\u5b50\u7248\u7684\u75c5\u4f8b\u62a5\u544a\u8868\uff0c\u4f46\u5236\u836f\u4e1a\u754c\u7684\u8d8b\u52bf\u662f\u9010\u6e10\u8f6c\u5411\u7535\u5b50\u7248<\/span>CRF<\/span>\u3002\u6211\u4eca\u5929\u8bb2\u7684\u5185\u5bb9\u5747\u9002\u7528\u4e8e\u7535\u5b50\u7248\u75c5\u4f8b\u62a5\u544a\u8868\u3002<\/span><\/span><\/p>\n

    \u6211\u4eec\u4ece<\/span>ICH<\/span>\u6307\u5357\u4e2d\u6458\u5f55\u4e86\u4e00\u4e9b\u6709\u5173\u5b8c\u6210\u75c5\u4f8b\u62a5\u544a\u8868\u7684\u6761\u4f8b\u3002\u9996\u5148\uff0c\u7814\u7a76\u8005\u5e94\u4fdd\u8bc1\u5728\u75c5\u4f8b\u62a5\u544a\u8868\u548c\u6240\u6709\u5176\u4ed6\u62a5\u544a\u4e2d\uff0c\u5176\u6570\u636e\u51c6\u786e\u3001\u5b8c\u6574\u3001\u53ef\u8bfb\u548c\u53ca\u65f6\u3002\u524d\u4e09\u70b9\uff0c\u51c6\u786e\u6027\u3001\u5b8c\u6574\u6027\u548c\u53ef\u8bfb\u6027\u5927\u5bb6\u5728\u5b8c\u6210\u75c5\u4f8b\u62a5\u544a\u8868\u65f6\u90fd\u6bd4\u8f83\u6ce8\u610f\uff0c\u5047\u8bbe\u5df2\u7ecf\u505a\u5230\u4e86\u8fd9\u4e09\u70b9\uff0c\u90a3\u4e48\u7b2c\u56db\u70b9\u53ca\u65f6\u6027\u5e38\u5e38\u662f\u5bb9\u6613\u88ab\u5ffd\u7565\u7684\u4f46\u53c8\u662f\u540c\u6837\u91cd\u8981\u7684\u3002\u5982\u679c\u4f60\u5df2\u7ecf\u5728\u51c6\u786e\u6027\u3001\u5b8c\u6574\u6027\u548c\u53ef\u8bfb\u6027\u4e0a\u82b1\u4e86\u5f88\u591a\u52aa\u529b\uff0c\u4f46\u5374\u62d6\u4e86\u51e0\u4e2a\u6708\u624d\u5199\u4e0b\u6765\u7684\uff0c\u90a3\u4e48\u8fd9\u4f1a\u524a\u5f31\u51c6\u786e\u6027\u3001\u5b8c\u6574\u6027\u548c\u53ef\u8bfb\u6027\u3002\u3002<\/span><\/span><\/p>\n

    \u7b2c\u4e8c\u4e2a\u6761\u4f8b\u662f\u5173\u4e8e\u75c5\u4f8b\u62a5\u544a\u8868\u4e2d\u6765\u6e90\u4e8e\u539f\u59cb\u8d44\u6599\u7684\u6570\u636e\u3002\u8fd9\u4e9b\u6570\u636e\u5e94\u8be5\u4e0e\u539f\u59cb\u6587\u4ef6\u4e00\u81f4\uff0c\u5982\u6709\u4efb\u4f55\u4e0d\u540c\uff0c\u5e94\u505a\u51fa\u89e3\u91ca\u3002\u5f53\u76d1\u67e5\u5458\u6765\u5230\u4f60\u7684\u4e2d\u5fc3\uff0c\u4ed6\u6216\u5979\u4f1a\u5c06\u539f\u59cb\u6587\u4ef6\u548c\u75c5\u4f8b\u62a5\u544a\u8868\u4e2d\u586b\u5165\u7684\u5185\u5bb9\u8fdb\u884c\u6bd4\u8f83\u3002\u51e0\u4e4e\u5728\u6240\u6709\u7684\u60c5\u51b5\u4e0b\uff0c\u4e8c\u8005\u5747\u5e94\u76f8\u7b26\uff0c\u5982\u4e0d\u76f8\u7b26\uff0c\u4f60\u8981\u77e5\u9053\u5176\u539f\u56e0\u3002\u6700\u540e\u4e00\u4e2a\u662f\uff0c<\/span>\u201c<\/span>\u75c5\u4f8b\u62a5\u544a\u8868\u4e2d\u7684\u4efb\u4f55\u4fee\u6539\u5fc5\u987b\u6807\u660e\u65e5\u671f\u3001\u59d3\u540d\u7f29\u5199\u4ee5\u53ca\u76f8\u5e94\u7684\u89e3\u91ca\uff0c\u5e76\u4e14\u4e0d\u80fd\u4f7f\u539f\u6709\u7684\u8bb0\u5f55\u4e0d\u80fd\u8fa8\u8ba4\u3002\u7814\u7a76\u8005\u5e94\u4fdd\u5b58\u66f4\u6539\u548c\u66f4\u6b63\u7684\u8bb0\u5f55\u3002<\/span>\u201d<\/span>\u4e5f\u5c31\u662f\u8bf4\uff0c\u5728\u586b\u5199\u75c5\u4f8b\u62a5\u544a\u8868\u51fa\u73b0\u9519\u8bef\u65f6\uff0c\u53ea\u8981\u5728\u9519\u8bef\u7684\u5730\u65b9\u5212\u4e0a\u4e00\u6761\u7ebf\uff0c\u7136\u540e\u6807\u660e\u65e5\u671f\u548c\u4f60\u7684\u59d3\u540d\u7f29\u5199\u3002\u5982\u679c\u662f\u4e00\u7ec4\u6570\u636e\u51fa\u73b0\u4e86\u9519\u8bef\uff0c\u5982\u836f\u7269\u53d1\u653e\u8bb0\u5f55\uff0c\u4f60\u53ef\u4ee5\u5728\u6574\u4e2a\u9519\u8bef\u5904\u5212\u7ebf\uff0c\u7136\u540e\u7b7e\u540d\u4ee5\u53ca\u65e5\u671f\uff0c\u800c\u4e0d\u9700\u8981\u5206\u522b\u5212\u8bb8\u591a\u7ebf\u548c\u6539\u8bb8\u591a\u9519\u3002<\/span><\/span><\/p>\n

    \u7b7e\u540d\u5355<\/span>: <\/span><\/strong>\u7b7e\u540d\u5355\u8bb0\u5f55\u4e86\u6240\u6709\u6388\u6743\u586b\u5199\u548c\u6539\u6b63\u75c5\u4f8b\u62a5\u544a\u8868\u4eba\u5458\u7684\u59d3\u540d\u548c\u4ed6\u4eec\u7684\u9996\u5b57\u6bcd\u7f29\u5199\uff0c\u4e5f\u8bb0\u5f55\u4e86\u4ed6\u4eec\u7684\u771f\u5b9e\u7b7e\u540d\u3002\u8fd9\u662f\u4e00\u4efd\u975e\u5e38\u91cd\u8981\u7684\u6587\u4ef6\uff0c\u5e94\u8be5\u4fdd\u5b58\u5728\u4e2d\u5fc3\u7684\u6587\u4ef6\u5939\u4e2d\u3002<\/span><\/span><\/p>\n

    \u75c5\u4f8b\u62a5\u544a\u8868\u7684\u7528\u9014\uff1a\u75c5\u4f8b\u62a5\u544a\u8868\u7684\u76ee\u7684\u662f\u4e3a\u4e86\u4fdd\u8bc1\u6839\u636e\u8bd5\u9a8c\u65b9\u6848\u7684\u8981\u6c42\u6709\u6548\u3001\u5b8c\u6574\u5730\u6536\u96c6\u6570\u636e\u3002\u8fd9\u6709\u5229\u4e8e\u5206\u6790\u548c\u6e05\u6670\u5730\u62a5\u544a\u6570\u636e\uff0c\u5176\u7ed3\u679c\u5c06\u5bf9\u8bc4\u4ef7\u8be5\u836f\u7684\u7597\u6548\u548c\u5b89\u5168\u6027\u8d77\u51b3\u5b9a\u6027\u7684\u4f5c\u7528\u3002\u5982\u679c\u8003\u8651\u4e00\u4e0b\u7533\u529e\u8005\u8bbe\u8ba1\u8bd5\u9a8c\u7684\u7406\u7531\uff0c\u663e\u7136\u662f\u4e3a\u4e86\u6536\u96c6\u7597\u6548\u548c\u5b89\u5168\u6027\u7684\u4fe1\u606f\u3002\u7531\u4e8e\u75c5\u4f8b\u62a5\u544a\u8868\u662f\u6536\u96c6\u6570\u636e\u7684\u4e3b\u8981\u8f7d\u4f53\uff0c\u56e0\u6b64\u5b83\u662f\u6574\u4e2a\u7814\u7a76\u8fc7\u7a0b\u4e2d\u975e\u5e38\u5173\u952e\u548c\u91cd\u8981\u7684\u4e00\u90e8\u5206\u3002<\/span><\/p>\n

    \u8bd5\u9a8c\u65b9\u6848\u548c\u75c5\u4f8b\u62a5\u544a\u8868\u7684\u5173\u7cfb<\/span>\uff1a<\/span>\u8bd5\u9a8c\u65b9\u6848\u51b3\u5b9a\u4e86\u75c5\u4f8b\u62a5\u544a\u8868\u9700\u8981\u8bb0\u5f55\u4ec0\u4e48\u6570\u636e\u3002\u6240\u6709\u5728\u8bd5\u9a8c\u65b9\u6848\u4e2d\u7279\u6307\u7684\u6570\u636e\u90fd\u5e94\u8be5\u8bb0\u5f55\u5728\u75c5\u4f8b\u62a5\u544a\u8868\u4e2d\u3002\u8fd9\u610f\u5473\u7740\u7814\u7a76\u8005\u4e0d\u8981\u5c06\u672a\u5728\u8bd5\u9a8c\u65b9\u6848\u4e2d\u8bbe\u5b9a\u7684\u4fe1\u606f\u5199\u5165\u75c5\u4f8b\u62a5\u544a\u8868\uff0c\u5426\u5219\u4f1a\u5e26\u6765\u4e00\u4e9b\u56f0\u96be\u3002\u5728\u75c5\u4f8b\u62a5\u544a\u8868\u4e0a\u7684\u4efb\u4f55<\/span>\u201c<\/span>\u81ea\u7531\u6587\u5b57<\/span>(free text)\u201d<\/span>\u90fd\u5e94\u8be5\u53ea\u662f\u4e3a\u4e86\u6f84\u6e05\u6570\u636e\u3002\u4f8b\u5982\uff0c\u6211\u4eec\u5e38\u5e38\u5728\u75c5\u4f8b\u62a5\u544a\u8868\u7684\u8fb9\u7f18\u90e8\u5206\u89c1\u5230\u586b\u5199\u7684\u6570\u636e\uff0c\u90a3\u4e0d\u662f\u4f60\u8be5\u8bb0\u5f55\u6570\u636e\u7684\u5730\u65b9\u3002\u552f\u4e00\u53ef\u4ee5\u5141\u8bb8\u81ea\u7531\u6587\u5b57\u7684\u60c5\u51b5\u662f\uff0c\u4f60\u5728\u770b\u4e86\u586b\u5165\u7684\u6570\u636e\u540e\u53d1\u73b0\uff0c\u5047\u5982\u4e0d\u505a\u4e00\u7b80\u77ed\u8bf4\u660e\uff0c\u4f60\u5c06\u4f1a\u6536\u5230\u6570\u636e\u6f84\u6e05\u8868\uff08<\/span>Data Clarification Form,DCF<\/span>\uff09\u800c\u88ab\u8981\u6c42\u8fdb\u4e00\u6b65\u8bf4\u660e\u3002\u5982\u679c\u8fd9\u6837\uff0c\u662f\u53ef\u4ee5\u7684\uff0c\u4f46\u5982\u662f\u6536\u96c6\u6570\u636e\uff0c\u5e94\u907f\u514d\u8fd9\u6837\u586b\u5199\u3002<\/span><\/span><\/p>\n

    \u539f\u59cb\u6587\u4ef6<\/span>: <\/span>\u75c5\u4f8b\u62a5\u544a\u8868\u4e2d\u586b\u5165\u7684\u5185\u5bb9\u4ee5\u539f\u59cb\u8d44\u6599\u4e3a\u4f9d\u636e\u3002\u8c61\u6211\u4eec\u524d\u9762\u770b\u5230\u7684\uff0c\u539f\u59cb\u6587\u4ef6\u662f\u6536\u96c6\u539f\u59cb\u6570\u636e\u7684\u5730\u65b9\uff0c\u8fd9\u4e9b\u6570\u636e\u9700\u8981\u8f93\u5165\u75c5\u4f8b\u62a5\u544a\u8868\u4e2d\u3002\u6240\u6709\u7684\u4fe1\u606f\u4ee5\u53ca\u4e34\u5e8a\u53d1\u73b0\u3001\u89c2\u5bdf\u6216\u8bd5\u9a8c\u4e2d\u5176\u4ed6\u6d3b\u52a8\u7684\u539f\u59cb\u8bb0\u5f55\u90fd\u662f\u91cd\u5efa\u548c\u8bc4\u4ef7\u4e34\u5e8a\u8bd5\u9a8c\u6240\u5fc5\u987b\u7684\u3002\u57fa\u672c\u4e0a\u8fd9\u5c31\u662f\u539f\u59cb\u6570\u636e\u7684\u6765\u6e90\u3002\u539f\u59cb\u8d44\u6599\u7684\u4e00\u4e9b\u4f8b\u5b50\u5982\u4f4f\u9662\u75c5\u5386\uff0c\u95e8\u8bca\u75c5\u5386\uff0c\u5b9e\u9a8c\u5ba4\u68c0\u67e5\u62a5\u544a\u5355\uff08\u5305\u62ec\u5f53\u5730\u548c\u4e2d\u5fc3\u5b9e\u9a8c\u5ba4\u7684\u62a5\u544a\uff09\uff0c\u75c5\u4eba\u65e5\u8bb0\u6216\u8005\u81ea\u8bc4\u8868\u3002\u836f\u7269\u7684\u53d1\u653e\u8bb0\u5f55\uff0c\u5f55\u97f3<\/span>\/<\/span>\u5f55\u50cf\u6570\u636e\u4ee5\u53ca\u81ea\u52a8\u4eea\u5668\u4e5f\u662f\u539f\u59cb\u8d44\u6599\u7684\u6765\u6e90\u3002\u5176\u4ed6\u7684\u4f8b\u5b50\u6709<\/span>X<\/span>\u5149\u7247\uff0c\u5305\u62ec\u62a5\u544a\u548c\u7247\u5b50\uff0c\u5fc3\u7535\u56fe\u8bb0\u5f55\uff08\u540c\u6837\uff0c\u5305\u62ec\u5fc3\u7535\u56fe\u7684\u62a5\u544a\u4ee5\u53ca\u5fae\u578b\u80f6\u5377\uff09\u3002<\/span><\/span><\/p>\n

    \u75c5\u4f8b\u62a5\u544a\u8868\u586b\u5199\u7684\u672f\u8bed<\/span>: <\/span>\u5fc5\u987b\u4f7f\u7528\u901a\u7528\u7684\u6807\u51c6\u533b\u5b66\u672f\u8bed\uff0c\u56e0\u4e3a\u4f60\u53ef\u80fd\u53c2\u52a0\u7684\u662f\u56fd\u9645\u7814\u7a76\u3002\u4e00\u4e9b\u5728\u4f60\u4eec\u533b\u9662\u7ecf\u5e38\u4f7f\u7528\u7684\u8bcd\u8bed\u53ef\u80fd\u4e0d\u80fd\u88ab\u5176\u5b83\u5730\u65b9\u63a5\u53d7\u6216\u7406\u89e3\u3002\u5e94\u8be5\u5c3d\u53ef\u80fd\u5730\u586b\u5165\u8bca\u65ad\u800c\u4e0d\u662f\u75c7\u72b6\u3002\u75c5\u4f8b\u62a5\u544a\u8868\u4e2d\u4e0d\u826f\u4e8b\u4ef6\u90e8\u5206\u7684\u586b\u5199\u5c31\u662f\u4e00\u4e2a\u4f8b\u5b50\u3002\u5982\u679c\u75c5\u4eba\u60a3\u6709<\/span>\u201c<\/span>\u6d41\u611f<\/span>\u201d<\/span>\uff08\u8bca\u65ad\uff09\uff0c\u5c31\u4e0d\u8981\u5199\u5bd2\u6218\u3001\u53d1\u70ed\u3001\u75bc\u75db\u3002\u4e5f\u4e0d\u8981\u4f7f\u7528\u7f29\u5199\uff0c\u56e0\u4e3a\u5b83\u5728\u5404\u4e2a\u56fd\u5bb6\u4f1a\u6709\u6240\u4e0d\u540c\u3002<\/span><\/span><\/p>\n

    \u4e0d\u7528\u8054\u5408\u672f\u8bed<\/span>: <\/span>\u4e0d\u8981\u7528\u8054\u5408\u7528\u8bed\uff0c\u5982<\/span>\u201c<\/span>\u5934\u6655\u6216\u7729\u6655<\/span>\u201d<\/span>\uff0c\u5e94\u8be5\u9009\u5176\u4e2d\u7684\u4e00\u4e2a\u3002\u5982\u679c\u786e\u5b9e\u4e24\u8005\u90fd\u6709\uff0c\u4e24\u4e2a\u5e94\u5206\u522b\u586b\u5199\u3002<\/span><\/span><\/p>\n

    \u8bf4\u660e\u90e8\u4f4d\u65f6\u5e94\u7279\u6307<\/span>: <\/span>\u5f53\u6d89\u53ca\u8eab\u4f53\u7684\u67d0\u4e00\u90e8\u5206\u65f6\uff0c\u5e94\u8be5\u7279\u522b\u6307\u660e\u3002\u5982\uff0c\u53f3\u4e0a\u5927\u817f\u3002<\/span><\/span><\/p>\n

    \u586b\u5199\u7b80\u660e<\/span>: <\/span>\u5e94\u8be5\u975e\u5e38\u6e05\u6670\u548c\u7b80\u660e\uff0c\u4ee5\u9632\u6b62\u9519\u8bef\u7684\u53d1\u751f\u3002\u75c5\u4f8b\u62a5\u544a\u8868\u5ba1\u6838\u4e2d\u5e38\u89c1\u7684\u9519\u8bef\u662f\u75c5\u4f8b\u62a5\u544a\u8868\u548c\u539f\u59cb\u6570\u636e\u4e0d\u4e00\u81f4\uff0c\u8fd9\u662f\u76d1\u67e5\u5458\u548c\u7a3d\u67e5\u5458\u5bfb\u627e\u7684\u4e1c\u897f\u3002<\/span><\/span><\/p>\n

    \u7f3a\u5931\u6570\u636e<\/span>: <\/span>\u586b\u5199\u75c5\u4f8b\u62a5\u544a\u8868\u65f6\uff0c\u6bcf\u4e2a\u7a7a\u683c\u90fd\u8981\u586b\u5165\uff0c\u5373\u4f7f\u662f<\/span>\u201c<\/span>\u65e0\u76f8\u5173\u6570\u636e<\/span>\u201d<\/span>\u6216\u8005<\/span>\u201c<\/span>\u4e0d\u9002\u7528<\/span>\u201d<\/span>\u6216\u7c7b\u4f3c\u8fd9\u6837\u7684\u4e00\u4e2a\u8868\u8ff0\u3002<\/span><\/span><\/p>\n

    \u968f\u8bbf\u95f4\u7684\u4e0d\u4e00\u81f4<\/span>: \u4e00\u4e2a\u4f8b\u5b50\u662f\uff0c\u75c5\u4eba\u5728\u968f\u8bbf<\/span>1\u65f6\u7684\u7f16\u53f7\u662f<\/span>101\uff0c\u5230\u968f\u8bbf<\/span>2\u65f6\u7f16\u53f7\u4e3a<\/span>103\u3002<\/span><\/span><\/p>\n

    \u4e0d\u53ef\u8bfb\u7684\u6570\u636e<\/span>: <\/span>\u5982\u679c\u4f60\u81ea\u5df1\u5728\u8bfb\u6570\u636e\u65f6\u53d1\u73b0\u6709\u56f0\u96be\uff0c\u90a3\u4e48\u80af\u5b9a\u5176\u4ed6\u4eba\u9605\u8bfb\u65f6\u56f0\u96be\u4f1a\u66f4\u5927\u3002\u8bf7\u82b1\u4e00\u5b9a\u7684\u65f6\u95f4\u6765\u786e\u4fdd\u4e66\u5199\u6e05\u6670\u5e76\u4e14\u6ca1\u6709\u62fc\u5199\u9519\u8bef\u3002<\/span><\/span><\/p>\n

    \u5fc5\u987b\u586b\u5199\u7684\u90e8\u5206\u7a7a\u7f3a<\/span>: <\/span>\u4f8b\u5982\uff0c\u8bc4\u8ff0\u4e00\u4e2a\u4e0d\u826f\u4e8b\u4ef6\u7684<\/span>\u201c<\/span>\u539f\u56e0<\/span>\u201d<\/span>\u65f6\uff0c\u5982\u679c\u4f60\u9009\u7684\u662f<\/span>\u201c<\/span>\u5176\u4ed6\u75be\u75c5<\/span>\u201d<\/span>\uff0c\u5e38\u5e38\u4f60\u4f1a\u88ab\u8981\u6c42\u5bf9<\/span>\u201c<\/span>\u5176\u4ed6\u75be\u75c5<\/span>\u201d<\/span>\u8fdb\u884c\u8bf4\u660e\uff08\u5373\uff0c\u5176\u4ed6\u75be\u75c5\u662f\u4ec0\u4e48\uff09\uff0c\u5982\u679c\u6b64\u5904\u7559\u4e86\u7a7a\u767d\uff0c\u4f60\u5c06\u4f1a\u6536\u5230\u6570\u636e\u6f84\u6e05\u8868\u3002<\/span><\/span><\/p>\n

    \u7814\u7a76\u8005\u7b7e\u540d\u7f3a\u5931<\/span>: <\/span>\u5e38\u5e38\u5728\u75c5\u4f8b\u62a5\u544a\u8868\u4e2d\uff0c\u53ea\u5728\u603b\u7ed3\u9875\u4e0a\u8981\u6c42\u6709\u7814\u7a76\u8005\u7684\u7b7e\u540d\uff0c\u8fd9\u8868\u660e\u7814\u7a76\u8005\u8ba4\u4e3a\u6570\u636e\u662f\u6e05\u6670\u548c\u53ef\u63a5\u53d7\u7684\u3002\u5982\u679c\u6ca1\u6709\u8fd9\u4e2a\u7b7e\u540d\uff0c\u8fd9\u5176\u4e2d\u7684\u6570\u636e\u5c31\u6ca1\u4ec0\u4e48\u4ef7\u503c\u3002<\/span><\/span><\/p>\n

    \u4e0d\u80fd\u63a5\u53d7\u7684\u672f\u8bed<\/span>: <\/span>\u4e0d\u8981\u4f7f\u7528\u4e00\u4e9b\u53e3\u5934\u672f\u8bed\uff0c\u56e0\u4e3a\u8fd9\u53ef\u80fd\u53ea\u5728\u4f60\u7684\u5730\u533a\u88ab\u7406\u89e3\uff0c\u800c\u4e0d\u80fd\u88ab\u5176\u4ed6\u5730\u533a\u7684\u4eba\u7406\u89e3\u3002<\/span><\/span><\/p>\n

    \u4e0b\u4e00\u90e8\u5206\u5c06\u8ba8\u8bba\u9ad8\u8d28\u91cf\u7684\u6570\u636e\u548c\u6d41\u7a0b\u3002<\/span> <\/p>\n

    \u75c5\u4f8b\u62a5\u544a\u8868\u586b\u5199\u6307\u5357 <\/span>(2)<\/span><\/strong><\/span><\/strong><\/p>\n

    Mr.Brian Peters<\/span><\/strong><\/p>\n

    \u6211\u4eec\u63a5\u7740\u8bb2\u9ad8\u8d28\u91cf\u6570\u636e\u4ee5\u53ca\u6570\u636e\u6d41\u7a0b\u53d6\u51b3\u4e8e\u4ec0\u4e48\u3002\u5b83\u53d6\u51b3\u4e8e\u53ef\u8bfb\u6027\uff0c\u51c6\u786e\u6027\uff0c\u5b8c\u6574\u6027\uff0c\u4e00\u81f4\u6027\uff0c\u53ef\u6838\u5b9e\u6027\u4ee5\u53ca\u65f6\u95f4\u6027\u3002\u6211\u4eec\u5df2\u7ecf\u8ba8\u8bba\u8fc7\u5b83\u4eec\uff0c\u4e0b\u9762\u662f\u4e2a\u5f88\u597d\u7684\u590d\u4e60\u3002<\/span><\/p>\n

    \u53ef\u8bfb\u6027<\/span>: <\/span>\u5e94\u8be5\u4fdd\u8bc1\u586b\u5199\u7684\u5185\u5bb9\u6e05\u6670\uff0c\u6bcf\u4e2a\u4eba\u90fd\u80fd\u8bfb\u3002<\/span><\/span><\/p>\n

    \u51c6\u786e\u6027\uff0c\u5b8c\u6574\u6027\u548c\u4e00\u81f4\u6027<\/span>: <\/span>\u5c31\u8c61\u6211\u4eec\u8c08\u5230\u7684\uff0c\u75c5\u4eba\u7f16\u7801\u5728\u6bcf\u6b21\u968f\u8bbf\u65f6\u90fd\u5e94\u4e00\u81f4\uff1b\u6570\u636e\u5e94\u8be5\u662f\u53ef\u6838\u5b9e\u7684\uff0c\u4fe1\u606f\u4e0e\u539f\u59cb\u6587\u4ef6\u4e2d\u7684\u5e94\u5b8c\u5168\u4e00\u81f4\uff0c\u5982\u679c\u4e0d\u4e00\u81f4\u8981\u505a\u8bf4\u660e\u3002\u6211\u4eec\u8fd8\u5e0c\u671b\u7814\u7a76\u8005\u80fd\u53ca\u65f6\u5730\u628a\u6570\u636e\u586b\u5165\u75c5\u4f8b\u62a5\u544a\u8868\u3002<\/span><\/span><\/p>\n

    \u8fd9\u5f20\u5e7b\u706f\u7247\u662f\u6570\u636e\u6d41\u7a0b\u7684\u4e00\u4e2a\u6982\u51b5\u56fe\uff0c\u7814\u7a76\u4eba\u5458\u548c\u76d1\u67e5\u5458\u4e00\u8d77\u5de5\u4f5c\uff0c\u7814\u7a76\u4eba\u5458\u5c06\u4fe1\u606f\u586b\u5165\u75c5\u4f8b\u62a5\u544a\u8868\uff1b\u76d1\u67e5\u5458\u5230\u4e2d\u5fc3\u8bbf\u89c6\u5e76\u4e14\u548c\u4ed6\u4eec\u4e00\u8d77\u8ba8\u8bba\u76f8\u5173\u4fe1\u606f\uff0c\u786e\u5b9a\u8fd9\u4e9b\u4fe1\u606f\u662f\u51c6\u786e\u7684\u3002\u8be5\u4fe1\u606f\u968f\u540e\u88ab\u4f20\u9001\u5230\u4e00\u4e34\u5e8a\u533b\u5e08\u6216\u8d1f\u8d23\u5b89\u5168\u6027\u7684\u4eba\u5458\u5904\u3002\u4ed6\u4eec\u4f1a\u4ece\u4e0d\u540c\u7684\u89d2\u5ea6\u6765\u770b\u6570\u636e\uff0c\u786e\u8ba4\u6570\u636e\u7684\u6d41\u7a0b\u6b63\u786e\u3001\u6240\u6709\u7684\u6570\u636e\u90fd\u5df2\u7ecf\u6536\u96c6\u3002<\/span><\/p>\n

    \u4f8b\u5982\uff0c\u4e00\u4e2a\u8d1f\u8d23\u5b89\u5168\u6027\u7684\u4eba\u5458\u5c06\u68c0\u67e5\u75c5\u4f8b\u62a5\u544a\u8868\u7684\u8fb9\u7f18\u5904\uff0c\u5e76\u786e\u8ba4\u6240\u6709\u7684\u4e25\u91cd\u4e0d\u826f\u4e8b\u4ef6\u90fd\u5df2\u7ecf\u6536\u96c6\u5e76\u4e14\u62a5\u544a\u3002\u7136\u540e\u662f\u6570\u636e\u7ba1\u7406\u5458\uff0c\u5c3d\u7ba1\u5728\u6574\u4e2a\u8fc7\u7a0b\u7684\u4efb\u4f55\u65f6\u5019\u90fd\u53ef\u4ee5\u53d1\u653e\u6570\u636e\u6838\u5b9e\u8868\uff0c\u8be5\u9636\u6bb5\u662f\u4ea7\u751f\u7684\u6570\u636e\u6f84\u6e05\u8868\u662f\u6700\u591a\u7684\u3002\u4e00\u65e6\u6570\u636e\u7ba1\u7406\u5458\u5b8c\u6210\u4e86\u4ed6\u7684\u5de5\u4f5c\uff0c\u4ed6\u4f1a\u4f20\u9012\u5230\u4e0b\u4e00\u4e2a\u73af\u8282\uff0c\u75c5\u4f8b\u62a5\u544a\u4e0a\u7684\u4fe1\u606f\u4f1a\u88ab\u7f16\u7801\uff0c\u7136\u540e\u8fdb\u5165\u6570\u636e\u5e93\u3002\u8d70\u5230\u6570\u636e\u5e93\u7684\u6700\u540e\u4e00\u6b65\u65f6\uff0c\u5373\u662f\u6700\u540e\u7684\u6570\u636e\u6f84\u6e05\u8868\u5df2\u89e3\u51b3\uff0c\u7136\u540e\u53ef\u4ee5\u9501\u5b9a\u6570\u636e\u5e93\u3002<\/span><\/p>\n

    \u6570\u636e\u6f84\u6e05\uff08<\/span>Data Clarification)<\/span><\/strong>: <\/span>\u5982\u524d\u6240\u8ff0\uff0c\u5728\u6574\u4e2a\u6d41\u7a0b\u4e2d\u4efb\u4f55\u4e00\u4e2a\u73af\u8282\u90fd\u53ef\u4ee5\u4ea7\u751f\u6570\u636e\u6f84\u6e05\u8868\uff08<\/span>DCF<\/span>\uff09\u3002\u7531\u7814\u7a76\u4e2d\u5fc3\u5bf9\u6b64\u63d0\u4f9b\u89e3\u7b54\uff0c\u7136\u540e\u4e0e\u539f\u59cb\u6587\u4ef6\u548c\u75c5\u4f8b\u62a5\u544a\u8868\u8fdb\u884c\u6838\u5b9e\u3002\u5e94\u8be5\u4ee5\u6b63\u5f0f\u7684\u65b9\u5f0f\u63d0\u4ea4\u7ed9\u7533\u529e\u8005\uff0c\u5305\u62ec\u5728\u75c5\u4f8b\u62a5\u544a\u8868\u4e0a\u505a\u51fa\u4fee\u6b63\u548c\u76f4\u63a5\u5199\u5728\u6570\u636e\u6f84\u6e05\u8868\u4e0a\u3002\u8fd9\u4e9b\u6570\u636e\u6f84\u6e05\u8868\u4f1a\u82b1\u8d39\u8bb8\u591a\u65f6\u95f4\u548c\u8d39\u7528\uff0c\u56e0\u6b64\u5f88\u91cd\u8981\u7684\u662f\uff0c\u5728\u6700\u521d\u586b\u5165\u6570\u636e\u65f6\u5c31\u8981\u5c3d\u91cf\u7684\u51c6\u786e\u3002\u7ed9\u5927\u5bb6\u4e00\u4e2a\u6570\u636e\u6f84\u6e05\u8868\u82b1\u8d39\u7684\u5927\u81f4\u6982\u5ff5\uff0c\u51e0\u5e74\u4ee5\u524d\uff0c\u6211\u5c31\u542c\u8bf4\uff0c\u4e00\u4efd\u6570\u636e\u6f84\u6e05\u8868\u5927\u7ea6\u4f1a\u82b1\u8d39\u516c\u53f8<\/span>100<\/span>\u7f8e\u5143\uff0c\u800c\u51e0\u5468\u524d\u6211\u542c\u8bf4\u6bcf\u4efd\u6570\u636e\u6f84\u6e05\u8868\u7684\u82b1\u8d39\u5230\u4e86<\/span>150<\/span>\u7f8e\u5143\u3002\u8fd9\u7ed9\u5927\u5bb6\u4e00\u4e2a\u5370\u8c61\u3002\u9ad8\u8d28\u91cf\u7684\u75c5\u4f8b\u62a5\u544a\u53ef\u4ee5\u63d0\u4f9b\u51c6\u786e\u7684\u8bd5\u9a8c\u6570\u636e\uff0c\u8fdb\u800c\u53ef\u4ee5\u901a\u8fc7\u51cf\u5c11\u91cd\u590d\u5de5\u4f5c\u6765\u8282\u7701\u65f6\u95f4\u548c\u8d44\u6e90\u3002<\/span><\/span><\/p>\n

    \u8fd9\u4e00\u8bb2\u7684\u6700\u540e\u4e00\u4e2a\u5185\u5bb9\u662f\u6587\u4ef6\u4fdd\u5b58\u7684\u8981\u6c42\u3002\u91cd\u8981\u7684\u8bd5\u9a8c\u6587\u4ef6\uff0c\u5305\u62ec\u539f\u59cb\u6587\u4ef6\u3001\u533b\u7597\u8bb0\u5f55\u4ee5\u53ca\u75c5\u4f8b\u62a5\u544a\u8868\uff0c\u5fc5\u987b\u5b89\u5168\u5730\u4fdd\u5b58\u5e76\u65b9\u4fbf\u7533\u529e\u8005\u7a3d\u67e5\u548c\u7ba1\u7406\u673a\u6784\u7684\u89c6\u5bdf\uff0c\u65f6\u95f4\u81f3\u5c11\u81f3\u6700\u540e\u4e00\u6b21\u4e0a\u5e02\u7533\u8bf7\u88ab\u6279\u51c6\u540e\u7684\u4e24\u5e74\u5185\u6216\u8005\u662f\u5728\u7814\u836f\u7269\u7684\u4e34\u5e8a\u5f00\u53d1\u4e2d\u6b62\u4e24\u5e74\u540e\u3002\u5728\u6ca1\u6709\u5f97\u5230\u7533\u529e\u8005\u7684\u4e66\u9762\u901a\u77e5\u4e4b\u524d\uff0c\u4f60\u4eec\u4e0d\u8981\u9500\u6bc1\u4efb\u4f55\u6587\u4ef6\u3002\u8fd9\u4e00\u70b9\u975e\u5e38\u91cd\u8981\u3002<\/span><\/p>\n

    \u8fd9\u4e00\u8bb2\u5c31\u5230\u8fd9\u91cc\u3002\u8c22\u8c22\u5927\u5bb6\u3002<\/span> <\/p>\n


    <\/p>\n

    \u7b2c\u5341\u4e03\u8bb2 <\/span><\/strong>\u8bd5\u9a8c\u76d1\u67e5<\/span><\/strong><\/p>\n

    Dr. Ana Mar\u00eda Valderrama<\/span><\/strong><\/span><\/p>\n

    \u5927\u5bb6\u597d\uff0c\u6211\u53eb<\/span>Ana Maria Valderrama<\/span>\u3002\u6211\u662f\u4e00\u540d\u4e34\u5e8a\u533b\u751f\uff0c\u6709\u6570\u5e74\u4ece\u4e8b\u4e34\u5e8a\u7814\u7a76\u7684\u7ecf\u9a8c\u3002\u5728\u672c\u6b21\u8bb2\u5ea7\u4e2d\uff0c\u6211\u4eec\u5c06\u8ba8\u8bba\u8bd5\u9a8c\u7684\u76d1\u67e5\u3002\u6211\u4eec\u5148\u8ba8\u8bba\u8bd5\u9a8c\u76d1\u67e5\u7684\u76ee\u7684\u548c\u76ee\u6807\u3002<\/span><\/span><\/p>\n

    \u76d1\u67e5\u5458\u7684\u8d23\u4efb\u662f\u5e2e\u52a9\u7533\u529e\u8005\u786e\u5b9a\u8bd5\u9a8c\u6700\u5408\u9002\u7684\u7814\u7a76\u4e2d\u5fc3\u3002\u4ed6\u6216\u5979\u5fc5\u987b\u786e\u5b9a\u7814\u7a76\u8005\u548c\u53c2\u4e0e\u7814\u7a76\u7684\u5de5\u4f5c\u4eba\u5458\u5bf9\u8bd5\u9a8c\u76f8\u5173\u7684\u4e49\u52a1\u6709\u5f88\u597d\u7684\u7406\u89e3\u3002\u76d1\u67e5\u5458\u8981\u4e3a\u7814\u7a76\u4e2d\u5fc3\u63d0\u4f9b\u4e0e\u8bd5\u9a8c\u65b9\u6848\u76f8\u5173\u7684\u57f9\u8bad\uff0c\u8fd8\u8981\u786e\u5b9a\u9075\u5faa\u4e86\u8bd5\u9a8c\u6240\u5728\u56fd\u5bb6\u7684<\/span>GCP<\/span>\u539f\u5219\u3002\u76d1\u67e5\u5458\u4e5f\u6709\u8d23\u4efb\u638c\u63e1\u8bd5\u9a8c\u76f8\u5173\u6587\u4ef6\u7684\u4fdd\u7ba1\u60c5\u51b5\u3002<\/span><\/span><\/p>\n

    \u4e3a\u4e86\u5b8c\u6210\u76d1\u67e5\u4efb\u52a1\uff0c\u76d1\u67e5\u5458\u8fdb\u884c\u56db\u79cd\u7c7b\u578b\u7684\u8bbf\u89c6\uff1a\u8bd5\u9a8c\u524d\u8bbf\u89c6\uff0c\u542f\u52a8\u8bbf\u89c6\uff0c\u5e38\u89c4\u76d1\u67e5\u8bbf\u89c6\u4ee5\u53ca\u7ed3\u675f\u65f6\u7684\u7ed3\u675f\u8bbf\u89c6\u3002<\/span><\/p>\n

    \u5728\u8bd5\u9a8c\u524d\u8bbf\u89c6\u4e2d\uff0c\u76d1\u67e5\u5458\u8981\u6838\u5b9e\u8bd5\u9a8c\u65b9\u6848\u7684\u8981\u6c42\u548c\u53d7\u8bd5\u8005\u7684\u6765\u6e90\u3002\u4ed6\u6216\u5979\u8981\u6309\u8bd5\u9a8c\u65b9\u6848\u8bbe\u5b9a\u7684\u6807\u51c6\u6765\u8bc4\u4ef7\u7814\u7a76\u8005\u4ee5\u53ca\u7814\u7a76\u4eba\u5458\u7684\u5de5\u4f5c\u7ecf\u9a8c\uff1b\u76d1\u67e5\u5458\u8fd8\u9700\u8981\u8bc4\u4ef7\u7814\u7a76\u4e2d\u5fc3\u88c5\u5907\u7684\u53ef\u63a5\u53d7\u6027\uff0c\u5982\u5b9e\u9a8c\u5ba4\u3001\u7814\u7a76\u8981\u6c42\u7684\u7279\u6b8a\u8bbe\u5907\u3001\u8fdb\u884c\u67e5\u4f53\u7684\u533a\u57df\u3001\u836f\u623f\uff08\u5982\u9700\u8981\uff09\u3001\u548c\u6587\u4ef6\u7684\u5b58\u653e\u5904\u3002\u4ed6\u6216\u5979\u8fd8\u5c06\u8ba8\u8bbaIRB\/IEC\u7684\u6279\u51c6\u8fc7\u7a0b\uff0c\u786e\u5b9a\u7814\u7a76\u4eba\u5458\u7684\u89d2\u8272\u4ee5\u53ca\u5728\u8bd5\u9a8c\u8fc7\u7a0b\u4e2d\u7684\u8d23\u4efb\uff0c\u4f8b\u5982\u53d6\u5f97\u77e5\u60c5\u540c\u610f\u4e66\u4ee5\u53ca\u586b\u5199\u75c5\u4f8b\u62a5\u544a\u8868\u3002\u8bd5\u9a8c\u524d\u8bbf\u89c6\u975e\u5e38\u91cd\u8981\uff0c\u56e0\u4e3a\u8fd9\u5c06\u51b3\u5b9a\u54ea\u4e9b\u4e2d\u5fc3\u6709\u8d44\u683c\u53c2\u52a0\u8bd5\u9a8c\u3002<\/span><\/p>\n

    \u4e00\u65e6\u5b8c\u6210\u4e86\u8bd5\u9a8c\u524d\u8bbf\u89c6\u5e76\u4e14\u9009\u62e9\u4e86\u7814\u7a76\u4e2d\u5fc3\uff0c\u5c06\u8fdb\u5165\u542f\u52a8\u8bbf\u89c6\u3002\u5728\u542f\u52a8\u8bbf\u89c6\u4e2d\uff0c\u76d1\u67e5\u5458\u8981\u51b3\u5b9a\u7814\u7a76\u4e2d\u5fc3\u7684\u8bbe\u5907\u662f\u5426\u4ecd\u662f\u7b26\u5408\u8981\u6c42\u7684\u4ee5\u53ca\u7814\u7a76\u4eba\u5458\u662f\u5426\u5f97\u5230\u4e86\u9002\u5f53\u7684\u57f9\u8bad\u3002\u4ed6\u6216\u5979\u5c06\u56de\u987e\u8bd5\u9a8c\u65b9\u6848\u53ca\u7814\u7a76\u8005\u624b\u518c\uff0c\u5e76\u5f3a\u8c03\u4e25\u91cd\u4e0d\u826f\u4e8b\u4ef6\u62a5\u544a\u8fc7\u7a0b\u7684\u91cd\u8981\u6027\u3002\u76d1\u67e5\u5458\u8fd8\u9700\u8981\u56de\u987e\u77e5\u60c5\u540c\u610f\u8fc7\u7a0b\uff0c\u4fdd\u8bc1\u6709\u8db3\u591f\u7684\u6700\u65b0\u7248\u672c\u88ab\u6279\u51c6\u4f7f\u7528\u7684\u77e5\u60c5\u540c\u610f\u4e66\u3002\u76d1\u67e5\u5458\u548c\u7814\u7a76\u8005\u7684\u8ba8\u8bba\u5fc5\u987b\u6d89\u53ca\u9009\u62e9\u53d7\u8bd5\u8005\u7684\u8fc7\u7a0b\u4ee5\u53ca\u5982\u4f55\u5b8c\u6210<\/span>CRF<\/span>\u3002<\/span><\/span><\/p>\n

    \u53e6\u5916\uff0c\u76d1\u67e5\u5458\u8981\u786e\u8ba4<\/span>IRB\/IEC<\/span>\u5df2\u7ecf\u6279\u51c6\u4e86\u4e0e\u8bd5\u9a8c\u65b9\u6848\u76f8\u5173\u7684\u6240\u6709\u4e8b\u60c5\u3002\u4ed6\u6216\u5979\u5c06\u5ba1\u67e5\u6587\u4ef6\u7684\u7ba1\u7406\u60c5\u51b5\uff0c\u5e76\u5f3a\u8c03\u6309\u7167\u8bd5\u9a8c\u65b9\u6848\u8981\u6c42\u4fdd\u5b58\u6240\u6709\u6587\u4ef6\u7684\u91cd\u8981\u6027\u3002\u5bf9\u4eca\u540e\u8bbf\u89c6\u7684\u8ba1\u5212\u4e5f\u8981\u63d0\u51fa\u6765\u3002\u5728\u542f\u52a8\u8bbf\u89c6\u4e2d\uff0c\u5f88\u91cd\u8981\u7684\u662f\u76d1\u67e5\u5458\u56de\u7b54\u4e86\u4e0e\u8bd5\u9a8c\u76f8\u5173\u7684\u6240\u6709\u95ee\u9898\uff0c\u5728\u8bbf\u89c6\u7ed3\u675f\u65f6\uff0c\u7814\u7a76\u4e2d\u5fc3\u7684\u4efb\u4f55\u7591\u95ee\u90fd\u5f97\u5230\u4e86\u89e3\u51b3\u3002<\/span><\/span><\/p>\n

    \u542f\u52a8\u8bbf\u89c6\u7ed3\u675f\u540e\u4e34\u5e8a\u8bd5\u9a8c\u5c31\u53ef\u4ee5\u5f00\u59cb\u3002\u6ce8\u610f\uff0c\u5982\u679c\u8bd5\u9a8c\u6d89\u53ca\u591a\u4e2a\u4e2d\u5fc3\uff0c\u542f\u52a8\u8bbf\u89c6\u4e5f\u53ef\u4ee5\u7531\u7814\u7a76\u8005\u4f1a\u8bae\u6765\u66ff\u4ee3\u3002\u5982\u679c\u8fd9\u662f\u591a\u4e2d\u5fc3\u7684\u7814\u7a76\uff0c\u6240\u6709\u7684\u542f\u52a8\u8bbf\u89c6\u7684\u6d3b\u52a8\u5185\u5bb9\u90fd\u5c06\u5305\u542b\u7814\u7a76\u8005\u4f1a\u8bae\u4e0a\u3002\u5728\u7814\u7a76\u8005\u4f1a\u8bae\u4e2d\uff0c\u542f\u52a8\u8bbf\u89c6\u7684\u6d3b\u52a8\u53ef\u4ee5\u540c\u65f6\u4e3a\u591a\u4e2a\u4e2d\u5fc3\u5f00\u5c55\u3002<\/span><\/p>\n

    \u4e00\u65e6\u53d7\u8bd5\u8005\u8fdb\u5165\u8bd5\u9a8c\uff0c\u5c31\u5f00\u59cb\u4e86\u5e38\u89c4\u7684\u76d1\u67e5\u8bbf\u89c6\u3002\u5728\u5e38\u89c4\u76d1\u67e5\u8bbf\u89c6\u4e2d\uff0c\u76d1\u67e5\u5458\u5c06\u5ba1\u6838\u5bf9\u8bd5\u9a8c\u65b9\u6848\u7684\u4f9d\u4ece\u6027\u3002\u4ed6\u6216\u5979\u5c06\u68c0\u67e5\u662f\u5426\u9075\u5faa\u4e86\u5165\u9009\u6807\u51c6\u548c\u6392\u9664\u6807\u51c6\uff0c\u53d7\u8bd5\u8005\u7684\u968f\u673a\u662f\u5426\u6b63\u786e\uff0c\u968f\u8bbf\u8ba1\u5212\u548c\u8bc4\u4ef7\u662f\u5426\u6309\u8ba1\u5212\u8fdb\u884c\uff0c\u836f\u7269\u53ca\u5176\u5242\u91cf\u662f\u5426\u5408\u9002\u3002\u76d1\u67e5\u5458\u8fd8\u8981\u5ba1\u6838\u4e25\u91cd\u4e0d\u826f\u4e8b\u4ef6\u7684\u62a5\u544a\u8fc7\u7a0b\uff0c\u5fc5\u987b\u5f3a\u8c03\u6240\u6709\u4e25\u91cd\u4e0d\u826f\u4e8b\u4ef6\u90fd\u5e94\u51c6\u786e\u3001\u53ca\u65f6\u5730\u5411\u7533\u529e\u8005\u548c<\/span>IRB\/IEC, <\/span>\u4ee5\u53ca\u5fc5\u8981\u65f6\u5411\u5f53\u5730\u836f\u653f\u7ba1\u7406\u90e8\u95e8\u62a5\u544a\u3002\u76d1\u67e5\u5458\u8fd8\u5fc5\u987b\u786e\u4fdd\u53d7\u8bd5\u8005\u5728\u6b63\u786e\u7248\u672c\u7684\u77e5\u60c5\u540c\u610f\u4e66\u4e0a\u7b7e\u540d\uff0c\u65e5\u671f\u6b63\u786e\u3002\u786e\u4fdd\u77e5\u60c5\u540c\u610f\u4e66\u586b\u5199\u6b63\u786e\u4e5f\u5f88\u91cd\u8981\u3002<\/span><\/span><\/p>\n

    \u5728\u5e38\u89c4\u76d1\u67e5\u8bbf\u89c6\u4e2d\uff0c\u76d1\u67e5\u5458\u7684\u53e6\u4e00\u4e2a\u8d23\u4efb\u5c31\u662f\u786e\u4fdd<\/span>CRF<\/span>\u7684\u586b\u5199\u662f\u6b63\u786e\u7684\uff0c\u5e76\u8981\u4e0e\u539f\u59cb\u6587\u4ef6\u5bf9\u7167\u68c0\u67e5\u3002<\/span>CRF<\/span>\u7684\u586b\u5199\u5e94\u8be5\u4ed4\u7ec6\u3001\u53ca\u65f6\uff0c\u9700\u8981\u4fee\u6539\u65f6\u5e94\u4ee5\u6b63\u786e\u7684\u65b9\u5f0f\u4fee\u6539\uff0c\u5e76\u4e14\u4e5f\u8981\u6709\u539f\u59cb\u6587\u4ef6\u7684\u652f\u6301\u3002\u76d1\u67e5\u5458\u8981\u67e5\u8bc1\u5bf9\u6240\u6709\u836f\u54c1\u7684\u7ba1\u7406\u662f\u6b63\u786e\u7684\uff0c\u8981\u786e\u8ba4\u836f\u7269\u7684\u8fd0\u8f93\u8bb0\u5f55\u4fdd\u6301\u826f\u597d\u3002\u76d1\u67e5\u5458\u8fd8\u8981\u6838\u5b9e\u6bcf\u4e2a\u60a3\u8005\u7684\u8bd5\u9a8c\u836f\u54c1\u53d1\u653e\u8bb0\u5f55\u51c6\u786e\u3001\u4fdd\u5b58\u5b8c\u597d\uff0c\u76f2\u6001\u4fdd\u6301\u826f\u597d\u3002\u4ed6\u6216\u5979\u9700\u8981\u786e\u8ba4\u8bd5\u9a8c\u836f\u54c1\u6216\u5176\u4ed6\u836f\u54c1\u88ab\u5b89\u5168\u5730\u5b58\u50a8\u5728\u5408\u9002\u7684\u6e29\u5ea6\u548c\u6e7f\u5ea6\u4e0b\u3002\u76d1\u67e5\u5458\u8fd8\u9700\u8981\u786e\u8ba4\u5b9e\u9a8c\u5ba4\u7684\u6807\u672c\u6536\u96c6\u6b63\u786e\uff0c\u5e76\u4e14\u5728\u7279\u5b9a\u7684\u65f6\u95f4\u524d\u9001\u5230\u4e86\u5b9e\u9a8c\u5ba4\u3002<\/span><\/span><\/p>\n

    \u6700\u540e\uff0c\u76d1\u67e5\u5458\u5fc5\u987b\u4fdd\u8bc1\u8bd5\u9a8c\u6587\u4ef6\u4fdd\u5b58\u6709\u5e8f\u3002\u4e5f\u5c31\u662f\uff0c<\/span> IRB\/IEC<\/span>\u6279\u51c6\u6587\u4ef6\uff0c\u4e0d\u540c\u7248\u672c\u7684\u8bd5\u9a8c\u65b9\u6848\u53ca\u65b9\u6848\u4fee\u6539\u90fd\u5df2\u5408\u9002\u5730\u5b58\u653e\u3002\u4ed6\u6216\u5979\u8fd8\u8981\u786e\u4fdd\u6240\u6709\u4fdd\u5b58\u7684\u6587\u4ef6\u5176\u7248\u672c\u90fd\u662f\u6b63\u786e\u7684\uff0c\u5305\u62ec\u6700\u65b0\u7684\u6216\u4fee\u6539\u8fc7\u7684\u77e5\u60c5\u540c\u610f\u4e66\u3002\u76d1\u67e5\u5458\u8fd8\u5e94\u8be5\u786e\u8ba4\u6240\u6709\u5728<\/span>\u201c<\/span>\u8bd5\u9a8c\u6587\u4ef6<\/span>\u201d<\/span>\u8bb2\u5ea7\u4e2d\u63d0\u53ca\u7684\u6587\u4ef6\u90fd\u4fdd\u5b58\u826f\u597d\u3002<\/span><\/span><\/p>\n

    \u5173\u4e8e\u5e38\u89c4\u76d1\u67e5\u8bbf\u89c6\u7684\u5185\u5bb9\u5c31\u5230\u8fd9\u91cc\u3002\u4e0b\u4e00\u8282\u6211\u4eec\u5c06\u8ba8\u8bba\u7ed3\u675f\u8bbf\u89c6\u3002<\/span><\/p>\n

    \u8bd5\u9a8c\u76d1\u67e5 <\/span>(2) <\/span><\/strong><\/span><\/p>\n

    Dr. Ana Mar\u00eda Valderrama<\/strong><\/span><\/h1>\n

    \u6211\u4eec\u7ee7\u7eed\u8bd5\u9a8c\u76d1\u67e5\u7684\u5185\u5bb9\uff0c\u73b0\u5728\u8ba8\u8bba\u7ed3\u675f\u8bbf\u89c6\u3002\u5728\u8fd9\u6b21\u8bbf\u89c6\u4e2d\uff0c\u5c06\u901a\u77e5\u7814\u7a76\u4e2d\u5fc3\u8bd5\u9a8c\u5df2\u5b8c\u6210\u4ee5\u53ca\u6709\u5173\u8d23\u4efb\u7684\u4e2d\u6b62\u3002\u8fd9\u4e9b\u5fc5\u987b\u603b\u662f\u4ee5\u4e66\u9762\u5f62\u5f0f\u6765\u901a\u77e5\u3002\u7533\u529e\u8005\u6709\u8d23\u4efb\u5bf9\u6240\u6709\u5165\u9009\u4e86\u75c5\u4eba\u7684\u4e2d\u5fc3\u8fdb\u884c\u7ed3\u675f\u8bbf\u89c6\uff0c\u5373\u4f7f\u6709\u4e9b\u4e2d\u5fc3\u63d0\u524d\u4e2d\u6b62\u4e86\u8bd5\u9a8c\u3002\u8fd9\u6b21\u8bbf\u89c6\u6700\u597d\u5728\u6700\u540e\u4e00\u4e2a\u75c5\u4eba\u5b8c\u6210\u8bd5\u9a8c\u540e<\/span>4<\/span>\uff0d<\/span>6<\/span>\u5468\u8fdb\u884c\u3002\u5728\u8fd9\u6b21\u8bbf\u89c6\u65f6\uff0c\u5c06\u8fdb\u884c\u7ec8\u6b62\u8bd5\u9a8c\u7684\u6240\u6709\u76f8\u5173\u6d3b\u52a8\u3002<\/span><\/span><\/p>\n

    \u8ba9\u6211\u4eec\u770b\u4e00\u4e0b\u76d1\u67e5\u5458\u548c\u7814\u7a76\u8005\u5728\u7ed3\u675f\u8bbf\u89c6\u4e2d\u7684\u8d23\u4efb\u3002\u76d1\u67e5\u5458\u5e94\u786e\u4fdd\u9075\u5faa\u4e86<\/span>GCP<\/span>\u548c\u5f53\u5730\u6cd5\u89c4\u7684\u8981\u6c42\u3002\u76d1\u67e5\u5458\u5e94\u63d0\u9192\u7814\u7a76\u8005\u6709\u5fc5\u8981\u901a\u77e5<\/span>IRB\/IEC<\/span>\u8bd5\u9a8c\u5df2\u7ecf\u7ed3\u675f\u3002\u4ed6\u6216\u5979\u5e94\u8be5\u56de\u987e\u6587\u4ef6\u4fdd\u5b58\u7684\u8981\u6c42\uff0c\u4fdd\u5b58\u65f6\u95f4\u5728\u8bd5\u9a8c\u5f00\u59cb\u4e4b\u524d\u65e2\u5df2\u8bbe\u5b9a\u4e14\u7814\u7a76\u8005\u5fc5\u987b\u9075\u5b88\u7684\u3002\u76d1\u67e5\u5458\u5e94\u6838\u5b9e<\/span>CRF<\/span>\u5df2\u7ecf\u5f88\u597d\u5730\u5b8c\u6210\uff0c\u5e76\u4e14\u4e0e\u539f\u59cb\u6587\u4ef6\u8fdb\u884c\u4e86\u6838\u5bf9\u3002\u76d1\u67e5\u5458\u8fd8\u8981\u6838\u5b9e<\/span>CRF<\/span>\u90fd\u5df2\u586b\u5199\u3001\u4fee\u6b63\u5e76\u5df2\u9001\u4ea4\u7ed9\u7533\u529e\u8005\u3002\u76d1\u67e5\u5458\u5e94\u786e\u4fdd\u6240\u6709\u5fc5\u987b\u7684\u6587\u4ef6\u5982\u5b9e\u9a8c\u5ba4\u68c0\u67e5\uff0c\u75c5\u53f2\u4ee5\u53ca\u5176\u4ed6\u539f\u59cb\u6587\u4ef6\u5747\u5b58\u653e\u5728\u7814\u7a76\u4e2d\u5fc3\uff0c\u6240\u6709\u5b9e\u9a8c\u5ba4\u68c0\u67e5\u62a5\u544a\u5c24\u5176\u662f\u63d0\u4ea4\u7ed9\u7533\u529e\u8005\u7684\u62a5\u544a\u7684\u590d\u5370\u4ef6\u90fd\u5df2\u6070\u5f53\u5730\u4fdd\u5b58\u3002\u76d1\u67e5\u5458\u5e94\u786e\u4fdd\u77e5\u60c5\u540c\u610f\u4e66\u5b58\u5728\u5e76\u4fdd\u5b58\u826f\u597d\uff0c\u5e94\u6e05\u70b9\u672a\u4f7f\u7528\u7684\u75c5\u4f8b\u62a5\u544a\u8868\u3002<\/span><\/span><\/p>\n

    \u6240\u6709\u7814\u7a76\u4e2d\u4f7f\u7528\u7684\u836f\u7269\u4e5f\u5fc5\u987b\u8fdb\u884c\u6e05\u70b9\uff0c\u76d1\u67e5\u5458\u5e94\u4fdd\u8bc1\u6bcf\u4e2a\u53c2\u52a0\u8bd5\u9a8c\u7684\u53d7\u8bd5\u8005\u7684\u6240\u6709\u62a5\u544a\u8868\u683c\u90fd\u586b\u5199\u6b63\u786e\u3002\u5e94\u6e05\u70b9\u6240\u6709\u7814\u7a76\u836f\u54c1\u7684\u6700\u540e\u53d1\u653e\u60c5\u51b5\uff0c\u5305\u62ec\u672a\u4f7f\u7528\u7684\u836f\u7269\uff0c\u4ee5\u524d\u5f52\u8fd8\u7684\u836f\u7269\uff0c\u548c<\/span>\/<\/span>\u6216\u7a7a\u7684\u836f\u74f6\u3002\u5fc5\u987b\u5bf9\u6240\u6709\u63d0\u4f9b\u7684\u8bd5\u9a8c\u836f\u54c1\u8fdb\u884c\u6e05\u70b9\u3002\u4efb\u4f55\u6ca1\u6709\u4f7f\u7528\u7684\u7269\u54c1\u90fd\u5e94\u8be5\u8fd4\u8fd8\uff0c\u4f8b\u5982\u5b9e\u9a8c\u5ba4\u7528\u54c1\u3002\u6700\u540e\uff0c\u76d1\u67e5\u5458\u8981\u6838\u5b9e\u6ca1\u6709\u7834\u76f2\u3002<\/span><\/span><\/p>\n

    \u73b0\u5728\uff0c\u6211\u4eec\u6765\u770b\u4e00\u4e0b\u7814\u7a76\u8005\u7684\u8d23\u4efb\u3002\u5728\u8bd5\u9a8c\u7ed3\u675f\u65f6\u7684\u8bbf\u89c6\u4e2d\uff0c\u7814\u7a76\u8005\u5e94\u8be5\u603b\u662f\u5728\u573a\uff0c\u4ee5\u89e3\u51b3\u548c\u56de\u7b54\u76d1\u67e5\u5458\u7684\u4efb\u4f55\u7591\u95ee\u548c\u8be2\u95ee\u3002\u7814\u7a76\u8005\u5e94\u8be5\u901a\u77e5\u4f26\u7406\u59d4\u5458\u4f1a\uff08<\/span>IRB\/IEC<\/span>\uff09\uff0c\u8bd5\u9a8c\u5df2\u7ecf\u5b8c\u6210\uff0c\u5e76\u51c6\u5907\u56de\u7b54\u6709\u5173\u8bd5\u9a8c\u7684\u4efb\u4f55\u95ee\u9898\u3002\u4ed6\u6216\u5979\u8fd8\u5e94\u8be5\u77e5\u9053\u5c06\u53ef\u80fd\u4f1a\u6536\u5230\u6570\u636e\u6f84\u6e05\u8868\uff0c\u8fd9\u662f\u9488\u5bf9<\/span>CRF<\/span>\u4e2d\u6570\u636e\u7684\u67d0\u4e9b\u7591\u95ee\u3001\u9700\u8981\u4ed6\u4eec\u7684\u89e3\u7b54\u3002\u7814\u7a76\u8005\u5e94\u8be5\u5c06\u8bd5\u9a8c\u76f8\u5173\u7684\u6587\u4ef6\u4ee5\u5408\u9002\u7684\u65b9\u5f0f\u5b58\u653e\u3002\u5982\u679c\u63a5\u5230\u836f\u653f\u7ba1\u7406\u673a\u6784\u7684\u8be2\u95ee\uff0c\u7814\u7a76\u8005\u5e94\u544a\u77e5\u7533\u529e\u8005\u3002<\/span><\/span><\/p>\n

    \u6700\u540e\uff0c\u6211\u4eec\u603b\u7ed3\u4e00\u4e0b\u6211\u4eec\u4eca\u5929\u7684\u8ba8\u8bba\u5185\u5bb9\u3002\u6211\u4eec\u8ba8\u8bba\u4e86\u4e0d\u540c\u7c7b\u578b\u7684\u76d1\u67e5\u8bbf\u89c6\uff0c\u5728\u6bcf\u79cd\u8bbf\u89c6\u4e2d\u7684\u76d1\u67e5\u5458\u8d23\u4efb\uff0c\u6700\u540e\uff0c\u662f\u7ed3\u675f\u8bbf\u89c6\u4e2d\u7684\u6d3b\u52a8\u3002<\/span><\/p>\n

    \u8c22\u8c22\u5927\u5bb6\u3002<\/span><\/p>\n


    <\/p>\n

    \u7b2c\u5341\u516b\u8bb2 <\/span><\/strong>\u5bf9\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u5fc3\u7684\u7a3d\u67e5<\/span><\/strong><\/p>\n

    Ms. Barbara O\u2019Neill<\/span><\/strong><\/span><\/p>\n

    \u5927\u5bb6\u597d\uff0c\u6211\u53eb<\/span>Barbara O\u2019Neill<\/span>\uff0c\u662f\u8d28\u91cf\u6807\u51c6\u7684\u9ad8\u7ea7\u7ecf\u7406\u3002\u6211\u7684\u5de5\u4f5c\u7ecf\u5386\u5305\u62ec\u53c2\u52a0\u4e34\u5e8a\u8bd5\u9a8c\u548c\u4ee3\u8868\u5236\u836f\u516c\u53f8\u8fdb\u884c\u7a3d\u67e5\uff0c\u4eca\u5929\u8bb2\u8bfe\u7684\u5185\u5bb9\u662f\u5bf9\u4e34\u5e8a\u8bd5\u9a8c\u5355\u4f4d\u7684\u7a3d\u67e5\u3002<\/span><\/span><\/p>\n

    \u5728\u4eca\u5929\u7684\u8bfe\u7a0b\u4e2d\uff0c\u6211\u4eec\u4e3b\u8981\u8bb2\u7684\u5185\u5bb9\u662f\uff1a\u7a3d\u67e5\u7684\u5b9a\u4e49\uff0c<\/span>FDA <\/span>\u89c6\u5bdf\uff0c\u7533\u529e\u8005\u7a3d\u67e5\u4ee5\u53ca\u89c6\u5bdf\u548c\u7a3d\u67e5\u4e2d\u5e38\u89c1\u7684\u95ee\u9898\u3002<\/span>ICH<\/span>\uff0d<\/span>GCP<\/span>\u5bf9\u7a3d\u67e5\u7684\u5b9a\u4e49\u5982\u4e0b\uff1a\u7a3d\u67e5\u662f\u5bf9\u8bd5\u9a8c\u76f8\u5173\u7684\u6d3b\u52a8\u548c\u6587\u4ef6\u8fdb\u884c\u7cfb\u7edf\u7684\u3001\u72ec\u7acb\u7684\u68c0\u67e5\uff0c\u4ee5\u786e\u5b9a\u8fd9\u4e9b\u8bd5\u9a8c\u76f8\u5173\u7684\u6d3b\u52a8\u548c\u6570\u636e\u7684\u8bb0\u5f55\u3001\u5206\u6790\u548c\u51c6\u786e\u7684\u62a5\u544a\u662f\u5426\u4e0e\u8bd5\u9a8c\u65b9\u6848\u3001\u7533\u529e\u8005\u7684\u6807\u51c6\u64cd\u4f5c\u89c4\u7a0b\u3001<\/span>GCP<\/span>\u4ee5\u53ca\u76f8\u5173\u7684\u6cd5\u89c4\u8981\u6c42\u76f8\u7b26\u3002<\/span><\/span><\/p>\n

    \u5728\u8fd9\u91cc\u6211\u8981\u5bf9\u5b9a\u4e49\u505a\u66f4\u8fdb\u4e00\u6b65\u7684\u89e3\u91ca\u3002<\/span>\u201c<\/span>\u7cfb\u7edf\u7684\u68c0\u67e5<\/span>\u201d<\/span>\u662f\u6307\u7a3d\u67e5\u5458\u6709\u4e00\u4e2a\u7a3d\u67e5\u7684\u8ba1\u5212\uff0c\u5e76\u4e14\u6309\u7167\u7a3d\u67e5\u8ba1\u5212\u8fdb\u884c\u7a3d\u67e5\u3002<\/span>\u201c<\/span>\u72ec\u7acb\u7684\u68c0\u67e5<\/span>\u201d<\/span>\u662f\u6307\u7a3d\u67e5\u5458\u4e0e\u8d1f\u8d23\u4e34\u5e8a\u8bd5\u9a8c\u7684\u4eba\u5458\uff0c\u5373\u90a3\u4e9b\u5bf9\u4e34\u5e8a\u8bd5\u9a8c\u4ea7\u751f\u7684\u6570\u636e\u8d1f\u6709\u8d23\u4efb\u7684\u4eba\u6ca1\u6709\u5173\u7cfb\u3002<\/span>\u201c<\/span>\u76f8\u5173\u7684\u6cd5\u89c4\u8981\u6c42<\/span>\u201d<\/span>\u6307\u5bf9\u7814\u7a76\u8005\u7684\u7a3d\u67e5\u548c\u89c6\u5bdf\u5c06\u4ee5\u5f53\u5730\u7684\u6cd5\u89c4\u4e3a\u6807\u51c6\u3002<\/span><\/span><\/p>\n

    \u6709\u4e24\u79cd\u7c7b\u578b\u7684\u7a3d\u67e5\u65b9\u5f0f\u3002\u5e38\u89c4\u7a3d\u67e5\uff1a\u7528\u4ee5\u786e\u8bc1\u9075\u5b88\u4e86\u7533\u529e\u8005\u7684\u8981\u6c42\u3001\u56fd\u5bb6\u548c\u5f53\u5730\u6cd5\u89c4\u3002\u8fd9\u5e38\u5e38\u662f\u7533\u529e\u8005\u5bf9\u4e34\u5e8a\u8bd5\u9a8c\u9884\u5148\u8ba1\u5212\u7684\u7a3d\u67e5\u6d3b\u52a8\u7684\u4e00\u90e8\u5206\uff0c\u9488\u5bf9\u90a3\u4e9b\u987b\u63d0\u4ea4\u7ed9\u836f\u653f\u7ba1\u7406\u673a\u6784\u4ee5\u652f\u6301\u5176\u4e0a\u5e02\u7533\u8bf7\u7684\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u3002\u7533\u529e\u8005\u4e5f\u53ef\u4ee5\u8fdb\u884c<\/span>\u201c<\/span>\u7a76\u56e0<\/span>\u201d<\/span>\u7a3d\u67e5<\/span>(for-causeaudit)<\/span>\uff0c\u6709\u65f6\u4e5f\u53ef\u4ee5\u79f0\u4e3a\u6307\u5bfc\u6027\u7a3d\u67e5\u3002\u5b83\u4eec\u901a\u5e38\u662f\u5728\u7533\u529e\u8005\u6709\u7406\u7531\u76f8\u4fe1\u7814\u7a76\u8005\u6ca1\u6709\u9075\u5b88\u4e34\u5e8a\u8bd5\u9a8c\u7684\u8981\u6c42\u5e76\u4e14\u62c5\u5fc3\u8be5\u4e2d\u5fc3\u8bd5\u9a8c\u6570\u636e\u7684\u8d28\u91cf\u65f6\u8fdb\u884c\u7684\u3002<\/span><\/span><\/p>\n

    \u8c01\u6765\u8fdb\u884c\u8fd9\u4e9b\u7a3d\u67e5\u5462\uff1f\u5bf9\u4e8e\u7533\u529e\u8005\u800c\u8a00\uff0c\u53ef\u4ee5\u662f\u6765\u81ea\u4e8e\u5176\u6cd5\u89c4\u7ba1\u7406\u90e8\u95e8\u3001\u8d28\u91cf\u4fdd\u8bc1\u6216\u8d28\u91cf\u6807\u51c6\u90e8\u95e8\u7684\u4e00\u4e2a\u72ec\u7acb\u4e8e\u4e34\u5e8a\u8bd5\u9a8c\u7684\u4eba\u3002\u56fd\u9645\u6743\u5a01\u7ba1\u7406\u673a\u6784\u5982\u7f8e\u56fd<\/span>FDA<\/span>\u3001\u65e5\u672c\u539a\u751f\u7701\u6216\u6b27\u76df\u7684\u836f\u653f\u7ba1\u7406\u673a\u6784\u4e5f\u53ef\u4ee5\u89c6\u5bdf\u67d0\u4e00\u7814\u7a76\u5355\u4f4d\u3002\u4f60\u4e5f\u53ef\u80fd\u53d7\u5230\u5f53\u5730\u7ba1\u7406\u673a\u6784\u7684\u89c6\u5bdf\u3002<\/span><\/span><\/p>\n

    \u7a3d\u67e5\u53ef\u4ee5\u5728\u8bd5\u9a8c\u4e2d\u6216\u8bd5\u9a8c\u540e\u8fdb\u884c\u3002\u5728\u8bd5\u9a8c\u4e2d\u7a3d\u67e5\u7684\u4f18\u70b9\u662f\uff0c\u7ed3\u679c\u53cd\u9988\u7ed9\u7533\u529e\u8005\uff0c\u6709\u5229\u4e8e\u4e86\u89e3\u8bd5\u9a8c\u8fdb\u884c\u7684\u60c5\u51b5\u5e76\u4e0e\u5176\u4ed6\u7814\u7a76\u5355\u4f4d\u5206\u4eab\u5171\u540c\u6539\u8fdb\u8bd5\u9a8c\u8d28\u91cf\u3002\u5982\u679c\u7a3d\u67e5\u662f\u5728\u8bd5\u9a8c\u7ed3\u675f\u540e\u8fdb\u884c\u7684\uff0c\u7533\u529e\u8005\u987b\u8981\u6c42\u7814\u7a76\u8005\u5728\u6307\u5b9a\u7684\u65f6\u95f4\u5185\u4fdd\u5b58\u6240\u6709\u7684\u8bd5\u9a8c\u76f8\u5173\u6587\u4ef6\u3002\u8fd9\u662f\u975e\u5e38\u91cd\u8981\u7684\uff0c\u56e0\u4e3a\u5728\u8bd5\u9a8c\u7ed3\u675f\u540e\u7684\u6570\u5e74\u5185\u90fd\u6709\u53ef\u80fd\u8fdb\u884c\u7a3d\u67e5\u548c\u89c6\u5bdf\u3002<\/span><\/p>\n

    \u4e0b\u9762\u4e24\u5f20\u5e7b\u706f\u663e\u793a\u7684\u662f\u5728\u7f8e\u56fd\u548c\u7f8e\u56fd\u4ee5\u5916\u6240\u8fdb\u884c\u7684\u5bf9\u4e34\u5e8a\u7814\u7a76\u8005\u7684\u89c6\u5bdf\u3002\u8fd9\u5f20\u4ece<\/span>1992<\/span>\uff0d<\/span>1997<\/span>\u5e74\uff0c\u53ef\u4ee5\u770b\u5230\u89c6\u5bdf\u6b21\u6570\u6709\u4e0a\u5347\u7684\u8d8b\u52bf\u3002\u4e0b\u4e00\u5f20\u5e7b\u706f\u662f\u5bf9\u7f8e\u56fd\u4ee5\u5916\u7684\u89c6\u5bdf\u60c5\u51b5\uff0c\u53ef\u4ee5\u770b\u5230\u5728\u7f8e\u56fd\u4ee5\u5916\u8fdb\u884c\u7684\u89c6\u5bdf\u5360\u89c6\u5bdf\u6570\u76ee\u7684<\/span>10<\/span>\uff05\u5de6\u53f3\u3002\u7f8e\u56fd<\/span>FDA<\/span>\u8bf4\u8fc7\uff0c\u5982\u679c\u4e34\u5e8a\u8bd5\u9a8c\u662f\u9075\u4ece<\/span>ICH-GCP<\/span>\u539f\u5219\u8fdb\u884c\u7684\uff0c\u90a3\u4e48\u4ed6\u4eec\u5c06\u540c\u610f\u63a5\u53d7\u8fd9\u4e9b\u56fd\u5916\u7684\u8bd5\u9a8c\u6570\u636e\u7528\u4ee5\u652f\u6301\u5728\u7f8e\u56fd\u7684\u4e0a\u5e02\u7533\u8bf7\u3002\u4e0a\u8ff0\u8981\u6c42\u4e2d\u5f88\u91cd\u8981\u7684\u51e0\u70b9\u5305\u62ec\u5728\u8bd5\u9a8c\u4e2d\u4fdd\u62a4\u53d7\u8bd5\u8005\u7684\u5b89\u5168\uff0c\u5373\u662f\u8fd9\u5f20\u5e7b\u706f\u7247\u4e0a\u7684\u524d\u4e24\u70b9\uff0c\u53e6\u4e00\u4e2a\u662f\u4f26\u7406\u5b66\u7684\u539f\u5219\u4ee5\u53ca\u9075\u7167\u8d6b\u5c14\u8f9b\u57fa\u5ba3\u8a00\u7684\u539f\u5219\u3002<\/span><\/span><\/p>\n

    \u8bd5\u9a8c\u5fc5\u987b\u662f\u6309\u7167\u79d1\u5b66\u7684\u539f\u5219\u6709\u826f\u597d\u7684\u8bbe\u8ba1\uff0c\u5e76\u4e14\u5f88\u597d\u5b9e\u65bd\u3002\u5fc5\u987b\u662f\u7531\u6709\u8d44\u683c\u7684\u4e34\u5e8a\u7814\u7a76\u8005\u8fdb\u884c\u7684\u3002\u6240\u8c13\u6709\u8d44\u683c\u7684\uff0c\u662f\u6307\u7814\u7a76\u8005\u987b\u6709\u8be5\u6cbb\u7597\u9886\u57df\u7684\u4e13\u4e1a\u77e5\u8bc6\u3002\u8bd5\u9a8c\u5e94\u8be5\u5f97\u5230\u72ec\u7acb\u7684\u4f26\u7406\u59d4\u5458\u4f1a\u7684\u6279\u51c6\uff0c\u7814\u7a76\u8005\u4e5f\u5fc5\u987b\u540c\u610f\uff0c\u5728\u9700\u8981\u65f6\u63a5\u53d7<\/span>FDA<\/span>\u7684\u89c6\u5bdf\u4ee5\u8bc1\u5b9e\u8be5\u7814\u7a76\u4e2d\u5fc3\u7684\u6570\u636e\u3002<\/span><\/span><\/p>\n

    \u7b2c\u4e00\u90e8\u5206\u7684\u5185\u5bb9\u5230\u6b64\u7ed3\u675f\uff0c\u7b2c\u4e8c\u90e8\u5206\u5c06\u8ba8\u8bba\u4e00\u4e9b\u5728\u7a3d\u67e5\u4e2d\u5e38\u89c1\u7684\u6d3b\u52a8\u3002<\/span><\/p>\n

    \u5bf9\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u5fc3\u7684\u7a3d\u67e5<\/span>(2)<\/span><\/strong><\/span><\/p>\n

    Ms. Barbara O\u2019Neill<\/span><\/strong><\/span><\/p>\n

    \u5728\u8fd9\u4e00\u8282\u6211\u4eec\u5c06\u8ba8\u8bba\u4e0b\u9762\u7684\u8bdd\u9898\uff1a\u7533\u529e\u8005\u7684\u7a3d\u67e5\u76ee\u7684\uff0c\u7a3d\u67e5\u5458\u5728\u8be5\u7814\u7a76\u4e2d\u5fc3\u7684\u6d3b\u52a8\uff0c\u4ee5\u53ca\u5e38\u89c1\u7684\u7a3d\u67e5\u53d1\u73b0\u3002<\/span><\/p>\n

    \u7533\u529e\u8005\u5bf9\u7814\u7a76\u5355\u4f4d\u8fdb\u884c\u7a3d\u67e5\u7684\u76ee\u7684\u6709\u8bb8\u591a\uff0c\u6700\u91cd\u8981\u4e4b\u4e00\u662f\u4fdd\u8bc1\u53d7\u8bd5\u8005\u7684\u6743\u76ca\u53d7\u5230\u4e86\u4fdd\u62a4\u3002\u8fd8\u6709\u5f88\u91cd\u8981\u7684\u662f\u7814\u7a76\u8005\u4f9d\u4ece\u4e86\u8bd5\u9a8c\u65b9\u6848\u548c\u9075\u5b88\u4e86\u6cd5\u89c4\u3002\u53e6\u4e00\u4e2a\u91cd\u8981\u7684\u7a3d\u67e5\u76ee\u7684\u662f\u8bc4\u4ef7\u7533\u529e\u8005\u7684\u76d1\u67e5\u6d3b\u52a8\u5e76\u5c06\u5176\u53cd\u9988\u7ed9\u4e34\u5e8a\u4eba\u5458\u3002\u4f5c\u4e3a\u4e00\u4e2a\u7814\u7a76\u8005\uff0c\u4f60\u53ef\u4ee5\u6839\u636e\u7a3d\u67e5\u7684\u7ed3\u679c\u6765\u6539\u8fdb\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u5b58\u5728\u7684\u95ee\u9898\uff0c\u5e76\u5bf9\u63d0\u9ad8\u4e34\u5e8a\u8bd5\u9a8c\u6c34\u5e73\u63d0\u51fa\u4f60\u7684\u5efa\u8bae\u3002\u7533\u529e\u8005\u4e5f\u53ef\u4ee5\u8fdb\u884c\u7a3d\u67e5\uff0c\u4e3a\u7ba1\u7406\u90e8\u95e8\u5bf9\u8be5\u7814\u7a76\u4e2d\u5fc3\u7684\u89c6\u5bdf\u505a\u51c6\u5907\u3002<\/span><\/p>\n

    \u7a3d\u67e5\u5458\u5728\u7814\u7a76\u4e2d\u5fc3\u7684\u6d3b\u52a8\u5305\u62ec\u68c0\u67e5\u5176\u8bbe\u65bd\uff0c\u5ba1\u6838\u7814\u7a76\u4eba\u5458\u7684\u8d44\u683c\u3001\u4f5c\u7528\u4ee5\u53ca\u4ed6\u4eec\u5728\u8bd5\u9a8c\u4e2d\u8d1f\u6709\u8d23\u4efb\u3002\u7a3d\u67e5\u5458\u8fd8\u4f1a\u68c0\u67e5\u8bd5\u9a8c\u6587\u4ef6\u5939\u5e76\u7279\u522b\u8981\u786e\u4fdd\u6709\u6b63\u786e\u7684\u4f26\u7406\u59d4\u5458\u4f1a\u6279\u51c6\u6587\u4ef6\u3002\u4ed6\u4eec\u5c06\u5ba1\u9605<\/span>CRF<\/span>\uff0c\u76f8\u5173\u7684\u539f\u59cb\u6587\u4ef6\uff0c\u786e\u5b9a\u8bd5\u9a8c\u836f\u54c1\u7684\u6e05\u70b9\uff0c\u4ee5\u53ca\u5ba1\u6838\u77e5\u60c5\u540c\u610f\u7684\u8fc7\u7a0b\u548c\u76f8\u5173\u7684\u77e5\u60c5\u540c\u610f\u4e66\u3002<\/span><\/span><\/p>\n

    \u4f5c\u4e3a\u4e00\u4e2a\u7814\u7a76\u8005\uff0c\u4e3a\u51c6\u5907\u7a3d\u67e5\uff0c\u5f88\u91cd\u8981\u7684\u4e00\u70b9\u662f\u5728\u6574\u4e2a\u7814\u7a76\u8fc7\u7a0b\u4e2d\u8981\u51c6\u786e\u3001\u5b8c\u6574\u5730\u4fdd\u5b58\u597d\u6240\u6709\u7684\u8bd5\u9a8c\u6587\u4ef6\uff0c\u800c\u4e14\u6240\u6709\u7684\u7814\u7a76\u4eba\u5458\u90fd\u8981\u719f\u6089<\/span>GCP<\/span>\u539f\u5219\u548c\u7533\u529e\u8005\u3001\u7814\u7a76\u673a\u6784\u4ee5\u53ca\u5f53\u5730\u7684\u6cd5\u89c4\u7684\u8981\u6c42\u3002\u6211\u7684\u5efa\u8bae\u662f\uff0c\u5982\u679c\u4f60\u7684\u7814\u7a76\u4e2d\u5fc3\u88ab\u8981\u6c42\u8fdb\u884c\u7a3d\u67e5\uff0c\u4e0d\u8981\u60ca\u614c\u3002\u4f60\u7684\u4e2d\u5fc3\u88ab\u9009\u4e2d\uff0c\u5f88\u53ef\u80fd\u662f\u56e0\u4e3a\u4f60\u4eec\u4e2d\u5fc3\u5165\u9009\u7684\u75c5\u4eba\u8f83\u591a\uff0c\u4f60\u4eec\u7684\u8d44\u6599\u88ab\u8ba4\u4e3a\u5bf9\u7533\u529e\u8005\u7684\u8bd5\u9a8c\u6709\u91cd\u8981\u7684\u5f71\u54cd\u3002<\/span><\/span><\/p>\n

    \u5f53\u4f60\u9762\u5bf9\u4e00\u4e2a\u7a3d\u67e5\u5458\u65f6\uff0c\u4f60\u5e94\u8be5\u8981\u6c42\u786e\u8ba4\u5176\u8eab\u4efd\uff0c\u660e\u786e\u7a3d\u67e5\u5458\u5e0c\u671b\u7a3d\u67e5\u54ea\u4e2a\u8bd5\u9a8c\uff0c\u7136\u540e\u53d6\u51fa\u76f8\u5173\u7684<\/span>CRF<\/span>\u4ee5\u53ca\u539f\u59cb\u6587\u4ef6\u3002\u786e\u5b9a\u8bd5\u9a8c\u4e2d\u6709\u54ea\u4e9b\u539f\u59cb\u6587\u4ef6\u5e76\u5c06\u6240\u6709\u53d7\u8bd5\u8005\u7684\u6587\u4ef6\u53d6\u51fa\uff0c\u8fd9\u5e94\u8be5\u5305\u62ec\u77e5\u60c5\u540c\u610f\u4e66\uff0c<\/span>X<\/span>\u5149\u7247\uff0c\u5fc3\u7535\u56fe\uff0c\u4e34\u5e8a\u8bb0\u5f55\u4ee5\u53ca\u5b9e\u9a8c\u5ba4\u68c0\u67e5\u7ed3\u679c\u3002\u4fdd\u8bc1\u7a3d\u67e5\u5458\u53ef\u4ee5\u627e\u5230\u53c2\u4e0e\u8bd5\u9a8c\u7684\u7814\u7a76\u4eba\u5458\u4ee5\u4fbf\u8be2\u95ee\u6709\u5173\u95ee\u9898\uff0c\u5e76\u4e14\u786e\u4fdd\u4f60\u5df2\u7ecf\u901a\u77e5\u4e86<\/span>IRB<\/span>\u6216<\/span>IEC<\/span>\u7684\u8d1f\u8d23\u4eba\u672c\u4e2d\u5fc3\u5c06\u8981\u88ab\u7a3d\u67e5\u3002<\/span><\/span><\/p>\n

    \u6211\u4eec\u6765\u770b\u4e00\u4e0b\u7a3d\u67e5\u4e2d\u7684\u5e38\u89c1\u53d1\u73b0\u3002\u6211\u9f13\u52b1\u7814\u7a76\u8005\u5229\u7528\u8fd9\u4e9b\u53d1\u73b0\u6765\u63d0\u9ad8\u81ea\u8eab\u4e34\u5e8a\u8bd5\u9a8c\u7684\u6c34\u5e73\u3002\u8fd9\u4e9b\u53d1\u73b0\u53ef\u4ee5\u5206\u6210\u51e0\u7c7b\uff1a\u672a\u4f9d\u4ece\u8bd5\u9a8c\u65b9\u6848\uff0c\u539f\u59cb\u6587\u4ef6\u4e0d\u5168\uff0c\u8bd5\u9a8c\u836f\u54c1\u7684\u8bb0\u5f55\u4e0d\u5168\u4ee5\u53ca\u77e5\u60c5\u540c\u610f\u7684\u95ee\u9898\u3002<\/span><\/p>\n

    \u5173\u4e8e\u672a\u4f9d\u4ece\u8bd5\u9a8c\u65b9\u6848\u7684\u95ee\u9898\uff0c\u7533\u529e\u8005\u9700\u8981\u4fdd\u8bc1\u6ca1\u6709\u8fdd\u53cd\u8bd5\u9a8c\u65b9\u6848\u4e2d\u7279\u5b9a\u7684\u5165\u9009\u6807\u51c6\u548c\u6392\u9664\u6807\u51c6\uff1b\u8bd5\u9a8c\u8fc7\u7a0b\u4e2d\u51fa\u73b0\u7684\u4e25\u91cd\u4e0d\u826f\u4e8b\u4ef6\u6216\u6b7b\u4ea1\u5747\u53ca\u65f6\u5730\u62a5\u544a\u7ed9\u7533\u529e\u8005\uff1b\u53d7\u8bd5\u8005\u6ca1\u6709\u670d\u7528\u7981\u6b62\u670d\u7528\u7684\u836f\u7269\uff1b\u800c\u4e14\u53d7\u8bd5\u8005\u6ca1\u6709\u540c\u65f6\u53c2\u52a0\u591a\u4e2a\u4e34\u5e8a\u8bd5\u9a8c\u3002\u53e6\u5916\uff0c\u8bd5\u9a8c\u65b9\u6848\u8981\u6c42\u7684\u68c0\u67e5\u5982\u679c\u6ca1\u6709\u505a\u8981\u6709\u8be6\u7ec6\u7684\u8bb0\u5f55\u3002<\/span><\/p>\n

    \u5173\u539f\u59cb\u6587\u4ef6\u4e0d\u5168\u7684\u95ee\u9898\uff0c\u6240\u6709\u53d7\u8bd5\u8005\u7684\u539f\u59cb\u8bb0\u5f55\u90fd\u5e94\u8be5\u63d0\u4ea4\u7ed9\u7a3d\u67e5\u5458\u3002\u6240\u6709\u7684\u7b5b\u9009\u5931\u8d25\u8005\u7684\u8bb0\u5f55\u4e5f\u5e94\u8be5\u5b58\u5728\u3002<\/span>CRF\u548c\u539f\u59cb\u6587\u4ef6\u7684\u4e0d\u4e00\u81f4\u662f\u5f88\u5e38\u89c1\u7684\u7a3d\u67e5\u53d1\u73b0\uff0c\u5982\u539f\u59cb\u6587\u4ef6\u4e0a\u7684\u4e0d\u826f\u4e8b\u4ef6\u6ca1\u6709\u8bb0\u5f55\u5728<\/span>CRF\u4e2d\u3002<\/span>[\u53e6\u5916\uff0c\u7814\u7a76\u8005\u6216\u5176\u4ed6\u7814\u7a76\u4eba\u5458\u7684\u8bb0\u5f55\u4e0d\u5168\uff0c\u5bf9\u8131\u843d\u7684\u53d7\u8bd5\u8005\u968f\u8bbf\u8bb0\u5f55\u5dee\u90fd\u662f\u5e38\u89c1\u7684\u53d1\u73b0<\/span>] \u3002\u8981\u8868\u73b0\u51fa\u4f60\u5df2\u7aed\u5c3d\u6240\u80fd\u8054\u7cfb\u5931\u8bbf\u7684\u53d7\u8bd5\u8005\u3002\u539f\u59cb\u6587\u4ef6\u4e2d\u6ca1\u6709\u8bb0\u5f55\u8be5\u53d7\u8bd5\u8005\u6b63\u5728\u53c2\u52a0\u8bd5\u9a8c\u4e5f\u662f\u7a3d\u67e5\u7684\u4e00\u4e2a\u5e38\u89c1\u53d1\u73b0\u3002<\/span><\/span><\/p>\n

    \u5173\u4e8e\u8bd5\u9a8c\u7528\u836f\u54c1\u7684\u8bb0\u5f55\uff0c\u7814\u7a76\u8005\u548c\u7814\u7a76\u4eba\u5458\u6709\u8d23\u4efb\u4fdd\u5b58\u51c6\u786e\u548c\u5b8c\u6574\u7684\u8bb0\u5f55\uff0c\u5305\u62ec\u836f\u7269\u7684\u6536\u8bab\u548c\u5f52\u8fd8\u8bb0\u5f55\uff0c\u8bd5\u9a8c\u7528\u836f\u54c1\u8bb0\u5f55\u8868\u548c<\/span>CRF<\/span>\u4e2d\u7528\u836f\u8bb0\u5f55\u7684\u4e00\u81f4\u6027\u3002\u60a3\u8005\u672a\u5f52\u8fd8\u7684\u836f\u7269\u4e5f\u5e94\u8be5\u6709\u6e05\u6670\u7684\u8bb0\u5f55\u3002<\/span><\/span><\/p>\n

    \u5bf9\u4e8e\u77e5\u60c5\u540c\u610f\u7684\u95ee\u9898\uff0c\u8bb8\u591a\u662f\u77e5\u60c5\u540c\u610f\u8fc7\u7a0b\u7684\u95ee\u9898\u3002\u6211\u4eec\u66fe\u53d1\u73b0\u6709\u4e9b\u53d7\u8bd5\u8005\u6ca1\u6709\u5728\u8fdb\u884c\u65b9\u6848\u4e2d\u89c4\u5b9a\u7684\u64cd\u4f5c\u4e4b\u524d\u7b7e\u7f72\u77e5\u60c5\u540c\u610f\u4e66\uff1b\u53d7\u8bd5\u8005\u6ca1\u6709\u5728\u8bd5\u9a8c\u65b9\u6848\u4fee\u6539\u540e\u7684\u65b0\u77e5\u60c5\u540c\u610f\u4e66\u4e0a\u7b7e\u5b57\uff1b\u77e5\u60c5\u540c\u610f\u4e66\u6ca1\u6709\u6b63\u786e\u5730\u7b7e\u7f72\u65e5\u671f\uff1b\u89c1\u8bc1\u4eba\u7684\u7b7e\u5b57\u5f80\u5f80\u7f3a\u5931\uff0c\u6216\u8005\u4f7f\u7528\u4e86\u672a\u6279\u51c6\u7684\u7248\u672c\u3002<\/span><\/p>\n

    \u5bf9\u8fd9\u90e8\u5206\u7684\u603b\u7ed3\u662f\uff1a\u7f8e\u56fd<\/span>FDA<\/span>\u63a5\u53d7\u4e25\u683c\u6309\u7167<\/span>ICH GCP<\/span>\u8fdb\u884c\u7684\u4e34\u5e8a\u8bd5\u9a8c\u7684\u8d44\u6599\u3002\u8fd9\u975e\u5e38\u91cd\u8981\uff0c\u56e0\u4e3a\u7533\u529e\u8005\u73b0\u5728\u5728\u65b0\u7684\u5730\u533a\u5f00\u5c55\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u7f8e\u56fd<\/span>FDA<\/span>\u548c\u5f53\u5730\u7684\u836f\u653f\u7ba1\u7406\u90e8\u95e8\u4ee5\u53ca\u7533\u529e\u8005\u90fd\u53ef\u80fd\u9009\u62e9\u6027\u5730\u5bf9\u7814\u7a76\u5355\u4f4d\u8fdb\u884c\u68c0\u67e5\u3002\u4fdd\u6301\u5bf9\u8bd5\u9a8c\u65b9\u6848\u7684\u4f9d\u4ece\u3001\u4fdd\u8bc1\u53d7\u8bd5\u8005\u7684\u5b89\u5168\u3001\u9ad8\u8d28\u91cf\u7684\u6570\u636e\u4ee5\u53ca\u5e38\u89c1\u7684\u7a3d\u67e5\u53d1\u73b0\u7684\u5173\u6ce8\u6709\u52a9\u4e8e\u9632\u6b62\u76f8\u5173\u95ee\u9898\u7684\u51fa\u73b0\u3002<\/span><\/span><\/p>\n

    \u8c22\u8c22\u5927\u5bb6\u3002<\/span><\/p>\n


    <\/span><\/strong><\/p>\n

    \u7b2c\u5341\u4e5d\u8bb2 <\/span><\/strong>21\u4e16\u7eaa\u7684\u4e34\u5e8a\u7814\u7a76: \u672a\u6765\u7684\u7814\u7a76\u9886\u57df<\/span><\/strong><\/p>\n

    Dr. Robert Rubin<\/span><\/strong><\/span><\/p>\n

    \u5728\u8fd9\u91cc\u6211\u5f88\u9ad8\u5174\u548c\u5927\u5bb6\u4e00\u8d77\u9884\u6d4b\u4e00\u4e0b21\u4e16\u7eaa\u7684\u4e34\u5e8a\u7814\u7a76\u3002\u5728\u6211\u770b\u6765\uff0c\u8fd9\u91cc\u6709\u4e2a\u5f88\u5927\u7684\u77db\u76fe\u3002\u4e00\u65b9\u9762\uff0c\u53f2\u65e0\u524d\u4f8b\u7684\u4e34\u5e8a\u7814\u7a76\u7684\u673a\u4f1a\uff0c\u4f46\u6211\u8ba4\u4e3a\uff0c\u4e5f\u5b58\u5728\u7740\u524d\u6240\u672a\u6709\u7684\u6311\u6218\u3002\u8ba9\u6211\u4eec\u6765\u8be6\u7ec6\u770b\u4e00\u4e0b\u8fd9\u4e24\u4e2a\u65b9\u9762\u3002<\/span><\/p>\n

    \u4e3a\u4ec0\u4e48\u8bf421\u4e16\u7eaa\u6709\u53f2\u65e0\u524d\u4f8b\u7684\u673a\u4f1a\u5462\uff1f\u7b2c\u4e00\u4e2a\u6211\u4eec\u80fd\u786e\u5b9a\u7684\u56e0\u7d20\u662f\u4e34\u5e8a\u7814\u7a76\u7684\u5168\u7403\u5316\u3002\u4eca\u5929\uff0c\u56fd\u9645\u5408\u4f5c\u7684\u8bd5\u9a8c\u662f\u4e3a\u4e86\u5728\u56fd\u9645\u4e0a\u6279\u51c6\u65b0\u7684\u836f\u7269\u3001\u75ab\u82d7\u548c\u6280\u672f\u3002\u5728\u4e16\u754c\u8303\u56f4\u90fd\u5728\u6301\u7eed\u5bfb\u627e\u90a3\u4e9b\u88ab\u6211\u79f0\u4e3a<\/span>\u201c<\/span>\u5177\u4ee3\u8868\u6027\u7684\u53d7\u8bd5\u8005\u4eba\u7fa4<\/span>\u201d<\/span>(<\/span>\u201c<\/span>leveragedsubject population<\/span>\u201d<\/span>)\u4ee5\u5b8c\u6210\u6240\u9700\u8981\u7684\u4e34\u5e8a\u8bd5\u9a8c\u3002\u6211\u7684\u610f\u601d\u662f\uff0c\u9700\u8981\u5bfb\u627e\u5177\u6709\u67d0\u79cd\u75be\u75c5\u7684\u8f83\u9ad8\u53d1\u75c5\u7387\u6216\u57fa\u56e0\u80cc\u666f\u6216\u73af\u5883\u56e0\u7d20\u7684\u4eba\u7fa4\u3002\u6b63\u56e0\u4e3a\u8fd9\u6837\uff0c\u6211\u4eec\u8ba4\u8bc6\u5230\u6709\u9700\u8981\u5e76\u4e14\u5728\u5bfb\u6c42\u8fdb\u884c\u56fd\u9645\u7814\u7a76\u3002\u7b2c\u4e09\u662f\uff0c\u901a\u8fc7\u56fd\u9645\u534f\u8c03\u53ef\u4ee5\u4f7f\u5f97\u4e0d\u8bba\u5728\u5730\u7403\u7684\u54ea\u4e2a\u5730\u65b9\u8fdb\u884c\u7684\u7814\u7a76\u90fd\u4f1a\u88ab\u8ba4\u53ef\u548c\u6709\u610f\u4e49\u3002<\/span><\/span><\/p>\n

    \u7b2c\u4e8c\u4e2a\u91cd\u8981\u7684\u65b9\u9762\u662f\u6211\u4eec\u7a81\u7136\u62e5\u6709\u4e86\u6570\u91cf\u4e0a\u524d\u6240\u672a\u6709\u7684\u65b0\u5316\u5408\u7269\uff0c\u8fd9\u662f\u5206\u5b50\u751f\u7269\u5b66\u548c\u751f\u7269\u6280\u672f\u9769\u547d\u7684\u7ed3\u679c\u3002\u8fd9\u4e9b\u4ea7\u54c1\u6216\u4ece\u5929\u7136\u7269\u8d28\u4e2d\u7b5b\u9009\u51fa\u6765\u3001\u6216\u662f\u5408\u6210\u5316\u5b66\u3001\u7406\u60f3\u836f\u7269\u8bbe\u8ba1\u548c\u65b0\u5206\u5b50\u9776\u6807\u7684\u9ad8\u901a\u91cf\u7b5b\u9009\u7684\u7ed3\u679c\u3002\u53ef\u80fd\u672a\u676525\u5e74\u4e2d\u6700\u91cd\u8981\u7684\u662f\u6765\u81ea\u5206\u5b50\u9057\u4f20\u5b66\u7684\u4fe1\u606f\u548c\u5206\u5b50\uff1a\u6765\u81ea\u4eba\u7c7b\u57fa\u56e0\u7ec4\u7684\u7814\u7a76\uff0c\u6765\u81ea\u9175\u6bcd\u83cc\u57fa\u56e0\u7ec4\u3001\u5927\u80a0\u6746\u83cc\u57fa\u56e0\u7ec4\u548c\u7ebf\u866b\u57fa\u56e0\u7ec4\u7684\u7814\u7a76\u548c\u8f6c\u57fa\u56e0\u52a8\u7269\u7684\u7814\u7a76\u7b49\u7b49\u3002\u7a81\u7136\u95f4\uff0c\u6211\u4eec\u4f3c\u4e4e\u63a5\u89e6\u5230\u4eba\u7c7b\u75be\u75c5\u7684\u6839\u672c\uff0c\u6211\u4eec\u80fd\u591f\u5f00\u59cb\u4e3a\u4eba\u7c7b\u7684\u75be\u75c5\u8bbe\u8ba1\u6cbb\u7597\u65b9\u6cd5\u3002<\/span><\/p>\n

    \u53e6\u4e00\u4e2a\u6709\u8fdc\u5927\u524d\u666f\u7684\u9886\u57df\u662f\u65b0\u7684\u836f\u7269\u91ca\u653e\u7cfb\u7edf\u3002\u6211\u4eec\u53ef\u80fd\u6709\u4e16\u754c\u4e0a\u6700\u597d\u7684\u5206\u5b50\uff0c\u4f46\u662f\u6211\u4eec\u9700\u8981\u5c06\u5b83\u8f93\u9001\u5230\u75be\u75c5\u6240\u5728\u7684\u90e8\u4f4d\uff0c\u6240\u91c7\u53d6\u7684\u65b9\u6cd5\u53c8\u80fd\u4f7f\u8fd9\u4e2a\u5206\u5b50\u6709\u6700\u5927\u7684\u7597\u6548\u3002\u8fd9\u4e2a\u9886\u57df\u6b63\u5728\u8fdb\u884c\u7684\u5de5\u4f5c\u975e\u5e38\u4ee4\u4eba\u6fc0\u52a8\uff1a\u690d\u5165\u6027\u7684\uff0c\u7a0b\u5e8f\u91ca\u653e\u6cf5\uff0c\u7f13\u91ca\u591a\u805a\u4f53\uff0c\u4ee5\u53ca\u672a\u6765\u6211\u4eec\u53ef\u80fd\u6709\u5fae\u578b\u673a\u5668\u4eba\u53ef\u4ee5\u611f\u53d7\u3001\u786e\u5b9a\u75be\u75c5\u5e76\u8fdb\u884c\u5c40\u90e8\u7684\u6cbb\u7597\uff0c\u8fd9\u6837\u53ef\u4ee5\u4f7f\u5f97\u4e34\u5e8a\u7597\u6548\u6700\u5927\uff0c\u5e76\u51cf\u5c11\u6bd2\u6027\u548c\u5168\u8eab\u4e0d\u826f\u53cd\u5e94\u3002<\/span><\/p>\n

    \u53e6\u5916\u503c\u5f97\u63d0\u5230\u7684\u9886\u57df\u662f\u65b0\u7684\u68c0\u6d4b\u6280\u672f\u3002\u5b83\u4eec\u5c06\u88ab\u7528\u4e8e\u8bc4\u4ef7\u53d7\u8bd5\u8005\u7684\u75c5\u7406\u751f\u7406\u3001\u836f\u4ee3\u52a8\u529b\u5b66\u4ee5\u53ca\u836f\u7269\u5bf9\u4e2a\u4f53\u7684\u836f\u6548\u52a8\u529b\u5b66\u5f71\u54cd\u3002\u8bf7\u8bb0\u4f4f\uff0c\u836f\u4ee3\u52a8\u529b\u5b66\u662f\u6307\u4eba\u4f53\u5bf9\u836f\u7269\u505a\u4e86\u4ec0\u4e48\uff0c\u800c\u836f\u6548\u52a8\u529b\u5b66\u662f\u6307\u836f\u7269\u5bf9\u4eba\u4f53\u505a\u4e86\u4ec0\u4e48\u3002<\/span><\/p>\n

    \u5173\u4e8e\u65b0\u7684\u68c0\u6d4b\u6280\u672f\uff0c\u76ee\u524d\u8fdb\u5c55\u6700\u5feb\u7684\u662f\u5f71\u50cf\u6280\u672f\u3002\u6b63\u7535\u5b50\u53d1\u5c04\u6210\u50cf\u4ee5\u53ca\u6838\u533b\u5b66\u6280\u672f\uff0c\u78c1\u5171\u632f\u6210\u50cf\uff0c\u8840\u7ba1\u548c\u8840\u7ba1\u5185\u8d85\u58f0\u4f7f\u5f97\u6211\u4eec\u53ef\u4ee5\u4e86\u89e3\u75be\u75c5\u7684\u8fc7\u7a0b\u3001\u53d7\u4f53\u914d\u4f53\u53cd\u5e94\u4ee5\u53ca\u5c06\u836f\u7269\u8f93\u9001\u5230\u67d0\u4e2a\u90e8\u4f4d\u7684\u80fd\u529b\u3002\u5b9e\u9645\u4e0a\u6240\u6709\u7684\u6cbb\u7597\u90fd\u662f\u57fa\u4e8e\u751f\u7269\u5316\u5b66\u7684\u5047\u8bbe\uff1b\u4e5f\u5c31\u662f\uff0c\u5982\u679c\u6211\u4eec\u80fd\u6291\u5236\u67d0\u79cd\u7269\u8d28\u6216\u7ed3\u5408\u4e86\u67d0\u79cd\u7269\u8d28\uff0c\u6211\u4eec\u5c31\u6709\u673a\u4f1a\u4ea7\u751f\u4e34\u5e8a\u7684\u6709\u76ca\u6548\u679c\u3002\u73b0\u5728\uff0c\u6211\u4eec\u6709\u80fd\u529b\u8bc4\u4ef7\u662f\u5426\u8fbe\u5230\u4e86\u751f\u7269\u5316\u5b66\u7684\u76ee\u7684\uff0c\u8fd9\u6837\u5c31\u6709\u6700\u5927\u7684\u673a\u4f1a\u6765\u89c2\u5bdf\u4e34\u5e8a\u7684\u7597\u6548\u3002\u53e6\u4e00\u4e2a\u9886\u57df\u662f\u57fa\u56e0\u8868\u8fbe\u82af\u7247\uff0c\u6211\u4eec\u53ef\u4ee5\u770b\u5230\u5728\u75c5\u4eba\u57fa\u56e0\u600e\u6837\u8868\u8fbe\u7684\uff0c\u8fdb\u800c\u600e\u6837\u8fdb\u884c\u4e34\u5e8a\u5e72\u9884\u3002\u6700\u540e\uff0c\u6211\u4eec\u6b63\u5728\u5f00\u53d1\u65b0\u7684\u751f\u7269\u6807\u8bb0\u7269\u4f5c\u4e3a\u7ec8\u70b9\u6d4b\u91cf\uff0c\u7531\u6b64\u53ef\u4ee5\u66f4\u597d\u5730\u8bc4\u4ef7\u75c5\u4eba\u4ee5\u53ca\u836f\u7269\u7684\u7597\u6548\u3002<\/span><\/p>\n

    \u8fd9\u4e9b\u5728<\/span>21\u4e16\u7eaa\u51fa\u73b0\u7684\u53f2\u65e0\u524d\u4f8b\u7684\u673a\u4f1a\uff0c\u5176\u7ed3\u679c\u662f\u4e3a\u90a3\u4e9b\u4ee5\u524d\u65e0\u6cd5\u6cbb\u7597\u7684\u75be\u75c5\u627e\u5230\u771f\u6b63\u7684\u75be\u75c5\u8c03\u63a7\u65b9\u6cd5\u7684\u5de8\u5927\u6f5c\u529b\u3002<\/span><\/span><\/p>\n

    21\u4e16\u7eaa\u7684\u4e34\u5e8a\u7814\u7a76: \u672a\u6765\u7684\u7814\u7a76\u9886\u57df \uff082\uff09<\/span><\/strong><\/span><\/p>\n

    Dr. RobertRubin<\/span><\/strong><\/span><\/p>\n

    \u81f3\u6b64\uff0c\u6211\u4eec\u5df2\u7ecf\u4e86\u89e3\u5230\u524d\u6240\u672a\u6709\u7684\u673a\u4f1a\u4f7f\u5f97\u4e34\u5e8a\u8bd5\u9a8c\u6b63\u5904\u4e8e\u4e00\u4e2a\u4ee4\u4eba\u6fc0\u52a8\u7684\u65f6\u4ee3\u3002\u4e3a\u4e86\u5168\u9762\u7684\u770b\u95ee\u9898\uff0c\u6211\u4eec\u63a5\u7740\u8981\u8c08\u7684\u662f\u6240\u9762\u4e34\u7684\u6311\u6218\u3002\u4e5f\u8bb8\u6700\u91cd\u8981\u7684\u662f\uff0c\u5728\u5168\u7403\u8303\u56f4\u5185\uff0c\u6211\u4eec\u7f3a\u4e4f\u8bad\u7ec3\u6709\u7d20\u7684\u4e34\u5e8a\u7814\u7a76\u8005\u3002\u5e0c\u671b\u4ee5\u4e92\u8054\u7f51\u4e3a\u57fa\u7840\u7684\u8fd9\u4e2aGCP\u57f9\u8bad\u9879\u76ee\u53ef\u4ee5\u5728\u8fd9\u65b9\u9762\u6709\u6240\u5e2e\u52a9\u3002\u7b2c\u4e8c\u70b9\u662f\u6709\u51e0\u4e2a\u7406\u7531\u9700\u8981\u91c7\u53d6\u65b0\u7684\u836f\u7269\u5f00\u53d1\u7b56\u7565\u3002\u9996\u5148\uff0c\u65b0\u7c7b\u578b\u7684\u836f\u7269\u6b63\u5728\u7814\u7a76\u4e2d\uff0c\u6ca1\u6709\u6709\u6548\u6cbb\u7597\u65b9\u6cd5\u7684\u75be\u75c5\u4e5f\u5f15\u8d77\u4e86\u91cd\u89c6\u3002\u6211\u4eec\u5c1a\u6ca1\u6709\u8db3\u591f\u7684\u77e5\u8bc6\u786e\u5b9a\u4ec0\u4e48\u662f\u6700\u5408\u9002\u7684\u5206\u5c42\u53d8\u91cf\uff0c\u4ec0\u4e48\u662f\u89c2\u5bdf\u7597\u6548\u7684\u6700\u4f73\u7ec8\u70b9\u6307\u6807\u3002\u76f8\u5bf9\u4e8e\u6025\u6027\u75be\u75c5\u800c\u8a00\uff0c\u91cd\u70b9\u5c24\u5176\u8981\u653e\u5728\u6162\u6027\u75be\u75c5\u4e0a\u3002\u5982\u679c\u8bf420\u4e16\u7eaa\u662f\u6025\u6027\u75be\u75c5\u53d6\u5f97\u5f88\u5927\u8fdb\u5c55\u7684\u5e74\u4ee3\uff0c\u90a3\u4e4821\u4e16\u7eaa\u5c06\u662f\u6162\u6027\u75be\u75c5\u53d6\u5f97\u8fdb\u6b65\u7684\u5e74\u4ee3\u3002<\/span><\/p>\n

    \u8fd9\u4e48\u8bf4\u662f\u4ec0\u4e48\u610f\u601d\u5462\uff1f20\u4e16\u7eaa\u5f88\u5927\u7684\u4e00\u4e2a\u80dc\u5229\u662f\u9488\u5bf9\u6025\u6027\u7ec6\u83cc\u6027\u611f\u67d3\u53d1\u5c55\u4e86\u6297\u5fae\u751f\u7269\u6cbb\u7597\uff0c\u8fd9\u662f\u4e00\u4e2a\u91cd\u5927\u7684\u8fdb\u6b65\u3002\u6b64\u65f6\uff0c\u75be\u75c5\u7684\u7ec8\u70b9\u975e\u5e38\u6e05\u695a\uff1a\u5b58\u6d3b\uff0c\u6b7b\u4ea1\uff0c\u611f\u67d3\u6d88\u9664\uff1b\u975e\u5e38\u76f4\u63a5\u4e86\u5f53\u3002\u66f4\u5177\u6709\u6311\u6218\u6027\u540c\u65f6\u4e5f\u6709\u66f4\u591a\u673a\u4f1a\u7684\u9886\u57df\u662f\uff0c\u5982\u7cbe\u795e\u5206\u88c2\u75c7\u7684\u6cbb\u7597\u3001\u8e81\u72c2\uff0d\u6291\u90c1\u75c7\u7684\u6cbb\u7597\u3001\u7c7b\u98ce\u6e7f\u6027\u5173\u8282\u708e\u3001\u67d0\u4e9b\u6076\u6027\u80bf\u7624\u4ee5\u53ca\u83b7\u5f97\u6027\u514d\u75ab\u7f3a\u4e4f\u7efc\u5408\u75c7\u3002<\/span><\/p>\n

    \u4e00\u4e2a\u7279\u522b\u7684\u6311\u6218\uff0c\u90e8\u5206\u6765\u81ea\u4e8e\u7814\u7a76\u66f4\u590d\u6742\u7684\u6162\u6027\u75be\u75c5\u7684\u9700\u8981\uff0c\u662f\u6211\u4eec\u5c06\u6536\u96c6\u7279\u522b\u4e30\u5bcc\u7684\u4fe1\u606f\u3002\u6211\u4eec\u9700\u8981\u66f4\u6709\u6548\u5730\u5904\u7406\u8fd9\u4e9b\u4fe1\u606f\u3002\u4e00\u4e2a\u4e3b\u8981\u7684\u9700\u8981\u662f\u65b0\u7684\u4fe1\u606f\u6280\u672f\u7528\u6765\u5b9e\u65f6\u5730\u8bc4\u4ef7\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u7279\u522b\u662f\uff0c\u6211\u4eec\u5c06\u5f88\u5feb\u8c08\u5230\uff0c\u4ece\u4eba\u7c7b\u57fa\u56e0\u7ec4\u7814\u7a76\u4e2d\u5f97\u5230\u7684\u5927\u91cf\u7684\u4fe1\u606f\u3002<\/span><\/p>\n

    \u4e34\u5e8a\u7814\u7a76\u7684\u4e00\u4e2a\u91cd\u8981\u7684\u89c4\u5f8b\u662f\u4e34\u5e8a\u7814\u7a76\u4e2d\u7684\u4e34\u5e8a\u8868\u73b0\u5206\u578b\u3002\u4efb\u4f55\u4e34\u5e8a\u7814\u7a76\u9879\u76ee\u4e2d\uff0c\u4e00\u4e2a\u5173\u952e\u7684\u6b65\u9aa4\u5c31\u662f\u5728\u7ed9\u4e88\u6cbb\u7597\u5e72\u9884\u524d\u51b3\u5b9a\u53d7\u8bd5\u8005\u5e94\u6709\u4ec0\u4e48\u6837\u7684\u7279\u70b9\u3001\u4ee5\u53ca\u75c5\u4eba\u7684\u7279\u70b9\u4e0e\u6240\u7814\u7a76\u836f\u7269\u6b32\u663e\u793a\u7684\u7597\u6548\u7279\u5f81\u95f4\u7684\u5339\u914d\u7a0b\u5ea6\u3002\u9700\u8981\u5f00\u53d1\u65b0\u7684\u6280\u672f\u6765\u5b8c\u6210\u4e34\u5e8a\u8868\u73b0\u578b\u7684\u5206\u578b\u3002\u5c06\u901a\u8fc7\u4e34\u5e8a\u7814\u7a76\u6765\u9a8c\u8bc1\u5728\u5e38\u89c4\u4e34\u5e8a\u5b9e\u8df5\u548c\u836f\u7269\u5f00\u53d1\u4e2d\u4f7f\u7528\u7684\u8868\u73b0\u5206\u578b\u5de5\u5177\u3002\u8ba9\u6211\u7ed9\u5927\u5bb6\u4e3e\u4e2a\u4f8b\u5b50\uff0c\u662f\u66f4\u590d\u6742\u548c\u6162\u6027\u7684\u75be\u75c5\u3002\u9644\u5e26\u8bf4\u660e\u4e00\u4e0b\uff0c\u75be\u75c5\u8d8a\u590d\u6742\uff0c\u8868\u73b0\u5206\u578b\u7684\u8fc7\u7a0b\u5c31\u4f1a\u8d8a\u91cd\u8981\u3002<\/span><\/p>\n

    \u6211\u8981\u4e3e\u7684\u4f8b\u5b50\u662f\u9aa8\u5bc6\u5ea6\u4eea\u300210\u5e74\u621615\u5e74\u4ee5\u524d\uff0c\u533b\u5b66\u754c\u5bf9\u9aa8\u5bc6\u5ea6\u4eea\u5e76\u4e0d\u91cd\u89c6\uff0c\u56e0\u4e3a\u8fd9\u53ea\u662f\u4e00\u4e2a\u7814\u7a76\u5de5\u5177\u3002\u800c\u73b0\u5728\u6211\u4eec\u5df2\u7ecf\u6709\u4e86\u66f4\u597d\u7684\u6cbb\u7597\u9aa8\u8d28\u758f\u677e\u6216\u5176\u4ed6\u9aa8\u5bc6\u5ea6\u5f02\u5e38\u7684\u65b9\u6cd5\uff0c\u6211\u4eec\u975e\u5e38\u9700\u8981\u6709\u8fdb\u884c\u6d4b\u91cf\u4ee5\u4fbf\u5bf9\u75c5\u4eba\u5206\u5c42\u3001\u53d1\u73b0\u9ad8\u5371\u7684\u75c5\u4eba\u548c\u5224\u5b9a\u73b0\u6709\u53ca\u672a\u6765\u6cbb\u7597\u7684\u7597\u6548\u3002<\/span><\/p>\n

    \u5728\u6240\u6709\u5305\u542b\u673a\u4f1a\u548c\u6311\u6218\u7684\u9886\u57df\uff0c\u6211\u60f3\u6ca1\u6709\u4ec0\u4e48\u80fd\u6bd4\u57fa\u56e0\u7ec4\u9769\u547d\u548c\u4eba\u7c7b\u57fa\u56e0\u7ec4\u7684\u7814\u7a76\u66f4\u6709\u610f\u4e49\u3002\u6211\u4eec\u5148\u6765\u8003\u8651\u4e00\u4e0b\u4f26\u7406\u89c4\u5219\uff0c\u8fd9\u662f\u6700\u91cd\u8981\u7684\u6311\u6218\u3002\u5982\u679c\u6211\u4eec\u60f3\u5229\u7528\u57fa\u56e0\u7ec4\u7814\u7a76\u7684\u7ed3\u679c\uff0c\u9996\u5148\u6211\u4eec\u8981\u9762\u5bf9\u7684\u5c31\u662f\u4eba\u7c7b\u6743\u5229\u548c\u9690\u79c1\u7684\u4fdd\u62a4\u3002\u5982\u679c\u6211\u4eec\u80fd\u505a\u5230\u8fd9\u70b9\uff0c\u6211\u4eec\u5c31\u53ef\u4ee5\u5f97\u5230\u57fa\u56e0\u4fe1\u606f\u800c\u540c\u65f6\u53c8\u4fdd\u62a4\u4e86\u4eba\u7c7b\u7684\u6743\u5229\u3002\u8fd9\u91cc\u6709\u51e0\u79cd\u65b9\u6cd5\u4f7f\u5f97\u6211\u4eec\u53ef\u4ee5\u5229\u7528\u57fa\u56e0\u7ec4\u9769\u547d\u7684\u4fe1\u606f\u3002<\/span><\/p>\n

    \u8ba9\u6211\u4eec\u82b1\u51e0\u5206\u949f\u6765\u8ba8\u8bba\u4e00\u4e0b\u8fd9\u4e2a\u95ee\u9898\u3002\u57fa\u56e0\u7ec4\u5e94\u8be5\u53ef\u4ee5\u5b9a\u4e49\u75be\u75c5\u7684\u5371\u9669\u3002\u5982\u679c\u6211\u4eec\u53ef\u4ee5\u5b9a\u4e49\u75be\u75c5\u7684\u5371\u9669\uff0c\u90a3\u4e48\u6211\u4eec\u5c31\u53ef\u4ee5\u5b9a\u4e49\u57fa\u56e0\u7c7b\u578b\u4ece\u800c\u5c31\u53ef\u4ee5\u5148\u53d1\u5236\u4eba\u7684\u8fdb\u884c\u6cbb\u7597\u3002\u4f8b\u5982\uff0c\u5982\u679c\u6211\u4eec\u5728\u68c0\u67e5\u4e86\u4e00\u4e2a<\/span>5<\/span>\u5c81\u7684\u5b69\u5b50\u540e\u80fd\u591f\u63a8\u6d4b\u4ed6\u5c06\u6765\u53ef\u80fd\u4f1a\u60a3\u4e0a\u65e9\u53d1\u52a8\u8109\u7ca5\u6837\u786c\u5316\u6216\u8005\u67d0\u79cd\u6076\u6027\u80bf\u7624\uff0c\u90a3\u4e48\u6211\u4eec\u5c31\u53ef\u4ee5\u63d0\u524d\u91c7\u53d6\u63aa\u65bd\u6765\u963b\u65ad\u6216\u5e72\u9884\u75be\u75c5\u7684\u53d1\u751f\u548c\u8fdb\u5c55\uff0c\u5b69\u5b50\u5c31\u53ef\u80fd\u514d\u4e8e\u8fd9\u4e9b\u91cd\u8981\u75be\u75c5\u5bfc\u81f4\u7684\u75c5\u60a3\u548c\u6b7b\u4ea1\u3002<\/span><\/span><\/p>\n

    \u57fa\u56e0\u7ec4\u8fd8\u6709\u5229\u4e8e\u4e00\u4e9b\u7279\u6b8a\u7684\u6cbb\u7597\u3002\u4e0d\u540c\u7684\u751f\u5316\u9014\u5f84\u548c\u75c5\u7406\u751f\u7406\u673a\u5236\u53ef\u80fd\u4f1a\u4ea7\u751f\u540c\u79cd\u75be\u75c5\u3002\u6700\u597d\u7684\u4f8b\u5b50\u662f\u9ad8\u8840\u538b\u3002\u5927\u7ea6\u6709<\/span>25<\/span>\u79cd\u75be\u75c5\u53ef\u4ee5\u5bfc\u81f4\u8840\u538b\u7684\u5347\u9ad8\u3002\u6211\u4eec\u53ef\u4ee5\u5f88\u5408\u7406\u5730\u5047\u8bbe\uff0c\u5982\u679c\u6211\u4eec\u77e5\u9053\u75c5\u4eba\u7684\u57fa\u56e0\u80cc\u666f\u4ee5\u53ca\u751f\u5316\u9014\u5f84\uff0c\u6211\u4eec\u5c31\u53ef\u4ee5\u77e5\u9053\u4ec0\u4e48\u6837\u7684\u75c5\u4eba\u8be5\u9009\u7528\u4ec0\u4e48\u7c7b\u578b\u7684\u836f\u7269\u53ef\u4ee5\u53d6\u5f97\u66f4\u597d\u7684\u6cbb\u7597\u6548\u679c\u3002\u7531\u4e8e\u6211\u4eec\u77e5\u9053\u4e86\u57fa\u56e0\u7ec4\uff0c\u6211\u4eec\u53ef\u4ee5\u66f4\u597d\u5730\u7ed9\u4e88\u548c\u8bd5\u9a8c\u65b0\u7684\u6cbb\u7597\u65b9\u6cd5\u3002<\/span><\/span><\/p>\n

    \u5df2\u7ecf\u6e05\u695a\u7684\u662f\uff0c\u57fa\u56e0\u7ec4\u7684\u7814\u7a76\u53ef\u4ee5\u4f7f\u6211\u4eec\u9884\u6d4b\u548c\u907f\u514d\u4e0d\u826f\u53cd\u5e94\u3002\u8fd9\u4e9b\u4e0d\u826f\u53cd\u5e94\u5305\u62ec\u80be\u6bd2\u6027\uff0c\u836f\u7269\u8bf1\u5bfc\u7684\u518d\u751f\u969c\u788d\u6027\u8d2b\u8840\uff0c\u7c92\u7ec6\u80de\u51cf\u5c11\u548c\u8840\u5c0f\u677f\u51cf\u5c11\uff0c\u7ee7\u53d1\u4e8e\u03b2\u5185\u9170\u80fa\u6297\u751f\u7d20\u7684\u95f4\u8d28\u80be\u708e\u4ee5\u53ca\u836f\u7269\u8bf1\u5bfc\u7684\u809d\u810f\u6bd2\u6027\u4ee5\u53ca\u80ba\u90e8\u635f\u5bb3\u3002\u8fd1\u5e74\u6765\uff0c\u7531\u4e8e\u672a\u9884\u6599\u7684\u809d\u810f\u6bd2\u6027\uff0c\u6211\u4eec\u5931\u53bb\u4e86\u4e0d\u5c11\u975e\u5e38\u6709\u6548\u7684\u836f\u7269\u3002\u8fd9\u4e9b\u5c11\u89c1\u7684\u4e8b\u4ef6\u5f88\u53ef\u80fd\u6709\u57fa\u56e0\u57fa\u7840\uff0c\u5982\u679c\u6211\u4eec\u80fd\u591f\u4e86\u89e3\u8fd9\u4e9b\u80cc\u666f\uff0c\u6211\u4eec\u5c31\u53ef\u4ee5\u5728\u8fd9\u4e00\u5c0f\u90e8\u5206\u75c5\u4eba\u4e2d\u907f\u514d\u4f7f\u7528\u8fd9\u6837\u7684\u836f\u7269\uff0c\u5e76\u4e14\u8ba9\u5927\u90e8\u5206\u75c5\u4eba\u4eab\u53d7\u836f\u7269\u5e26\u6765\u7684\u76ca\u5904\u3002<\/span><\/p>\n

    \u53e6\u4e00\u4e2a\u91cd\u8981\u7684\u65b9\u9762\u662f\u9884\u9632\u836f\u7269\u53cd\u5e94\uff0c\u4ece\u76ae\u75b9\u3001\u836f\u7269\u70ed\u5230\u5a01\u80c1\u751f\u547d\u7684\u8fc7\u654f\u53cd\u5e94\u3002\u4e5f\u8bb8\u7b2c\u4e00\u4e2a\u53ef\u5e94\u7528\u4e8e\u4e34\u5e8a\u7684\u5728\u8bd5\u57fa\u56e0\u7814\u7a76\u662f\u4e0e\u836f\u7269\u4ee3\u8c22\u6709\u5173\u7684\u836f\u7269\u57fa\u56e0\u5b66\u7814\u7a76\u3002\u4f8b\u5982\uff0c\u57fa\u56e0\u7ec4\u51b3\u5b9a\u4e86\u4f60\u600e\u6837\u5904\u7406\u53ca\u4ee3\u8c22\u836f\u7269\u3002\u73b0\u5728\u6700\u597d\u7684\u4f8b\u5b50\u662f\u809d\u810f\u7ec6\u80de\u8272\u7d20<\/span>P450<\/span>\u57fa\u56e0\u578b\uff0c\u5b83\u51b3\u5b9a\u8bb8\u591a\u836f\u7269\u7684\u4ee3\u8c22\u4ee5\u53ca\u836f\u7269\u7684\u76f8\u4e92\u53cd\u5e94\u3002\u8fd9\u53ea\u662f\u836f\u7269\u4ee3\u8c22\u7684<\/span>100<\/span>\u591a\u79cd\u9014\u5f84\u4e2d\u7684\u4e00\u79cd\u3002<\/span><\/span><\/p>\n

    \u518d\u7ed9\u5927\u5bb6\u4e3e\u4e2a\u4f8b\u5b50\uff0c\u53ef\u4ee5\u8ba9\u6211\u4eec\u6e05\u9192\u5730\u8ba4\u8bc6\u5230\u8fd9\u79cd\u4fe1\u606f\u7684\u91cd\u8981\u6027\u4ee5\u53ca\u6211\u4eec\u5728\u8fc7\u53bb\u72af\u8fc7\u600e\u6837\u7684\u9519\u8bef\u3002\u8fd9\u662f\u4e00\u4e2a\u975e\u5e38\u590d\u6742\u7684\u9886\u57df\uff0c\u8bf7\u5927\u5bb6\u4ed4\u7ec6\u542c\u3002\u5b83\u4ece\u8ba4\u8bc6\u4e00\u79cd\u9176\uff0c\u786b\u560c\u5464\u8f6c\u79fb\u9176\u5f00\u59cb\uff0c\u6b64\u9176\u53c8\u88ab\u79f0\u4e3a<\/span>TMT<\/span>\uff0c\u662f\u4ee3\u8c22\u786b\u560c\u5464\u7c7b\u836f\u7269\u7684\u5173\u952e\u9176\u3002\u836f\u7269\u5982<\/span>6<\/span>\uff0d\u786b\u9187\u560c\u5464\uff0c\u786b\u5511\u560c\u5464\uff0c\u786b\u9e1f\u560c\u5464\uff0c\u4ee5\u53ca\u7528\u4e8e\u6cbb\u7597\u767d\u8840\u75c5\u548c\u6709\u514d\u75ab\u6291\u5236\u4f5c\u7528\u7684\u836f\u4e0e\u6b64\u76f8\u5173\u3002\u6211\u4eec\u4ee5\u524d\u4f7f\u7528\u8fd9\u4e9b\u836f\u7269\u662f\u6309\u7167<\/span>mg\/kg<\/span>\u6216\u4f53\u8868\u9762\u79ef\u6765\u8ba1\u7b97\u7684\u3002\u8fd9\u4e9b\u836f\u7269\u7684\u4f5c\u7528\u4e4b\u4e00\u662f\u6cbb\u7597\u513f\u7ae5\u767d\u8840\u75c5\u3002\u6211\u4eec\u53d1\u73b0\uff0c\u6309\u7167\u4f20\u7edf\u7684\u5242\u91cf\u8ba1\u7b97\u65b9\u6cd5\u7528\u836f\uff0c\u90a3\u4e9b<\/span>TMT<\/span>\u6c34\u5e73\u8f83\u9ad8\u7684\u513f\u7ae5\u4ee3\u8c22\u8f83\u5feb\uff0c\u6240\u4ee5\u6709\u6548\u7684\u836f\u7269\u5faa\u73af\u6d53\u5ea6\u8f83\u4f4e\uff0c\u75c5\u513f\u8f83\u5c11\u8fdb\u5165\u7f13\u89e3\u671f\u3002\u7531\u4e8e\u6211\u4eec\u4f7f\u7528\u7684\u836f\u7269\u5242\u91cf\u4e0d\u591f\uff0c<\/span>30<\/span>\uff05\u7684\u513f\u7ae5\u6b7b\u4ea1\uff0c\u5982\u679c\u6211\u4eec\u77e5\u9053\u7531\u4e8e\u57fa\u56e0\u4e0d\u540c\u9020\u6210\u7684\u836f\u7269\u4ee3\u8c22\u4e0d\u540c\uff0c\u8fd9\u4e9b\u513f\u7ae5\u5c31\u53ef\u80fd\u83b7\u6551\u3002\u8fd1\u6765\uff0c<\/span>TMT<\/span>\u7684\u57fa\u56e0\u5df2\u7ecf\u786e\u5b9a\uff0c\u6211\u4eec\u4e0d\u4f1a\u7ee7\u7eed\u72af\u9519\u8bef\u3002\u663e\u7136\uff0c\u8fd9\u53ea\u662f\u6539\u5584\u4e34\u5e8a\u5b9e\u8df5\u7684\u8bb8\u591a\u673a\u4f1a\u4e2d\u7684\u4e00\u4e2a\u3002<\/span><\/span><\/p>\n

    \u53e6\u4e00\u4e2a\u7279\u522b\u7684\u6311\u6218\u662f\u9488\u5bf9\u75be\u75c5\u8fc7\u7a0b\u4e2d\u7a0b\u5e8f\u6027\u6216\u8005\u751f\u5316\u7011\u5e03\u4e2d\u7684\u5173\u952e\u90e8\u4f4d\u5f00\u53d1\u6cbb\u7597\u65b9\u6cd5\u3002\u5c31\u6cbb\u7597\u5e72\u9884\u800c\u8a00\uff0c\u7011\u5e03\u7684\u65f6\u95f4\u6027\u662f\u5f88\u91cd\u8981\u7684\u3002\u4e5f\u5c31\u662f\u4f60\u53ef\u4ee5\u5c06\u75be\u75c5\u8fc7\u7a0b\u5206\u6210<\/span>1\u671f\uff0c<\/span>2\u671f\uff0c<\/span>3\u671f\uff0c\u4e0d\u540c\u7684\u4e8b\u4ef6\u51fa\u73b0\u5728\u4e0d\u540c\u7684\u65f6\u671f\u3002\u5f88\u53ef\u80fd\uff0c\u5b9e\u9645\u4e0a\u6709\u4e9b\u75be\u75c5\u5df2\u7ecf\u662f\u8fd9\u6837\u7684\u60c5\u51b5\uff0c\u5728<\/span>1\u671f\u8fdb\u884c\u6cbb\u7597\u5c06\u53ca\u5176\u6709\u6548\uff0c\u5728<\/span>2\u671f\u5219\u65e0\u6548\uff0c\u800c\u5728<\/span>3\u671f\u751a\u81f3\u53ef\u80fd\u6709\u5bb3\u3002<\/span><\/span><\/p>\n

    \u8fd9\u6837\u7684\u4f8b\u5b50\u6709\u8d25\u8840\u75c7\u3001\u7f3a\u8840\uff0d\u518d\u704c\u6ce8\u3001\u518d\u704c\u6ce8\u635f\u4f24\u548c\u5176\u4ed6\u7684\u4e00\u4e9b\u60c5\u51b5\u3002\u6240\u4ee5\uff0c\u6211\u4eec\u8feb\u5207\u5730\u9700\u8981\u786e\u5b9a\u673a\u4f53\u5904\u4e8e\u7011\u5e03\u7684\u4ec0\u4e48\u4f4d\u7f6e\u3002\u5b83\u53ef\u4ee5\u5e2e\u52a9\u6211\u4eec\u5bf9\u75c5\u4eba\u5206\u5c42\u5e76\u5f00\u53d1\u76f8\u5e94\u7684\u65b0\u6cbb\u7597\u65b9\u6cd5\u3002\u6211\u4eec\u89e3\u51b3\u8fd9\u4e2a\u95ee\u9898\u7684\u65b9\u6cd5\u4e4b\u4e00\u5c06\u76f4\u63a5\u6765\u81ea\u4e8e\u57fa\u56e0\u7ec4\u9769\u547d\u3002\u57fa\u56e0\u8868\u8fbe\u82af\u7247\u5c06\u8ba9\u6211\u4eec\u770b\u5230\u57fa\u56e0\u662f\u600e\u6837\u8868\u8fbe\u7684\uff0c\u5e76\u4e14\u53ef\u4ee5\u66f4\u52a0\u7cbe\u786e\u5730\u5b9a\u4e49\u75be\u75c5\u5904\u4e8e\u54ea\u4e00\u671f\u3002\u8fd9\u6837\uff0c\u6211\u4eec\u53ef\u4ee5\u56de\u7b54\u7684\u95ee\u9898\u4e4b\u4e00\u5c31\u662f<\/span>\u201c\u8be5\u65b9\u6cd5\u6709\u9884\u9632\u7684\u6548\u679c\u5417\uff1f\u6709\u6cbb\u7597\u7684\u6548\u679c\u5417\uff1f\u8fd8\u662f\u4e24\u8005\u90fd\u6709\uff1f<\/span>\u201d \u5982\u679c\u662f\u6cbb\u7597\u6548\u679c\uff0c<\/span>\u201c\u5728\u75be\u75c5\u7684\u8fc7\u7a0b\u4e2d\u5176\u4f7f\u7528\u662f\u5426\u6709\u65f6\u95f4\u4e0a\u7684\u9650\u5236\uff1f<\/span>\u201d <\/span><\/p>\n

    GCPLecture19 Version: FINAL Date: 02\/18\/2004 6<\/span> <\/p>\n

    21\u4e16\u7eaa\u7684\u4e34\u5e8a\u7814\u7a76: \u672a\u6765\u7684\u7814\u7a76\u9886\u57df \uff083\uff09<\/span><\/strong><\/p>\n

    Dr. RobertRubin<\/span><\/strong><\/p>\n

    \u6211\u4eec\u5df2\u7ecf\u5b66\u4e60\u4e86\u8bb8\u591a\u5185\u5bb9\uff0c\u4e86\u89e3\u4e8621\u4e16\u7eaa\u4e34\u5e8a\u7814\u7a76\u9762\u4e34\u7684\u673a\u4f1a\u548c\u6311\u6218\u3002\u6211\u4eec\u73b0\u5728\u603b\u7ed3\u4e00\u4e0b\u4f5c\u4e3a\u672c\u6b21\u8bfe\u7a0b\u7684\u7ed3\u675f\u3002<\/span><\/p>\n

    \u9996\u5148\uff0c\u6211\u4eec\u5f3a\u8c03\u4e00\u4e0b\u673a\u4f1a\uff0c\u56e0\u4e3a\u6211\u4eec\u786e\u5b9e\u53ef\u4ee5\u8fd9\u6837\u8bf4\uff0c\u4ece\u6765\u4e5f\u6ca1\u6709\u8c61\u4eca\u5929\u8fd9\u6837\uff0c\u4e34\u5e8a\u7814\u7a76\u5145\u6ee1\u4e86\u673a\u4f1a\u3002\u7406\u7531\u5f88\u6e05\u695a\u3002\u4e34\u5e8a\u7814\u7a76\u7684\u5168\u7403\u5316\uff0c\u90e8\u5206\u662f\u7531\u56fd\u9645\u534f\u8c03\u8ba1\u5212\u6765\u542f\u52a8\u548c\u534f\u8c03\uff0c\u5c06\u5728\u5168\u7403\u8303\u56f4\u5185\u4e3a\u4e34\u5e8a\u7814\u7a76\u63d0\u4f9b\u5927\u91cf\u7684\u673a\u4f1a\u3002\u7b2c\u4e8c\uff0c\u6211\u4eec\u6709\u5927\u91cf\u7684\u5206\u5b50\u6709\u6f5c\u5728\u7684\u6cbb\u7597\u76ca\u5904\u3002\u7b2c\u4e09\uff0c\u6211\u4eec\u5c06\u62e5\u6709\u65b0\u7684\u80fd\u529b\u6765\u68c0\u6d4b\u5b83\u4eec\u7684\u6548\u5e94\u3002\u65b0\u4e00\u4ee3\u7684\u68c0\u6d4b\u6280\u672f\u53ef\u4ee5\u4f7f\u6211\u4eec\u5bf9\u75c5\u4eba\u548c\u5e72\u9884\u65b9\u6cd5\u8fdb\u884c\u8bc4\u4ef7\u3002<\/span><\/p>\n

    \u6211\u5df2\u7ecf\u8c08\u5230\u8fc7\u6211\u7684<\/span>\u201c<\/span>\u9519\u4f4d<\/span>\u201d<\/span>\u7406\u8bba\u4ee5\u53ca\u5b83\u4eec\u5728\u4e34\u5e8a\u7814\u7a76\u4e2d\u7684\u5e94\u7528\u3002\u6211\u7684\u89c2\u70b9\u662f\uff0c\u5982\u679c\u4f60\u80fd\u7528\u67d0\u79cd\u68c0\u6d4b\u6280\u672f\u7cbe\u786e\u5730\u5c06\u60a3\u8005\u505a\u51fa\u4e34\u5e8a\u5206\u578b\uff0c\u7136\u540e\u5e94\u7528\u7279\u5f02\u7684\u5e72\u9884\u65b9\u6cd5\u9020\u6210\u4e00\u5b9a\u7684\u9519\u4f4d\uff0c\u7136\u540e\u518d\u505a\u53e6\u4e00\u6b21\u5e72\u9884\uff0c\u8fd9\u6837\u4f60\u5bf9\u4e8e\u75be\u75c5\u8fc7\u7a0b\u7684\u4e86\u89e3\u5c06\u5927\u5927\u591a\u4e8e<\/span>\u201c<\/span>\u9759\u89c2<\/span>\u201d<\/span>\u7684\u7814\u7a76\u3002\u5bf9\u4e8e\u6162\u6027\u75be\u75c5\u7684\u6cbb\u7597\uff0c\u6211\u4eec\u6709\u80fd\u529b\u505a\u8fc7\u53bb\u505a\u4e0d\u5230\u7684\u4e8b\uff0c\u4e5f\u5c31\u662f\uff0c\u6211\u4eec\u8c08\u5230\u7684\u662f\u4ece<\/span>\u201c<\/span>\u5934\u75db\u533b\u5934\uff0c\u811a\u75db\u533b\u811a<\/span>\u201d<\/span>\u7684<\/span>\u201c<\/span>\u4e34\u65f6\u6cbb\u7597<\/span>\u201d<\/span>\uff08Band-Aidtherapies)\u8fdb\u5165\u5230\u6539\u9020\u75be\u75c5\u7684\u6cbb\u7597\uff0c\u8fd9\u5c06\u5927\u5927\u5f71\u54cd\u6574\u4e2a\u4eba\u7fa4\u7684\u5065\u5eb7\u72b6\u6001\u3002<\/span><\/span><\/p>\n

    \u8fd9\u4e9b\u662f\u597d\u6d88\u606f\uff0c\u4f46\u4ec0\u4e48\u662f\u6311\u6218\u5462\uff1f\u9996\u5148\u4e5f\u662f\u6700\u91cd\u8981\u7684\u662f\u5168\u7403\u8303\u56f4\u5185\u7f3a\u4e4f\u8bad\u7ec3\u6709\u7d20\u7684\u4e34\u5e8a\u7814\u7a76\u8005\u3002\u7b2c\u4e8c\u70b9\u65e2\u662f\u6311\u6218\uff0c\u4e5f\u662f\u673a\u4f1a\uff0c\u5373\u4eba\u7c7b\u57fa\u56e0\u7ec4\u7814\u7a76\u7684\u8d1f\u9762\u6548\u5e94\u548c\u57fa\u56e0\u9769\u547d\u3002\u9996\u5148\u4e00\u4e2a\u6211\u4eec\u5fc5\u987b\u59cb\u7ec8\u8bb0\u4f4f\u7684\u662f<\/span>\u201c<\/span>\u4f26\u7406\u89c4\u5219<\/span>\u201d<\/span>\uff0d\u4fdd\u62a4\u4eba\u7c7b\u6743\u5229\u548c\u9690\u79c1\u7684\u9700\u8981\uff0c\u5e76\u4e14\u8981\u4fdd\u8bc1\u57fa\u56e0\u4fe1\u606f\u53ea\u7528\u4e8e\u6709\u76ca\u7684\u5730\u65b9\uff0c\u800c\u4e0d\u80fd\u727a\u7272\u4e2a\u4eba\u3002<\/span><\/span><\/p>\n

    \u7b2c\u4e09\u4e2a\u6311\u6218\u662f\u6211\u4eec\u9700\u8981\u5f00\u53d1\u836f\u7269\u7684\u65b0\u7b56\u7565\uff0c\u5c24\u5176\u662f\u5bf9\u6162\u6027\u75be\u75c5\u800c\u8a00\u3002\u5982\u679c\u4f60\u7ed9\u6211\u4e00\u4e2a\u6cbb\u7597\u7cbe\u795e\u5206\u88c2\u75c7\u7684\u836f\u7269\uff0c\u518d\u7ed9\u6211\u4e09\u3001\u56db\u5e74\u65f6\u95f4\u6765\u8bc4\u4ef7\u5b83\uff0c\u6211\u53ef\u4ee5\u627e\u51fa\u4f7f\u7528\u8be5\u836f\u7684\u65b9\u6cd5\u3002\u4f46\u662f\u8fd9\u65f6\u95f4\u592a\u957f\u4e86\u3002\u4e00\u79cd\u6709\u6548\u7684\u836f\u7269\u4e0d\u80fd\u53ca\u65f6\u5730\u5e94\u7528\u5230\u75c5\u4eba\u8eab\u4e0a\uff0c\u8fd9\u751a\u81f3\u53ef\u4ee5\u8bf4\u662f\u4e0d\u7b26\u5408\u4f26\u7406\u7684\u3002\u6211\u4eec\u9700\u8981\u65b0\u7684\u68c0\u6d4b\u65b9\u6cd5\u3002\u6211\u4eec\u9700\u8981\u5bfb\u627e\u8bc4\u4ef7\u6162\u6027\u75be\u75c5\u6cbb\u7597\u7684\u65b0\u65b9\u6cd5\uff0c\u4ee5\u4fbf\u8ba9\u6211\u4eec\u5c3d\u5feb\u5730\u5f97\u51fa\u7ed3\u8bba\u3002\u6211\u4eec\u5c06\u62e5\u6709\u975e\u5e38\u4e30\u5bcc\u7684\u4fe1\u606f\uff0c\u6765\u81ea\u4e8e\u57fa\u56e0\u7ec4\u7814\u7a76\u4e5f\u6765\u81ea\u4e8e\u4e34\u5e8a\u7814\u7a76\u3002\u5f88\u6e05\u695a\u7684\u662f\uff0c\u6211\u4eec\u9700\u8981\u65b0\u4e00\u4ee3\u7684\u4fe1\u606f\u6280\u672f\u6765\u5229\u7528\u8fd9\u4e9b\u4fe1\u606f\u3002<\/span><\/p>\n

    \u6211\u4eec\u600e\u6837\u5c06\u8fd9\u4e24\u8005\u7ed3\u5408\u8d77\u6765\u5462\uff1f\u6211\u4eec\u79f0\u5b83\u4e3a<\/span>\u201c\u4f1f\u5927\u7684\u7ed3\u5408<\/span>\u201d\uff08<\/span>The Grand Synthesis)\u3002\u8be5\u7ed3\u5408\u7684\u9996\u8981\u6210\u5206\u662f\u8bad\u7ec3\u6709\u7d20\u7684\u7814\u7a76\u8005\u901a\u8fc7\u4e92\u8054\u7f51\u5f62\u6210\u7f51\u7edc\uff0c\u53cc\u5411\u4f5c\u7528\u3002\u4e0d\u518d\u662f\u8c61\u6211\u8fd9\u6837\u5750\u5728\u6ce2\u58eb\u987f\u6765\u8bf4\u660e\u4e8b\u60c5\u5c06\u4f1a\u662f\u600e\u6837\uff0c\u800c\u662f\u5728\u5168\u7403\u90fd\u6709\u6211\u7684\u540c\u4e8b\u3002\u4e00\u65b9\u9762\uff0c\u4ed6\u4eec\u4f1a\u53c2\u52a0\u6211\u542f\u52a8\u7684\u4e34\u5e8a\u7814\u7a76\uff0c\u53e6\u4e00\u65b9\u9762\uff0c\u6211\u4e5f\u4f1a\u53c2\u52a0\u4ed6\u4eec\u542f\u52a8\u7684\u7814\u7a76\uff0d\u53cc\u5411\u7684\u5173\u7cfb\u3002\u6211\u4eec\u4f1a\u5206\u4eab\u77e5\u8bc6\u548c\u8d44\u6e90\uff0c\u53bb\u5b8c\u6210\u6709\u610f\u4e49\u7684\u4e34\u5e8a\u7814\u7a76\u3002\u6211\u4eec\u8fd8\u4f1a\u4e92\u76f8\u63d0\u4f9b\u627e\u5230<\/span>\u201c\u5177\u4ee3\u8868\u6027\u7684<\/span>\u201d\u4eba\u7fa4\u7684\u9014\u5f84\uff0c\u8fd9\u6837\u6211\u4eec\u53ef\u4ee5\u66f4\u597d\u5730\u7406\u89e3\u75be\u75c5\u7684\u8fc7\u7a0b\u4ee5\u53ca\u627e\u5230\u66f4\u6709\u6548\u7684\u6cbb\u7597\u65b9\u6cd5\u3002<\/span><\/span><\/p>\n

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    \u6700\u540e\uff0c\u6211\u4eec\u8981\u4e3a\u4e92\u52a8\u533b\u5b66\u6559\u5b66\u505a\u51fa\u8d21\u732e\u3002\u4f1f\u5927\u7684\u7ed3\u5408\u5e26\u6765\u4e86\u8fdb\u6b65\u7684\u673a\u4f1a\u548c\u6311\u6218\uff0c\u53cc\u5411\u5173\u7cfb\u4e2d\u5171\u540c\u7684\u5fd7\u8da3\u662f\u91cd\u70b9\u3002<\/span><\/p>\n

    \u8c22\u8c22\u5927\u5bb6\u3002<\/span><\/p>\n


    <\/p>\n

    \u7b2c\u4e8c\u5341\u8bb2 <\/span><\/strong>ICIC: \u62c9\u4e01\u7f8e\u6d32\u7684\u4e34\u5e8a\u7814\u7a76\u6a21\u5f0f<\/span><\/strong><\/p>\n

    Dr. Guillermo Rodriguez<\/span><\/strong><\/p>\n

    Bienvenidos!\u6211\u662f\u6765\u81ea\u54e5\u65af\u8fbe\u9ece\u52a0\u7684Guillermo Rodriguez\u533b\u751f\u3002\u6211\u4eec\u4eca\u5929\u8981\u8ba8\u8bba\u7684\u662f\u62c9\u4e01\u7f8e\u6d32\u7684\u4e34\u5e8a\u7814\u7a76\u3002<\/span><\/p>\n

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    \u5728\u62c9\u4e01\u7f8e\u6d32\uff0c\u6709\u4e09\u4e2a\u56fd\u5bb6\u662f\u53c2\u4e0e\u4e34\u5e8a\u7814\u7a76\u7684\u4e3b\u8981\u56fd\u5bb6\u3002\u4ed6\u4eec\u662f\uff1a\u5df4\u897f\uff0c\u963f\u6839\u5ef7\u548c\u58a8\u897f\u54e5\uff0c\u4ed6\u4eec\u4e5f\u5360\u533b\u836f\u5e02\u573a\u7684<\/span>80\uff05\uff0c\u5f53\u7136\u8fd8\u6709\u6765\u81ea\u667a\u5229\u3001\u59d4\u5185\u745e\u62c9\u548c\u54e5\u4f26\u6bd4\u4e9a\u7684\u8d21\u732e\u3002\u5927\u5bb6\u53ef\u80fd\u8981\u60f3\uff0c\u662f\u4ec0\u4e48\u51b3\u5b9a\u4e86\u5c06\u4e34\u5e8a\u7814\u7a76\u653e\u5728\u4ec0\u4e48\u5730\u65b9\u8fdb\u884c\uff1f\u5171\u6709\u56db\u9879\u56e0\u7d20\u5de6\u53f3\u4e86\u5236\u836f\u516c\u53f8\u51b3\u5b9a\u5c06\u4e34\u5e8a\u7814\u7a76\u653e\u5728\u4ec0\u4e48\u56fd\u5bb6\u3002\u7b2c\u4e00\u4e2a\u56e0\u7d20\u662f\u8bad\u7ec3\u6709\u7d20\u7684\u4e34\u5e8a\u7814\u7a76\u8005\u3002\u7b2c\u4e8c\u4e2a\u662f\u826f\u597d\u7684\u836f\u653f\u7ba1\u7406\u4f53\u7cfb\u3002\u7b2c\u4e09\u662f\u793e\u4f1a\u7684\u6001\u5ea6\uff0c\u4ee5\u53ca\u662f\u5426\u6709\u8db3\u591f\u7684\u53d7\u8bd5\u8005\u53c2\u52a0\u7814\u7a76\u3002\u7b2c\u56db\u662f\u836f\u7269\u7684\u6f5c\u5728\u5e02\u573a\u3002<\/span><\/span><\/p>\n

    \u6709\u4e9b\u4eba\u4f1a\u60f3\uff0c\u65e2\u7136\u4e34\u5e8a\u7814\u7a76\u5728\u7f8e\u56fd\u548c\u897f\u6b27\u5df2\u7ecf\u975e\u5e38\u6210\u529f\uff0c\u4e3a\u4ec0\u4e48\u8fd8\u8981\u5728\u4e16\u754c\u7684\u5176\u5b83\u5730\u65b9\u8fdb\u884c\u7814\u7a76\u5462\uff1f\u6709\u8bb8\u591a\u539f\u56e0\u3002\u4e00\u4e2a\u539f\u56e0\u662f\u5bfb\u627e\u7b26\u5408\u6761\u4ef6\u7684\u53d7\u8bd5\u8005\u7684\u7ade\u4e89\u5c0f\uff0c\u5927\u5bb6\u5f88\u5bb9\u6613\u60f3\u8c61\uff0c\u5728\u8bd5\u9a8c<\/span>8000<\/span>\u591a\u79cd\u65b0\u836f\u65f6\u6240\u9700\u8981\u7684\u53d7\u8bd5\u8005\u7684\u4eba\u6570\uff0c\u4e5f\u5c31\u5f88\u5bb9\u6613\u7406\u89e3\uff0c\u4e3a\u7814\u7a76\u6240\u6709\u8fd9\u4e9b\u9002\u5e94\u75c7\uff0c\u53d7\u8bd5\u75c5\u4eba\u7684\u6570\u91cf\u4e0d\u8db3\u3002\u800c\u4e14\uff0c\u5728\u6211\u4eec\u7684\u56fd\u5bb6\uff0c\u53c2\u52a0\u4e00\u9879\u4e34\u5e8a\u8bd5\u9a8c\u4ee3\u8868\u7740\u4e00\u4e2a\u8bf1\u4eba\u7684\u673a\u4f1a\uff0c\u5c31\u662f\u80fd\u5f97\u5230\u8f83\u597d\u7684\u4e34\u5e8a\u548c\u533b\u7597\u7167\u987e\u3002\u6709\u8d44\u8d28\u7684\u533b\u751f\u613f\u610f\u53c2\u52a0\u4e34\u5e8a\u7814\u7a76\u4e5f\u662f\u63a8\u52a8\u5c06\u4e34\u5e8a\u7814\u7a76\u8f6c\u79fb\u5230\u8fd9\u4e9b\u5730\u533a\u7684\u53e6\u4e00\u4e2a\u539f\u56e0\u3002\u8d39\u7528\u8f83\u4f4e\u662f\u53e6\u4e00\u4e2a\u56e0\u7d20\u3002\u4e0e\u7f8e\u56fd\u548c\u897f\u6b27\u76f8\u6bd4\uff0c\u6211\u4eec\u53ef\u4ee5\u4ee5\u8f83\u4f4e\u7684\u8d39\u7528\u5b8c\u6210\u4e34\u5e8a\u7814\u7a76\u3002\u6211\u4eec\u5e76\u4e0d\u5ec9\u4ef7\uff0c\u4f46\u6211\u4eec\u4fbf\u5b9c\u4e00\u70b9\uff0c\u8fd9\u4f7f\u5f97\u65b0\u4ea7\u54c1\u7684\u7814\u53d1\u603b\u9884\u7b97\u53ef\u4ee5\u6709\u5f88\u5927\u7684\u4e0d\u540c\u3002\u5165\u9009\u53d7\u8bd5\u8005\u66f4\u5feb\u4e5f\u662f\u4e00\u4e2a\u539f\u56e0\uff0c\u56e0\u4e3a\u6211\u4eec\u7684\u7ade\u4e89\u5c0f\uff0c\u8f83\u5feb\u5165\u9009\u60a3\u8005\u7684\u53ef\u80fd\u6027\u66f4\u5927\u3002\u8fd8\u6709\u4e00\u4e2a\u56e0\u7d20\u662f\uff0c\u9700\u8981\u5728\u4e0d\u540c\u7684\u4eba\u7fa4\uff0c\u5373\u5177\u6709\u4e0d\u540c\u79cd\u65cf\u548c\u9057\u4f20\u80cc\u666f\u7684\u4eba\u7fa4\u4e2d\u5bf9\u8fd9\u4e9b\u65b0\u836f\u8fdb\u884c\u8bd5\u9a8c\u3002\u5982\u679c\u8003\u8651\u5230\u76ee\u524d\u5728\u7f8e\u56fd\u5b9a\u5c45\u7684\u62c9\u4e01\u7f8e\u6d32\u4eba\u8d8a\u6765\u8d8a\u591a\u65f6\uff0c\u4f60\u5c31\u5f88\u80fd\u7406\u89e3\u7f8e\u56fd\u6279\u51c6\u7684\u65b0\u836f\u9700\u8981\u5728\u8fd9\u4e00\u4eba\u7fa4\u4e2d\u88ab\u68c0\u9a8c\u8fc7\u3002<\/span><\/span><\/p>\n

    \u5c3d\u7ba1\u6709\u8fd9\u4e48\u591a\u5728\u6211\u4eec\u7684\u56fd\u5bb6\u5f00\u5c55\u4e34\u5e8a\u7814\u7a76\u7684\u7406\u7531\uff0c\u4f46\u662f\u8fd9\u6837\u505a\u8fd8\u5b58\u5728\u7740\u969c\u788d\u3002\u4e3b\u8981\u7684\u969c\u788d\uff0c\u4e3a\u9996\u7684\u5f88\u91cd\u8981\u7684\u4e00\u70b9\u662f\uff1a\u7f3a\u4e4f\u8bad\u7ec3\u6709\u7d20\u7684\u4e34\u5e8a\u7814\u7a76\u8005\u3002\u8fd9\u5c31\u662f\u6211\u4eec\u5728\u8fd9\u91cc\u7684\u539f\u56e0\uff0c\u8fd9\u5c31\u662f\u4e3a\u4ec0\u4e48\u6211\u4eec\u8bbe\u8ba1\u4e86\u8fd9\u4e2a\u57f9\u8bad\u9879\u76ee\uff1a\u4e3a\u4e86\u57f9\u8bad\u4e34\u5e8a\u7814\u7a76\u8005\u3002\u5982\u679c\u6ca1\u6709\u597d\u7684\u7814\u7a76\u8005\u5c31\u4e0d\u80fd\u5f00\u5c55\u4e34\u5e8a\u7814\u7a76\u3002\u7f3a\u4e4f\u826f\u597d\u7684\u836f\u653f\u7ba1\u7406\u4f53\u7cfb\u662f\u53e6\u5916\u4e00\u4e2a\u969c\u788d\u3002\u4e34\u5e8a\u7814\u7a76\u662f\u4e00\u79cd\u9700\u8981\u7ba1\u7406\u7684\u6d3b\u52a8\uff0c\u6240\u4ee5\u9700\u8981\u653f\u5e9c\u7684\u53c2\u4e0e\u4ee5\u5236\u5b9a\u76f8\u5e94\u7684\u7ba1\u7406\u6761\u4f8b\u3002\u7f3a\u4e4f\u7ed3\u6784\u5408\u7406\u7684\u4f26\u7406\u59d4\u5458\u4f1a\u3002\u5982\u679c\u6ca1\u6709\u597d\u7684\u4f26\u7406\u59d4\u5458\u4f1a\uff0c\u600e\u4e48\u80fd\u505a\u51fa\u597d\u7684\u4e34\u5e8a\u7814\u7a76\u5462\uff1f\u5408\u8d77\u6765\u7684\u8bdd\uff0c\u4f60\u53ef\u4ee5\u8bf4\u8fd9\u4e09\u8005\u4ee3\u8868\u4e86\u4e00\u4e2a\u56e0\u7d20\uff1a\u7f3a\u4e4f\u4e34\u5e8a\u7814\u7a76\u7684\u6587\u5316\u3002\u8fd9\u662f\u6211\u4eec\u9700\u8981\u53d1\u5c55\u7684\u3002\u8fd8\u6709\u5176\u5b83\u4e00\u4e9b\u969c\u788d\uff0c\u4f8b\u5982\u6279\u51c6\u8bd5\u9a8c\u65b9\u6848\u65f6\u7684\u5b98\u50da\u4f5c\u98ce\u3002\u5728\u6709\u4e9b\u56fd\u5bb6\uff0c\u9700\u8981\u516d\u6216\u4e03\u4e2a\u6708\u6765\u6279\u51c6\u4e00\u4e2a\u8bd5\u9a8c\u65b9\u6848\u3002\u8bd5\u9a8c\u65b9\u6848\u6279\u51c6\u4e86\uff0c\u7814\u7a76\u4e5f\u7ed3\u675f\u4e86\u3002\u6d77\u5173\u901a\u5173\u6162\u3002\u6709\u4e9b\u53ef\u6015\u7684\u6545\u4e8b\uff0c\u7814\u7a76\u836f\u7269\u9700\u8981\u5728\u6d77\u5173\u653e\u516d\u5230\u4e03\u4e2a\u6708\uff0c\u751a\u81f3\u662f\u8bd5\u9a8c\u65b9\u6848\u5df2\u88ab\u6279\u51c6\u540e\u3002\u7531\u4e8e\u65e0\u6cd5\u5c06\u836f\u7269\u4ece\u6d77\u5173\u53d6\u51fa\uff0c\u7814\u7a76\u5c31\u53d6\u6d88\u4e86\u3002<\/span><\/p>\n

    \u8bf7\u5927\u5bb6\u6ce8\u610f\u4e0b\u4e00\u4e2a\u969c\u788d\uff0c\u56e0\u4e3a\u5b83\u975e\u5e38\u91cd\u8981\u3002\u8fd9\u5c31\u662f<\/span>\u201c\u5b9e\u9a8c\u8001\u9f20<\/span>\u201d\u7efc\u5408\u75c7\uff08<\/span>Guinea Pig Syndrome\uff09\u3002\u6709\u4e00\u4e2a\u9519\u8bef\u7684\u6982\u5ff5\uff0c\u6bcf\u6b21\u8c08\u5230\u5728\u6211\u4eec\u7684\u56fd\u5bb6\u8fdb\u884c\u4e34\u5e8a\u7814\u7a76\u65f6\uff0c\u4f3c\u4e4e\u90fd\u8ba4\u4e3a\u5916\u56fd\u4eba\u8981\u5229\u7528\u6211\u4eec\u7684\u56fd\u6c11\u3002\u8fd9\u662f\u4e0d\u6b63\u786e\u7684\u3002\u4e8b\u5b9e\u4e0a\u6b63\u76f8\u53cd\u3002\u6211\u4eec\u5e94\u8be5\u6c14\u6124\u7684\u662f\u4ed6\u4eec\u6ca1\u8ba9\u6211\u4eec\u505a\u66f4\u591a\u7684\u4e34\u5e8a\u7814\u7a76\u3002\u6211\u4eec\u5e94\u8be5\u4e0d\u4ec5\u4ec5\u662f\u89c1\u8bc1\u4e86\u836f\u7269\u7684\u5f00\u53d1\uff0c\u6211\u4eec\u66f4\u5e94\u8be5\u4eb2\u8eab\u53c2\u4e0e\u5176\u4e2d\u3002\u6211\u4eec\u5e94\u8be5\u4e3a\u5f00\u53d1\u65b0\u7684\u6cbb\u7597\u65b9\u6cd5\u505a\u8d21\u732e\u3002\u5728\u53c2\u52a0\u4e34\u5e8a\u7814\u7a76\u4e0a\u6709\u6587\u5316\u548c\u5b97\u6559\u7684\u504f\u89c1\u3002\u8fd9\u662f\u5927\u4f17\u7f3a\u4e4f\u77e5\u8bc6\u3002\u8bb8\u591a\u4eba\u4e0d\u77e5\u9053\u4e34\u5e8a\u7814\u7a76\u662f\u4ec0\u4e48\u3002\u4e5f\u6709\u53e6\u4e00\u4e2a\u56e0\u7d20\uff1a\u79d8\u5bc6\u7814\u7a76<\/span>(Clandestine Research) \u7684\u957f\u671f\u4f20\u7edf\u3002\u8fc7\u53bb\u4e00\u4e9b\u7814\u7a76\u8005\u4e3a\u4e86\u907f\u5f00\u8fd9\u4e9b\u969c\u788d\uff0c\u51b3\u5b9a\u4e0d\u53bb\u5b8c\u6210\u9700\u8981\u7ba1\u7406\u673a\u6784\u6279\u51c6\u8fd9\u6837\u7684\u6b65\u9aa4\u3002\u8fd9\u4ea7\u751f\u4e86\u4e00\u4e2a\u9519\u8bef\u7684\u5f62\u8c61\uff0c\u5373\u4e34\u5e8a\u7814\u7a76\u4e0d\u662f\u4e00\u79cd\u900f\u660e\u7684\u6d3b\u52a8\u3002\u6211\u4eec\u5fc5\u987b\u6d88\u9664\u8fd9\u4e9b\u969c\u788d\uff0c\u548c\u5b83\u4eec\u6597\u4e89\uff0c\u6211\u4eec\u5e94\u8be5\u6559\u80b2\u5927\u4f17\u3002<\/span><\/span><\/p>\n

    \u4e0b\u4e00\u8282\u6211\u4eec\u5c06\u8ba8\u8bba\u6211\u4eec\u5728\u54e5\u65af\u8fbe\u9ece\u52a0\u5f00\u521b\u7684\u4e00\u79cd\u8fdb\u884c\u4e34\u5e8a\u7814\u7a76\u7684\u6a21\u5f0f\u3002<\/span><\/p>\n

    ICIC: \u62c9\u4e01\u7f8e\u6d32\u4e34\u5e8a\u7814\u7a76\u7684\u6a21\u5f0f\uff082\uff09<\/span><\/strong><\/span><\/p>\n

    Dr.Guillermo Rodriguez<\/span><\/strong><\/span><\/p>\n

    \u5728\u672c\u8282\uff0c\u6211\u4eec\u5c06\u8ba8\u8bba\u54e5\u65af\u8fbe\u9ece\u52a0\u4e34\u5e8a\u7814\u7a76\u5b66\u9662\uff0dICIC\u3002ICIC\u6307\u54e5\u65af\u8fbe\u9ece\u52a0\u4e34\u5e8a\u7814\u7a76\u5b66\u9662\u7684\u7f29\u5199\uff0c\u57281991\u5e74\u6210\u7acb\uff0c\u4e3a\u79c1\u8425\u7814\u7a76\u4e2d\u5fc3\u3002\u90a3\u662f\u6211\u4eec\u5df2\u7ecf\u8ba4\u8bc6\u5230\u4e86\u5728\u672c\u8bfe\u7a0b\u7684\u524d\u534a\u90e8\u5206\u8c08\u5230\u7684\u6570\u5b57\uff0c\u6211\u4eec\u4e5f\u5f88\u5173\u5fc3\u62c9\u4e01\u7f8e\u6d32\u5728\u5f00\u53d1\u65b0\u836f\u548c\u4eba\u7c7b\u75be\u75c5\u7684\u65b0\u7597\u6cd5\u4e0a\u8d21\u732e\u5f88\u5c0f\u7684\u95ee\u9898\u3002<\/span><\/p>\n

    \u6211\u4eec\u662f\u4ece\u5f88\u5c0f\u7684\u8fd0\u4f5c\u5f00\u59cb\u7684\uff0c\u4e00\u5f00\u59cb\u53ea\u6709\u4e09\u4e2a\u4eba\u3002\u73b0\u5728\uff0c\u5728\u7ecf\u8fc7\u4e8610\u5e74\u4ee5\u540e\uff0c\u6211\u4eec\u6709\u4e86\u5f88\u5927\u7684\u53d1\u5c55\u3002\u6211\u4eec\u73b0\u5728\u670960\u4e2a\u5168\u804c\u8fdb\u884c\u4e34\u5e8a\u7814\u7a76\u7684\u4eba\u5458\uff0c\u6211\u4eec\u6709120\u591a\u540d\u53c2\u52a0\u5404\u79cd\u4e34\u5e8a\u8bd5\u9a8c\u7684\u7814\u7a76\u8005\u30021994\u5e74\uff0c\u5728\u6709\u4e86\u6570\u5e74\u7684\u7ecf\u9a8c\u4ee5\u540e\uff0c\u6211\u4eec\u6709\u4e86\u4e00\u4e2a\u60f3\u6cd5\uff0c\u8ba4\u4e3a\u6211\u4eec\u81ea\u5df1\u5c31\u662f<\/span>\u201c<\/span>\u51fa\u53e3\u5546<\/span>\u201d<\/span>\uff0c\u8fd9\u6837\u6211\u4eec\u5411\u54e5\u65af\u8fbe\u9ece\u52a0\u5546\u4e1a\u90e8\u7533\u8bf7\u4e3a\u81ea\u7531\u8d38\u6613\u7684\u7279\u533a\u3002\u6211\u4eec\u6210\u4e86\u54e5\u65af\u8fbe\u9ece\u52a0\u7b2c\u4e00\u4e2a\u7279\u533a\u51fa\u53e3\u77e5\u8bc6\u4ea7\u6743\u7684\u516c\u53f8\u3002\u8fd9\u5bf9\u6211\u4eec\u5f88\u6709\u5229\uff0c\u9664\u4e86\u81ea\u7531\u8d38\u6613\u7279\u533a\u7684\u5176\u5b83\u76ca\u5904\u5916\uff0c\u6211\u4eec\u53ef\u4ee5\u4e0d\u53d7\u9650\u5236\u5730\u4ece\u6d77\u5173\u53d6\u51fa\u6211\u4eec\u7684\u4e1c\u897f\u3002<\/span><\/span><\/p>\n

    1995\u5e74\uff0c\u6211\u4eec\u6709\u4e86\u81ea\u5df1\u7684\u603b\u90e8\u3002\u6211\u4eec\u5efa\u9020\u4e86\u4e00\u5e62\u5927\u697c\u6210\u4e3a\u884c\u653f\u7ba1\u7406\u4e2d\u5fc3\u3002\u57281995\u52302000\u5e74\u4e4b\u95f4\uff0cFDA\u5bf9\u6211\u4eec\u8fdb\u884c\u4e86\u4e09\u6b21\u7a3d\u67e5\u3002\u8fd9\u5bf9\u6211\u4eec\u6765\u8bf4\u662f\u975e\u5e38\u597d\u7684\u5b66\u4e60\u673a\u4f1a\u3002\u901a\u8fc7FDA\u7684\u7a3d\u67e5\uff0c\u63d0\u9ad8\u4e86\u6211\u4eec\u7684\u7814\u7a76\u8d28\u91cf\u3002\u57281998\u5e74\uff0c\u6211\u4eec\u610f\u8bc6\u5230\u5728\u54e5\u65af\u8fbe\u9ece\u52a0\u6211\u4eec\u5df2\u7ecf\u6709\u4e86\u975e\u5e38\u5de9\u56fa\u7684\u6a21\u5f0f\u3002\u6211\u4eec\u5728\u7528\u4e0e\u53d1\u8fbe\u56fd\u5bb6\u4e00\u6837\u7684\u6807\u51c6\u8fdb\u884c\u4e34\u5e8a\u7814\u7a76\u3002\u5f53\u7136\uff0c\u6211\u4eec\u610f\u8bc6\u5230\uff0c\u4e3a\u4e86\u63d0\u9ad8\u5176\u4ed6\u62c9\u7f8e\u56fd\u5bb6\u4e34\u5e8a\u7814\u7a76\u7684\u8d28\u91cf\uff0c\u6211\u4eec\u9700\u8981\u6559\u80b2\u5927\u4f17\u4e86\u89e3\u4ec0\u4e48\u662f\u4e34\u5e8a\u7814\u7a76\u3002\u6211\u4eec\u4e5f\u8ba4\u8bc6\u5230\u57f9\u8bad\u4e34\u5e8a\u7814\u7a76\u8005\u548c\u4f26\u7406\u59d4\u5458\u4f1a\u6210\u5458\u7684\u91cd\u8981\u6027\u3002<\/span><\/p>\n

    \u57281998\u5e745\u6708\uff0c\u6211\u4eec\u5f00\u59cb\u4e86\u57f9\u8bad\u4e34\u5e8a\u7814\u7a76\u8005\u7684\u7b2c\u4e00\u6b21\u8bfe\u7a0b\u3002\u5728\u8f89\u745e\u516c\u53f8\u7684\u8d5e\u52a9\u548c\u54c8\u4f5b\u56fd\u9645\u533b\u5b66\u4e2d\u5fc3(Harvard Medical International)\u7684\u652f\u6301\u4e0b\uff0c\u6211\u4eec\u5728\u963f\u6839\u5ef7\u3001\u667a\u5229\u3001\u5df4\u897f\u3001\u54e5\u65af\u8fbe\u9ece\u52a0\u548c\u58a8\u897f\u54e5\u5f00\u5c55\u4e86GCP\u6559\u80b2\u8bfe\u7a0b\u3002\u7136\u540e\uff0c\u6211\u4eec\u8fdb\u884c\u4e86\u4e0b\u4e00\u6b65\uff0c\u5373\u5f00\u5c55\u4e86\u9488\u5bf9IRB\u548c\u4f26\u7406\u59d4\u5458\u4f1a\u6210\u5458\u7684\u57f9\u8bad\u8bfe\u7a0b\u3002\u53bb\u5e74\u6211\u4eec\u6210\u529f\u5730\u8fdb\u884c\u4e86\u8fd9\u4e9b\u57f9\u8bad\u3002\u5728\u54e5\u65af\u8fbe\u9ece\u52a0\u3001\u58a8\u897f\u54e5\u3001\u59d4\u5185\u745e\u62c9\u548c\u5df4\u897f\u5206\u522b\u4e3e\u529e\u8bb2\u5ea7\u3002\u4ee5\u540e\uff0c\u6211\u4eec\u610f\u8bc6\u5230\u8fd9\u8fd8\u4e0d\u591f\uff0c\u6211\u4eec\u8fd8\u5e94\u8be5\u4f7f\u66f4\u591a\u7684\u4eba\u80fd\u63a5\u89e6\u5230\u8fd9\u4e2a\u8bfe\u7a0b\u3002\u7136\u540e\u624d\u6709\u4e86\u4f60\u4eec\u73b0\u5728\u6b63\u5728\u770b\u5230\u7684\u8bfe\u7a0b\u3002<\/span><\/p>\n

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    \u5546\u52a1\u53d1\u5c55\u90e8\u8d1f\u8d23\u5f62\u8c61\u3001\u5408\u540c\u548c\u5e02\u573a\u7684\u53d1\u5c55\uff0c\u662f\u6574\u4e2a\u8fc7\u7a0b\u5f88\u91cd\u8981\u7684\u4e00\u90e8\u5206\u3002\u7533\u529e\u8005\u5e0c\u671b\u8ba9\u6211\u4eec\u505a\u7814\u7a76\u65f6\u6700\u65e9\u63a5\u89e6\u7684\u5c31\u662f\u4ed6\u4eec\u3002\u5e02\u573a\u90e8\u5c06\u7814\u7a76\u8bd5\u9a8c\u7684\u53ef\u884c\u6027\u3002<\/span><\/p>\n

    \u6211\u4eec\u6709\u4e86\u663e\u8457\u7684\u53d1\u5c55\u3002\u6700\u65e9\u6211\u4eec\u53ea\u6709\u4e09\u4e2a\u4eba\uff0c\u73b0\u5728\u6211\u4eec\u6709\u4e86<\/span>60\u4e2a\u4eba\u3002\u6211\u4eec\u8fdb\u884c\u7684\u4e34\u5e8a\u7814\u7a76\u6570\u76ee\u4e5f\u6709\u4e86\u76f8\u4f3c\u7684\u589e\u957f\u3002\u5728<\/span>2000\u5e74\uff0c\u6211\u4eec\u505a\u4e86<\/span>45\u9879\u7814\u7a76\uff0c\u800c\u4e14\u8fd8\u5728\u589e\u52a0\u3002\u6211\u4eec\u76f8\u4fe1\uff0c\u5728\u67d0\u4e9b\u9886\u57df\u6211\u4eec\u5e94\u8be5\u66f4\u52aa\u529b\u5730\u53bb\u53d1\u5c55\uff0c\u4f8b\u5982\u4e34\u5e8a\u5b9e\u9a8c\u5ba4\u90e8\u5206\u3002\u6211\u4eec\u9700\u8981\u63d0\u9ad8\u5b9e\u9a8c\u5ba4\u7684\u8d28\u91cf\uff0c\u6709\u80fd\u529b\u5904\u7406\u7814\u7a76\u7684\u6240\u6709\u6807\u672c\u5305\u62ec<\/span>I\u671f\u7814\u7a76\u4e2d\u836f\u7269\u6d53\u5ea6\u7684\u6d4b\u5b9a\u3002<\/span>I\u671f\u8bd5\u9a8c\u548c\u836f\u4ee3\u52a8\u529b\u90e8\u4e5f\u662f\u5e94\u8be5\u5927\u529b\u53d1\u5c55\u7684\u3002\u5728\u62c9\u4e01\u7f8e\u6d32\u5f88\u9700\u8981\u8fdb\u884c\u751f\u7269\u7b49\u6548\u6027\u7814\u7a76\u3002\u6211\u4eec\u7684\u8bca\u6240\u6570\u76ee\u4e5f\u5728\u4e0d\u65ad\u589e\u52a0\u3002\u73b0\u5728\uff0c\u6211\u4eec\u6709\u4e09\u4e2a\u8bca\u6240\u6765\u5165\u9009\u53c2\u52a0\u4e34\u5e8a\u7814\u7a76\u7684\u75c5\u4eba\u3002\u6211\u4eec\u76f8\u4fe1\u8fd9\u6837\u7684\u8bca\u6240\u7684\u6570\u76ee\u81f3\u5c11\u5e94\u8be5\u52a0\u500d\u3002<\/span><\/span><\/p>\n

    \u7ee7\u7eed\u533b\u5b66\u6559\u80b2\u4e2d\u5fc3\u4e00\u76f4\u662f\u6211\u4eec\u7684\u4e00\u4e2a\u68a6\u60f3\u3002\u6211\u4eec\u9700\u8981\u53d1\u5c55\u4e00\u4e2a\u8fd9\u6837\u7684\u4e2d\u5fc3\uff0c\u8ba9\u6211\u4eec\u7684\u7814\u7a76\u8005\u53ef\u4ee5\u53d7\u5230\u826f\u597d\u7684\u57f9\u8bad\u548c\u7ee7\u7eed\u6559\u80b2\uff0c\u6765\u66f4\u597d\u5730\u5b8c\u6210\u4e00\u6d41\u7684\u4e34\u5e8a\u7814\u7a76\u3002\u62c9\u4e01\u7f8e\u6d32\u7684\u56fd\u9645\u4e2d\u5fc3\uff1a\u6211\u4eec\u5df2\u7ecf\u5728\u5370\u5ea6\u7684\u65b0\u5fb7\u91cc\u6709\u4e86\u7b2c\u4e00\u4e2a\u4e2d\u5fc3\uff0c\u4f46\u6211\u4eec\u7684\u4e3b\u8981\u76ee\u6807\u662f\u5728\u62c9\u4e01\u7f8e\u6d32\uff0c\u5df4\u62ff\u9a6c\u3001\u58a8\u897f\u54e5\u3001\u5df4\u897f\u548c\u963f\u6839\u5ef7\u53d1\u5c55\u8fd9\u6837\u7684\u4e2d\u5fc3\u3002\u8fd9\u662f\u4e3b\u8981\u7684\u52aa\u529b\u65b9\u5411\uff0c\u6211\u4eec\u76f8\u4fe1\uff0c\u62c9\u4e01\u7f8e\u6d32\u8981\u5b8c\u6210\u4e16\u754c\u7ea7\u7684\u4e34\u5e8a\u7814\u7a76\u9700\u8981\u53d1\u5c55\u7531\u8bad\u7ec3\u6709\u7d20\u7684\u7814\u7a76\u961f\u4f0d\u548c\u57fa\u7840\u8bbe\u65bd\u6784\u6210\u7684\u7814\u7a76\u4e2d\u5fc3\u3002\u8fd9\u662f\u552f\u4e00\u7684\u53ef\u4ee5\u6539\u53d8\u524d\u9762\u63d0\u5230\u7684\u72b6\u6001\u3001\u5373\u6211\u4eec\u53ea\u5360\u4e16\u754c\u7684<\/span>0.28%<\/span>\u7684\u529e\u6cd5\u3002<\/span><\/span><\/p>\n

    ICIC<\/span>\u80fd\u591f\u6709\u6548\u5730\u5efa\u7acb\u4e86\u57fa\u7840\u8bbe\u65bd\u5e76\u4e14\u77e5\u9053\u600e\u6837\u5b8c\u6210\u9ad8\u8d28\u91cf\u7684\u4e34\u5e8a\u7814\u7a76\u3002\u4f46\u662f\uff0c\u4e3a\u4e86\u5b9e\u73b0\u5c06\u8fd9\u79cd\u80fd\u529b\u6269\u5c55\u5230\u5176\u4ed6\u56fd\u5bb6\u7684\u4f7f\u547d\uff0c\u6211\u4eec\u5e94\u8be5\u52a0\u5f3a\u5728\u54e5\u65af\u8fbe\u9ece\u52a0\u7684\u4e34\u5e8a\u7814\u7a76\u5e76\u628a\u5b83\u62d3\u5c55\u5230\u8be5\u56fd\u4ee5\u5916\u7684\u5730\u65b9\u3002\u6211\u4eec\u5e0c\u671b\u5728\u5176\u4ed6\u62c9\u7f8e\u56fd\u5bb6\u91cd\u590d\u8fd9\u6837\u7684\u6a21\u578b\uff0c\u6211\u4eec\u5e0c\u671b\u53d1\u5c55\u57f9\u8bad\u4e34\u5e8a\u7814\u7a76\u8005\u3001\u4f26\u7406\u59d4\u5458\u4f1a\u6210\u5458\u4ee5\u53ca\u5a92\u4f53\u548c\u5927\u4f17\u7684\u57f9\u8bad\u9879\u76ee\u3002<\/span><\/span><\/p>\n

    \u6211\u60f3\u4ee5<\/span>Eleanor Roosevelt<\/span>\u7684\u8bdd\u7ed3\u675f\u4eca\u5929\u7684\u8bb2\u8bfe<\/span>: “<\/span>\u672a\u6765\u5c5e\u4e8e\u90a3\u4e9b\u8ffd\u968f\u68a6\u60f3\u7684\u4eba\u3002<\/span>” <\/span>\u6211\u4eec\u6570\u5e74\u4ee5\u524d\u6709\u4e00\u4e2a\u68a6\u60f3\uff0c\u6211\u4eec\u73b0\u5728\u5df2\u7ecf\u80fd\u591f\u4f7f\u5b83\u6210\u4e3a\u73b0\u5b9e\u3002\u6211\u76f8\u4fe1\uff0c\u4f60\u4eec\u6240\u6709\u7684\u4eba\uff0c\u5982\u679c\u6309\u7167\u76f8\u540c\u7684\u6b65\u9aa4\u505a\uff0c\u4f60\u4eec\u4e00\u5b9a\u4e5f\u80fd\u5728\u4f60\u4eec\u7684\u56fd\u5bb6\u505a\u5230\u540c\u6837\u7684\u4e8b\u3002<\/span><\/span><\/p>\n

    \u975e\u5e38\u8c22\u8c22\u5927\u5bb6\u7684\u53c2\u4e0e\u3002\u4eca\u5929\u7684\u8bfe\u7a0b\u5bf9\u6240\u6709\u7684\u4eba\u90fd\u5341\u5206\u91cd\u8981\uff0c\u6211\u4eec\u76f8\u4fe1\u5b83\u5c06\u4e3a\u62c9\u4e01\u7f8e\u6d32\u53d1\u5c55\u4e34\u5e8a\u7814\u7a76\u505a\u51fa\u91cd\u8981\u7684\u8d21\u732e\u3002\u8c22\u8c22\u5927\u5bb6\u3002<\/span><\/p>\n


    <\/p>\n

    \u95ed\u5e55\u8bcd<\/span><\/strong><\/span><\/p>\n

    Dr. RobertRubin<\/span><\/strong><\/span><\/p>\n

    \u81f3\u6b64\uff0c\u6211\u4eec\u5df2\u7ecf\u7ed3\u675f\u4e86\u8fd9\u6b21<\/span>\u201c<\/span>\u4e34\u5e8a\u8bd5\u9a8c\u8d28\u91cf\u7ba1\u7406\u89c4\u8303<\/span>(<\/span>\u76f4\u8bd1\u4e3a\u826f\u597d\u7684\u4e34\u5e8a\u5b9e\u8df5\uff0c<\/span>GCP)\u201d<\/span>\u7684\u5168\u90e8\u8bfe\u7a0b\u3002\u5230\u603b\u7ed3\u6211\u4eec\u5728\u8bfe\u7a0b\u4e2d\u5b66\u5230\u7684\u6700\u91cd\u8981\u7684\u5185\u5bb9\u7684\u65f6\u5019\u4e86\u3002<\/span><\/span><\/p>\n

    \u9996\u5148\uff0c\u4e5f\u662f\u6700\u91cd\u8981\u7684\uff0c\u5c31\u662f\u5f3a\u8c03\u4e34\u5e8a\u7814\u7a76\u8005\u7684\u4f26\u7406\u8d23\u4efb\uff0c\u4e00\u65e6\u4ed6\u62db\u52df\u4e86\u53d7\u8bd5\u8005\u8fdb\u884c\u4e34\u5e8a\u7814\u7a76\uff0c\u4ed6\u6240\u627f\u62c5\u7684\u4f26\u7406\u8d23\u4efb\u5c31\u662f\u4e00\u540d\u533b\u751f\u6240\u6709\u7684\u8d23\u4efb\u4e2d\u6700\u91cd\u8981\u548c\u6700\u4e25\u8083\u7684\u3002<\/span><\/p>\n

    \u5176\u6b21\uff0c\u662f\u4e34\u5e8a\u5b9e\u8df5\u7684\u6982\u5ff5\uff0c\u826f\u597d\u7684\u4e34\u5e8a\u5b9e\u8df5\uff08<\/span>GCP)<\/span>\u662f\u4e00\u79cd\u65b9\u6cd5\u5b66\uff0c\u7528\u4ee5\u5728\u4fdd\u8bc1\u79d1\u5b66\u7684\u4e25\u8c28\u6027\u7684\u540c\u65f6\uff0c\u6700\u5927\u9650\u5ea6\u5730\u4fdd\u62a4\u53d7\u7814\u7a76\u7684\u4e2a\u4f53\u3002<\/span><\/span><\/p>\n

    \u7b2c\u4e09\uff0c\u6211\u4eec\u5f3a\u8c03\u4e86\u4e34\u5e8a\u7814\u7a76\u7684\u57fa\u77f3\uff0c\u5b83\u4eec\u662f\u4fdd\u8bc1\u6211\u4eec\u8d1f\u8d77\u4f26\u7406\u8d23\u4efb\u7684\u4e09\u6761\u57fa\u672c\u539f\u5219\uff1a\u5bf9\u4eba\u7684\u5c0a\u91cd\u3001\u53d7\u76ca\u6027\u548c\u516c\u6b63\u6027\u3002\u6211\u4eec\u575a\u4fe1\uff0c\u4eca\u5929\u4e0e\u4ee5\u5f80\u5176\u4ed6\u4efb\u4f55\u65f6\u5019\u76f8\u6bd4\uff0c\u4e34\u5e8a\u7814\u7a76\u4eba\u5458\u90fd\u6709\u66f4\u591a\u7684\u673a\u4f1a\u4e3a\u63d0\u9ad8\u4eba\u7c7b\u751f\u5b58\u6761\u4ef6\u548c\u4fc3\u8fdb\u751f\u7269\u533b\u5b66\u53d1\u5c55\u505a\u51fa\u8d21\u732e\uff0c\u53ea\u8981\u8fdb\u884c\u7814\u7a76\u7684\u4eba\u7ecf\u8fc7\u4e86\u5fc5\u8981\u7684\u65b9\u6cd5\u5b66\u7684\u826f\u597d\u57f9\u8bad\u3002<\/span><\/p>\n

    \u6700\u540e\uff0c\u6211\u4eec\u63cf\u7ed8\u4e86\u6211\u4eec\u7684\u4fe1\u5ff5<\/span>\u2014\u2014<\/span>\u7531\u5fd7\u540c\u9053\u5408\u7684\u4eba\u4eec\u5efa\u7acb\u8d77\u7f51\u7edc\u5e76\u638c\u63e1\u4e86\u8fdb\u884c\u6b64\u9879\u5de5\u4f5c\u6240\u5fc5\u9700\u7684\u5de5\u5177\uff0c\u6211\u4eec\u5c06\u5728\u4e16\u754c\u8303\u56f4\u5185\u63a8\u52a8\u533b\u7597\u7684\u8fdb\u6b65\u3002<\/span><\/span><\/p>\n

    \u611f\u8c22\u60a8\u7684\u53c2\u4e0e\u3002<\/span><\/p>\n


    <\/span><\/p>\n


    <\/p>\n

    \u5185\u5bb9\u6765\u6e90\uff1a\u7f51\u7edc\uff0c\u7f16\u8f91\u6574\u7406<\/span><\/em><\/p>\n


    <\/p>\n

    \n


    <\/p>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"

    \u7b2c\u5341\u4e00\u8bb2 \u8bd5\u9a8c\u65b9\u6848\uff1a\u4e34\u5e8a\u7814\u7a76\u7684\u5de5\u5177 Dr. Pierre Etienne \u5927\u5bb6\u597d\uff0c\u6211\u662fPierreE […]<\/p>\n","protected":false},"author":1,"featured_media":61187,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[2],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/61186"}],"collection":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/comments?post=61186"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/61186\/revisions"}],"predecessor-version":[{"id":61189,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/61186\/revisions\/61189"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/61187"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=61186"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=61186"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=61186"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}

    <\/span>\u4e0a\u7bc7\uff1a\u8f89\u745eGCP\u57f9\u8bad\uff08\u4e00\uff09<\/a>
    <\/span>
    <\/p>\n