{"id":640,"date":"2023-12-12T15:57:56","date_gmt":"2023-12-12T07:57:56","guid":{"rendered":"https:\/\/consulting-hmk.com\/?post_type=products&p=640"},"modified":"2024-02-20T14:57:20","modified_gmt":"2024-02-20T06:57:20","slug":"support-in-clinical-trial-application","status":"publish","type":"products","link":"https:\/\/www.consulting-hmk.com\/ja\/products\/support-in-clinical-trial-application\/","title":{"rendered":"NMPA\u81e8\u5e8a\u8a66\u9a13\u7533\u8acb\u306e\u30b5\u30dd\u30fc\u30c8"},"content":{"rendered":"

\u00a0 \u00a0 \u00a0 \u533b\u7642\u6a5f\u5668\u81e8\u5e8a\u8a66\u9a13\u306f\u6a5f\u68b0\u5b89\u5168\u6027\u3092\u691c\u8a3c\u3059\u308b\u91cd\u8981\u306a\u4e00\u74b0\u3067\u3042\u308a\u3001\u305d\u306e\u7d50\u679c\u306e\u4fe1\u983c\u6027\u304c\u76f4\u63a5\u6a5f\u68b0\u30ed\u30fc\u30f3\u30c1\u5f8c\u306e\u5b89\u5168\u306b\u95a2\u308f\u308a\u307e\u3059\u3002\u81e8\u5e8a\u8a66\u9a13\u306e\u54c1\u8cea\u304c\u81e8\u5e8a\u8a66\u9a13\u306e\u30ab\u30ae\u3067\u3059\u3002\u533b\u7642\u6a5f\u5668\u81e8\u5e8a\u8a66\u9a13\u306e\u5404\u6bb5\u968e\u306b\u304a\u3051\u308b\u54c1\u8cea\u30ea\u30b9\u30c8\u306b\u5bfe\u3059\u308b\u4f01\u753b\u3001\u8b58\u5225\u3068\u8a55\u4fa1\u3092\u901a\u3058\u3001\u30ea\u30b9\u30af\u4f4e\u6e1b\u306e\u5bfe\u5fdc\u63aa\u7f6e\u306e\u691c\u8a0e\u3092\u884c\u3044\u3001\u5b8c\u5099\u3055\u308c\u308b\u533b\u7642\u6a5f\u5668\u30ea\u30b9\u30af\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u3092\u69cb\u7bc9\u3057\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u5168\u904e\u7a0b\u54c1\u8cea\u7ba1\u7406\u3092\u5b9f\u73fe\u3057\u307e\u3059\u3002<\/span><\/p>\n

\u5b9a\u7fa9<\/span><\/strong><\/h2>\n

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\u3069\u3093\u306a <\/b><\/strong>\u533b\u7642\u6a5f\u5668 <\/b><\/strong>\u304c\u81e8\u5e8a\u8a66\u9a13\u3092\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u304b<\/b><\/strong><\/span><\/h2>\n

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    \n
  • \u5de5\u4f5c\u5668\u68b0\u539f\u7406\u304c\u660e\u78ba\u3067\u3001\u8a2d\u8a08\u304c\u5b9a\u756a\u5316\u3055\u308c\u3001\u751f\u7523\u5de5\u7a0b\u3082\u6210\u719f\u3067\u3001\u30ed\u30fc\u30f3\u30c1\u3057\u3066\u3044\u308b\u540c\u7a2e\u985e\u306e\u533b\u7642\u6a5f\u5668\u304c\u6570\u5e74\u306e\u81e8\u5e8a\u5fdc\u7528\u5b9f\u7e3e\u304c\u3042\u308a\u3001\u4e14\u3064\u53b3\u91cd\u306a\u4e0d\u826f\u4e8b\u4ef6\u306e\u8a18\u9332\u3082\u306a\u304f\u3001\u901a\u5e38\u306e\u7528\u9014\u3092\u5909\u66f4\u3057\u306a\u3044\u5834\u5408\u3067\u3059\u3002<\/span><\/li>\n
  • \u975e\u81e8\u5e8a\u8a55\u4fa1\u3092\u901a\u3058\u3001\u533b\u7642\u6a5f\u5668\u306e\u5b89\u5168\u6027\u3001\u6709\u52b9\u6027\u3092\u8a3c\u660e\u3067\u304d\u308b\u5834\u5408\u3067\u3059\u3002<\/span><\/li>\n
  • \u540c\u7a2e\u985e\u306e\u533b\u7642\u6a5f\u5668\u306e\u81e8\u5e8a\u8a66\u9a13\u6216\u3044\u306f\u81e8\u5e8a\u5fdc\u7528\u3067\u53d6\u5f97\u3057\u305f\u30c7\u30fc\u30bf\u3092\u5206\u6790\u3057\u3001\u8a72\u5f53\u533b\u7642\u6a5f\u5668\u306e\u5b89\u5168\u6027\u3001\u6709\u52b9\u6027\u3092\u8a3c\u660e\u3067\u304d\u308b\u5834\u5408\u3067\u3059\u3002<\/span><\/li>\n<\/ul>\n

    \u00a0 \u00a0 \u00a0 \u307e\u305f\u3001\u56fd\u5bb6\u85ac\u54c1\u76e3\u7763\u7ba1\u7406\u5c40\u304c2019\u5e7412\u6708\u767a\u884c\u3057\u305f\u300c\u81e8\u5e8a\u8a66\u9a13\u3092\u514d\u9664\u3059\u308b\u533b\u7642\u6a5f\u5668\u76ee\u9332\u307e\u3068\u3081\u300d\u306e\u4e2d\u3067\u3001\u533b\u7642\u6a5f\u5668\u76ee\u9332\u306f1003\u9805\u76ee\u3001\u4f53\u5916\u8a3a\u65ad\u88fd\u54c1416\u9805\u76ee\u304c\u5168\u90e8\u81e8\u5e8a\u8a66\u9a13\u3092\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u305b\u3093\u3002<\/span><\/p>\n

    \u00a0 \u00a0 \u00a0 \u3054\u9023\u7d61\u3057\u3066\u304f\u3060\u3055\u308b\u65b9\u304c\u7121\u6599\u306b\u300c\u81e8\u5e8a\u8a66\u9a13\u3092\u514d\u9664\u3059\u308b\u533b\u7642\u6a5f\u5668\u76ee\u9332\u307e\u3068\u3081\u300d\u3001\u300c\u81e8\u5e8a\u8a66\u9a13\u3092\u514d\u9664\u3059\u308b\u4f53\u5916\u8a3a\u65ad\u8a66\u85ac\u76ee\u9332\u307e\u3068\u3081\u300d\u3092\u3082\u3089\u3048\u307e\u3059\u3002<\/span><\/p>\n

    \u533b\u7642\u6a5f\u5668\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u30d5\u30ed\u30fc\u306f\u3069\u3046\u306a\u3063\u3066\u3044\u307e\u3059\u304b<\/b><\/strong><\/span><\/h2>\n
      \n
    • \u524d\u63d0\u6761\u4ef6<\/span><\/strong><\/li>\n<\/ul>\n

      \u88fd\u54c1\u691c\u67fb\u5831\u544a\uff08\u81ea\u5df1\u691c\u67fb\u5831\u544a\/\u7b2c\u4e09\u8005\u691c\u67fb\u30c6\u30b9\u30c8\u5831\u544a\uff09\u3001\u52d5\u7269\u8a66\u9a13\u5831\u544a\u3092\u5b8c\u4e86\u3057\u3066\u3044\u307e\u3059\u3002<\/span><\/p>\n

        \n
      • \u8a66\u9a13\u524d\uff08\u6e96\u5099\u6bb5\u968e\uff09<\/span><\/strong><\/li>\n<\/ul>\n

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          \n
        • \u8a66\u9a13\u4e2d\uff08\u5b9f\u65bd\u6bb5\u968e\uff09<\/span><\/strong><\/li>\n<\/ul>\n

          1. \u4e2d\u5fc3\u30b9\u30bf\u30fc\u30c8\u30d5\u30ed\u30fc<\/span><\/strong><\/p>\n

            <\/ol>\n
              <\/ul>\n

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              2. \u30b0\u30eb\u30fc\u30d7\u5165\u308a\u6bb5\u968e<\/span><\/strong><\/p>\n

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              3. \u8a66\u9a13\u7d42\u4e86<\/span><\/strong><\/p>\n

                \n
              • \u30c7\u30fc\u30bf\u6574\u7406<\/span><\/strong><\/li>\n<\/ul>\n

                DM\u306b\u3088\u308a\u3001\u30c7\u30fc\u30bf\u306e\u8cea\u7591\u3092\u3057\u3001CRC\/\u7814\u7a76\u8005\u304c\u56de\u7b54\u3092\u3057\u307e\u3059\u3002\u6574\u7406\u5f8c\u306e\u30c7\u30fc\u30bf\u304c\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u3068\u3057\u3066\u7d71\u8a08\u5206\u6790\u3092\u884c\u3044\u307e\u3059\u3002<\/span><\/p>\n

                  \n
                • \u7d71\u8a08\u5206\u6790<\/span><\/strong><\/li>\n<\/ul>\n

                  \u7d71\u8a08\u62c5\u5f53\u304c\u8a2d\u8a08\u6848\u306e\u7d71\u8a08\u65b9\u6cd5\u306b\u5f93\u3044\u3001\u30c7\u30fc\u30bf\u306e\u5206\u6790\u3092\u3057\u3001\u7d71\u8a08\u5206\u6790\u5831\u544a\u66f8\u3092\u51fa\u3057\u307e\u3059\u3002<\/span><\/p>\n

                    \n
                  • \u5831\u544a\u66f8\u4f5c\u6210<\/span><\/strong><\/li>\n<\/ul>\n

                    \u533b\u5b66\u304c\u8a66\u9a13\u5b9f\u969b\u306e\u5b8c\u6210\u72b6\u6cc1\u3068\u7d71\u8a08\u5206\u6790\u306b\u3088\u308a\u3001\u5831\u544a\u66f8\u3092\u4f5c\u6210\u3057\u307e\u3059\u3002<\/span><\/p>\n

                    \u4e2d\u5fc3\u3092\u5360\u3081\u308b<\/span><\/strong><\/p>\n

                    CRA\u304c\u6a5f\u95a2\u3001\u502b\u7406\u63d0\u51fa\u4e2d\u5fc3\u306b\u901a\u77e5\u30ec\u30bf\u30fc\u3001\u7533\u8acb\u6848\u3001\u637a\u5370\u4ed8\u304d\u5831\u544a\u66f8\u3092\u63d0\u51fa\u3057\u3001\u8a66\u9a13\u66f8\u985e\u3092\u30d5\u30a1\u30a4\u30eb\u4fdd\u7ba1\u3057\u307e\u3059\uff08ISF\/\u7814\u7a76\u8005\u30d5\u30a1\u30a4\u30eb\u3001\u8a66\u9a13\u8005\u30d5\u30a1\u30a4\u30eb\uff09\u3002<\/span><\/p>","protected":false},"excerpt":{"rendered":"

                    \u533b\u7642\u6a5f\u5668\u306e\u81e8\u5e8a\u8a66\u9a13\u3068\u306f\u3001\u767b\u9332\u7533\u8acb\u3059\u308b\u533b\u7642\u6a5f\u5668\uff08\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u85ac\u54c1\u3092\u542b\u3080\uff09\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u3001\u533b\u7642\u6a5f\u5668\u306e\u81e8\u5e8a\u8a66\u9a13\u5b9f\u65bd\u6a5f\u95a2\u306b\u304a\u3044\u3066\u3001\u901a\u5e38\u306e\u4f7f\u7528\u6761\u4ef6\u4e0b\u3067\u78ba\u8a8d\u3059\u308b\u30d7\u30ed\u30bb\u30b9\u3092\u6307\u3059\u3002<\/span><\/p>","protected":false},"featured_media":641,"template":"","adweb_product_categories":[159],"adweb_product_tags":[89,514,515,516,517,518,519,520,521,522,523,524],"gallery":[],"order":"0","acf":[],"_links":{"self":[{"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/adweb_products\/640"}],"collection":[{"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/adweb_products"}],"about":[{"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/types\/products"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/media\/641"}],"wp:attachment":[{"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/media?parent=640"}],"wp:term":[{"taxonomy":"adweb_product_cat","embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/adweb_product_categories?post=640"},{"taxonomy":"adweb_product_tag","embeddable":true,"href":"https:\/\/www.consulting-hmk.com\/ja\/wp-json\/wp\/v2\/adweb_product_tags?post=640"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}