{"id":40754,"date":"2017-10-11T11:00:17","date_gmt":"2017-10-11T02:00:17","guid":{"rendered":"http:\/\/www.veeva.com\/jp\/?p=40754"},"modified":"2017-10-11T11:07:30","modified_gmt":"2017-10-11T02:07:30","slug":"industry-survey-reveals-clinical-data-management-delays-slow-trial-completion","status":"publish","type":"post","link":"https:\/\/pantheon.veeva.com\/jp\/news\/industry-survey-reveals-clinical-data-management-delays-slow-trial-completion\/","title":{"rendered":"\u81e8\u5e8a\u8a66\u9a13\u30c7\u30fc\u30bf\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306b\u95a2\u3059\u308b\u696d\u754c\u8abf\u67fb\u3067\u3001\u81e8\u5e8a\u8a66\u9a13\u5b8c\u4e86\u306e\u9045\u5ef6\u8981\u56e0\u304c\u660e\u3089\u304b\u306b"},"content":{"rendered":"<p style=\"text-align: right;\">2017\u5e7410\u670811\u65e5<\/p>\n<p style=\"text-align: right;\">\u30bf\u30d5\u30c4\u533b\u85ac\u54c1\u958b\u767a\u7814\u7a76\u30bb\u30f3\u30bf\u30fc<br \/>\nVeeva Japan\u682a\u5f0f\u4f1a\u793e<\/p>\n<p>&nbsp;<\/p>\n<p>\u81e8\u5e8a\u8a66\u9a13\u30c7\u30fc\u30bf\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306e\u5c02\u9580\u5bb6\u3092\u5bfe\u8c61\u306b\u3057\u305f\u6700\u5927\u304b\u3064\u6700\u3082\u8a73\u7d30\u306a\u8abf\u67fb\u306b\u3088\u3063\u3066\u3001\u4f01\u696d\u304c\u81e8\u5e8a\u8a66\u9a13\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u306e\u69cb\u7bc9\u3068\u30ea\u30ea\u30fc\u30b9\u306b\u304b\u3051\u308b\u6642\u9593\u304c\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u30fb\u5b8c\u4e86\u306b\u30de\u30a4\u30ca\u30b9\u306e\u5f71\u97ff\u3092\u53ca\u307c\u3057\u3066\u3044\u308b\u3053\u3068\u660e\u3089\u304b\u306b\u306a\u308a\u307e\u3057\u305f\u3002 (\u672c\u30ea\u30ea\u30fc\u30b9\u306f\u3001Veeva\u7c73\u56fd\u672c\u793e\u304c\u767a\u8868\u3057\u305f\u5831\u9053\u8cc7\u6599\u306e\u6284\u8a33\u3067\u3059)<\/p>\n<p><a href=\"http:\/\/www.veeva.com\/jp\/wp-content\/uploads\/2017\/10\/EDC-Survey1\u30bf\u30a4\u30c8\u30eb\u4ed8\u304d-1.png\"><img loading=\"lazy\" decoding=\"async\" class=\" wp-image-40757 alignright\" src=\"http:\/\/www.veeva.com\/jp\/wp-content\/uploads\/2017\/10\/EDC-Survey1\u30bf\u30a4\u30c8\u30eb\u4ed8\u304d-1.png\" alt=\"\" width=\"234\" height=\"286\" \/><\/a><\/p>\n<p><a href=\"http:\/\/csdd.tufts.edu\"><strong>\u30bf\u30d5\u30c4\u533b\u85ac\u54c1\u958b\u767a\u7814\u7a76\u30bb\u30f3\u30bf\u30fc<\/strong><\/a>\u306e<strong><a href=\"https:\/\/www.veeva.com\/jp\/edc-survey\">2017 eClinical Landscape Study<\/a><\/strong>\u306b\u3088\u308b\u3068\u3001\u4f01\u696d\u304c\u81e8\u5e8a\u8a66\u9a13\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u306e\u69cb\u7bc9\u3068\u30ea\u30ea\u30fc\u30b9\u306b\u304b\u3051\u308b\u65e5\u6570\u306f\u5e73\u574768\u65e5\u3067\u3059\u3002\u81e8\u5e8a\u8a66\u9a13\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u306e\u30ea\u30ea\u30fc\u30b9\u306e\u9045\u308c\u306f\u3001\u60a3\u8005\u30c7\u30fc\u30bf\u306e\u5165\u529b\u3084\u8a66\u9a13\u7d42\u4e86\u6642\u306b\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u30ed\u30c3\u30af\u307e\u3067\u306e\u65e5\u6570\u306a\u3069\u3001\u4ed6\u306e\u30c7\u30fc\u30bf\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d7\u30ed\u30bb\u30b9\u306e\u6700\u7d42\u6bb5\u968e\u3067\u7d041\u30ab\u6708\u9045\u5ef6\u3059\u308b\u8981\u56e0\u3068\u306a\u3063\u3066\u3044\u307e\u3059\u3002FPFV(First Patient First Visit)\u5f8c\u306b\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u3092\u30ea\u30ea\u30fc\u30b9\u3059\u308b\u5834\u5408\u306f\u3001FPFV\u524d\u306b\u6700\u7d42\u7684\u306a\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u3092\u30ea\u30ea\u30fc\u30b9\u3059\u308b\u5834\u5408\u3068\u6bd4\u3079\u3001\u8a66\u9a13\u5168\u4f53\u3092\u901a\u3057\u3066\u60a3\u8005\u30c7\u30fc\u30bf\u3092\u5165\u529b\u3059\u308b\u671f\u9593\u304c2\u500d\u8fd1\u304f\u304b\u304b\u308a\u3001\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u30ed\u30c3\u30af\u304c\u7d0475\uff05\u9045\u304f\u306a\u3063\u3066\u3044\u307e\u3057\u305f\u3002<\/p>\n<p>\u30bf\u30d5\u30c4\u533b\u85ac\u54c1\u958b\u767a\u7814\u7a76\u30bb\u30f3\u30bf\u30fc\u9577\u3067\u3042\u308bKen Getz\u7279\u4efb\u51c6\u6559\u6388\u306f\u6b21\u306e\u3088\u3046\u306b\u8ff0\u3079\u3066\u3044\u307e\u3059\u3002\u300c\u8abf\u67fb\u7d50\u679c\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u306e\u69cb\u7bc9\u3068\u7ba1\u7406\u306b\u304a\u3044\u3066\u3001\u4f01\u696d\u304c\u307e\u3059\u307e\u3059\u591a\u304f\u306e\u8ab2\u984c\u306b\u76f4\u9762\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002\u307e\u305f\u3001\u8a66\u9a13\u5b9f\u65bd\u533b\u7642\u6a5f\u95a2\u3067\u75c7\u4f8b\u767b\u9332\u3092\u958b\u59cb\u3057\u305f\u5f8c\u306e\u81e8\u5e8a\u8a66\u9a13\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u3092\u30ea\u30ea\u30fc\u30b9\u3059\u308b\u3053\u3068\u304c\u3001\u8a66\u9a13\u7d42\u4e86\u6642\u3084\u5b9f\u65bd\u533b\u7642\u6a5f\u95a2\u3067\u306e\u6700\u7d42\u6bb5\u968e\u306e\u30b5\u30a4\u30af\u30eb\u30bf\u30a4\u30e0\u3092\u9577\u5f15\u304b\u305b\u308b\u8981\u56e0\u306b\u306a\u3063\u3066\u3044\u308b\u3053\u3068\u3082\u5206\u304b\u308a\u307e\u3057\u305f\u3002\u300d<\/p>\n<p>&nbsp;<\/p>\n<p><strong>Electronic Data Capture \uff08EDC\uff09\u30d7\u30ed\u30d0\u30a4\u30c0\u30fc\u53ca\u3073\u30b7\u30b9\u30c6\u30e0\u5229\u7528<\/strong><\/p>\n<p>EDC\u306f\u6700\u3082\u5e83\u304f\u63a1\u7528\u3055\u308c\u3066\u3044\u308b\u81e8\u5e8a\u696d\u52d9\u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3\u3067\u3001\u3059\u3079\u3066\u306e\u56de\u7b54\u8005\uff08100\uff05\uff09\u304c\u4f7f\u7528\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignright wp-image-40760\" src=\"http:\/\/www.veeva.com\/jp\/wp-content\/uploads\/2017\/10\/EDC-Survey3\u30bf\u30a4\u30c8\u30eb\u4ed8\u304d.png\" alt=\"\" width=\"340\" height=\"328\" \/><\/p>\n<p>\u6b21\u306b\u3001RTSM (Rndomization and Trial Supply Management)\uff0877\uff05\uff09\u3001eTMF\uff0870\uff05\uff09\u3001\u5b89\u5168\u6027\uff0870\uff05\uff09\u306e\u5404\u30b7\u30b9\u30c6\u30e0\u3068\u7d9a\u304d\u307e\u3059\u3002\u56de\u7b54\u8005\u306e\u5927\u591a\u6570\uff0858\uff05\uff09\u304c\u4e3b\u8981\u306aEDC\u30b7\u30b9\u30c6\u30e0\u3068\u3057\u3066Medidata Rave\u304bOracle Inform\u306e\u3044\u305a\u308c\u304b\u3092\u4f7f\u7528\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>EDC\u3067\u7ba1\u7406\u3057\u3066\u3044\u308b\u30c7\u30fc\u30bf\u306e\u7a2e\u985e\u306b\u3064\u3044\u3066\u306f\u3001\u3059\u3079\u3066\u306eCRO\u3068\u6cbb\u9a13\u4f9d\u983c\u8005\u304c\u96fb\u5b50\u75c7\u4f8b\u5831\u544a\u66f8\uff08eCRF\uff09\u30c7\u30fc\u30bf\uff08100\uff05\uff09\u3068\u56de\u7b54\u3057\u3001\u30ed\u30fc\u30ab\u30eb\u691c\u67fb\u30c7\u30fc\u30bf\u3068QOL\u30c7\u30fc\u30bf\u304c\u305d\u308c\u305e\u308c60\uff05\u3067\u7d9a\u304d\u307e\u3059\u3002\u4f46\u3057\u3001\u30c7\u30fc\u30bf\u91cf\u3067\u3044\u3046\u3068\u3001EDC\u30b7\u30b9\u30c6\u30e0\u3067\u7ba1\u7406\u3059\u308b\u30c7\u30fc\u30bf\u306e\u4e2d\u3067\u6700\u3082\u30c7\u30fc\u30bf\u91cf\u304c\u591a\u3044\u306e\u306feCRF\u30c7\u30fc\u30bf\uff08\u7ba1\u7406\u3059\u308b\u30c7\u30fc\u30bf\u306e\u5e73\u574778\uff05\uff09\u3068\u56de\u7b54\u3057\u3066\u3044\u307e\u3059\u3002\u6b21\u306b\u91cf\u306e\u591a\u3044\u30c7\u30fc\u30bf\u306f\u3001\u4e2d\u592e\u691c\u67fb\u30c7\u30fc\u30bf\u3068\u30ed\u30fc\u30ab\u30eb\u691c\u67fb\u30c7\u30fc\u30bf\u3067\u305d\u308c\u305e\u308c5\uff05\u3067\u3059\u3002\u6b8b\u308a\u306e\u30c7\u30fc\u30bf\u306e\u7a2e\u985e\u306f\u3044\u305a\u308c\u30824\uff05\u4ee5\u4e0b\u3067\u3059\u3002\u3053\u306e\u7d50\u679c\u306f\u3001EDC\u3067\u5168\u8a66\u9a13\u30c7\u30fc\u30bf\u3092\u7ba1\u7406\u3059\u308b\u3068\u3044\u3046\u696d\u754c\u306e\u30d3\u30b8\u30e7\u30f3\u3092\u30b5\u30dd\u30fc\u30c8\u3059\u308b\u30d7\u30ed\u30bb\u30b9\u3068\u30b7\u30b9\u30c6\u30e0\u306e\u5fc5\u8981\u6027\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>\u305d\u3057\u3066\u30014\u5206\u306e3\u4ee5\u4e0a\uff0877\uff05\uff09\u304cEDC\u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3\u3078\u306e\u30c7\u30fc\u30bf\u306e\u30ed\u30fc\u30c9\u306b\u554f\u984c\u304c\u3042\u308b\u3068\u56de\u7b54\u3057\u3001\u5927\u534a\uff0866\uff05\uff09\u304cEDC\u30b7\u30b9\u30c6\u30e0\u305d\u306e\u3082\u306e\u307e\u305f\u306fEDC\u30b7\u30b9\u30c6\u30e0\u3068\u306e\u9023\u643a\u306e\u554f\u984c\u304c\u3001\u8a66\u9a13\u30c7\u30fc\u30bf\u3092\u30ed\u30fc\u30c9\u3067\u304d\u306a\u3044\u4e3b\u306a\u7406\u7531\u3067\u3042\u308b\u3068\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-40759 alignleft\" src=\"http:\/\/www.veeva.com\/jp\/wp-content\/uploads\/2017\/10\/EDC-Survey2\u30bf\u30a4\u30c8\u30eb\u4ed8\u304d.png\" alt=\"\" width=\"340\" height=\"271\" \/><\/p>\n<p><strong>\u81e8\u5e8a\u8a66\u9a13\u30b5\u30a4\u30af\u30eb\u30bf\u30a4\u30e0\u306b\u53ca\u307c\u3059\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u69cb\u7bc9\u9045\u5ef6\u306e\u5f71\u97ff<\/strong><\/p>\n<p>\u4eca\u56de\u306e\u8abf\u67fb\u7d50\u679c\u304b\u3089\u3001\u81e8\u5e8a\u8a66\u9a13\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u69cb\u7bc9\u9045\u5ef6\u306e\u4e00\u822c\u7684\u306a\u8981\u56e0\u304c\u3044\u304f\u3064\u304b\u5206\u304b\u308a\u307e\u3057\u305f\u3002\u30d7\u30ed\u30c8\u30b3\u30fc\u30eb\u306e\u5909\u66f4\u3068\u7b54\u3048\u305f\u56de\u7b54\u8005\u306e\u5272\u5408\u304c\u6700\u3082\u591a\u304f45\uff05\u3067\u3001\u30c7\u30fc\u30bf\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u62c5\u5f53\u8005\u304c\u81e8\u5e8a\u8a66\u9a13\u958b\u59cb\u6642\u306b\u81e8\u5e8a\u8a66\u9a13\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u3092\u5b8c\u6210\u3055\u305b\u306a\u304c\u3089\u5909\u66f4\u306b\u5bfe\u51e6\u3057\u3066\u3044\u308b\u3068\u3044\u3046\u554f\u984c\u3092\u6d6e\u304d\u5f6b\u308a\u306b\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u3053\u3068\u306f\u3001\u3088\u308a\u67d4\u8edf\u306a\u8a2d\u8a08\u3068\u8fc5\u901f\u306a\u958b\u767a\u3092\u30b5\u30dd\u30fc\u30c8\u3059\u308b\u6a19\u6e96\u3068\u30b7\u30b9\u30c6\u30e0\u3067\u3001\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u8a2d\u8a08\u306e\u30d7\u30ed\u30bb\u30b9\u3092\u6700\u9069\u5316\u3059\u308b\u5fc5\u8981\u6027\u3092\u5f37\u8abf\u3059\u308b\u3082\u306e\u3067\u3059\u3002<\/p>\n<p>\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u306e\u30ea\u30ea\u30fc\u30b9\u306e\u9045\u308c\u3082\u307e\u305f\u3001\u5b9f\u65bd\u533b\u7642\u6a5f\u95a2\u304c\u81e8\u5e8a\u8a66\u9a13\u5168\u4f53\u3092\u901a\u3057\u3066EDC\u306b\u60a3\u8005\u30c7\u30fc\u30bf\u3092\u5165\u529b\u3059\u308b\u6642\u9593\u3001\u305d\u3057\u3066\u8a66\u9a13\u7d42\u4e86\u6642\u306e\u6700\u7d42\u7684\u306a\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u30ed\u30c3\u30af\u306b\u5927\u304d\u306a\u5f71\u97ff\u3092\u53ca\u307c\u3057\u307e\u3059\u3002FPFV\u524d\u306b\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u3092\u30ea\u30ea\u30fc\u30b9\u3059\u308b\u4f01\u696d\u306f\u3001EDC\u3078\u306e\u30c7\u30fc\u30bf\u5165\u529b\u304c\u60a3\u8005\u306e\u6765\u9662\u304b\u3089\u5e73\u57475\u65e5\u3067\u3059\u304c\u3001 FPFV\u5f8c\u306b\u30ea\u30ea\u30fc\u30b9\u3059\u308b\u4f01\u696d\u306e\u30c7\u30fc\u30bf\u5165\u529b\u306f\u3001\u305d\u306e\u500d\u306e10\u65e5\u304b\u304b\u308a\u307e\u3059\u3002<\/p>\n<p>\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u69cb\u7bc9\u9045\u5ef6\u306f\u3001\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u30ed\u30c3\u30af\u307e\u3067\u306e\u65e5\u6570\u306b\u3055\u3089\u306b\u5927\u304d\u304f\u5f71\u97ff\u3057\u307e\u3059\u3002\u5e38\u306bFPFV\u524d\u306b\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u3092\u30ea\u30ea\u30fc\u30b9\u3059\u308b\u4f01\u696d\u306f\u3001\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u30ed\u30c3\u30af\u307e\u3067\u5e73\u574731\u65e5\u3067\u3059\u304c\u3001\u5e38\u306bFPFV\u5f8c\u306b\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u3092\u30ea\u30ea\u30fc\u30b9\u3059\u308b\u4f01\u696d\u306f\u3001\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u30ed\u30c3\u30af\u304c3\u9031\u9593\u4ee5\u4e0a\uff0854\u65e5\uff09\u9045\u304f\u306a\u3063\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>\u6cbb\u9a13\u4f9d\u983c\u8005\u306fCRO\u3088\u308a\u3082\u7d044\u5272\u9577\u304f\u3001\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u69cb\u7bc9\u306b73\u65e5\uff08CRO\u306f53\u65e5\uff09\u3001\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u30ed\u30c3\u30af\u306b39\u65e5\uff08CRO\u306f28\u65e5\uff09\u304b\u304b\u3063\u3066\u3044\u307e\u3059\u3002\u307e\u305f\u3001\u30c7\u30fc\u30bf\u30b5\u30a4\u30af\u30eb\u30bf\u30a4\u30e0\u306f\u30012\u5927EDC\u30b7\u30b9\u30c6\u30e0\u3092\u4f7f\u7528\u3057\u3066\u3044\u308b\u4f01\u696d\u304c123\u65e5\u3067\u3001\u4ed6\u306e\u30b7\u30b9\u30c6\u30e0\u3092\u5229\u7528\u3057\u3066\u3044\u308b\u4f01\u696d\u306e99\u65e5\u3088\u308a\u7d042\u5272\u9577\u304f\u306a\u3063\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u5185\u8a33\u306f\u3001\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u69cb\u7bc9\u304c75\u65e5\u5bfe60\u65e5\u3001\u60a3\u8005\u30c7\u30fc\u30bf\u5165\u529b\u304c9\u65e5\u5bfe7\u65e5\u3001\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u30ed\u30c3\u30af\u304c39\u65e5\u5bfe32\u65e5\u3067\u3059\u3002<\/p>\n<p>Veeva Vault EDC\u62c5\u5f53\u30f4\u30a1\u30a4\u30b9\u30d7\u30ec\u30b8\u30c7\u30f3\u30c8\u306eRichard Young\u306f\u6b21\u306e\u3088\u3046\u306b\u8ff0\u3079\u3066\u3044\u307e\u3059\u3002\u300c\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u69cb\u7bc9\u30d7\u30ed\u30bb\u30b9\u306f10\u5e74\u524d\u304b\u3089\u307b\u3068\u3093\u3069\u5909\u308f\u3063\u3066\u3044\u307e\u305b\u3093\u3002CRO\u3084\u6cbb\u9a13\u4f9d\u983c\u8005\u304c\u7ba1\u7406\u3059\u308b\u81e8\u5e8a\u8a66\u9a13\u30c7\u30fc\u30bf\u306e\u7a2e\u985e\u304c\u5897\u3048\u305f\u3053\u3068\u306b\u3088\u308a\u3001\u30d7\u30ed\u30bb\u30b9\u304c\u8907\u96d1\u5316\u3057\u305f\u3060\u3051\u3067\u3059\u3002\u4f01\u696d\u306f\u5165\u529b\u3059\u308b\u30c7\u30fc\u30bf\u306e\u91cf\u3092\u6e1b\u3089\u3059\u3053\u3068\u306b\u3088\u308a\u6280\u8853\u7684\u306a\u9650\u754c\u3092\u88dc\u3063\u3066\u3044\u307e\u3059\u3002\u79c1\u305f\u3061\u306f\u6cbb\u9a13\u4f9d\u983c\u8005\u3084CRO\u304c\u5236\u9650\u3055\u308c\u305a\u306b\u81e8\u5e8a\u8a66\u9a13\u3092\u884c\u3048\u308b\u3088\u3046\u3001EDC\u30b7\u30b9\u30c6\u30e0\u306e\u6539\u5584\u306b\u91cd\u70b9\u3092\u7f6e\u304f\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u300d<\/p>\n<p>Veeva Systems\u3010NYSE: VEEV\u3011\uff08\u672c\u793e\uff1a\u30ab\u30ea\u30d5\u30a9\u30eb\u30cb\u30a2\u5dde\u30d7\u30ec\u30b6\u30f3\u30c8\u30f3\u3001\u65e5\u672c\u6cd5\u4eba \u672c\u793e\uff1a\u6771\u4eac\u90fd\u6e0b\u8c37\u533a\u3001\u65e5\u672c\u6cd5\u4eba\u4ee3\u8868\u53d6\u7de0\u5f79\uff1a\u5ca1\u6751 \u5d07\uff09\u304c\u51fa\u8cc7\u3059\u308b\u30bf\u30d5\u30c4\u533b\u85ac\u54c1\u958b\u767a\u7814\u7a76\u30bb\u30f3\u30bf\u30fc \u306e\u300c<strong><a href=\"https:\/\/www.veeva.com\/jp\/edc-survey\">2017 eClinical Landscape Study: Assessing Data Management Practices, Performance, and Challenges<\/a><\/strong>\u300d\u306b\u3088\u308a\u3001\u5e73\u574717\u5e74\u306e\u81e8\u5e8a\u8a66\u9a13\u30c7\u30fc\u30bf\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u7d4c\u9a13\u3092\u6301\u3064\u6cbb\u9a13\u4f9d\u983c\u8005\u3084CRO\u3092\u542b\u3080250\u793e\u4ee5\u4e0a\u306e\u81e8\u5e8a\u8a66\u9a13\u30c7\u30fc\u30bf\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306e\u5c02\u9580\u5bb6\u306e\u77e5\u898b\u3084\u610f\u898b\u3092\u5fb9\u5e95\u7684\u306b\u8abf\u67fb\u3057\u3001\u30e9\u30a4\u30d5\u30b5\u30a4\u30a8\u30f3\u30b9\u696d\u754c\u306b\u304a\u3051\u308b\u30c7\u30fc\u30bf\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306e\u5b9f\u614b\u3092\u898b\u76f4\u3057\u307e\u3057\u305f\u3002\u8abf\u67fb\u5831\u544a\u66f8\u306f<strong><a href=\"https:\/\/www.veeva.com\/jp\/edc-survey\">veeva.com\/jp\/EDCSurvey<\/a><\/strong>\u3088\u308a\u30c0\u30a6\u30f3\u30ed\u30fc\u30c9\u3067\u304d\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<p><strong>\u3010\u30bf\u30d5\u30c4\u533b\u85ac\u54c1\u958b\u767a\u7814\u7a76\u30bb\u30f3\u30bf\u30fc\u306b\u3064\u3044\u3066\u3011<\/strong><br \/>\n\u30bf\u30d5\u30c4\u5927\u5b66\u306e\u30bf\u30d5\u30c4\u533b\u85ac\u54c1\u958b\u767a\u7814\u7a76\u30bb\u30f3\u30bf\u30fc\u306f\u3001\u533b\u85ac\u54c1\u306e\u958b\u767a\u3001\u898b\u76f4\u3057\u3001\u5229\u7528\u306e\u8cea\u3068\u52b9\u7387\u306e\u6539\u5584\u306b\u5f79\u7acb\u3064\u6226\u7565\u7684\u60c5\u5831\u3092\u533b\u85ac\u54c1\u958b\u767a\u4f01\u696d\u3001\u898f\u5236\u5f53\u5c40\u3001\u653f\u7b56\u7acb\u6848\u8005\u306b\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u3002\u30dc\u30b9\u30c8\u30f3\u3092\u62e0\u70b9\u3068\u3059\u308b\u30bf\u30d5\u30c4\u533b\u85ac\u54c1\u958b\u767a\u7814\u7a76\u30bb\u30f3\u30bf\u30fc\u306f\u3001\u533b\u85ac\u54c1\u306b\u95a2\u3059\u308b\u554f\u984c\u306e\u5e45\u5e83\u304f\u8a73\u7d30\u306a\u5206\u6790\u3001\u30b7\u30f3\u30dd\u30b8\u30a6\u30e0\u3001\u30ef\u30fc\u30af\u30b7\u30e7\u30c3\u30d7\u3001\u30d1\u30d6\u30ea\u30c3\u30af\u30d5\u30a9\u30fc\u30e9\u30e0\u306e\u4e3b\u50ac\u3001\u30bf\u30d5\u30c4\u533b\u85ac\u54c1\u958b\u767a\u7814\u7a76\u30bb\u30f3\u30bf\u30fc\u5f71\u97ff\u5831\u544a\u66f8\u306e\u767a\u8868\u3001\u9694\u6708\u30cb\u30e5\u30fc\u30b9\u30ec\u30bf\u30fc\u306e\u767a\u884c\u306a\u3069\u3001\u91cd\u8981\u306a\u533b\u85ac\u54c1\u958b\u767a\u306e\u554f\u984c\u306e\u5206\u6790\u3068\u77e5\u898b\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002\u8a73\u7d30\u306b\u3064\u3044\u3066\u306f<strong><a href=\"http:\/\/csdd.tufts.edu\">csdd.tufts.edu<\/a><\/strong>\u3092\u3054\u89a7\u304f\u3060\u3055\u3044\u3002<\/p>\n<p><strong>\u3010Veeva Systems\u793e\u306b\u3064\u3044\u3066\u3011<\/strong><br \/>\nVeeva Systems\u793e\u306f\u30b0\u30ed\u30fc\u30d0\u30eb\u306a\u30e9\u30a4\u30d5\u30b5\u30a4\u30a8\u30f3\u30b9\u4f01\u696d\u5411\u3051\u306b\u30af\u30e9\u30a6\u30c9\u30d9\u30fc\u30b9\u306e\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3092\u63d0\u4f9b\u3059\u308b\u30ea\u30fc\u30c7\u30a3\u30f3\u30b0\u30ab\u30f3\u30d1\u30cb\u30fc\u3067\u3059\u3002\u4e16\u754c\u6700\u5927\u898f\u6a21\u306e\u88fd\u85ac\u4f1a\u793e\u304b\u3089\u30d0\u30a4\u30aa\u30c6\u30af\u30ce\u30ed\u30b8\u30fc\u5206\u91ce\u306e\u65b0\u8208\u4f01\u696d\u307e\u3067550\u793e\u3092\u8d85\u3048\u308b\u9867\u5ba2\u3092\u64c1\u3057\u3001\u6280\u8853\u9769\u65b0\u3078\u306e\u53d6\u308a\u7d44\u307f\u3084\u5353\u8d8a\u3057\u305f\u88fd\u54c1\u529b\u306b\u3088\u3063\u3066\u3001\u304a\u5ba2\u69d8\u306e\u6210\u529f\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u3066\u3044\u307e\u3059\u3002Veeva\u306f\u3001\u30b5\u30f3\u30d5\u30e9\u30f3\u30b7\u30b9\u30b3\u306e\u30d9\u30a4\u30a8\u30ea\u30a2\u306b\u672c\u793e\u3092\u7f6e\u304d\u3001\u30e8\u30fc\u30ed\u30c3\u30d1\u3001\u30a2\u30b8\u30a2\u3001\u30e9\u30c6\u30f3\u30a2\u30e1\u30ea\u30ab\u306b\u62e0\u70b9\u3092\u5c55\u958b\u3057\u3066\u3044\u307e\u3059\u3002\u8a73\u3057\u304f\u306f\u3001<span style=\"color: #ff991c;\"><a style=\"text-decoration: none; font-weight: bold; color: #ff991c;\" href=\"https:\/\/veeva.com\/jp\/\" target=\"_blank\" rel=\"noopener noreferrer\">\u516c\u5f0f\u30b5\u30a4\u30c8<\/a><\/span>\u3092\u3054\u89a7\u304f\u3060\u3055\u3044\u3002<\/p>\n<p>&nbsp;<\/p>\n<h4 style=\"text-align: center;\"><strong>\u8abf\u67fb\u306e\u30cf\u30a4\u30e9\u30a4\u30c8<\/strong><br \/>\n<strong>2017 eClinical Landscape Study\uff1a\u30c7\u30fc\u30bf\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u696d\u52d9\u3001\u5b9f\u7e3e\u3001\u8ab2\u984c\u306e\u8a55\u4fa1<\/strong><\/h4>\n<p><a href=\"https:\/\/www.veeva.com\/jp\/edc-survey\"><strong>2017 eClinical Landscape Study<\/strong><\/a>\u306f\u3001\u30e9\u30a4\u30d5\u30b5\u30a4\u30a8\u30f3\u30b9\u696d\u754c\u306b\u304a\u3051\u308b\u81e8\u5e8a\u8a66\u9a13\u30c7\u30fc\u30bf\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306e\u72b6\u6cc1\u8abf\u67fb\u3067\u3059\u3002\u8abf\u67fb\u306e\u76ee\u7684\u306f\u3001\u73fe\u5728\u306e\u81e8\u5e8a\u8a66\u9a13\u30c7\u30fc\u30bf\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u696d\u52d9\u306e\u628a\u63e1\u3068Electronic Data Capture\uff08EDC\uff09\u30b7\u30b9\u30c6\u30e0\u306e\u5b9f\u7e3e\u304a\u3088\u3073\u8ab2\u984c\u306e\u8a55\u4fa1\u3067\u3059\u3002<\/p>\n<p>\u3053\u308c\u307e\u3067\u3067\u6700\u5927\u304b\u3064\u6700\u3082\u8a73\u7d30\u306a\u81e8\u5e8a\u8a66\u9a13\u30c7\u30fc\u30bf\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u8abf\u67fb\u306e\u4e00\u3064\u3067\u3042\u308b\u672c\u8abf\u67fb\u306f\u3001\u5e73\u574717\u5e74\u306b\u308f\u305f\u308b\u81e8\u5e8a\u8a66\u9a13\u30c7\u30fc\u30bf\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u7d4c\u9a13\u3092\u6301\u3064\u6cbb\u9a13\u4f9d\u983c\u8005\u3084CRO\u3092\u542b\u3080250\u540d\u306e\u81e8\u5e8a\u8a66\u9a13\u30c7\u30fc\u30bf\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306e\u5c02\u9580\u5bb6\u306e\u77e5\u898b\u3084\u610f\u898b\u3092\u96c6\u3081\u307e\u3057\u305f\u3002<\/p>\n<p><strong>\u81e8\u5e8a\u696d\u52d9\u30b7\u30b9\u30c6\u30e0\u53ca\u3073EDC\u30c7\u30fc\u30bf\u72b6\u6cc1<\/strong><\/p>\n<ul>\n<li>EDC\u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3\u306f\u6700\u3082\u5e83\u304f\u666e\u53ca\u3057\u3066\u3044\u308b\u81e8\u5e8a\u696d\u52d9\u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3\u3067\u3001\u3059\u3079\u3066\u306e\u56de\u7b54\u8005\uff08100\uff05\uff09\u304c\u4f7f\u7528\u3057\u3066\u3044\u307e\u3059\u3002\u6b21\u306b\u3001RTSM (Rndomization and Trial Supply Management)\uff0877\uff05\uff09\u3001\u5b89\u5168\u6027\uff0f\u533b\u85ac\u54c1\u5b89\u5168\u6027\u76e3\u8996\uff0870\uff05\uff09\u3001eTMF\uff0870\uff05\uff09\u3001\u81e8\u5e8a\u8a66\u9a13\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\uff08CTMS\uff09\uff0861\uff05\uff09\u3068\u7d9a\u304d\u307e\u3059\u3002<\/li>\n<li>\u56de\u7b54\u8005\u306e\u5927\u591a\u6570\uff0858\uff05\uff09\u304c\u4e3b\u8981\u306aEDC\u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3\u3068\u3057\u3066Medidata Rave\u304bOracle Inform\u306e\u3044\u305a\u308c\u304b\u3092\u4f7f\u7528\u3057\u3066\u3044\u307e\u3059\u3002\u4ed6\u306b6\uff05\u4ee5\u4e0a\u4f7f\u7528\u3055\u308c\u3066\u3044\u308b\u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3\u306f\u3042\u308a\u307e\u305b\u3093\u3067\u3057\u305f\u3002<\/li>\n<li>\u3059\u3079\u3066\u306e\u56de\u7b54\u8005\u304cEDC\u30b7\u30b9\u30c6\u30e0\u3092\u4f7f\u7528\u3057\u3066\u3044\u307e\u3059\u304c\u3001\u7d043\u5206\u306e1\uff0832\uff05\uff09\u306f\u7d19\u306e\u75c7\u4f8b\u5831\u544a\u66f8\uff08CRF\uff09\u3082\u4f7f\u7528\u3057\u3066\u304a\u308a\u3001\u3053\u3046\u3057\u305f\u4f01\u696d\u304c\u81e8\u5e8a\u8a66\u9a13\u30c7\u30fc\u30bf\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u3092\u4f9d\u7136\u3068\u3057\u3066\u624b\u4f5c\u696d\u3067\u884c\u3063\u3066\u3044\u308b\u3053\u3068\u3092\u793a\u5506\u3057\u3066\u3044\u307e\u3059\u3002<\/li>\n<li>\u4f01\u696d\u306b\u3088\u308b\u3068\u3001eCRF\u30c7\u30fc\u30bf\uff08100\uff05\uff09\u3001\u30ed\u30fc\u30ab\u30eb\u691c\u67fb\u30c7\u30fc\u30bf\uff0860\uff05\uff09\u3001QOL\u30c7\u30fc\u30bf\uff0860\uff05\uff09\u3001\u4e2d\u592e\u691c\u67fb\u30c7\u30fc\u30bf\uff0857\uff05\uff09\u3001ePRO\u30c7\u30fc\u30bf\uff0834\uff05\uff09\u306a\u3069\u5e45\u5e83\u3044\u7a2e\u985e\u306e\u30c7\u30fc\u30bf\u3092\u4e3b\u8981EDC\u30b7\u30b9\u30c6\u30e0\u3067\u7ba1\u7406\u3057\u3066\u3044\u307e\u3059\u3002\u907a\u4f1d\u5b50\u30c7\u30fc\u30bf\u307e\u305f\u306f\u30e2\u30d0\u30a4\u30eb\u30d8\u30eb\u30b9\u30c7\u30fc\u30bf\u3092EDC\u3067\u7ba1\u7406\u3057\u3066\u3044\u308b\u4f01\u696d\u306f\u308f\u305a\u304b10\uff05\u306b\u904e\u304e\u307e\u305b\u3093\u3002<\/li>\n<li>\u4f01\u696d\u306fEDC\u3067\u69d8\u3005\u306a\u7a2e\u985e\u306e\u30c7\u30fc\u30bf\u3092\u7ba1\u7406\u3057\u3066\u3044\u307e\u3059\u304c\u3001\u6700\u3082\u5272\u5408\u304c\u9ad8\u3044\u3068\u56de\u7b54\u3057\u305f\u30c7\u30fc\u30bf\u306feCRF\u30c7\u30fc\u30bf\u3067\u3059\uff08\u63a8\u5b9a\u3055\u308c\u308b\u5272\u5408\u306f\u7ba1\u7406\u3059\u308b\u30c7\u30fc\u30bf\u306e78\uff05\uff09\u3002\u305d\u306e\u4ed6\u306e\u7a2e\u985e\u306e\u30c7\u30fc\u30bf\u306f\u3001\u30ed\u30fc\u30ab\u30eb\u691c\u67fb\u30c7\u30fc\u30bf\uff085\uff05\uff09\u3001\u4e2d\u592e\u691c\u67fb\u30c7\u30fc\u30bf\uff085\uff05\uff09\u3001QOL\u30c7\u30fc\u30bf\uff084\uff05\uff09\u3001ePRO\u30c7\u30fc\u30bf\uff083\uff05\uff09\u3067EDC\u306e\u30c7\u30fc\u30bf\u7dcf\u91cf\u306e5\uff05\u4ee5\u4e0b\u3068\u63a8\u5b9a\u3055\u308c\u307e\u3059\u3002EDC\u30b7\u30b9\u30c6\u30e0\u3067\u907a\u4f1d\u5b50\u30c7\u30fc\u30bf\u3068\u30e2\u30d0\u30a4\u30eb\u30d8\u30eb\u30b9\u30c7\u30fc\u30bf\u304c\u5360\u3081\u308b\u5272\u5408\u306f\u6700\u3082\u5c0f\u3055\u304f\u3001\u305d\u308c\u305e\u308c0.4\uff05\u30680.3\uff05\u3067\u3059\u3002<\/li>\n<\/ul>\n<p><strong>\u81e8\u5e8a\u8a66\u9a13\u30c7\u30fc\u30bf\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b5\u30a4\u30af\u30eb\u30bf\u30a4\u30e0<\/strong><\/p>\n<ul>\n<li>\u5e73\u5747\u3059\u308b\u3068\u3001\u8a66\u9a13\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u306e\u8a2d\u8a08\u3068\u30ea\u30ea\u30fc\u30b9\u306b68\u65e5\u3001\u8a66\u9a13\u5168\u4f53\u3092\u901a\u3057\u3066EDC\u30b7\u30b9\u30c6\u30e0\u3078\u306e\u30c7\u30fc\u30bf\u5165\u529b\u306f\u60a3\u8005\u306e\u6765\u9662\u304b\u30898\u65e5\u3001LPV(Last Patient Visit)\u304b\u3089\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u30ed\u30c3\u30af\u307e\u3067\u306b36\u65e5\u304b\u304b\u3063\u3066\u3044\u307e\u3059\u3002<\/li>\n<li>\u6cbb\u9a13\u4f9d\u983c\u8005\u3068\u540c\u69d8\u306b\u3001\u6700\u3082\u5e83\u304f\u666e\u53ca\u3057\u3066\u3044\u308b2\u5927EDC\u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3\uff08Medidata Rave\u3068Oracle Inform\uff09\u3092\u4f7f\u7528\u3057\u3066\u3044\u308b\u4f01\u696d\u306e\u65b9\u304c\u3001\u8a66\u9a13\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u306e\u8a2d\u8a08\u3068\u30ea\u30ea\u30fc\u30b9\u3001LPLV(Last Patient Last Visit)\u5f8c\u306e\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u30ed\u30c3\u30af\u306b\u6642\u9593\u304c\u304b\u304b\u3063\u3066\u3044\u307e\u3059\u3002<\/li>\n<\/ul>\n<p style=\"padding-left: 30px;\">\u25cb\u3000\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u306e\u69cb\u7bc9\u3068\u30ea\u30ea\u30fc\u30b9\u306e\u5e73\u5747\u65e5\u6570<\/p>\n<p style=\"padding-left: 60px;\">\u25a0\u3000\u6cbb\u9a13\u4f9d\u983c\u8005\u306e73\u65e5\u306b\u5bfe\u3057CRO\u306f53\u65e5<br \/>\n\u25a0\u3000\u6700\u3082\u5e83\u304f\u4f7f\u7528\u3055\u308c\u3066\u3044\u308b2\u5927EDC\u30b7\u30b9\u30c6\u30e0\u5229\u7528\u800575\u65e5\u306b\u5bfe\u3057\u3001\u4ed6\u306eEDC\u30b7\u30b9\u30c6\u30e0\u5229\u7528\u8005\u306f60\u65e5<\/p>\n<p style=\"padding-left: 30px;\">\u25cb\u3000\u8a66\u9a13\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u30ed\u30c3\u30af\u307e\u3067\u306e\u5e73\u5747\u65e5\u6570<\/p>\n<p style=\"padding-left: 60px;\">\u25a0\u3000\u6cbb\u9a13\u4f9d\u983c\u8005\u306e39\u65e5\u306b\u5bfe\u3057CRO\u306f28\u65e5<br \/>\n\u25a0\u3000\u6700\u3082\u5e83\u304f\u666e\u53ca\u3057\u3066\u3044\u308b2\u5927EDC\u30b7\u30b9\u30c6\u30e0\u5229\u7528\u8005\u306e39\u65e5\u306b\u5bfe\u3057\u3001\u4ed6\u306eEDC\u30b7\u30b9\u30c6\u30e0\u5229\u7528\u8005\u306f32\u65e5<\/p>\n<p><strong>\u81e8\u5e8a\u8a66\u9a13\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u69cb\u7bc9\u6642\u9593\u3068\u81e8\u5e8a\u8a66\u9a13\u30b5\u30a4\u30af\u30eb\u30bf\u30a4\u30e0\u3078\u306e\u5f71\u97ff<\/strong><\/p>\n<ul>\n<li>\u81e8\u5e8a\u8a66\u9a13\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u306e\u69cb\u7bc9\u3068\u30ea\u30ea\u30fc\u30b9\u306b\u304b\u304b\u308b\u521d\u671f\u6642\u9593\u306f\u3001\u8a66\u9a13\u5168\u4f53\u3092\u901a\u3058\u305fEDC\u3078\u306e\u60a3\u8005\u30c7\u30fc\u30bf\u5165\u529b\u6642\u9593\u3001LPLV(Last Patient Last Visit)\u5f8c\u306e\u6700\u7d42\u7684\u306a\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u30ed\u30c3\u30af\u6642\u9593\u306a\u3069\u3001\u6700\u7d42\u6bb5\u968e\u306e\u30d7\u30ed\u30bb\u30b9\u306b\u5927\u304d\u306a\u5f71\u97ff\u3092\u53ca\u307c\u3059\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002<\/li>\n<\/ul>\n<p style=\"padding-left: 30px;\">\u25cb\u3000FPFV<em>\u524d<\/em>\u306b\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u3092\u30ea\u30ea\u30fc\u30b9\u3059\u308b\u4f01\u696d\u306f\u3001\u60a3\u8005\u306e\u6765\u9662\u304b\u3089EDC\u306b\u30c7\u30fc\u30bf\u3092\u5165\u529b\u3059\u308b\u307e\u3067\u304c\u5e73\u57475\u65e5\u3001\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u30ed\u30c3\u30af\u671f\u9593\u304c31\u65e5\u3067\u3059\u3002<br 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