{"id":7660,"date":"2020-05-26T10:57:43","date_gmt":"2020-05-26T10:57:43","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=7660"},"modified":"2020-05-26T13:07:15","modified_gmt":"2020-05-26T13:07:15","slug":"literature-reviews-for-medical-devices-6-expert-tips","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/ja\/literature-reviews-for-medical-devices-6-expert-tips\/","title":{"rendered":"\u533b\u7642\u6a5f\u5668\u306e\u6587\u732e\u30ec\u30d3\u30e5\u30fc\u30026\u3064\u306e\u30a2\u30c9\u30d0\u30a4\u30b9"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_45_1 counter-flat ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\">table of contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" area-label=\"ez-toc-toggle-icon-1\"><label for=\"item-69f73d3c9463e\" aria-label=\"Table of Content\"><span style=\"display: flex;align-items: center;width: 35px;height: 30px;justify-content: center;direction:ltr;\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewbox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewbox=\"0 0 24 24\" version=\"1.2\" baseprofile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/label><input  type=\"checkbox\" id=\"item-69f73d3c9463e\"><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1' ><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/literature-reviews-for-medical-devices-6-expert-tips\/#Literature_Reviews_for_Medical_Devices\" title=\"\u533b\u7642\u6a5f\u5668\u306e\u6587\u732e\u8abf\u67fb\">\u533b\u7642\u6a5f\u5668\u306e\u6587\u732e\u8abf\u67fb<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/literature-reviews-for-medical-devices-6-expert-tips\/#1_Search_protocol_Stage_1\" title=\"1.\u691c\u7d22\u30d7\u30ed\u30c8\u30b3\u30eb\uff08\u30b9\u30c6\u30fc\u30b81\">1.\u691c\u7d22\u30d7\u30ed\u30c8\u30b3\u30eb\uff08\u30b9\u30c6\u30fc\u30b81<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/literature-reviews-for-medical-devices-6-expert-tips\/#2_Possible_errors\" title=\"2.\u53ef\u80fd\u306a\u30a8\u30e9\u30fc\">2.\u53ef\u80fd\u306a\u30a8\u30e9\u30fc<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/literature-reviews-for-medical-devices-6-expert-tips\/#3_Appraisal_of_the_clinical_data\" title=\"3.\u81e8\u5e8a\u30c7\u30fc\u30bf\u306e\u8a55\u4fa1\">3.\u81e8\u5e8a\u30c7\u30fc\u30bf\u306e\u8a55\u4fa1<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/literature-reviews-for-medical-devices-6-expert-tips\/#4_Analysis_and_conclusions_generated_from_the_clinical_data\" title=\"4.\u81e8\u5e8a\u30c7\u30fc\u30bf\u304b\u3089\u5f97\u3089\u308c\u305f\u5206\u6790\u3068\u7d50\u8ad6\">4.\u81e8\u5e8a\u30c7\u30fc\u30bf\u304b\u3089\u5f97\u3089\u308c\u305f\u5206\u6790\u3068\u7d50\u8ad6<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/literature-reviews-for-medical-devices-6-expert-tips\/#5_Informatic_tools\" title=\"5.\u30a4\u30f3\u30d5\u30a9\u30de\u30c6\u30a3\u30af\u30b9\u30c4\u30fc\u30eb\">5.\u30a4\u30f3\u30d5\u30a9\u30de\u30c6\u30a3\u30af\u30b9\u30c4\u30fc\u30eb<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/literature-reviews-for-medical-devices-6-expert-tips\/#6_Process_flow\" title=\"6.\u30d7\u30ed\u30bb\u30b9\u30d5\u30ed\u30fc\">6.\u30d7\u30ed\u30bb\u30b9\u30d5\u30ed\u30fc<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/literature-reviews-for-medical-devices-6-expert-tips\/#Conclusions\" title=\"\u7d50\u8ad6\">\u7d50\u8ad6<\/a><\/li><\/ul><\/nav><\/div>\n<p><em><span style=\"font-weight: 400;\"><a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/catarina-carrao\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDLitSearch\">Catarina Carr\u00e3o<\/a>, <a href=\"https:\/\/www.kolabtree.com\/services\/medical-writing\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDLitSearch\">\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306e\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30bf\u30fc<\/a> \u306eKolabtree\u3067\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u6587\u732e\u30ec\u30d3\u30e5\u30fc\u306e\u91cd\u8981\u6027\u3068\u3001\u305d\u308c\u306b\u5f93\u3046\u3079\u304d\u30d9\u30b9\u30c8\u30d7\u30e9\u30af\u30c6\u30a3\u30b9\u3092\u7d39\u4ecb\u3057\u3066\u3044\u307e\u3059\u3002\u00a0<\/span><\/em><\/p>\n<p><span style=\"font-weight: 400;\">\u81e8\u5e8a\u8a55\u4fa1\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u3092\u901a\u3057\u3066\u884c\u308f\u308c\u308b\u7d99\u7d9a\u7684\u306a\u30d7\u30ed\u30bb\u30b9\u3067\u3059\u3002\u81e8\u5e8a\u8a55\u4fa1\u306f\u3001\u901a\u5e38\u3001\u533b\u7642\u6a5f\u5668\u306e\u958b\u767a\u6bb5\u968e\u3067\u521d\u3081\u3066\u884c\u308f\u308c\u3001\u5e02\u5834\u53c2\u5165\u306b\u5fc5\u8981\u306a\u30c7\u30fc\u30bf\u3092\u7279\u5b9a\u3059\u308b\u305f\u3081\u306b\u884c\u308f\u308c\u307e\u3059\u3002\u6b27\u5dde\u9023\u5408\uff08EU\uff09\u3067\u306f\u3001\u6700\u521d\u306bCE\u30de\u30fc\u30af\u3092\u53d6\u5f97\u3059\u308b\u305f\u3081\u306b\u306f <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-evaluation-report-cer\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDLitSearch\">\u81e8\u5e8a\u8a55\u4fa1\u30ec\u30dd\u30fc\u30c8<\/a> (CER\uff09\u304c\u5fc5\u9808\u3067\u3042\u308a\u3001\u305d\u306e\u5f8c\u3082\u7d99\u7d9a\u3057\u3066\u7a4d\u6975\u7684\u306b\u66f4\u65b0\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044[<\/span><span style=\"font-weight: 400;\">1]<\/span><span style=\"font-weight: 400;\">.\u7c73\u56fd\u3067\u306f <\/span><span style=\"font-weight: 400;\">\u5e02\u8ca9\u524d\u627f\u8a8d\uff08PMA<\/span><span style=\"font-weight: 400;\">)[\u533b\u7642\u6a5f\u5668\uff08\u30af\u30e9\u30b9III\uff09\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u8a55\u4fa1\u3057\u3001\u6d88\u8cbb\u8005\u306b\u5c4a\u3051\u308b\u305f\u3081\u306e\u79d1\u5b66\u7684\u30fb\u898f\u5236\u7684\u5be9\u67fb\u306e\u305f\u3081\u306eFDA\uff08\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff09\u306e\u30d7\u30ed\u30bb\u30b9\u3067\u3042\u308b\u3002\u307e\u305f\u3001\u533b\u7642\u6a5f\u5668\u306e\u79d1\u5b66\u7684\u8a55\u4fa1\u306b\u306f\u3001\u30a8\u30d3\u30c7\u30f3\u30b9\u306b\u57fa\u3065\u3044\u305f\u30ec\u30d3\u30e5\u30fc\u30b7\u30b9\u30c6\u30e0\u3092\u63a1\u7528\u3057\u3066\u3044\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u3053\u306e\u81e8\u5e8a\u8a55\u4fa1\u30d7\u30ed\u30bb\u30b9\u306f\u3001\u533b\u7642\u6a5f\u5668\u304c\u5e02\u5834\u3067\u8ca9\u58f2\u3055\u308c\u308b\u307e\u3067\u306e\u671f\u9593\u3001\u8c4a\u5bcc\u306a\u81e8\u5e8a\u30a8\u30d3\u30c7\u30f3\u30b9\u306b\u57fa\u3065\u3044\u3066\u3001\u6a5f\u5668\u306e\u5b89\u5168\u6027\u3068\u6027\u80fd\u3092\u4fdd\u8a3c\u3059\u308b\u305f\u3081\u306e\u57fa\u672c\u7684\u306a\u3082\u306e\u3067\u3059\u3002\u3053\u306e\u30d7\u30ed\u30bb\u30b9\u306b\u3088\u308a\u3001\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30dc\u30c7\u30a3\uff08NB\uff09\u3084\u6240\u8f44\u5b98\u5e81\u306f\u3001\u6700\u521d\u306e\u8ca9\u58f2\u3060\u3051\u3067\u306a\u304f\u3001\u305d\u306e\u30e9\u30a4\u30d5\u30bf\u30a4\u30e0\u3092\u901a\u3057\u3066\u3001\u6a5f\u5668\u304c\u5fc5\u9808\u8981\u4ef6\u306b\u9069\u5408\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u8a3c\u660e\u3059\u308b\u305f\u3081\u306e\u81e8\u5e8a\u7684\u8a3c\u62e0\u306b\u76ee\u3092\u901a\u3059\u3053\u3068\u304c\u3067\u304d\u307e\u3059(<\/span><i><span style=\"font-weight: 400;\">e.g.<\/span><\/i><span style=\"font-weight: 400;\">\u5e02\u8ca9\u5f8c\u306e\u76e3\u8996\u3068\u5831\u544a\u306e\u8981\u4ef6\u3092\u6e80\u305f\u3059\u3053\u3068\uff09 [<\/span><span style=\"font-weight: 400;\">1]<\/span><span style=\"font-weight: 400;\">.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Literature_Reviews_for_Medical_Devices\"><\/span><strong>\u533b\u7642\u6a5f\u5668\u306e\u6587\u732e\u8abf\u67fb<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u6587\u732e\u30ec\u30d3\u30e5\u30fc\u306f\u3001CER\u304a\u3088\u3073PMA\u3092\u6210\u529f\u3055\u305b\u308b\u305f\u3081\u306b\u975e\u5e38\u306b\u91cd\u8981\u3067\u3059\u3002\u306a\u305c\u306a\u3089\u3001\u3057\u3063\u304b\u308a\u3068\u3057\u305f\u4f53\u7cfb\u7684\u306a <a href=\"https:\/\/www.kolabtree.com\/services\/literature-search\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDLitSearch\">\u6587\u5b66\u7814\u7a76\u6226\u7565<\/a> \u30b3\u30f3\u30bb\u30d7\u30c8\u3001\u30c7\u30b6\u30a4\u30f3\u3001\u81e8\u5e8a\u8a66\u9a13\u3001\u533b\u7642\u6a5f\u5668\u306e\u767a\u58f2\u3001\u4fdd\u967a\u511f\u9084\u307e\u3067\u3001\u533b\u7642\u6a5f\u5668\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u30d7\u30ed\u30bb\u30b9\u306e\u5404\u6bb5\u968e\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u307e\u3059\u3002<\/span><span style=\"font-weight: 400;\">3]<\/span><span style=\"font-weight: 400;\">\u3064\u307e\u308a\u3001\u5358\u306a\u308b\u8ce2\u660e\u306a\u6295\u8cc7\u3068\u3044\u3046\u3060\u3051\u3067\u306a\u304f\u3001\u627f\u8a8d\u30d7\u30ed\u30bb\u30b9\u3084\u5e02\u8ca9\u5f8c\u306e\u76e3\u8996\u306e\u305f\u3081\u306b\u898f\u5236\u5f53\u5c40\u306b\u6e96\u62e0\u3057\u305f\u6587\u732e\u3092\u30b9\u30af\u30ea\u30fc\u30cb\u30f3\u30b0\u3059\u308b\u3053\u3068\u306f\u3001\u5e02\u8ca9\u3055\u308c\u305f\u533b\u7642\u6a5f\u5668\u304c\u4e16\u754c\u7684\u306b\u6210\u529f\u3059\u308b\u305f\u3081\u306e\u57fa\u672c\u3068\u306a\u308b\u306e\u3067\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u591a\u304f\u306e\u4f01\u696d\u3001\u7279\u306b\u4e2d\u5c0f\u4f01\u696d\u3067\u306f\u3001\u53ce\u96c6\u3057\u305f\u30c7\u30fc\u30bf\u306e\u3059\u3079\u3066\u3067\u306f\u306a\u3044\u306b\u3057\u3066\u3082\u3001\u6587\u732e\u691c\u7d22\u304b\u3089\u5f97\u3089\u308c\u305f\u30c7\u30fc\u30bf\u304c\u5927\u534a\u3092\u5360\u3081\u307e\u3059\u3002\u305d\u306e\u305f\u3081\u3001\u3053\u306e\u691c\u7d22\u3067\u306f\u3001\u5bfe\u5fdc\u3059\u308b\u533b\u7642\u5206\u91ce\u306e\u81e8\u5e8a\u7684\u80cc\u666f\u3092\u8aac\u660e\u3059\u308b\u73fe\u5728\u306e\u77e5\u8b58\u307e\u305f\u306f\u300cThe-State-of-the-Edge\u300d\u3092\u78ba\u7acb\u3059\u308b\u305f\u3081\u306e\u81e8\u5e8a\u30c7\u30fc\u30bf\u306e\u60c5\u5831\u6e90\u3092\u7279\u5b9a\u3057\u307e\u3059\u3002\u8a55\u4fa1\u4e2d\u306e\u30c7\u30d0\u30a4\u30b9\u3001\u307e\u305f\u306f\u540c\u7b49\u306e\u30c7\u30d0\u30a4\u30b9\uff08CER\u3067\u540c\u7b49\u6027\u304c\u4e3b\u5f35\u3055\u308c\u3066\u3044\u308b\u5834\u5408\uff09\u306b\u95a2\u9023\u3059\u308b\u81e8\u5e8a\u30c7\u30fc\u30bf\u3092\u7279\u5b9a\u3057\u307e\u3059\u3002<\/span><span style=\"font-weight: 400;\">1<\/span><span style=\"font-weight: 400;\">\u307e\u305f\u306f510K[<\/span><span style=\"font-weight: 400;\">4]<\/span><span style=\"font-weight: 400;\">\u307e\u305f\u3001\u6f5c\u5728\u7684\u306a\u81e8\u5e8a\u4e0a\u306e\u5371\u967a\u6027\u3092\u7279\u5b9a\u3059\u308b\u3053\u3068\u3082\u3067\u304d\u307e\u3059\u3002\u3060\u304b\u3089\u3053\u305d\u3001\u5805\u7262\u3067\u3001\u305d\u306e\u5f8c\u306e\u66f4\u65b0\u6642\u306b\u8ab0\u3082\u304c\u518d\u73fe\u3067\u304d\u308b\u3088\u3046\u306a\u6587\u732e\u691c\u7d22\u6226\u7565\u3092\u958b\u767a\u3059\u308b\u3053\u3068\u304c\u975e\u5e38\u306b\u91cd\u8981\u306a\u306e\u3067\u3059\u3002<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"1_Search_protocol_Stage_1\"><\/span><strong>1.\u691c\u7d22\u30d7\u30ed\u30c8\u30b3\u30eb\uff08\u30b9\u30c6\u30fc\u30b81<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u691c\u7d22\u6226\u7565\u306f\u5fb9\u5e95\u7684\u306b\u3001\u305d\u3057\u3066\u5ba2\u89b3\u7684\u306b\u884c\u3046\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002 <\/span><i><span style=\"font-weight: 400;\">i.e.<\/span><\/i><span style=\"font-weight: 400;\"> \u6709\u5229\u306a\u30c7\u30fc\u30bf\u3068\u4e0d\u5229\u306a\u30c7\u30fc\u30bf\u306e\u3059\u3079\u3066\u3092\u7279\u5b9a\u3057\u3001\u691c\u7d22\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u57fa\u3065\u3044\u3066\u5b9f\u65bd\u3055\u308c\u308b\u3079\u304d\u3067\u3042\u308b\u3002<\/span><span style=\"font-weight: 400;\">1]<\/span><span style=\"font-weight: 400;\">.\u691c\u7d22\u30d7\u30ed\u30c8\u30b3\u30eb\u306f\u3001\u5b9f\u884c\u524d\u306e\u691c\u7d22\u306e\u8a08\u753b\u3092\u6587\u66f8\u5316\u3057\u305f\u3082\u306e\u3067\u3042\u308b\u3002\u691c\u7d22\u304c\u5b9f\u884c\u3055\u308c\u305f\u3089\uff0c\u691c\u7d22\u306e\u59a5\u5f53\u6027\u3092\u691c\u8a3c\u3057\uff0c\u691c\u7d22\u7d50\u679c\u3068\u3068\u3082\u306b\u6587\u732e\u691c\u7d22\u30d7\u30ed\u30c8\u30b3\u30eb\u304b\u3089\u306e\u9038\u8131\u3092\u6587\u66f8\u5316\u3057\u305f\u4e0a\u3067\uff0c\u8a73\u7d30\u3092\u793a\u3059\u6587\u732e\u691c\u7d22\u5831\u544a\u66f8\u3092\u4f5c\u6210\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002\u65b9\u6cd5\u3092\u6279\u5224\u7684\u306b\u8a55\u4fa1\u3057\u3001\u7d50\u679c\u3092\u691c\u8a3c\u3057\u3001\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u691c\u7d22\u3092\u518d\u73fe\u3067\u304d\u308b\u3088\u3046\u306a\u7a0b\u5ea6\u306b\u3001\u6587\u732e\u691c\u7d22\u3092\u6587\u66f8\u5316\u3059\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3042\u308b\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u898f\u5247\u306b\u3088\u308b\u3068\u3001[<\/span><span style=\"font-weight: 400;\">1], [2]<\/span><span style=\"font-weight: 400;\">\u6587\u732e\u691c\u7d22\u306e\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u306f\u3001\u4ee5\u4e0b\u306e\u8981\u7d20\u304c\u542b\u307e\u308c\u3066\u3044\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002<\/span><span style=\"font-weight: 400;\">5]<\/span><span style=\"font-weight: 400;\">:<\/span><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\">\u4f7f\u7528\u3057\u305f\u30c7\u30fc\u30bf\u306e\u30bd\u30fc\u30b9 (<\/span><i><span style=\"font-weight: 400;\">e.g.<\/span><\/i><span style=\"font-weight: 400;\">, MEDLINE\/PubMed, Embase, Google Scholar, ResearchGate, \u30a4\u30f3\u30bf\u30fc\u30cd\u30c3\u30c8\u691c\u7d22\u306a\u3069\uff09\u3092\u4f7f\u7528\u3057\u3066\u3044\u307e\u3059\u3002)<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u691c\u7d22\u306b\u4f7f\u7528\u3057\u305f\u65b9\u6cd5\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u79d1\u5b66\u7684\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u3092\u691c\u7d22\u3059\u308b\u305f\u3081\u306b\u4f7f\u7528\u3055\u308c\u305f\u6b63\u78ba\u306a\u691c\u7d22\u7528\u8a9e\u3068\u30d1\u30e9\u30e1\u30fc\u30bf(<\/span><i><span style=\"font-weight: 400;\">e.g.<\/span><\/i><span style=\"font-weight: 400;\">\u65e5\u4ed8\uff09\u3002)<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u5177\u4f53\u7684\u306a\u9078\u629e\u57fa\u6e96\u307e\u305f\u306f\u9664\u5916\u57fa\u6e96\u3068\u3001\u305d\u308c\u305e\u308c\u306e\u6b63\u5f53\u306a\u7406\u7531\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u8907\u6570\u306e\u30bd\u30fc\u30b9\u304b\u3089\u306e\u30c7\u30fc\u30bf\u306e\u91cd\u8907\u306b\u3069\u306e\u3088\u3046\u306b\u5bfe\u51e6\u3057\u305f\u304b\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u30c7\u30fc\u30bf\u306e\u6574\u5408\u6027\u306f\u3069\u306e\u3088\u3046\u306b\u78ba\u4fdd\u3055\u308c\u307e\u3057\u305f\u304b\uff1f<\/span><i><span style=\"font-weight: 400;\">e.g.<\/span><\/i><span style=\"font-weight: 400;\">, \u54c1\u8cea\u7ba1\u7406\u65b9\u6cd5\u307e\u305f\u306f\u7b2c\u4e8c\u5be9\u67fb\u54e1\uff09\u3002)<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u5404\u30c7\u30fc\u30bf\u30bd\u30fc\u30b9\u304c\u3069\u306e\u3088\u3046\u306b\u8a55\u4fa1\u3055\u308c\u305f\u304b\u3001\u305d\u3057\u3066\u7279\u5b9a\u306e\u30c7\u30d0\u30a4\u30b9\u306b\u5bfe\u3059\u308b\u305d\u306e\u95a2\u9023\u6027\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u5206\u6790\u3068\u30c7\u30fc\u30bf\u51e6\u7406\u306e\u51e6\u7406\u3002<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\u691c\u7d22\u6226\u7565\u306f\u3001\u91cd\u8981\u306a\u60c5\u5831\u3092\u898b\u843d\u3068\u3055\u306a\u3044\u3088\u3046\u306b\u5341\u5206\u306a\u5e45\u3092\u6301\u305f\u305b\u3064\u3064\u3001\u95a2\u9023\u3059\u308b\u7d50\u679c\u3092\u6b63\u78ba\u306b\u7279\u5b9a\u3067\u304d\u308b\u3088\u3046\u306b\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u3053\u308c\u306b\u306f\u3001\u7d50\u679c\u30bb\u30c3\u30c8\u3092\u7d5e\u308a\u8fbc\u3080\u305f\u3081\u306e\u30d5\u30a3\u30eb\u30bf\u30fc\u306a\u3069\u306e\u691c\u7d22\u6a5f\u80fd\u3001\u6a5f\u5668\u306e\u526f\u4f5c\u7528\u3084\u6a5f\u5668\u306e\u6bd4\u8f03\u306a\u3069\u306e\u91cd\u8981\u306a\u6982\u5ff5\u306b\u57fa\u3065\u304f\u5c0f\u898b\u51fa\u3057\u3001\u6700\u3082\u95a2\u9023\u6027\u306e\u9ad8\u3044\u6587\u732e\u3092\u7279\u5b9a\u3059\u308b\u305f\u3081\u306e\u30c8\u30ea\u30a2\u30fc\u30b8\u304a\u3088\u3073\u5206\u6790\u65b9\u6cd5\u306a\u3069\u304c\u542b\u307e\u308c\u307e\u3059\u3002\u7d50\u679c\u81ea\u4f53\u306f\u3001\u4e00\u822c\u7684\u306b\u3001\u8aac\u660e\u7684\u306a\u30a4\u30f3\u30c7\u30c3\u30af\u30b9\u30bf\u30b0\u3084\u305d\u306e\u4ed6\u306e\u91cd\u8981\u306a\u60c5\u5831\u3092\u542b\u3080\u3001\u5f15\u7528\u307e\u305f\u306f\u30c7\u30fc\u30bf\u306e\u30ea\u30b9\u30c8\u306e\u5f62\u3067\u8868\u793a\u3055\u308c\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u6284\u9332\u306f\u3001\u554f\u984c\u3092\u5fb9\u5e95\u7684\u306b\u72ec\u7acb\u3057\u3066\u8a55\u4fa1\u3059\u308b\u306e\u306b\u5341\u5206\u306a\u8a73\u7d30\u304c\u306a\u3044\u304c\u3001\u8ad6\u6587\u306e\u59a5\u5f53\u6027\u3092\u6700\u521d\u306b\u8a55\u4fa1\u3059\u308b\u306e\u306b\u306f\u5341\u5206\u3067\u3042\u308b\u3002<\/span><span style=\"font-weight: 400;\">1]<\/span><span style=\"font-weight: 400;\">.\u512a\u308c\u305f\u30ea\u30b5\u30fc\u30c1\u30a4\u30f3\u30d5\u30a9\u30de\u30c6\u30a3\u30af\u30b9\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u3067\u306f\u3001\u5f15\u7528\u306e\u30d5\u30e9\u30b0\u4ed8\u3051\u3068\u8ad6\u6587\u30c6\u30ad\u30b9\u30c8\u306e\u30a2\u30ce\u30c6\u30fc\u30b7\u30e7\u30f3\u306e\u4e21\u65b9\u304c\u53ef\u80fd\u306a\u305f\u3081\u3001\u30c1\u30fc\u30e0\u306f\u500b\u3005\u306e\u30a2\u30a4\u30c6\u30e0\u306b\u5bc6\u63a5\u306b\u53d6\u308a\u7d44\u3080\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/span><span style=\"font-weight: 400;\">3]<\/span><span style=\"font-weight: 400;\">.\u8ad6\u6587\u306e\u30d5\u30eb\u30c6\u30ad\u30b9\u30c8\u306e\u30b3\u30d4\u30fc\u306f\u3001\u6700\u7d42\u30d5\u30a1\u30a4\u30eb\u306b\u542b\u307e\u308c\u308b\u3079\u304d\u3067\u3042\u308b\u3002\u6587\u732e\u691c\u7d22\u30d7\u30ed\u30c8\u30b3\u30eb\uff08\u8907\u6570\u53ef\uff09\u3001\u6587\u732e\u691c\u7d22\u30ec\u30dd\u30fc\u30c8\uff08\u8907\u6570\u53ef\uff09\u3001\u8ad6\u6587\u304a\u3088\u3073\u95a2\u9023\u6587\u66f8\u306e\u30d5\u30eb\u30c6\u30ad\u30b9\u30c8\u30b3\u30d4\u30fc\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u6700\u7d42\u7684\u306a\u6280\u8853\u6587\u66f8\u306e\u4e00\u90e8\u3068\u306a\u308b\u3002<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"2_Possible_errors\"><\/span><strong>2.\u53ef\u80fd\u306a\u30a8\u30e9\u30fc<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u6b63\u78ba\u306a\u6587\u732e\u691c\u7d22\u306f\u3001\u6b63\u78ba\u306a\u30a8\u30d3\u30c7\u30f3\u30b9\u3092\u63d0\u4f9b\u3057\u307e\u3059\u304c\u3001\u6b63\u3057\u304f\u5b9f\u65bd\u3055\u308c\u306a\u3051\u308c\u3070\u3001\u7d50\u679c\u306f\u8aa4\u89e3\u3092\u62db\u304d\u3001\u6642\u9593\u304c\u304b\u304b\u308a\u3001\u3042\u308b\u3044\u306f\u5f79\u306b\u7acb\u305f\u306a\u3044\u3082\u306e\u306b\u306a\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002<\/span><span style=\"font-weight: 400;\">6]<\/span><span style=\"font-weight: 400;\">.\u30a8\u30d3\u30c7\u30f3\u30b9\u306e\u91cf\u3001\u30c7\u30fc\u30bf\u306e\u95a2\u9023\u6027\u3001\u30a8\u30d3\u30c7\u30f3\u30b9\u306e\u30c8\u30fc\u30f3\u3001\u7814\u7a76\u30c6\u30fc\u30de\u306b\u5bfe\u3059\u308b\u4fa1\u5024\u306a\u3069\u3001\u9ad8\u3044\u30b9\u30ad\u30eb\u3092\u6301\u3063\u305f\u7814\u7a76\u8005\u3067\u3042\u3063\u3066\u3082\u60a9\u3080\u3088\u3046\u306a\u30a8\u30e9\u30fc\u304c\u3042\u308a\u307e\u3059\u3002\u6587\u732e\u8abf\u67fb\u3092\u7684\u78ba\u306a\u30c6\u30fc\u30de\u306b\u7d5e\u308a\u3001\u5b9a\u3081\u3089\u308c\u305f\u6642\u9593\u5185\u306b\u95a2\u9023\u3059\u308b\u30a8\u30d3\u30c7\u30f3\u30b9\u3092\u5f97\u308b\u3053\u3068\u304c\u5fc5\u8981\u3067\u3042\u308a\u3001\u305d\u3046\u3057\u306a\u3044\u3068\u7d50\u679c\u304c\u4e56\u96e2\u3057\u3066\u3057\u307e\u3044\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u901a\u5e38\u3001\u30a8\u30e9\u30fc\u306e\u539f\u56e0\u306f\u3001\u6587\u732e\u691c\u7d22\u306e\u4e3b\u8981\u306a\u5c5e\u6027\u3092\u6b63\u3057\u304f\u4f7f\u7528\u3057\u3066\u3044\u306a\u3044\u3053\u3068\u306b\u3042\u308a\u307e\u3059\u3002 <\/span><i><span style=\"font-weight: 400;\">\u306e\u3053\u3068\u3067\u3059\u3002<\/span><\/i><span style=\"font-weight: 400;\">, \u30ad\u30fc\u30ef\u30fc\u30c9, \u30d6\u30fc\u30eb, \u30c7\u30fc\u30bf\u30d9\u30fc\u30b9 [<\/span><span style=\"font-weight: 400;\">6]<\/span><span style=\"font-weight: 400;\">.\u4f8b\u3048\u3070\u3001\u8a55\u4fa1\u8005\u304c\u9069\u683c\u57fa\u6e96\uff08\u6587\u732e\u306e\u7a2e\u985e\u3084\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\uff09\u306e\u8a2d\u5b9a\u306b\u8aa4\u308a\u304c\u3042\u3063\u305f\u308a\u3001\u30ad\u30fc\u30ef\u30fc\u30c9\u3084\u30d6\u30fc\u30eb\u30ed\u30b8\u30c3\u30af\u306e\u9078\u629e\u306b\u8aa4\u308a\u304c\u3042\u3063\u305f\u308a\u3001\u3055\u3089\u306b\u306f\u3001\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u306e\u691c\u7d22\u30d5\u30ec\u30fc\u30ba\u306e\u8a2d\u5b9a\u306b\u8aa4\u308a\u304c\u3042\u3063\u305f\u308a\u3059\u308b\u3053\u3068\u304c\u8003\u3048\u3089\u308c\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u3053\u308c\u3089\u306e\u5c5e\u6027\u306f\u3001\u5305\u542b\u306e\u30a8\u30e9\u30fc\uff08\u30c7\u30fc\u30bf\u304c\u591a\u3059\u304e\u3066\u3001\u4e00\u90e8\u304c\u554f\u984c\u306b\u95a2\u9023\u3057\u3066\u3044\u306a\u3044\uff09\u3084\u3001\u30ad\u30fc\u30ef\u30fc\u30c9\u306e\u4f7f\u7528\u304c\u53b3\u3057\u3059\u304e\u308b\u305f\u3081\u306b\u91cd\u8981\u306a\u30c7\u30fc\u30bf\u304c\u9664\u5916\u3055\u308c\u308b\u3053\u3068\u306b\u3064\u306a\u304c\u308a\u307e\u3059\u3002\u3057\u304b\u3057\u3001\u6587\u732e\u306e\u5c02\u9580\u5bb6\u306b\u3088\u308b\u691c\u7d22\u306e\u504f\u308a\u306b\u3088\u308b\u300c\u5305\u62ec\u7684\u9664\u5916\u300d\u306e\u30a8\u30e9\u30fc\u3084\u3001\u4e0d\u5341\u5206\u306a\u30d6\u30fc\u30ea\u30a2\u30f3\u3092\u4f7f\u7528\u3057\u305f\u975e\u5e38\u306b\u7279\u6b8a\u306a\u30ad\u30fc\u30ef\u30fc\u30c9\u306e\u4f7f\u7528\u3001\u3042\u308b\u3044\u306f\u540c\u3058\u533b\u7642\u7528\u8a9e\u306e\u540c\u7fa9\u8a9e\u306e\u9664\u5916\u306a\u3069\u306b\u3088\u308b\u300c\u6392\u4ed6\u7684\u9664\u5916\u300d\u306e\u30a8\u30e9\u30fc\u306b\u3064\u306a\u304c\u308b\u3053\u3068\u3082\u3042\u308a\u307e\u3059\u3002\u6392\u4ed6\u7684\u306a\u9664\u5916\u300d\u306e\u30a8\u30e9\u30fc\u306f\u300c\u9650\u5b9a\u7684\u306a\u95a2\u9023\u6027\u306e\u30a8\u30e9\u30fc\u300d\u3068\u3082\u547c\u3070\u308c\u3001\u591a\u304f\u306e\u30b1\u30fc\u30b9\u3067\u767a\u751f\u3057\u307e\u3059\u3002\u3053\u306e\u30a8\u30e9\u30fc\u306f\u3001\u504f\u308a\u3068\u7279\u5b9a\u306e\u6392\u4ed6\u6027\u304c\u7d44\u307f\u5408\u308f\u3055\u3063\u305f\u3082\u306e\u3067\u3001\u69cb\u7bc9\u3055\u308c\u305f\u691c\u7d22\u30d5\u30ec\u30fc\u30ba\u304c\u4e00\u65b9\u7684\u306a\u30c7\u30fc\u30bf\u30c8\u30ec\u30f3\u30c9\u306e\u307f\u306b\u504f\u308a\u3001\u9078\u629e\u3055\u308c\u305f\u7528\u8a9e\u304c\u6392\u4ed6\u7684\u3059\u304e\u3066\u5341\u5206\u306a\u60c5\u5831\u304c\u5f97\u3089\u308c\u306a\u3044\u5834\u5408\u306b\u767a\u751f\u3057\u307e\u3059[<\/span><span style=\"font-weight: 400;\">6]<\/span><span style=\"font-weight: 400;\">.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u91cd\u8981\u306a\u81e8\u5e8a\u30c7\u30fc\u30bf\u3092\u53d6\u5f97\u3059\u308b\u969b\u306e\u30a8\u30e9\u30fc\u306e\u53ef\u80fd\u6027\u306b\u52a0\u3048\u3066\u3001\u6700\u7d42\u7684\u306a\u6587\u732e\u30ec\u30d3\u30e5\u30fc\u306e\u4e0d\u78ba\u5b9f\u6027\u306f\u3001\u30c7\u30fc\u30bf\u306e\u65b9\u6cd5\u8ad6\u7684\u54c1\u8cea\u3068\u3001\u610f\u56f3\u3055\u308c\u305f\u76ee\u7684\u306e\u3055\u307e\u3056\u307e\u306a\u5074\u9762\u306b\u95a2\u9023\u3057\u305f\u30c7\u30d0\u30a4\u30b9\u306e\u8a55\u4fa1\u306b\u5bfe\u3059\u308b\u30c7\u30fc\u30bf\u306e\u95a2\u9023\u6027\u3068\u3044\u30462\u3064\u306e\u30bd\u30fc\u30b9\u304b\u3089\u751f\u3058\u307e\u3059\u3002<\/span><span style=\"font-weight: 400;\">1]<\/span><span style=\"font-weight: 400;\">.\u5404\u30c7\u30fc\u30bf\u30bb\u30c3\u30c8\u306e\u91cd\u307f\u4ed8\u3051\u3092\u6c7a\u5b9a\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u4e21\u65b9\u306e\u4e0d\u78ba\u5b9f\u6027\u306e\u8981\u56e0\u3092\u5206\u6790\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u306e\u3088\u3046\u306b\u3001\u30c7\u30fc\u30bf\u306e\u8cea\u3092\u30d0\u30e9\u30f3\u30b9\u3088\u304f\u8a55\u4fa1\u3059\u308b\u3053\u3068\u304c\u3001\u6587\u732e\u30ec\u30d3\u30e5\u30fc\u691c\u7d22\u306e\u6210\u529f\u306b\u306f\u6b20\u304b\u305b\u307e\u305b\u3093\u3002<\/span><\/p>\n<p><strong><a href=\"https:\/\/www.kolabtree.com\/blog\/clinical-evaluation-for-eu-mdr-compliance-5-dos-and-donts\/\">\u3053\u3061\u3089\u3082\u304a\u8aad\u307f\u304f\u3060\u3055\u3044\u3002EU MDR\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u305f\u3081\u306e\u81e8\u5e8a\u8a55\u4fa1\u30025\u3064\u306e\u3084\u308b\u3079\u304d\u3053\u3068\u3001\u3084\u3063\u3066\u306f\u3044\u3051\u306a\u3044\u3053\u3068\u00a0<\/a><\/strong><\/p>\n<h2><span class=\"ez-toc-section\" id=\"3_Appraisal_of_the_clinical_data\"><\/span><strong>3.\u81e8\u5e8a\u30c7\u30fc\u30bf\u306e\u8a55\u4fa1<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u691c\u7d22\u3067\u5f97\u3089\u308c\u305f\u30c7\u30fc\u30bf\u3092\u8a55\u4fa1\u3059\u308b\u969b\uff08\u30b9\u30c6\u30fc\u30b82\uff09\u3001\u8a55\u4fa1\u8005\u306f\u3001\u7d71\u8a08\u7684\u306b\u6709\u610f\u306a\u30c7\u30fc\u30bf\u30bb\u30c3\u30c8\u3067\u3042\u308b\u3053\u3068\u3001\u9069\u5207\u306a\u7d71\u8a08\u624b\u6cd5\u3092\u7528\u3044\u3066\u3044\u308b\u3053\u3068\u3001\u9069\u5207\u306a\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u3092\u884c\u3063\u3066\u3044\u308b\u3053\u3068\u3001\u6b7b\u4ea1\u7387\u3084\u91cd\u7be4\u306a\u6709\u5bb3\u4e8b\u8c61\u306e\u30c7\u30fc\u30bf\u3092\u9069\u5207\u306b\u53ce\u96c6\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u307e\u3059\u3002<\/span><span style=\"font-weight: 400;\"> \u6284\u9332\u3084\u8981\u7d04\u3092\u8aad\u3080\u3060\u3051\u3067\u306f\u306a\u304f\u3001\u898b\u3064\u304b\u3063\u305f\u51fa\u7248\u7269\u306e\u5168\u6587\u306b\u57fa\u3065\u3044\u3066\u6b63\u3057\u3044\u8a55\u4fa1\u3092\u884c\u3046\u3053\u3068\u304c\u4e0d\u53ef\u6b20\u3067\u3059\u3002\u8a55\u4fa1\u3055\u308c\u305f\u5404\u6587\u66f8\u306b\u3064\u3044\u3066\u3001\u4ed6\u306e\u4eba\u304c\u5408\u7406\u7684\u306b\u691c\u8a0e\u3067\u304d\u308b\u7a0b\u5ea6\u306e\u8a55\u4fa1\u306e\u6587\u66f8\u304c\u5fc5\u8981\u3067\u3042\u308b\u3002\u307e\u305f\u3001\u8a55\u4fa1\u7d50\u679c\u306f\u3001\u5b8c\u6210\u3057\u305f\u6a5f\u5668\u306e\u81e8\u5e8a\u7684\u5b89\u5168\u6027\u3068\u6027\u80fd\u306b\u95a2\u3059\u308b\u7d50\u8ad6\u3092\u88cf\u4ed8\u3051\u308b\u3082\u306e\u3067\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044(<\/span><i><span style=\"font-weight: 400;\">e.g.<\/span><\/i><span style=\"font-weight: 400;\">\u30c7\u30d0\u30a4\u30b9\u95a2\u9023\u4ee5\u5916\u306e\u6587\u732e\u3092\u5f15\u7528\u3057\u305f\u5834\u5408\u3001\u8a55\u4fa1\u3068\u3057\u3066\u306f\u4f4e\u304f\u306a\u308a\u307e\u3059\u3002)<\/span><span style=\"font-weight: 400;\">5<\/span><span style=\"font-weight: 400;\">.\u533b\u5b66\u51fa\u7248\u7269\u3092\u8a55\u4fa1\u3059\u308b\u305f\u3081\u306b\u3001\u898f\u5247\u3067\u5b9a\u3081\u3089\u308c\u305f\u3044\u304f\u3064\u304b\u306e\u30ec\u30c3\u30c9\u30d5\u30e9\u30c3\u30b0\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\">\u3053\u306e\u8a18\u4e8b\u306b\u306f\u3001\u4f7f\u7528\u3055\u308c\u305f\u65b9\u6cd5\u3001\u60a3\u8005\u6570\u3001\u88fd\u54c1\u306e\u540c\u4e00\u6027\u306a\u3069\u306e\u57fa\u672c\u7684\u306a\u60c5\u5831\u304c\u6b20\u3051\u3066\u3044\u307e\u3059\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u7d71\u8a08\u7684\u306b\u6709\u610f\u3067\u3042\u308b\u306b\u306f\u5c0f\u3055\u3059\u304e\u308b\u30c7\u30fc\u30bf\u30bb\u30c3\u30c8\u3092\u6301\u3063\u3066\u3044\u307e\u3059\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u4e0d\u9069\u5207\u306a\u7d71\u8a08\u624b\u6cd5\u3092\u7528\u3044\u305f\u30c7\u30fc\u30bf\u304c\u542b\u307e\u308c\u3066\u3044\u307e\u3059\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u9069\u5207\u306a\u30b3\u30f3\u30c8\u30ed\u30fc\u30eb\u3092\u6b20\u3044\u305f\u7814\u7a76\u3092\u63a1\u7528\u3057\u3066\u3044\u308b\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u6b7b\u4ea1\u7387\u304a\u3088\u3073\u91cd\u7be4\u306a\u6709\u5bb3\u4e8b\u8c61\u30c7\u30fc\u30bf\u306e\u53ce\u96c6\u304c\u4e0d\u9069\u5207\u3067\u3042\u308b\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u8457\u8005\u306b\u3088\u308b\u8aa4\u5831\u3092\u63cf\u304f\u3002<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\u8a55\u4fa1\u8005\u306f\u3001\u6a5f\u5668\u306b\u5bfe\u3059\u308b\u88fd\u9020\u8005\u306e\u4e3b\u5f35\u3092\u78ba\u8a8d\u307e\u305f\u306f\u5426\u5b9a\u3059\u308b\u3088\u3046\u306a\u65b9\u6cd5\u3067\u3001\u81e8\u5e8a\u8a66\u9a13\u304c\u5b9a\u7fa9\u3055\u308c\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u3001\u307e\u305f\u3001\u3053\u308c\u3089\u306e\u8a66\u9a13\u306b\u306f\u3001\u7d50\u8ad6\u306e\u79d1\u5b66\u7684\u59a5\u5f53\u6027\u3092\u4fdd\u8a3c\u3059\u308b\u305f\u3081\u306e\u5341\u5206\u306a\u6570\u306e\u89b3\u5bdf\u7d50\u679c\u304c\u542b\u307e\u308c\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u3092\u691c\u8a3c\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/span><span style=\"font-weight: 400;\">1]<\/span><span style=\"font-weight: 400;\">.\u8a66\u9a13\u30c7\u30b6\u30a4\u30f3\u3084\u89e3\u6790\u304c\u4e0d\u5341\u5206\u306a\u305f\u3081\u306b\u3001\u5341\u5206\u306a\u6027\u80fd\u3092\u793a\u3059\u3053\u3068\u304c\u3067\u304d\u306a\u3044\u3068\u8003\u3048\u3089\u308c\u305f\u8ad6\u6587\u3067\u3082\u3001\u5b89\u5168\u6027\u306e\u89e3\u6790\u306b\u9069\u3057\u305f\u30c7\u30fc\u30bf\u304c\u542b\u307e\u308c\u3066\u3044\u308b\u5834\u5408\u304c\u3042\u308a\u3001\u305d\u306e\u9006\u3082\u307e\u305f\u7136\u308a\u3067\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u4e00\u822c\u7684\u306b\u3001\u81e8\u5e8a\u30c7\u30fc\u30bf\u306f\u3001\u5bfe\u8c61\u3068\u306a\u308b\u4eba\u53e3\u3092\u4ee3\u8868\u3059\u308b\u60a3\u8005\u3084\u30e6\u30fc\u30b6\u30fc\u3092\u5bfe\u8c61\u306b\u3001\u610f\u56f3\u3055\u308c\u305f\u76ee\u7684\u3067\u8a55\u4fa1\u5bfe\u8c61\u306e\u6a5f\u5668\u3092\u7528\u3044\u3066\u5b9f\u65bd\u3055\u308c\u305f\u3001\u9069\u5207\u306b\u8a2d\u8a08\u3055\u308c\u76e3\u8996\u3055\u308c\u305f\u7121\u4f5c\u70ba\u5316\u5bfe\u7167\u81e8\u5e8a\u8a66\u9a13\uff08\u7121\u4f5c\u70ba\u5316\u5bfe\u7167\u8a66\u9a13\u3068\u3082\u547c\u3070\u308c\u308b\uff09\u306b\u3088\u3063\u3066\u5f97\u3089\u308c\u305f\u3082\u306e\u3067\u3042\u308c\u3070\u3001\u6700\u3082\u9ad8\u3044\u91cd\u307f\u3092\u6301\u3064\u3079\u304d\u3067\u3042\u308b\u3068\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/span><span style=\"font-weight: 400;\">1]<\/span><span style=\"font-weight: 400;\">.\u898f\u5236\u5f53\u5c40\u306f\u3001\u7121\u4f5c\u70ba\u5316\u81e8\u5e8a\u8a66\u9a13\u304c\u5e38\u306b\u5b9f\u884c\u53ef\u80fd\u304a\u3088\u3073\uff0f\u307e\u305f\u306f\u9069\u5207\u3068\u306f\u9650\u3089\u306a\u3044\u3053\u3068\u3092\u8a8d \u3081\u3066\u304a\u308a\u3001\u4ee3\u66ff\u7684\u306a\u8a66\u9a13\u30c7\u30b6\u30a4\u30f3\u3092\u7528\u3044\u308b\u3053\u3068\u3067\u3001\u9069\u5207\u306a\u91cd\u307f\u4ed8\u3051\u306e\u3042\u308b\u95a2\u9023\u81e8\u5e8a\u60c5\u5831\u304c\u5f97\u3089\u308c\u308b\u53ef\u80fd\u6027\u304c \u3042\u308b\u3053\u3068\u3092\u8a8d\u3081\u3066\u3044\u308b\u3002\u30a8\u30d3\u30c7\u30f3\u30b9\u3092\u5426\u5b9a\u3059\u308b\u5834\u5408\u3001\u8a55\u4fa1\u8005\u306f\u305d\u306e\u7406\u7531\u3092\u6587\u66f8\u5316\u3059\u3079\u304d\u3067\u3042\u308b\u3002<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"4_Analysis_and_conclusions_generated_from_the_clinical_data\"><\/span><strong>4.\u81e8\u5e8a\u30c7\u30fc\u30bf\u304b\u3089\u5f97\u3089\u308c\u305f\u5206\u6790\u3068\u7d50\u8ad6<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u5206\u6790\u6bb5\u968e\uff08\u30b9\u30c6\u30fc\u30b83\uff09\u3067\u306f\u3001\u767a\u898b\u3055\u308c\u305f\u30c7\u30fc\u30bf\u304c\u5b9f\u969b\u306b\u81e8\u5e8a\u5b89\u5168\u8981\u6c42\u4e8b\u9805\u3001\u81e8\u5e8a\u6027\u80fd\u8981\u6c42\u4e8b\u9805\u3001\u304a\u3088\u3073\u4e00\u822c\u5b89\u5168\u6027\u80fd\u8981\u6c42\u4e8b\u9805\uff08GSPR\uff09\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u3092\u5224\u65ad\u3059\u308b\u305f\u3081\u306b\u3001\u7dcf\u5408\u7684\u306a\u8a55\u4fa1\u304c\u884c\u308f\u308c\u307e\u3059\u3002\u533b\u7642\u6a5f\u5668\u306e\u30ea\u30b9\u30af\u30fb\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u6bd4\u304c\u533b\u7642\u6a5f\u5668\u306e\u610f\u56f3\u3055\u308c\u305f\u76ee\u7684\u306b\u57fa\u3065\u3044\u3066\u9069\u5207\u3067\u3042\u308b\u304b\u3069\u3046\u304b\u3001\u3042\u308b\u3044\u306f\u533b\u7642\u6a5f\u5668\u304c\u88fd\u9020\u8005\u306e\u4e3b\u5f35\u3059\u308b\u3059\u3079\u3066\u306e\u6027\u80fd\u3092\u5b9f\u969b\u306b\u9054\u6210\u3067\u304d\u308b\u304b\u3069\u3046\u304b\u3092\u8a55\u4fa1\u3059\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002\u307e\u305f\u3001\u88fd\u9020\u8005\u304c\u63d0\u4f9b\u3059\u308b\u8cc7\u6599\uff08\u8868\u793a\uff0f\u8aac\u660e\u66f8\uff09\u304c\u3001\u610f\u56f3\u3055\u308c\u305f\u76ee\u7684\u3092\u8aac\u660e\u3057\u3001\u30ea\u30b9\u30af\u3092\u8efd\u6e1b\u3059\u308b\u306e\u306b\u5341\u5206\u3067\u3042\u308b\u304b\u3069\u3046\u304b [<\/span><span style=\"font-weight: 400;\">7]<\/span><span style=\"font-weight: 400;\">.\u5168\u4f53\u3068\u3057\u3066\u3001\u3053\u306e\u8a55\u4fa1\u306f\u3001\u6a5f\u5668\u306e\u30ea\u30b9\u30af\u304c\u6700\u5c0f\u9650\u3067\u3042\u308a\u3001\u305d\u306e\u76ee\u7684\u306b\u5fdc\u3058\u3066\u53d7\u3051\u5165\u308c\u3089\u308c\u308b\u304b\u3069\u3046\u304b\u3092\u7d50\u8ad6\u3065\u3051\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u3066\u3044\u307e\u3059\u3002\u305d\u306e\u305f\u3081\u3001\u6a5f\u5668\u3068\u8eab\u4f53\u306e\u9593\u306e\u76f8\u4e92\u4f5c\u7528\u3001\u6709\u5bb3\u4e8b\u8c61\u306e\u6570\u3068\u91cd\u75c7\u5ea6\u3001\u73fe\u5728\u306e\u533b\u7642\u6c34\u6e96\u306a\u3069\u3092\u7406\u89e3\u3059\u308b\u3053\u3068\u306f\u3001\u8003\u616e\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u70b9\u306e\u4e00\u3064\u3067\u3059\u3002<\/span><span style=\"font-weight: 400;\">1]<\/span><span style=\"font-weight: 400;\">.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u6587\u732e\u306e\u30c7\u30fc\u30bf\u306fExcel\u306e\u8868\u306b\u307e\u3068\u3081\u3089\u308c\u308b\u3053\u3068\u304c\u591a\u304f\u3001\u7570\u306a\u308b\u8a66\u9a13\u306e\u8a73\u7d30\u3001\u60a3\u8005\u96c6\u56e3\u3001\u30a8\u30f3\u30c9\u30dd\u30a4\u30f3\u30c8\u3001\u6709\u5bb3\u4e8b\u8c61\u306a\u3069\u3092\u6bd4\u8f03\u3059\u308b\u306e\u306b\u4fbf\u5229\u306a\u65b9\u6cd5\u3067\u3059\u3002[<\/span><span style=\"font-weight: 400;\">7]<\/span><span style=\"font-weight: 400;\">.\u3053\u308c\u306f\u3001\u8981\u7d04\u3068\u7d50\u8ad6\u3092\u66f8\u304f\u969b\u306b\u3001\u7814\u7a76\u9593\u306e\u9055\u3044\u3092\u6307\u6458\u3059\u308b\u306e\u306b\u975e\u5e38\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002\u307e\u305f\u3001\u8a55\u4fa1\u8005\u306f\u3001\u7a00\u306a\u5408\u4f75\u75c7\u3001\u4e2d\u9577\u671f\u7684\u306a\u6027\u80fd\u306b\u95a2\u3059\u308b\u4e0d\u78ba\u5b9f\u6027\u3001\u5e83\u304f\u4f7f\u7528\u3055\u308c\u305f\u5834\u5408\u306e\u5b89\u5168\u6027\u306a\u3069\u306e\u5074\u9762\u3092\u542b\u3081\u3001\u4e0d\u8db3\u3057\u3066\u3044\u308b\u30c7\u30fc\u30bf\u3092\u751f\u6210\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u8ffd\u52a0\u306e\u81e8\u5e8a\u7814\u7a76\u3084\u305d\u306e\u4ed6\u306e\u624b\u6bb5\u3092\u7279\u5b9a\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059[<\/span><span style=\"font-weight: 400;\">1]<\/span><span style=\"font-weight: 400;\">.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"5_Informatic_tools\"><\/span><strong>5.\u30a4\u30f3\u30d5\u30a9\u30de\u30c6\u30a3\u30af\u30b9\u30c4\u30fc\u30eb<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u3053\u306e\u81a8\u5927\u306a\u91cf\u306e\u6587\u732e\u691c\u7d22\u3068\u3044\u3046\u4f5c\u696d\u306f\u3001\u9069\u5207\u306a\u30ea\u30b5\u30fc\u30c1\u30a4\u30f3\u30d5\u30a9\u30de\u30c6\u30a3\u30af\u30b9\u306e\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u306b\u3088\u3063\u3066\u52b9\u7387\u5316\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u73fe\u5728\u3067\u306f\u3001\u30b3\u30f3\u30c6\u30f3\u30c4\u3068\u30a4\u30f3\u30c7\u30c3\u30af\u30b9\u306e\u89b3\u70b9\u304b\u3089\u3001\u533b\u7642\u6a5f\u5668\u3092\u9069\u5207\u306b\u30ab\u30d0\u30fc\u3059\u308b\u6587\u732e\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u3092\u9078\u629e\u3059\u308b\u3053\u3068\u304c\u9375\u3068\u306a\u308a\u307e\u3059\u3002 <strong>\u3042\u308b\u533b\u7642\u6a5f\u5668\u306b\u95a2\u3059\u308b\u6587\u732e\u3092\u8abf\u67fb\u3057\u305f\u30b1\u30fc\u30b9\u3067\u306f\u3001Embase\u3068SCI\uff08Science Citation Index\uff09\u304c\u4e0a\u4f4d\u306b\u30e9\u30f3\u30af\u30a4\u30f3\u3057\u307e\u3057\u305f\u3002<\/strong><\/span><strong>3].\u3057\u304b\u3057\u3001Medline\u3084BioMed Central\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u6587\u732e\u3092\u691c\u7d22\u3059\u308b\u305f\u3081\u306e\u30c8\u30c3\u30d7\u7814\u7a76\u60c5\u5831\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u3068\u8003\u3048\u3089\u308c\u3066\u304a\u308a\u3001\u8ab0\u3067\u3082\u5229\u7528\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/strong><\/p>\n<p><span style=\"font-weight: 400;\">\u81ea\u52d5\u691c\u7d22\u3092\u884c\u3044\u3001\u95a2\u9023\u3059\u308b\u65b0\u3057\u3044\u30c7\u30fc\u30bf\u3092E\u30e1\u30fc\u30eb\u30a2\u30e9\u30fc\u30c8\u3084RSS\u30d5\u30a3\u30fc\u30c9\u3067\u30e6\u30fc\u30b6\u30fc\u306b\u901a\u77e5\u3059\u308b\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u3092\u4f7f\u7528\u3059\u308b\u3053\u3068\u3067\u3001\u5927\u5e45\u306a\u6642\u9593\u306e\u7bc0\u7d04\u306b\u306a\u308a\u3001\u8a55\u4fa1\u8005\u306f\u63d0\u51fa\u306e\u6700\u7d42\u6bb5\u968e\u307e\u3067\u6700\u65b0\u306e\u60c5\u5831\u3092\u5f97\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/span><span style=\"font-weight: 400;\">3]<\/span><span style=\"font-weight: 400;\">.\u30c4\u30fc\u30eb\u306b\u9069\u5207\u306a\u30a4\u30f3\u30c7\u30c3\u30af\u30b9\u3068\u30bf\u30b0\u4ed8\u3051\u304c\u3055\u308c\u3066\u3044\u308c\u3070\u3001\u6587\u732e\u306e\u30c8\u30ea\u30a2\u30fc\u30b8\u3092\u7c21\u7d20\u5316\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u3055\u3089\u306b\u91cd\u8981\u306a\u3053\u3068\u306f\u3001\u6709\u5bb3\u4e8b\u8c61\u306e\u5831\u544a\u3092\u898b\u9003\u3059\u30ea\u30b9\u30af\u3092\u5287\u7684\u306b\u6e1b\u3089\u3059\u3053\u3068\u304c\u3067\u304d\u308b\u3068\u3044\u3046\u3053\u3068\u3067\u3059\u3002\u512a\u308c\u305f\u6587\u732e\u691c\u7d22\u30c4\u30fc\u30eb\u3068\u8a13\u7df4\u3055\u308c\u305f\u8a55\u4fa1\u8005\u306e\u7d44\u307f\u5408\u308f\u305b\u306f\u3001\u6587\u732e\u30ec\u30d3\u30e5\u30fc\u691c\u7d22\u306e\u30a8\u30e9\u30fc\u3084\u9650\u754c\u3092\u56de\u907f\u3059\u308b\u305f\u3081\u306e\u6700\u826f\u306e\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u3068\u306a\u308a\u307e\u3059\u3002<\/span><\/p>\n<p><strong><a href=\"https:\/\/www.kolabtree.com\/blog\/writing-a-clinical-evaluation-report-5-quick-tips\/\">\u3082\u304a\u8aad\u307f\u304f\u3060\u3055\u3044\u3002\u81e8\u5e8a\u8a55\u4fa1\u30ec\u30dd\u30fc\u30c8\u306e\u66f8\u304d\u65b9\u30025\u3064\u306e\u30af\u30a4\u30c3\u30af\u30d2\u30f3\u30c8<\/a><\/strong><\/p>\n<h2><span class=\"ez-toc-section\" id=\"6_Process_flow\"><\/span><strong>6.\u30d7\u30ed\u30bb\u30b9\u30d5\u30ed\u30fc<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u73fe\u4ee3\u306e\u898f\u5236\u8981\u4ef6\u306b\u3088\u308a\u3001\u751f\u7269\u533b\u5b66\u6587\u732e\u8abf\u67fb\u306f\u533b\u7642\u6a5f\u5668\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u306b\u304a\u3044\u3066\u4e0d\u53ef\u6b20\u306a\u3082\u306e\u3068\u306a\u3063\u3066\u3044\u307e\u3059\u3002\u305d\u306e\u305f\u3081\u3001\u95a2\u9023\u3059\u308b\u3059\u3079\u3066\u306e\u81e8\u5e8a\u30c7\u30fc\u30bf\u3092\u898b\u3064\u3051\u3066\u8981\u7d04\u3059\u308b\u305f\u3081\u306e\u512a\u308c\u305f\u6226\u7565\u304c\u5fc5\u8981\u3067\u3059\u3002<\/span><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\">\u7b54\u3048\u308b\u3079\u304d\u8cea\u554f\u3092\u7279\u5b9a\u3059\u308b\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u3069\u3061\u3089\u306e\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u304c\u8cea\u554f\u306b\u9069\u3057\u3066\u3044\u308b\u304b\u3092\u5224\u65ad\u3057\u307e\u3059\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Medical Subject Headings\uff08MeSH\uff09\u3001\u307e\u305f\u306fEmbase Subject Headings\uff08EmTree\uff09\u3092\u7279\u5b9a\u3059\u308b\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u4f7f\u7528\u3059\u3079\u304d\u6b63\u3057\u3044\u30d6\u30fc\u30eb\u8a9e\u3092\u8a8d\u8b58\u3059\u308b\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u6587\u732e\u691c\u7d22\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u4f5c\u6210\u3068\u6587\u66f8\u5316<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u6587\u732e\u691c\u7d22\u81ea\u52d5\u5316\u30c4\u30fc\u30eb\u3092\u5b9f\u884c\u3057\u307e\u3059\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u6587\u732e\u306e\u8a55\u4fa1\u3068\u5206\u6790\uff08\u96c6\u8a08\uff09\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u7d50\u8ad6\u3092\u307e\u3068\u3081\u307e\u3059\u3002<\/span><\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"Conclusions\"><\/span><strong>\u7d50\u8ad6<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u3092\u3059\u308b\u3068\u3044\u3046\u5f35\u308a\u307c\u3066\u306e\u3088\u3046\u306a\u4f5c\u696d\u3082\u3001\u5c06\u6765\u7684\u306b\u306f\u671f\u5f85\u3067\u304d\u305d\u3046\u3067\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/systematic-review?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDLitSearch\">\u7cfb\u7d71\u7684\u6587\u732e\u8abf\u67fb<\/a>, since <a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">\u4eba\u5de5\u77e5\u80fd<\/a> and natural language processing based-tools with cognitive capabilities provide a near-perfect solution [<\/span><span style=\"font-weight: 400;\">6]<\/span><span style=\"font-weight: 400;\">.\u3057\u304b\u3057\u3001\u305d\u308c\u307e\u3067\u306f\u3001\u6587\u732e\u306e\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3001\u30c8\u30ea\u30a2\u30fc\u30b8\u3001\u5206\u6790\u306e\u305f\u3081\u306e\u5c02\u7528\u306e\u6226\u7565\u3092\u5b9f\u884c\u3059\u308b\u305f\u3081\u306b\u3001\u7d44\u7e54\u5316\u3055\u308c\u305f\u9ad8\u5ea6\u306a\u6280\u8853\u3092\u6301\u3063\u305f\u7814\u7a76\u8a55\u4fa1\u8005\u304c\u4e0d\u53ef\u6b20\u3067\u3059\u3002<\/span><\/p>\n<blockquote><p><strong>\u56f0\u3063\u305f\u3068\u304d\u306f <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/literature-search?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDLitSearch\">\u6587\u732e\u8abf\u67fb<\/a> \u533b\u7642\u6a5f\u5668\u306e\u305f\u3081\u306e\uff1fKolabtree\u3067\u306f\u3001\u81e8\u5e8a\u8a55\u4fa1\u306e\u5c02\u9580\u5bb6\u3084\u6587\u732e\u8abf\u67fb\u306e\u5c02\u9580\u5bb6\u3092\u96c7\u3046\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u00a0<\/strong><\/p><\/blockquote>\n<p><strong>\u30ea\u30d5\u30a1\u30ec\u30f3\u30b9<\/strong><\/p>\n<ol>\n<li><a href=\"https:\/\/ec.europa.eu\/docsroom\/documents\/17522\/attachments\/1\/translations\/en\/renditions\/native\"><span style=\"font-weight: 400;\">\u6b27\u5dde\u59d4\u54e1\u4f1aCLINICAL EVALUATION: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES UNDER DIRECTIVES 93\/42\/EEC and 90\/385\/EEC. <\/span><i><span style=\"font-weight: 400;\">MEDDEV 27\/1 \u30ea\u30d3\u30b8\u30e7\u30f34<\/span><\/i><span style=\"font-weight: 400;\">. 2016.<\/span><\/a><\/li>\n<li><span style=\"font-weight: 400;\">FDA\u5e02\u8ca9\u627f\u8a8d\uff08PMA\uff09\u3092\u53d6\u5f97\u3057\u307e\u3057\u305f\u30022019;18 2020\u5e745\u6708\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u30a8\u30eb\u30bc\u30d3\u30a2\u30b7\u30b9\u30c6\u30de\u30c6\u30a3\u30c3\u30af\u306a\u6587\u732e\u30ec\u30d3\u30e5\u30fc\u3067\u533b\u7642\u6a5f\u5668\u958b\u767a\u306e\u6210\u529f\u3092\u5f8c\u62bc\u3057\u3059\u308b\u30022014;18th May 2020.<\/span><\/li>\n<li><a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfpmn\/pmn.cfm\"><span style=\"font-weight: 400;\">FDA\u5e02\u8ca9\u524d\u901a\u77e5510(k)\u30022020;19th May 2020.<\/span><\/a><\/li>\n<li><span style=\"font-weight: 400;\">OrielStat.EU CER\u6587\u732e\u30ec\u30d3\u30e5\u30fc\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u4f5c\u6210\u3068\u533b\u7642\u6a5f\u5668\u81e8\u5e8a\u30c7\u30fc\u30bf\u306e\u30ec\u30d3\u30e5\u30fc\u30022019\u5e74;2020\u5e745\u670818\u65e5\u306b\u958b\u50ac\u3055\u308c\u307e\u3059\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Ashish Indani* SRB, Nadeem Ansari.\u533b\u7642\u6a5f\u5668\u306b\u304a\u3051\u308b\u79d1\u5b66\u7684\u30d7\u30ed\u30bb\u30b9\u306e\u6587\u732e\u691c\u7d22\u3002\u8ab2\u984c\u3001\u30a8\u30e9\u30fc\u3001\u304a\u3088\u3073\u7de9\u548c\u6226\u7565\u3002 <\/span><i><span style=\"font-weight: 400;\">\u30bf\u30bf \u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30b7\u30fc<\/span><\/i><span style=\"font-weight: 400;\">. 2017;7.<\/span><\/li>\n<li><span style=\"font-weight: 400;\">OrielStat.\u3042\u306a\u305f\u306e\u533b\u7642\u6a5f\u5668\u306e\u81e8\u5e8a\u30c7\u30fc\u30bf\u30bb\u30c3\u30c8\u3092\u5206\u6790\u3057\u3001\u7d50\u8ad6\u3092\u5c0e\u304d\u307e\u3059\u30022019;18\u5e745\u67082020\u5e74\u3002<\/span><\/li>\n<\/ol>","protected":false},"excerpt":{"rendered":"<p>Catarina Carr\u00e3o, freelance medical writer on Kolabtree, outlines the importance of literature reviews for medical devices and best practices to follow.\u00a0 A clinical evaluation is an ongoing process, conducted throughout the life cycle of a medical device. It is usually first performed during the development phase of the medical device, in order to identify the data that it needs to be granted market access. In the European Union, for an initial CE-marking, a Clinical Evaluation Report (CER) is mandatory, and it must be actively updated continuously afterwards[1]. In the United States, a Pre-Market Approval (PMA) [2] is the Food and Drug Administration (FDA) process for scientific and regulatory review, to<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/literature-reviews-for-medical-devices-6-expert-tips\/\" title=\"\u7d9a\u304d\u3092\u8aad\u3080\">\u7d9a\u304d\u3092\u8aad\u3080<\/a><\/div>","protected":false},"author":12,"featured_media":7672,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[540],"tags":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.1 (Yoast SEO v20.1) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Literature Reviews for Medical Devices: 6 Expert Tips - The Kolabtree Blog<\/title>\n<meta name=\"description\" content=\"Expert tips to follow while conducting literature reviews for medical devices, including tips on search strategy, clinical data appraisal and regulations.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/literature-reviews-for-medical-devices-6-expert-tips\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Literature Reviews for Medical Devices: 6 Expert Tips\" \/>\n<meta property=\"og:description\" content=\"Expert tips to follow while conducting literature reviews for medical devices, including tips on search strategy, clinical data appraisal and regulations.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.kolabtree.com\/blog\/ja\/literature-reviews-for-medical-devices-6-expert-tips\/\" \/>\n<meta property=\"og:site_name\" content=\"The Kolabtree Blog\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/kolabtree\" \/>\n<meta property=\"article:published_time\" content=\"2020-05-26T10:57:43+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2020-05-26T13:07:15+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/05\/Literature-Reviews-for-Medical-Devices-6-Expert-Tips.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1280\" \/>\n\t<meta property=\"og:image:height\" content=\"816\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Ramya Sriram\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@kolabtree\" \/>\n<meta name=\"twitter:site\" content=\"@kolabtree\" \/>\n<meta name=\"twitter:label1\" content=\"\u57f7\u7b46\u8005\" \/>\n\t<meta name=\"twitter:data1\" content=\"Ramya Sriram\" \/>\n\t<meta name=\"twitter:label2\" content=\"\u63a8\u5b9a\u8aad\u307f\u53d6\u308a\u6642\u9593\" \/>\n\t<meta name=\"twitter:data2\" content=\"11\u5206\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Literature Reviews for Medical Devices: 6 Expert Tips - 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