{"id":3898,"date":"2022-10-18T09:22:56","date_gmt":"2022-10-18T01:22:56","guid":{"rendered":"https:\/\/regask.com\/?p=3898"},"modified":"2024-11-22T05:20:25","modified_gmt":"2024-11-21T21:20:25","slug":"%e5%88%86%e6%95%a3%e5%9e%8b%e8%87%a8%e5%ba%8a%e8%a9%a6%e9%a8%93%e3%82%ac%e3%82%a4%e3%83%89%e3%83%96%e3%83%83%e3%82%af","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/decentralized-clinical-trials-guidebooks\/","title":{"rendered":"\u898f\u5236\u30ac\u30a4\u30c9\u30d6\u30c3\u30af\u304c\u5206\u6563\u578b\u30af\u30e9\u30a6\u30c9\u3078\u306e\u9053\u3092\u62d3\u304f"},"content":{"rendered":"<p><span data-contrast=\"none\">\u30cf\u30a4\u30d6\u30ea\u30c3\u30c9\u578b\u304a\u3088\u3073\u5206\u6563\u578b\u81e8\u5e8a\u8a66\u9a13\uff08DCT\uff09\u306e\u5c0e\u5165\u306f\u4e16\u754c\u4e2d\u3067\u52a0\u901f\u3057\u3066\u3044\u308b\u3002\u30a8\u30d9\u30ec\u30b9\u30c8\u30b0\u30eb\u30fc\u30d7\u306b\u3088\u308b\u3068\u3001 <\/span><a href=\"https:\/\/www.obviohealth.com\/resources\/a-look-ahead-decentralized-clinical-trials-in-2023\"><span data-contrast=\"none\">\u696d\u754c\u306e90%\u306f2024\u5e74\u307e\u3067\u306b\u81e8\u5e8a\u8a66\u9a13\u306bDCT\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u3092\u7d44\u307f\u8fbc\u3080\u4e88\u5b9a<\/span><\/a><span data-contrast=\"none\">\u3057\u304b\u3057\u3001\u30b9\u30dd\u30f3\u30b5\u30fc\u3084\u958b\u767a\u696d\u52d9\u53d7\u8a17\u6a5f\u95a2 (CRO) \u306b\u3068\u3063\u3066\u3001DCT \u3092\u6210\u529f\u3055\u305b\u308b\u306b\u306f\u8ab2\u984c\u3082\u5897\u3048\u3066\u3044\u307e\u3059\u3002\u4e3b\u306a\u8ab2\u984c\u306e 1 \u3064\u306f\u3001\u898f\u5236\u306b\u30a2\u30af\u30bb\u30b9\u3057\u3066\u7406\u89e3\u3059\u308b\u3053\u3068\u3067\u3059\u3002<\/span><span data-ccp-props=\"{&quot;134233117&quot;:true,&quot;134233118&quot;:false,&quot;201341983&quot;:2,&quot;335559739&quot;:240,&quot;335559740&quot;:330}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">DCT \u306e\u5c0e\u5165\u3092\u53d6\u308a\u5dfb\u304f\u898f\u5236\u74b0\u5883\u306f\u8907\u96d1\u304b\u3064\u65ad\u7247\u5316\u3057\u3066\u3044\u307e\u3059\u3002DCT \u898f\u5236\u306f\u7d76\u3048\u305a\u5909\u5316\u3057\u306a\u304c\u3089\u9032\u5316\u3057\u3066\u304a\u308a\u3001\u56fd\u3054\u3068\u306b\u7570\u306a\u308a\u307e\u3059\u3002\u3057\u304b\u3057\u3001DCT \u74b0\u5883\u306b\u95a2\u3059\u308b\u7d71\u5408\u3055\u308c\u305f\u4e16\u754c\u7684\u306a\u898f\u5236\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306f\u307e\u3060\u7b56\u5b9a\u3055\u308c\u3066\u304a\u3089\u305a\u3001\u8a66\u9a13\u5c0e\u5165\u306b\u306f\u591a\u304f\u306e\u4e0d\u78ba\u5b9f\u6027\u3068\u6f5c\u5728\u7684\u306a\u9045\u5ef6\u304c\u751f\u3058\u3066\u3044\u307e\u3059\u3002\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:true,&quot;134233118&quot;:false,&quot;201341983&quot;:2,&quot;335559739&quot;:240,&quot;335559740&quot;:330}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">\u30b9\u30dd\u30f3\u30b5\u30fc\u3068 CRO \u304c\u8ab2\u984c\u3092\u514b\u670d\u3067\u304d\u308b\u3088\u3046\u3001RegASK \u306f 24 \u304b\u56fd\u3092\u7db2\u7f85\u3059\u308b DCT \u898f\u5236\u30ac\u30a4\u30c9\u30d6\u30c3\u30af \u30b7\u30ea\u30fc\u30ba\u3092\u958b\u767a\u3057\u307e\u3057\u305f\u3002\u3053\u306e\u30ac\u30a4\u30c9\u30d6\u30c3\u30af\u306f\u3001DCT \u306e\u8981\u7d20\u3068\u305d\u306e\u30cb\u30e5\u30a2\u30f3\u30b9\u3092\u8a73\u7d30\u306b\u89e3\u8aac\u3057\u3001\u73fe\u5728\u306e DCT \u898f\u5236\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u306b\u95a2\u3059\u308b\u91cd\u8981\u304b\u3064\u691c\u8a3c\u6e08\u307f\u306e\u60c5\u5831\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002\u30ac\u30a4\u30c9\u30d6\u30c3\u30af\u306e\u60c5\u5831\u306f\u308f\u304b\u308a\u3084\u3059\u3044\u30c7\u30b8\u30bf\u30eb \u30e9\u30a4\u30d6\u30e9\u30ea\u3067\u63d0\u4f9b\u3055\u308c\u3066\u304a\u308a\u3001\u8aad\u8005\u306f\u4e00\u822c\u7684\u306a\u81e8\u5e8a\u8a66\u9a13\u898f\u5236\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\u3068 DCT \u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u3092\u3088\u308a\u8fc5\u901f\u304b\u3064\u7c21\u5358\u306b\u7406\u89e3\u3067\u304d\u307e\u3059\u3002\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:true,&quot;134233118&quot;:false,&quot;201341983&quot;:2,&quot;335559739&quot;:240,&quot;335559740&quot;:330}\">\u00a0<\/span><\/p>\n<p><b><span data-contrast=\"none\">\u30b1\u30fc\u30b9 \u30b9\u30bf\u30c7\u30a3\u3092\u8aad\u3093\u3067\u3001RegASK \u306e\u30ac\u30a4\u30c9\u30d6\u30c3\u30af\u304c\u3001\u30cf\u30a4\u30d6\u30ea\u30c3\u30c9\u307e\u305f\u306f\u5206\u6563\u578b\u81e8\u5e8a\u8a66\u9a13\u306e\u3042\u3089\u3086\u308b\u898f\u5236\u9762\u3067 CRO \u3092\u652f\u63f4\u3057\u3001\u52b9\u7387\u7684\u304b\u3064\u6210\u529f\u3059\u308b\u8a66\u9a13\u306e\u5b9f\u65bd\u306b\u3069\u306e\u3088\u3046\u306b\u5f79\u7acb\u3064\u304b\u3092\u5b66\u3073\u307e\u3059\u3002\u00a0<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:240,&quot;335559740&quot;:240}\">\u00a0<\/span><\/p>\n<h2 class=\"h4\"><strong>\u5ba2\u89b3\u7684<\/strong><\/h2>\n<p><span data-contrast=\"none\">\u30d0\u30fc\u30c1\u30e3\u30eb\u81e8\u5e8a\u8a66\u9a13\u3092\u5c02\u9580\u3068\u3059\u308b\u4e16\u754c\u7684\u306a CRO \u306f\u3001\u4e16\u754c\u4e2d\u306e\u81e8\u5e8a\u8a66\u9a13\u30b9\u30dd\u30f3\u30b5\u30fc\u306b\u30c6\u30af\u30ce\u30ed\u30b8\u30fc\u3092\u6d3b\u7528\u3057\u305f DCT \u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u3092\u63d0\u4f9b\u3057\u3066\u304d\u307e\u3057\u305f\u3002 <\/span><span data-contrast=\"none\">\u308f<\/span><span data-contrast=\"none\">\u65b0\u3057\u3044\u56fd\u3067 DCT \u3092\u767b\u9332\u3057\u305f\u308a\u3001\u81e8\u5e8a\u8a66\u9a13\u3067\u30c6\u30af\u30ce\u30ed\u30b8\u30fc\u3092\u6d3b\u7528\u3057\u305f\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u3092\u4f7f\u7528\u3057\u305f\u308a\u3059\u308b\u3053\u3068\u3092\u8a08\u753b\u3057\u3066\u3044\u308b\u5834\u5408\u3001\u898f\u5236\u4e0a\u306e\u7591\u554f\u304c\u751f\u3058\u3001\u8a66\u9a13\u3092\u9045\u3089\u305b\u308b\u969c\u5bb3\u3068\u306a\u308b\u3053\u3068\u304c\u3088\u304f\u3042\u308a\u307e\u3059\u3002\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:160,&quot;335559740&quot;:259}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">\u8a66\u9a13\u306e\u5b9f\u65bd\u3092\u5c0e\u304f\u305f\u3081\u306b\u3001\u30c1\u30fc\u30e0\u306f\u3055\u307e\u3056\u307e\u306a\u56fd\u306e DCT \u898f\u5236\u5f53\u5c40\u304b\u3089\u898f\u5236\u60c5\u5831\u3092\u624b\u4f5c\u696d\u3067\u53ce\u96c6\u3057\u3066\u3044\u307e\u3057\u305f\u304c\u3001\u3053\u308c\u306f\u6642\u9593\u304c\u304b\u304b\u308a\u3001\u6574\u7406\u3055\u308c\u3066\u304a\u3089\u305a\u3001\u8a66\u9a13\u306e\u767b\u9332\u3068\u5b9f\u884c\u306b\u95a2\u9023\u3059\u308b\u3059\u3079\u3066\u306e\u8cea\u554f\u306b\u7b54\u3048\u308b\u306b\u306f\u4e0d\u5341\u5206\u3067\u3057\u305f\u3002<\/span><span data-ccp-props=\"{&quot;134233117&quot;:true,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559739&quot;:240,&quot;335559740&quot;:240}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">CRO \u306f\u3001\u30af\u30e9\u30a4\u30a2\u30f3\u30c8\u306e\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u3092\u3088\u308a\u9069\u5207\u306b\u30ac\u30a4\u30c9\u3057\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u52b9\u7387\u6027\u3092\u5411\u4e0a\u3055\u305b\u308b\u305f\u3081\u306b\u3001\u4e16\u754c\u7684\u306a DCT \u898f\u5236\u74b0\u5883\u306b\u95a2\u3059\u308b\u5b8c\u5168\u304b\u3064\u5fb9\u5e95\u3057\u305f\u6d1e\u5bdf\u3092\u63d0\u4f9b\u3067\u304d\u308b\u30ef\u30f3\u30b9\u30c8\u30c3\u30d7\u898f\u5236\u30b5\u30fc\u30d3\u30b9\u3092\u63a2\u3057\u3066\u3044\u307e\u3057\u305f\u3002<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;201341983&quot;:0,&quot;335559738&quot;:0,&quot;335559739&quot;:312,&quot;335559740&quot;:240}\">\u00a0<\/span><\/p>\n<h2 class=\"h4\"><strong>\u89e3\u6c7a<\/strong><\/h2>\n<ul>\n<li><span class=\"TextRun SCXW65571966 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW65571966 BCX0\">RegASK d<\/span><span class=\"NormalTextRun SCXW65571966 BCX0\">\u30cf\u30a4\u30d6\u30ea\u30c3\u30c9\u578b\u307e\u305f\u306f\u5b8c\u5168\u306b\u5206\u6563\u5316\u3055\u308c\u305f\u81e8\u5e8a\u8a66\u9a13\u3092\u5b9f\u65bd\u3059\u308b\u305f\u3081\u306e\u898f\u5236\u8981\u4ef6\u306e\u3042\u3089\u3086\u308b\u5074\u9762\u3092\u5f37\u8abf\u3057\u305f\u8a73\u7d30\u306a\u30ac\u30a4\u30c9\u30d6\u30c3\u30af\u3092\u4f5c\u6210\u3057\u305f\u3002 <\/span><span class=\"NormalTextRun SCXW65571966 BCX0\">\u4ee5\u4e0a <\/span><span class=\"NormalTextRun SCXW65571966 BCX0\">3<\/span><span class=\"NormalTextRun SCXW65571966 BCX0\">0<\/span><span class=\"NormalTextRun SCXW65571966 BCX0\"> \u30a2\u30b8\u30a2\u3001\u30e9\u30c6\u30f3\u30a2\u30e1\u30ea\u30ab\u3001EU\u3092\u30ab\u30d0\u30fc\u3059\u308b\u5e02\u5834<\/span><span class=\"NormalTextRun SCXW65571966 BCX0\">,<\/span><span class=\"NormalTextRun SCXW65571966 BCX0\"> \u5317\u7c73<\/span><span class=\"NormalTextRun SCXW65571966 BCX0\">. <\/span><\/span>\u30c7\u30b8\u30bf\u30eb \u30ac\u30a4\u30c9\u30d6\u30c3\u30af\u306b\u306f\u3001\u8abf\u67fb\u30b5\u30f3\u30d7\u30eb\u306e\u30a4\u30f3\u30dd\u30fc\u30c8\u3001\u8abf\u67fb\u54e1\u306e\u6240\u5728\u5730\u3068\u8cc7\u683c\u8981\u4ef6\u3001eConsent\u3001eSingature\u3001ePRO\u3001HHCP \u8a2a\u554f\u304b\u3089\u3001\u30c7\u30fc\u30bf\u4fdd\u5b58\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u691c\u8a3c\u3068\u59a5\u5f53\u6027\u78ba\u8a8d\u3001\u30c7\u30fc\u30bf\u8ee2\u9001\u898f\u5236\u307e\u3067\u3001DCT \u6226\u7565\u306e\u69cb\u7bc9\u306b\u5fc5\u8981\u306a\u30a8\u30f3\u30c9\u30c4\u30fc\u30a8\u30f3\u30c9\u306e\u60c5\u5831\u304c\u7db2\u7f85\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/li>\n<\/ul>\n<ul>\n<li><span data-contrast=\"none\">RegASK \u306f\u3001\u30c7\u30b8\u30bf\u30eb\u81e8\u5e8a\u8a66\u9a13\u306e\u767b\u9332\u306b\u95a2\u3059\u308b\u56fd\u5225\u306e\u8981\u4ef6\u306e\u6982\u8981\u3092\u4f5c\u6210\u3057\u3001\u63d0\u51fa\u30d7\u30ed\u30bb\u30b9\u306e\u30ed\u30fc\u30c9\u30de\u30c3\u30d7\u3092\u8a2d\u8a08\u3057\u307e\u3057\u305f\u3002\u00a0<\/span><\/li>\n<li>\u30ac\u30a4\u30c9\u30d6\u30c3\u30af\u306f\u3001RegASK\u306e\u30a4\u30f3\u30c6\u30ea\u30b8\u30a7\u30f3\u30b9\u3068\u7d99\u7d9a\u7684\u306a\u76e3\u8996\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u3092\u901a\u3058\u3066\u5e38\u306b\u66f4\u65b0\u3055\u308c\u3066\u3044\u307e\u3059\u3002 <a href=\"https:\/\/regask.com\/ja\/our-solution\/\"><span data-contrast=\"none\">\u767b\u9332\u30a2\u30e9\u30fc\u30c8<\/span><\/a><span data-contrast=\"none\"> \u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u3002<\/span><span data-ccp-props=\"{&quot;134233117&quot;:true,&quot;201341983&quot;:0,&quot;335559739&quot;:144,&quot;335559740&quot;:240}\">\u00a0<\/span><\/li>\n<\/ul>\n<h2 class=\"h4\"><strong>\u7d50\u679c<\/strong><\/h2>\n<p><span class=\"TextRun SCXW21309744 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW21309744 BCX0\">\u306e <\/span><span class=\"NormalTextRun SCXW21309744 BCX0\">\u6700\u9ad8\u7d4c\u55b6\u8cac\u4efb\u8005<\/span> <span class=\"NormalTextRun SCXW21309744 BCX0\">\u7372\u5f97\u3057\u305f<\/span> <span class=\"NormalTextRun SCXW21309744 BCX0\">\u660e\u78ba\u5316<\/span><span class=\"NormalTextRun SCXW21309744 BCX0\"> \u95a2\u9023\u3059\u308b\u898f\u5236 <\/span><span class=\"NormalTextRun SCXW21309744 BCX0\">\u3060<\/span><span class=\"NormalTextRun SCXW21309744 BCX0\">CT\u767b\u9332<\/span><span class=\"NormalTextRun SCXW21309744 BCX0\"> \u305d\u3057\u3066 <\/span><span class=\"NormalTextRun SCXW21309744 BCX0\">\u5b9f\u88c5\u3001 <\/span><span class=\"NormalTextRun SCXW21309744 BCX0\">\u8a08\u753b\u3092\u7acb\u3066\u3001 <\/span><span class=\"NormalTextRun SCXW21309744 BCX0\">DCT\u3092\u5b9f\u88c5\u3059\u308b<\/span> <span class=\"NormalTextRun SCXW21309744 BCX0\">3<\/span><span class=\"NormalTextRun SCXW21309744 BCX0\">0<\/span><span class=\"NormalTextRun SCXW21309744 BCX0\"> \u56fd\u3068 <\/span><span class=\"NormalTextRun SCXW21309744 BCX0\">\u3055\u3089\u306b\u3001\u898f\u5236\u8abf\u67fb\u306b\u8cbb\u3084\u3059\u6570\u767e\u6642\u9593\u3092\u7bc0\u7d04\u3057\u3001\u8a66\u9a13\u306e\u52b9\u7387\u3092\u5927\u5e45\u306b\u5411\u4e0a\u3055\u305b\u307e\u3059\u3002\u00a0<\/span><\/span><span class=\"EOP SCXW21309744 BCX0\" data-ccp-props=\"{&quot;134233117&quot;:true,&quot;201341983&quot;:0,&quot;335559739&quot;:144,&quot;335559740&quot;:240}\">\u00a0<\/span><\/p>\n<p>&nbsp;<\/p>\n<h2 style=\"text-align: center;\" data-line-height=\"xs\">DCT \u306b\u95a2\u3059\u308b\u898f\u5236\u30b5\u30dd\u30fc\u30c8\u304c\u5fc5\u8981\u3067\u3059\u304b?<\/h2>\n<h2 style=\"text-align: center;\" data-line-height=\"xs\">\u5c02\u9580\u5bb6\u306b\u3054\u76f8\u8ac7\u304f\u3060\u3055\u3044<\/h2>\n<p style=\"text-align: center;\">\u307e\u305f\u306f\u3001\u3053\u306e\u756a\u53f7\u3092\u30af\u30ea\u30c3\u30af\u3057\u3066WhatsApp\u3067\u304a\u554f\u3044\u5408\u308f\u305b\u3044\u305f\u3060\u304f\u3053\u3068\u3082\u3067\u304d\u307e\u3059\u3002\u00a0<a href=\"https:\/\/wa.me\/+6581282161?text=I%27m%20interested%20in%20RegASK%20solution\">+65 8128 2161<\/a><\/p>\n\n\t<section class=\"section\" id=\"section_867582417\">\n\t\t<div class=\"section-bg fill\" >\n\t\t\t\t\t\t\t\t\t\n\t\t\t\n\n\t\t<\/div>\n\n\t\t\n\n\t\t<div class=\"section-content relative\">\n\t\t\t\n\n<div class=\"row\"  id=\"row-1728398551\">\n\n\n\t<div id=\"col-1416478862\" class=\"col medium-10 small-12 large-10\"  >\n\t\t\t\t<div class=\"col-inner text-center\"  >\n\t\t\t\n\t\t\t\n\n\n\n<script charset=\"utf-8\" type=\"text\/javascript\" src=\"\/\/js.hsforms.net\/forms\/embed\/v2.js\"><\/script>\n<script>\n  hbspt.forms.create({\n    region: \"na1\",\n    portalId: \"20908020\",\n    formId: \"0af2c091-f9d4-497e-812e-14d3abddf395\"\n  });\n<\/script>\n\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n<\/div>\n\n\t\t<\/div>\n\n\t\t\n<style>\n#section_867582417 {\n  padding-top: 30px;\n  padding-bottom: 30px;\n  background-color: rgb(242,246,253);\n}\n<\/style>\n\t<\/section>","protected":false},"excerpt":{"rendered":"<p>The adoption of hybrid and decentralized clinical trials (DCTs) has been accelerating across the world. According to Everest Group, 90% of the industry will incorporate some DCT components for their clinical trials by 2024. However, challenges have also increased for sponsors and Contract Research Organizations (CROs) to carry out DCTs successfully. One of the key challenges is accessing and understanding the regulations.\u00a0 The regulatory landscape surrounding the implementation of DCTs is complex and fragmented. DCT regulations are evolving with constant changes and are varying country by country. But a consolidated global regulatory guidance on the DCT landscape is yet to be developed, which brings many uncertainties and potential delays in&#8230;<\/p>","protected":false},"author":39,"featured_media":3913,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[17,22],"tags":[],"class_list":["post-3898","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-case-study","category-medical-devices"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Decentralized Clinical Trials Guidebooks | RegASK<\/title>\n<meta name=\"description\" content=\"Regulatory guidebooks are paving the way for decentralized clinical trials. 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