{"id":2317,"date":"2020-03-25T10:50:29","date_gmt":"2020-03-25T01:50:29","guid":{"rendered":"https:\/\/plaza.umin.ac.jp\/~OIO\/?p=2317"},"modified":"2020-05-25T11:39:41","modified_gmt":"2020-05-25T02:39:41","slug":"fda-covid-19%e6%b5%81%e8%a1%8c%e4%b8%8b%e3%81%a7%e3%81%ae%e6%b2%bb%e9%a8%93%e3%81%ae%e5%ae%9f%e6%96%bd%e3%81%ab%e4%bf%82%e3%82%8b%e3%82%ac%e3%82%a4%e3%83%80%e3%83%b3%e3%82%b9%e3%82%92%e5%85%ac","status":"publish","type":"post","link":"https:\/\/plaza.umin.ac.jp\/~OIO\/?p=2317","title":{"rendered":"FDA COVID-19\u6d41\u884c\u4e0b\u3067\u306e\u6cbb\u9a13\u306e\u5b9f\u65bd\u306b\u4fc2\u308b\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u516c\u958b"},"content":{"rendered":"<h1>FDA\u306fCOVID-19\u6d41\u884c\u4e0b\u3067\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u516c\u958b<\/h1>\n<h2>\u5bfe\u8c61<\/h2>\n<p>\u6cbb\u9a13\u4f9d\u983c\u8005\u30fb\u6cbb\u9a13\u8cac\u4efb\u533b\u5e2b\u30fbIRB<\/p>\n<h2>\u516c\u958b\u65e5\u6642<\/h2>\n<p>2020\u5e743\u670818\u65e5<\/p>\n<h2>\u80cc\u666f<\/h2>\n<p>\u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9COVID-19\u306b\u3088\u308b\u611f\u67d3\u75c7\u304c\u8513\u5ef6\u3057\u3064\u3064\u3042\u308b\u3002<\/p>\n<p>\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\u306b\u8a66\u9a13\u65bd\u8a2d\u306e\u4eba\u54e1\u306e\u611f\u67d3\u3084\u88ab\u9a13\u8005\u306e\u611f\u67d3\u306a\u3069\u304c\u767a\u751f\u3057\u305f\u5834\u5408\u3001\u8a66\u9a13\u65bd\u8a2d\u306e\u9589\u9396\u3001\u79fb\u52d5\u5236\u9650\u3001\u6cbb\u9a13\u85ac\u306e\u305f\u3081\u306e\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u306e\u969c\u5bb3\u306a\u3069\u304c\u751f\u3058\u3046\u308b\u3002\u3053\u306e\u3088\u3046\u306a\u5834\u5408\u306b\u306f\u3001\u30d7\u30ed\u30c8\u30b3\u30fc\u30eb\u306e\u5909\u66f4\u306f\u907f\u3051\u3089\u308c\u306a\u3044\u3002<\/p>\n<p>COVID-19\u306b\u3088\u308b\u5f71\u97ff\u306f\u3001\u8a66\u9a13\u4e2d\u306e\u75be\u60a3\u306e\u7279\u5fb4\u3001\u8a66\u9a13\u30c7\u30b6\u30a4\u30f3\u3001\u8a66\u9a13\u304c\u5b9f\u65bd\u3055\u308c\u3066\u3044\u308b\u5730\u57df\u306a\u3069\u591a\u6570\u306e\u8981\u56e0\u306b\u3088\u3063\u3066\u8d77\u3053\u308a\u3046\u308b\u3002<\/p>\n<h2>\u63a8\u5968\u4e8b\u9805<\/h2>\n<ul>\n<li id=\"h.p_C7Sfh7iJStEk\" class=\"zfr3Q\">GCP\u9806\u5b88\u3092\u7dad\u6301\u3057\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u5b8c\u5168\u6027\u3092\u640d\u306a\u3046\u30ea\u30b9\u30af\u3092\u6700\u5c0f\u5316\u3057\u306a\u304c\u3089\u8a66\u9a13\u53c2\u52a0\u8005\u306e\u5b89\u5168\u6027\u3092\u78ba\u4fdd\u3059\u308b\u3053\u3068<\/li>\n<\/ul>\n<h2>\u5b9f\u65bd\u4e2d\u306e\u8a66\u9a13<\/h2>\n<p>\u4ee3\u66ff\u30d7\u30ed\u30bb\u30b9\u306e\u5b9f\u65bd\u306f\u53ef\u80fd\u306a\u9650\u308a\u30d7\u30ed\u30c8\u30b3\u30fc\u30eb\u3068\u4e00\u81f4\u3057\u3066\u3044\u308b\u3079\u304d\u3067\u3042\u308a\u3001\u6cbb\u9a13\u4f9d\u983c\u8005\u53ca\u3073\u6cbb\u9a13\u8cac\u4efb\u533b\u5e2b\u306f\u3001\u5b9f\u65bd\u3057\u305f\u4e0d\u6e2c\u306e\u63aa\u7f6e\u306e\u7406\u7531\u3092\u6587\u66f8\u5316\u3059\u3079\u304d\u3067\u3042\u308b\u3002\u6cbb\u9a13\u4f9d\u983c\u8005\u53ca\u3073\u6cbb\u9a13\u8cac\u4efb\u533b\u5e2b\u306f\u3001COVID-19\u306b\u95a2\u9023\u3057\u305f\u5236\u9650\u304c\u3001\u3069\u306e\u3088\u3046\u306b\u8a66\u9a13\u5b9f\u65bd\u306e\u5909\u66f4\u3068\u305d\u306e\u5909\u66f4\u306e\u671f\u9593\u306b\u3064\u306a\u304c\u3063\u305f\u306e\u304b\u3092\u6587\u66f8\u5316\u3057\u3001\u3069\u306e\u8a66\u9a13\u53c2\u52a0\u8005\u304c\u5f71\u97ff\u3092\u53d7\u3051\u305f\u306e\u304b\u3001\u3069\u306e\u3088\u3046\u306b\u5f71\u97ff\u3092\u53d7\u3051\u305f\u306e\u304b\u3092\u793a\u3059\u3079\u304d\u3067\u3042\u308b\u3002<\/p>\n<p>\u8a66\u9a13\u306e\u8a55\u4fa1\u306b\u3064\u3044\u3066\u306f\u3001\u96fb\u8a71\u9023\u7d61\u3084\u30d0\u30fc\u30c1\u30e3\u30eb\u306a\u8a2a\u554f\u306a\u3069\u3067\u4ee3\u66ff\u3067\u304d\u308b\u65b9\u6cd5\u306b\u3088\u308a\u5b9f\u65bd\u3001\u307e\u305f\u3001\u3082\u306f\u3084\u6cbb\u9a13\u85ac\u3084\u8a66\u9a13\u30b5\u30a4\u30c8\u306b\u30a2\u30af\u30bb\u30b9\u3059\u308b\u5fc5\u8981\u306e\u306a\u3044\u53c2\u52a0\u8005\u306b\u306f\u8ffd\u52a0\u306e\u5b89\u5168\u6027\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3092\u5b9f\u65bd\u3059\u308b\u3053\u3068<\/p>\n<p>\u8a66\u9a13\u306e\u53d7\u8a3a\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u306e\u5909\u66f4\u3001\u6b20\u5e2d\u3001\u307e\u305f\u306f\u60a3\u8005\u306e\u4e2d\u6b62\u306f\u3001\u60c5\u5831\u306e\u6b20\u843d\u306b\u3064\u306a\u304c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\uff08\u4f8b\u3048\u3070\u3001\u30d7\u30ed\u30c8\u30b3\u30fc\u30eb\u3067\u6307\u5b9a\u3055\u308c\u305f\u624b\u6280\u306e\u5834\u5408\uff09\u3002\u75c7\u4f8b\u5831\u544a\u66f8\u306b\u306f\u3001\u6b20\u843d\u3057\u305f\u30d7\u30ed\u30c8\u30b3\u30fc\u30eb\u6307\u5b9a\u60c5\u5831\uff08\u4f8b\u3048\u3070\u3001COVID-19\u306b\u3088\u308b\u8a66\u9a13\u53d7\u8a3a\u306e\u6b20\u5e2d\u3084\u8a66\u9a13\u4e2d\u6b62\u306a\u3069\uff09\u306eCOVID-19\u3068\u306e\u95a2\u4fc2\u3092\u542b\u3081\u3001\u6b20\u843d\u3057\u305f\u30c7\u30fc\u30bf\u306e\u6839\u62e0\u3092\u8aac\u660e\u3059\u308b\u5177\u4f53\u7684\u306a\u60c5\u5831\u3092\u8a18\u8f09\u3059\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3042\u308d\u3046\u3002\u81e8\u5e8a\u8a66\u9a13\u5831\u544a\u66f8\u306b\u307e\u3068\u3081\u3089\u308c\u305f\u3053\u306e\u60c5\u5831\u306f\u3001\u6cbb\u9a13\u4f9d\u983c\u8005\u53ca\u3073FDA\u306b\u3068\u3063\u3066\u6709\u7528\u3067\u3042\u308b\u3002<\/p>\n<p>\u81e8\u5e8a\u73fe\u5834\u3067\u306e\u4e88\u5b9a\u3055\u308c\u305f\u8a3a\u5bdf\u306b\u5927\u304d\u306a\u5f71\u97ff\u304c\u51fa\u308b\u5834\u5408\u3001\u901a\u5e38\u3001\u81ea\u5df1\u6295\u4e0e\u3067\u914d\u5e03\u3055\u308c\u3066\u3044\u308b\u3088\u3046\u306a\u7279\u5b9a\u306e\u6cbb\u9a13\u85ac\u306f\u3001\u4ee3\u66ff\u306e\u5b89\u5168\u306a\u6295\u4e0e\u65b9\u6cd5\u3092\u5229\u7528\u3059\u308b\u3053\u3068\u304c\u53ef\u80fd\u3067\u3042\u308b\u304b\u3082\u3057\u308c\u306a\u3044\u3002\u901a\u5e38\u3001\u533b\u7642\u74b0\u5883\u3067\u6295\u4e0e\u3055\u308c\u308b\u4ed6\u306e\u6cbb\u9a13\u85ac\u306b\u3064\u3044\u3066\u306f\u3001\u4ee3\u66ff\u6295\u4e0e\uff08\u4f8b\u3048\u3070\u3001\u8a13\u7df4\u3092\u53d7\u3051\u3066\u3044\u308b\u304c\u7814\u7a76\u8005\u4ee5\u5916 \u306e\u8077\u54e1\u306b\u3088\u308b\u8a2a\u554f\u770b\u8b77\u3084\u4ee3\u66ff\u65bd\u8a2d\u306a\u3069\uff09\u306e\u8a08\u753b\u306b\u3064\u3044\u3066FDA\u306e\u5be9\u67fb\u90e8\u9580\u306b\u76f8\u8ac7\u3059\u308b\u3053\u3068\u304c\u63a8\u5968\u3055\u308c\u308b\u3002\u3044\u305a\u308c\u306e\u5834\u5408\u3082\u3001\u6cbb\u9a13\u85ac\u306e\u8aac\u660e\u8cac\u4efb\u3092\u7dad\u6301\u3059\u308b\u305f\u3081\u306e\u65e2\u5b58\u306e\u898f\u5236\u8981\u4ef6\u306f\u4f9d\u7136\u3068\u3057\u3066\u6b8b\u3063\u3066\u304a\u308a\u3001\u3053\u308c\u306b\u5bfe\u51e6\u3057\u3001\u6587\u66f8\u5316\u3059\u3079\u304d\u3067\u3042\u308b\u3002<\/p>\n<p>\u6709\u52b9\u6027\u8a55\u4fa1\u306b\u3064\u3044\u3066\u306f\u3001\u53ef\u80fd\u3067\u3042\u308c\u3070\u3001\u30d0\u30fc\u30c1\u30e3\u30eb\u8a55\u4fa1\u306e\u5229\u7528\u3001\u8a55\u4fa1\u306e\u9045\u5ef6\u3001\u7814\u7a76\u7279\u7570\u7684\u691c\u4f53\u306e\u4ee3\u66ff\u63a1\u53d6\u7b49\u3001\u6709\u52b9\u6027\u8a55\u4fa1\u306e\u30d7\u30ed\u30c8 \u30b3\u30eb\u306e\u5909\u66f4\u306b\u3064\u3044\u3066\u3001\u9069\u5207\u306a\u5be9\u67fb\u90e8\u9580\u3068\u306e\u5354\u8b70\u3092\u884c\u3046\u3053\u3068\u3092\u63a8\u5968\u3059\u308b\u3002\u6709\u52b9\u6027\u8a55\u4fa1\u9805\u76ee\u304c\u53ce\u96c6\u3055\u308c\u306a\u304b\u3063\u305f\u500b\u5225\u306e\u4e8b\u4f8b\u306b\u3064\u3044\u3066\u306f\u3001\u6709\u52b9\u6027\u8a55\u4fa1\u3092\u53d6\u5f97\u3067\u304d\u306a\u304b\u3063\u305f\u7406\u7531\u3092\u6587\u66f8\u5316\u3059\u308b\uff08\u4f8b\uff1aCOVID-19 \u306b\u3088 \u308b\u5177\u4f53\u7684\u306a\u5236\u9650\u4e8b\u9805\u3092\u660e\u3089\u304b\u306b\u3057\u3001\u30d7\u30ed\u30c8\u30b3\u30fc\u30eb\u3067\u6307\u5b9a\u3055\u308c\u305f\u8a55\u4fa1\u3092\u5b9f\u65bd\u3067\u304d\u306a\u304b\u3063\u305f\u7406\u7531\u3092\u660e\u3089\u304b\u306b\u3059\u308b\uff09\u3002<\/p>\n<h2>\u958b\u59cb\u524d\u306e\u8a66\u9a13<\/h2>\n<p>\u6cbb\u9a13\u4f9d\u983c\u8005\u3001\u6cbb\u9a13\u8cac\u4efb\u533b\u5e2b\u3001\u53ca\u3073 IRB \u306f\u3001\u8a66\u9a13\u5b9f\u65bd\u65bd\u8a2d\u306b\u304a\u3051\u308b COVID-19 \u5bfe\u7167\u63aa\u7f6e\u306e\u7d50\u679c\u3068\u3057\u3066\u8a66\u9a13\u304c\u4e2d\u65ad\u3055\u308c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u5834\u5408\u306b\u3001\u8a66\u9a13\u53c2\u52a0\u8005\u3092\u4fdd\u8b77\u3057\u3001 \u8a66\u9a13\u306e\u5b9f\u65bd\u3092\u7ba1\u7406\u3059\u308b\u305f\u3081\u306b\u4f7f\u7528\u3059\u308b\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u8a18\u8ff0\u3059\u308b\u305f\u3081\u306e\u65b9\u91dd\u3068\u624b\u9806\u306e\u78ba\u7acb\u3068\u5b9f\u65bd\u3001\u53c8\u306f\u65e2\u5b58\u306e\u65b9\u91dd\u3068 \u624b\u9806\u306e\u6539\u8a02\u3092\u691c\u8a0e\u3059\u3079\u304d\u3067\u3042\u308b\u3002\u65b9\u91dd\u3068\u624b\u9806\u306e\u5909\u66f4\u306f\u3001\u30a4\u30f3\u30d5\u30a9\u30fc\u30e0\u30c9\u30fb\u30b3\u30f3\u30bb\u30f3\u30c8\u306e\u30d7\u30ed\u30bb\u30b9\u3001\u8a66\u9a13\u306e\u8a2a\u554f\u3068\u624b\u9806\u3001\u30c7\u30fc\u30bf\u53ce\u96c6\u3001\u8a66\u9a13\u306e\u30e2\u30cb \u30bf\u30ea\u30f3\u30b0\u3001\u6709\u5bb3\u4e8b\u8c61\u306e\u5831\u544a\u3001\u53ca\u3073\u6e21\u822a\u5236\u9650\u3001\u691c\u75ab\u63aa\u7f6e\u3001\u307e\u305f\u306f COVID-19 \u75be\u75c5\u305d\u306e\u3082\u306e\u306b\u8d77\u56e0\u3059\u308b\u6cbb\u9a13\u8cac\u4efb\u533b\u5e2b\u3001\u6cbb\u9a13\u5b9f\u65bd\u65bd\u8a2d\u306e\u30b9\u30bf\u30c3\u30d5\u3001\u53ca\u3073\uff0f\u307e\u305f\u306f\u30e2\u30cb\u30bf\u30fc\u306e\u5909\u66f4\u3078\u306e\u5f71\u97ff\u306b \u5bfe\u51e6\u3057\u3046\u308b\u304c\u3001\u3053\u308c\u3089\u306b\u9650\u5b9a\u3055\u308c\u308b\u3082\u306e\u3067\u306f\u306a\u3044\u3002\u65b9\u91dd\u3068\u624b\u9806\u306f\u3001COVID-19\u306e\u7ba1\u7406\u3068\u7ba1\u7406\u306e\u305f\u3081\u306b\u9069\u7528\u3055\u308c\u308b\uff08\u5730\u57df\u307e\u305f\u306f\u56fd\u306e\uff09\u65b9\u91dd\u306b\u6e96\u62e0\u3057\u3066\u3044\u308b\u3079\u304d\u3067\u3042\u308b\u3002\u4e0a\u8a18\u306e\u5909\u66f4\u306e\u6027\u8cea\u306b\u5fdc\u3058\u3066\u3001\u9069\u7528\u3055\u308c\u308b\u898f\u5247\u306e\u4e0b\u3067\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u4fee\u6b63\u304c\u8981\u6c42\u3055\u308c\u308b\u3053\u3068\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<p>\u4ee5\u4e0a\u306f\u4e00\u90e8\u629c\u7c8b\u306e\u60c5\u5831\u3067\u3059\u3002\u8a73\u7d30\u306f\u30aa\u30ea\u30b8\u30ca\u30eb\u3092\u3054\u53c2\u7167\u304f\u3060\u3055\u3044\u3002<\/p>\n<p><a href=\"https:\/\/drive.google.com\/open?id=1tAseo0zJPvQnoBu5lw5WOtSX-c340xBe\">\u30ac\u30a4\u30c0\u30f3\u30b9\uff08\u30aa\u30ea\u30b8\u30ca\u30eb\uff09<\/a><\/p>\n<p>EMA\u3082<a href=\"https:\/\/www.ema.europa.eu\/en\/news\/guidance-sponsors-how-manage-clinical-trials-during-covid-19-pandemic\">\u6cbb\u9a13\u4f9d\u983c\u8005\u5411\u3051\u30ac\u30a4\u30c0\u30f3\u30b9<\/a>\u30923\u670820\u65e5\u4ed8\u3067\u516c\u958b<\/p>\n<p><a href=\"https:\/\/drive.google.com\/open?id=1AElK_7Rzm_8BttZzoHwrtZpa9rl0_B6k\">PMDA\u3082\u95a2\u9023\u306eQA<\/a>\u30923\u670830\u65e5\u4ed8\u3067\u516c\u958b<\/p>\n<p><a href=\"https:\/\/drive.google.com\/file\/d\/1WMnGAdLys7bRP3twrpImK4Bp1JwOf2NW\/view?usp=sharing\">\u5404\u65bd\u8a2d\u3067\u306e\u5bfe\u5fdc\u72b6\u6cc1<\/a>\uff085\u670814\u65e5\u4ed8\uff09<\/p>\n","protected":false},"excerpt":{"rendered":"<p>FDA\u306fCOVID-19\u6d41\u884c\u4e0b\u3067\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u516c\u958b \u5bfe\u8c61 \u6cbb\u9a13\u4f9d\u983c\u8005\u30fb\u6cbb\u9a13\u8cac\u4efb\u533b\u5e2b\u30fbIRB \u516c\u958b\u65e5\u6642 2020\u5e743\u670818\u65e5 \u80cc\u666f \u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9COVID-19\u306b\u3088\u308b\u611f\u67d3\u75c7\u304c\u8513\u5ef6\u3057\u3064\u3064\u3042\u308b\u3002 \u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\u306b\u8a66\u9a13\u65bd\u8a2d&#8230;<\/p>\n","protected":false},"author":1,"featured_media":2444,"comment_status":"open","ping_status":"open","sticky":true,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[5],"tags":[],"class_list":["post-2317","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-miscellaneous"],"jetpack_featured_media_url":"https:\/\/plaza.umin.ac.jp\/~OIO\/wp-content\/uploads\/2020\/03\/FDA_silverspring.jpg","jetpack_shortlink":"https:\/\/wp.me\/p9b6zl-Bn","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/plaza.umin.ac.jp\/~OIO\/index.php?rest_route=\/wp\/v2\/posts\/2317","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/plaza.umin.ac.jp\/~OIO\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/plaza.umin.ac.jp\/~OIO\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/plaza.umin.ac.jp\/~OIO\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/plaza.umin.ac.jp\/~OIO\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=2317"}],"version-history":[{"count":0,"href":"https:\/\/plaza.umin.ac.jp\/~OIO\/index.php?rest_route=\/wp\/v2\/posts\/2317\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/plaza.umin.ac.jp\/~OIO\/index.php?rest_route=\/wp\/v2\/media\/2444"}],"wp:attachment":[{"href":"https:\/\/plaza.umin.ac.jp\/~OIO\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=2317"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/plaza.umin.ac.jp\/~OIO\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=2317"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/plaza.umin.ac.jp\/~OIO\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=2317"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}