{"id":91429,"date":"2019-04-18T00:00:50","date_gmt":"2019-04-23T04:31:06","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/91429\/"},"modified":"2019-04-23T12:31:08","modified_gmt":"2019-04-23T04:31:08","slug":"64902fe0c7","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/91429\/","title":{"rendered":"\u52a0\u901f\u63a5\u8f68ICH\uff0c\u300a\u4e34\u5e8a\u5b89\u5168\u6027\u6570\u636e\u5feb\u901f\u62a5\u544a\u5e38\u89c1\u95ee\u7b54\uff081.0\u7248\uff09\u300b\u91cd\u78c5\u53d1\u5e03"},"content":{"rendered":"
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\u70b9\u51fb\u4e0a\u65b9\u7684<\/span>  \u25b2<\/span> \u6dfb\u52a0\u5173\u6ce8<\/span><\/span><\/p>\n


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       <\/span>\"\u52a0\u901f\u63a5\u8f68ICH\uff0c\u300a\u4e34\u5e8a\u5b89\u5168\u6027\u6570\u636e\u5feb\u901f\u62a5\u544a\u5e38\u89c1\u95ee\u7b54\uff081.0\u7248\uff09\u300b\u91cd\u78c5\u53d1\u5e03\"<\/p>\n

      <\/p>\n

2019\u5e744\u670811\u65e5\uff0c\u5404\u5927\u670b\u53cb\u5708\u3001\u7f51\u7edc\u5e73\u53f0\u88ab\u4e00\u5219”CDE\u53d1\u5e03\u4e86\u300a\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4\u5b89\u5168\u6027\u6570\u636e\u5feb\u901f\u62a5\u544a\u5e38\u89c1\u95ee\u7b54\uff081.0\u7248\uff09\u300b\u7684\u901a\u77e5”\u7684\u6d88\u606f\u75af\u72c2\u5237\u5c4f\uff0c\u8ba9\u6211\u4eec\u518d\u6b21\u770b\u5230\u4e86\u4e2d\u56fd\u836f\u76d1\u5c40\u52a0\u901f\u4e0e\u56fd\u9645\u63a5\u8f68\u7684\u51b3\u5fc3\u4e0e\u884c\u52a8\uff0c\u52a0\u5feb\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u5b89\u5168\u6027\u6570\u636e\u5feb\u901f\u62a5\u544a\u7684\u653f\u7b56\u843d\u5730\uff0c\u4e2d\u56fd\u836f\u54c1\u51fa\u53e3\u7684\u74f6\u9888\u5728\u4e8e\u56fd\u9645\u8ba4\u8bc1\u7ed3\u679c\u4e92\u8ba4\uff0c\u4e2d\u56fd\u7684\u836f\u54c1\u8981\u60f3\u8fdb\u5165\u56fd\u9645\u4e3b\u6d41\u5e02\u573a\uff0c\u9996\u5148\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4\u5b89\u5168\u6027\u6570\u636e\u5feb\u901f\u62a5\u544a\u8981\u9002\u7528ICH\u4e8c\u7ea7\u6307\u5bfc\u539f\u5219\uff0c\u672c\u6587\u4e3a\u5927\u5bb6\u68b3\u7406\u4e86<\/strong>ICH<\/strong>\u4e8c\u7ea7\u6307\u5bfc\u539f\u5219\u76f8\u5173\u77e5\u8bc6\u70b9\uff0c\u4e00\u8d77\u5b66\u4e60\u4e86\u89e3\u4e34\u5e8a\u5b89\u5168\u6570\u636e\u5feb\u901f\u62a5\u544a\u7684\u77e5\u8bc6\u3002<\/strong><\/p>\n

       <\/strong><\/p>\n

\u4e00\u3001\u4e2d\u56fd\u5982\u4f55\u5e03\u5c40\u52a0\u5165ICH<\/strong><\/span><\/p>\n

       <\/p>\n

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\u65e5\u671f<\/strong><\/p>\n<\/td>\n

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\u4e34\u5e8a\u5b89\u5168\u6027\u6570\u636e\u5feb\u901f\u62a5\u544a\u91cc\u7a0b\u7891\u4e8b\u4ef6<\/strong><\/p>\n<\/td>\n<\/tr>\n

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2017<\/strong>\u5e745\u670831\u65e5\u81f36\u67081\u65e5<\/strong><\/p>\n<\/td>\n

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2017<\/strong>\u5e74\u7b2c\u4e00\u6b21\u4f1a\u8bae\u5728\u52a0\u62ff\u5927\u8499\u7279\u5229\u5c14\u53ec\u5f00\uff0c\u4f1a\u8bae\u901a\u8fc7\u4e86\u4e2d\u56fd\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40\u7684\u7533\u8bf7\uff0c\u603b\u5c40\u6210\u4e3a\u56fd\u9645\u4eba\u7528\u836f\u54c1\u6ce8\u518c\u6280\u672f\u534f\u8c03\u4f1a\u6b63\u5f0f\u6210\u5458\u3002<\/strong><\/p>\n<\/td>\n<\/tr>\n

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2018<\/strong>\u5e741\u670825\u65e5<\/strong><\/p>\n<\/td>\n

\n

\u603b\u5c40\u5728\u52a0\u5165ICH\u540e\uff0c\u9996\u6b21\u516c\u544a\u6211\u56fd\u9002\u7528ICH\u6307\u5bfc\u539f\u5219\u3002\u51b3\u5b9a\u5206\u56db\u4e2a\u9636\u6bb5\u5728\u6211\u56fd\u9002\u75285\u4e2aICH\u4e8c\u7ea7\u6307\u5bfc\u539f\u5219\u3002<\/strong><\/p>\n

E2A<\/strong>\uff1a\u4e34\u5e8a\u5b89\u5168\u6570\u636e\u7684\u7ba1\u7406\uff1a\u5feb\u901f\u62a5\u544a\u7684\u5b9a\u4e49\u548c\u6807\u51c6\uff08<\/strong>2018<\/strong>\u5e745\u67081\u65e5\u8d77\u9002\u7528<\/strong><\/span>\uff09<\/strong><\/p>\n

E2B<\/strong>\uff08R3\uff09\uff1a\u4e34\u5e8a\u5b89\u5168\u6570\u636e\u7684\u7ba1\u7406\uff1a\u4e2a\u4f8b\u5b89\u5168\u62a5\u544a\u4f20\u8f93\u7684\u6570\u636e\u5143\u7d20\uff08<\/strong>2018<\/strong>\u5e745\u67081\u65e5\u8d77\u9002\u7528<\/strong><\/span>\uff09<\/strong><\/p>\n

E2D<\/strong>\uff1a\u4e0a\u5e02\u540e\u5b89\u5168\u6570\u636e\u7684\u7ba1\u7406\uff1a\u5feb\u901f\u62a5\u544a\u7684\u5b9a\u4e49\u548c\u6807\u51c6\uff08<\/strong>2018<\/strong>\u5e747\u67081\u65e5\u8d77\u9002\u7528<\/strong><\/span>\uff09<\/strong><\/p>\n

M1<\/strong>\uff1a\u76d1\u7ba1\u6d3b\u52a8\u533b\u5b66\u8bcd\u5178\uff08MedDRA\uff09\uff08<\/strong>2018<\/strong>\u5e745\u67081\u65e5\u8d77\u9002\u7528<\/strong>\uff09<\/strong><\/p>\n

M4<\/strong>\uff1a\u4eba\u7528\u836f\u7269\u6ce8\u518c\u7533\u8bf7\u901a\u7528\u6280\u672f\u6587\u6863\uff08CTD\uff09<\/strong><\/p>\n<\/td>\n<\/tr>\n

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2018<\/strong>\u5e744\u670827\u65e5<\/strong><\/p>\n<\/td>\n

\n

\u836f\u76d1\u5c40\u53d1\u5e03\u4e86\u6309\u7167ICH\u6280\u672f\u6307\u5bfc\u539f\u5219\u8981\u6c42\u5236\u5b9a\u7684\u300a\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4\u5b89\u5168\u6027\u6570\u636e\u5feb\u901f\u62a5\u544a\u6807\u51c6\u548c\u7a0b\u5e8f\u300b\uff0c\u8fdb\u4e00\u6b65\u660e\u786e\u4e86\u6211\u56fd\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4\u975e\u9884\u671f\u4e25\u91cd\u4e0d\u826f\u53cd\u5e94\uff08SUSAR\uff09\u5feb\u901f\u62a5\u544a\u7684\u91cd\u70b9\u5185\u5bb9\u548c\u62a5\u544a\u9014\u5f84\u3002<\/strong><\/p>\n<\/td>\n<\/tr>\n

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2018<\/strong>\u5e746\u67083\u65e5<\/strong><\/p>\n<\/td>\n

\n

\u836f\u76d1\u5c40\u9881\u5e03\u4e86\u300a\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4\u5b89\u5168\u6027\u6570\u636e\u5feb\u901f\u62a5\u544a\u6807\u51c6\u548c\u7a0b\u5e8f\u300b\uff0c\u8be5\u901a\u77e5\u7684\u5185\u5bb9\u4e3b\u8981\u5305\u62ec\u4e24\u4e2a\u65b9\u9762\uff1a<\/strong><\/p>\n

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  • \n

    E2B R2<\/strong>\u7684\u5927\u9650\u653e\u5bbd\u52302019\u5e745\u67081\u65e5\u3002<\/strong><\/span><\/p>\n<\/li>\n

  • \n

    \u5173\u4e8e\u82f1\u6587\u62a5\u544a\u7684\u63a5\u53d7\u6001\u5ea6\uff0c\u4e3a\u4e86\u5b9e\u73b0E2A\u5feb\u901f\u62a5\u544a\u7684\u76ee\u7684\uff0c\u53ef\u4ee5\u7b2c\u4e00\u65f6\u95f4\u63a5\u6536\u82f1\u6587\u7248\u7684\u62a5\u544a\uff0c\u4f46\u9700\u5728\u89c4\u5b9a\u7684\u63d0\u4ea4\u65f6\u95f4\u540e15\u5929\u5185\u9012\u4ea4\u4e2d\u6587\u7248\u62a5\u544a\u3002<\/strong><\/span><\/p>\n<\/li>\n<\/ul>\n<\/td>\n<\/tr>\n

\n

2018<\/strong>\u5e746\u67087\u65e5<\/strong><\/p>\n<\/td>\n

\n

\u5728\u65e5\u672c\u795e\u6237\u4e3e\u884c\u7684\u56fd\u9645\u4eba\u7528\u836f\u54c1\u6ce8\u518c\u6280\u672f\u534f\u8c03\u4f1a\uff08ICH\uff092018\u5e74\u7b2c\u4e00\u6b21\u5927\u4f1a\u4e0a\uff0c\u4e2d\u56fd\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u5f53\u9009\u4e3aICH\u7ba1\u7406\u59d4\u5458\u4f1a\u6210\u5458\u3002<\/strong><\/p>\n<\/td>\n<\/tr>\n

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2019<\/strong>\u5e747\u670830\u65e5<\/strong><\/p>\n<\/td>\n

\n

\u836f\u76d1\u5c40\u53d1<\/em>\u5e03\u300aE2B(R2)\u5b89\u5168\u6027\u6d88\u606f\u5904\u7406\u548c\u4e2a\u4f8b\u5b89\u5168\u6027\u62a5\u544a\u6280\u672f\u89c4\u8303\u300b\u3002<\/strong><\/p>\n

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  • \n

    \u7533\u8bf7\u4eba\u5e94\u53ca\u65f6\u5b8c\u6210\u7cfb\u7edf\u914d\u7f6e,\u5e76\u6309\u7167\u672c\u89c4\u8303\u8981\u6c42\u6b63\u5f0f\u5b9e\u65bdE2B(R2),\u65f6\u95f4\u4e0d\u5f97\u665a\u4e8e2018\u5e7410\u67081\u65e5\uff1b<\/strong><\/span><\/p>\n<\/li>\n

  • \n

    \u8bd5\u9a8c\u5728\u5883\u5185\u6709\u5165\u7ec4\u65f6\uff0c\u5148\u7533\u8bf7\u4eba\u4e4b\u7a97\u6216fax\uff0f\u5feb\u9012\u63d0\u4ea4\uff0c\u7533\u8bf7\u4eba\u6d4b\u8bd5E2B(R2)\u6210\u529f\u540e30\u5929\u5185,\u4ee5\u7535\u5b50\u4f20\u8f93\u65b9\u5f0f\u5c3d\u65e9\u91cd\u65b0\u9012\u4ea4,\u4e0d\u5f97\u665a\u4e8e2018\u5e7410\u670831\u65e5\uff1b<\/strong><\/span><\/p>\n<\/li>\n

  • \n

    \u8bd5\u9a8c\u5728\u5883\u5185\u65e0\u5165\u7ec4\u65f6\uff0c\u7533\u8bf7\u4eba\u6d4b\u8bd5E2B(R2) \u6210\u529f\u540e\u4ee5\u7535\u5b50\u4f20\u8f93\u65b9\u5f0f\u5c3d\u65e9\u8865\u5145\u9012\u4ea4,\u4e0d\u5f97\u665a\u4e8e2018\u5e7410\u670831\u65e5\u3002<\/strong><\/span><\/p>\n<\/li>\n<\/ul>\n<\/td>\n<\/tr>\n

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2019<\/strong>\u5e744\u670811\u65e5<\/strong><\/p>\n<\/td>\n

\n

\u836f\u76d1\u5c40\u53d1\u5e03\u4e86\u300a\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4\u5b89\u5168\u6027\u6570\u636e\u5feb\u901f\u62a5\u544a\u5e38\u89c1\u95ee\u7b54\uff081.0\u7248\uff09\u300b\u3002<\/strong><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

       <\/strong><\/p>\n

\u4e8c\u3001\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4\u5b89\u5168\u6027\u6570\u636e\u5feb\u901f\u62a5\u544a\u5e38\u89c1\u95ee\u7b54<\/span><\/strong><\/p>\n

       <\/p>\n

2019\u5e744\u670811\u65e5\uff0c\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3\u53d1\u5e03\u300a\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4\u5b89\u5168\u6027\u6570\u636e\u5feb\u901f\u62a5\u544a\u5e38\u89c1\u95ee\u7b54\uff081.0\u7248\uff09\u300b\uff0c\u8be5\u6587\u4ef6\u5bf9\u300a\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4\u5b89\u5168\u6027\u6570\u636e\u5feb\u901f\u62a5\u544a\u7684\u6807\u51c6\u548c\u7a0b\u5e8f\u300b\u7684\u53cd\u9988\u95ee\u9898\uff0c\u5305\u62ec\u4f46\u4e0d\u9650\u4e8e\u5feb\u901f\u62a5\u544a\u7684\u8303\u56f4\u3001\u5feb\u901f\u62a5\u544a\u7684\u65f6\u9650\u3001\u63d0\u4ea4\u65b9\u5f0f\u3001\u5173\u4e8e\u8d2d\u4e70\u7b2c\u4e09\u65b9\u670d\u52a1\u3001Gateway\u8d26\u6237\u7533\u8bf7\u53ca\u6d4b\u8bd5 \u7533\u8bf7\u4eba\u4e4b\u7a97\u4e0eXML\u683c\u5f0f\u6587\u4ef6\u3001E2B\u6570\u636e\u5143\u7d20\u76f8\u5173\u8981\u6c42\u3001\u7834\u76f2\u4e0e\u9633\u6027\u5bf9\u7167\u836f\u3001\u5b89\u6170\u5242\u62a5\u544a\u95ee\u9898\u3001\u53d7\u7406\u53f7\u586b\u5199\u7b49\u65b9\u9762\u7684\u95ee\u9898\u8fdb\u884c\u4e86\u7edf\u4e00\u89e3\u91ca\u548c\u6f84\u6e05\uff0c\u4f9b\u7533\u8bf7\u4eba\u548c CRO\u516c\u53f8\u53c2\u8003\uff0c\u5b89\u5168\u6027\u6570\u636e\u5feb\u901f\u62a5\u544a\u5b9e\u65bd\u5e38\u89c1\u95ee\u9898\u548c\u89e3\u8bfb\u5982\u4e0b\uff1a<\/p>\n

       <\/strong><\/p>\n

2.1 \u5feb\u901f\u62a5\u544a\u7684\u8303\u56f4<\/strong><\/p>\n


<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n
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\u53cd\u9988\u95ee\u9898<\/strong><\/p>\n<\/td>\n

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\u5185\u5bb9\u89e3\u8bfb<\/strong><\/p>\n<\/td>\n<\/tr>\n

\n

Q1. \u300a\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4\u5b89\u5168\u6027\u6570\u636e\u5feb\u901f\u62a5\u544a\u7684\u6807\u51c6\u548c\u7a0b\u5e8f\u300b\uff08\u4ee5\u4e0b\u7b80\u79f0\u300a\u6807\u51c6\u548c\u7a0b\u5e8f\u300b\uff09\u4e2d\u7b2c\u4e00\u6761\u201c\u7533\u8bf7\u4eba\u83b7\u51c6\u5f00\u5c55\u836f\u7269(\u5305\u62ec\u4e2d\u836f\u3001\u5316\u836f\u53ca\u751f\u7269\u5236\u54c1)\u4e34\u5e8a\u8bd5\u9a8c\u540e\uff0c\u5bf9\u4e8e\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4\u53d1\u751f\u7684\u6240\u6709\u4e0e\u8bd5\u9a8c\u836f\u7269\u80af\u5b9a\u76f8\u5173\u6216\u53ef\u7591\u7684\u975e\u9884\u671f\u4e14\u4e25\u91cd\u7684\u4e0d\u826f\u53cd\u5e94\u90fd\u5e94\u5411\u56fd\u5bb6\u836f\u54c1\u5ba1\u8bc4\u673a\u6784\u8fdb\u884c\u5feb\u901f\u62a5\u544a\u201d\u3002\u6b64\u5904\u7684\u836f\u7269\u5305\u542b\u8303\u56f4\u662f\u4ec0\u4e48\uff1f\u75ab\u82d7\u662f\u5426\u5305\u542b\u5728\u5185\uff1f<\/p>\n<\/td>\n

\n

A1.\u6b64\u5904\u7684\u836f\u7269\u5305\u542b\u4e0e\u6ce8\u518c\u7533\u8bf7\u6709\u5173\u7684\u4e2d\u836f\u3001\u5316\u836f\u3001\u751f\u7269\u5236\u54c1\u3002\u75ab\u82d7\u5305\u542b\u4e8e\u751f\u7269\u5236\u54c1\u4e2d\uff0c\u56e0\u6b64\uff0c\u75ab\u82d7\u4e34\u5e8a\u8bd5\u9a8c\u4e5f\u9700\u6309\u7167\u4e0a\u8ff0\u300a\u6807\u51c6\u4e0e\u7a0b\u5e8f\u300b\u8fdb\u884c\u53ef\u7591\u4e14\u975e\u9884\u671f\u4e25\u91cd\u4e0d\u826f\u53cd\u5e94\u7684\u5feb\u901f\u62a5\u544a\u3002<\/p>\n<\/td>\n<\/tr>\n

\n

Q2.\u75ab\u82d7\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u662f\u5426\u53ef\u4ee5\u6309\u71672014\u5e74\u53d1\u5e03\u7684\u300a\u75ab\u82d7\u4e34\u5e8a\u8bd5\u9a8c\u4e25\u91cd\u4e0d\u826f\u4e8b\u4ef6\u62a5\u544a\u7ba1\u7406\u89c4\u5b9a\uff08\u8bd5\u884c\uff09\u300b\uff0c\u800c\u4e0d\u5fc5\u6267\u884c\u300a\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4\u5b89\u5168\u6027\u6570\u636e\u5feb\u901f\u62a5\u544a\u7684\u6807\u51c6\u4e0e\u7a0b\u5e8f\u300b\uff1f<\/p>\n<\/td>\n

\n

A2.\u75ab\u82d7\u4e34\u5e8a\u8bd5\u9a8c\u5e94\u8be5\u6267\u884c\u300a\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4\u5b89\u5168\u6027\u6570\u636e\u5feb\u901f\u62a5\u544a\u7684\u6807\u51c6\u4e0e\u7a0b\u5e8f\u300b\u3002
2014\u5e74\u53d1\u5e03\u300a\u75ab\u82d7\u4e34\u5e8a\u8bd5\u9a8c\u4e25\u91cd\u4e0d\u826f\u4e8b\u4ef6\u62a5\u544a\u7ba1\u7406\u89c4\u5b9a\uff08\u8bd5\u884c\uff09\u300b\u65f6\uff0c\u6211\u56fd\u5c1a\u672a\u52a0\u5165ICH\uff0c\u800c\u76ee\u524d\u6211\u56fd\u5df2\u52a0\u5165ICH\u5e76\u6210\u4e3a\u7ba1\u59d4\u4f1a\u6210\u5458\u30022018\u5e741\u670825\u65e5\u539f\u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40\u53d1\u5e03\u300a\u5173\u4e8e\u9002\u7528\u56fd\u9645\u4eba\u7528\u836f\u54c1\u6ce8\u518c\u6280\u672f\u534f\u8c03\u4f1a\u4e8c\u7ea7\u6307\u5bfc\u539f\u5219\u7684\u516c\u544a\u300b\uff082018\u5e74\u7b2c10\u53f7\uff09\u7b2c\u4e8c\u6761\u660e\u786e\u89c4\u5b9a\uff0c\u81ea2018
\u5e745\u67081\u65e5\u8d77\uff0c\u836f\u7269\u4e34\u5e8a\u7814\u7a76\u671f\u95f4\u62a5\u544a\u4e25\u91cd\u4e14\u975e\u9884\u671f\u7684\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u9002\u7528ICH E2A\u3001M1\u3001E2B\uff08R3\uff09\u3002E2A\u3001E2B\u76f8\u5173\u6280\u672f\u8981\u6c42\uff0c\u662f\u76ee\u524d\u901a\u884c\u7684\u56fd\u9645\u6807\u51c6\u5316\u683c\u5f0f\u548c\u8981\u6c42\uff0c\u6309\u7167E2A\u3001E2B\u6280\u672f\u8981\u6c42\u8fdb\u884c\u5feb\u901f\u62a5\u544a\uff0c\u6709\u5229\u4e8e\u5b89\u5168\u6027\u4fe1\u606f\u5728\u7533\u8bf7\u4eba\u4e0e\u76d1\u7ba1\u673a\u6784\u3001\u76d1\u7ba1\u673a\u6784\u4e0e\u76d1\u7ba1\u673a\u6784\u4e4b\u95f4\u8fdb\u884c\u66f4\u5feb\u901f\u3001\u9ad8\u6548\u7684\u4f20
\u9012\uff0c\u4ee5\u4fbf\u66f4\u52a0\u53ca\u65f6\u3001\u6709\u6548\u5730\u8fdb\u884c\u98ce\u9669\u63a7\u5236\uff0c\u4fdd\u62a4\u53d7\u8bd5\u8005\u5b89\u5168\u3002<\/p>\n<\/td>\n<\/tr>\n

\n

Q3.\u201c\u7533\u8bf7\u4eba\u83b7\u51c6\u5f00\u5c55\u836f\u7269 ( \u5305\u62ec\u4e2d\u836f\u3001\u5316\u836f\u53ca\u751f\u7269\u5236\u54c1 ) \u4e34\u5e8a\u8bd5\u9a8c\u540e\uff0c\u5bf9\u4e8e\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4\u53d1\u751f\u7684\u6240\u6709\u4e0e\u8bd5\u9a8c\u836f\u7269\u80af\u5b9a\u76f8\u5173\u6216\u53ef\u7591\u7684\u975e\u9884\u671f\u4e14\u4e25\u91cd\u7684\u4e0d\u826f\u53cd\u5e94\u90fd\u5e94\u5411\u56fd\u5bb6\u836f\u54c1\u5ba1\u8bc4\u673a\u6784\u8fdb\u884c\u5feb\u901f\u62a5\u544a\u201d\u3002\u6b64\u5904\u7684\u4e34\u5e8a\u8bd5\u9a8c\u5305\u542b\u8303\u56f4\u662f\u4ec0\u4e48\uff1f<\/p>\n<\/td>\n

\n

A3.\u6b64\u5904\u7684\u4e34\u5e8a\u8bd5\u9a8c\u5305\u542b\u4e0e\u65b0\u836f\uff08\u4e2d\u836f\u3001\u5316\u836f\u3001\u751f\u7269\u5236\u54c1\uff09\u6ce8\u518c\u7533\u8bf7\u6709\u5173\u7684\u2160\u3001\u2161\u3001\u2162\u671f\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u6279\u4ef6\u4e2d\u6709\u7279\u522b\u8981\u6c42\u7684\u2163\u671f\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u627f\u8bfa\u6027\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u9700\u8981\u5f00\u5c55\u4e34\u5e8a\u8bd5\u9a8c\u7684\u5df2\u4e0a\u5e02\u4ea7\u54c1\u7533\u8bf7\u589e\u52a0\u65b0\u7684\u4eba\u7fa4\u6216\u65b0\u7684\u9002\u5e94\u75c7\uff0c\u4ee5\u53ca\u9700\u8981\u5f00\u5c55\u4e34\u5e8a\u8bd5\u9a8c\u7684\u5df2\u4e0a\u5e02\u4ea7\u54c1\u7684\u91cd\u5927\u6539\u53d8\uff08\u5982\uff0c\u65b0\u5242\u578b\uff0c\u65b0\u7ed9\u836f\u9014\u5f84\uff0c\u65b0\u751f\u4ea7\u5de5\u827a\uff09\uff0c\u7b49\u3002\u6279\u4ef6\u4e2d\u65e0\u7279\u522b\u8981\u6c42\u7684\u2163\u671f\u4e34\u5e8a\u8bd5\u9a8c\u4e0d\u6309\u6b64\u8981\u6c42\u62a5\u544a\uff0c\u53ef\u6309\u4e0a\u5e02\u540e\u76f8\u5173\u8981\u6c42 \u8fdb\u884c\u62a5\u544a\u3002
\u4ee5\u4e0a\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4\uff0c\u7533\u8bf7\u4eba\u4ece\u5176\u5b83\u6765\u6e90\u83b7\u5f97\u7684\u4e0e\u8bd5\u9a8c\u836f\u7269\u76f8\u5173\u7684\u975e\u9884\u671f\u4e25\u91cd\u4e0d\u826f\u53cd\u5e94\u53ca\u5176\u4ed6\u6f5c\u5728\u4e25\u91cd\u5b89\u5168\u6027\u98ce\u9669\u7684\u4fe1\u606f\u4e5f\u5e94\u5f53\u5411\u56fd\u5bb6\u836f\u54c1\u5ba1\u8bc4\u673a\u6784\u8fdb\u884c\u5feb\u901f\u62a5\u544a\u3002<\/p>\n<\/td>\n<\/tr>\n

\n

Q4.2018\u5e745\u67081\u65e5\u524d\u83b7\u5f97\u4e34\u5e8a\u8bd5\u9a8c\u6279\u4ef6\uff0c\u4f46\u76ee\u524d\u5c1a\u672a\u8fdb\u884c\u7684\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u662f\u5426\u5e94\u6309\u300a\u6807\u51c6\u4e0e\u7a0b\u5e8f\u300b\u6267\u884c\uff1f<\/p>\n<\/td>\n

\n

A4.2018\u5e745\u67081\u65e5\u524d\u83b7\u5f97\u4e34\u5e8a\u8bd5\u9a8c\u6279\u4ef6\uff0c\u5c1a\u672a\u5f00\u5c55\u4e34\u5e8a\u8bd5\u9a8c\u6216\u5df2\u5f00\u5c55\u90e8\u5206\u4e34\u5e8a\u8bd5\u9a8c\u7684\uff0c\u5bf9\u4e8e\u76ee\u524d\u51c6\u5907\u8fdb\u884c\u3001\u5c1a\u672a\u5b9e\u65bd\u7684\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u5747\u5e94\u6309\u6b64\u300a\u6807\u51c6\u4e0e\u7a0b\u5e8f\u300b\u6267\u884c\u3002\u5b9e\u65bd\u7684\u6807\u5fd7\u4e3a\u9996\u4f8b\u53d7\u8bd5\u8005\u7b7e\u7f72\u77e5\u60c5\u540c\u610f\u4e66<\/p>\n<\/td>\n<\/tr>\n

\n

Q5.\u5bf9\u4e8e\u56fd\u9645\u591a\u4e2d\u5fc3\u4e34\u5e8a\u7814\u7a76\uff0c\u201c\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4\u201dSUSAR\u5feb\u901f\u62a5\u544a\u662f\u6307\u4ece\u4f55\u65f6\u5f00\u59cb\u5230\u4f55\u65f6\u7ed3\u675f\uff1f\u662f\u5426\u4ece\u7b2c\u4e00\u4f8b\u4e2d\u56fd\u53d7\u8bd5\u8005\u7b7e\u7f72\u77e5\u60c5\u540c\u610f\u4e66\u5f00\u59cb\u5230\u6700\u540e\u4e00\u4f8b\u4e2d\u56fd\u53d7\u8bd5\u8005\u968f\u8bbf\u7ed3\u675f\uff1f<\/p>\n<\/td>\n

\n

A5.\u5bf9\u4e8e\u56fd\u9645\u591a\u4e2d\u5fc3\u4e34\u5e8a\u7814\u7a76\uff0c\u201c\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4\u201dSUSAR\u5feb\u901f\u62a5\u544a\u662f\u6307\u4ece\u4e34\u5e8a\u8bd5 \u9a8c\u6279\u51c6\u65e5\u671f\/\u56fd\u5bb6\u836f\u54c1\u5ba1\u8bc4\u673a\u6784\u9ed8\u793a\u8bb8\u53ef\u5f00\u59cb\u65e5\u671f\u5f00\u59cb\uff0c\u81f3\u5168\u7403\u6700\u540e\u4e00\u4f8b\u53d7\u8bd5\u8005\u968f\u8bbf\u7ed3\u675f\u65e5\u671f\u3002<\/p>\n<\/td>\n<\/tr>\n

\n

Q6.\u6839\u636e\u300a\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4\u5b89\u5168\u6027\u6570\u636e\u5feb\u901f\u62a5\u544a\u6807\u51c6\u548c\u7a0b\u5e8f\u300b\u7b2c\u5341\u56db\u6761\u201c\u7533\u8bf7\u4eba\u4ece\u5176\u5b83\u6765\u6e90\u83b7\u5f97\u7684\u4e0e\u8bd5\u9a8c\u836f\u7269\u76f8\u5173\u7684\u975e\u9884\u671f\u4e25\u91cd\u4e0d\u826f\u53cd\u5e94\u53ca\u5176\u4ed6\u6f5c\u5728\u4e25\u91cd\u5b89\u5168\u6027\u98ce\u9669\u7684\u4fe1\u606f\u4e5f\u5e94\u5f53\u5411\u56fd\u5bb6\u836f\u54c1\u5ba1\u8bc4\u673a\u6784\u8fdb\u884c\u5feb\u901f\u62a5\u544a\u201d\u3002\u201c\u4ece\u5176\u5b83\u6765\u6e90\u83b7\u5f97\u7684\u201d\u662f\u5426\u5305\u62ec\u81ea\u53d1\u62a5\u544a\uff1f<\/p>\n<\/td>\n

\n

A6. \u6765\u6e90\u4e8e\u81ea\u53d1\u62a5\u544a\u7684ICSR\uff0c\u53ef\u6309\u4e0a\u5e02\u540e\u836f\u54c1\u76f8\u5173\u8981\u6c42\u8fdb\u884c\u5feb\u901f\u62a5\u544a\u3002<\/p>\n<\/td>\n<\/tr>\n

\n

Q7.\u540c\u4e00\u8bd5\u9a8c\u836f\u7269\u7684\u4e0d\u540c\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u662f\u5426\u8981\u8fdb\u884c\u4ea4\u53c9\u62a5\u544a\uff1f<\/p>\n<\/td>\n

\n

A7.\u5883\u5185\u540c\u65f6\u5f00\u5c55\u4e0d\u540c\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u6216\u8005\u5883\u5185\u5916\u540c\u65f6\u5f00\u5c55\u4e0d\u540c\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u5176\u4e2d\u51fa\u73b0SUSAR\uff0c\u5747\u9700\u8981\u5feb\u901f\u62a5\u544a\uff0c\u4f46\u53ea\u9700\u8981\u62a5\u544a\u4e00\u6b21\uff0c\u586b\u5199\u6e05\u695a\u6240\u6709\u7684\u53d7\u7406\u53f7\u5373\u53ef\uff0c\u5e76\u5c06\u672c\u75c5\u4f8b\u6240\u5c5e\u4e34\u5e8a\u8bd5\u9a8c\u7684\u53d7\u7406\u53f7\u6392\u5217\u5728\u7b2c\u4e00\u4f4d\u3002<\/p>\n<\/td>\n<\/tr>\n

\n

Q8. \u540c\u4e00\u836f\u7269\u7684\u4e0d\u540c\u7528\u6cd5\uff08\u5982\u836f\u7269\u5242\u91cf\u3001\u5242\u578b\u3001\u7ed9\u836f\u9014\u5f84\uff09\u6216\u7528\u9014\uff08\u5982\u9002\u5e94\u75c7\u6216\u9002\u7528\u4eba\u7fa4\uff09\uff0c\u662f\u5426\u8981\u8fdb\u884c\u4ea4\u53c9\u62a5\u544a\uff1f<\/p>\n<\/td>\n

\n

A8. \u9700\u8981\u62a5\u544a\uff0c\u4e14\u53ea\u9700\u8981\u62a5\u544a\u4e00\u6b21\uff0c\u586b\u5199\u6e05\u695a\u6240\u6709\u7684\u53d7\u7406\u53f7\uff0c\u5e76\u5c06\u672c\u75c5\u4f8b\u6240\u5c5e\u4e34\u5e8a\u8bd5\u9a8c\u7684\u53d7\u7406\u53f7\u6392\u5217\u5728\u7b2c\u4e00\u4f4d\u3002<\/p>\n<\/td>\n<\/tr>\n

\n

Q9. \u56e0\u679c\u5173\u7cfb\u4e3a\u201c\u65e0\u6cd5\u8bc4\u4ef7\u201d\u6216\u8005\u201c\u672a\u77e5\u201d\u7684\u75c5\u4f8b\uff0c\u662f\u5426\u9700\u8981\u6309\u7167SUSAR\u5feb\u901f\u62a5\u544a\uff1f<\/p>\n<\/td>\n

\n

A9.\u201c\u65e0\u6cd5\u8bc4\u4ef7\u201d\u3001\u201c\u672a\u77e5\u201d\u8868\u8ff0\u4e0d\u89c4\u8303\uff0c\u4f46\u5747\u65e0\u6cd5\u9664\u5916\u76f8\u5173\u6027\uff0c\u9700\u8981\u6309\u7167SUSAR\u5feb\u901f\u62a5\u544a\u3002<\/p>\n<\/td>\n<\/tr>\n

\n

Q10. \u4e34\u5e8a\u8bd5\u9a8c\u7ed3\u675f\u4e4b\u540e\u3001\u83b7\u5f97\u5ba1\u6279\u7ed3\u8bba\u4e4b\u524d\u53d1\u751f\u7684\u975e\u9884\u671f\u4e25\u91cd\u4e0d\u826f\u53cd\u5e94\uff0c\u7533\u8bf7\u4eba\u5e94\u901a\u8fc7\u4f55\u9014\u5f84\u4e0a\u62a5\u836f\u76d1\u90e8\u95e8\uff1f\u4e0e\u8bd5\u9a8c\u7ed3\u675f\u4e4b\u524d\u7684\u5feb\u901f\u62a5\u544a\u65b9\u5f0f\u4e00\u81f4\u4e48\uff1f<\/p>\n<\/td>\n

\n

A10. \u4e0e\u8bd5\u9a8c\u7ed3\u675f\u4e4b\u524d\u7684\u5feb\u901f\u62a5\u544a\u65b9\u5f0f\u4e00\u81f4\u3002<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

       <\/strong><\/p>\n

2.2 \u5feb\u901f\u62a5\u544a\u7684\u65f6\u9650<\/strong><\/p>\n


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

\u53cd\u9988\u95ee\u9898<\/strong><\/p>\n<\/td>\n

\n

\u5185\u5bb9\u89e3\u8bfb<\/strong><\/p>\n<\/td>\n<\/tr>\n

\n

Q1.\u901a\u8fc7\u7533\u8bf7\u4eba\u4e4b\u7a97\u4ee5XML\u6587\u4ef6\u65b9\u5f0f\u63d0\u4ea4\u65f6\uff0cCDE\u662f\u5426\u4e5f\u4f1a\u8fd4\u56deACK\uff1f\u5bf9\u4e8e7\/15\u5929\u7684\u65f6\u9650\u754c\u5b9a\uff0c\u662f\u4ee5\u4f01\u4e1a\u4e0a\u4f20\u7533\u8bf7\u4eba\u4e4b\u7a97\u7684\u65e5\u671f\u8fd8\u662f\u4ee5CDE\u5bfc\u5165\u7cfb\u7edf\u7684\u65e5\u671f\u4e3a\u51c6\uff1f<\/p>\n<\/td>\n

\n

A1.\u5728\u7533\u8bf7\u4eba\u4e4b\u7a97\u4e0a\u4f20XML\u6587\u4ef6\u540e\uff0c\u4e0d\u4f1a\u81ea\u52a8\u8fd4\u56deACK\u3002
\u4e0a\u4f20\u81f3\u7533\u8bf7\u4eba\u4e4b\u7a97\u7684XML\u6587\u4ef6\uff0c\u9700\u8981CDE\u5de5\u4f5c\u4eba\u5458\u4eba\u5de5\u5bfc\u5165CDE\u7684\u836f\u7269\u8b66\u6212\u7cfb\u7edf\uff0c\u5982\u679cXML\u6587\u4ef6\u4e0d\u7b26\u5408\u8981\u6c42\u3001\u53d1\u751f\u5bfc\u5165\u5931\u8d25\uff0cCDE\u5de5\u4f5c\u4eba\u5458\u5c06\u4f1a\u901a\u8fc7\u7535\u5b50\u90ae\u7bb1\u5411\u7533\u8bf7\u4eba\u53cd\u9988ACK\uff0c\u7533\u8bf7\u4eba\u6839\u636eACK\u7684\u63d0\u793a\uff0c\u4fee\u6539\u3001\u5b8c\u5584\u6587\u4ef6\u540e\u91cd\u65b0\u4e0a\u4f20\u3002
XML\u6587\u4ef6\u63d0\u4ea4\u65b9\u5f0f\u4e0b\uff0c\u5bf9\u4e8e7\/15\u5929\u7684\u65f6\u9650\u754c\u5b9a\uff0c\u4e00\u822c\u4ee5\u7533\u8bf7\u4eba\u5c06XML\u6587\u4ef6\u4e0a\u4f20\u7533\u8bf7\u4eba\u4e4b\u7a97\u7684\u65e5\u671f\u4e3a\u51c6\u3002\u4f46\u662f\uff0c\u5982\u679cXML\u6587\u4ef6\u6709\u9519\u8bef\u3001CDE\u5bfc\u5165\u7cfb\u7edf\u65f6\u5931\u8d25\uff0cCDE\u5de5\u4f5c\u4eba\u5458\u518d\u901a\u8fc7\u7535\u5b50\u90ae\u7bb1\u5c06ACK\u53d1\u9001\u56de\u7533\u8bf7\u4eba\uff0c\uff08\u4e0a\u8ff0\u4eba\u5de5\u64cd\u4f5c\u8fc7\u7a0b\u4e00\u822c\u9700\u89812\u4e2a\u5de5\u4f5c\u65e5\u5b8c\u6210\uff09\u3002\u7533\u8bf7\u4eba\u4fee\u6539\u540e\u518d\u6b21\u4e0a\u62a5\uff0c\u4e0a\u8ff0\u8fc7\u7a0b
\u9020\u6210\u7684\u65f6\u95f4\u5ef6\u8bef\u8d23\u4efb\u5e94\u5f52\u4e3a\u7533\u8bf7\u4eba\u3002\u56e0\u6b64\uff0c\u5efa\u8bae\u7533\u8bf7\u4eba\u53ca\u76f8\u5173\u4e13\u4e1a\u4eba\u5458\u52a0\u5f3a\u5bf9\u62a5\u544a\u8d28\u91cf\u7684\u7ba1\u7406\uff0c\u4e0d\u65ad\u964d\u4f4e\u62a5\u544a\u9519\u8bef\u7387\uff0c\u4ee5\u786e\u4fdd\u5728\u89c4\u5b9a\u671f\u9650\u5185\u63d0\u4ea4\u6210\u529f\u3002<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

       <\/strong><\/p>\n

2.3 \u63d0\u4ea4\u65b9\u5f0f<\/strong><\/p>\n


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

\u53cd\u9988\u95ee\u9898<\/strong><\/p>\n<\/td>\n

\n

\u5185\u5bb9\u89e3\u8bfb<\/strong><\/p>\n<\/td>\n<\/tr>\n

\n

Q1.\u76ee\u524d\u4e24\u79cd\u4f20\u8f93\u65b9\u5f0f\uff08GATEWAY\u65b9\u5f0f\u548cXML\u6587\u4ef6\u65b9\u5f0f\uff09\u662f\u4e8c\u9009\u4e00\u5417\uff1f\u5982\u679c\u968f\u7740\u516c\u53f8\u7cfb\u7edf\u7684\u5f00\u53d1\u548c\u4e1a\u52a1\u7684\u53d8\u66f4\uff0c\u662f\u5426\u53ef\u4ee5\u4e2d\u9014\u53d8\u66f4\u63d0\u4ea4\u65b9\u5f0f\uff1f<\/p>\n<\/td>\n

\n

A1.\u7533\u8bf7\u4eba\u53ef\u4ee5\u6839\u636e\u81ea\u8eab\u60c5\u51b5\u81ea\u884c\u9009\u62e9\u4e0a\u8ff0\u4efb\u4e00\u79cd\u4f20\u8f93\u65b9\u5f0f\uff1b\u6839\u636e\u60c5\u51b5\u53d8\u5316\uff0c\u4e2d\u9014\u53ef\u4ee5\u53d8\u66f4\u63d0\u4ea4\u65b9\u5f0f\u3002\u63a8\u8350\u4ee5Gateway\u65b9\u5f0f\u4f20\u8f93\u3002<\/p>\n<\/td>\n<\/tr>\n

\n

Q2.\u516c\u53f8\u5c1a\u672a\u5efa\u7acb\u836f\u7269\u8b66\u6212\u7cfb\u7edf\uff0c\u76ee\u524d\u5c1a\u4e0d\u5177\u5907\u6761\u4ef6\u901a\u8fc7GATEWAY\u6216\u8005XML\u6587\u4ef6\u65b9\u5f0f\u63d0\u4ea4\u4e34\u5e8a\u671f\u95f4SUSAR\u4e2a\u4f8b\u62a5\u544a\uff0c\u53ef\u5426\u901a\u8fc7\u5176\u4ed6\u65b9\u5f0f\u8fdb\u884c\u62a5\u544a\uff0c\u6bd4\u5982\u901a\u8fc7\u90ae\u4ef6\/\u7eb8\u8d28\/\u6216\u5176\u4ed6\u65b9\u5f0f\u9012\u4ea4CIOMS\u8868\uff1f<\/p>\n<\/td>\n

\n

A2.SUSAR\u5feb\u901f\u62a5\u544a\u4f20\u8f93\u65b9\u5f0f\u76ee\u524d\u4ec5\u9650\u4e8eGATEWAY\u65b9\u5f0f\u548cXML\u6587\u4ef6\u65b9\u5f0f\uff0c\u4e0d\u63a5\u53d7\u4ee5\u90ae\u4ef6\/\u7eb8\u8d28\/\u6216\u5176\u4ed6\u65b9\u5f0f\u9012\u4ea4CIOMS\u8868\u7b49\u5176\u4ed6\u65b9\u5f0f\u3002\u5bf9\u4e8e\u5c1a\u672a\u5efa\u7acb\u836f\u7269\u8b66\u6212\u7cfb\u7edf\u3001\u76ee\u524d\u5c1a\u4e0d\u5177\u5907\u6761\u4ef6\u901a\u8fc7GATEWAY\u6216\u8005XML\u6587\u4ef6\u65b9\u5f0f\u63d0\u4ea4SUSAR\u4e2a\u4f8b\u62a5\u544a\u7684\u7533\u8bf7\u4eba\uff0c\u53ef\u4ee5\u91c7\u7528\u8d2d\u4e70\u7b2c\u4e09\u65b9\uff08\u5982CRO\u516c\u53f8\uff09\u670d\u52a1\u7684\u65b9\u5f0f\uff0c\u4ee5\u5e2e\u52a9\u5b9e\u73b0GATEWAY\u6216XML\u6587\u4ef6\u65b9\u5f0f\u63d0\u4ea4\u3002<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

       <\/strong><\/p>\n

2.4 \u5173\u4e8e\u8d2d\u4e70\u7b2c\u4e09\u65b9\u670d\u52a1<\/strong><\/p>\n


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

\u53cd\u9988\u95ee\u9898<\/strong><\/p>\n<\/td>\n

\n

\u5185\u5bb9\u89e3\u8bfb<\/strong><\/p>\n<\/td>\n<\/tr>\n

\n

Q1.\u516c\u53f8\u5c1a\u672a\u5efa\u7acb\u836f\u7269\u8b66\u6212\u7cfb\u7edf\uff0c\u4e0d\u5177\u5907\u8fdb\u884cGATEWAY\u6216\u8005XML\u6587\u4ef6\u65b9\u5f0f\u63d0\u4ea4\u7684\u6761\u4ef6\uff0c\u76ee\u524d\u62df\u91c7\u53d6\u4e0eCRO\u516c\u53f8\u7b7e\u8ba2\u5408\u540c\uff0c\u5b8c\u5168\u7531CRO \u516c\u53f8\u5168\u6743\u4ee3\u7406\u63d0\u4ea4\u4e34\u5e8a\u671f\u95f4SUSAR\u4e2a\u4f8b\u62a5\u544a\u3002\u8bf7\u95ee\u662f\u5426\u53ef\u4ee5\uff1f<\/p>\n<\/td>\n

\n

A1.\u7533\u8bf7\u4eba\u53ef\u4ee5\u4e0eCRO\u516c\u53f8\u7b7e\u8ba2\u670d\u52a1\u5408\u540c\uff0c\u7531CRO \u516c\u53f8\u534f\u52a9\u63d0\u4ea4\u4e34\u5e8a\u671f\u95f4SUSAR\u4e2a\u4f8b\u62a5\u544a\uff0c\u4f46\u662f\uff0c\u4f5c\u4e3a\u836f\u7269\u7814\u53d1\u53ca\u6ce8\u518c\u7533\u529e\u65b9\uff0c\u7533\u8bf7\u4eba\u4ecd\u7136\u662f\u4e34\u5e8a\u671f\u95f4\u5b89\u5168\u6027\u76d1\u7ba1\u53ca\u62a5\u544a\u7684\u8d23\u4efb\u4e3b\u4f53\u3002<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

       <\/strong><\/p>\n

2.5 Gateway\u8d26\u6237\u7533\u8bf7\u53ca\u6d4b\u8bd5<\/strong><\/p>\n


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

\u53cd\u9988\u95ee\u9898<\/strong><\/p>\n<\/td>\n

\n

\u5185\u5bb9\u89e3\u8bfb<\/strong><\/p>\n<\/td>\n<\/tr>\n

\n

Q1.\u5982\u679c\u7533\u8bf7\u4eba\u62df\u91c7\u53d6\u8d2d\u4e70\u7b2c\u4e09\u65b9\u670d\u52a1\u65b9\u5f0f\uff0c\u7531CRO\u516c\u53f8\u534f\u52a9\u63d0\u4ea4\u4e34\u5e8a\u671f\u95f4SUSAR\u4e2a\u4f8b\u62a5\u544a\uff0c\u90a3\u4e48\uff0cgateway\u8d26\u53f7\u662f\u7531\u7533\u8bf7\u4eba\u6765\u7533\u8bf7\uff0c\u8fd8\u662f\u4f7f\u7528CRO\u516c\u53f8\u81ea\u5df1\u7533\u8bf7\u7684\u8d26\u53f7\uff1f<\/p>\n<\/td>\n

\n

A1. \u5982\u679c\u7533\u8bf7\u4eba\u7f3a\u5c11\u4e13\u4e1a\u4eba\u5458\uff0c\u53ef\u4ee5\u7531CRO\u516c\u53f8\u534f\u52a9\u7533\u8bf7gateway\u7535\u5b50\u4f20\u8f93\u8d26\u6237\uff0c\u4f46\u4f01\u4e1a\u8bc6\u522bID\u5fc5\u987b\u4e3a\u7533\u8bf7\u4eba\u7684\u8bc6\u522bID\uff0c\u800c\u975eCRO\u516c\u53f8\u7684\u8bc6\u522bID\u3002<\/p>\n<\/td>\n<\/tr>\n

\n

Q2.\u300aICSR\u7535\u5b50\u4f20\u8f93\u8d26\u6237\u7533\u8bf7\u8868\u300b\u4e2d\u8981\u6c42\u586b\u5199\u201c\u5728\u7535\u5b50\u4f20\u8f93\u4fe1\u606f\u4e2d\u4f01\u4e1a\u7684\u8bc6\u522bID\u201d\uff0c\u8bf7\u95ee\u8bc6\u522bID\u662f\u5426\u6709\u7f16\u5236\u89c4\u8303\uff1f<\/p>\n<\/td>\n

\n

A2. \u4f01\u4e1a\u8bc6\u522bID\u65e0\u4e25\u683c\u7684\u7f16\u5236\u89c4\u8303\uff0c\u5982\u53ef\u4f7f\u7528\u5355\u4f4d\u540d\u79f0\u7684\u82f1\u6587\u540d\u79f0\u6216\u7f29\u5199\u3001\u6c49\u8bed\u62fc\u97f3\u6216\u7f29\u5199\u7b49\u4f5c\u4e3a\u8bc6\u522bID \u3002<\/p>\n<\/td>\n<\/tr>\n

\n

Q3. \u300aICSR\u7535\u5b50\u4f20\u8f93\u8d26\u6237\u7533\u8bf7\u8868\u300b\u8981\u6c42\u586b\u5199\u201c\u5bf9\u6240\u4f20\u8f93\u7684\u62a5\u544a\u8fdb\u884c\u6570\u5b57\u7b7e\u540d\u548c\u52a0\u5bc6\u7684\u6570\u5b57\u8bc1\u4e66\u4fe1\u606f\uff08\u5728\u90ae\u4ef6\u4e2d\u4ee5\u9644\u4ef6\u7684\u5f62\u5f0f\u63d0\u4ea4\u7535\u5b50\u6570\u5b57\u8bc1\u4e66\uff0c\u4f8b\u5982\u540e\u7f00\u4e3a.cer\u7684\u8bc1\u4e66\uff09\u201d\uff0c\u8bf7\u95ee\u5bf9\u4e8e\u63d0\u4f9b\/\u751f\u6210\u6570\u5b57\u8bc1\u4e66\u7684\u673a\u6784\u662f\u5426\u6709\u8d44\u8d28\u6216\u8005\u662f\u5176\u4ed6\u8981\u6c42\uff1f<\/p>\n<\/td>\n

\n

A3.\u53ef\u4ee5\u662f\u81ea\u7b7e\u540d\u8bc1\u4e66\u6216\u901a\u8fc7\u7b2c\u4e09\u65b9\u673a\u6784\u8d2d\u4e70\u7684\u8bc1\u4e66\uff0c\u5bf9\u63d0\u4f9b\/\u751f\u6210\u6570\u5b57\u8bc1\u4e66\u7684\u673a\u6784\u65e0\u8d44\u8d28\u6216\u8005\u5176\u4ed6\u7279\u6b8a\u8981\u6c42\uff0c\u53ea\u8981\u662f\u540e\u7f00\u4e3a.cer\u6216.p7b\u7684\u8bc1\u4e66\u5373\u53ef\uff0c\u5bfc\u51fa\u65f6\u9700\u63d0\u4f9b\u5b8c\u6574\u7684\u8bc1\u4e66\u94fe\u3002\u201d<\/p>\n<\/td>\n<\/tr>\n

\n

Q4. \u300aICSR\u7535\u5b50\u4f20\u8f93\u8d26\u6237\u7533\u8bf7\u8868\u300b\u8981\u6c42\u586b\u5199\u201c\u53d1\u9001\u6d4b\u8bd5\u62a5\u544a\u7684URL\uff0c\u4ee5\u53ca\u6536\u5230CDE\u7535\u5b50\u56de\u6267\u7684URL\u5730\u5740\u201d\uff0c\u8bf7\u95ee\u5bf9\u4e8e\u8fd9\u4e24\u4e2aURL\u5730\u5740\u6709\u4f55\u8981\u6c42\uff1f\u662f\u5426\u4e24\u4e2aURL\u5730\u5740\u90fd\u5fc5\u987b\u662f\u7aef\u53e3\u4e3a4080\u7684\u516c\u7f51\u5730\u5740\uff1f<\/p>\n<\/td>\n

\n

A4.\u8fd9\u4e24\u4e2aURL\u5730\u5740\u4e3aAS2 URL\uff0c\u4e24\u4e2aURL\u5730\u5740\u90fd\u5fc5\u987b\u662f\u7aef\u53e3\u4e3a4080\u7684\u516c\u7f51\u5730\u5740\u3002\u7533\u8bf7\u4eba\u4e4b\u7a97\u4e0eXML\u683c\u5f0f\u6587\u4ef6<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

       <\/strong><\/p>\n

2.6 \u7533\u8bf7\u4eba\u4e4b\u7a97\u4e0eXML\u683c\u5f0f\u6587\u4ef6<\/strong><\/p>\n


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

\u53cd\u9988\u95ee\u9898<\/strong><\/p>\n<\/td>\n

\n

\u5185\u5bb9\u89e3\u8bfb<\/strong><\/p>\n<\/td>\n<\/tr>\n

\n

Q1.\u516c\u53f8\u7684\u6ce8\u518c\u90e8\u95e8\u5df2\u7ecf\u6709\u4e00\u4e2a\u7533\u8bf7\u4eba\u4e4b\u7a97\u8d26\u53f7\uff0c\u73b0\u516c\u53f8\u60f3\u518d\u7533\u8bf7\u4e00\u4e2a\u8d26\u53f7\u7528\u4e8eSUSAR\u4e0a\u62a5\uff0c\u8bf7\u95ee\u662f\u5426\u53ef\u884c\uff1f\u5982\u679c\u4e0d\u884c\uff0c\u5e94\u8be5\u5982\u4f55\u64cd\u4f5c\uff0c\u4ee5\u5b9e\u73b0\u901a\u8fc7\u7533\u8bf7\u4eba\u4e4b\u7a97\u6765\u62a5\u544aSUSAR\u5462\uff1f<\/p>\n<\/td>\n

\n

A1. \u6839\u636e\u76ee\u524d\u7533\u8bf7\u4eba\u4e4b\u7a97\u8d26\u53f7\u6ce8\u518c\u89c4\u5b9a\uff0c\u4e00\u4e2a\u6cd5\u4eba\u5b9e\u4f53\u53ea\u80fd\u6ce8\u518c\u4e00\u4e2a\u7533\u8bf7\u4eba\u4e4b\u7a97\u4e3b\u8d26\u53f7\uff1b\u4e3b\u8d26\u53f7\u4e0b\u53ef\u5206\u8bbe\u4e0d\u540c\u7684\u5b50\u8d26\u53f7\uff0c\u4ee5\u6ee1\u8db3\u540c\u4e00\u516c\u53f8\u5185\u90e8\u4e0d\u540c\u90e8\u95e8\u6216\u4e0d\u540c\u4e8b\u52a1\u7684\u9700\u6c42\u3002<\/p>\n<\/td>\n<\/tr>\n

\n

Q2.CRO\u516c\u53f8\u53ef\u4ee5\u5728\u7533\u8bf7\u4eba\u4e4b\u7a97\u6ce8\u518c\u8d26\u53f7\u4ee3\u66ff\u7533\u8bf7\u4eba\u63d0\u4ea4\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4SUSAR\u4e2a\u4f8b\u62a5\u544a\u5417\uff1f<\/p>\n<\/td>\n

\n

A2. \u4e0d\u53ef\u4ee5\u3002\u7533\u8bf7\u4eba\u53ef\u4ee5\u59d4\u6258CRO\u534f\u52a9\u5728\u7533\u8bf7\u4eba\u4e4b\u7a97\u9012\u4ea4SUSAR\u62a5\u544a\uff0c\u4f46\u987b\u901a\u8fc7\u7533\u8bf7\u4eba\u4e3a\u6cd5\u4eba\u7684\u7533\u8bf7\u4eba\u4e4b\u7a97\u8d26\u53f7\u8fdb\u884c\u9012\u4ea4\u3002\u62a5\u544a\u8d23\u4efb\u4e3b\u4f53\u4ecd\u7136\u4e3a\u7533\u8bf7\u4eba\u3002<\/p>\n<\/td>\n<\/tr>\n

\n

Q3.\u7533\u529e\u65b9\u4e3a\u5916\u7c4d\u516c\u53f8\uff0c\u76ee\u524d\u5728\u4e2d\u56fd\u6ca1\u6709\u5b9e\u4f53\u6216\u529e\u4e8b\u673a\u6784\uff0c\u4e5f\u6ca1\u6709\u4f01\u4e1a\u7edf\u4e00\u793e\u4f1a\u4fe1\u7528\u4ee3\u7801\uff0c\u65e0\u6cd5\u7533\u8bf7\u7533\u8bf7\u4eba\u4e4b\u7a97\u8d26\u53f7\uff0c\u4e5f\u65e0\u6cd5\u586b\u5199ICSR\u7535\u5b50\u4f20\u8f93\u8d26\u53f7\u7533\u8bf7\u8868\u3002\u8bf7\u95ee\u5e94\u5982\u4f55\u9012\u4ea4SUSAR\u62a5\u544a\uff1f<\/p>\n<\/td>\n

\n

A3.\u6b64\u79cd\u60c5\u51b5\u6d89\u53ca\u7684\u5916\u7c4d\u516c\u53f8\u6570\u91cf\u4e0d\u591a\uff0c\u60c5\u51b5\u8f83\u4e3a\u7279\u6b8a\u3002\u76ee\u524d\u7684\u89e3\u51b3\u65b9\u6cd5\u662f\u53ef\u4ee5\u7531\u4ee3\u7406\u673a\u6784\u4ee3\u7406\u7533\u8bf7\u7533\u8bf7\u4eba\u4e4b\u7a97\u5e10\u53f7\uff0c\u7136\u540e\u9009\u62e9GATEWAY\u65b9\u5f0f\u6216XML\u6587\u4ef6\u65b9\u5f0f\u63d0\u4ea4SUSAR\u62a5\u544a\u3002\u4f46\u300aICSR\u7535\u5b50\u4f20\u8f93\u8d26\u6237\u7533\u8bf7\u8868\u300b\u4e2d\u4f01\u4e1a\u8bc6\u522bID\u4ee5\u53caXML\u6587\u4ef6\u4e2d\u4f01\u4e1a\u8bc6\u522bID\u5747\u5fc5\u987b\u4e3a\u7533\u8bf7\u4eba\u7684\u8bc6\u522bID\uff0c\u800c\u975e\u4ee3\u7406\u673a\u6784 \/ CRO\u516c\u53f8\u7684\u8bc6\u522bID\u3002<\/p>\n<\/td>\n<\/tr>\n

\n

Q4.\u901a\u8fc7\u7533\u8bf7\u4eba\u4e4b\u7a97\u4e0a\u4f20 XML\u6587\u4ef6\u7684\u65b9\u5f0f\u9012\u4ea4SUSAR\u62a5\u544a\uff0c\u662f\u5426\u9700\u8981\u63d0\u524d\u6d4b\u8bd5\uff0c\u8fd8\u662f\u53ef\u4ee5\u65e0\u9700\u6d4b\u8bd5\u76f4\u63a5\u767b\u9646\u4e0a\u4f20XML\u683c\u5f0f\u7684SUSAR\u62a5\u544a\uff1f<\/p>\n<\/td>\n

\n

A4.\u901a\u8fc7\u7533\u8bf7\u4eba\u4e4b\u7a97\u4e0a\u4f20XML\u6587\u4ef6\u9012\u4ea4SUSAR\u62a5\u544a\uff0c\u7533\u8bf7\u4eba\u9700\u5148\u63d0\u4ea4\u6d4b\u8bd5\u62a5\u544a\uff0c\u6d4b\u8bd5\u901a\u8fc7\u540e\u518d\u9012\u4ea4\u6b63\u5f0f\u62a5\u544a\u3002<\/p>\n<\/td>\n<\/tr>\n

\n

Q5.\u5982\u679c\u901a\u8fc7\u201c\u7533\u8bf7\u4eba\u4e4b\u7a97\u201d\u63d0\u4ea4XML\u683c\u5f0f\u6587\u4ef6\uff0c\u8bf7\u95eeXML\u683c\u5f0f\u6587\u4ef6\u662f\u901a\u8fc7\u4f55\u79cd\u9014\u5f84\u751f\u6210\u7684\uff1f<\/p>\n<\/td>\n

\n

A5 \u53ef\u6269\u5c55\u6807\u8bb0\u8bed\u8a00\uff08XML\uff09\u662f\u4e00\u79cd\u6807\u8bb0\u8bed\u8a00\uff0c\u5b83\u5b9a\u4e49\u4e86\u4e00\u7ec4\u89c4\u5219\uff0c\u7528\u4e8e\u4ee5\u4eba\u7c7b\u53ef\u8bfb\u548c\u673a\u5668\u53ef\u8bfb\u7684\u683c\u5f0f\u7f16\u7801\u6587\u6863\u3002\u7b26\u5408E2B\u8981\u6c42\u7684XML\u683c\u5f0f\u6587\u4ef6\u5fc5\u987b\u901a\u8fc7\u4e13\u4e1a\u7684\u7535\u5b50\u7cfb\u7edf\u751f\u6210\u3002<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

       <\/strong><\/p>\n

2.7 E2B\u6570\u636e\u5143\u7d20\u76f8\u5173\u8981\u6c42<\/strong><\/p>\n


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

\u53cd\u9988\u95ee\u9898<\/strong><\/p>\n<\/td>\n

\n

\u5185\u5bb9\u89e3\u8bfb<\/strong><\/p>\n<\/td>\n<\/tr>\n

\n

Q1.E2B\uff08R2\uff09\u4e2dB.4.k.2.1\uff08 medicinal product \uff09\uff0cE2B\uff08R3\uff09\u4e2dG.k.2.2\uff08 Medicinal Product Name as Reported by the Primary Source \uff09\uff0c\u4ee5\u4e0a\u6570\u636e\u5143\u7d20\u4e2d\u5982\u6d89\u53ca\u591a\u4e2a\u836f\u7269\uff0c\u5e94\u5982\u4f55\u6392\u5217\u987a\u5e8f\uff1f<\/p>\n<\/td>\n

\n

A1.\u4e3a\u65b9\u4fbf\u540e\u7eed\u7edf\u4e00\u7ba1\u7406\uff0c\u5e94\u5c06\u8bd5\u9a8c\u836f\u7269\u586b\u5199\u5728\u7b2c\u4e00\u4f4d\uff0c\u5176\u4f59\u836f\u7269\u6309\u7167\u53ef\u7591\u7a0b\u5ea6\u7531\u9ad8\u5230\u4f4e\u7684\u987a\u5e8f\u4f9d\u6b21\u6392\u5217\u3002<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

       <\/strong><\/p>\n

2.8 \u7834\u76f2\u4e0e\u9633\u6027\u5bf9\u7167\u836f\u3001\u5b89\u6170\u5242\u62a5\u544a\u95ee\u9898<\/strong><\/p>\n


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

\u53cd\u9988\u95ee\u9898<\/strong><\/p>\n<\/td>\n

\n

\u5185\u5bb9\u89e3\u8bfb<\/strong><\/p>\n<\/td>\n<\/tr>\n

\n

Q1.SUSAR\u5feb\u901f\u62a5\u544a\u65f6\uff0c\u53ef\u4ee5\u4ecd\u7136\u4fdd\u6301\u76f2\u6001\u800c\u4e0d\u660e\u786e\u4f7f\u7528\u7684\u662f\u8bd5\u9a8c\u836f\u7269\u3001\u9633\u6027\u5bf9\u7167\u836f\u8fd8\u662f\u5b89\u6170\u5242\u5417\uff1f\u662f\u5426\u9700\u8981\u7834\u76f2\uff1f<\/p>\n<\/td>\n

\n

A1.\u53d1\u751f\u4e25\u91cd\u4e0d\u826f\u4e8b\u4ef6\u65f6\uff0c\u5e94\u8fdb\u884c\u56e0\u679c\u5173\u7cfb\u5206\u6790\uff0c\u4e0e\u8bd5\u9a8c\u836f\u7269\u76f8\u5173\u6216\u53ef\u7591\u7684\u3001\u975e\u9884\u671f\u7684\u4e25\u91cd\u4e0d\u826f\u53cd\u5e94\u624d\u9700\u8981\u6309\u7167\u300a\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4\u5b89\u5168\u6027\u6570\u636e\u5feb\u901f\u62a5\u544a\u7684\u6807\u51c6\u548c\u7a0b\u5e8f\u300b\u5411\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3\u8fdb\u884c\u5feb\u901f\u62a5\u544a\u3002
\u76f2\u6cd5\u8bd5\u9a8c\u4e2d\u53d1\u751f\u975e\u9884\u671f\u4e25\u91cd\u4e0d\u826f\u4e8b\u4ef6\u65f6\uff0c\u4e3a\u4fbf\u4e8e\u5224\u65ad\u4e25\u91cd\u4e0d\u826f\u4e8b\u4ef6\u4e0e\u8bd5\u9a8c\u836f\u7269\u7684\u76f8\u5173\u6027\uff0c\u7533\u8bf7\u4eba\u53ef\u53ea\u5bf9\u4e2a\u4f8b\u8fdb\u884c\u201c\u7834\u76f2\u201d\u3002\u5728\u6b64\u8fc7\u7a0b\u4e2d\uff0c\u4ec5\u7531\u4e2a\u522b\u4e13\u95e8\u4eba\u5458\u8fdb\u884c\u76f8\u5173\u4e2a\u4f8b\u7834\u76f2\uff0c\u800c\u5bf9\u7597\u6548\u7ed3\u679c\u8fdb\u884c\u5206\u6790\u548c\u9610\u8ff0\u7684\u4eba\u5458\u4ecd\u5e94\u4fdd\u6301\u201c\u76f2\u6001\u201d\u3002\u901a\u8fc7\u5408\u7406\u7684\u4e34\u5e8a\u8bd5\u9a8c\u8bbe\u8ba1\u4e0e\u7ba1\u7406\uff0c\u4e2a\u522b\u75c5\u4f8b\u7684\u7834\u76f2\u901a\u5e38\u4e0d\u4f1a\u5f71\u54cd\u4e34\u5e8a\u8bd5\u9a8c\u7684\u5b9e\u65bd\u6216\u6700\u7ec8\u7ed3\u679c\u7684\u5206\u6790\u3002\u5982\u4fdd\u6301\u201c\u76f2\u6001\u201d\uff0c\u800c\u4e0d\u8fdb\u884c\u4e2a\u522b\u75c5\u4f8b\u201c\u7834\u76f2\u201d\uff0c\u4e0d\u80fd\u53ca\u65f6\u660e\u786e\u8bd5\u9a8c\u836f\u3001\u5bf9\u7167\u836f\u8fd8\u662f\u5b89\u6170\u5242\uff0c\u5c06\u4e0d\u5229\u4e8e\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u4e2d\u7684\u98ce\u9669\u63a7\u5236\u4e0e\u53d7\u8bd5\u8005\u4fdd\u62a4\u3002\u56e0\u6b64\uff0c\u9700\u8981\u8fdb\u884c\u4e2a\u4f8b\u7834\u76f2\uff0c\u7b26\u5408\u300a\u6807\u51c6\u4e0e\u7a0b\u5e8f\u300b\u89c4\u5b9a\u7684\u65b9\u53ef\u6309\u7167SUSAR\u8fdb\u884c\u5feb\u901f\u62a5\u544a\u3002<\/p>\n<\/td>\n<\/tr>\n

\n

Q2.\u9633\u6027\u5bf9\u7167\u836f\u7ec4\u53d1\u751f\u7684\u4e25\u91cd\u4e0d\u826f\u53cd\u5e94\u5982\u4f55\u62a5\u544a\uff1f\u662f\u5426\u9700\u8981\u5411\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3\u8fdb\u884c\u5feb\u901f\u62a5\u544a\uff1f<\/p>\n<\/td>\n

\n

A2.\u9633\u6027\u5bf9\u7167\u836f\u7ec4\u53d1\u751f\u7684\u4e25\u91cd\u4e0d\u826f\u53cd\u5e94\u4e0d\u9700\u8981\u5411\u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3\u8fdb\u884c\u5feb\u901f\u62a5\u544a\u3002\u9633\u6027\u5bf9\u7167\u836f\u7ec4\u53d1\u751f\u7684\u4e25\u91cd\u4e0d\u826f\u53cd\u5e94\uff0c\u5e94\u5411\u9633\u6027\u5bf9\u7167\u836f\u7684\u751f\u4ea7\u5546\u548c\/\u6216\u7531\u4e34\u5e8a\u673a\u6784\u76f4\u63a5\u5411\u56fd\u5bb6\u836f\u54c1\u8bc4\u4ef7\u4e2d\u5fc3\u8fdb\u884c\u62a5\u544a\u3002<\/p>\n<\/td>\n<\/tr>\n

\n

Q3.\u5b89\u6170\u5242\u7ec4\u53d1\u751f\u7684\u4e25\u91cd\u4e0d\u826f\u4e8b\u4ef6\u662f\u5426\u9700\u8981\u5feb\u901f\u62a5\u544a\uff1f<\/p>\n<\/td>\n

\n

A3.\u5b89\u6170\u5242\u7ec4\u53d1\u751f\u7684\u4e25\u91cd\u4e0d\u826f\u4e8b\u4ef6\u4e0d\u9700\u8981\u5feb\u901f\u62a5\u544a\u3002<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

       <\/strong><\/p>\n

2.9 \u53d7\u7406\u53f7\u586b\u5199<\/strong><\/p>\n


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

\u53cd\u9988\u95ee\u9898<\/strong><\/p>\n<\/td>\n

\n

\u5185\u5bb9\u89e3\u8bfb<\/strong><\/p>\n<\/td>\n<\/tr>\n

\n

Q1.\u300a\u6807\u51c6\u4e0e\u7a0b\u5e8f\u300b\u7b2c\u5341\u516d\u6761\u4e2d\u201c\u4e2a\u4f8b\u4e0d\u826f\u53cd\u5e94\u5feb\u901f\u62a5\u544a\u4e2d\uff0c\u7533\u8bf7\u4e34\u5e8a\u8bd5\u9a8c\u7684\u53d7\u7406\u53f7\u586b\u5199\u5728\u6570\u636e\u5143\u7d20G.k.3.1\u6279\u51c6\u53f7\/\u8bb8\u53ef\u53f7\uff08G.k.3.1 Authorisation \/ Application Number\uff09\u9879\u4e0b\u201d\u3002\u4e3a\u4ec0\u4e48\u8981\u586b\u5199\u53d7\u7406\u53f7\uff1f\u5177\u4f53\u5982\u4f55\u586b\u5199\uff1f<\/p>\n<\/td>\n

\n

A1.\u6b64\u5904\u7684\u53d7\u7406\u53f7\u7279\u6307\u5728\u4e2d\u56fd\u83b7\u51c6\u8fdb\u884c\u4e34\u5e8a\u8bd5\u9a8c\u7684\u76f8\u5173\u7533\u8bf7\u7684\u53d7\u7406\u53f7\u3002\u53d7\u7406\u53f7\u662f\u4e2d\u56fd\u836f\u76d1\u673a\u6784\u5728\u836f\u7269\u6ce8\u518c\u5ba1\u8bc4\u5ba1\u6279\u8fc7\u7a0b\u4e2d\u5bf9\u4e8e\u836f\u7269\u8eab\u4efd\u53ca\u5173\u8054\u8d44\u6599\u4fe1\u606f\u8bc6\u522b\u7684\u6700\u91cd\u8981\u4ee3\u7801\u3002\u56e0\u6b64\uff0c\u586b\u5199\u53d7\u7406\u53f7\u6709\u5229\u4e8e\u540e\u7eed\u5bf9\u4e8eICSRs\u7684\u8bc6\u522b\u548c\u5ba1\u6838\u3002
\u2160\u3001\u2161\u3001\u2162\u671f\u4e34\u5e8a\u8bd5\u9a8c\u586b\u5199\u7533\u8bf7\u4e34\u5e8a\u8bd5\u9a8c\u7684\u53d7\u7406\u53f7\u3002\u6279\u4ef6\u4e2d\u7279\u522b\u8981\u6c42\u7684\u2163\u671f\u4e34\u5e8a\u8bd5\u9a8c\u3001\u627f\u8bfa\u6027\u4e34\u5e8a\u8bd5\u9a8c\u53ef\u586b\u5199\u7533\u8bf7\u751f\u4ea7\u4e0a\u5e02\u7684\u53d7\u7406\u53f7\u3002\u8865\u5145\u7533\u8bf7\u7684\u4e34\u5e8a\u8bd5\u9a8c\u53ef\u586b\u5199\u8865\u5145\u7533\u8bf7\u53d7\u7406\u53f7\u3002<\/p>\n<\/td>\n<\/tr>\n

\n

Q2.\u540c\u4e00\u836f\u7269\uff0c\u4e0d\u540c\u7684\u53d7\u7406\u53f7\uff0c\u662f\u5426\u53ef\u4ee5\u53ea\u63d0\u4ea4\u4e00\u6b21SUSAR\u62a5\u544a\uff1f<\/p>\n<\/td>\n

\n

A2.\u540c\u4e00\u836f\u7269\uff0c\u4e0d\u540c\u7684\u53d7\u7406\u53f7\uff0c\u53ea\u63d0\u4ea4\u4e00\u6b21SUSAR\u62a5\u544a\uff0c\u4f46\u5e94\u5728\u5176\u4e2d\u5217\u51fa\u6240\u6709\u7684\u53d7\u7406\u53f7\u3002\u5982\u679c\u6d89\u53ca\u591a\u4e2a\u53d7\u7406\u53f7\uff0c\u5e94\u5c06\u672c\u75c5\u4f8b\u6240\u5c5e\u4e34\u5e8a\u8bd5\u9a8c\u7684\u53d7\u7406\u53f7\u6392\u5217\u5728\u7b2c\u4e00\u4f4d\u3002<\/p>\n<\/td>\n<\/tr>\n

\n

Q3.\u6309\u7167E2B\uff08R3\uff09\u683c\u5f0f\u7533\u62a5\u7684ICSR\uff0c\u8981\u6c42\u53d7\u7406\u53f7\u586b\u5199\u5728\u6570\u636e\u5143\u7d20G.k.3.1\u6279\u51c6\u53f7\/\u8bb8\u53ef\u53f7\uff08G.k.3.1 Authorisation \/ Application Number\uff09\u9879\u4e0b\u3002\u5982\u679c\u6d89\u53ca\u7684\u53d7\u7406\u53f7\u592a\u591a\uff0c\u8be5\u9879\u4e0b\u5b57\u7b26\u6570\u65e0\u6cd5\u6ee1\u8db3\uff0c\u5982\u4f55\u5904\u7406\uff1f<\/p>\n<\/td>\n

\n

A3 .\u5982\u679c\u6d89\u53ca\u7684\u53d7\u7406\u53f7\u592a\u591a\uff0cG.k.3.1\u9879\u4e0b\u5b57\u7b26\u6570\u65e0\u6cd5\u6ee1\u8db3\uff0c\u53ef\u586b\u5199\u5728\u6570\u636e\u5143\u7d20H.1 \uff08 Case Narrative Including Clinical Course, Therapeutic Measures, Outcome and Additional Relevant Information \uff09\u9879\u4e0b\u3002<\/p>\n<\/td>\n<\/tr>\n

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Q4.\u6309\u7167E2B\uff08R2\uff09\u683c\u5f0f\u7533\u62a5\u7684ICSR\uff0c\u662f\u5426\u9700\u8981\u586b\u5199\u53d7\u7406\u53f7\uff1f\u5982\u4f55\u586b\u5199\uff1f<\/p>\n<\/td>\n

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A4 .\u6309\u7167E2B\uff08R2\uff09\u683c\u5f0f\u7533\u62a5\u7684ICSR\uff0c\u4e0d\u5f3a\u5236\u8981\u6c42\u586b\u5199\u53d7\u7406\u53f7\uff0c\u4f46\u5efa\u8bae\u586b\u5199\uff0c\u53ef\u586b\u5199\u5728\u6570\u636e\u5143\u7d20B.5.1\uff08 narrative include clinical \uff09\u9879\u4e0b\u3002<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

       <\/strong><\/p>\n

2.10 MedDRA\u8bcd\u5178<\/strong><\/p>\n


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\u5185\u5bb9\u89e3\u8bfb<\/strong><\/p>\n<\/td>\n<\/tr>\n

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Q1.MedDRA\u8bcd\u5178\u901a\u8fc7\u4ec0\u4e48\u9014\u5f84\u6216\u65b9\u5f0f\u8d2d\u4e70\uff1f\u5982\u4f55\u652f\u4ed8\u8d39\u7528\uff1f<\/p>\n<\/td>\n

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A1. MedDRA\u8bcd\u5178\u9700\u8981\u901a\u8fc7MedDRA\u5b98\u65b9\u7f51\u7ad9\u8fdb\u884c\u8ba2\u9605\uff0c\u8be6\u7ec6\u7684\u8ba2\u9605\u65b9\u5f0f\u3001\u6536\u8d39\u65b9\u5f0f\u7b49\u4fe1\u606f\u53ef\u767b\u5f55MedDRA\u5b98\u65b9\u7f51\u7ad9(https:\/\/www.meddra.org\/)\u8fdb\u884c\u4e86\u89e3\u3002<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

       <\/strong><\/p>\n

2.11 \u5176\u5b83\u6f5c\u5728\u4e25\u91cd\u5b89\u5168\u6027\u98ce\u9669\u4fe1\u606f<\/strong><\/p>\n


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\u5185\u5bb9\u89e3\u8bfb<\/strong><\/p>\n<\/td>\n<\/tr>\n

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Q1. \u201c\u5176\u5b83\u6f5c\u5728\u4e25\u91cd\u5b89\u5168\u6027\u98ce\u9669\u4fe1\u606f\u7684\u5feb\u901f\u62a5\u544a\u201d\u662f\u6307\u54ea\u4e9b\uff1f\u90ae\u4ef6\u62a5\u544a\u7684\u5185\u5bb9\u548c\u683c\u5f0f\u6709\u54ea\u4e9b\u8981\u6c42\uff1f<\/p>\n<\/td>\n

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A1. \u4e00\u822c\u800c\u8a00\uff0c\u5bf9\u4e8e\u660e\u663e\u5f71\u54cd\u836f\u54c1\u98ce\u9669\u83b7\u76ca\u8bc4\u4f30\u7684\u4fe1\u606f\u6216\u53ef\u80fd\u8003\u8651\u836f\u54c1\u7528\u6cd5\u6539\u53d8\uff0c\u6216\u5f71\u54cd\u603b\u4f53\u836f\u54c1\u7814\u53d1\u8fdb\u7a0b\u7684\u4fe1\u606f\uff0c\u4f46\u4e0d\u662f\u4e2a\u4f8b\u7684\u75c5\u4f8b\u62a5\u544a\uff0c\u5747\u53ef\u5f52\u5c5e\u4e8e\u201c\u5176\u5b83\u6f5c\u5728\u4e25\u91cd\u5b89\u5168\u6027\u98ce\u9669\u201d\uff0c\u4f8b\u5982\uff1a(1)\u5bf9\u4e8e\u5df2\u77e5\u7684\u3001\u4e25\u91cd\u7684\u4e0d\u826f\u53cd\u5e94\uff0c\u5176\u53d1\u751f\u7387\u589e\u52a0\uff0c\u5224\u65ad\u5177\u6709\u4e34\u5e8a\u91cd\u8981\u6027\uff1b(2)\u5bf9\u66b4\u9732\u4eba\u7fa4\u6709\u660e\u663e\u7684\u5371\u5bb3\uff0c\u5982\u5728\u6cbb\u7597\u5371\u53ca\u751f\u547d\u75be\u75c5\u65f6\u836f\u54c1\u65e0\u6548\uff1b(3)\u5728\u65b0\u8fd1\u5b8c\u6210\u7684\u52a8\u7269\u8bd5\u9a8c\u4e2d\u7684\u91cd\u5927\u5b89\u5168\u6027\u53d1\u73b0(\u5982\u81f4\u764c\u6027) \u3002
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\uff081\uff09 \u5bf9\u4e8e\u201c\u5176\u5b83\u6f5c\u5728\u4e25\u91cd\u5b89\u5168\u6027\u98ce\u9669\u201d\u8fdb\u884c\u8be6\u7ec6\u3001\u89c4\u8303\u7684\u8bf4\u660e\u5e76\u63d0\u4f9b\u76f8\u5173\u8d44\u6599\uff1b
\uff082\uff09 \u63d0\u4f9b\u8bd5\u9a8c\u836f\u7269\u7684\u76f8\u5173\u6ce8\u518c\u7533\u8bf7\u4fe1\u606f\uff0c\u5982\u6ce8\u518c\u7533\u8bf7\u7684\u836f\u7269\u540d\u79f0\u3001\u53d7\u7406\u53f7\u7b49\uff1b
\uff083\uff09 \u63d0\u4f9b\u8054\u7cfb\u4eba\u53ca\u8054\u7cfb\u65b9\u5f0f\uff08\u5982\u7535\u8bdd\u53f7\u7801\u3001\u624b\u673a\u53f7\u7801\u7b49\uff09\uff0c\u4ee5\u65b9\u4fbf\u3001\u53ca\u65f6\u53d6\u5f97\u8054\u7cfb\uff0c\u4e86\u89e3\u76f8\u5173\u60c5\u51b5\u3002<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

       <\/strong><\/p>\n

2.12 \u95ee\u9898\u54a8\u8be2\u9014\u5f84\u548c\u65b9\u6cd5<\/strong><\/p>\n


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\u5185\u5bb9\u89e3\u8bfb<\/strong><\/p>\n<\/td>\n<\/tr>\n

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Q1.\u65e5\u5e38\u9047\u5230\u5173\u4e8e\u836f\u7269\u4e34\u5e8a\u8bd5\u9a8c\u671f\u95f4\u975e\u9884\u671f\u4e25\u91cd\u4e0d\u826f\u53cd\u5e94\uff08SUSAR\uff09\u5feb\u901f\u62a5\u544a\u76f8\u5173\u7684\u7591\u95ee\uff0c\u6709\u54ea\u4e9b\u54a8\u8be2\u9014\u5f84\u548c\u65b9\u6cd5\uff1f<\/p>\n<\/td>\n

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A1.SUSAR\u5feb\u901f\u62a5\u544a\u76f8\u5173\u95ee\u9898\u7684\u54a8\u8be2\uff0c\u901a\u5e38\u53ef\u901a\u8fc7\u4ee5\u4e0b\u51e0\u79cd\u9014\u5f84\u548c\u65b9\u6cd5\uff1a
\u2460 \u7535\u5b50\u90ae\u7bb1\uff1aywjjxtwt@cde.org.cn
\u2461 \u836f\u54c1\u5ba1\u8bc4\u4e2d\u5fc3\u7f51\u7ad9\uff08www.cde.org.cn\uff09\u2192\u7533\u8bf7\u4eba\u4e4b\u7a97 \u2192 \u4ea4\u6d41\u4e0e\u53cd\u9988\u3002<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

       <\/strong><\/p>\n

\u53c2\u8003\u6587\u732e<\/strong><\/p>\n

       <\/p>\n

[1] picscheme.org\/en\/news?itemid=51<\/p>\n

       <\/p>\n

[2] www.360doc.com\/content\/18\/0526\/16\/33765370_757202884.shtml<\/p>\n

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[3] http:\/\/samr.cfda.gov.cn\/WS01\/CL0087\/223345.html<\/p>\n

       <\/strong><\/p>\n

\u4f5c\u8005\u7b80\u4ecb\uff1a<\/strong><\/span>\u6ef4\u6c34\u53f8\u5357\uff0c\u7537\uff0c\u751f\u7269\u533b\u836f\u9ad8\u7ea7\u5de5\u7a0b\u5e08\uff0c\u7acb\u8db3\u4e8e\u751f\u7269\u533b\u836f\u884c\u4e1a\u8d28\u91cf\u7ba1\u7406\u5de5\u4f5c\uff0c\u4e13\u6ce8\u4e8e\u751f\u7269\u533b\u836f\u4ea7\u4e1a\uff0c\u5e0c\u671b\u5728\u77e5\u8bc6\u7684\u6d77\u6d0b\u91cc\uff0c\u7528\u7b80\u5355\u7684\u8bed\u8a00\u8bb2\u8ff0\u4e0d\u7b80\u5355\u7684\u4e13\u4e1a\u77e5\u8bc6\uff0c\u63d0\u4f9b\u4e00\u679a\u77e5\u8bc6\u7684\u6307\u5357\u9488\uff0c\u6307\u5f15\u8bfb\u8005\u5230\u8fbe\u77e5\u8bc6\u7684\u5f7c\u5cb8\u3002    <\/span><\/p>\n<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n


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\u6587\u7ae0\u4fe1\u606f<\/span>\u6e90<\/span>\u4e8e\u516c\u4f17\u53f7<\/span>CPhI\u5236\u836f\u5728\u7ebf<\/span>\uff0c<\/span>\u767b\u8f7d\u8be5\u6587\u7ae0\u76ee\u7684\u4e3a\u66f4\u5e7f\u6cdb\u7684\u4f20\u9012\u884c\u4e1a\u4fe1\u606f\uff0c\u4e0d\u4ee3\u8868\u8d5e\u540c\u5176\u89c2\u70b9\u6216\u5bf9\u5176<\/span>\u771f\u5b9e\u6027\u8d1f\u8d23\u3002\u6587\u7ae0\u7248\u6743\u5f52\u539f\u4f5c\u8005\u53ca\u539f\u51fa\u5904\u6240\u6709\uff0c\u6587\u7ae0\u5185\u5bb9\u4ec5\u4f9b\u53c2\u8003\u3002\u672c\u7f51\u62e5\u6709\u5bf9\u6b64\u58f0\u660e\u7684\u6700\u7ec8\u89e3\u91ca\u6743\uff0c\u82e5\u65e0\u610f\u4fb5\u72af\u7248\u6743\uff0c\u8bf7\u8054\u7cfb\u5c0f\u7f16\u5220\u9664\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\u5b66\u5982\u9006\u6c34\u884c\u821f\uff0c\u4e0d\u8fdb\u5219\u9000\uff1b<\/span><\/p>\n

\u5fc3\u4f3c\u5e73\u539f\u8d70\u9a6c\uff0c\u6613\u653e\u96be\u6536\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\u6bcf\u65e5\u66f4\u65b0 \u6b22\u8fce\u8ba2\u9605+<\/span><\/p>\n

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\"\u52a0\u901f\u63a5\u8f68ICH\uff0c\u300a\u4e34\u5e8a\u5b89\u5168\u6027\u6570\u636e\u5feb\u901f\u62a5\u544a\u5e38\u89c1\u95ee\u7b54\uff081.0\u7248\uff09\u300b\u91cd\u78c5\u53d1\u5e03\"<\/p>\n<\/section>\n


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\u533b\u836f\u5927\u6570\u636e|\u884c\u4e1a\u52a8\u6001|\u653f\u7b56\u89e3\u8bfb<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section><\/div>\n","protected":false},"excerpt":{"rendered":"

\u70b9\u51fb\u4e0a\u65b9\u7684  \u25b2 \u6dfb\u52a0\u5173\u6ce8       &nbsp […]<\/p>\n","protected":false},"author":1,"featured_media":91430,"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\/91429"}],"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=91429"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/91429\/revisions"}],"predecessor-version":[{"id":91436,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/91429\/revisions\/91436"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/91430"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=91429"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=91429"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=91429"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}