{"id":1780,"date":"2020-04-03T12:07:38","date_gmt":"2020-04-03T03:07:38","guid":{"rendered":"https:\/\/clarivate.com\/jp\/blog\/%e6%b2%bb%e9%a8%93%e3%81%af%e7%b6%9a%e3%81%91%e3%81%aa%e3%81%91%e3%82%8c%e3%81%b0%e3%81%aa%e3%82%89%e3%81%aa%e3%81%84%ef%bc%9acovid-19%e3%83%91%e3%83%b3%e3%83%87%e3%83%9f%e3%83%83%e3%82%af%e6%99%82\/?lang=ja"},"modified":"2020-04-03T12:07:38","modified_gmt":"2020-04-03T03:07:38","slug":"the-trials-must-go-on-conducting-clinical-studies-during-the-covid-19-pandemic-2","status":"publish","type":"post","link":"https:\/\/clarivate.com\/life-sciences-healthcare\/ja\/blog\/the-trials-must-go-on-conducting-clinical-studies-during-the-covid-19-pandemic-2\/","title":{"rendered":"\u6cbb\u9a13\u306f\u7d9a\u3051\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\uff1aCOVID-19\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u6642\u306b\u304a\u3051\u308b\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd"},"content":{"rendered":"<p><strong>JAIME POLYCHRONES<\/strong><br \/>\nMedical Writer, Cortellis Regulatory Intelligence<br \/>\nClarivate<\/p>\n<p>&nbsp;<\/p>\n<p><a href=\"https:\/\/clarivate.com\/cortellis\/blog\/the-trials-must-go-on-conducting-clinical-studies-during-the-covid-19-pandemic\/\">\u82f1\u8a9e\u539f\u6587<\/a><\/p>\n<p>&nbsp;<\/p>\n<p>\u672c\u8a18\u4e8b\u4e2d\u306b\u5f15\u7528\u306e\u3042\u308bRegulatory Document\u306f\u3001<a href=\"https:\/\/clarivate.com\/cortellis\/ja\/solutions\/regulatory-intelligence-solutions\/\">Cortellis Regulatory Intelligence<\/a>\u306b\u53ce\u9332\u306e\u8a72\u5f53\u6587\u66f8\u3078\u30ea\u30f3\u30af\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<p><em>COVID-19\u306e\u5f71\u97ff\u3067\u4e16\u754c\u4e2d\u304c\u4e00\u6642\u505c\u6b62\u3057\u3066\u3044\u308b\u304b\u306e\u3088\u3046\u306a\u72b6\u6cc1\u306b\u3042\u3063\u3066\u3082\u3001\u7c73\u56fd\u3067\u306e\u81e8\u5e8a\u8a66\u9a13\u306f\u3001\u898f\u5236\u3092\u9075\u5b88\u3057\u3001\u60a3\u8005\u306e\u5b89\u5168\u6027\u3092\u78ba\u4fdd\u3057\u306a\u304c\u3089\u3001\u6761\u4ef6\u3084\u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u8abf\u6574\u3057\u3066\u7d99\u7d9a\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u3053\u306e\u8a18\u4e8b\u3067\u306f\u3001\u6700\u8fd1\u306eFDA\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306b\u3064\u3044\u3066\u3054\u8aac\u660e\u3057\u307e\u3059\u3002<\/em><\/p>\n<p>&nbsp;<\/p>\n<p>COVID-19\u304c\u4e16\u754c\u4e2d\u3067\u5927\u6d41\u884c\u3059\u308b\u4e2d\u3001\u533b\u85ac\u54c1\u3001\u533b\u7642\u6a5f\u5668\u3001\u751f\u7269\u5b66\u7684\u88fd\u5264\u306e\u81e8\u5e8a\u8a66\u9a13\u306f\u3001\u4ed6\u306e\u75be\u60a3\u3084\u75c5\u72b6\u306b\u5bfe\u3057\u3066\u3082\u7d99\u7d9a\u3057\u3066\u5b9f\u65bd\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u3092\u3069\u306e\u3088\u3046\u306b\u9042\u884c\u3059\u3079\u304d\u304b\u306b\u3064\u3044\u3066\u306e\u6f5c\u5728\u7684\u306a\u61f8\u5ff5\u306b\u5bfe\u51e6\u3059\u308b\u305f\u3081\u306b\u30012020\u5e743\u670818\u65e5\u306b\u3001FDA\u306f\u696d\u754c\u3001\u6cbb\u9a13\u8cac\u4efb\u533b\u5e2b\u3001\u304a\u3088\u3073\u6a5f\u95a2\u5be9\u67fb\u59d4\u54e1\u4f1a\uff08IRB\uff09\u306e\u305f\u3081\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u3001\u300c<a href=\"https:\/\/www.cortellis.com\/intelligence\/report\/ri\/regulatory\/307826\/\" target=\"_blank\" rel=\"noopener\"><em>FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic<\/em><\/a>\u300d\u3092\u767a\u884c\u3057\u307e\u3057\u305f\u3002<\/p>\n<p>FDA\u306f\u3001\u9023\u90a6\u98df\u54c1\u533b\u85ac\u54c1\u5316\u7ca7\u54c1\u6cd5\uff08FD&amp;C\u6cd5\uff09\u7b2c701\u6761(h)(1)(C)(i)\u304a\u3088\u307321 CFR 10.115(g)(2)\u306b\u57fa\u3065\u304d\u3001\u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u4e8b\u524d\u306e\u30d1\u30d6\u30ea\u30c3\u30af\u30b3\u30e1\u30f3\u30c8\u306a\u3057\u3067\u516c\u958b\u3057\u3066\u3044\u307e\u3059\u304c\u3001\u73fe\u5728\u306f\u30d1\u30d6\u30ea\u30c3\u30af\u30b3\u30e1\u30f3\u30c8\u3092\u53d7\u3051\u4ed8\u3051\u3066\u3044\u307e\u3059\uff08Docket No. FDA 2020-D-1106\uff09\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>\u7523\u696d\u754c\u304c\u76f4\u9762\u3057\u3066\u3044\u308b\u554f\u984c\u306e\u3044\u304f\u3064\u304b\u306b\u306f\u3001\u691c\u75ab\u3001\u65bd\u8a2d\u9589\u9396\u3001\u6e21\u822a\u5236\u9650\u3001\u6cbb\u9a13\u85ac\u306e\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u306e\u5bf8\u65ad\u306a\u3069\u304c\u3042\u308a\u307e\u3059\u3002\u3055\u3089\u306b\u3001\u6cbb\u9a13\u65bd\u8a2d\u306e\u8077\u54e1\u3084\u81e8\u5e8a\u8a66\u9a13\u53c2\u52a0\u8005\u304cCOVID-19\u306e\u539f\u56e0\u3068\u306a\u308b\u30a6\u30a4\u30eb\u30b9\u3067\u3042\u308bSARS-CoV-2\u306b\u611f\u67d3\u3057\u305f\u5834\u5408\u3001\u8a66\u9a13\u304c\u5ef6\u671f\u3055\u308c\u305f\u308a\u3001\u6700\u60aa\u306e\u5834\u5408\u306f\u4e2d\u6b62\u3055\u308c\u305f\u308a\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u3089\u3092\u8003\u616e\u3057\u3066\u3001FDA\u306f\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u5909\u66f4\u3084\u9038\u8131\u306b\u5bfe\u51e6\u3059\u308b\u65b9\u6cd5\u306b\u3064\u3044\u3066\u306e\u60c5\u5831\u3092\u63d0\u4f9b\u3057\u307e\u3057\u305f\u3002\u5177\u4f53\u7684\u306b\u306f\u3001\u4ee5\u4e0b\u306e\u70b9\u306b\u91cd\u70b9\u3092\u7f6e\u3044\u305f\u30ac\u30a4\u30c0\u30f3\u30b9\u3068\u306a\u3063\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>\u8a66\u9a13\u53c2\u52a0\u8005\u306e\u5b89\u5168\u6027\u306e\u78ba\u4fdd\uff08<a href=\"https:\/\/www.cortellis.com\/intelligence\/report\/ri\/regulatory\/40916\/\" target=\"_blank\" rel=\"noopener\">45 CFR 46<\/a>\u3092\u53c2\u7167\uff09\u3002<\/li>\n<li>good clinical practice\uff08GCP\uff09\u9075\u5b88\u306e\u7dad\u6301<\/li>\n<li>\u8a66\u9a13\u306e\u5b8c\u5168\u6027\u306b\u5bfe\u3059\u308b\u30ea\u30b9\u30af\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u308b\uff08FDA\u306e\u7523\u696d\u754c\u5411\u3051\u30ac\u30a4\u30c0\u30f3\u30b9\u00a0<em><a href=\"https:\/\/www.cortellis.com\/intelligence\/report\/ri\/regulatory\/287604\/\" target=\"_blank\" rel=\"noopener\">Data Integrity and Compliance with Drug CGMP \u2013 Questions and Answers<\/a><\/em>\u3092\u53c2\u7167)<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<blockquote><p>FDA\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306b\u3088\u308a\u3001\u7c73\u56fd\u3067\u5b9f\u65bd\u3055\u308c\u308b\u81e8\u5e8a\u8a66\u9a13\u306f\u3001\u6761\u4ef6\u3084\u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u8abf\u6574\u3057\u306a\u304c\u3089\u3082\u3001\u7c73\u56fd\u306e\u898f\u5236\u3092\u9075\u5b88\u3057\u3001\u60a3\u8005\u306e\u5b89\u5168\u6027\u3092\u78ba\u4fdd\u3057\u306a\u304c\u3089\u7d99\u7d9a\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p><\/blockquote>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<h4><strong>\u9032\u884c\u4e2d\u306e\u81e8\u5e8a\u8a66\u9a13<\/strong><\/h4>\n<p>\u8a66\u9a13\u53c2\u52a0\u8005\u306b\u5bfe\u3057\u3066\u3001\u5f7c\u3089\u304c\u53c2\u52a0\u3057\u3066\u3044\u308b\u4efb\u610f\u306e\u7814\u7a76\u3078\u306e\u5909\u66f4\u306b\u3064\u3044\u3066\u306e\u60c5\u5831\u3092\u63d0\u4f9b\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3068FDA\u306f\u6307\u6458\u3057\u307e\u3057\u305f\u3002\u60a3\u8005\u306e\u5b89\u5168\u6027\u304c\u7b2c\u4e00\u3067\u3042\u308b\u305f\u3081\u3001\u30b9\u30dd\u30f3\u30b5\u30fc\u306fCOVID-19\u304c\u61f8\u5ff5\u3055\u308c\u3001\u305d\u306e\u30d7\u30ed\u30bb\u30b9\u304c\u8a66\u9a13\u306b\u53d7\u3051\u5165\u308c\u3089\u308c\u308b\u5834\u5408\u306b\u306f\u3001\u96fb\u8a71\u3084\u30d0\u30fc\u30c1\u30e3\u30eb\u9762\u8ac7\u307e\u305f\u306f\u4ee3\u66ff\u306e\u624b\u6bb5\u3092\u4ecb\u3057\u3066\u5b89\u5168\u6027\u8a55\u4fa1\u306b\u53c2\u52a0\u3059\u308b\u65b9\u304c\u60a3\u8005\u306b\u3068\u3063\u3066\u5b89\u5168\u3067\u3042\u308b\u304b\u3069\u3046\u304b\u3092\u5224\u65ad\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u6cbb\u9a13\u8cac\u4efb\u533b\u5e2b\u306f\u3001\u305d\u308c\u3089\u306e\u8a66\u9a13\u306e\u7279\u5b9a\u306e\u72b6\u6cc1\u306b\u5fdc\u3058\u3066\u8a66\u9a13\u3092\u4fee\u6b63\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>\u6cbb\u9a13\u4f9d\u983c\u8005\u306f\u3001\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u5909\u66f4\u306b\u3064\u3044\u3066\u3001\u3067\u304d\u308b\u3060\u3051\u65e9\u304f\u6a5f\u95a2\u5be9\u67fb\u59d4\u54e1\u4f1a\uff08IRB\uff09\uff0f\u72ec\u7acb\u502b\u7406\u59d4\u54e1\u4f1a\uff08IEC\uff09\u306b\u901a\u77e5\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\uff08\u30c7\u30d0\u30a4\u30b9\u306b\u3064\u3044\u3066\u306f\u3001FDA\u306e\u300c<em><a href=\"https:\/\/www.cortellis.com\/intelligence\/report\/ri\/regulatory\/47647\/\" target=\"_blank\" rel=\"noopener\">Final Guidance for Industry and CDRH Staff<\/a>\uff1aChanges or Modifications During the Conduct of Clinical Investigation\u300d<\/em>\u3092\u53c2\u7167\uff09\u3002\u88ab\u9a13\u8005\u306e\u798f\u7949\u3084\u751f\u547d\u304c\u5371\u967a\u306b\u3055\u3089\u3055\u308c\u3066\u3044\u308b\u5834\u5408\u3001\u305d\u306e\u3088\u3046\u306a\u5909\u66f4\u306fIRB\u306e\u627f\u8a8d\u304c\u306a\u304f\u3066\u3082\u5b9f\u65bd\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u304c\u3001\u305d\u306e\u5f8c\u306b\u5831\u544a\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u6cbb\u9a13\u4f9d\u983c\u8005\u306f\u3001\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u5909\u66f4\u304c\u3042\u308b\u5834\u5408\u306b\u306f\u3001\u9069\u5207\u306a\u5be9\u67fb\u90e8\u9580\u306b\u76f8\u8ac7\u3057\u3066\u6709\u52b9\u6027\u8a55\u4fa1\u3092\u691c\u8a0e\u3059\u308b\u3053\u3068\u3092FDA\u306f\u63a8\u5968\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>\u3055\u3089\u306b\u3001\u9045\u5ef6\u304c\u9069\u5207\u306a\u5834\u5408\u304c\u3042\u308a\u3001\u30b9\u30dd\u30f3\u30b5\u30fc\u306f\u52df\u96c6\u3092\u505c\u6b62\u3059\u308b\u304b\u53c2\u52a0\u8005\u3092\u64a4\u56de\u3059\u308b\u3053\u3068\u304c\u9078\u629e\u3067\u304d\u307e\u3059\u3002\u8208\u5473\u6df1\u3044\u3053\u3068\u306b\u3001\u30b9\u30dd\u30f3\u30b5\u30fc\u304c\u305d\u306e\u30c7\u30fc\u30bf\u3092\u65b0\u305f\u306a\u7814\u7a76\u76ee\u7684\u306e\u4e00\u90e8\u3068\u3057\u3066\u7d44\u307f\u8fbc\u3080\u4e88\u5b9a\u304c\u306a\u3044\u9650\u308a\u3001\u8a66\u9a13\u304c\u5b9f\u65bd\u3055\u308c\u3066\u3044\u308b\u533b\u7642\u30b7\u30b9\u30c6\u30e0\u3067COVID-19\u30b9\u30af\u30ea\u30fc\u30cb\u30f3\u30b0\u304c\u5fc5\u8981\u306a\u5834\u5408\u3001FDA\u306f\u8a66\u9a13\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u4fee\u6b63\u3092\u8981\u6c42\u3057\u3066\u3044\u307e\u305b\u3093\u3002\uff08<a href=\"https:\/\/www.cortellis.com\/intelligence\/report\/ri\/regulatory\/8714\/\" target=\"_blank\" rel=\"noopener\">21 CFR 312.30<\/a>\u53c2\u7167\uff09\u3002<\/p>\n<\/div>\n<p>&nbsp;<\/p>\n<div class=\"entry-content\">\n<h4><strong>\u4eca\u5f8c\u306e\u8a66\u9a13<\/strong><\/h4>\n<p>\u73fe\u5728\u3001\u7acb\u6848\u3055\u308c\u3066\u3044\u308b\u81e8\u5e8a\u8a66\u9a13\u306b\u3064\u3044\u3066\u306f\u3001\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u4e2d\u306b\u53c2\u52a0\u8005\u304c\u3069\u306e\u3088\u3046\u306b\u4fdd\u8b77\u3055\u308c\u308b\u304b\u3001\u307e\u305f\u8a66\u9a13\u304c\u4e2d\u65ad\u3055\u308c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u5834\u5408\u306b\u306f\u3069\u306e\u3088\u3046\u306b\u8a66\u9a13\u306e\u5b9f\u65bd\u304c\u7ba1\u7406\u3055\u308c\u308b\u304b\u3092\u8aac\u660e\u3059\u308b\u305f\u3081\u306b\u3001\u65b9\u91dd\u3084\u624b\u9806\u3092\u6539\u8a02\u307e\u305f\u306f\u4f5c\u6210\u3059\u308b\u3053\u3068\u3092FDA\u306f\u63a8\u5968\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u306b\u306f\u3001\u30a4\u30f3\u30d5\u30a9\u30fc\u30e0\u30c9\u30fb\u30b3\u30f3\u30bb\u30f3\u30c8\u3001\u8a66\u9a13\u8a2a\u554f\u3001\u30c7\u30fc\u30bf\u53ce\u96c6\u3001\u8a66\u9a13\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3001\u6709\u5bb3\u4e8b\u8c61\u5831\u544a\u3001COVID-19\u306e\u75be\u75c5\u306b\u3088\u308b\u30b9\u30bf\u30c3\u30d5\u306e\u5909\u66f4\u306e\u53ef\u80fd\u6027\u3078\u306e\u5f71\u97ff\u304c\u542b\u307e\u308c\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<h4><strong>COVID-19<\/strong><strong>\u306e\u5f71\u97ff\u3092\u53d7\u3051\u308b\u3059\u3079\u3066\u306e\u81e8\u5e8a\u8a66\u9a13<\/strong><\/h4>\n<p>FDA\u306f\u6cbb\u9a13\u4f9d\u983c\u8005\u304c\u9069\u5207\u306a\u8a66\u9a13\u5831\u544a\u66f8\u306e\u30bb\u30af\u30b7\u30e7\u30f3\u307e\u305f\u306f\u5225\u306e\u6587\u66f8\u306b\u4ee5\u4e0b\u306e\u5185\u5bb9\u3092\u8a18\u8f09\u3059\u308b\u3053\u3068\u3092\u63a8\u5968\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<ul>\n<li>\u5b9f\u65bd\u3055\u308c\u305f\u7dca\u6025\u6642\u5bfe\u7b56\u3002<\/li>\n<li>COVID-19\u306b\u95a2\u9023\u3057\u305f\u8a66\u9a13\u4e2d\u65ad\u306e\u5f71\u97ff\u3092\u53d7\u3051\u305f\u3059\u3079\u3066\u306e\u53c2\u52a0\u8005\u306e\u30ea\u30b9\u30c8\u3068\u3001\u305d\u306e\u53c2\u52a0\u304c\u3069\u306e\u3088\u3046\u306b\u5f71\u97ff\u3092\u53d7\u3051\u305f\u304b\u3002<\/li>\n<li>\u5831\u544a\u3055\u308c\u305f\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u306e\u7d50\u679c\u306b\u5bfe\u3059\u308b\u5076\u767a\u7684\u63aa\u7f6e\u306e\u5f71\u97ff\u306e\u5206\u6790\u3002<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>COVID-19\u306e\u5f71\u97ff\u3067\u4e16\u754c\u5168\u4f53\u304c\u4e00\u6642\u505c\u6b62\u3057\u3066\u3044\u308b\u304b\u306e\u3088\u3046\u306a\u72b6\u6cc1\u306b\u3042\u3063\u3066\u3082\u3001\u304c\u3093\u60a3\u8005\u306f\u4eca\u3067\u3082\u6551\u547d\u6cbb\u7642\u3092\u5fc5\u8981\u3068\u3057\u3066\u304a\u308a\u3001\u5e0c\u5c11\u75be\u60a3\u306e\u5b50\u4f9b\u305f\u3061\u306f\u4eca\u3067\u3082\u6cbb\u7642\u3092\u5fc5\u8981\u3068\u3057\u3066\u304a\u308a\u3001\u4eba\u306e\u547d\u3092\u652f\u3048\u308b\u533b\u7642\u6a5f\u5668\u306e\u91cd\u8981\u6027\u306f\u3053\u308c\u307e\u3067\u4ee5\u4e0a\u306b\u9ad8\u307e\u3063\u3066\u3044\u307e\u3059\u3002FDA\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306b\u3088\u308a\u3001\u7c73\u56fd\u3067\u5b9f\u65bd\u3055\u308c\u308b\u81e8\u5e8a\u8a66\u9a13\u306f\u3001\u7c73\u56fd\u306e\u898f\u5236\u3092\u9075\u5b88\u3057\u3001\u60a3\u8005\u3055\u3093\u306e\u5b89\u5168\u6027\u3092\u78ba\u4fdd\u3057\u306a\u304c\u3089\u3001\u6761\u4ef6\u3084\u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u8abf\u6574\u3057\u3066\u7d99\u7d9a\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>COVID-19 \u306b\u95a2\u9023\u3059\u308b\u6700\u65b0\u60c5\u5831\u3084\u6700\u65b0\u30cb\u30e5\u30fc\u30b9\u306b\u3064\u3044\u3066\u306f\u3001\u5f15\u304d\u7d9a\u304d\u5f0a\u793e\u30d6\u30ed\u30b0\u3092\u30c1\u30a7\u30c3\u30af\u3057\u3066\u304f\u3060\u3055\u3044\u3002<a href=\"https:\/\/clarivate.com\/cortellis\/ja\/solutions\/regulatory-intelligence-solutions\/\">Cortellis Regulatory Intelligence<\/a> \u3092\u3054\u5229\u7528\u306e\u65b9\u306f\u3001\u30c7\u30b9\u30af\u30c8\u30c3\u30d7\u307e\u305f\u306f <a href=\"https:\/\/clarivate.com\/cortellis\/ja\/solutions\/regulatory-intelligence-solutions\/\">Cortellis Regulatory Intelligence<\/a> \u306e\u30e2\u30d0\u30a4\u30eb\u30a2\u30d7\u30ea\u3067\u30a2\u30e9\u30fc\u30c8\u3092\u8a2d\u5b9a\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n<p>&nbsp;<\/p>\n<p><strong><a href=\"https:\/\/clarivate.com\/cortellis\/ja\/solutions\/regulatory-intelligence-solutions\/\">Cortellis Regulatory Intelligence<\/a> \u3092\u5229\u7528\u3059\u308b\u3053\u3068\u3067\u3001\u6700\u65b0\u306e\u898f\u5236\u5909\u66f4\u3092\u5e38\u306b\u628a\u63e1\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>JAIME POLYCHRONES Medical Writer, Cortellis Regulatory Intelligence Clarivate &nbsp; \u82f1\u8a9e\u539f\u6587 &nbsp; \u672c\u8a18\u4e8b\u4e2d\u306b\u5f15\u7528\u306e\u3042\u308bRegulatory Document\u306f\u3001Cortellis Regulatory Intelligence\u306b\u53ce\u9332\u306e\u8a72\u5f53\u6587\u66f8\u3078\u30ea\u30f3\u30af\u3057\u3066\u3044\u307e\u3059\u3002 &nbsp; COVID-19\u306e\u5f71\u97ff\u3067\u4e16\u754c\u4e2d\u304c\u4e00\u6642\u505c\u6b62\u3057\u3066\u3044\u308b\u304b\u306e\u3088\u3046\u306a\u72b6\u6cc1\u306b\u3042\u3063\u3066\u3082\u3001\u7c73\u56fd\u3067\u306e\u81e8\u5e8a\u8a66\u9a13\u306f\u3001\u898f\u5236\u3092\u9075\u5b88\u3057\u3001\u60a3\u8005\u306e\u5b89\u5168\u6027\u3092\u78ba\u4fdd\u3057\u306a\u304c\u3089\u3001\u6761\u4ef6\u3084\u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u8abf\u6574\u3057\u3066\u7d99\u7d9a\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u3053\u306e\u8a18\u4e8b\u3067\u306f\u3001\u6700\u8fd1\u306eFDA\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306b\u3064\u3044\u3066\u3054\u8aac\u660e\u3057\u307e\u3059\u3002 &nbsp; COVID-19\u304c\u4e16\u754c\u4e2d\u3067\u5927\u6d41\u884c\u3059\u308b\u4e2d\u3001\u533b\u85ac\u54c1\u3001\u533b\u7642\u6a5f\u5668\u3001\u751f\u7269\u5b66\u7684\u88fd\u5264\u306e\u81e8\u5e8a\u8a66\u9a13\u306f\u3001\u4ed6\u306e\u75be\u60a3\u3084\u75c5\u72b6\u306b\u5bfe\u3057\u3066\u3082\u7d99\u7d9a\u3057\u3066\u5b9f\u65bd\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u3092\u3069\u306e\u3088\u3046\u306b\u9042\u884c\u3059\u3079\u304d\u304b\u306b\u3064\u3044\u3066\u306e\u6f5c\u5728\u7684\u306a\u61f8\u5ff5\u306b\u5bfe\u51e6\u3059\u308b\u305f\u3081\u306b\u30012020\u5e743\u670818\u65e5\u306b\u3001FDA\u306f\u696d\u754c\u3001\u6cbb\u9a13\u8cac\u4efb\u533b\u5e2b\u3001\u304a\u3088\u3073\u6a5f\u95a2\u5be9\u67fb\u59d4\u54e1\u4f1a\uff08IRB\uff09\u306e\u305f\u3081\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u3001\u300cFDA Guidance on Conduct of Clinical Trials of Medical Products during the&#8230;<\/p>\n","protected":false},"author":61,"featured_media":1721,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_links_to":"","_links_to_type":0,"footnotes":""},"categories":[1071,1073],"tags":[1114,1187,1225,1075],"class_list":["post-1780","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog","category-cortellis","tag-cortellis-regulatory-intelligence","tag-covid-19","tag-fda","tag-life-sciences"],"acf":[],"lang":"ja","translations":{"ja":1780},"publishpress_future_workflow_manual_trigger":{"enabledWorkflows":[]},"pll_sync_post":[],"_links":{"self":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/posts\/1780","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/users\/61"}],"replies":[{"embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/comments?post=1780"}],"version-history":[{"count":0,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/posts\/1780\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/"}],"wp:attachment":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/media?parent=1780"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/categories?post=1780"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/tags?post=1780"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}