{"id":167,"date":"2023-04-02T09:26:44","date_gmt":"2023-04-02T00:26:44","guid":{"rendered":"http:\/\/kdss.org\/?page_id=167"},"modified":"2026-04-16T15:30:21","modified_gmt":"2026-04-16T06:30:21","slug":"kdss%e3%81%ae%e7%b4%b9%e4%bb%8b","status":"publish","type":"page","link":"http:\/\/kdss.org\/?page_id=167","title":{"rendered":"KDSS\u306e\u7d39\u4ecb"},"content":{"rendered":"<h3 class=\"paragraph\">\u3054\u6328\u62f6<\/h3>\n<div id=\"sp-block-container-4\" class=\"sp-part-top sp-block-container\">\n<p class=\"paragraph\">\u3000\u8fd1\u5e74\uff0c\u300c\u4eba\u3092\u5bfe\u8c61\u3068\u3059\u308b\u751f\u547d\u79d1\u5b66\u30fb\u533b\u5b66\u7cfb\u7814\u7a76\u306b\u95a2\u3059\u308b\u502b\u7406\u6307\u91dd\u300d\u3042\u308b\u3044\u306f\uff0c\u300c\u81e8\u5e8a\u7814\u7a76\u6cd5\u300d\u306e\u65bd\u884c\u7b49\uff0c\u81e8\u5e8a\u7814\u7a76\u3092\u53d6\u308a\u5dfb\u304f\u74b0\u5883\u304c\u76ee\u307e\u3050\u308b\u3057\u304f\u5909\u5316\u3057\u3066\u3044\u307e\u3059\uff0e\u305d\u306e\u3088\u3046\u306a\u306a\u304b\u3067\uff0cARO (Academic Research Organization)\u306e\u91cd\u8981\u6027\u304c\u5897\u3057\u3066\u3044\u307e\u3059\uff0e\u307e\u305f\uff0cAMED\u306b\u3088\u308b\u751f\u7269\u7d71\u8a08\u5bb6\u306e\u80b2\u6210\u4e8b\u696d\u304c\u9032\u3093\u3067\u304a\u308a\uff0c\u82e5\u624b\u306e\u533b\u5b66\u751f\u7269\u7d71\u8a08\u5bb6\u304c\u5897\u52a0\u3057\u3066\u3044\u307e\u3059\uff0e\u4e00\u65b9\u3067\uff0c\u88fd\u85ac\u4f01\u696d\u30fbCRO\u306b\u76ee\u3092\u5411\u3051\u307e\u3059\u3068\uff0c\u30ea\u30a2\u30eb\u30ef\u30fc\u30eb\u30c9\u30fb\u30c7\u30fc\u30bf(RWD)\u306e\u81e8\u5e8a\u8a55\u4fa1\u3078\u306e\u5229\u6d3b\u7528\uff0c\u30d7\u30ed\u30b0\u30e9\u30e0\u533b\u7642\u6a5f\u5668\uff0cDCT (Decentralized Clinical Trial)\uff0cDX(Digital Transformation)\u306b\u4ee3\u8868\u3055\u308c\u308bICT\u6280\u8853\u306e\u5c0e\u5165\u304c\u7a4d\u6975\u7684\u306b\u9032\u3093\u3067\u3044\u307e\u3059\uff0e<\/p>\n<p class=\"paragraph\">\u3000\u307e\u305f\uff0c\u7d71\u8a08\u79d1\u5b66\u306b\u76ee\u3092\u79fb\u3059\u3068\uff0c\u300c\u30c7\u30fc\u30bf\u30b5\u30a4\u30a8\u30f3\u30b9\u300d\u306e\u547c\u79f0\u306e\u3082\u3068\uff0c\u69d8\u3005\u306a\u5834\u9762\u3067\u6ce8\u76ee\u3055\u308c\u3066\u304a\u308a\uff0c\u591a\u304f\u306e\u5b66\u90e8\u304c\u65b0\u8a2d\u3055\u308c\u3066\u304d\u3066\u3044\u307e\u3059\uff0e<\/p>\n<p class=\"paragraph\">\u3000\u3053\u306e\u3088\u3046\u306a\u6642\u6d41\u306e\u306a\u304b\u3067\uff0c\u300c\u4ea4\u6d41\u306e\u5834\u300d\u306b\u76ee\u3092\u5411\u3051\u307e\u3059\u3068\uff0c\u533b\u7642\u5206\u91ce\u3067\u306f\uff0c\u30c7\u30fc\u30bf\u30de\u30cd\u30fc\u30b8\u30e3\u30fc\uff0cCRA(Clinical Reseach Administrator)\uff0c\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30bf\u30fc\uff0c\u81e8\u5e8a\u7814\u7a76\u306b\u95a2\u4fc2\u3059\u308bIT\u6280\u8853\u8005\uff0c\u30ec\u30ae\u30e5\u30e9\u30c8\u30ea\u30fc\u30b5\u30a4\u30a8\u30f3\u30b9\u306b\u95a2\u9023\u3059\u308b\u30b9\u30bf\u30c3\u30d5\u7b49\u304c\u4ea4\u6d41\u3059\u308b\u6a5f\u4f1a\u306f\u3042\u307e\u308a\u306a\u3044\u3088\u3046\u306b\u601d\u3044\u307e\u3059\uff0e\u307e\u305f\uff0c\u88fd\u85ac\u4f01\u696d\uff0cCRO\uff0c\u30a2\u30ab\u30c7\u30df\u30a2\u306a\u3069\u306e\u8077\u7a2e\u6a2a\u65ad\u7684\u306a\u4ea4\u6d41\u3042\u308b\u3044\u306f\u7d71\u8a08\u79d1\u5b66\uff0c\u533b\u7642\u306e\u3042\u3044\u3060\u306e\u5206\u91ce\u6a2a\u65ad\u578b\u306e\u4ea4\u6d41\u3082\u5341\u5206\u3067\u306a\u3044\u3088\u3046\u306b\u601d\u3044\u307e\u3059\uff0e<\/p>\n<p class=\"paragraph\">\u3000\u3055\u3089\u306b\u306f\uff0c\u82e5\u624b\u306e\u533b\u5b66\u7d71\u8a08\u5bb6\uff0c\u75ab\u5b66\u8005(\u3068\u304f\u306b\uff0c\u30a2\u30ab\u30c7\u30df\u30a2)\u306e\u65b9\u3005\u304c\u5148\u8f29\u65b9\u306e\u610f\u898b\u3092\u8074\u304d\u306a\u304c\u3089\uff0c\u7814\u7a76\u30fb\u696d\u52d9\u306b\u30d5\u30a3\u30fc\u30c9\u30d0\u30c3\u30af\u3059\u308b\u5834\u3068\u3044\u3046\u306e\u3082\u305d\u308c\u307b\u3069\u306a\u3044\u3088\u3046\u306b\u601d\u3044\u307e\u3059\uff0e<\/p>\n<p class=\"paragraph\">\u3000\u672c\u30b7\u30f3\u30dd\u30b8\u30a6\u30e0\u306e\u76ee\u6a19\u306f\uff0c\u65e5\u9803\uff0c\u81e8\u5e8a\u7814\u7a76\u306b\u643a\u308f\u308b\u65b9\u3005\u304c\u65e5\u672c\u306e\u4e2d\u5fc3\u5730(\u6771\u4eac)\u304b\u3089\u5c11\u3057\u96e2\u308c\u305f\u5834\u6240\u3067\u4ea4\u6d41\u3057\uff0c\u73fe\u5728\u306e\u696d\u52d9\u30fb\u7814\u7a76\u306e\u306a\u304b\u3067\u306e\u5171\u901a\u306e\u8ab2\u984c\u3092\u5171\u6709\u30fb\u89e3\u6c7a\u3059\u308b\u300c\u5834\u300d\u3092\u63d0\u4f9b\u3059\u308b\u3053\u3068\u3067\u3059\uff0e\u307f\u306a\u3055\u307e\u306e\u7a4d\u6975\u7684\u306a\u3054\u53c2\u52a0\u3092\u3088\u308d\u3057\u304f\u304a\u9858\u3044\u7533\u3057\u4e0a\u3052\u307e\u3059\uff0e<\/p>\n<div id=\"sp-block-container-5\" class=\"sp-part-top sp-block-container\">\n<p style=\"text-align : right;\" class=\"paragraph\">\u548c\u6b4c\u5c71\u770c\u7acb\u533b\u79d1\u5927\u5b66 \u30c7\u30fc\u30bf\u30b5\u30a4\u30a8\u30f3\u30b9\u30bb\u30f3\u30bf\u30fc \u526f\u30bb\u30f3\u30bf\u30fc\u9577\uff0f\u533b\u5b66\u90e8 \u533b\u7642\u7d71\u8a08\u5b66\u8b1b\u5ea7 \u6559\u6388<br \/>\u4e0b\u5ddd\u654f\u96c4<\/p>\n<\/div>\n<\/div>\n<div id=\"sp-block-container-6\" class=\"sp-part-top sp-block-container\">\n<h3 class=\"paragraph\">\u304b\u3054\u3057\u307e\u30c7\u30fc\u30bf\u79d1\u5b66\u30b7\u30f3\u30dd\u30b8\u30a6\u30e0\u304c\u76ee\u6307\u3059\u3082\u306e<\/h3>\n<p><a style=\"display: block\"><img decoding=\"async\" id=\"sp-image-3\" class=\"sp-part-top sp-image\" src=\"http:\/\/kdss.org\/wp\/wp-content\/uploads\/hpb-media\/img\/Connect1.png\" \/><\/a><\/p>\n<p class=\"paragraph\">\n<p class=\"paragraph\">\u300c\u533b\u7642\u300d\u3042\u308b\u3044\u306f\u300c\u30d8\u30eb\u30b9\u30b1\u30a2\u300d\u3092\u53d6\u308a\u5dfb\u304f\u74b0\u5883\u306b\u304a\u3044\u3066\uff0c\u305d\u308c\u3092\u652f\u63f4\u3059\u308b\u5b66\u8853\u5206\u91ce\u30fb\u8077\u7a2e\u30fb\u5b66\u4f1a\u7b49\u306b\u306f\uff0c\u6b21\u306e\u3088\u3046\u306a\u9694\u305f\u308a\u304c\u3042\u308b\u306e\u3067\u306f\u306a\u3044\u3067\u3057\u3087\u3046\u304b\uff0e<\/p>\n<ul id=\"sp-list-1\" class=\"sp-part-top sp-list\">\n<li>\u300c\u7d71\u8a08\u79d1\u5b66\u300d\uff0c\u300cCDM\u300d\uff0c\u300c\u81e8\u5e8a\u85ac\u7406\u300d\uff0c\u300c\u77e5\u8b58\u60c5\u5831\u5b66\u300d\uff0c\u300c\u75ab\u5b66\u300d\uff0c\u300c\u60c5\u5831\u79d1\u5b66(\u533b\u7642\u60c5\u5831\u5b66\u3092\u542b\u3080)\u300d\u306a\u3069\u306e\u5b66\u8853\u5206\u91ce\u306e\u9694\u305f\u308a\n<li>\u533b\u85ac\u54c1\u958b\u767a\u7b49\u306b\u304a\u3051\u308b\u300c\u533b\u5b66\u7d71\u8a08\u5bb6\u300d\uff0c\u300c\u30c7\u30fc\u30bf\u30de\u30cd\u30fc\u30b8\u30e3\u2015\u300d\uff0c\u300c\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30bf\u30fc\u300d\uff0c\u300c\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u30de\u30cd\u30fc\u30b8\u30e3\u30fc\/\u30b9\u30bf\u30c7\u30a3\u30de\u30cd\u30fc\u30b8\u30e3\u30fc\u300d\uff0c\u300c\u30e2\u30cb\u30bf\u30fc(CRA)\u300d\u306a\u3069\u306e\u8077\u7a2e\u3054\u3068\u306e\u9694\u305f\u308a\n<li>\u300c\u533b\u85ac\u54c1\/\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u30fbCRO\u30fbARO\u300d\uff0c\u300c\u30a2\u30ab\u30c7\u30df\u30a2\u3068\u4f01\u696d\u300d\u3068\u3044\u3063\u305f\u6240\u5c5e\u5148\u306b\u62e0\u308b\u9694\u305f\u308a\uff0e\n<li>\u305d\u306e\u4ed6\uff0c\u300c\u5b66\u4f1a\u300d\u306b\u3088\u308b\u9694\u305f\u308a\uff0e\n<\/ul>\n<p class=\"paragraph\">\u304b\u3054\u3057\u307e\u30c7\u30fc\u30bf\u79d1\u5b66\u30b7\u30f3\u30dd\u30b8\u30a6\u30e0\u3067\u3067\u306f\uff0c\u3055\u307e\u3056\u307e\u306a\u300c\u9694\u305f\u308a\u300d\u3092\u8d85\u3048\uff0c\u5b66\u8853\u5206\u91ce\u30fb\u8077\u7a2e\u30fb\u5b66\u4f1a\u306e\u305d\u308c\u305e\u308c\u3092\u7d50\u3073\u3064\u3051\u308b(Connect)\u3059\u308b\u3053\u3068\u3092\u76ee\u6307\u3057\u3066\u3044\u307e\u3059\uff0e\u305d\u3057\u3066\uff0c\u6771\u4eac\u3042\u308b\u3044\u306f\u5927\u962a\u304b\u3089\u96e2\u308c\u305f\u300c\u304b\u3054\u3057\u307e\u300d\u306a\u3069\u3067\u4ea4\u6d41\u3092\u6df1\u3081\u3066\u3044\u305f\u3060\u304d\u305f\u3044\u3068\u8003\u3048\u3066\u3044\u307e\u3059\uff0e<\/p>\n<\/div>\n<div id=\"sp-block-container-7\" class=\"sp-part-top sp-block-container\">\n<h3 class=\"paragraph\">\u304b\u3054\u3057\u307e\u30c7\u30fc\u30bf\u79d1\u5b66\u30b7\u30f3\u30dd\u30b8\u30a6\u30e0\u3067\u3068\u308a\u4e0a\u3052\u308b\u30c6\u30fc\u30de<\/h3>\n<ul id=\"sp-list-2\" class=\"sp-part-top sp-list\">\n<li>\u7d71\u8a08\u79d1\u5b66\u304a\u3088\u3073\u30c7\u30fc\u30bf\u30b5\u30a4\u30a8\u30f3\u30b9\n<li>\u7d71\u8a08\u6559\u80b2\u304a\u3088\u3073\u30c7\u30fc\u30bf\u30ea\u30c6\u30e9\u30b7\u30fc\u6559\u80b2\n<li>\u533b\u7642\u30c7\u30fc\u30bf\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306b\u95a2\u3059\u308b\u6700\u8fd1\u306e\u8a71\u984c\n<li>\u81e8\u5e8a\u7814\u7a76\u306b\u95a2\u9023\u3059\u308bICT\u6280\u8853\u306b\u95a2\u3059\u308b\u8a71\u984c\n<li>\u30ec\u30ae\u30e5\u30e9\u30c8\u30ea\u30fc\u30b5\u30a4\u30a8\u30f3\u30b9 (\u81e8\u5e8a\u7814\u7a76\u6cd5\uff0c\u7d71\u5408\u6307\u91dd\uff0c\u85ac\u6a5f\u6cd5\uff0cGCP\uff0cICH\u7b49)\n<li>\u81e8\u5e8a\u8a66\u9a13\u304a\u3088\u3073\u6cbb\u9a13\u306b\u304a\u3051\u308b\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u3042\u308b\u3044\u306f\u30b9\u30bf\u30c7\u30a3\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\n<li>\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0(CRA)\uff0c\u76e3\u67fb\u7b49\u306b\u95a2\u9023\u3059\u308b\u5185\u5bb9\n<li>\u30ea\u30a2\u30eb\u30ef\u30fc\u30eb\u30c9\u30fb\u30c7\u30fc\u30bf\u7b49\u306e\u30d3\u30c3\u30b0\u30c7\u30fc\u30bf\u3092\u6d3b\u7528\u3057\u305f\u7814\u7a76\n<li>\u516c\u7684\u30c7\u30fc\u30bf\u3092\u7528\u3044\u305f\u30c7\u30fc\u30bf\u30b5\u30a4\u30a8\u30f3\u30b9\u7814\u7a76\n<li>AI\u306a\u3069\u3092\u7528\u3044\u305f\u30c7\u30fc\u30bf\u30b5\u30a4\u30a8\u30f3\u30b9\u304a\u3088\u3073\u533b\u7642\u3078\u306e\u5fdc\u7528\n<li>\u81e8\u5e8a\u85ac\u7406\u5b66\n<li>\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30c6\u30a3\u30f3\u30b0\n<li>\u305d\u306e\u4ed6\u306e\u81e8\u5e8a\u7814\u7a76\u306b\u95a2\u9023\u3059\u308b\u8a71\u984c\n<\/ul>\n<\/div>\n<div id=\"sp-block-container-8\" class=\"sp-part-top sp-block-container\">\n<h3 class=\"paragraph\">\u304b\u3054\u3057\u307e\u30c7\u30fc\u30bf\u79d1\u5b66\u30b7\u30f3\u30dd\u30b8\u30a6\u30e0\u306e\u904b\u55b6<\/h3>\n<ul id=\"sp-list-3\" class=\"sp-part-top sp-list\">\n<li><b class=\"character\">\u4e3b\u50ac<\/b>\uff1a\u548c\u6b4c\u5c71\u770c\u7acb\u533b\u79d1\u5927\u5b66 \u30c7\u30fc\u30bf\u30b5\u30a4\u30a8\u30f3\u30b9\u30bb\u30f3\u30bf\u30fc\uff0f\u548c\u6b4c\u5c71\u770c\u7acb\u533b\u79d1\u5927\u5b66 \u533b\u5b66\u90e8 \u533b\u7642\u7d71\u8a08\u5b66\u8b1b\u5ea7\n<li><b class=\"character\">\u5171\u50ac<\/b>\uff1a<a href=\"https:\/\/www.ppdsnbl.co.jp\/\">\u682a\u5f0f\u4f1a\u793e \u65b0\u65e5\u672c\u79d1\u5b66PPD CDS (\u30c7\u30fc\u30bf\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\uff0c\u751f\u7269\u7d71\u8a08\uff0c\u81e8\u5e8a\u85ac\u7406\uff0c\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30c6\u30a3\u30f3\u30b0)<\/a>\n<li><b class=\"character\">\u5f8c\u63f4<\/b>\uff1a\n<ul id=\"sp-list-4\" class=\"sp-part-top sp-list\">\n<li><a href=\"https:\/\/jscs.jp\/\" target=\"_blank\" rel=\"noopener\">\u4e00\u822c\u793e\u56e3\u6cd5\u4eba \u65e5\u672c\u8a08\u7b97\u6a5f\u7d71\u8a08\u5b66\u4f1a<\/a> (\u7b2c4\u56de\u30b7\u30f3\u30dd\u30b8\u30a6\u30e0\uff5e)\n<li><a href=\"https:\/\/www.jcroa.or.jp\/\" target=\"_blank\" rel=\"noopener\">\u4e00\u822c\u793e\u56e3\u6cd5\u4eba \u65e5\u672cCRO\u5354\u4f1a<\/a>(\u7b2c6\u56de\u30b7\u30f3\u30dd\u30b8\u30a6\u30e0\uff5e)\n<\/ul>\n<li>\n<li><b class=\"character\">\u9023\u7d61\u5148<\/b>\uff1aCRGjpkdss(atmark)Thermofisher.com\n<\/ul>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>\u3054\u6328\u62f6 \u3000\u8fd1\u5e74\uff0c\u300c\u4eba\u3092\u5bfe\u8c61\u3068\u3059\u308b\u751f\u547d\u79d1\u5b66\u30fb\u533b\u5b66\u7cfb\u7814\u7a76\u306b\u95a2\u3059\u308b\u502b\u7406\u6307\u91dd\u300d\u3042\u308b\u3044\u306f\uff0c\u300c\u81e8\u5e8a\u7814\u7a76\u6cd5\u300d\u306e\u65bd\u884c\u7b49\uff0c\u81e8\u5e8a\u7814\u7a76\u3092\u53d6\u308a\u5dfb\u304f\u74b0\u5883\u304c\u76ee\u307e\u3050\u308b\u3057\u304f\u5909\u5316\u3057\u3066\u3044\u307e\u3059\uff0e\u305d\u306e\u3088\u3046\u306a\u306a\u304b\u3067\uff0cARO (Academic Research Organization)\u306e\u91cd\u8981\u6027\u304c\u5897\u3057\u3066\u3044\u307e\u3059\uff0e\u307e\u305f\uff0cAMED\u306b\u3088\u308b\u751f\u7269\u7d71\u8a08\u5bb6\u306e\u80b2\u6210\u4e8b\u696d\u304c\u9032\u3093\u3067\u304a\u308a\uff0c\u82e5\u624b\u306e\u533b\u5b66\u751f\u7269\u7d71\u8a08\u5bb6\u304c\u5897\u52a0\u3057\u3066\u3044\u307e\u3059\uff0e\u4e00\u65b9\u3067\uff0c\u88fd\u85ac\u4f01\u696d\u30fbCRO\u306b\u76ee\u3092\u5411\u3051\u307e\u3059\u3068\uff0c\u30ea\u30a2\u30eb\u30ef\u30fc\u30eb\u30c9\u30fb\u30c7\u30fc\u30bf(RWD)\u306e\u81e8\u5e8a\u8a55\u4fa1\u3078\u306e\u5229\u6d3b\u7528\uff0c\u30d7\u30ed\u30b0\u30e9\u30e0\u533b\u7642\u6a5f\u5668\uff0cDCT (Decentralized Clinical Trial)\uff0cDX(Digital Transformation)\u306b\u4ee3\u8868\u3055\u308c\u308bICT\u6280\u8853\u306e\u5c0e\u5165\u304c\u7a4d\u6975\u7684\u306b\u9032\u3093\u3067\u3044\u307e\u3059\uff0e 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