{"id":980,"date":"2019-12-18T09:42:18","date_gmt":"2019-12-18T14:42:18","guid":{"rendered":"https:\/\/mrctcenter.org\/clinical-trial-competency\/?page_id=980"},"modified":"2019-12-18T09:42:18","modified_gmt":"2019-12-18T14:42:18","slug":"domains-japanese","status":"publish","type":"page","link":"https:\/\/mrctcenter.org\/clinical-trial-competency\/framework\/domains-japanese\/","title":{"rendered":"Domains (Japanese)"},"content":{"rendered":"<section class=\"wpb-content-wrapper\"><p>[vc_row][vc_column][vc_column_text]\u81e8\u5e8a\u7814\u7a76\u5c02\u9580\u8077\u306e\u305f\u3081\u306e\u8abf\u548c\u306e\u3068\u308c\u305f\u30b3\u30a2\u30b3\u30f3\u30d4\u30c6\u30f3\u30b7\u30fc\uff08\u6838\u3068\u306a\u308b\u5c02\u9580\u7684\u80fd\u529b\uff09<strong>\u9818\u57df<\/strong>[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column width=&#8221;1\/6&#8243;][vc_single_image image=&#8221;149&#8243;][\/vc_column][vc_column width=&#8221;5\/6&#8243;][vc_column_text el_id=&#8221;domain1&#8243;]<\/p>\n<h2>\u9818\u57df \uff11\uff1a\u79d1\u5b66\u7684\u30b3\u30f3\u30bb\u30d7\u30c8\u3068\u7814\u7a76\u30c7\u30b6\u30a4\u30f3\uff1a\u81e8\u5e8a\u8a66\u9a13\u306e\u30c7\u30b6\u30a4\u30f3\u3068\u5206\u6790\u306b\u95a2\u308f\u308b\u79d1\u5b66\u7684\u6982\u5ff5\u306b\u3064\u3044\u3066\u306e\u77e5\u898b<\/h2>\n<p>\u81e8\u5e8a\u8a66\u9a13\u306e\u30c7\u30b6\u30a4\u30f3\u3068\u5206\u6790\u306b\u95a2\u308f\u308b\u79d1\u5b66\u7684\u6982\u5ff5\u306b\u3064\u3044\u3066\u306e\u77e5\u898b\u3002[\/vc_column_text][vc_tta_accordion active_section=&#8221;0&#8243; collapsible_all=&#8221;true&#8221;][vc_tta_section title=&#8221;1.1 \u751f\u7269\u533b\u5b66\u306e\u539f\u7406\u3092\u6cbb\u9a13\u85ac\u306e\u767a\u898b\u30fb\u958b\u767a\u304a\u3088\u3073\u5065\u5eb7\u306b\u95a2\u9023\u3059\u308b\u884c\u52d5\u4ecb\u5165\u8a66\u9a13\u306b\u9069\u7528\u3059\u308b&#8221; tab_id=&#8221;1576684589043-f9cb0390-c629&#8243;][vc_column_text]\n<table id=\"tablepress-103\" class=\"tablepress tablepress-id-103\">\n<thead>\n<tr class=\"row-1 odd\">\n\t<th class=\"column-1\">A.\u57fa\u790e\u30ec\u30d9\u30eb<\/th><th class=\"column-2\">B. \u4e2d\u7d1a\u30ec\u30d9\u30eb<\/th><th class=\"column-3\">C. \u4e0a\u7d1a\u30ec\u30d9\u30eb<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-hover\">\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\"><b>A1.<\/b> \u751f\u7269\u533b\u5b66\u7cfb\u88fd\u5264\u306e\u767a\u898b\u30fb\u958b\u767a\u304a\u3088\u3073\u5065\u5eb7\u306b\u95a2\u9023\u3059\u308b\u884c\u52d5\u4ecb\u5165\u8a66\u9a13\u306b\u79d1\u5b66\u7684\u539f\u7406\u3092\u9069\u7528\u3059\u308b\u5fc5\u8981\u6027\u3092\u8a8d\u8b58\u3059\u308b <br \/>\n<\/td><td class=\"column-2\"><b>B1.<\/b> \u81e8\u5e8a\u8a66\u9a13\u307e\u305f\u306f\u884c\u52d5\u5b66\u7684\u7814\u7a76\u306e\u5b9f\u65bd\u6642\u306b\u79d1\u5b66\u7684\u539f\u7406\u3092<br \/>\n\u9069\u7528\u3059\u308b <\/td><td class=\"column-3\"><b>C1.<\/b> \u79d1\u5b66\u7684\u539f\u7406\u306b\u57fa\u3065\u3044\u3066\u751f\u7269\u533b\u5b66\u7814\u7a76\u3092\u8a08\u753b\u3059\u308b <\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\"><b>A2. <\/b>\u751f\u7269\u533b\u5b66\u7cfb\u88fd\u5264\u306e\u767a\u898b\u30fb\u958b\u767a\u304a\u3088\u3073\u5065\u5eb7\u306b\u95a2\u9023\u3059\u308b\u884c\u52d5\u4ecb\u5165\u8a66\u9a13\u306b\u9069\u7528\u3059\u3079\u304d\u57fa\u790e\u7684\u306a\u79d1\u5b66\u7684\u539f\u7406\u306b\u3064\u3044\u3066\u8aac\u660e\u3059\u308b <\/td><td class=\"column-2\"><b>B2.<\/b> \u79d1\u5b66\u7684\u539f\u7406\u3068\u30d7\u30ed\u30c8\u30b3\u30eb\u30c7\u30b6\u30a4\u30f3\u306b\u57fa\u3065\u3044\u3066\u30c7\u30fc\u30bf\u53ce<br \/>\n\u96c6\u3092\u5b9f\u65bd\u3059\u308b <\/td><td class=\"column-3\"><b>C2.<\/b> \u79d1\u5b66\u7684\u539f\u7406\u306b\u57fa\u3065\u3044\u3066\u30c7\u30fc\u30bf\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u8a08\u753b\u3092\u69cb\u7bc9\u3059\u308b <\/td>\n<\/tr>\n<tr class=\"row-4 even\">\n\t<td class=\"column-1\"><b>\u4f8b\uff1a<\/b>\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u30ec\u30d3\u30e5\u30fc\u306e\u969b\u306b\u751f\u7269\u533b\u5b66\u7684\u7814\u7a76\u306e\u30c7\u30b6\u30a4\u30f3\u30fb\u5b9f\u65bd\u306b\u4f7f\u7528\u3059\u308b\u79d1\u5b66\u7684\u306a\u624b\u6cd5\u3068\u76ee\u7684\u3092\u8aac\u660e\u3059\u308b <\/td><td class=\"column-2\"><b>\u4f8b\uff1a<\/b>\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u304a\u3044\u3066\u3001\u30c7\u30fc\u30bf\u53ce\u96c6\u65b9\u6cd5\u306b\u95a2\u3057\u3066\u3069\u306e\u539f\u5247\u304c\u5f71\u97ff\u3059\u308b\u304b\u8b58\u5225\u3057\u3001\u305d\u308c\u306b\u5fdc\u3058\u305f\u6700\u826f\u306e\u65b9\u6cd5\u306b\u3088\u3063\u3066\u5b9f\u65bd\u3059\u308b <\/td><td class=\"column-3\"><b>\u4f8b\uff1a<\/b>\u30d7\u30ed\u30c8\u30b3\u30eb\u3068\u53ce\u96c6\u6e08\u307f\u306e\u30c7\u30fc\u30bf\u306b\u3064\u3044\u3066\u767a\u898b\u3057\u305f\u3053\u3068<br \/>\n\u3092\u8a55\u4fa1\u3057\u3001\u79d1\u5b66\u7684\u306a\u67a0\u7d44\u307f\u3092\u901a\u3057\u305f\u7d50\u679c\u306e\u5224\u5b9a\u3092\u884c\u3046 <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-103 from cache -->[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;1.2 \u81e8\u5e8a\u8a66\u9a13\u306b\u304a\u3044\u3066\u4eee\u8aac\u3092\u7acb\u3066\u3066\u691c\u8a3c\u3057\u3046\u308b\u79d1\u5b66\u7684\u306a\u8ab2\u984c\u3092\u7279\u5b9a\u3059\u308b&#8221; tab_id=&#8221;1576685437093-387b291b-3f5d&#8221;][vc_column_text]\n<table id=\"tablepress-104\" class=\"tablepress tablepress-id-104\">\n<thead>\n<tr class=\"row-1 odd\">\n\t<th class=\"column-1\">A.\u57fa\u790e\u30ec\u30d9\u30eb<\/th><th class=\"column-2\">B. \u4e2d\u7d1a\u30ec\u30d9\u30eb<\/th><th class=\"column-3\">C. \u4e0a\u7d1a\u30ec\u30d9\u30eb<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-hover\">\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\"><b>A1.<\/b> \u8a66\u9a13\u306e\u76ee\u7684\u3092\u660e\u78ba\u306b\u8ff0\u3079\u308b<\/td><td class=\"column-2\"><b>B1.<\/b> \u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u304a\u3051\u308b\u7814\u7a76\u4eee\u8aac\u3092\u7279\u5b9a\u3059\u308b <\/td><td class=\"column-3\"><b>C1. <\/b>\u79d1\u5b66\u7684\u539f\u7406\u306b\u57fa\u3065\u3044\u3066\u751f\u7269\u533b\u5b66\u7814\u7a76\u3092\u8a08\u753b\u3059\u308b <\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\"><b>A2. <\/b>\u8a66\u9a13\u306e\u91cd\u8981\u6027\u3092\u8aac\u660e\u3059\u308b <\/td><td class=\"column-2\"><b>B2.<\/b> \u30a2\u30a6\u30c8\u30ab\u30e0\u6e2c\u5b9a\u306e\u305f\u3081\u306e\u30c7\u30fc\u30bf\u89e3\u6790\u306b\u7528\u3044\u308b\u8a55\u4fa1\u9805\u76ee\uff08\u4e3b\u8981\u304a\u3088\u3073\u526f\u6b21\u7684\u8a55\u4fa1\u9805\u76ee\uff09\u3092\u7279\u5b9a\u3059\u308b<\/td><td class=\"column-3\"><b>C2.<\/b> \u79d1\u5b66\u7684\u539f\u7406\u306b\u57fa\u3065\u3044\u3066\u30c7\u30fc\u30bf\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u8a08\u753b\u3092\u69cb\u7bc9<br \/>\n\u3059\u308b <\/td>\n<\/tr>\n<tr class=\"row-4 even\">\n\t<td class=\"column-1\"><b>\u4f8b\uff1a<\/b>\u9078\u629e\u3057\u305f\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u304a\u3044\u3066\u4ee5\u4e0b\u306e\u8981\u7d20\u306b<br \/>\n\u3064\u3044\u3066\u8b58\u5225\u3059\u308b\uff1a <br \/>\n  \u8a66\u9a13\u8868\u984c\u3001\u8a66\u9a13\u306e\u4e3b\u8981\u76ee\u7684\u3001\u672c\u8a66\u9a13\u5b9f\u65bd\u306e\u91cd\u8981\u6027\u306f\u4f55\u304b\u3001\u8a66\u9a13\u306e\u5bfe\u8c61\u3068\u306a\u308b\u6bcd\u96c6\u56e3\u306f\u8ab0\u304b <\/td><td class=\"column-2\"><b>\u4f8b\uff1a<\/b>\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u304a\u3044\u3066\u3001\u76ee\u7684\u3068\u4eee\u8aac\u306e\u691c\u8a3c\u306b\u4f7f\u7528\u3059\u308b<br \/>\n\u5b89\u5168\u6027\u30fb\u6709\u52b9\u6027\u95a2\u9023\u306e\u30a8\u30f3\u30c9\u30dd\u30a4\u30f3\u30c8\u306b\u3064\u3044\u3066\u8aac\u660e\u30fb\u5206\u985e\u3057\u3001\u30a8\u30f3\u30c9\u30dd\u30a4\u30f3\u30c8\u306e\u6e2c\u5b9a\u306b\u4f7f\u7528\u3055\u308c\u308b <br \/>\n(\u81e8\u5e8a\u3001\u793e\u4f1a\u7684\uff0f\u884c\u52d5\u5b66\u7684\u3001\u307e\u305f\u306f\u7d4c\u6e08\u7684) \u8a55\u4fa1\u9805\u76ee\u306b\u3064\u3044\u3066\u8b58\u5225\u3059\u308b\u3002 <\/td><td class=\"column-3\"><b>\u4f8b\uff1a<\/b>\u30d7\u30ed\u30c8\u30b3\u30eb\u3068\u53ce\u96c6\u6e08\u307f\u306e\u30c7\u30fc\u30bf\u306b\u3064\u3044\u3066\u767a\u898b\u3057\u305f\u3053\u3068<br \/>\n\u3092\u8a55\u4fa1\u3057\u3001\u79d1\u5b66\u7684\u306a\u67a0\u7d44\u307f\u3092\u901a\u3057\u305f\u7d50\u679c\u306e\u5224\u5b9a\u3092\u884c\u3046<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-104 from cache -->[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;1.3 \u81e8\u5e8a\u8a66\u9a13\u306e\u30c7\u30b6\u30a4\u30f3\u306b\u304a\u3051\u308b\u8981\u7d20\u3092\u7279\u5b9a\u3057\u3001\u30c7\u30b6\u30a4\u30f3\u306e\u539f\u7406\u3068\u904e\u7a0b\u3092\u8aac\u660e\u3059\u308b&#8221; tab_id=&#8221;1576686695920-1badc352-5284&#8243;][vc_column_text]\n<table id=\"tablepress-105\" class=\"tablepress tablepress-id-105\">\n<thead>\n<tr class=\"row-1 odd\">\n\t<th class=\"column-1\">A.\u57fa\u790e\u30ec\u30d9\u30eb<\/th><th class=\"column-2\">B. \u4e2d\u7d1a\u30ec\u30d9\u30eb<\/th><th class=\"column-3\">C. \u4e0a\u7d1a\u30ec\u30d9\u30eb<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-hover\">\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\"><b>A1.<\/b> \u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u304a\u3051\u308b\u4e3b\u8981\u8981\u7d20\u3092\u7279\u5b9a\u3059\u308b <\/td><td class=\"column-2\"><b>B1.<\/b> \u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u30ec\u30d3\u30e5\u30fc\u3057\u3001\u5168\u3066\u306e\u5fc5\u8981\u8981\u7d20\u304c\u542b\u307e\u308c<br \/>\n\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b <\/td><td class=\"column-3\"><b>C1. <\/b>\u81e8\u5e8a\u8a66\u9a13\u30c7\u30b6\u30a4\u30f3\u3092\u8a55\u4fa1\u3057\u3001\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u5b9f\u65bd\u624b\u9806\u3092\u8abf\u6574\u3059\u308b <\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\"><b>A2. <\/b>\u8a66\u9a13\u306e\u91cd\u8981\u6027\u3092\u8aac\u660e\u3059\u308b <\/td><td class=\"column-2\"><\/td><td class=\"column-3\"><b>C2.<\/b> \u5404\u75be\u75c5\u9818\u57df\u306b\u9069\u3057\u305f\u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u4f5c\u6210\u3059\u308b <\/td>\n<\/tr>\n<tr class=\"row-4 even\">\n\t<td class=\"column-1\"><b>A3.<\/b> \u7a2e\u985e\u306e\u7570\u306a\u308b\u81e8\u5e8a\u8a66\u9a13\u306e\u57fa\u672c\u7684\u306a\u9055\u3044\u3092\u8a8d\u8b58\u3059<br \/>\n\u308b <\/td><td class=\"column-2\"><\/td><td class=\"column-3\"><b>C3. <\/b>\u8a66\u9a13\u8a2d\u8a08\u306e\u5f37\u307f\u3068\u5f31\u307f\u3092\u8a55\u4fa1\u3057\u3001\u8aac\u660e\u3059\u308b <\/td>\n<\/tr>\n<tr class=\"row-5 odd\">\n\t<td class=\"column-1\"><b>\u4f8b\uff1a<\/b>\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u304a\u3044\u3066\u3001\u6a21\u64ec\u88ab\u9a13\u8005\u306b\u304a\u3044\u3066\u9078\u629e\u9664\u5916\u57fa\u6e96\u3092\u8b58\u5225\u3059\u308b<\/td><td class=\"column-2\"><b>\u4f8b\uff1a<\/b>\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u304a\u3044\u3066\u3001\u4e0d\u8db3\u7b87\u6240\u3001\u4e0d\u5b8c\u5168\u306a\u7b87\u6240\u3001\u4e0d\u9069\u5207\u306a\u7b87\u6240\u306b\u3064\u3044\u3066\u8b58\u5225\u3059\u308b<\/td><td class=\"column-3\"><b>\u4f8b\uff1a<\/b>\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u304a\u3044\u3066\u76ee\u7684\u3068\u624b\u6bb5\u306b\u9f5f\u9f6c\u304c\u3042\u308b\u5834\u5408\u9069\u5207\u306b\u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u4fee\u6b63\u3059\u308b <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-105 from cache -->[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;1.4 \u81e8\u5e8a\u8a66\u9a13\u306e\u7d50\u679c\u3092\u5ba2\u89b3\u7684\u306b\u5206\u6790\u3059\u308b&#8221; tab_id=&#8221;1576689691968-a81cebae-dd0d&#8221;][vc_column_text]\n<table id=\"tablepress-106\" class=\"tablepress tablepress-id-106\">\n<thead>\n<tr class=\"row-1 odd\">\n\t<th class=\"column-1\">A.\u57fa\u790e\u30ec\u30d9\u30eb<\/th><th class=\"column-2\">B. \u4e2d\u7d1a\u30ec\u30d9\u30eb<\/th><th class=\"column-3\">C. \u4e0a\u7d1a\u30ec\u30d9\u30eb<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-hover\">\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\"><b>A1.<\/b> \u8a66\u9a13\u7d50\u679c\u3092\u7406\u89e3\u3059\u308b <\/td><td class=\"column-2\"><b>B1.<\/b> \u8a66\u9a13\u5831\u544a\u66f8\u3084\u6587\u732e\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u7d50\u679c\u306e\u8cea\u306e\u30ec\u30d9\u30eb<br \/>\n\u3092\u6bd4\u8f03\u3057\u8a55\u4fa1\u3059\u308b <\/td><td class=\"column-3\"><b>C1. <\/b>\u7d50\u679c\u306e\u9069\u7528\u53ef\u80fd\u6027\u3092\u5224\u65ad\u3059\u308b <\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\"><b>A2. <\/b>\u7814\u7a76\u8ab2\u984c\u306b\u5bfe\u3059\u308b\u7d50\u679c\u306e\u95a2\u9023\u6027\u3092\u8aac\u660e\u3059\u308b<\/td><td class=\"column-2\"><b>B2.<\/b> \u8a18\u8ff0\u7684\u5206\u6790\u30fb\u63a2\u7d22\u7684\u30c7\u30fc\u30bf\u89e3\u6790\u3092\u7406\u89e3\u3059\u308b <\/td><td class=\"column-3\"><b>C2.<\/b> \u81e8\u5e8a\u8a66\u9a13\u30c7\u30fc\u30bf\u306e\u50be\u5411\u3068\u504f\u5dee\u3092\u7279\u5b9a\u3059\u308b <\/td>\n<\/tr>\n<tr class=\"row-4 even\">\n\t<td class=\"column-1\"><b>\u4f8b\uff1a<\/b>\u8a66\u9a13\u5831\u544a\u66f8\u306b\u3064\u3044\u3066\u3001\u8a66\u9a13\u306e\u7d50\u679c\u3092\u8a00\u3044\u63db\u3048\u3001\u8981\u7d04\u3059\u308b<\/td><td class=\"column-2\"><b>\u4f8b\uff1a<\/b>\u540c\u69d8\u306e\u7814\u7a76\u30c6\u30fc\u30de\u306b\u3064\u3044\u3066\uff12\u3064\u306e\u7814\u7a76\u8ad6\u6587\u304c\u3042\u308b\u5834\u5408\u306b\u3001\u4f55\u304c\u5f71\u97ff\u3092\u4e0e\u3048\u3001\u30c7\u30fc\u30bf\u3092\u3069\u306e\u3088\u3046\u306b\u89e3\u91c8\u3067\u304d\u308b\u304b\u306b2\u3064\u3092\u6bd4\u8f03\u3057\u3001\u5bfe\u6bd4\u3055\u305b\u308b<\/td><td class=\"column-3\"><b>\u4f8b\uff1a<\/b>\u53ce\u96c6\u3057\u305f\u30c7\u30fc\u30bf\u306b\u3064\u3044\u3066\u533b\u85ac\u54c1\u5b89\u5168\u6027\u76e3\u8996\u306e\u89b3\u70b9\u304b\u3089\u8a55\u4fa1\u3057\u3001\u30c7\u30fc\u30bf\u306e\u9f5f\u9f6c\u3092\u57cb\u3081\u308b\u305f\u3081\u306e\u30af\u30a8\u30ea\u3092\u4f5c\u6210\u3059\u308b <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-106 from cache -->[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row][vc_row][vc_column width=&#8221;1\/6&#8243;][vc_single_image image=&#8221;253&#8243;][\/vc_column][vc_column width=&#8221;5\/6&#8243;][vc_column_text el_id=&#8221;domain2&#8243;]<\/p>\n<h2><strong>\u502b\u7406\u9762\u304a\u3088\u3073\u88ab\u9a13\u8005\u306e\u5b89\u5168\u3078\u306e\u914d\u616e<\/strong><\/h2>\n<p>\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u306b\u304a\u3051\u308b\u60a3\u8005\u306e\u30b1\u30a2\u3001\u88ab\u9a13\u8005\u4fdd\u8b77\u3001\u5b89\u5168\u6027\u3002[\/vc_column_text][vc_tta_accordion active_section=&#8221;0&#8243; collapsible_all=&#8221;true&#8221;][vc_tta_section title=&#8221;2.1 \u81e8\u5e8a\u8a66\u9a13\u3068\u901a\u5e38\u306e\u6cbb\u7642\u306e\u533a\u5225&#8221; tab_id=&#8221;1576690102803-445051ec-b4ca&#8221;][vc_column_text]\n<table id=\"tablepress-107\" class=\"tablepress tablepress-id-107\">\n<thead>\n<tr class=\"row-1 odd\">\n\t<th class=\"column-1\">A.\u57fa\u790e\u30ec\u30d9\u30eb<\/th><th class=\"column-2\">B. \u4e2d\u7d1a\u30ec\u30d9\u30eb<\/th><th class=\"column-3\">C. \u4e0a\u7d1a\u30ec\u30d9\u30eb<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-hover\">\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\"><b>A1.<\/b>  \u81e8\u5e8a\u8a66\u9a13\u306f\u672a\u78ba\u8a3c\u306a\u7814\u7a76\u6bb5\u968e\u306e\u3082\u306e\u3067\u3042\u308a\u3001\u65e2<br \/>\n\u306b\u5b9f\u65bd\u3055\u308c\u3066\u3044\u308b\u6a19\u6e96\u7684\u6cbb\u7642\u3068\u306f\u7570\u306a\u308b\u3053\u3068\u3092\u8aac\u660e\u3059\u308b <\/td><td class=\"column-2\"><b>B1.<\/b> \u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u5f93\u3063\u3066\u81e8\u5e8a\u8a66\u9a13\u3092\u5b9f\u65bd\u3059\u308b\u3053\u3068\u306e\u91cd\u8981\u6027\u3092\u660e\u793a\u3059\u308b <\/td><td class=\"column-3\"><b>C1. <\/b>\u7814\u7a76\u56fa\u6709\u306e\u624b\u9806\u3068\u6a19\u6e96\u7684\u6cbb\u7642\u3092\u660e\u78ba\u306b\u533a\u5225\u3057\u3066\u7d44\u307f\u8fbc\u307f\u3001\u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u4f5c\u6210\u3059\u308b <\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\"><b>\u4f8b\uff1a<\/b>\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u4e00\u90e8\u306b\u542b\u307e\u308c\u3066\u3044\u308b\u624b\u9806\u306f\u5fc5\u305a\u3057\u3082\u6a19\u6e96\u7684\u6cbb\u7642\u3067\u306f\u306a\u3044\u3053\u3068\u3092\u88ab\u9a13\u8005\u306b\u8aac\u660e\u3059\u308b<\/td><td class=\"column-2\"><b>\u4f8b\uff1a<\/b>\u81e8\u5e8a\u306e\u30b9\u30bf\u30c3\u30d5\u306b\u30b7\u30d5\u30c8\u4e2d\u306e\u7814\u7a76\u306e\u305f\u3081\u306e\u63a1\u8840\u306e\u30bf\u30a4\u30df\u30f3\u30b0\u3068\u901a\u5e38\u306e\u63a1\u8840\u306e\u30bf\u30a4\u30df\u30f3\u30b0\u3092\u5bfe\u6bd4\u3055\u305b\u3066\u8aac\u660e\u3059\u308b<\/td><td class=\"column-3\"><b>\u4f8b\uff1a<\/b>\u5b9f\u65bd\u9805\u76ee\u306b\u5fdc\u3058\u3066\u4fdd\u967a\u8acb\u6c42\u3059\u3079\u304d\u8cbb\u7528\u3068\u8a66\u9a13\u4f9d\u983c\u8005\u3078\u306e\u8acb\u6c42\u306b\u542b\u3081\u308b\u8cbb\u7528\u3092\u9069\u5207\u306b\u533a\u5225\u3059\u308b <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-107 from cache -->[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;2.2 \u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u306b\u95a2\u308f\u308b\u300c\u81e8\u5e8a\u7684\u5747\u8861\u300d\u3068\u300c\u7814\u7a76\u306e\u6cbb\u7642\u7684\u8aa4\u8a8d\u300d\uff08\u6cbb\u9a13\u3068\u6cbb\u7642\u306e\u6df7\u540c\uff09\u3092\u5b9a\u7fa9\u3059\u308b&#8221; tab_id=&#8221;1576690645386-5fd54eff-938b&#8221;][vc_column_text]\n<table id=\"tablepress-108\" class=\"tablepress tablepress-id-108\">\n<thead>\n<tr class=\"row-1 odd\">\n\t<th class=\"column-1\">A.\u57fa\u790e\u30ec\u30d9\u30eb<\/th><th class=\"column-2\">B. \u4e2d\u7d1a\u30ec\u30d9\u30eb<\/th><th class=\"column-3\">C. \u4e0a\u7d1a\u30ec\u30d9\u30eb<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-hover\">\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\"><b>A1.<\/b>  \u81e8\u5e8a\u7684\u5747\u8861\u3068\u7814\u7a76\u306e\u6cbb\u7642\u7684\u8aa4\u8a8d\uff08\u6cbb\u9a13\u3068\u6cbb\u7642\u306e\u6df7\u540c\uff09\u306f\u81e8\u5e8a\u7814\u7a76\u306e\u6839\u5e79\u3068\u306a\u308b\u57fa\u672c\u306e\u502b\u7406\u7684\u539f\u5247\u3067\u3042\u308a\u3001\u61f8\u5ff5\u4e8b\u9805\u3067\u3042\u308b\u3053\u3068\u3092\u8a8d\u8b58\u3059\u308b <\/td><td class=\"column-2\"><b>B1.<\/b>\u81e8\u5e8a\u7684\u5747\u8861\u3068\u7814\u7a76\u306e\u6cbb\u7642\u7684\u8aa4\u8a8d\uff08\u6cbb\u9a13\u3068\u6cbb\u7642\u306e\u6df7\u540c\uff09\u306e\u8ad6\u7406\u7684\u6839\u62e0\u3092\u8aac\u660e\u3057\u3001\u305d\u308c\u306b\u3064\u3044\u3066\u5305\u62ec\u7684\u306a\u77e5\u8b58\u3092\u6301\u3063\u3066\u3044\u308b\u3053\u3068\u3001\u304a\u3088\u3073\u60a3\u8005\u306e\u7406\u89e3\u306b\u3069\u306e\u3088\u3046\u306a\u5f71\u97ff\u3092\u4e0e\u3048\u3046\u308b\u304b\u3092\u7406\u89e3\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u793a\u3059\u3053\u3068\u304c\u3067\u304d\u308b <\/td><td class=\"column-3\"><b>C1. <\/b>\u30a8\u30ad\u30b9\u30d1\u30fc\u30c8\u3068\u3057\u3066\u306e\u5f79\u5272\u3092\u62c5\u3044\u3001\u88ab\u9a13\u8005\u5019\u88dc\u3068\u30b9\u30bf\u30c3\u30d5\u306b\u81e8\u5e8a\u7684\u5747\u8861\u3068\u7814\u7a76\u306e\u6cbb\u7642\u7684\u8aa4\u8a8d\uff08\u6cbb\u9a13\u3068\u6cbb\u7642\u306e\u6df7\u540c\uff09\u3078\u306e\u7406\u89e3\u3092\u4fc3\u3059<\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\"><\/td><td class=\"column-2\"><b>B2. <\/b>\u8a66\u9a13\u4e2d\u4e00\u8cab\u3057\u3066\u81e8\u5e8a\u7684\u5747\u8861\u3068\u7814\u7a76\u306e\u6cbb\u7642\u7684\u8aa4\u8a8d\u306b\u3064\u3044<br \/>\n\u3066\u306e\u77e5\u8b58\u3092\u9069\u7528\u3059\u308b <\/td><td class=\"column-3\"><\/td>\n<\/tr>\n<tr class=\"row-4 even\">\n\t<td class=\"column-1\"><\/td><td class=\"column-2\"><b>B3.<\/b>\u81e8\u5e8a\u7684\u5747\u8861\u3068\u7814\u7a76\u306e\u6cbb\u7642\u7684\u8aa4\u8a8d\u306b\u3064\u3044\u3066\u3001\u88ab\u9a13\u8005\u306e\u61f8\u5ff5\u306b\u5bfe\u51e6\u304c\u5fc5\u8981\u3068\u306a\u308b\u5834\u9762\u3092\u8a8d\u8b58\u30fb\u89e3\u91c8\u3057\u3001\u5fc5\u8981\u306a\u652f\u63f4\u3092\u6c42\u3081\u308b <\/td><td class=\"column-3\"><\/td>\n<\/tr>\n<tr class=\"row-5 odd\">\n\t<td class=\"column-1\"><b>\u4f8b\uff1a<\/b>2\u3064\u306e\u5bfe\u7167\u6cbb\u7642\u306b\u3064\u3044\u3066\u8b58\u5225\u3057\u3001\u306a\u305c\u305d\u306e\uff12\u3064\u304c\u5bfe\u7167\u6cbb\u7642\u3068\u3057\u3066\u9078\u629e\u3055\u308c\u305f\u304b\u3092\u5354\u8b70\u3059\u308b <\/td><td class=\"column-2\"><b>\u4f8b\uff1a<\/b>\u30a4\u30f3\u30d5\u30a9\u30fc\u30e0\u30c9\u30b3\u30f3\u30bb\u30f3\u30c8\u306e\u30d7\u30ed\u30bb\u30b9\u306b\u304a\u3044\u3066\u3001\u88ab\u9a13\u8005\u5019\u88dc\u304c\u8a66\u9a13\u306f\u7814\u7a76\u3067\u3042\u308a\u3001\u4e88\u6e2c\u901a\u308a\u306e\u7d50\u679c\u304c\u5f97\u3089\u308c\u308b\u3082\u306e\u3067\u306f\u306a\u3044\u3053\u3068\u3092\u771f\u306b\u7406\u89e3\u3057\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u3092\u5224\u5225\u3059\u308b <\/td><td class=\"column-3\"><b>\u4f8b\uff1a<\/b>\u81e8\u5e8a\u7684\u5747\u8861\u3068\u7814\u7a76\u306e\u6cbb\u7642\u7684\u8aa4\u8a8d\uff08\u6cbb\u9a13\u3068\u6cbb\u7642\u306e\u6df7\u540c\uff09\u306b\u95a2\u3057\u3066\u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u89e3\u91c8\u3057\u3001\u9662\u5185(\u793e\u5185)\u6559\u80b2\u306e\u5b9f\u65bd\u3092\u4e3b\u5c0e\u3059\u308b <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-108 from cache -->[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;2.3 \u81e8\u5e8a\u8a66\u9a13\u306e\u5168\u6bb5\u968e\u306b\u304a\u3044\u3066\u3001\u88ab\u9a13\u8005\u4fdd\u8b77\u3068\u30d7\u30e9\u30a4\u30d0\u30b7\u30fc\u306e\u78ba\u4fdd\u306b\u95a2\u3059\u308b\u56fd\u5185\u5916\u306e\u539f\u5247\u3092\u9069\u7528\u3059\u308b&#8221; tab_id=&#8221;1576690701848-e2363473-095b&#8221;][vc_column_text]\n<table id=\"tablepress-109\" class=\"tablepress tablepress-id-109\">\n<thead>\n<tr class=\"row-1 odd\">\n\t<th class=\"column-1\">A.\u57fa\u790e\u30ec\u30d9\u30eb<\/th><th class=\"column-2\">B. \u4e2d\u7d1a\u30ec\u30d9\u30eb<\/th><th class=\"column-3\">C. \u4e0a\u7d1a\u30ec\u30d9\u30eb<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-hover\">\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\"><b>A1.<\/b> \u3044\u304b\u306a\u308b\u5730\u57df\u306b\u304a\u3044\u3066\u3082\u3001\u81e8\u5e8a\u8a66\u9a13\u306b\u53c2\u52a0\u3059<\/td><td class=\"column-2\"><b>B1.<\/b>\u30d7\u30ed\u30c8\u30b3\u30eb\u5185\u306b\u304a\u3051\u308b\u3001\u88ab\u9a13\u8005\u4fdd\u8b77\u3068\u30d7\u30e9\u30a4\u30d0\u30b7\u30fc\u306e\u78ba\u4fdd\u306e\u539f\u5247\u3092\u5ba2\u89b3\u7684\u306b\u541f\u5473\u3057\u5b9f\u65bd\u3059\u308b <\/td><td class=\"column-3\"><b>C1. <\/b>\u4e16\u754c\u306e\u3069\u306e\u5730\u57df\u3067\u5b9f\u65bd\u3055\u308c\u308b\u81e8\u5e8a\u8a66\u9a13\u306b\u304a\u3044\u3066\u3082\u3001\u88ab\u9a13\u8005\u306e\u30d7\u30e9\u30a4\u30d0\u30b7\u30fc\u30fb\u5b89\u5168\u30fb\u798f\u7949\u30fb\u6a29\u5229\u3092\u5b88\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u6d3b\u52d5\u3092\u7ba1\u7406\u30fb\u76e3\u7763\u3059\u308b <\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\"><\/td><td class=\"column-2\"><\/td><td class=\"column-3\"><b>C2. <\/b> \u81e8\u5e8a\u8a66\u9a13\u306b\u304a\u3051\u308b\u88ab\u9a13\u8005\u306e\u30d7\u30e9\u30a4\u30d0\u30b7\u30fc\u3068\u5b89\u5168\u3092\u78ba\u4fdd\u3059\u308b\u65b9\u6cd5\u306b\u95a2\u3057\u3066\u3001\u898f\u5236\u6a5f\u95a2\uff08IRB  :Institutional Review Board\u3084\u502b\u7406\u5be9\u67fb\u59d4\u54e1\u4f1a\uff09\u304b\u3089\u306e\u8cea\u554f\u306b\u7b54\u3048\u308b <\/td>\n<\/tr>\n<tr class=\"row-4 even\">\n\t<td class=\"column-1\"><b>\u4f8b\uff1a<\/b>\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u304a\u3051\u308b\u52df\u96c6\u3084\u540c\u610f\u30d7\u30ed\u30bb\u30b9\u306b\u304a\u3051\u308b\u3001\u81ea\u4e3b\u6027\u3001\u6b63\u5f53\u6027\u3001\u5584\u884c\u306e\u4f8b\u306b\u3064\u3044\u3066\u8b58\u5225\u3059\u308b <\/td><td class=\"column-2\"><b>\u4f8b\uff1a<\/b>\u3059\u3079\u3066\u306e\u9069\u5207\u306a\u6bcd\u96c6\u56e3\u3092\u7d44\u307f\u5165\u308c\u3089\u308c\u308b\u3088\u3046\u3001\u52df\u96c6\u6226\u7565\u3092\u30c7\u30b6\u30a4\u30f3\u3059\u308b <\/td><td class=\"column-3\"><b>\u4f8b\uff1a<\/b>\u5be9\u67fb\u306e\u305f\u3081\u306b\u63d0\u51fa\u3059\u308b\u4e88\u5b9a\u306e\u81e8\u5e8a\u8a66\u9a13\u306b\u304a\u3044\u3066\u88ab\u9a13\u8005\u306b\u5bfe\u3059\u308b\u5b88\u79d8\u7fa9\u52d9\u3092\u78ba\u5b9f\u306b\u9806\u5b88\u3059\u308b\u305f\u3081\u306e\u8a08\u753b\u306b\u3064\u3044\u3066\u62c5\u5f53\u6a5f\u95a2\uff08IRB\u3084\u502b\u7406\u5be9\u67fb\u59d4\u54e1\u4f1a\uff09\u306b\u8aac\u660e\u3059\u308b <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-109 from cache -->[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;2.4 \u88ab\u9a13\u8005\u304b\u3089\u5f97\u308b\u30a4\u30f3\u30d5\u30a9\u30fc\u30e0\u30c9\u30b3\u30f3\u30bb\u30f3\u30c8\u306e\u5fc5\u9808\u8981\u4ef6\u306e\u5909\u9077\u3001\u304a\u3088\u3073\u81e8\u5e8a\u8a66\u9a13\u306b\u304a\u3051\u308b\u88ab\u9a13\u8005\u4fdd\u8b77\u3092\u78ba\u5b9f\u306b\u3059\u308b\u305f\u3081\u306e\u539f\u5247\u3068\u91cd\u8981\u306a\u6587\u66f8\u306e\u5185\u5bb9\u3092\u8aac\u660e\u3059\u308b&#8221; tab_id=&#8221;1576691317187-7bf29ab8-d289&#8243;][vc_column_text]\n<table id=\"tablepress-110\" class=\"tablepress tablepress-id-110\">\n<thead>\n<tr class=\"row-1 odd\">\n\t<th class=\"column-1\">A.\u57fa\u790e\u30ec\u30d9\u30eb<\/th><th class=\"column-2\">B. \u4e2d\u7d1a\u30ec\u30d9\u30eb<\/th><th class=\"column-3\">C. \u4e0a\u7d1a\u30ec\u30d9\u30eb<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-hover\">\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\"><b>A1.<\/b> \u73fe\u5728\u306e\u30a4\u30f3\u30d5\u30a9\u30fc\u30e0\u30c9\u30b3\u30f3\u30bb\u30f3\u30c8\u898f\u5236\u306b\u81f3\u3063<br \/>\n\u305f\u6b74\u53f2\u7684\u7d4c\u7def\u3092\u7406\u89e3\u3059\u308b <\/td><td class=\"column-2\"><b>B1.<\/b>\u30a4\u30f3\u30d5\u30a9\u30fc\u30e0\u30c9\u30b3\u30f3\u30bb\u30f3\u30c8\u306e\u30d7\u30ed\u30bb\u30b9\u306b\u304a\u3044\u3066\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u5229\u76ca\u3060\u3051\u3067\u306a\u304f\u3001\u6f5c\u5728\u7684\u306a\u30ea\u30b9\u30af\u3084\u5371\u967a\u6027\u306b\u3064\u3044\u3066\u3082\u3001\u88ab\u9a13\u8005\u5019\u88dc\u304c\u7406\u89e3\u3067\u304d\u308b\u65b9\u6cd5\u3068\u7528\u8a9e\u3092\u7528\u3044\u3066\u4f1d\u3048\u308b\u3053\u3068\u306e\u91cd\u8981\u6027\u3092\u8a8d\u8b58\u3059\u308b <\/td><td class=\"column-3\"><b>C1. <\/b>\u5168\u8a66\u9a13\u306b\u304a\u3044\u3066\u88ab\u9a13\u8005\u4fdd\u8b77\u306e\u305f\u3081\u306e\u898f\u5236\u8981\u4ef6\u3092\u6e80<br \/>\n\u305f\u3059\u3053\u3068\u3092\u5fb9\u5e95\u3059\u308b\u305f\u3081\u306e\u30d7\u30ed\u30bb\u30b9\u3068\u7ba1\u7406\u624b\u6cd5\u3092\u5b9f\u88c5\u3059\u308b <\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\"><b>A2.<\/b>\u81e8\u5e8a\u8a66\u9a13\u306b\u304a\u3044\u3066\u88ab\u9a13\u8005\u4fdd\u8b77\u3092\u5fb9\u5e95\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u3068\u306a\u308b\u91cd\u8981\u306a\u6587\u66f8\u3092\u7279\u5b9a\u3059\u308b\uff08\u30d8\u30eb\u30b7\u30f3\u30ad\u5ba3\u8a00\u3001\u30d9\u30eb\u30e2\u30f3\u30c8\u30ec\u30dd\u30fc\u30c8\u3001CIOMS\u3001\u30cb \u30e5\u30eb\u30f3\u30d9\u30eb\u30af\u7db1\u9818\u3001ICH\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3001\u6cbb\u9a13\u85ac\u6982\u8981\u66f8\u3001\u533b\u85ac\u54c1\u6dfb\u4ed8\u6587\u66f8\u306a\u3069<\/td><td class=\"column-2\"><b>B2.<\/b> \u81e8\u5e8a\u8a66\u9a13\u306e\u305f\u3081\u306e\u30a4\u30f3\u30d5\u30a9\u30fc\u30e0\u30c9\u30b3\u30f3\u30bb\u30f3\u30c8\u6587\u66f8\u6848\u3092\u4f5c\u6210\u3059\u308b\u969b\u3001\u3053\u308c\u307e\u3067\u660e\u3089\u304b\u306b\u306a\u3063\u3066\u3044\u308b\u5b89\u5168\u6027\u60c5\u5831\u3068\u5408\u308f\u305b\u3001\u4e3b\u8981\u306a\u898f\u5236\u304a\u3088\u3073\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306e\u539f\u5247\u3092\u9069\u7528\u3059\u308b <\/td><td class=\"column-3\"><b>C2. <\/b>\u30a4\u30f3\u30d5\u30a9\u30fc\u30e0\u30c9\u30b3\u30f3\u30bb\u30f3\u30c8\u6587\u66f8\u304c\u73fe\u5728\u306e\u898f\u5247\u30fb\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u6e96\u3058\u3066\u3044\u308b\u3060\u3051\u3067\u306a\u304f\u3001\u88ab\u9a13\u8005\u5019\u88dc\u304c\u8a66\u9a13\u306b\u53c2\u52a0\u3059\u308b\u304b\u3069\u3046\u304b\u3092\u5224\u65ad\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u3001\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u95a2\u9023\u3059\u308b\u5341\u5206\u306a\u60c5\u5831\u3092\u63d0\u4f9b\u3059\u308b\u3082\u306e\u3068\u306a\u3063\u3066\u3044\u308b\u304b\u3092\u8a55\u4fa1\u3059\u308b <\/td>\n<\/tr>\n<tr class=\"row-4 even\">\n\t<td class=\"column-1\"><b>\u4f8b\uff1a<\/b>\u30d9\u30eb\u30e2\u30f3\u30c8\u30ec\u30dd\u30fc\u30c8\u306e3\u3064\u306e\u539f\u5247\u3001FDA\u898f\u5236\u3068ICH\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306e\u9055\u3044\u3092\u8b58\u5225\u3057\u3001\u8aac\u660e\u3059\u308b\u3002<\/td><td class=\"column-2\"><b>\u4f8b\uff1a<\/b>\u81e8\u5e8a\u8a66\u9a13\u306b\u5408\u308f\u305b\u3066\u30a4\u30f3\u30d5\u30a9\u30fc\u30e0\u30c9\u30b3\u30f3\u30bb\u30f3\u30c8\u6587\u66f8\u3092\u4f5c\u6210\u3057\u3001\u88ab\u9a13\u8005\u306b\u3068\u3063\u3066\u7406\u89e3\u3067\u304d\u308b\u8868\u73fe\u3067\u30ea\u30b9\u30af\u3068\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u306e\u53ef\u80fd\u6027\u3092\u8a18\u8f09\u3059\u308b <\/td><td class=\"column-3\"><b>\u4f8b\uff1a<\/b>\u88ab\u9a13\u8005\u4fdd\u8b77\u3092\u78ba\u5b9f\u306b\u3059\u308b\u305f\u3081\u306b\u52b9\u679c\u7684\u306a\u5f79\u5272\u3092\u62c5\u3046IRB\u59d4\u54e1\u3068\u3057\u3066\u5f93\u4e8b\u3059\u308b <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-110 from cache -->[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;2.5 \u793e\u4f1a\u7684\u5f31\u8005\u3067\u3042\u308b\u96c6\u56e3\u3092\u5bfe\u8c61\u306b\u3059\u308b\u5834\u5408\u306b\u691c\u8a0e\u3059\u3079\u304d\u502b\u7406\u7684\u306a\u554f\u984c\u3068\u3001\u305d\u306e\u96c6\u56e3\u306e\u305f\u3081\u306b\u8ffd\u52a0\u3067\u6574\u5099\u3059\u3079\u304d\u4fdd\u8b77\u7b56\u306b\u3064\u3044\u3066\u8aac\u660e\u3059\u308b\u3002&#8221; tab_id=&#8221;1576691687500-0bf78f9f-e655&#8243;][vc_column_text]\n<table id=\"tablepress-111\" class=\"tablepress tablepress-id-111\">\n<thead>\n<tr class=\"row-1 odd\">\n\t<th class=\"column-1\">A.\u57fa\u790e\u30ec\u30d9\u30eb<\/th><th class=\"column-2\">B. \u4e2d\u7d1a\u30ec\u30d9\u30eb<\/th><th class=\"column-3\">C. \u4e0a\u7d1a\u30ec\u30d9\u30eb<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-hover\">\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\"><b>A1.<\/b> \u3069\u306e\u3088\u3046\u306a\u96c6\u56e3\u304c\u793e\u4f1a\u7684\u5f31\u8005\u3068\u3055\u308c\u308b\u306e\u304b\u3092\u7279\u5b9a\u3059\u308b <\/td><td class=\"column-2\"><b>B1.<\/b>\u88ab\u9a13\u8005\u306b\u5bfe\u3057\u3001\u9069\u5207\u306a\u4fdd\u8b77\u7b56\u3092\u6b63\u78ba\u306b\u9069\u7528\u3059\u308b<\/td><td class=\"column-3\"><b>C1. <\/b>\u5bfe\u8c61\u3068\u306a\u308b\u96c6\u56e3\u304c\u9069\u5207\u306a\u4fdd\u8b77\u3092\u53d7\u3051\u3089\u308c\u3066\u3044\u308b<br \/>\n\u304b\u3001\u3042\u308b\u3044\u306f\u66f4\u306a\u308b\u4fdd\u8b77\u7b56\u304c\u5fc5\u8981\u304b\u3092\u5224\u65ad\u3059<br \/>\n\u308b\u305f\u3081\u306b\u3001\u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u8a55\u4fa1\u3059\u308b <\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\"><b>A2.<\/b>\u898f\u5236\u304c\u793e\u4f1a\u7684\u5f31\u8005\u3068\u3055\u308c\u308b\u4eba\u3005\u3092\u5b88\u308b\u305f\u3081\u306e\u3082\u306e\u3067\u3042\u308b\u3053\u3068\u3092\u7406\u89e3\u3059\u308b <\/td><td class=\"column-2\"><b>B2.<\/b> \u88ab\u9a13\u8005\u304c\u793e\u4f1a\u7684\u5f31\u8005\u3068\u307f\u306a\u3055\u308c\u308b\u72b6\u6cc1\u3092\u4e88\u6e2c\u3059\u308b<\/td><td class=\"column-3\"><b>C2. <\/b>\u793e\u4f1a\u7684\u5f31\u8005\u306e\u96c6\u56e3\u304c\u81ea\u8eab\u3067\u6700\u5584\u306e\u610f\u601d\u6c7a\u5b9a\u3092\u3057\u305f\u3046<br \/>\n\u3048\u3067\u81e8\u5e8a\u8a66\u9a13\u306b\u53c2\u52a0\u3067\u304d\u308b\u3088\u3046\u306a\u65b9\u7b56\u3092\u7acb\u6848\u3059\u308b <\/td>\n<\/tr>\n<tr class=\"row-4 even\">\n\t<td class=\"column-1\"><\/td><td class=\"column-2\"><\/td><td class=\"column-3\"><b>C3. <\/b>\u793e\u4f1a\u7684\u5f31\u8005\u3067\u3042\u308b\u96c6\u56e3\u306e\u8a66\u9a13\u3078\u306e\u53c2\u52a0\u306b\u5f71\u97ff\u3092\u53ca\u307c<br \/>\n\u3059\u56fa\u6709\u306e\u72b6\u6cc1\u3092\u8a55\u4fa1\u3059\u308b <\/td>\n<\/tr>\n<tr class=\"row-5 odd\">\n\t<td class=\"column-1\"><\/td><td class=\"column-2\"><\/td><td class=\"column-3\"><b>C4. <\/b> \u793e\u4f1a\u7684\u5f31\u8005\u3067\u3042\u308b\u96c6\u56e3\u304cIRB\u307e\u305f\u306f\u898f\u5236\u5f53\u5c40\u304b\u3089\u306e\u7279\u5225<br \/>\n\u306a\u914d\u616e\u3092\u5fc5\u8981\u3068\u3059\u308b\u304b\u3069\u3046\u304b\u3092\u8a55\u4fa1\u3059\u308b <\/td>\n<\/tr>\n<tr class=\"row-6 even\">\n\t<td class=\"column-1\"><b>\u4f8b\uff1a<\/b>\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u96c6\u56e3\u304c\u793e\u4f1a\u7684\u5f31\u8005\u3067\u3042\u308b\u3053\u3068\u3092\u7406\u89e3\u3059\u308b\uff1a\u5c0f\u5150\u3001\u53d7\u5211\u8005\u3001\u598a\u5a66\u3001\u7cbe\u795e\u75be\u60a3\u60a3\u8005\u3001\u7d4c\u6e08\u7684\u307e\u305f\u306f\u6559\u80b2\u6c34\u6e96\u7684\u306b\u4e0d\u5229\u306a\u7acb\u5834\u306b\u3042\u308b\u4eba\u3005 <br \/>\n  \u305d\u306e\u4e0a\u3067\u305d\u308c\u305e\u308c\u306e\u96c6\u56e3\u306b\u5bfe\u3059\u308b\u8ffd\u52a0\u306e\u4fdd\u8b77\u7b56\u306b\u3064\u3044\u3066\u6b63\u78ba\u306b\u8aac\u660e\u3059\u308b <\/td><td class=\"column-2\"><b>\u4f8b\uff1a<\/b>\u793e\u4f1a\u7684\u5f31\u8005\u306b\u3064\u3044\u3066\u306e\u77e5\u8b58\u3092\u88ab\u9a13\u8005\u306e\u540c\u610f\u30d7\u30ed\u30bb\u30b9\u3078\u9069\u7528\u3059\u308b\u3002\u793e\u4f1a\u7684\u8106\u5f31\u6027\u3092\u7279\u5b9a\u3057\u3001\u88ab\u9a13\u8005\u4fdd\u8b77\u306e\u305f\u3081\u306b\u4fdd\u8b77\u7b56\u3092\u9069\u7528\u3059\u308b <\/td><td class=\"column-3\"><b>\u4f8b\uff1a<\/b>\u793e\u4f1a\u7684\u5f31\u8005\u96c6\u56e3\u3092\u5bfe\u8c61\u3068\u3057\u305f\u7814\u7a76\u30fb\u8a66\u9a13\u306e\u88ab\u9a13\u8005\u52df\u96c6\u3084\u4fdd\u6301\u306e\u904e\u7a0b\u306b\u304a\u3044\u3066\u88ab\u9a13\u8005\u3092\u4fdd\u8b77\u3059\u308b\u305f\u3081\u306e\u6226\u7565\u3092\u7b56\u5b9a\u3059\u308b <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-111 from cache -->[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;2.6 \u81e8\u5e8a\u8a66\u9a13\u3068\u533b\u85ac\u54c1\u958b\u767a\u306e\u30d7\u30ed\u30bb\u30b9\u306e\u5546\u696d\u7684\u306a\u5074\u9762\u306b\u95a2\u308f\u308b\u502b\u7406\u7684\u554f\u984c\u3068\u6587\u5316\u7684\u591a\u69d8\u6027\u3092\u8a55\u4fa1\u30fb\u9069\u7528\u3059\u308b\u3002&#8221; tab_id=&#8221;1576692083440-10940399-8cf9&#8243;][vc_column_text]\n<table id=\"tablepress-112\" class=\"tablepress tablepress-id-112\">\n<thead>\n<tr class=\"row-1 odd\">\n\t<th class=\"column-1\">A.\u57fa\u790e\u30ec\u30d9\u30eb<\/th><th class=\"column-2\">B. \u4e2d\u7d1a\u30ec\u30d9\u30eb<\/th><th class=\"column-3\">C. \u4e0a\u7d1a\u30ec\u30d9\u30eb<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-hover\">\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\"><b>A1.<\/b> \u65b0\u85ac\u958b\u767a\u306e\u305f\u3081\u306e\u56fd\u969b\u5171\u540c\u6cbb\u9a13\u3092\u884c\u3046\u969b\u306b\u80cc<br \/>\n\u666f\u306b\u3042\u308b\u6587\u5316\u7684\u591a\u69d8\u6027\u3092\u8a8d\u8b58\u3059\u308b <\/td><td class=\"column-2\"><b>B1.<\/b>\u4e16\u754c\u5404\u5730\u306e\u7570\u306a\u308b\u5730\u57df\u306b\u304a\u3044\u3066\u5b9f\u65bd\u3055\u308c\u308b\u81e8\u5e8a\u8a66\u9a13\u306e\u6307\u91dd\u3068\u306a\u308b\u502b\u7406\u539f\u5247\u3092\u6bd4\u8f03\u3057\u3001\u9055\u3044\u3092\u660e\u3089\u304b\u306b\u3059\u308b<br \/>\n\uff08ICH\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u5bfeFDA\u898f\u5247\u3001\u4ed6\u56fd\u306e\u898f\u5247\u3068\u306e\u6bd4\u8f03\u306a\u3069\uff09 <\/td><td class=\"column-3\"><b>C1. <\/b>\u5404\u5730\u57df\u306e\u7570\u306a\u308b\u6587\u5316\u7684\u8996\u70b9\u3084\u5730\u57df\u3054\u3068\u306e\u502b\u7406\u7684\u306a\u8ab2\u984c\u3092\u8a8d\u8b58\u3057\u3001\u305d\u306e\u3088\u3046\u306a\u6982\u5ff5\u3092\u81e8\u5e8a\u8a66\u9a13\u306b\u53d6\u308a\u5165\u308c\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3059\u308b <\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\"><b>A2.<\/b>\u7570\u306a\u308b\u6587\u5316\u3092\u6301\u3064\u4eba\u540c\u58eb\u306e\u95a2\u4fc2\u6027\u3092\u7406\u89e3\u3059\u308b\u80fd\u529b(cultural competency) \u306b\u5bfe\u3059\u308b\u8003\u3048\u65b9\u3068\u3001\u305d\u308c\u304c\u591a\u69d8\u6027\u306e\u3042\u308b\u96c6\u56e3\u3067\u306e\u81e8\u5e8a\u8a66\u9a13\u306e\u904b\u55b6\u306b\u3069\u306e\u3088\u3046\u306b\u5f71\u97ff\u3059\u308b\u306e\u304b\u3092\u8aac\u660e\u3059\u308b <\/td><td class=\"column-2\"><b>B2.<\/b> \u81e8\u5e8a\u8a66\u9a13\u3092\u4f4e\u4e2d\u6240\u5f97\u56fd\u3067\u5b9f\u65bd\u3059\u308b\u3053\u3068\u306e\u5229\u70b9\u3084\u61f8\u5ff5\u3092\u7cbe\u67fb\u3057\u3001\u56fd\u969b\u5171\u540c\u81e8\u5e8a\u8a66\u9a13\u3092\u5b9f\u65bd\u3059\u308b\u969b\u306b\u4f4e\u4e2d\u6240\u5f97<br \/>\n\u56fd\u306e\u4eba\u3005\u304c\u76f4\u9762\u3057\u3046\u308b\u643e\u53d6\u3084\u5229\u76ca\u306e (\u4ed6\u306e\u56fd\u3005\u3068\u306e)\u9055\u3044\u3092\u660e\u78ba\u5316\u3059\u308b <\/td><td class=\"column-3\"><b>C2. <\/b>\u6cbb\u7642\u5019\u88dc\u3078\u306e\u5e73\u7b49\u306a\u30a2\u30af\u30bb\u30b9\u3092\u63d0\u4f9b\u3059\u308b\u5fc5\u8981\u6027\u3092\u9069\u5207\u306b\u8003\u616e\u3057\u3001\u6cbb\u9a13\u5b9f\u65bd\u5730\u57df\u306e\u9078\u5b9a\u306e\u305f\u3081\u306e\u6226\u7565\u3092\u7acb\u6848\u3059\u308b <\/td>\n<\/tr>\n<tr class=\"row-4 even\">\n\t<td class=\"column-1\"><b>\u4f8b\uff1a<\/b>\u30b0\u30ed\u30fc\u30d0\u30eb\u898f\u6a21\u3067\u306e\u533b\u7642\u958b\u767a\u30c1\u30fc\u30e0\u306b\u8ca2\u732e\u3059\u308b\u4e00\u54e1\u3068\u3057\u3066\u696d\u52d9\u306b\u5f93\u4e8b\u3059\u308b<\/td><td class=\"column-2\"><b>\u4f8b\uff1a<\/b>\u81e8\u5e8a\u8a66\u9a13\u304c\u5fc5\u8981\u306a\u30a4\u30f3\u30d5\u30e9(\u51b7\u8535\u4fdd\u7ba1\u65bd\u8a2d\u306a\u3069)\u304c\u6574\u3063\u305f\u5834\u6240\u3001\u304b\u3064\u88fd\u54c1\u304c\u8ca9\u58f2\u3055\u308c\u308b\u4e88\u5b9a\u306e\u5730\u57df\u3067\u306e\u307f\u5b9f\u65bd\u3055\u308c\u308b\u3088\u3046\u52a9\u8a00\u3059\u308b <\/td><td class=\"column-3\"><b>\u4f8b\uff1a<\/b>\u88ab\u9a13\u8005\u5019\u88dc\u306e\u5065\u5eb7\u30cb\u30fc\u30ba\u3092\u8003\u616e\u3057\u3001\u307e\u305f\u6cbb\u9a13\u7d42\u4e86\u5f8c\u306e\u6cbb\u9a13\u85ac\u3078\u306e\u30a2\u30af\u30bb\u30b9\u3092\u78ba\u4fdd\u3057\u3001\u30b0\u30ed\u30fc\u30d0\u30eb\u3067\u306e\u533b\u85ac\u54c1\u958b\u767a\u30d7\u30ed\u30b0\u30e9\u30e0\u3092\u30c7\u30b6\u30a4\u30f3\u3059\u308b <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-112 from cache -->[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;2.7 \u88ab\u9a13\u8005\u4fdd\u8b77\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u3001\u306a\u305c\u9078\u629e\u30fb\u9664\u5916\u306a\u3069\u306e\u57fa\u6e96\u304c\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u8a2d\u3051\u3089\u308c\u3066\u3044\u308b\u306e\u304b\u3092\u8aac\u660e\u3059\u308b&#8221; tab_id=&#8221;1576692506040-5001381a-2893&#8243;][vc_column_text]\n<table id=\"tablepress-113\" class=\"tablepress tablepress-id-113\">\n<thead>\n<tr class=\"row-1 odd\">\n\t<th class=\"column-1\">A.\u57fa\u790e\u30ec\u30d9\u30eb<\/th><th class=\"column-2\">B. \u4e2d\u7d1a\u30ec\u30d9\u30eb<\/th><th class=\"column-3\">C. \u4e0a\u7d1a\u30ec\u30d9\u30eb<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-hover\">\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\"><b>A1.<\/b> \u5e74\u9f62\u3001\u6027\u5225\u3001\u75c5\u6c17\u306e\u7a2e\u985e\u3084\u30b9\u30c6\u30fc\u30b8\u3001\u6cbb\u7642\u6b74\u3001\u305d\u306e\u4ed6\u306e\u75c5\u72b6\u306b\u3088\u308a\u3001\u88ab\u9a13\u8005\u304c\u5b89\u5168\u306b\u8a66\u9a13\u306b<br \/>\n\u53c2\u52a0\u3067\u304d\u308b\u304b\u5426\u304b\u3092\u7814\u7a76\u30c1\u30fc\u30e0\u304c\u5224\u65ad\u3059\u308b\u305f\u3081\u306e\u88ab\u9a13\u8005\u306e\u9069\u683c\u57fa\u6e96\uff08\u88ab\u9a13\u8005\u3092\u9078\u629e\u30fb\u9664\u5916\u3059\u308b\u305f\u3081\u306e\u3082\u306e\u306a\u3069\uff09\u3092\u7406\u89e3\u3059\u308b <\/td><td class=\"column-2\"><b>B1.<\/b>\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u5b9a\u7fa9\u3055\u308c\u305f\u57fa\u6e96\u306b\u57fa\u3065\u304f\u5747\u8cea\u306a\u60a3\u8005\u96c6\u56e3\u306e\u5fc5\u8981\u6027\u3068\u3001\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u57fa\u3065\u3044\u305f\u4e00\u8cab\u6027\u306e\u3042\u308b\u88ab\u9a13\u8005\u52df\u96c6\u306e\u5fc5\u8981\u6027\u3092\u660e\u78ba\u306b\u8ff0\u3079\u308b <\/td><td class=\"column-3\"><b>C1. <\/b>\u65b0\u3057\u3044\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u4f5c\u6210\u306b\u3042\u305f\u308a\u9069\u683c\u57fa\u6e96\u3092\u4f5c\u6210\u3057\u7de8<br \/>\n\u96c6\u3059\u308b <\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\"><b>A2.<\/b>\u30ec\u30b8\u30b9\u30c8\u30ea\u3084\u30a2\u30f3\u30b1\u30fc\u30c8\u8abf\u67fb\u7b49\u306e\u8907\u96d1\u3067\u306f\u306a\u3044\u8a66\u9a13\u306b\u304a\u3051\u308b\u88ab\u9a13\u8005\u306e\u9069\u683c\u53ef\u80fd\u6027\u3092\u5224\u65ad\u3059\u308b <\/td><td class=\"column-2\"><b>B2.<\/b>\u9078\u629e\u30fb\u9664\u5916\u57fa\u6e96\u304b\u3089\u306e\u4e56\u96e2\u304c\u30c7\u30fc\u30bf\u306e\u8cea\u3068\u8a66\u9a13\u306e\u6709<br \/>\n\u52b9\u6027\u306b\u53ca\u307c\u3059\u5f71\u97ff\u3092\u8aac\u660e\u3057\u3001\u7d50\u679c\u3092\u3069\u306e\u3088\u3046\u306b\u4e00\u822c\u5316\u3067\u304d\u308b\u306e\u304b\u3092\u8aac\u660e\u3059\u308b <\/td><td class=\"column-3\"><b>C2. <\/b>\u30a8\u30d3\u30c7\u30f3\u30b9\u3084\u904e\u53bb\u306e\u7d4c\u9a13\u306b\u57fa\u3065\u3044\u3066\u8a2d\u5b9a\u3057\u305f\u9078\u629e\u30fb\u9664\u5916\u57fa\u6e96\u306e\u8ad6\u7406\u7684\u6839\u62e0\u3092\u8aac\u660e\u3059\u308b <\/td>\n<\/tr>\n<tr class=\"row-4 even\">\n\t<td class=\"column-1\"><\/td><td class=\"column-2\"><b>B3.<\/b>\u9078\u629e\u30fb\u9664\u5916\u57fa\u6e96\u304c\u9069\u5207\u306b\u9069\u7528\u3055\u308c\u308b\u305f\u3081\u306e\u8cc7\u6599\uff08\u30ac<br \/>\n\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u3001\u88ab\u9a13\u8005\u52df\u96c6\u8a08\u753b\u7b49\uff09\u3092\u4f5c\u6210\u3059\u308b<\/td><td class=\"column-3\"><\/td>\n<\/tr>\n<tr class=\"row-5 odd\">\n\t<td class=\"column-1\"><\/td><td class=\"column-2\"><b>B4.<\/b>\u65bd\u8a2d\u5b9f\u65bd\u8a66\u9a13\uff08\u751f\u7269\u533b\u5b66\u3001\u4ecb\u5165\u8a66\u9a13\u7b49\uff09\u306b\u53c2\u52a0\u3059\u308b\u88ab<br \/>\n\u9a13\u8005\u306e\u9069\u683c\u53ef\u80fd\u6027\u3092\u5224\u65ad\u3059\u308b <\/td><td class=\"column-3\"><\/td>\n<\/tr>\n<tr class=\"row-6 even\">\n\t<td class=\"column-1\"><b>\u4f8b\uff1a<\/b>\u4eca\u5f8c\u306e\u81e8\u5e8a\u8a66\u9a13\u306b\u5411\u3051\u3001\u30b5\u30f3\u30d7\u30eb\u75c7\u4f8b\u96c6\u304b\u3089\u9078\u5b9a\u9664\u5916\u3001\u9069\u683c\u6027\u57fa\u6e96\u3092\u78ba\u8a8d\u3059\u308b<\/td><td class=\"column-2\"><b>\u4f8b\uff1a<\/b>\u8a66\u9a13\u306e\u76e3\u67fb\u306b\u304a\u3044\u3066\u9069\u683c\u6027\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u304b\u3089\u306e\u9038\u8131\u3092\u78ba\u8a8d\u3057\u3001\u8d77\u3053\u308a\u3046\u308b\u7d50\u679c\u306b\u3064\u3044\u3066\u8aac\u660e\u3057\u3001\u6b21\u306e\u5bfe\u7b56\u3068\u3057\u3066\u5fc5\u8981\u306a\u4e8b\u9805\u306b\u3064\u3044\u3066\u5354\u8b70\u3059\u308b <\/td><td class=\"column-3\"><b>\u4f8b\uff1a<\/b>\u65b0\u898f\u306e\u6cbb\u9a13\u306b\u304a\u3044\u3066\u9069\u683c\u6027\u306b\u95a2\u3059\u308b\u30ea\u30b9\u30af\u8a55\u4fa1\u3068\u30ea\u30b9\u30af\u4f4e\u6e1b\u8a08\u753b\u3092\u4f5c\u6210\u3057\u3001\u901a\u5e38\u306e\u65bd\u8a2d\u76e3\u67fb\u3067\u767a\u898b\u3055\u308c\u305f\u9038\u8131\u306b\u5bfe\u3059\u308b\u662f\u6b63\u30fb\u4e88\u9632\u63aa\u7f6e\u6226\u7565\u3092\u7acb\u3066\u308b <\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-113 from cache -->[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;2.8 \u88ab\u9a13\u8005\u306e\u9078\u629e\u3068\u7ba1\u7406\u3092\u901a\u3057\u3066\u3001\u30ea\u30b9\u30af\u3068\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u306e\u30d0\u30e9\u30f3\u30b9\u3092\u4fdd\u3061\u3001\u305d\u3057\u3066\u5206\u6563\u3055\u305b\u308b\u305f\u3081\u306e\u539f\u5247\u3068\u65b9\u6cd5\u3092\u307e\u3068\u3081\u308b&#8221; tab_id=&#8221;1576692689206-77b84c26-c951&#8243;][vc_column_text]\n<table id=\"tablepress-114\" class=\"tablepress tablepress-id-114\">\n<thead>\n<tr class=\"row-1 odd\">\n\t<th class=\"column-1\">A.\u57fa\u790e\u30ec\u30d9\u30eb<\/th><th class=\"column-2\">B. \u4e2d\u7d1a\u30ec\u30d9\u30eb<\/th><th class=\"column-3\">C. \u4e0a\u7d1a\u30ec\u30d9\u30eb<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-hover\">\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\"><b>A1.<\/b> \u30ea\u30b9\u30af\u3068\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u306e\u30d0\u30e9\u30f3\u30b9\u3092\u9069\u5207\u306b\u4fdd\u3064\u305f\u3081\u306b\u5fc5\u8981\u306a\u30d7\u30ed\u30bb\u30b9\uff08\u9078\u629e\u30fb\u9664\u5916\u3001\u8a66\u9a13\u65b9\u6cd5\u3001\u6709\u5bb3\u4e8b\u8c61\u306e\u5224\u5b9a\u3068\u8a18\u9332\u3001\u8a66\u9a13\u306e\u7d99\u7d9a\u306a\u3069\uff09\u3092\u7406\u89e3\u3059\u308b <\/td><td class=\"column-2\"><b>B1.<\/b>\u30ea\u30b9\u30af\u3068\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u306e\u30d0\u30e9\u30f3\u30b9\u3092\u9069\u5207\u306b\u4fdd\u3064\u305f\u3081\u306b\u5fc5\u8981\u306a\u30d7\u30ed\u30bb\u30b9\uff08\u9078\u629e\u30fb\u9664\u5916\u3001\u8a66\u9a13\u65b9\u6cd5\u3001\u6709\u5bb3\u4e8b\u8c61\u306e\u5224\u5b9a\u3068\u8a18\u9332\u3001\u8a66\u9a13\u306e\u7d99\u7d9a\u306a\u3069\uff09\u3092\u5b9f\u65bd\u3059\u308b <\/td><td class=\"column-3\"><b>C1. <\/b>\u30ea\u30b9\u30af\u3068\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u306e\u30d0\u30e9\u30f3\u30b9\u3092\u9069\u5207\u306b\u4fdd\u3064\u305f\u3081\u306b\u5fc5\u8981\u306a\u30d7\u30ed\u30bb\u30b9\uff08\u9078\u629e\u30fb\u9664\u5916\u3001\u8a66\u9a13\u65b9\u6cd5\u3001\u6709\u5bb3\u4e8b\u8c61\u306e\u5224\u5b9a\u3068\u8a18\u9332\u3001\u8a66\u9a13\u306e\u7d99\u7d9a\u306a\u3069\uff09\u3092\u69cb\u7bc9\u3059\u308b <\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\"><\/td><td class=\"column-2\"><\/td><td class=\"column-3\"><b>C2. <\/b>\u88ab\u9a13\u8005\u306e\u9078\u629e\u304b\u3089\u7ba1\u7406\u307e\u3067\u306e\u4e00\u9023\u306e\u6d41\u308c\u3092\u30c7\u30b6\u30a4\u30f3\u304a\u3088\u3073\uff0f\u307e\u305f\u306f\u76e3\u7763\u3059\u308b\u4e2d\u3067\u3001\u5e38\u306b\u30ea\u30b9\u30af\u3068\u30d9\u30cd\u30d5\u30a3 \u30c3\u30c8\u306e\u539f\u5247\u3068\u65b9\u6cd5\u3092\u308f\u304b\u308a\u3084\u3059\u304f\u8aac\u660e\u3059\u308b <\/td>\n<\/tr>\n<tr class=\"row-4 even\">\n\t<td class=\"column-1\"><b>\u4f8b\uff1a<\/b>\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u95a2\u9023\u3059\u308b\u9855\u5728\u7684\u30fb\u6f5c\u5728\u7684\u306a\u81e8\u5e8a\u4e0a\u306e\u30ea\u30b9\u30af\u3092\u7279\u5b9a\u3057\u3001\u30ea\u30b9\u30af\u8a55\u4fa1\u6d3b\u52d5\u3092\u88ab\u9a13\u8005\u306e\u6765\u9662\u6642\u306b\u7d99\u7d9a\u3057\u3066\u5b9f\u65bd\u3059\u308b <\/td><td class=\"column-2\"><b>\u4f8b\uff1a<\/b>\u88ab\u9a13\u8005\u306e\u52df\u96c6\u30fb\u4fdd\u6301\u306e\u6226\u7565\u306b\u57fa\u3065\u3044\u305f\u8a08\u753b\u307e\u305f\u306f\u30a4\u30f3\u30d5\u30a9\u30fc\u30e0\u30c9\u30b3\u30f3\u30bb\u30f3\u30c8\u306b\u7d10\u3065\u304f\u4e3b\u8981\u306a\u30ea\u30b9\u30af\u3068\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u306e\u69cb\u6210\u8981\u7d20\u3092\u7279\u5b9a\u3059\u308b<\/td><td class=\"column-3\"><b>\u4f8b\uff1a<\/b>\u30ea\u30b9\u30af\u3068\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u306e\u30d0\u30e9\u30f3\u30b9\u3092\u4fdd\u3061\u3001\u305d\u3057\u3066\u5206\u6563\u3055\u305b\u308b\u305f\u3081\u306e\u539f\u5247\u3068\u65b9\u6cd5\u3092\u7d44\u307f\u8fbc\u3093\u3060\u30d7\u30ed\u30c8\u30b3\u30eb\u3001\u30a4\u30f3\u30d5\u30a9\u30fc\u30e0\u30c9\u30b3\u30f3\u30bb\u30f3\u30c8\u3001\u88ab\u9a13\u8005\u52df\u96c6\u30fb\u4fdd\u6301\u8a08\u753b\u3092\u72ec\u529b\u3067\u69cb\u7bc9\u3059\u308b<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-114 from cache -->[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row][vc_row][vc_column width=&#8221;1\/6&#8243;][vc_single_image image=&#8221;317&#8243;][\/vc_column][vc_column width=&#8221;5\/6&#8243;][vc_column_text el_id=&#8221;domain3&#8243;]<\/p>\n<h2><strong>\u6cbb\u9a13\u85ac\u306e\u958b\u767a\u304a\u3088\u3073\u898f\u5236<\/strong><\/h2>\n<p>\u6cbb\u9a13\u85ac\u306e\u958b\u767a\u30fb\u898f\u5236\u306e\u4ed5\u7d44\u307f\u306b\u95a2\u3059\u308b\u77e5\u8b58\u3002[\/vc_column_text][vc_tta_accordion active_section=&#8221;0&#8243; collapsible_all=&#8221;true&#8221;][vc_tta_section title=&#8221;3.1\u653f\u5e9c\u306b\u3088\u308b\u6cbb\u9a13\u85ac\u306b\u95a2\u3059\u308b\u898f\u5236\u30d7\u30ed\u30bb\u30b9\u7b56\u5b9a\u306e\u304d\u3063\u304b\u3051\u3068\u306a\u3063\u305f\u6b74\u53f2\u7684\u51fa\u6765\u4e8b\u306b\u3064\u3044\u3066\u8003\u5bdf\u3059\u308b&#8221; tab_id=&#8221;1577112355495-846b586a-565f&#8221;][vc_column_text]\n<table id=\"tablepress-115\" class=\"tablepress tablepress-id-115\">\n<thead>\n<tr class=\"row-1 odd\">\n\t<th class=\"column-1\">A.\u57fa\u790e\u30ec\u30d9\u30eb<\/th><th class=\"column-2\">B. \u4e2d\u7d1a\u30ec\u30d9\u30eb<\/th><th class=\"column-3\">C. \u4e0a\u7d1a\u30ec\u30d9\u30eb<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-hover\">\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\"><b>A1.<\/b> \u73fe\u5728\u306e\u898f\u5236\u72b6\u6cc1\uff08FDA\u304a\u3088\u3073\u56fd\u969b\u7684\u306a\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\uff09\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u305f\u91cd\u8981\u306a\u904e\u53bb\u306e\u51fa\u6765\u4e8b\u3092\u7279\u5b9a\u3059\u308b<\/td><td class=\"column-2\"><b>B1.<\/b>FDA\u898f\u5247\u3001\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3001\u53ca\u3073\u56fd\u969b\u7684\u306a\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u95a2\u9023\u3057\u3066\u3001\u898f\u5236\u30d7\u30ed\u30bb\u30b9\u3084\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u305f\u8fd1\u5e74\u306e\u51fa\u6765\u4e8b\u306b\u3064\u3044\u3066\u7406\u89e3\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u793a\u3059<\/td><td class=\"column-3\"><b>C1. <\/b>\u65e2\u5b58\u306e\u898f\u5236\u3084ICH\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306e\u6539\u8a02\u3092\u4e88\u6e2c\u3057\u3001\u304a\u3088\u3073\uff0f\u307e\u305f\u306f\u6539\u8a02\u3092\u9069\u7528\u3059\u308b\u305f\u3081\u306e\u8a08\u753b\u3092\u4f5c\u6210\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\"><\/td><td class=\"column-2\"><\/td><td class=\"column-3\"><b>C2. <\/b>\u4f5c\u6210\u4e2d\u307e\u305f\u306f\u73fe\u884c\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u3084\u898f\u5236\u306b\u3064\u3044\u3066\u5185\u90e8\u30b9\u30bf\u30c3\u30d5\u3001\u8cac\u4efb\u533b\u5e2b\u3001\u305d\u306e\u4ed6\u306e\u30b9\u30c6\u30fc\u30af\u30db\u30eb\u30c0\u30fc\u3092\u6559\u80b2\u3057\u3001\u6cbb\u9a13\u30c1\u30fc\u30e0\u5168\u4f53\u306e\u6cbb\u9a13\u9042\u884c\u3092\u652f\u63f4\u3059\u308b\u3002\uff08\u4f8b:\u6700\u65b0\u7248\u306eICH E6\u306b\u5bfe\u5fdc\u3059\u308b\u305f\u3081\u306e\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u306b\u95a2\u3059\u308b\u8a18\u9332\u7b49\uff09<\/td>\n<\/tr>\n<tr class=\"row-4 even\">\n\t<td class=\"column-1\"><b>\u4f8b\uff1a<\/b>\u306a\u305c\u5834\u5408\u306b\u3088\u3063\u3066\u306f\u81e8\u5e8a\u8a66\u9a13\u306b\u598a\u5a20\u306e\u53ef\u80fd\u6027\u306e\u3042\u308b\u5973\u6027\u306b\u5bfe\u3059\u308b\u9078\u629e\u9664\u5916\u57fa\u6e96\u304c\u8a2d\u5b9a\u3055\u308c\u308b\u306e\u304b\u3092\u7406\u89e3\u3059\u308b<\/td><td class=\"column-2\"><b>\u4f8b\uff1a<\/b>FDA\u30ac\u30a4\u30c0\u30f3\u30b9\u3067\u306e\u3001\u81e8\u5e8a\u7814\u7a76\u306b\u304a\u3051\u308b\u30b2\u30ce\u30df\u30af\u30b9\u306b\u95a2\u3059\u308b\u8a18\u8f09\u7b87\u6240\u3092\u7279\u5b9a\u3057\u3001\u8aac\u660e\u3059\u308b<\/td><td class=\"column-3\"><b>\u4f8b\uff1a<\/b>FDA\u898f\u5236\u3068ICH GCP\u306b\u78ba\u5b9f\u306b\u6e96\u62e0\u3059\u308b\u305f\u3081\u3001\u65b0\u898f\u6cbb\u9a13\u306e\u305f\u3081\u306e\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u30c9\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u8a08\u753b\u3092\u4f5c\u6210\u3059\u308b<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-115 from cache -->[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;3.2 \u6cbb\u9a13\u85ac\u958b\u767a\u306e\u30d7\u30ed\u30bb\u30b9\u306b\u95a2\u308f\u308b\u5404\u65bd\u8a2d\u306e\u5f79\u5272\u3068\u8cac\u4efb\u3092\u8aac\u660e\u3059\u308b&#8221; tab_id=&#8221;1577112851086-90b403d0-b063&#8243;][vc_column_text]\n<table id=\"tablepress-116\" class=\"tablepress tablepress-id-116\">\n<thead>\n<tr class=\"row-1 odd\">\n\t<th class=\"column-1\">A.\u57fa\u790e\u30ec\u30d9\u30eb<\/th><th class=\"column-2\">B. \u4e2d\u7d1a\u30ec\u30d9\u30eb<\/th><th class=\"column-3\">C. \u4e0a\u7d1a\u30ec\u30d9\u30eb<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-hover\">\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\"><b>A1.<\/b>\u8cac\u4efb\u533b\u5e2b\u3001\u6cbb\u9a13\u4f9d\u983c\u8005\u3001CRO\u3001\u898f\u5236\u5f53\u5c40\u306e\u8cac\u4efb\u306e\u9055\u3044\u3092\u7279\u5b9a\u3059\u308b<\/td><td class=\"column-2\"><b>B1.<\/b>\u6cbb\u9a13\u85ac\u958b\u767a\u306b\u95a2\u308f\u308b\u5404\u6a5f\u95a2\uff08\u8cac\u4efb\u533b\u5e2b\u3001\u6cbb\u9a13\u4f9d\u983c\u8005\u3001CRO\u3001\u898f\u5236\u5f53\u5c40\uff09\u306e\u5f79\u5272\u3068\u8cac\u4efb\u3092\u4e00\u89a7\u306b\u3059\u308b<\/td><td class=\"column-3\"><b>C1. <\/b>\u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u8a55\u4fa1\u3057\u3001\u69d8\u3005\u306a\u65bd\u8a2d\u30fb\u7d44\u7e54\u9593\u3067\u5fc5\u8981\u306a\u5354\u529b\u4f53\u5236\u3092\u6c7a\u5b9a\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\"><b>A2.<\/b>\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u627f\u8a8d\u3001\u30ea\u30b9\u30af\u306e\u8a55\u4fa1\u3001\u4f8b\u5916\u7684\u5bfe\u5fdc\u3078\u306e\u5224\u65ad\u3001\u306b\u304a\u3051\u308bIRB\u306e\u5f79\u5272\u3092\u793a\u3059<\/td><td class=\"column-2\"><b>B2.<\/b>\u6cbb\u9a13\u85ac\u7ba1\u7406\u90e8\u9580\uff08Research Pharmacy\uff09\u3084\u30c7\u30fc\u30bf\u5b89\u5168\u6027\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u59d4\u54e1\u4f1a\uff08Data Safety Monitoring Boards\uff09\u306a\u3069\u306e\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3092\u884c\u3046\u7d44\u7e54\u306e\u8cac\u4efb\u7bc4\u56f2\u3092\u8a8d\u8b58\u3059\u308b<\/td><td class=\"column-3\"><b>C2. <\/b>\u7814\u7a76\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3092\u5b8c\u9042\u3055\u305b\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u65bd\u8a2d\u306e\u5f79\u5272\u3068\u8cac\u4efb\u3092\u5b9a\u7fa9\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-4 even\">\n\t<td class=\"column-1\"><b>\u4f8b\uff1a<\/b>FDA1572(Statement of Investigator)\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u6cbb\u9a13\u533b\u5e2b\u306e\u5f79\u5272\u3084\u3001\u6cbb\u9a13\u4f9d\u983c\u8005\u304b\u3089CRO\u3078\u306e\u8cac\u4efb\u306e\u59d4\u8b72\u306b\u3064\u3044\u3066\u8aac\u660e\u3059\u308b<\/td><td class=\"column-2\"><b>\u4f8b\uff1a<\/b>IRB\u304c\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u627f\u8a8d\u3001\u30ea\u30b9\u30af\u306e\u8a55\u4fa1\u3001\u4f8b\u5916\u7684\u5bfe\u5fdc\u3078\u306e\u5224\u65ad\u3092\u884c\u3046\u30d7\u30ed\u30bb\u30b9\u3068\u5fc5\u8981\u306a\u60c5\u5831\u3092\u8aac\u660e\u3059\u308b<\/td><td class=\"column-3\"><b>\u4f8b\uff1a<\/b>\u591a\u65bd\u8a2d\u5171\u540c\u6cbb\u9a13\u3067\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u696d\u52d9\u3092CRO\u306b\u4f9d\u983c\u3059\u308b\u969b\u306b\u3001\u30cb\u30fc\u30ba\u3092\u8a55\u4fa1\u3057\u3001\u63d0\u6848\u4f9d\u983c\u66f8\u3092\u4f5c\u6210\u3059\u308b<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-116 from cache -->[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;3.3\u533b\u85ac\u54c1\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306b\u88fd\u54c1\u5316\u3092\u7d44\u307f\u8fbc\u3093\u3060\u3001\u6cbb\u9a13\u85ac\u958b\u767a\u306e\u30d7\u30ed\u30bb\u30b9\u304a\u3088\u3073\u6d3b\u52d5\u3092\u8aac\u660e\u3059\u308b&#8221; tab_id=&#8221;1577113246869-d2e59345-35f8&#8243;][vc_column_text]\n<table id=\"tablepress-117\" class=\"tablepress tablepress-id-117\">\n<thead>\n<tr class=\"row-1 odd\">\n\t<th class=\"column-1\">A.\u57fa\u790e\u30ec\u30d9\u30eb<\/th><th class=\"column-2\">B. \u4e2d\u7d1a\u30ec\u30d9\u30eb<\/th><th class=\"column-3\">C. \u4e0a\u7d1a\u30ec\u30d9\u30eb<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-hover\">\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\"><b>A1.<\/b> \u533b\u85ac\u54c1\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d7\u30ed\u30bb\u30b9\u306b\u304a\u3051\u308b\u6cbb\u9a13\u85ac\u958b\u767a\u306e\u6982\u5ff5\u3001\u4e3b\u8981\u8981\u7d20\u3001\u76ee\u7684\u3092\u7406\u89e3\u3059\u308b<\/td><td class=\"column-2\"><b>B1.<\/b>\u533b\u85ac\u54c1\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d7\u30ed\u30bb\u30b9\u306b\u304a\u3051\u308b\u6cbb\u9a13\u85ac\u958b\u767a\u306e\u6982\u5ff5\u3001\u4e3b\u8981\u8981\u7d20\u3001\u76ee\u7684\u3092\u89e3\u91c8\u3057\u3001\u5b9f\u884c\u3059\u308b<\/td><td class=\"column-3\"><b>C1. <\/b>\u6226\u7565\u7684\u306a\u6cbb\u9a13\u85ac\u958b\u767a\u8a08\u753b\u304a\u3088\u3073\u533b\u85ac\u54c1\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u8a08\u753b\u3092\u4f5c\u6210\u3059\u308b\u3001\u307e\u305f\u306f\u65e2\u5b58\u306e\u8a08\u753b\u3092\u8a55\u4fa1\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\"><\/td><td class=\"column-2\"><\/td><td class=\"column-3\"><b>C2. <\/b>\u898f\u5236\u5f53\u5c40\u3068\u5171\u540c\u3067\u6cbb\u9a13\u85ac\u958b\u767a\u8a08\u753b\u306e\u8abf\u6574\u3092\u884c\u3046<\/td>\n<\/tr>\n<tr class=\"row-4 even\">\n\t<td class=\"column-1\"><\/td><td class=\"column-2\"><\/td><td class=\"column-3\"><b>C3. <\/b>\u533b\u85ac\u54c1\u3001\u30d0\u30a4\u30aa\u533b\u85ac\u54c1\u3001\u533b\u7642\u6a5f\u5668\u306e\u627f\u8a8d\u30d7\u30ed\u30bb\u30b9\u306e\u9055\u3044\u3092\u7406\u89e3\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-5 odd\">\n\t<td class=\"column-1\"><b>\u4f8b\uff1a<\/b> \u57fa\u672c\u7684\u306a\u85ac\u5264\u306e\u958b\u767a\u30fb\u627f\u8a8d\u30d7\u30ed\u30bb\u30b9\u3092\u7406\u89e3\u3057\u3001\u30a2\u30e1\u30ea\u30ab\u56fd\u5185\u3067\u533b\u85ac\u54c1\u3092\u8ca9\u58f2\u3059\u308b\u306b\u306fFDA\u306e\u627f\u8a8d\u53d6\u5f97\u304c\u5fc5\u8981\u3067\u3042\u308b\u3053\u3068\u3092\u8a8d\u8b58\u3059\u308b\u3002\u65bd\u8a2d\u306b\u304a\u3051\u308b\u6cbb\u9a13\u85ac\u306e\u8ffd\u8de1\u8a18\u9332\u3084\u75c7\u4f8b\u5831\u544a\u66f8\u3092\u9069\u5207\u306a\u72b6\u614b\u306b\u7dad\u6301\u3057\u3001\u6cbb\u9a13\u85ac\u6982\u8981\u66f8\u307e\u305f\u306f\u6cbb\u9a13\u6a5f\u5668\u30de\u30cb\u30e5\u30a2\u30eb\u306e\u60c5\u5831\u3092\u719f\u77e5\u3057\u3066\u3044\u308b<\/td><td class=\"column-2\"><b>\u4f8b\uff1a<\/b>\u6cbb\u9a13\u85ac\u7b49\u3092\u4f7f\u7528\u3059\u308b\u81e8\u5e8a\u8a66\u9a13\u3067IND(\u6cbb\u9a13\u85ac)\u3001IDE(\u6cbb\u9a13\u7528\u533b\u7642\u6a5f\u5668)\u53c8\u306f(\u6cbb\u9a13\u85ac)\u9069\u7528\u9664\u5916\u901a\u77e5\u304c\u5fc5\u8981\u304b\u3069\u3046\u304b\u3092FDA\u306e\u30a6\u30a7\u30d6\u30b5\u30a4\u30c8\u3092\u4f7f\u7528\u3057\u3066\u5224\u65ad\u3059\u308b<\/td><td class=\"column-3\"><b>\u4f8b\uff1a<\/b>\u65b0\u898f\u6cbb\u9a13\u85ac\u306e\u30aa\u30fc\u30d5\u30a1\u30f3\u30c9\u30e9\u30c3\u30b0(\u5e0c\u5c11\u75be\u75c5\u7528\u533b\u85ac\u54c1)\u6307\u5b9a\u306e\u4f9d\u983c\u3092\u8a08\u753b\u3057\u3001\u4f9d\u983c\u66f8\u3092\u4f5c\u6210\u3059\u308b<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-117 from cache -->[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;3.4\u6cbb\u9a13\u85ac\u306e\u958b\u767a\u3068\u5c4a\u51fa\u3092\u652f\u3048\u3001\u6cbb\u9a13\u85ac\u306e\u5b89\u5168\u6027\u30fb\u6709\u52b9\u6027\u30fb\u54c1\u8cea\u3092\u62c5\u4fdd\u3059\u308b\u6cd5\u5f8b\u4e0a\u30fb\u898f\u5236\u4e0a\u306e\u67a0\u7d44\u307f\u3092\u8aac\u660e\u3059\u308b&#8221; tab_id=&#8221;1577114458220-5cd3ae75-c20d&#8221;][vc_column_text]\n<table id=\"tablepress-118\" class=\"tablepress tablepress-id-118\">\n<thead>\n<tr class=\"row-1 odd\">\n\t<th class=\"column-1\">A.\u57fa\u790e\u30ec\u30d9\u30eb<\/th><th class=\"column-2\">B. \u4e2d\u7d1a\u30ec\u30d9\u30eb<\/th><th class=\"column-3\">C. \u4e0a\u7d1a\u30ec\u30d9\u30eb<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-hover\">\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\"><b>A1.<\/b>\u6cbb\u9a13\u85ac\u306e\u958b\u767a\u3068\u5c4a\u51fa\u306b\u95a2\u308f\u308b\u9069\u5207\u306a\u898f\u5236\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3078\u306e\u30a2\u30af\u30bb\u30b9\u65b9\u6cd5\u3001\u304a\u3088\u3073\u5404\u5730\u57df\u3067\u305d\u306e\u3088\u3046\u306a\u88fd\u54c1\u3092\u767b\u9332\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u81e8\u5e8a\u8a66\u9a13\u306e\u30d7\u30ed\u30bb\u30b9\u306b\u3064\u3044\u3066\u8aac\u660e\u3059\u308b\uff08US-FDA\u3001Europe-EMA\u3001UK-MHRA\uff09<\/td><td class=\"column-2\"><b>B1.<\/b>\u8907\u96d1\u306a\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u6642\u306b\u3001US\u30fbEMA\u30fb\u305d\u306e\u4ed6\u306e\u9023\u90a6\u653f\u5e9c\u306b\u3088\u308b\u898f\u5236\u306e\u305f\u3081\u306e\u6cd5\u5f8b\u3084\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u8aac\u660e\u3057\u9069\u7528\u3059\u308b<\/td><td class=\"column-3\"><b>C1. <\/b>\u8a66\u9a13\u53c2\u52a0\u8005\u306e\u5b89\u5168\u3068\u6a29\u5229\u3092\u62c5\u4fdd\u3059\u308b\u305f\u3081\u306b\u3001\u3069\u306e\u3088\u3046\u306bICH GCP\u3084\u627f\u8a8d\u6e08\u307f\u306e\u30d7\u30ed\u30c8\u30b3\u30eb\u3001\u6cbb\u9a13\u4f9d\u983c\u8005\u306e\u6a19\u6e96\u696d\u52d9\u624b\u9806\u66f8\u3092\u8abf\u548c\u3055\u305b\u308b\u304b\u3092\u542b\u3081\u3001 \u95a2\u9023\u5f53\u5c40\u3084\u898f\u5236\u95a2\u9023\u306e\u67a0\u7d44\u307f\u306b\u3064\u3044\u3066\u76e3\u7763\u3057\u6307\u5c0e\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\"><b>A2. <\/b> \u88ab\u9a13\u8005\u4fdd\u8b77\u3068ICH GCP\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u3064\u3044\u3066\u306e\u57fa\u672c\u7684\u77e5\u8b58\u304c\u3042\u308b\u3053\u3068\u3092\u793a\u3059<\/td><td class=\"column-2\"><b>B2.<\/b>\u627f\u8a8d\u3055\u308c\u305f\u30d7\u30ed\u30c8\u30b3\u30eb\u30fb\u6cbb\u9a13\u4f9d\u983c\u8005\u306e\u8a66\u9a13\u306b\u95a2\u9023\u3059\u308b\u6a19\u6e96\u696d\u52d9\u624b\u9806\u66f8\u306e\u8981\u4ef6\u3092\u89e3\u91c8\u30fb\u8aac\u660e\u3059\u308b<\/td><td class=\"column-3\"><b>C2. <\/b>\u65bd\u8a2d\u3067\u306e\u8a66\u9a13\u5b9f\u65bd\u306e\u9032\u6357\u3001\u307e\u305f\u8a66\u9a13\u304c\u5730\u57df\u30fb\u56fd\u30fb\u56fd\u969b\u898f\u5236\u306e\u67a0\u7d44\u307f\u306b\u6cbf\u3063\u3066\u5b9f\u65bd\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u30e2\u30cb\u30bf\u30fc\u3057\u3001\u8a66\u9a13\u306e\u5b9f\u65bd\u6642\u306b\u3053\u306e\u3088\u3046\u306a\u8981\u4ef6\u3092\u6e80\u305f\u3059\u3053\u3068\u304c\u3067\u304d\u308b\u3088\u3046\u30b5\u30dd\u30fc\u30c8\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-4 even\">\n\t<td class=\"column-1\"><\/td><td class=\"column-2\"><b>B3.<\/b> \u8a66\u9a13\u306b\u95a2\u9023\u3059\u308b\u6a19\u6e96\u696d\u52d9\u624b\u9806\u66f8\u3068\u5831\u544a\u66f8\u3092\u4f5c\u6210\u30fb\u7de8\u96c6\u3057\u3001\u305d\u3057\u3066\uff0f\u307e\u305f\u306f\u95a2\u9023\u3059\u308b\u898f\u5236\u5f53\u5c40\u306b\u3088\u308b\u8a66\u9a13\u306e\u627f\u8a8d\u306b\u5411\u3051\u63d0\u51fa\u3059\u308b<\/td><td class=\"column-3\"><\/td>\n<\/tr>\n<tr class=\"row-5 odd\">\n\t<td class=\"column-1\"><b>\u4f8b\uff1a<\/b> \u4ee5\u4e0b\u306e\u4e8b\u9805\u306b\u95a2\u9023\u3059\u308b\u5404\u56fd\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306b\u30a2\u30af\u30bb\u30b9\u3059\u308b\uff1a<br \/>\n\u3000\u3000\u30a4\u30f3\u30d5\u30a9\u30fc\u30e0\u30c9\u30b3\u30f3\u30bb\u30f3\u30c8\u3001\u85ac\u5264\u306e\u958b\u767a\u3068\u627f\u8a8d\u3001IRB\uff0f\u502b\u7406\u5be9\u67fb\u59d4\u54e1\u4f1a\u3001\u5229\u76ca\u76f8\u53cd\u3001\u6cbb\u9a13\u8cac\u4efb\u533b\u5e2b\u306e\u8cac\u52d9\u3001\u6cbb\u9a13\u4f9d\u983c\u8005\u306e\u8cac\u52d9<br \/>\n<\/td><td class=\"column-2\"><b>\u4f8b\uff1a<\/b> \u898f\u5236\u3084\u30ac\u30a4\u30c0\u30f3\u30b9\u304c\u3001ICH GCP\u306e\u8981\u4ef6\u3084\u533b\u5b66\u7814\u7a76\u898f\u5236\u5f53\u5c40\u306e\u627f\u8a8d\u30d7\u30ed\u30bb\u30b9\u3001\u7814\u7a76\u502b\u7406\u5be9\u67fb\u59d4\u54e1\u4f1a\u306e\u627f\u8a8d\u3068\u306e\u8abf\u548c\u306e\u4e0b\u306b\u3069\u306e\u3088\u3046\u306b\u9069\u7528\u3055\u308c\u308b\u304b\u3092\u3001\u8a66\u9a13\u3067\u5b9f\u65bd\u3057\u305f\u4e8b\u9805\u306b\u95a2\u3059\u308b\u5e83\u7bc4\u306b\u6e21\u308b\u8a18\u9332\u3084\u3001\u6cbb\u9a13\u8cac\u4efb\u533b\u5e2b\u65bd\u8a2d(\u5fc5\u9808\u6587\u66f8)\u30d5\u30a1\u30a4\u30eb\u306e\u7dad\u6301\u30fb\u7ba1\u7406\u3092\u901a\u3057\u3066\u8aac\u660e\u3059\u308b\u3002<\/td><td class=\"column-3\"><b>\u4f8b\uff1a<\/b>\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u306e\u6307\u91dd\u3001\u6587\u66f8\u3001\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u3092\u4f5c\u6210\u3057\u3001\u8a66\u9a13\u306b\u5f93\u4e8b\u3059\u308b\u30b9\u30bf\u30c3\u30d5\u304c\u7279\u5b9a\u306e\u8a66\u9a13\u306b\u304a\u3044\u3066\u8a72\u5f53\u3059\u308b\u898f\u5236\u306e\u67a0\u7d44\u307f\u3092\u78ba\u5b9f\u306b\u9075\u5b88\u3067\u304d\u308b\u3088\u3046\u306b\u3059\u308b<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-118 from cache -->[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;3.5 \u898f\u5236\u5f53\u5c40\u304b\u3089\u533b\u85ac\u54c1\u8ca9\u58f2\u306e\u627f\u8a8d\u3092\u5f97\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u5177\u4f53\u7684\u306a\u30d7\u30ed\u30bb\u30b9\u3084\u30d5\u30a7\u30fc\u30ba\u3092\u8aac\u660e\u3059\u308b&#8221; tab_id=&#8221;1577118093488-bea943f2-a0b9&#8243;][vc_column_text]\n<table id=\"tablepress-119\" class=\"tablepress tablepress-id-119\">\n<thead>\n<tr class=\"row-1 odd\">\n\t<th class=\"column-1\">A.\u57fa\u790e\u30ec\u30d9\u30eb<\/th><th class=\"column-2\">B. \u4e2d\u7d1a\u30ec\u30d9\u30eb<\/th><th class=\"column-3\">C. \u4e0a\u7d1a\u30ec\u30d9\u30eb<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-hover\">\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\"><b>A1.<\/b>\u524d\u81e8\u5e8a\u8a66\u9a13\u3068\u81e8\u5e8a\u8a66\u9a13\u306e\u5185\u5bb9\u30fb\u76ee\u7684\u3092\u8aac\u660e\u3057\u3001\u3069\u306e\u3088\u3046\u306bIND(Investigational New Drug)\u30fbNDA(New Drug Application)\u30fbCTA(Clinical Trial Authorization)\u30fbBLA(Biologics License Application)\u306e\u7533\u8acb\u306b\u7e4b\u304c\u308b\u304b\u3092\u8aac\u660e\u3059\u308b<\/td><td class=\"column-2\"><b>B1.<\/b>\u30d5\u30a7\u30fc\u30ba1-3\u306e\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u306b\u7a4d\u6975\u7684\u306b\u53c2\u52a0\u3059\u308b<\/td><td class=\"column-3\"><b>C1. <\/b>\u524d\u81e8\u5e8a\u8a66\u9a13\u307e\u305f\u306f\u81e8\u5e8a\u8a66\u9a13\u306e\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u5186\u6ed1\u306a\u5b9f\u65bd\u53ef\u80fd\u6027\u3068\u3001\u5fc5\u8981\u3068\u306a\u308b\u30ea\u30bd\u30fc\u30b9\u3092\u660e\u78ba\u306b\u8ff0\u3079\u308b<\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\"><b>A2. <\/b> \u30d5\u30a7\u30fc\u30ba1-3\u306e\u30c7\u30fc\u30bf\u304c\u3069\u306e\u3088\u3046\u306bIND\u3068NDA\u306e\u7533\u8acb\u306b\u7e4b\u304c\u308b\u306e\u304b\u3092\u7406\u89e3\u3059\u308b<\/td><td class=\"column-2\"><b>B2.<\/b>IND\u3001NDA\u3001BLA\u306e\u76ee\u7684\u306e\u9055\u3044\u3092\u8a8d\u8b58\u3059\u308b\u3002\u307e\u305f\u3001\u81e8\u5e8a\u958b\u767a\u306e\u5404\u30d5\u30a7\u30fc\u30ba\u306e\u9055\u3044\u3068\u305d\u306e\u30d5\u30a7\u30fc\u30ba\u3054\u3068\u306b\u5f97\u3089\u308c\u308b\u77e5\u898b\u3068\u306e\u95a2\u4fc2\u6027\u3082\u8a8d\u8b58\u3059\u308b<\/td><td class=\"column-3\"><b>C2. <\/b>\u898f\u5236\u5f53\u5c40\u3078\u306e\u7533\u8acb\uff08IND, BLA, NDA\u7b49\uff09\u307e\u305f\u306f\u81e8\u5e8a\u30d7\u30ed\u30b0\u30e9\u30e0\u306b\u7e4b\u304c\u308b\u305f\u3081\u306e\u524d\u81e8\u5e8a\u8a66\u9a13\u307e\u305f\u306f\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u958b\u767a\u30fb\u81e8\u5e8a\u7684\u8a08\u753b\u7b56\u5b9a\u30fb\u5b9f\u65bd\u3092\u76e3\u7763\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-4 even\">\n\t<td class=\"column-1\"><b>\u4f8b\uff1a<\/b>NDA(New Drug Application)\u306e\u7533\u8acb\u306b\u5fc5\u8981\u306a\u6587\u66f8\u306e\u53ce\u96c6\u306b\u53c2\u52a0\u3059\u308b<\/td><td class=\"column-2\"><b>\u4f8b\uff1a<\/b>\u6cbb\u9a13\u85ac\u6982\u8981\u66f8\u3092\u4f7f\u7528\u3057\u3066\u3001\u6cbb\u9a13\u306b\u5b89\u5168\u6027\u306b\u5bfe\u3059\u308b\u3069\u306e\u3088\u3046\u306a\u30ea\u30b9\u30af\u304c\u3082\u305f\u3089\u3055\u308c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u304b\u3092\u7406\u89e3\u3057\u3001\u4e88\u6e2c\u3059\u308b<\/td><td class=\"column-3\"><b>\u4f8b\uff1a<\/b>\u30c7\u30fc\u30bf\u3092\u89e3\u6790\u3057\u3001\u30d5\u30a7\u30fc\u30ba\u2160\u8a66\u9a13\u30c7\u30fc\u30bf\u306e\u89e3\u6790\u5f8c\u306b\u7d99\u7d9a\u304b\u4e2d\u6b62\u304b\u3092\u6c7a\u5b9a\u3059\u308b<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-119 from cache -->[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;3.6 \u898f\u5236\u5f53\u5c40\u3078\u306e\u627f\u8a8d\u524d\u30fb\u627f\u8a8d\u5f8c\u306e\u5831\u544a\u7fa9\u52d9\u3092\u8aac\u660e\u3059\u308b&#8221; tab_id=&#8221;1577118129068-1b548eb8-2db4&#8243;][vc_column_text]\n<table id=\"tablepress-120\" class=\"tablepress tablepress-id-120\">\n<thead>\n<tr class=\"row-1 odd\">\n\t<th class=\"column-1\">A.\u57fa\u790e\u30ec\u30d9\u30eb<\/th><th class=\"column-2\">B. \u4e2d\u7d1a\u30ec\u30d9\u30eb<\/th><th class=\"column-3\">C. \u4e0a\u7d1a\u30ec\u30d9\u30eb<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-hover\">\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\"><b>A1.<\/b>\u88fd\u9020\u8ca9\u58f2\u627f\u8a8d\u524d\u306e\u8a66\u9a13\u3068\u8ca9\u58f2\u627f\u8a8d\u5f8c\u306e\u8a66\u9a13\u306b\u304a\u3044\u3066\u7fa9\u52d9\u4ed8\u3051\u3089\u308c\u3066\u3044\u308b\u6709\u5bb3\u4e8b\u8c61\u5831\u544a\u306e\u9055\u3044\u3092\u7279\u5b9a\u3059\u308b<\/td><td class=\"column-2\"><b>B1.<\/b>\u81e8\u5e8a\u8a66\u9a13\u5b9f\u65bd\u6642\u306b\u767a\u751f\u3059\u308b\u6709\u5bb3\u4e8b\u8c61\u306e\u767a\u751f\u983b\u5ea6\u3092\u8a55\u4fa1\u3057\u3001\u8cac\u4efb\u533b\u5e2b\u3068\u5354\u529b\u3057\u6709\u5bb3\u4e8b\u8c61\u3092\u5206\u985e\u3059\u308b<\/td><td class=\"column-3\"><b>C1. <\/b>\u5b89\u5168\u6027\u30c7\u30fc\u30bf\uff08\u5b89\u5168\u6027\u30b7\u30b0\u30ca\u30eb\u3084\u30b5\u30fc\u30d9\u30a4\u30e9\u30f3\u30b9\u30b7\u30b9\u30c6\u30e0\u304b\u3089\u306e\u30c7\u30fc\u30bf\u306a\u3069\uff09\u3092\u7279\u5b9a\u3057\u89e3\u91c8\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\"><b>A2. <\/b>\u6709\u5bb3\u4e8b\u8c61\u306e\u5206\u985e\u5225\u306b\u8a2d\u3051\u3089\u308c\u3066\u3044\u308b\u5831\u544a\u7fa9\u52d9\u3092\u7406\u89e3\u3059\u308b<\/td><td class=\"column-2\"><b>B2.<\/b>\u9069\u7528\u3059\u308b\u8981\u4ef6\u3068\u5831\u544a\u671f\u9650\u306b\u6cbf\u3063\u3066\u6709\u5bb3\u4e8b\u8c61\u5831\u544a\u66f8\u3092\u4f5c\u6210\u3057\u63d0\u51fa\u3059\u308b<\/td><td class=\"column-3\"><b>C2. <\/b>\u5730\u57df\u5dee\u304c\u5b58\u5728\u3059\u308b\u53ef\u80fd\u6027\u306e\u3042\u308b\u5b89\u5168\u6027\u306b\u95a2\u3059\u308b\u5831\u544a\u7fa9\u52d9\u3092\u6bd4\u8f03\u3067\u304d\u308b\u3088\u3046\u52a9\u8a00\u3057\u6307\u5c0e\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-4 even\">\n\t<td class=\"column-1\"><\/td><td class=\"column-2\"><\/td><td class=\"column-3\"><b>C3. <\/b>REMS(Risk Evaluation and Mitigation Strategy\uff1a\u30ea\u30b9\u30af\u8a55\u4fa1\u30fb\u30ea\u30b9\u30af\u4f4e\u6e1b)\u30d7\u30ed\u30b0\u30e9\u30e0\u306b\u6e96\u62e0\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-5 odd\">\n\t<td class=\"column-1\"><b>\u4f8b\uff1a<\/b>\u300c\u91cd\u7be4\u300d\u306b\u5206\u985e\u3055\u308c\u308b\u57fa\u6e96\u306b\u8a72\u5f53\u3059\u308b\u6709\u5bb3\u4e8b\u8c61\u3092\u8b58\u5225\u3059\u308b<\/td><td class=\"column-2\"><b>\u4f8b\uff1a<\/b>\u4f8b\uff1a\u539f\u8cc7\u6599\u3068\u9069\u5207\u306a\u30b3\u30fc\u30c9\u5316\u306e\u305f\u3081\u306e\u7528\u8a9e\u96c6\u3092\u4f7f\u7528\u3057\u3066\u3001\u6709\u5bb3\u4e8b\u8c61\u3092\u8b58\u5225\u3001\u5206\u985e\u3001\u30b3\u30fc\u30c9\u5316\u3059\u308b\u3002<br \/>\n3.7 \u533b\u85ac\u54c1\u306e\u627f\u8a8d\u3068\u898f\u5236\u306b\u95a2\u3057\u3066\u767a\u751f\u3059\u308b\u554f\u984c\u3068\u305d\u306e\u4e16\u754c\u7684\u306a\u6ce2\u53ca\u306b\u3088\u308b\u5f71\u97ff\u3092\u8a55\u4fa1\u3059\u308b<br \/>\n<\/td><td class=\"column-3\"><b>\u4f8b\uff1a<\/b>\u627f\u8a8d\u524d\u30fb\u627f\u8a8d\u5f8c\u4e21\u65b9\u306e\u5b89\u5168\u6027\u5831\u544a\u306b\u95a2\u9023\u3059\u308b\u554f\u984c\u306e\u9023\u7d61\u5148\u3068\u3057\u3066\u306e\u5f79\u5272\u3092\u62c5\u3044\u3001\u95a2\u4fc2\u8005\u3068\u5354\u529b\u3057\u3066\u898f\u5236\u5f53\u5c40\u304b\u3089\u306e\u5b89\u5168\u6027\u5831\u544a\u306b\u95a2\u3059\u308b\u554f\u3044\u5408\u308f\u305b\u306b\u5bfe\u5fdc\u3059\u308b<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-120 from cache -->[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;3.7 \u533b\u85ac\u54c1\u306e\u627f\u8a8d\u3068\u898f\u5236\u306b\u95a2\u3057\u3066\u767a\u751f\u3059\u308b\u554f\u984c\u3068\u305d\u306e\u4e16\u754c\u7684\u306a\u6ce2\u53ca\u306b\u3088\u308b\u5f71\u97ff\u3092\u8a55\u4fa1\u3059\u308b&#8221; tab_id=&#8221;1577118676029-7208509b-c3dd&#8221;][vc_column_text]\n<table id=\"tablepress-121\" class=\"tablepress tablepress-id-121\">\n<thead>\n<tr class=\"row-1 odd\">\n\t<th class=\"column-1\">A.\u57fa\u790e\u30ec\u30d9\u30eb<\/th><th class=\"column-2\">B. \u4e2d\u7d1a\u30ec\u30d9\u30eb<\/th><th class=\"column-3\">C. \u4e0a\u7d1a\u30ec\u30d9\u30eb<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-hover\">\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\"><b>A1.<\/b>\u69d8\u3005\u306a\u56fd\u306e\u898f\u5236\u304c\u533b\u85ac\u54c1\u627f\u8a8d\u30d7\u30ed\u30bb\u30b9\u306b\u5f71\u97ff\u3057\u5f97\u308b\u3053\u3068\u3092\u7406\u89e3\u3059\u308b<\/td><td class=\"column-2\"><b>B1.<\/b>\u5404\u5730\u57df\u306e\u898f\u5236\u3092\u6bd4\u8f03\u3057\u3001\u307e\u305f\u305d\u306e\u9055\u3044\u304c\u3069\u306e\u3088\u3046\u306b\u8a66\u9a13\u306e\u5b9f\u65bd\u3084\u533b\u85ac\u54c1\u627f\u8a8d\u5be9\u67fb\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u5f97\u308b\u304b\u3092\u6bd4\u8f03\u3059\u308b<\/td><td class=\"column-3\"><b>C1. <\/b>\u56fd\u969b\u5171\u540c\u6cbb\u9a13\u3092\u5b9f\u65bd\u3059\u308b\u305f\u3081\u306e\u6226\u7565\u3092\u7acb\u6848\u3057\u5b9f\u8df5\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\"><\/td><td class=\"column-2\"><\/td><td class=\"column-3\"><b>C2. <\/b>\u88fd\u9020\u8ca9\u58f2\u627f\u8a8d\u7533\u8acb\u306b\u304a\u3044\u3066\u5fc5\u8981\u306a\u5be9\u67fb\u3068\u627f\u8a8d\u3092\u6700\u9069\u306b\u884c\u3046\u305f\u3081\u306e\u30b0\u30ed\u30fc\u30d0\u30eb\u306a\u6226\u7565\u3092\u7acb\u6848\u3057\u5b9f\u65bd\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-4 even\">\n\t<td class=\"column-1\"><\/td><td class=\"column-2\"><\/td><td class=\"column-3\"><b>C3. <\/b>\u8907\u6570\u306e\u56fd\u3067\u533b\u85ac\u54c1\u306e\u627f\u8a8d\u3092\u5f97\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u30ea\u30bd\u30fc\u30b9\u3092\u5206\u6790\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-5 odd\">\n\t<td class=\"column-1\"><b>\u4f8b\uff1a<\/b>\u591a\u5730\u57df\u3067\u5b9f\u65bd\u3055\u308c\u308b\u8a66\u9a13\u3067\u306fGCP\u3092\u9806\u5b88\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u4e00\u65b9\u3067\u3001\u305d\u306e\u4ed6\u306e\u898f\u5236\u306f\u56fd\u3054\u3068\u306e\u7570\u306a\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u3053\u3068\u3092\u7406\u89e3\u3059\u308b<\/td><td class=\"column-2\"><b>\u4f8b\uff1a<\/b>\u5404\u5730\u57df\u306e\u898f\u5236\u3092\u6bd4\u8f03\u3057\u3001\u307e\u305f\u305d\u306e\u9055\u3044\u304c\u3069\u306e\u3088\u3046\u306b\u8a66\u9a13\u306e\u5b9f\u65bd\u3084\u533b\u85ac\u54c1\u627f\u8a8d\u5be9\u67fb\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u5f97\u308b\u304b\u3092\u6bd4\u8f03\u3059\u308b<\/td><td class=\"column-3\"><b>\u4f8b\uff1a<\/b>\u4ed6\u56fd\u3067\u5f53\u5c40\u3078\u306e\u7533\u8acb\u3092\u884c\u3046\u969b\u306b\u306f\u30a2\u30e1\u30ea\u30ab\u3067\u540c\u69d8\u306e\u7533\u8acb\u3092\u884c\u3046\u3088\u308a\u304b\u306a\u308a\u591a\u304f\u306e\u30ea\u30bd\u30fc\u30b9\u3092\u8981\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u3053\u3068\u3092\u7406\u89e3\u3057\u3001ICH,EU,WHO\u306a\u3069\u306e\u56fd\u969b\u7684\u306a\u8abf\u548c\u306e\u53d6\u308a\u7d44\u307f\u306b\u6cbf\u3063\u305f\u6226\u7565\u306b\u3088\u308b\u533b\u85ac\u54c1\u306e\u627f\u8a8d\u53d6\u5f97\u306e\u969b\u306e\u969c\u58c1\u3092\u53d6\u308a\u9664\u304f\u305f\u3081\u3001\u4ee3\u66ff\u3068\u306a\u308b\u8907\u6570\u306e\u89e3\u6c7a\u7b56\u3092\u63d0\u4f9b\u3059\u308b<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-121 from cache -->[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row][vc_row][vc_column width=&#8221;1\/6&#8243;][vc_single_image image=&#8221;318&#8243;][\/vc_column][vc_column width=&#8221;5\/6&#8243;][vc_column_text el_id=&#8221;domain4&#8243;]<\/p>\n<h2><strong>\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\uff08Good Clinical Practice: GCP)<\/strong><\/h2>\n<p>\u8a66\u9a13\u7ba1\u7406\u3068GCP\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3002\u5b89\u5168\u6027\u7ba1\u7406\uff08\u6709\u5bb3\u4e8b\u8c61\u306e\u5224\u5b9a\u3068\u5831\u544a\u3001\u533b\u85ac\u54c1\u5e02\u8ca9\u5f8c\u8abf\u67fb\uff08PMS\uff09\u3001\u533b\u85ac\u54c1\u5b89\u5168\u6027\u76e3\u8996\uff09\u3001\u6cbb\u9a13\u85ac\u306e\u53d6\u308a\u6271\u3044\u7ba1\u7406\u3002[\/vc_column_text][vc_tta_accordion active_section=&#8221;0&#8243; collapsible_all=&#8221;true&#8221;][vc_tta_section title=&#8221;4.1\u5404\u81e8\u5e8a\u8a66\u9a13\u306e\u30c7\u30b6\u30a4\u30f3\u30fb\u76ee\u7684\u30fb\u5b9f\u65bd\u304c\u65b0\u898f\u306e\u6cbb\u7642\u4ecb\u5165\u3092\u958b\u767a\u3059\u308b\u3068\u3044\u3046\u76ee\u7684\u306b\u3069\u306e\u3088\u3046\u306b\u5408\u81f4\u3059\u308b\u304b\u8aac\u660e\u3059\u308b&#8221; tab_id=&#8221;1577118789096-a962b971-b7c7&#8243;][vc_column_text]\n<table id=\"tablepress-122\" class=\"tablepress tablepress-id-122\">\n<thead>\n<tr class=\"row-1 odd\">\n\t<th class=\"column-1\">A.\u57fa\u790e\u30ec\u30d9\u30eb<\/th><th class=\"column-2\">B. \u4e2d\u7d1a\u30ec\u30d9\u30eb<\/th><th class=\"column-3\">C. \u4e0a\u7d1a\u30ec\u30d9\u30eb<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-hover\">\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\"><b>A1.<\/b>\u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u8aad\u307f\u7406\u89e3\u3059\u308b\u3053\u3068\u3067\u3001\u65b0\u898f\u306e\u4ecb\u5165\u306e\u958b\u767a\u3068\u3001\u76f8\u4e92\u306b\u95a2\u4fc2\u3059\u308b\u8a66\u9a13\u306e\u30b4\u30fc\u30eb\u304a\u3088\u3073\u30c7\u30b6\u30a4\u30f3\u3068\u306e\u95a2\u9023\u6027\u3092\u7279\u5b9a\u3059\u308b<\/td><td class=\"column-2\"><b>B1.<\/b>\u65b0\u898f\u306e\u6cbb\u7642\u4ecb\u5165\u3092\u958b\u767a\u3059\u308b\u76ee\u7684\u3068\u3001\u305d\u308c\u306b\u95a2\u9023\u3059\u308b\u8a66\u9a13\u306e\u30b4\u30fc\u30eb\u304a\u3088\u3073\u30c7\u30b6\u30a4\u30f3\u304c\u78ba\u5b9f\u306b\u3064\u306a\u304c\u308b\u3088\u3046\u306b\u3001\u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u30ec\u30d3\u30e5\u30fc\u3057\u30b3\u30e1\u30f3\u30c8\u3059\u308b<\/td><td class=\"column-3\"><b>C1. <\/b>\u65b0\u898f\u306e\u6cbb\u7642\u4ecb\u5165\u3092\u958b\u767a\u3059\u308b\u76ee\u7684\u3068\u3001\u305d\u306e\u8a66\u9a13\u306e\u30b4\u30fc\u30eb\u304c\u6b63\u78ba\u306b\u3064\u306a\u304c\u308b\u3088\u3046\u306b\u3001\u72ec\u529b\u3067\u81e8\u5e8a\u8a66\u9a13\u3092\u30c7\u30b6\u30a4\u30f3\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\"><\/td><td class=\"column-2\"><b>B2.<\/b> \u8a66\u9a13\u30c7\u30b6\u30a4\u30f3\u306b\u3064\u3044\u3066\u7a4d\u6975\u7684\u30fb\u53d7\u52d5\u7684\u306b\u610f\u898b\u3092\u8ff0\u3079\u3001\u5171\u6709\u3059\u308b<\/td><td class=\"column-3\"><b>C2. <\/b>\u5f8c\u8f29\u30fb\u82e5\u624b\u306e\u81e8\u5e8a\u8a66\u9a13\u30c7\u30b6\u30a4\u30f3\u62c5\u5f53\u8005\u3092\u6559\u80b2\u30fb\u6307\u5c0e\u30fb\u76e3\u7763\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-4 even\">\n\t<td class=\"column-1\"><b>\u4f8b\uff1a<\/b>\u7d50\u679c\u304c\u4fe1\u983c\u3067\u304d\u308b\u3001\u6b63\u5f53\u6027\u306e\u3042\u308b\u3082\u306e\u3068\u306a\u308b\u3088\u3046\u306b\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u9078\u629e\u30d0\u30a4\u30a2\u30b9\u3092\u907f\u3051\u308b\u305f\u3081\u306e\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u624b\u9806\u3092\u8b58\u5225\u3059\u308b<\/td><td class=\"column-2\"><b>\u4f8b\uff1a<\/b>\u4f5c\u6210\u306e\u521d\u671f\u6bb5\u968e\u306b\u304a\u3044\u3066\u3001\u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u30ec\u30d3\u30e5\u30fc\u3057\u3001\u672c\u8cea\u7684\u306a\u4fee\u6b63\u30fb\u7de8\u96c6\u306b\u3064\u3044\u3066\u30b3\u30e1\u30f3\u30c8\u3059\u308b<\/td><td class=\"column-3\"><b>\u4f8b\uff1a<\/b>\u8a72\u5f53\u3059\u308b\u898f\u5236\u8981\u4ef6\u3001\u4e88\u7b97\u306e\u7bc4\u56f2\u3001\u30d0\u30a4\u30a2\u30b9\u306e\u306a\u3044\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u306e\u8a3c\u660e\u306e\u89b3\u70b9\u304b\u3089\u5b9f\u884c\u53ef\u80fd\u306a\u6cbb\u9a13\u3092\u72ec\u529b\u3067\u30c7\u30b6\u30a4\u30f3\u3059\u308b<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-122 from cache -->[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;4.2 GCP\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u5b9a\u7fa9\u3055\u308c\u308b\u901a\u308a\u306b\u3001\u81e8\u5e8a\u8a66\u9a13\u30c1\u30fc\u30e0\u306e\u5f79\u5272\u3068\u8cac\u4efb\u3092\u8aac\u660e\u3059\u308b&#8221; tab_id=&#8221;1577119322847-692a26eb-57fd&#8221;][vc_column_text]\n<table id=\"tablepress-123\" class=\"tablepress tablepress-id-123\">\n<thead>\n<tr class=\"row-1 odd\">\n\t<th class=\"column-1\">A.\u57fa\u790e\u30ec\u30d9\u30eb<\/th><th class=\"column-2\">B. \u4e2d\u7d1a\u30ec\u30d9\u30eb<\/th><th class=\"column-3\">C. \u4e0a\u7d1a\u30ec\u30d9\u30eb<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-hover\">\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\"><b>A1.<\/b>GCP\u306e\u57fa\u672c\u539f\u5247\u3092\u8aac\u660e\u3059\u308b<\/td><td class=\"column-2\"><b>B1.<\/b>GCP\u306e\u539f\u5247\u304c\u3069\u306e\u3088\u3046\u306b\u81e8\u5e8a\u8a66\u9a13\u306b\u7d44\u307f\u8fbc\u307e\u308c\u3066\u3044\u308b\u304b\u3092\u8aac\u660e\u3059\u308b<\/td><td class=\"column-3\"><b>C1. <\/b>\u81e8\u5e8a\u7814\u7a76\u306e\u5b9f\u65bd\u306bGCP\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u9069\u7528\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\"><b>A2.<\/b> \u65bd\u8a2d\u3084\u7d44\u7e54\u30fb\u898f\u5236\u3084GCP\u3067\u5b9a\u7fa9\u3055\u308c\u3066\u3044\u308b\u901a\u308a\u306b\u3001\u81e8\u5e8a\u958b\u767a\u30c1\u30fc\u30e0\u306b\u304a\u3051\u308b\u81ea\u8eab\u306e\u5f79\u5272\u3092\u8aac\u660e\u3059\u308b\u3002\u307e\u305f\u3001\u4ed6\u8005\u306e\u5f79\u5272\u3092\u8a8d\u8b58\u3059\u308b<\/td><td class=\"column-2\"><b>B2.<\/b>\u9023\u90a6\u306e\u898f\u5236\u3084GCP\u306b\u5b9a\u7fa9\u3055\u308c\u3066\u3044\u308b\u901a\u308a\u306b\u3001IRB\u3084\u6cbb\u9a13\u4f9d\u983c\u8005\u306e\u5f79\u5272\u3068\u8cac\u4efb\u3092\u8aac\u660e\u3059\u308b<\/td><td class=\"column-3\"><b>C2. <\/b>\u81e8\u5e8a\u8a66\u9a13\u30c1\u30fc\u30e0\u306e\u5168\u30e1\u30f3\u30d0\u30fc\u306e\u5f79\u5272\u3092\u30ec\u30d3\u30e5\u30fc\u3057\u8a55\u4fa1\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-4 even\">\n\t<td class=\"column-1\"><b>A3.<\/b> \u6a29\u9650\u306e\u59d4\u8b72\u3068\u5b9f\u65bd\u306e\u7bc4\u56f2\u306b\u3064\u3044\u3066\u7406\u89e3\u3059\u308b<\/td><td class=\"column-2\"><b>B3.<\/b>GCP\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u6cbf\u3063\u3066\u5f79\u5272\u3092\u679c\u305f\u3059<\/td><td class=\"column-3\"><b>C3.<\/b> \u81e8\u5e8a\u8a66\u9a13\u30c1\u30fc\u30e0\u30e1\u30f3\u30d0\u30fc\u3092\u76e3\u7763\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-5 odd\">\n\t<td class=\"column-1\"><\/td><td class=\"column-2\"><\/td><td class=\"column-3\"><b>C4. <\/b>GCP\u306e\u9075\u5b88\u3092\u5fb9\u5e95\u3059\u308b\u305f\u3081\u3001\u81e8\u5e8a\u7814\u7a76\u306e\u76e3\u67fb\u3092\u5b9f\u65bd\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-6 even\">\n\t<td class=\"column-1\"><b>\u4f8b\uff1a<\/b>\u81ea\u8eab\u306e\u5f79\u5272\u3068\u8cac\u52d9\u306b\u3064\u3044\u3066\u660e\u78ba\u306b\u8ff0\u3079\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u696d\u52d9\u306b\u304a\u3051\u308b\u500b\u4eba\u306e\u5f79\u5272\u306e\u9650\u754c\u306b\u3064\u3044\u3066\u8aac\u660e\u3059\u308b<\/td><td class=\"column-2\"><b>\u4f8b\uff1a<\/b>\u81e8\u5e8a\u8a66\u9a13\u30c1\u30fc\u30e0\u306e\u30e1\u30f3\u30d0\u30fc\u304c\u5404\u81ea\u306e\u8cac\u52d9\u3092\u679c\u305f\u305b\u306a\u304b\u3063\u305f\u3068\u304d\u306b\u305d\u306e\u72b6\u6cc1\u3092\u6b63\u78ba\u306b\u8a8d\u8b58\u30fb\u5831\u544a\u3057\u3001\u8ab0\u306b\u652f\u63f4\u3092\u6c42\u3081\u308b\u3079\u304d\u304b\u3092\u5224\u65ad\u3059\u308b<\/td><td class=\"column-3\"><b>\u4f8b\uff1a<\/b>\u8907\u6570\u306e\u81e8\u5e8a\u7814\u7a76\u30fb\u8a66\u9a13\u3067\u9069\u5207\u306a\u30c1\u30fc\u30e0\u3092\u7d44\u7e54\u3001\u7ba1\u7406\u30fb\u76e3\u7763\u3001\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u3059\u308b<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-123 from cache -->[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;4.3 GCP\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u9075\u5b88\u3059\u308b\u305f\u3081\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u30c7\u30b6\u30a4\u30f3\u30fb\u5b9f\u65bd\u30fb\u8a18\u9332\u306b\u3064\u3044\u3066\u5fc5\u8981\u306a\u8a55\u4fa1\u3092\u3059\u308b&#8221; tab_id=&#8221;1577121835201-2497d6f1-eafd&#8221;][vc_column_text]\n<table id=\"tablepress-124\" class=\"tablepress tablepress-id-124\">\n<thead>\n<tr class=\"row-1 odd\">\n\t<th class=\"column-1\">A.\u57fa\u790e\u30ec\u30d9\u30eb<\/th><th class=\"column-2\">B. \u4e2d\u7d1a\u30ec\u30d9\u30eb<\/th><th class=\"column-3\">C. \u4e0a\u7d1a\u30ec\u30d9\u30eb<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-hover\">\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\"><b>A1.<\/b>\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u3092\u53d7\u3051\u305f\u5f8c\u3001ICH GCP\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u304c\u3001\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u30c7\u30b6\u30a4\u30f3\u3001\u81e8\u5e8a\u8a66\u9a13\u5b9f\u65bd\u6642\u306e\u624b\u9806\u3001\u8a66\u9a13\u306b\u95a2\u4fc2\u3059\u308b\u30c7\u30fc\u30bf\u306e\u53ce\u96c6\u306b\u3069\u306e\u3088\u3046\u306b\u7d44\u307f\u8fbc\u307e\u308c\u3066\u3044\u308b\u304b\u8aac\u660e\u3059\u308b<\/td><td class=\"column-2\"><b>B1.<\/b>\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u5b9f\u65bd\u306b\u8ca2\u732e\u3057\u3001\u6700\u5c0f\u9650\u306e\u7ba1\u7406\u76e3\u7763\u3092\u53d7\u3051\u3066\u3001\u8a66\u9a13\u5b9f\u65bd\u3068\u30c7\u30fc\u30bf\u53ce\u96c6\u304cICH GCP\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u6cbf\u3063\u3066\u884c\u308f\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3059\u308b<\/td><td class=\"column-3\"><b>C1. <\/b>\u81e8\u5e8a\u8a66\u9a13\u306e\u904b\u7528\u304cICH GCP\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u9075\u5b88\u3057\u3066\u884c\u308f\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\"><\/td><td class=\"column-2\"><\/td><td class=\"column-3\"><b>C2. <\/b>\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u6642\u306b\u767a\u751f\u3059\u308b\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u95a2\u9023\u306e\u554f\u984c\u3092\u9069\u5207\u306b\u89e3\u6c7a\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-4 even\">\n\t<td class=\"column-1\"><\/td><td class=\"column-2\"><\/td><td class=\"column-3\"><b>C3.<\/b>\u8a66\u9a13\u3092\u5b9f\u65bd\u3059\u308b\u62c5\u5f53\u8005\u304c\u9069\u5207\u306a\u7814\u4fee\u3092\u53d7\u3051\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u5b9f\u306b\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-5 odd\">\n\t<td class=\"column-1\"><b>\u4f8b\uff1a<\/b>\u30d8\u30eb\u30b7\u30f3\u30ad\u5ba3\u8a00\u306b\u542b\u307e\u308c\u308b\u6982\u5ff5\u3068\u3001\u305d\u308c\u3089\u304c\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u3069\u306e\u3088\u3046\u306b\u7d44\u307f\u8fbc\u307e\u308c\u3001\u8a66\u9a13\u4e2d\u3001\u78ba\u5b9f\u306b\u502b\u7406\u9762\u3084\u6a19\u6e96\u7684\u306a\u8cea\u3092\u7dad\u6301\u3059\u308b\u305f\u3081\u306b\u88ab\u9a13\u8005\u306b\u5bfe\u3057\u3066\u3069\u306e\u3088\u3046\u306b\u5b9f\u65bd\u3055\u308c\u308b\u306e\u304b\u3092\u8aac\u660e\u3059\u308b<\/td><td class=\"column-2\"><b>\u4f8b\uff1a<\/b>\u56fd\u969b\u7684\u306b\u8a8d\u3081\u3089\u308c\u305f\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u4f7f\u7528\u3057\u3066\u81e8\u5e8a\u8a66\u9a13\u3092\u78ba\u5b9f\u306b\u5b9f\u65bd\u30fb\u5831\u544a\u30fb\u8a18\u9332\u3059\u308b\u3053\u3068\u3068\u540c\u69d8\u306b\u3001\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u304a\u3044\u3066\u30c7\u30fc\u30bf\u3092\u751f\u6210\u30fb\u53ce\u96c6\u3059\u308b\u30c1\u30fc\u30e0\u3092\u4e3b\u5c0e\u3059\u308b<\/td><td class=\"column-3\"><b>\u4f8b\uff1a<\/b>\u81e8\u5e8a\u7814\u7a76\u30fb\u8a66\u9a13\u306e\u5b9f\u65bd\u671f\u9593\u3092\u901a\u3057\u3066\u5e38\u306bICH GCP\u304c\u9806\u5b88\u3055\u308c\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u3001\u307e\u305f\u8a66\u9a13\u671f\u9593\u4e2d\u306e\u3069\u306e\u3088\u3046\u306a\u6642\u306b\u502b\u7406\u9762\u30fb\u8cea\u306e\u62c5\u4fdd\u306e\u6982\u5ff5\u304b\u3089\u9069\u5207\u306a\u6307\u5c0e\u8005\u3084\u6559\u80b2\u62c5\u5f53\u8005\u304c\u5fc5\u8981\u3068\u306a\u308b\u306e\u304b\u3092\u5224\u65ad\u3057\u3001\u78ba\u5b9f\u306b\u5bfe\u5fdc\u3059\u308b<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-124 from cache -->[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;4.4 \u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u306b\u95a2\u3059\u308b\u56fd\u969b\u7684\u306a\u898f\u5236\u6a5f\u95a2\u306e\u898f\u5236\u30fb\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u6bd4\u8f03\u3059\u308b&#8221; tab_id=&#8221;1577122102817-963d7996-9247&#8243;][vc_column_text]\n<table id=\"tablepress-125\" class=\"tablepress tablepress-id-125\">\n<thead>\n<tr class=\"row-1 odd\">\n\t<th class=\"column-1\">A.\u57fa\u790e\u30ec\u30d9\u30eb<\/th><th class=\"column-2\">B. \u4e2d\u7d1a\u30ec\u30d9\u30eb<\/th><th class=\"column-3\">C. \u4e0a\u7d1a\u30ec\u30d9\u30eb<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-hover\">\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\"><b>A1.<\/b>\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u306b\u3042\u305f\u308a\u56fd\u969b\u7684\u306a\u898f\u5236\u6a5f\u95a2\u306e\u5f79\u5272\u3092\u8aac\u660e\u3059\u308b<\/td><td class=\"column-2\"><b>B1.<\/b> \u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u6642\u306b\u9069\u7528\u3055\u308c\u308b\u56fd\u5225\u306e\u898f\u5236\u3092\u7279\u5b9a\u3059\u308b\u4f5c\u696d\u3092\u30b5\u30dd\u30fc\u30c8\u3059\u308b<\/td><td class=\"column-3\"><b>C1. <\/b>\u56fd\u969b\u5171\u540c\u8a66\u9a13\u306e\u5b9f\u73fe\u53ef\u80fd\u6027\u3092\u5224\u65ad\u3059\u308b\u305f\u3081\u306e\u65b9\u6cd5\u3084\u624b\u9806\u3092\u4f5c\u6210\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\"><b>A2. <\/b>\u69d8\u3005\u306a\u56fd\u306e\u898f\u5236\u5f53\u5c40\u3068\u305d\u306e\u56fd\u306b\u7279\u5316\u3057\u305f\u898f\u5236\u3092\u7279\u5b9a\u3059\u308b<\/td><td class=\"column-2\"><b>B2.<\/b>\u69d8\u3005\u306a\u56fd\u306e\u898f\u5236\u5f53\u5c40\u3078\u306e\u81e8\u5e8a\u8a66\u9a13\u306e\u7533\u8acb\u8981\u4ef6\u306b\u6cbf\u3063\u305f\u65b9\u6cd5\u3084\u904e\u7a0b\u3092\u9069\u7528\u3059\u308b<\/td><td class=\"column-3\"><b>C2. <\/b>\u9069\u5207\u306a\u627f\u8a8d\u7533\u8acb\u306e\u8981\u4ef6\u3068\u8a66\u9a13\u306e\u7533\u8acb\u6642\u671f\u306b\u3064\u3044\u3066\u898b\u6975\u3081\u3001\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u3092\u6c7a\u5b9a\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-4 even\">\n\t<td class=\"column-1\"><b>A3. <\/b>\u533b\u85ac\u54c1\u3001\u30d0\u30a4\u30aa\u533b\u85ac\u54c1\u3001\u533b\u7642\u6a5f\u5668\u306b\u5bfe\u3059\u308b\u56fd\u969b\u7684\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306e\u9055\u3044\u3092\u8a8d\u8b58\u3059\u308b<\/td><td class=\"column-2\"><\/td><td class=\"column-3\"><b>C3.<\/b>\u8a66\u9a13\u5b9f\u65bd\u65bd\u8a2d\u5019\u88dc\u306e\u7279\u5b9a\u3068\u81e8\u5e8a\u8a66\u9a13\u306e\u958b\u59cb\u30fb\u5b9f\u65bd\u306b\u95a2\u308f\u308b\u56fd\u969b\u898f\u5236\u306e\u5168\u4f53\u50cf\u3092\u6307\u5c0e\u30fb\u6559\u80b2\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-5 odd\">\n\t<td class=\"column-1\"><b>\u4f8b\uff1a<\/b>\u30a2\u30e1\u30ea\u30ab\u3068\u30e8\u30fc\u30ed\u30c3\u30d1\u306b\u304a\u3051\u308b\u6cbb\u9a13\u7528\u533b\u85ac\u54c1\u306e\u958b\u767a\u3068\u8ca9\u58f2\u306b\u95a2\u3059\u308b\u898f\u5236\u3084\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306e\u9055\u3044\u3092\u8b58\u5225\u3059\u308b<\/td><td class=\"column-2\"><b>\u4f8b\uff1a<\/b>\u591a\u65bd\u8a2d\u56fd\u969b\u5171\u540c\u8a66\u9a13\u306e\u5b9f\u65bd\u53ef\u80fd\u6027\u8abf\u67fb\u306b\u969b\u3057\u3066\u3001\u5404\u56fd\u898f\u5236\u3068\u56fd\u969b\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306e\u77e5\u8b58\u3092\u9069\u7528\u3059\u308b<\/td><td class=\"column-3\"><b>\u4f8b\uff1a<\/b>\u4eca\u5f8c\u306e\u591a\u65bd\u8a2d\u56fd\u969b\u5171\u540c\u8a66\u9a13\u306b\u304a\u3051\u308b\u8a66\u9a13\u5b9f\u65bd\u7533\u8acb\u3001\u30c7\u30fc\u30bf\u306e\u5171\u6709\u3001\u81e8\u5e8a\u691c\u4f53\u306e\u53d6\u5f97\u306b\u3064\u3044\u3066\u6700\u9069\u306a\u8a08\u753b\u306e\u7acb\u6848\u3092\u4fc3\u9032\u3059\u308b\u305f\u3081\u306b\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u3092\u4f5c\u6210\u3059\u308b<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-125 from cache -->[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;4.5 \u6cbb\u9a13\u85ac\u306e\u9069\u5207\u306a\u7ba1\u7406\u30fb\u4fdd\u7ba1\u30fb\u8abf\u5264\u3092\u8aac\u660e\u3059\u308b&#8221; tab_id=&#8221;1577122422080-3ed86126-adbc&#8221;][vc_column_text]\n<table id=\"tablepress-126\" class=\"tablepress tablepress-id-126\">\n<thead>\n<tr class=\"row-1 odd\">\n\t<th class=\"column-1\">A.\u57fa\u790e\u30ec\u30d9\u30eb<\/th><th class=\"column-2\">B. \u4e2d\u7d1a\u30ec\u30d9\u30eb<\/th><th class=\"column-3\">C. \u4e0a\u7d1a\u30ec\u30d9\u30eb<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-hover\">\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\"><b>A1.<\/b>\u6cbb\u9a13\u85ac\u306b\u306f\u7279\u5b9a\u306e\u7ba1\u7406\u30fb\u4fdd\u7ba1\u30fb\u8abf\u5264\u304c\u5fc5\u8981\u3067\u3042\u308b\u3053\u3068\u3092\u7406\u89e3\u3059\u308b<\/td><td class=\"column-2\"><b>B1.<\/b>\u6cbb\u9a13\u85ac\u306e\u7ba1\u7406\u30fb\u4fdd\u83c5\u30fb\u8abf\u5264\u306b\u95a2\u3059\u308b\u7279\u5b9a\u306e\u65b9\u6cd5\u3084\u8981\u7d20\u3092\u660e\u78ba\u306b\u8ff0\u3079\u308b<\/td><td class=\"column-3\"><b>C1. <\/b>\u6cbb\u9a13\u85ac\u306e\u7ba1\u7406\u30fb\u4fdd\u83c5\u30fb\u8abf\u5264\u306b\u95a2\u3059\u308b\u7279\u5b9a\u306e\u65b9\u6cd5\u3084\u8981\u7d20\u3092\u542b\u3080\u6a19\u6e96\u696d\u52d9\u624b\u9806\u66f8\u3092\u4f5c\u6210\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\"><b>A2. <\/b>\u6cbb\u9a13\u85ac\u306e\u7ba1\u7406\u30fb\u4fdd\u83c5\u30fb\u8abf\u5264\u306b\u3064\u3044\u3066\u66f8\u304b\u308c\u305f\u65e2\u5b58\u306e\u6a19\u6e96\u696d\u52d9\u624b\u9806\u66f8\u3092\u7279\u5b9a\u3057\u9075\u5b88\u3059\u308b<\/td><td class=\"column-2\"><b>B2.<\/b>\u6cbb\u9a13\u85ac\u306e\u53d6\u308a\u6271\u3044\u306b\u304a\u3051\u308b\u9038\u8131\u4e8b\u9805\u3092\u7279\u5b9a\u3057\u3001\u5831\u544a\u3059\u308b\u3001\u307e\u305f\u306f\u554f\u984c\u3092\u89e3\u6c7a\u3059\u308b<\/td><td class=\"column-3\"><b>C2. <\/b>\u6cbb\u9a13\u85ac\u306e\u53d6\u308a\u6271\u3044\u306b\u554f\u984c\u304c\u751f\u3058\u305f\u969b\u306b\u3001\u66f4\u306a\u308b\u9038\u8131\u304c\u767a\u751f\u3059\u308b\u3053\u3068\u3092\u9632\u3050\u305f\u3081\u306b\u662f\u6b63\u30fb\u4e88\u9632\u63aa\u7f6e(CAPA)\u3092\u8b1b\u3058\u308b<\/td>\n<\/tr>\n<tr class=\"row-4 even\">\n\t<td class=\"column-1\"><b>\u4f8b\uff1a<\/b>\u65bd\u8a2d\u306b\u304a\u3051\u308b\u81e8\u5e8a\u8a66\u9a13\u306e\u305f\u3081\u306e\u6cbb\u9a13\u85ac\u306e\u53d7\u9818\u3001\u4fdd\u7ba1\u3001\u4f7f\u7528\u306b\u95a2\u3059\u308b\u6a19\u6e96\u696d\u52d9\u624b\u9806\u66f8\u3092\u6574\u5099\u3057\u3001\u9069\u7528\u3059\u308b<\/td><td class=\"column-2\"><b>\u4f8b\uff1a<\/b>\u69d8\u3005\u306a\u72b6\u6cc1\u4e0b\u306b\u304a\u3044\u3066\u3001\u9069\u5207\u306a\u74b0\u5883\u4e0b\u306b\u304a\u3051\u308b\u4fdd\u7ba1\u72b6\u614b\u306e\u7dad\u6301\u7ba1\u7406\u3001\u51fa\u5165\u5eab\u7ba1\u7406\u3001\u6cbb\u9a13\u85ac\u306e\u8a18\u9332\u5831\u544a(\u767a\u6ce8\u3001\u53d7\u9818\u3001\u51fa\u5165\u5eab\u3001\u7834\u68c4\u3001\u79fb\u9001)\u3092\u5b9f\u65bd\u3057\u3001\u81e8\u5e8a\u8a66\u9a13\u306b\u53c2\u52a0\u3057\u3066\u3044\u308b\u88ab\u9a13\u8005\u3078\u306e\u9069\u5207\u3067\u5b89\u5168\u306a(\u6cbb\u9a13\u85ac\u306e)\u4f9b\u7d66\u3092\u78ba\u4fdd\u3059\u308b<\/td><td class=\"column-3\"><b>\u4f8b\uff1a<\/b>FDA\u306e\u898f\u5236\u3084GCP\u306b\u5f93\u3063\u3066\u6cbb\u9a13\u85ac\u306e\u7ba1\u7406\u3092\u884c\u3046\u305f\u3081\u306b\u76e3\u67fb\u3092\u5b9f\u65bd\u3057\u3001\u662f\u6b63\u63aa\u7f6e\u30fb\u4e88\u9632\u63aa\u7f6e(CAPA)\u3092\u4f5c\u6210\u3057\u3001SOP\u3092\u6539\u8a02\u3059\u308b<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-126 from cache -->[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;4.6 \u81e8\u5e8a\u8a66\u9a13\u3067\u767a\u751f\u3057\u5f97\u308b\u6709\u5bb3\u4e8b\u8c61\u306e\u5206\u985e\u3092\u7279\u5b9a\u3057\u3001\u305d\u306e\u5224\u5b9a\u3068\u5831\u544a\u306e\u30d7\u30ed\u30bb\u30b9\u3001\u307e\u305fIRB\/\u502b\u7406\u5be9\u67fb\u59d4\u54e1\u4f1a\u30fb\u6cbb\u9a13\u4f9d\u983c\u8005\u30fb\u898f\u5236\u5f53\u5c40\u3078\u306e\u5831\u544a\u7fa9\u52d9\u3092\u8aac\u660e\u3059\u308b&#8221; tab_id=&#8221;1577122676769-353c9332-f141&#8243;][vc_column_text]\n<table id=\"tablepress-127\" class=\"tablepress tablepress-id-127\">\n<thead>\n<tr class=\"row-1 odd\">\n\t<th class=\"column-1\">A.\u57fa\u790e\u30ec\u30d9\u30eb<\/th><th class=\"column-2\">B. \u4e2d\u7d1a\u30ec\u30d9\u30eb<\/th><th class=\"column-3\">C. \u4e0a\u7d1a\u30ec\u30d9\u30eb<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-hover\">\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\"><b>A1.<\/b>\u7570\u306a\u308b\u5206\u985e\u306e\u6709\u5bb3\u4e8b\u8c61\u9593\u306e\u9055\u3044\u3092\u8a8d\u8b58\u3059\u308b<\/td><td class=\"column-2\"><b>B1.<\/b>\u69d8\u3005\u306a\u56fd\u969b\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\uff08FDA\u3001EMA\u3001ICH\u306a\u3069\uff09\u3067\u5b9a\u3081\u3089\u308c\u305f\u91cd\u7be4\u306a\u6709\u5bb3\u4e8b\u8c61\u30fb\u4e88\u6e2c\u3067\u304d\u306a\u3044\u91cd\u7be4\u306a\u526f\u4f5c\u7528\u306e\u5831\u544a\u671f\u9650\u3084\u5fc5\u8981\u4e8b\u9805\u3092\u8b58\u5225\u3059\u308b<\/td><td class=\"column-3\"><b>C1. <\/b>\u5404\u6a5f\u95a2\u3084\u56e3\u4f53\u304c\u5b9a\u3081\u308b\u3001\u4e88\u6e2c\u3067\u304d\u306a\u3044\u91cd\u7be4\u306a\u526f\u4f5c\u7528\u306e\u5831\u544a\u8981\u4ef6\u3092\u5ba2\u89b3\u7684\u306b\u5224\u65ad\u3057\u3001\u5831\u544a\u8981\u4ef6\u306e\u66f4\u306a\u308b\u8abf\u548c\u306e\u305f\u3081\u306b\u65b0\u3057\u3044\u63d0\u6848\u3092\u4f5c\u6210\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\"><b>A2. <\/b>\u81e8\u5e8a\u8a66\u9a13\u5b9f\u65bd\u6642\u306b\u91cd\u7be4\u306a\u6709\u5bb3\u4e8b\u8c61\u304c\u767a\u751f\u3057\u305f\u969b\u305d\u308c\u3092\u8a8d\u8b58\u3057\u3001\u8a72\u5f53\u3059\u308b\u898f\u5236\u5f53\u5c40\u3067\u5b9a\u3081\u3089\u308c\u305f\u671f\u9593\u4ee5\u5185\u306b\u5831\u544a\u3059\u308b<\/td><td class=\"column-2\"><b>B2.<\/b>\u5404\u8005\u306e\u5f79\u5272\uff08\u8cac\u4efb\u533b\u5e2b\u3001CRA\u3001\u6cbb\u9a13\u4f9d\u983c\u8005\uff09\u306b\u5fdc\u3058\u3066\u3001\u91cd\u7be4\u306a\u6709\u5bb3\u4e8b\u8c61\u3092\u9069\u5207\u306a\u6a5f\u95a2\uff08\u6cbb\u9a13\u4f9d\u983c\u8005\u3001\u898f\u5236\u5f53\u5c40\u3001IRB\/\u502b\u7406\u5be9\u67fb\u59d4\u54e1\u4f1a\uff09\u306b\u5831\u544a\u3059\u308b<\/td><td class=\"column-3\"><\/td>\n<\/tr>\n<tr class=\"row-4 even\">\n\t<td class=\"column-1\"><b>\u4f8b\uff1a<\/b>\u53c2\u8003\u75c7\u4f8b\u306e\u6709\u5bb3\u4e8b\u8c61\u3092\u6b63\u78ba\u306b\u5206\u985e\u3059\u308b(\u6709\u5bb3\u4e8b\u8c61\u3001\u91cd\u7be4\u306a\u6709\u5bb3\u4e8b\u8c61\u3001\u4e88\u6e2c\u3067\u304d\u306a\u3044\u91cd\u7be4\u306a\u6709\u5bb3\u4e8b\u8c61\u3001\u526f\u4f5c\u7528\u306a\u3069)<\/td><td class=\"column-2\"><b>\u4f8b\uff1a<\/b>\u6cbb\u9a13\u5b9f\u65bd\u671f\u9593\u4e2d\u306e\u91cd\u7be4\u306a\u6709\u5bb3\u4e8b\u8c61\u3092\u8a8d\u77e5\u3057\u3001\u9069\u5207\u306a\u5831\u544a\u671f\u9650\u5185\u306b\u9069\u5207\u306a\u6a5f\u95a2\u306b\u5831\u544a\u3059\u308b\u80fd\u529b\u3092\u793a\u3059<\/td><td class=\"column-3\"><b>\u4f8b\uff1a<\/b>\u5404\u6a5f\u95a2\u3084\u56e3\u4f53\u304c\u5b9a\u3081\u308b\u3001\u4e88\u6e2c\u3067\u304d\u306a\u3044\u91cd\u7be4\u306a\u526f\u4f5c\u7528\u306e\u5831\u544a\u8981\u4ef6\u3092\u5ba2\u89b3\u7684\u306b\u5224\u65ad\u3057\u3001\u5831\u544a\u8981\u4ef6\u306e\u66f4\u306a\u308b\u8abf\u548c\u306e\u305f\u3081\u306b\u65b0\u3057\u3044\u63d0\u6848\u3092\u4f5c\u6210\u3059\u308b<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-127 from cache -->[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;4.7 \u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u6642\u306b\u3001\u56fd\u969b\u7684\u306a\u898f\u5236\u3084\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u304c\u3069\u306e\u3088\u3046\u306b\u88ab\u9a13\u8005\u4fdd\u8b77\u3068\u30d7\u30e9\u30a4\u30d0\u30b7\u30fc\u306e\u78ba\u4fdd\u3092\u4fdd\u8a3c\u3059\u308b\u304b\u8aac\u660e\u3059\u308b&#8221; tab_id=&#8221;1577123096190-bab04aee-d106&#8243;][vc_column_text]\n<table id=\"tablepress-128\" class=\"tablepress tablepress-id-128\">\n<thead>\n<tr class=\"row-1 odd\">\n\t<th class=\"column-1\">A.\u57fa\u790e\u30ec\u30d9\u30eb<\/th><th class=\"column-2\">B. \u4e2d\u7d1a\u30ec\u30d9\u30eb<\/th><th class=\"column-3\">C. \u4e0a\u7d1a\u30ec\u30d9\u30eb<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-hover\">\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\"><b>A1.<\/b>\u88ab\u9a13\u8005\u306f\u88ab\u9a13\u8005\u4fdd\u8b77\u3068\u30d7\u30e9\u30a4\u30d0\u30b7\u30fc\u306e\u78ba\u4fdd\u3092\u53d7\u3051\u308b\u6a29\u5229\u304c\u3042\u308b\u3053\u3068\u3092\u7406\u89e3\u3057\u3001\u307e\u305f\u3001\u56fd\u969b\u7684\u306a\u898f\u5236\u306f\u81e8\u5e8a\u8a66\u9a13\u5b9f\u65bd\u6642\u306b\u88ab\u9a13\u8005\u3092\u5b88\u308b\u305f\u3081\u306b\u5b58\u5728\u3059\u308b\u3053\u3068\u3092\u7406\u89e3\u3059\u308b<\/td><td class=\"column-2\"><b>B1.<\/b>\u81e8\u5e8a\u8a66\u9a13\u5b9f\u65bd\u6642\u306b\u3001\u9069\u5207\u306a\u88ab\u9a13\u8005\u4fdd\u8b77\u3068\u30d7\u30e9\u30a4\u30d0\u30b7\u30fc\u78ba\u4fdd\u3092\u4fdd\u969c\u3059\u308b\u65b9\u7b56\u3092\u9069\u7528\u3059\u308b<\/td><td class=\"column-3\"><b>C1. <\/b>\u81e8\u5e8a\u8a66\u9a13\u306b\u304a\u3044\u3066\u88ab\u9a13\u8005\u4fdd\u8b77\u3068\u30d7\u30e9\u30a4\u30d0\u30b7\u30fc\u78ba\u4fdd\u306e\u305f\u3081\u306e\u6226\u7565\u3092\u7acb\u6848\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\"><b>A2. <\/b>\u88ab\u9a13\u8005\u4fdd\u8b77\u3068\u30d7\u30e9\u30a4\u30d0\u30b7\u30fc\u306e\u78ba\u4fdd\u306b\u95a2\u3059\u308b\u500b\u5225\u306e\u898f\u5236\u3092\u793a\u3059<\/td><td class=\"column-2\"><b>B2.<\/b>\u88ab\u9a13\u8005\u4fdd\u8b77\u3068\u30d7\u30e9\u30a4\u30d0\u30b7\u30fc\u78ba\u4fdd\u306b\u95a2\u3057\u3066\u3001\u65e2\u5b58\u306e\u56fd\u969b\u7684\u306a\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3068\u56fd\u306b\u3088\u3063\u3066\u7570\u306a\u308b\u5404\u56fd\u306e\u30eb\u30fc\u30eb\u304c\u3042\u308b\u3053\u3068\u3092\u8a8d\u8b58\u3059\u308b<\/td><td class=\"column-3\"><b>C2. <\/b>(\u88ab\u9a13\u8005)\u4fdd\u8b77\u3068\u30d7\u30e9\u30a4\u30d0\u30b7\u30fc\u78ba\u4fdd\u306e\u305f\u3081\u306e\u6226\u7565\u304c\u9069\u5207\u304b\u8a55\u4fa1\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-4 even\">\n\t<td class=\"column-1\"><\/td><td class=\"column-2\"><b>B3.<\/b> \u88ab\u9a13\u8005\u4fdd\u8b77\u3068\u30d7\u30e9\u30a4\u30d0\u30b7\u30fc\u78ba\u4fdd\u306b\u95a2\u3057\u3066\u3001\u65e2\u5b58\u306e\u56fd\u969b\u7684\u306a\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3068\u56fd\u306b\u3088\u3063\u3066\u7570\u306a\u308b\u5404\u56fd\u306e\u30eb\u30fc\u30eb\u304c\u3042\u308b\u3053\u3068\u3092\u8a8d\u8b58\u3059\u308b<\/td><td class=\"column-3\"><b>C3.<\/b> \u88ab\u9a13\u8005\u4fdd\u8b77\u3068\u30d7\u30e9\u30a4\u30d0\u30b7\u30fc\u78ba\u4fdd\u306e\u305f\u3081\u306e\u3001\u56fd\u5185\u5916\u306e\u898f\u5236\u3092\u52a0\u5473\u3057\u305f\u56fd\u969b\u6226\u7565\u3092\u4f5c\u6210\u3057\u5b9f\u65bd\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-5 odd\">\n\t<td class=\"column-1\"><b>\u4f8b\uff1a<\/b>\u56fd\u969b\u7684\u306a\u3001\u307e\u305f\u56fd\u5185\u3084\u5730\u57df\u306e\u898f\u5236\u3084\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u304a\u3051\u308b\u88ab\u9a13\u8005\u4fdd\u8b77\u3068\u30d7\u30e9\u30a4\u30d0\u30b7\u30fc\u306e\u78ba\u4fdd\u306e\u305f\u3081\u306e\u4fdd\u8b77\u7b56\u306b\u3064\u3044\u3066\u6b63\u78ba\u306b\u8aac\u660e\u3059\u308b<\/td><td class=\"column-2\"><b>\u4f8b\uff1a<\/b>\u88ab\u9a13\u8005\u304c\u8a66\u9a13\u306e\u305f\u3081\u306b\u6765\u9662\u3057\u305f\u969b\u306b\u5b9f\u65bd\u3059\u308b\u9805\u76ee\u3092\u8aac\u660e\u3057\u3001\u88ab\u9a13\u8005\u4fdd\u8b77\u3084\u30d7\u30e9\u30a4\u30d0\u30b7\u30fc\u306e\u78ba\u4fdd\u306b\u95a2\u3059\u308b\u69d8\u3005\u306a\u56fd\u306e\u898f\u5236\u5f53\u5c40\u3084\u898f\u5236(\u9023\u90a6\u898f\u5236-FDA\/\u30a2\u30e1\u30ea\u30ab\u3001EU\u6307\u4ee4\u3068\u898f\u5236(EMA\/EU)\u3001J-GCP-PMDA\/\u65e5\u672c\u3001C-GCP-CFDA\/\u4e2d\u56fd)\u3001\u88ab\u9a13\u8005\u306e\u30d7\u30e9\u30a4\u30d0\u30b7\u30fc\u78ba\u4fdd\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u5bfe\u5fdc\u3057\u305f\u9069\u5207\u306a\u5bfe\u7b56\u3092\u7279\u5b9a\u3059\u308b<\/td><td class=\"column-3\"><b>\u4f8b\uff1a<\/b>\u88ab\u9a13\u8005\u4fdd\u8b77\u3084\u30d7\u30e9\u30a4\u30d0\u30b7\u30fc\u78ba\u4fdd\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u53ef\u80fd\u6027\u306e\u3042\u308b\u5730\u57df\u30fb\u56fd\u30fb\u56fd\u969b\u7684\u306a\u533b\u7642\u72b6\u6cc1\u3001\u898f\u7bc4\u3001\u6c11\u65cf\u6027\u3092\u5bfe\u6bd4\u3055\u305b\u3001\u7d44\u307f\u8fbc\u3093\u3060\u3046\u3048\u3067\u65b0\u3057\u3044\u81e8\u5e8a\u8a66\u9a13\u3092\u8a08\u753b\u3059\u308b<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-128 from cache -->[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;4.8 \u81e8\u5e8a\u8a66\u9a13\u306e\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u306b\u95a2\u3059\u308b\u5f79\u5272\u3068\u30d7\u30ed\u30bb\u30b9\u3092\u8aac\u660e\u3059\u308b&#8221; tab_id=&#8221;1577123617036-39b9ee7f-a107&#8243;][vc_column_text]\n<table id=\"tablepress-129\" class=\"tablepress tablepress-id-129\">\n<thead>\n<tr class=\"row-1 odd\">\n\t<th class=\"column-1\">A.\u57fa\u790e\u30ec\u30d9\u30eb<\/th><th class=\"column-2\">B. \u4e2d\u7d1a\u30ec\u30d9\u30eb<\/th><th class=\"column-3\">C. \u4e0a\u7d1a\u30ec\u30d9\u30eb<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-hover\">\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\"><b>A1.<\/b>\u81e8\u5e8a(\u8a66\u9a13\u306e)\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u306e\u8ad6\u7406\u7684\u6839\u62e0\u3001\u307e\u305f\u9069\u7528\u3055\u308c\u308b\u898f\u5247\u3084ICH\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u8a8d\u8b58\u3057\u7406\u89e3\u3059\u308b<\/td><td class=\"column-2\"><b>B1.<\/b>\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u696d\u52d9\/\u6d3b\u52d5\u3092\u5b8c\u4e86\u3059\u308b\u305f\u3081\u306b\u3001\u81e8\u5e8a(\u8a66\u9a13)\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u8a08\u753b\u3092\u63a1\u7528\u3057\u5b9f\u65bd\u3059\u308b<\/td><td class=\"column-3\"><b>C1. <\/b>\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u306e\u305f\u3081\u306e\u65bd\u8a2d\u8a2a\u554f\u306e\u8a08\u753b\u3068\u5b9f\u65bd\u306b\u3064\u3044\u3066\u6307\u5c0e\u3057\u3001\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u306e\u53d6\u308a\u7d44\u307f\u3092\u5148\u5c0e\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\"><b>A2. <\/b>\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u8a08\u753b\u3068\u6a19\u6e96\u696d\u52d9\u624b\u9806\u66f8\u3092\u9806\u5b88\u3059\u308b<\/td><td class=\"column-2\"><b>B2.<\/b>\u6700\u4f4e\u9650\u306e\u76e3\u7763\u3068\u52a9\u8a00\u306e\u3082\u3068\u306b\u8907\u96d1\u306a\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u306b\u95a2\u3059\u308b\u554f\u984c\u306b\u5bfe\u51e6\u3059\u308b<\/td><td class=\"column-3\"><b>C2. <\/b>\u5404\u8a66\u9a13\u306b\u7279\u5316\u3057\u305f\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u8a08\u753b\u306e\u4f5c\u6210\u3068\u8a08\u753b\u3092\u76e3\u7763\u3059\u308b\u3002\u7279\u306b\u3001\u8a08\u753b\u306e\u4e2d\u306b\u3001\u9045\u6ede\u306a\u304f\u30c7\u30fc\u30bf\u306e\u30ec\u30d3\u30e5\u30fc\u304c\u884c\u308f\u308c\u308b\u305f\u3081\u306b\u9069\u5207\u306a\u30ea\u30bd\u30fc\u30b9\u914d\u5206\u304c\u306a\u3055\u308c\u3066\u3044\u308b\u304b\u3001\u307e\u305f\u88ab\u9a13\u8005\u306e\u5b89\u5168\u6027\u3068\u30c7\u30fc\u30bf\u306e\u5b8c\u5168\u6027\u3092\u5b88\u308b\u305f\u3081\u306e\u3059\u3067\u306b\u78ba\u7acb\u3055\u308c\u305f\u57fa\u6e96\u304c\u9075\u5b88\u3055\u308c\u3066\u3044\u308b\u304b\u3001\u306b\u6ce8\u610f\u3059\u308b\u3002<\/td>\n<\/tr>\n<tr class=\"row-4 even\">\n\t<td class=\"column-1\"><b>A3.<\/b> \u30ac\u30a4\u30c0\u30f3\u30b9\u3068\u7ba1\u7406\u306e\u5143\u3001\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u8a08\u753b\u306b\u6cbf\u3063\u3066\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3092\u5b9f\u884c\u3057\u3001\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u8a08\u753b\u306b\u8a18\u3055\u308c\u3066\u3044\u306a\u3044\u554f\u984c\u306b\u76f4\u9762\u3057\u305f\u6642\u306b\u5831\u544a\u3059\u308b<\/td><td class=\"column-2\"><b>B3.<\/b>\u5358\u7d14\u306a\u3001\u3042\u308b\u3044\u306f\u3084\u3084\u8907\u96d1\u306a\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u306b\u95a2\u3059\u308b\u554f\u984c\u3092\u89e3\u6c7a\u3059\u308b\u305f\u3081\u306e\u52a9\u8a00\u3092\u3059\u308b<\/td><td class=\"column-3\"><\/td>\n<\/tr>\n<tr class=\"row-5 odd\">\n\t<td class=\"column-1\"><b>\u4f8b\uff1a<\/b> CRO\u306e\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u8a2a\u554f\u306b\u5099\u3048\u3066\u3001\u65bd\u8a2d\u5185\u306b\u304a\u3051\u308b\u81e8\u5e8a\u8a66\u9a13\u306e\u54c1\u8cea\u4fdd\u8a3c\u76e3\u67fb\u306b\u53c2\u52a0\u3059\u308b<\/td><td class=\"column-2\"><b>\u4f8b\uff1a<\/b>\u30c7\u30fc\u30bf\u306e\u8cea\u3092\u78ba\u4fdd\u3057\u3001\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u306b\u3088\u3063\u3066\u767a\u751f\u3059\u308b\u30af\u30a8\u30ea\u306b\u8fc5\u901f\u304b\u3064\u6b63\u78ba\u306a\u5bfe\u5fdc\u3092\u78ba\u5b9f\u306b\u5b9f\u65bd\u3059\u308b\u305f\u3081\u3001\u524d\u3082\u3063\u3066\u8a2d\u5b9a\u3057\u305f\u30ea\u30b9\u30af\u30d9\u30fc\u30b9\u30c9\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u9069\u7528\u3059\u308b<\/td><td class=\"column-3\"><b>\u4f8b\uff1a<\/b>\u81e8\u5e8a\u8a66\u9a13\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u8a08\u753b\u3092\u4f5c\u6210\u3057\u3001\u5168\u3066\u306e\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u306b\u95a2\u3059\u308b\u6d3b\u52d5\u3068\u4f5c\u696d\u30d5\u30ed\u30fc\u304c\u78ba\u5b9f\u306b\u5404\u7a2e\u898f\u5b9a\u3092\u9806\u5b88\u3057\u76e3\u67fb\u306b\u8010\u3048\u3046\u308b\u3082\u306e\u3068\u306a\u308b\u3088\u3046\u3001\u4e3b\u5c0e\u3057\u3001\u52a9\u8a00\u3057\u3001\u6307\u5c0e\u3059\u308b\u3002<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-129 from cache -->[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;4.9 \u81e8\u5e8a\u8a66\u9a13\u76e3\u67fb\u306e\u5f79\u5272\u3068\u76ee\u7684\u3092\u8aac\u660e\u3059\u308b&#8221; tab_id=&#8221;1577125257242-7ad625f5-953d&#8221;][vc_column_text]\n<table id=\"tablepress-130\" class=\"tablepress tablepress-id-130\">\n<thead>\n<tr class=\"row-1 odd\">\n\t<th class=\"column-1\">A.\u57fa\u790e\u30ec\u30d9\u30eb<\/th><th class=\"column-2\">B. \u4e2d\u7d1a\u30ec\u30d9\u30eb<\/th><th class=\"column-3\">C. \u4e0a\u7d1a\u30ec\u30d9\u30eb<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-hover\">\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\"><b>A1.<\/b>\u76e3\u67fb\u30fb\u67fb\u5bdf\u306e\u6e96\u5099\u306b\u5411\u3051\u305f\u624b\u9806\u3092\u8aac\u660e\u3059\u308b<\/td><td class=\"column-2\">\u57fa\u790e\u30ec\u30d9\u30eb\u306e\u30b3\u30f3\u30d4\u30c6\u30f3\u30b7\u30fc\u3092\u6e80\u305f\u3059\u3053\u3068\u3001\u66f4\u306b\uff1a<br \/>\n<b>B1.<\/b>\u6cbb\u9a13\u4f9d\u983c\u8005\u30fbIRB\u30fb\u898f\u5236\u5f53\u5c40\u304c\u5b9f\u65bd\u3059\u308b\u76e3\u67fb\u7bc4\u56f2\u306e\u9055\u3044\u3092\u8a8d\u8b58\u3059\u308b<\/td><td class=\"column-3\"><b>C1. <\/b>\u6cbb\u9a13\u4f9d\u983c\u8005\u307e\u305f\u306f\u898f\u5236\u5f53\u5c40\u306b\u3088\u308a\u5b9f\u65bd\u3055\u308c\u308b\u76e3\u67fb\u30fb\u67fb\u5bdf\u3078\u5411\u3051\u305f\u6e96\u5099\u3092\u76e3\u7763\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\"><b>A2. <\/b>\u76e3\u67fb\u3092\u5b9f\u65bd\u3059\u308b\u6a29\u9650\u306e\u3042\u308b\u56e3\u4f53\u306e\u540d\u524d\u3092\u6319\u3052\u308b<\/td><td class=\"column-2\"><b>B2.<\/b>\u81e8\u5e8a\u8a66\u9a13\u76e3\u67fb\u306b\u304a\u3044\u3066\u8abf\u67fb\u3055\u308c\u308b\u7814\u7a76\u306e\u8981\u7d20\u3092\u7279\u5b9a\u3059\u308b<\/td><td class=\"column-3\"><b>C2. <\/b>\u76e3\u67fb\u30fb\u67fb\u5bdf\u306e\u7d50\u679c\u306b\u5fdc\u3058\u3066\u30dd\u30ea\u30b7\u30fc\u3084\u6a19\u6e96\u696d\u52d9\u624b\u9806\u66f8\u3092\u4f5c\u6210\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-4 even\">\n\t<td class=\"column-1\"><b>A3.<\/b> \u76e3\u67fb\u30fb\u67fb\u5bdf\u3092\u898f\u5b9a\u3059\u308b\u9023\u90a6\u306e\u898f\u5236\u3092\u7279\u5b9a\u3057\u8aac\u660e\u3059\u308b<\/td><td class=\"column-2\"><b>B3.<\/b>\u3042\u3089\u304b\u3058\u3081\u8a08\u753b\u3055\u308c\u305froutine audit\u3068\u3001\u91cd\u5927\u306a\u7591\u7fa9\u304c\u767a\u751f\u3057\u305f\u5834\u5408\u306b\u884c\u308f\u308c\u308b\u201dfor-cause audit\u201d\u3068\u547c\u3070\u308c\u308b\u76e3\u67fb\u30fb\u67fb\u5bdf\u3092\u533a\u5225\u3059\u308b<\/td><td class=\"column-3\"><\/td>\n<\/tr>\n<tr class=\"row-5 odd\">\n\t<td class=\"column-1\"><b>\u4f8b\uff1a<\/b> \u81e8\u5e8a\u8a66\u9a13\u76e3\u67fb\u306e\u6e96\u5099\u3092\u88dc\u52a9\u3057\u3001\u76e3\u67fb\u4e2d\u306e\u8a66\u9a13\u30c1\u30fc\u30e0\u306e\u5f79\u5272\u3092\u7406\u89e3\u3059\u308b<\/td><td class=\"column-2\"><b>\u4f8b\uff1a<\/b>\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u304a\u3044\u3066\u3001\u76e3\u67fb\u62c5\u5f53\u8005\u3084\u67fb\u3000\u5bdf\u62c5\u5f53\u8005\u304b\u3089\u8981\u8acb\u3055\u308c\u305f\u7279\u5b9a\u306e\u60c5\u5831\u3084\u30c7\u30fc\u30bf\u306e\u60c5\u5831\u6e90\u3092\u5206\u985e\u3059\u308b<\/td><td class=\"column-3\"><b>\u4f8b\uff1a<\/b>\u76e3\u67fb\u5831\u544a\u66f8\u304c\u767a\u884c\u3055\u308c\u305f\u969b\u306b\u3001\u76e3\u67fb\u30fb\u67fb\u5bdf\u3078\u306e\u5bfe\u5fdc\u3068\u3057\u3066\u5305\u62ec\u7684\u306a\u662f\u6b63\u30fb\u4e88\u9632\u63aa\u7f6e(CAPA)\u306e\u8a08\u753b\u3092\u7acb\u3066\u3001\u9069\u5207\u306a\u6a19\u6e96\u696d\u52d9\u624b\u9806\u66f8\u3092\u4f5c\u6210\u3059\u308b<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-130 from cache -->[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;4.10 \u81e8\u5e8a\u8a66\u9a13\u306b\u304a\u3044\u3066\u3001\u5b89\u5168\u6027\u306b\u95a2\u3059\u308b\u554f\u984c\u3092\u7279\u5b9a\u3057\u7ba1\u7406\u3059\u308b\u305f\u3081\u306e\u69d8\u3005\u306a\u65b9\u6cd5\u3092\u8aac\u660e\u3059\u308b&#8221; tab_id=&#8221;1577126102720-9bb9470b-7862&#8243;][vc_column_text]\n<table id=\"tablepress-131\" class=\"tablepress tablepress-id-131\">\n<thead>\n<tr class=\"row-1 odd\">\n\t<th class=\"column-1\">A.\u57fa\u790e\u30ec\u30d9\u30eb<\/th><th class=\"column-2\">B. \u4e2d\u7d1a\u30ec\u30d9\u30eb<\/th><th class=\"column-3\">C. \u4e0a\u7d1a\u30ec\u30d9\u30eb<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-hover\">\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\"><b>A1.<\/b>\u5b89\u5168\u6027\u304c\u81e8\u5e8a\u8a66\u9a13\u306b\u304a\u3044\u3066\u91cd\u8981\u306a\u4e8b\u9805\u3067\u3042\u308b\u3053\u3068\u3092\u7406\u89e3\u3057\u3001\u5b89\u5168\u6027\u306e\u76e3\u8996\u304c\u4e0d\u5341\u5206\u306a\u5834\u5408\u88ab\u9a13\u8005\u3092\u69d8\u3005\u306a\u9762\u3067\u5371\u967a\u306b\u3055\u3089\u3059\u53ef\u80fd\u6027\u304c\u3042\u308b\u3053\u3068\u3092\u7406\u89e3\u3059\u308b<\/td><td class=\"column-2\"><b>B1.<\/b>\u9069\u5207\u306a\u624b\u6bb5\u3092\u901a\u3058\u3001\u5b9a\u3081\u3089\u308c\u305f\u671f\u9593\u5185\u306b\u5b89\u5168\u6027\u5831\u544a\u3092\u5b9f\u65bd\u3059\u308b<\/td><td class=\"column-3\"><b>C1. <\/b>\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u6642\u306b\u8d77\u3053\u308a\u3046\u308b\u5b89\u5168\u6027\u306e\u554f\u984c\u3092\u4e88\u6e2c\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\"><b>A2. <\/b>\u81e8\u5e8a\u8a66\u9a13\u306b\u304a\u3044\u3066\u88ab\u9a13\u8005\u3092\u5b88\u308b\u305f\u3081\u306b\u7528\u3044\u3089\u308c\u308b\u30c4\u30fc\u30eb\u3084\u30d7\u30ed\u30bb\u30b9\u3092\u7406\u89e3\u3059\u308b<\/td><td class=\"column-2\"><b>B2.<\/b>\u5b89\u5168\u6027\u306e\u554f\u984c\u3092\u5206\u985e\u3057\u3001\u898f\u5236\u5f53\u5c40\u3084IRB\u306b\u5831\u544a\u3059\u308b<\/td><td class=\"column-3\"><b>C2. <\/b>\u30ea\u30b9\u30af\u3092\u6700\u5c0f\u5316\u3059\u308b\u305f\u3081\u306e\u65bd\u7b56\u3092\u8a2d\u3051\u308b <\/td>\n<\/tr>\n<tr class=\"row-4 even\">\n\t<td class=\"column-1\"><b>A3.<\/b>\u5b89\u5168\u6027\u78ba\u4fdd\u306b\u652f\u969c\u3092\u304d\u305f\u3059\u7591\u3044\u306e\u3042\u308b\u884c\u70ba\u3084\u51fa\u6765\u4e8b\u3092\u78ba\u5b9f\u306b\u5831\u544a\u3059\u308b<\/td><td class=\"column-2\"><b>B3.<\/b>\u8a72\u5f53\u3059\u308b\u6a5f\u95a2\uff08FDA\u3001EMA\u3001ICH\u7b49\uff09\u304c\u56fd\u969b\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3084\u8981\u4ef6\u306b\u5b9a\u3081\u308b\u4e8b\u9805\u3092\u5b9f\u65bd\u3059\u308b<\/td><td class=\"column-3\"><b>C3. <\/b>\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u304a\u3088\u3073\u5b89\u5168\u6027\u76e3\u8996\u8a08\u753b\u3092\u5ba2\u89b3\u7684\u306b\u8003\u5bdf\u3057\u6539\u5584\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-5 odd\">\n\t<td class=\"column-1\"><\/td><td class=\"column-2\"><\/td><td class=\"column-3\"><b>C4.<\/b>\u8a66\u9a13\u30c1\u30fc\u30e0\u3078\u5411\u3051\u305f\u5b89\u5168\u6027\u306b\u95a2\u3059\u308b\u7814\u4fee\u3092\u63d0\u6848\u3057\u5b9f\u65bd\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-6 even\">\n\t<td class=\"column-1\"><b>\u4f8b\uff1a<\/b> \u7cd6\u5c3f\u75c5\u60a3\u8005\u304c\u9577\u6642\u9593\u306e\u8a66\u9a13\u6765\u9662\u4e2d\u3001\u7d76\u98df\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u969b\u306b\u3001\u5b89\u5168\u4e0a\u306e\u554f\u984c\u3084\u30ea\u30b9\u30af\u306e\u4f4e\u6e1b\u3001\u884c\u52d5\u8a08\u753b\u3092\u7279\u5b9a\u3059\u308b<\/td><td class=\"column-2\"><b>\u4f8b\uff1a<\/b>\u65bd\u8a2d\u5185\u3067\u306e\u5b89\u5168\u4e0a\u306e\u554f\u984c\u306e\u53d6\u308a\u6271\u3044\u3001\u6709\u5bb3\u4e8b\u8c61\u306e\u691c\u77e5\u3001\u5831\u544a\u306b\u95a2\u3059\u308b\u6a19\u6e96\u696d\u52d9\u624b\u9806\u66f8\u3092\u4f5c\u6210\u3059\u308b<\/td><td class=\"column-3\"><b>\u4f8b\uff1a<\/b>\u672a\u5831\u544a\/\u5831\u544a\u4e0d\u5341\u5206\u306a\u6709\u5bb3\u4e8b\u8c61\u3092\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u306b\u3088\u308a\u6307\u6458\u3055\u308c\u305f\u5834\u5408\u306b\u662f\u6b63\u30fb\u4e88\u9632\u63aa\u7f6e\u8a08\u753b\u3068\u30b9\u30bf\u30c3\u30d5\u3078\u306e\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u3092\u4f5c\u6210\u30fb\u5b9f\u65bd\u3059\u308b<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-131 from cache -->[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row][vc_row][vc_column width=&#8221;1\/6&#8243;][vc_single_image image=&#8221;319&#8243;][\/vc_column][vc_column width=&#8221;5\/6&#8243;][vc_column_text el_id=&#8221;domain5&#8243;]<\/p>\n<h2><strong>\u8a66\u9a13\u304a\u3088\u3073\u65bd\u8a2d\u306e\u7ba1\u7406<\/strong><\/h2>\n<p>\u65bd\u8a2d\u306b\u304a\u3044\u3066\u3001\u81e8\u5e8a\u8a66\u9a13\u3092\u5b9f\u65bd\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u7d4c\u6e08\u7684\u30fb\u4eba\u7684\u8981\u7d20\u3002\u8a66\u9a13\u304a\u3088\u3073\u65bd\u8a2d\u30aa\u30da\u30ec\u30fc\u30b7\u30e7\u30f3\u3092\u542b\u3080\uff08\u898f\u5236\/GCP\u95a2\u9023\u306e\u8981\u7d20\u306f\u9664\u304f\uff09\u3002[\/vc_column_text][vc_tta_accordion active_section=&#8221;0&#8243; collapsible_all=&#8221;true&#8221;][vc_tta_section title=&#8221;5.1 \u81e8\u5e8a\u8a66\u9a13\u306e\u30b9\u30dd\u30f3\u30b5\u30fc\u3068\u306a\u308b\u30fb\u76e3\u7763\u3059\u308b\u30fb\u3042\u308b\u3044\u306f(\u5b9f\u65bd\u65bd\u8a2d\u3068\u3057\u3066)\u53c2\u52a0\u3059\u308b\u304b\u3069\u3046\u304b\u306e\u5224\u65ad\u3092\u884c\u3046\u65b9\u6cd5\u3092\u8aac\u660e\u3059\u308b&#8221; tab_id=&#8221;1577717219265-1c541599-512e&#8221;][vc_column_text]\n<table id=\"tablepress-132\" class=\"tablepress tablepress-id-132\">\n<thead>\n<tr class=\"row-1 odd\">\n\t<th class=\"column-1\">A.\u57fa\u790e\u30ec\u30d9\u30eb<\/th><th class=\"column-2\">B. \u4e2d\u7d1a\u30ec\u30d9\u30eb<\/th><th class=\"column-3\">C. \u4e0a\u7d1a\u30ec\u30d9\u30eb<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-hover\">\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\"><b>A1.<\/b>\u65bd\u8a2d\u3067\u65b0\u898f\u306e\u8a66\u9a13\u3092\u9078\u629e\u3059\u308b\u30d7\u30ed\u30bb\u30b9\u306e\u57fa\u6e96\u3068\u306a\u308b\u6c7a\u5b9a\u8981\u7d20\u306b\u95a2\u3057\u3066\u3001\u57fa\u672c\u7684\u306a\u77e5\u8b58\u3092\u6301\u3064\u3053\u3068\u3092\u793a\u3059<\/td><td class=\"column-2\"><b>B1.<\/b>\u8a66\u9a13\u306e\u9078\u629e\u30d7\u30ed\u30bb\u30b9\u306b\u304a\u3044\u3066\u610f\u898b\u3084\u52a9\u8a00\u3092\u8ff0\u3079\u308b\u3002\u3053\u308c\u306b\u306f\u3001\u65bd\u8a2d\u304c\u7d4c\u6e08\u7684\u306b\u3001\u307e\u305f\u4e8b\u696d\u8a08\u753b\u4e0a\u8a66\u9a13\u3092\u5b9f\u65bd\u3059\u308b\u3053\u3068\u304c\u53ef\u80fd\u304b\u3069\u3046\u304b\u3092\u8a55\u4fa1\u3059\u308b\u80fd\u529b\u3092\u542b\u3080\u3002<\/td><td class=\"column-3\"><b>C1. <\/b>\u30d7\u30ed\u30b0\u30e9\u30e0\u307e\u305f\u306f\u65bd\u8a2d\u30ec\u30d9\u30eb\u3067\u306e\u8a66\u9a13\u306e\u9078\u629e\u3092\u6307\u5c0e\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\"><b>A2. <\/b>(\u9078\u5b9a)\u524d\u65bd\u8a2d\u8a55\u4fa1\u8a2a\u554f\u306e\u76ee\u7684\u3092\u7406\u89e3\u3059\u308b<\/td><td class=\"column-2\"><b>B2.<\/b>(\u9078\u5b9a)\u524d\u65bd\u8a2d\u8a2a\u554f\u306e\u8abf\u6574\u30fb\u5b9f\u65bd\u306e\u30b5\u30dd\u30fc\u30c8\u3092\u884c\u3046<\/td><td class=\"column-3\"><b>C2. <\/b>\u79d1\u5b66\u7684\u59a5\u5f53\u6027\u3068\u4fa1\u5024 \u3092\u8003\u616e\u3057\u3066\u3001\u8a66\u9a13\u306e\u9078\u629e\u306b\u95a2\u3059\u308b\u610f\u601d\u6c7a\u5b9a\u3092\u8868\u660e\u3059\u308b\u3002\u5177\u4f53\u7684\u306b\u306f\u3001\u671b\u307e\u3057\u3044\u30ea\u30b9\u30af\u5bfe\u5229\u76ca\u6bd4\u3001\uff08\u7d4c\u6e08\u7684\u30fb\u4e8b\u696d\u8a08\u753b\u9762\u3067\u306e\uff09\u5b9f\u65bd\u53ef\u80fd\u6027\u3092\u691c\u8a0e\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-4 even\">\n\t<td class=\"column-1\"><b>A3.<\/b>\u30aa\u30f3\u30e9\u30a4\u30f3\u307e\u305f\u306f\u5bfe\u9762\u306e(\u9078\u5b9a)\u524d\u65bd\u8a2d\u8a2a\u554f\u306b\u53c2\u52a0\u3059\u308b<\/td><td class=\"column-2\"><\/td><td class=\"column-3\"><b>C3. <\/b>\u8a66\u9a13\u306e\u9078\u629e\u3068\u53c2\u52a0\u306b\u95a2\u3059\u308b\u610f\u601d\u6c7a\u5b9a\u306e\u30d7\u30ed\u30bb\u30b9\u3092\u6307\u5c0e\u3059\u308b\u305f\u3081\u306e\u4ea4\u6e09\u30fb\u30c4\u30fc\u30eb\u306e\u4f5c\u6210\u30fb\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u306e\u4f5c\u6210\u30fb\u30dd\u30ea\u30b7\u30fc\u306e\u4f5c\u6210\u3092\u4e3b\u5c0e\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-5 odd\">\n\t<td class=\"column-1\"><b>\u4f8b\uff1a<\/b>\u65b0\u898f\u306e\u30d7\u30ed\u30c8\u30b3\u30eb\u5019\u88dc\u306b\u3064\u3044\u3066\u3001\u65bd\u8a2d\u3067\u305d\u306e\u8a66\u9a13\u3092\u5b9f\u65bd\u53ef\u80fd\u306b\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u3068\u306a\u308b\u3053\u3068\u3092\u7406\u89e3\u3059\u308b<\/td><td class=\"column-2\"><b>\u4f8b\uff1a<\/b>\u65b0\u898f\u8a66\u9a13\u5019\u88dc\u306b\u3064\u3044\u3066\u4e88\u5099\u7684\u306a\u4e88\u7b97\u898b\u7a4d\u3082\u308a\u3092\u542b\u3080\u5b9f\u65bd\u53ef\u80fd\u6027\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u3092\u8a18\u8f09\u3059\u308b<\/td><td class=\"column-3\"><b>\u4f8b\uff1a<\/b>\u90e8\u7f72\u5168\u4f53\u3067\u4f7f\u7528\u3059\u308b\u8a66\u9a13\u306e\u5b9f\u65bd\u53ef\u80fd\u6027\u5224\u65ad\u30c4\u30fc\u30eb\u3092\u4f5c\u6210\u3057\u3001(\u8a66\u9a13\u5b9f\u65bd\u306e\u5224\u65ad\u3092\u3059\u308b\u306b\u3042\u305f\u3063\u3066\u306e)\u52a9\u8a00\u3092\u884c\u3046\u306b\u81f3\u3063\u305f\u5224\u65ad\u904e\u7a0b\u306b\u3064\u3044\u3066\u8a55\u4fa1\u3059\u308b<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-132 from cache -->[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;5.2 \u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u306b\u5fc5\u8981\u306a\u7d4c\u6e08\u7684\u30fb\u6642\u9593\u7684\u30fb\u4eba\u7684\u30ea\u30bd\u30fc\u30b9\u3092\u78ba\u4fdd\u3057\u7ba1\u7406\u3059\u308b&#8221; tab_id=&#8221;1577722530041-8883a8c2-68b6&#8243;][vc_column_text]\n<table id=\"tablepress-133\" class=\"tablepress tablepress-id-133\">\n<thead>\n<tr class=\"row-1 odd\">\n\t<th class=\"column-1\">A.\u57fa\u790e\u30ec\u30d9\u30eb<\/th><th class=\"column-2\">B. \u4e2d\u7d1a\u30ec\u30d9\u30eb<\/th><th class=\"column-3\">C. \u4e0a\u7d1a\u30ec\u30d9\u30eb<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-hover\">\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\"><b>A1.<\/b>\u81e8\u5e8a\u8a66\u9a13\u306e\u4e88\u7b97\u306e\u4e3b\u8981\u69cb\u6210\u8981\u7d20\u3092\u7279\u5b9a\u3059\u308b<\/td><td class=\"column-2\"><b>B1.<\/b>\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u306b\u5fc5\u8981\u306a\u4e88\u7b97\u30fb\u6642\u9593\u30fb\u4eba\u7684\u30ea\u30bd\u30fc\u30b9\u306e\u8cea\u3068\u91cf\u306b\u95a2\u3059\u308b\u63d0\u6848\u3092\u5ba2\u89b3\u7684\u306b\u8a55\u4fa1\u3057\u5909\u66f4\u3092\u63d0\u6848\u3059\u308b<\/td><td class=\"column-3\"><b>C1. <\/b>\u81e8\u5e8a\u8a66\u9a13\u3092\u5b9f\u65bd\u3059\u308b\u305f\u3081\u306e\u4e88\u7b97\u3001\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3\u3001\u305d\u3057\u3066\uff0f\u307e\u305f\u306f\u4eba\u7684\u306a\u30ea\u30bd\u30fc\u30b9\u3092\u7372\u5f97\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\"><\/td><td class=\"column-2\"><b>B2.<\/b>\u30de\u30a4\u30eb\u30b9\u30c8\u30fc\u30f3\u3068\u7167\u3089\u3057\u5408\u308f\u305b\u3066\u81e8\u5e8a\u8a66\u9a13\u306e\u9032\u6357\u3092\u30e2\u30cb\u30bf\u30fc\u3057\u3001\u8a66\u9a13\u306e\u5b9f\u65bd\u4e2d\u306b\u50be\u5411\u3084\u30ea\u30b9\u30af\u3092\u7279\u5b9a\u3059\u308b\u3002\u30ea\u30b9\u30af\u4f4e\u6e1b\u8a08\u753b\u3092\u5b9f\u65bd\u3059\u308b<\/td><td class=\"column-3\"><b>C2. <\/b>(\u30ea\u30b9\u30af\u306e)\u50be\u5411\u3092\u7279\u5b9a\u3057\u3001\u4f4e\u6e1b\u8a08\u753b\u3092\u5b9f\u65bd\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-4 even\">\n\t<td class=\"column-1\"><\/td><td class=\"column-2\"><\/td><td class=\"column-3\"><b>C3. <\/b>\u81e8\u5e8a\u8a66\u9a13\u306e\u62c5\u5f53\u8005\u3092\u7ba1\u7406\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-5 odd\">\n\t<td class=\"column-1\"><b>\u4f8b\uff1a<\/b>\u8a66\u9a13\u306e\u305f\u3081\u306e(\u88ab\u9a13\u8005)\u6765\u9662\u3092\u8abf\u6574\u3057\u3001\u6b63\u3057\u3044\u4f9d\u983c\u66f8\u3068\u8a66\u9a13\u8b58\u5225\u756a\u53f7\u3092\u4f7f\u7528\u3057\u3066\u691c\u67fb\u306e\u4f9d\u983c\u3092\u3057\u3001\u305d\u308c\u3089\u306b\u95a2\u3059\u308b\u6587\u66f8\u306e\u8ffd\u8de1\u3001\u8abf\u6574\u3092\u884c\u3046\u3053\u3068\u304c\u3067\u304d\u308b<\/td><td class=\"column-2\"><b>\u4f8b\uff1a<\/b>\u30d7\u30ed\u30c8\u30b3\u30eb\u4e0a\u306e\u5fc5\u9808\u4e8b\u9805\u304c\u78ba\u5b9f\u306b\u3059\u3079\u3066\u542b\u307e\u308c\u308b\u3088\u3046\u306b\u3001\u8a66\u9a13\u306e\u4e88\u7b97\u3092\u5206\u6790\u3059\u308b<\/td><td class=\"column-3\"><b>\u4f8b\uff1a<\/b>\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u6539\u8a02\u306b\u4f34\u3046\u65b0\u898f\u306e\u5fc5\u9808\u4e8b\u9805\u3092\u53cd\u6620\u3057\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u306b\u304a\u3051\u308b\u4e88\u6e2c\u3067\u304d\u306a\u3044\u8cbb\u7528\u4e0a\u306e\u554f\u984c\u3092\u89e3\u6c7a\u3059\u308b\u305f\u3081\u306b\u3001\u8a66\u9a13\u306e\u4e88\u7b97\u3068\u30de\u30a4\u30eb\u30b9\u30c8\u30fc\u30f3\u578b\u306e\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3\u3092\u4f5c\u6210\u3057\u3001\u6539\u8a02\u3059\u308b<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-133 from cache -->[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;5.3 \u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u72b6\u6cc1\u3092\u6539\u5584\u3059\u308b\u305f\u3081\u306e\u30ea\u30b9\u30af\u4f4e\u6e1b\u306b\u5411\u3051\u305f\u7ba1\u7406\u3068\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u306b\u3064\u3044\u3066\u8aac\u660e\u3059\u308b&#8221; tab_id=&#8221;1577731673337-3abd7fda-fbdd&#8221;][vc_column_text]\n<table id=\"tablepress-134\" class=\"tablepress tablepress-id-134\">\n<thead>\n<tr class=\"row-1 odd\">\n\t<th class=\"column-1\">A.\u57fa\u790e\u30ec\u30d9\u30eb<\/th><th class=\"column-2\">B. \u4e2d\u7d1a\u30ec\u30d9\u30eb<\/th><th class=\"column-3\">C. \u4e0a\u7d1a\u30ec\u30d9\u30eb<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-hover\">\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\"><b>A1.<\/b>\u30ea\u30b9\u30af\u3092\u8efd\u6e1b\u3059\u308b\u305f\u3081\u81e8\u5e8a\u8a66\u9a13\u306b\u7d44\u307f\u8fbc\u307e\u308c\u305f\u4ed5\u7d44\u307f\u3092\u7279\u5b9a\u3059\u308b<\/td><td class=\"column-2\"><b>B1.<\/b>\u54c1\u8cea\u7ba1\u7406\u8a08\u753b\u306e\u91cd\u8981\u6027\u3092\u7279\u5b9a\u3057\u7406\u89e3\u3059\u308b\u3002\u54c1\u8cea\u7ba1\u7406\u8a08\u753b\u306e\u5168\u4f53\u50cf\u306b\u3064\u3044\u3066\u6559\u80b2\u3059\u308b<\/td><td class=\"column-3\"><b>C1. <\/b>\u54c1\u8cea\u7ba1\u7406\u8a08\u753b\u306b\u95a2\u3059\u308b\u7814\u4fee\u30d7\u30ed\u30b0\u30e9\u30e0\uff08\u4e00\u822c\u7684\u306a\u3082\u306e\u3068\u500b\u5225\u306e\u8a66\u9a13\u306b\u7279\u5316\u3057\u305f\u3082\u306e\uff09\u3092\u958b\u767a\u3057\u3001\u305d\u306e\u7814\u4fee\u3092\u5b9f\u65bd\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\"><b>A2. <\/b>\u81e8\u5e8a\u8a66\u9a13\u306e\u904b\u7528\u3068\u88ab\u9a13\u8005\u306e\u5b89\u5168\u306e\u305f\u3081\u306b\u30ea\u30b9\u30af\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u304c\u3069\u306e\u3088\u3046\u306b\u5b9f\u65bd\u3055\u308c\u3066\u3044\u308b\u304b\u7406\u89e3\u3059\u308b<\/td><td class=\"column-2\"><b>B2.<\/b>\u8a08\u753b\u306b\u5b9a\u7fa9\u3055\u308c\u3066\u3044\u308b\u901a\u308a\u306b\u30ea\u30b9\u30af\u4f4e\u6e1b\u7b56\u3092\u6bb5\u968e\u7684\u306b\u5b9f\u65bd\u3057\u3001\u305d\u306e\u5185\u5bb9\u3068\u9069\u7528\u306b\u3064\u3044\u3066\u6559\u80b2\u3059\u308b\u305f\u3081\u306e\u6226\u7565\u3092\u7acb\u6848\u3059\u308b<\/td><td class=\"column-3\"><b>C2. <\/b>\u81e8\u5e8a\u8a66\u9a13\u306e\u4e3b\u8981\u696d\u52d9\u8a55\u4fa1\u6307\u6a19\u3092\u5b9a\u7fa9\u3057\u3001\u500b\u5225\u306e\u8a66\u9a13\u306b\u7279\u5316\u3057\u305f\u54c1\u8cea\u7ba1\u7406\u8a08\u753b\u306b\u7d44\u307f\u8fbc\u3080<\/td>\n<\/tr>\n<tr class=\"row-4 even\">\n\t<td class=\"column-1\"><\/td><td class=\"column-2\"><\/td><td class=\"column-3\"><b>C3. <\/b>\u4e3b\u8981\u696d\u52d9\u8a55\u4fa1\u6307\u6a19\u306e\u5185\u90e8\u54c1\u8cea\u4fdd\u8a3c\u30c7\u30fc\u30bf\u3092\u89e3\u91c8\u3057\u3001\u662f\u6b63\u63aa\u7f6e\u30fb\u4e88\u9632\u63aa\u7f6e(CAPA)\u8a08\u753b\u3092\u901a\u3057\u3066\u30ea\u30b9\u30af\u3092\u4f4e\u6e1b\u3059\u308b\u6226\u7565\u3092\u7acb\u3066\u308b<\/td>\n<\/tr>\n<tr class=\"row-5 odd\">\n\t<td class=\"column-1\"><b>\u4f8b\uff1a<\/b>\u306a\u305c\u4e3b\u8981\u696d\u52d9\u8a55\u4fa1\u6307\u6a19(\u3078\u306e\u5230\u9054\u5ea6)\u306b\u652f\u969c\u304c\u51fa\u305f\u306e\u304b\u3001\u8003\u3048\u5f97\u308b\u7406\u7531(\u88ab\u9a13\u8005\u304c\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u898f\u5b9a\u3055\u308c\u3066\u3044\u308b\u30a2\u30ed\u30fc\u30ef\u30f3\u30b9\u5185\u3067\u8a66\u9a13\u306e\u305f\u3081\u306e\u6765\u9662\u3092\u5b8c\u4e86\u3057\u306a\u304b\u3063\u305f\u306a\u3069)\u3068\u3001\u30ea\u30b9\u30af\u306e\u767a\u751f\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u53ef\u80fd\u6027\u306e\u9ad8\u3044\u904b\u7528\u306b\u3064\u3044\u3066\u660e\u78ba\u306b\u8ff0\u3079\u308b<\/td><td class=\"column-2\"><b>\u4f8b\uff1a<\/b>\u4e3b\u8981\u696d\u52d9\u8a55\u4fa1\u6307\u6a19(\u5b9f\u65bd\u306b\u3088\u308b\u5230\u9054\u5ea6)\u306e\u8a55\u4fa1\u3092\u5143\u306b\u3001\u5831\u544a\u66f8\u3092\u5206\u6790\u3057\u3001\u898f\u5b9a\u3055\u308c\u3066\u3044\u308b\u30ea\u30b9\u30af\u4f4e\u6e1b\u7b56\u3092\u5b9f\u65bd\u3059\u308b<\/td><td class=\"column-3\"><b>\u4f8b\uff1a<\/b>\u54c1\u8cea\u76e3\u67fb\u306e\u6307\u6458\u4e8b\u9805\u3092\u5206\u6790\u30fb\u5831\u544a\u3057\u3001\u30b9\u30bf\u30c3\u30d5\u306e\u4f1a\u8b70\u306b\u304a\u3044\u3066(\u30ea\u30b9\u30af)\u4f4e\u6e1b\u306e\u305f\u3081\u306e\u5354\u8b70\u8ab2\u984c\u3068\u3057\u3066\u63d0\u793a\u3059\u308b\u3000\u304b\u3064\uff0f\u307e\u305f\u306f\u3000\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u304c\u3069\u306e\u3088\u3046\u81e8\u5e8a\u8a66\u9a13\u306b\u9069\u7528\u3055\u308c\u308b\u304b\u3092\u30b9\u30bf\u30c3\u30d5\u304c\u78ba\u5b9f\u306b\u7406\u89e3\u3067\u304d\u308b\u3088\u3046\u3001\u54c1\u8cea\u7ba1\u7406\u6559\u80b2\u30d7\u30ed\u30b0\u30e9\u30e0\u306b\u7d44\u307f\u8fbc\u3080<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-134 from cache -->[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;5.4 \u88ab\u9a13\u8005\u306e\u52df\u96c6\u3001\u4fdd\u6301\uff08\u8131\u843d\u3055\u305b\u306a\u3044\u4e8b\uff09\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u7ba1\u7406\u3057\u3001\u8a66\u9a13\u306e\u7d4c\u904e\u3092\u8ffd\u3046\u305f\u3081\u306e\u6226\u7565\u3092\u7acb\u6848\u3059\u308b&#8221; tab_id=&#8221;1577733692128-f34c1734-93a7&#8243;][vc_column_text]\n<table id=\"tablepress-135\" class=\"tablepress tablepress-id-135\">\n<thead>\n<tr class=\"row-1 odd\">\n\t<th class=\"column-1\">A.\u57fa\u790e\u30ec\u30d9\u30eb<\/th><th class=\"column-2\">B. \u4e2d\u7d1a\u30ec\u30d9\u30eb<\/th><th class=\"column-3\">C. \u4e0a\u7d1a\u30ec\u30d9\u30eb<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-hover\">\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\"><b>A1.<\/b>\u52df\u96c6\u7387\u3068\u4fdd\u6301\u7387\u306e\u671f\u5f85\u5024\u3092\u660e\u78ba\u306b\u8ff0\u3079\u308b<\/td><td class=\"column-2\"><b>B1.<\/b>\u88ab\u9a13\u8005\u306e\u52df\u96c6\u3068\u4fdd\u6301\u306e\u8ffd\u8de1\u30c7\u30fc\u30bf\u3092\u89e3\u6790\u3057\u3001\u5909\u66f4\u306e\u5fc5\u8981\u6027\u3092\u5224\u65ad\u3059\u308b<\/td><td class=\"column-3\"><b>C1. <\/b>\u91cd\u8981\u306a\u502b\u7406\u7684\u914d\u616e\u3092\u3057\u306a\u304c\u3089\u3001\u52df\u96c6\u3068\u4fdd\u6301\u306e\u8ab2\u984c\u306b\u5bfe\u3059\u308b\u9769\u65b0\u7684\u306a\u89e3\u6c7a\u7b56\u3092\u63d0\u4f9b\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\"><b>A2. <\/b>\u88ab\u9a13\u8005\u306e\u52df\u96c6\u3068\u4fdd\u6301\u306e\u5b9f\u884c\u30fb\u8ffd\u8de1\u306e\u305f\u3081\u306e\u30c4\u30fc\u30eb\u30fb\u6226\u7565\u30fb\u65b9\u6cd5\u3092\u7279\u5b9a\u3057\u4f7f\u7528\u3059\u308b<\/td><td class=\"column-2\"><b>B2.<\/b>\u52df\u96c6\u3068\u4fdd\u6301\u306e\u628a\u63e1\u304a\u3088\u3073\u5831\u544a\u3092\u884c\u3046\u305f\u3081\u306e\u57fa\u672c\u7684\u306a\u65b9\u6cd5\u3092\u78ba\u7acb\u3059\u308b<\/td><td class=\"column-3\"><b>C2. <\/b>\u305d\u308c\u305e\u308c\u306e\u56fd\u3068\u5730\u57df\u306e\u898f\u5236\u8981\u4ef6\u3092\u30d9\u30fc\u30b9\u306b\u69d8\u3005\u306a\u52df\u96c6\u7528\u306e\u30c4\u30fc\u30eb\u3092\u63d0\u6848\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-4 even\">\n\t<td class=\"column-1\"><b>A3.<\/b>\u52df\u96c6\u306e\u305f\u3081\u306e\u5404\u30c4\u30fc\u30eb\u306e\u4f7f\u7528\u306b\u5f71\u97ff\u3059\u308b\u56fd\u5185\u898f\u5236\u3068\u56fd\u969b\u7684\u306a\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u3064\u3044\u3066\u8aac\u660e\u3059\u308b<\/td><td class=\"column-2\"><b>C3. <\/b> \u52df\u96c6\u306e\u305f\u3081\u306e\u5404\u30c4\u30fc\u30eb\u306e\u4f7f\u7528\u306b\u5f71\u97ff\u3059\u308b\u56fd\u5185\u898f\u7d04\u3068\u56fd\u969b\u898f\u7d04\u3092\u9069\u7528\u3059\u308b<\/td><td class=\"column-3\"><\/td>\n<\/tr>\n<tr class=\"row-5 odd\">\n\t<td class=\"column-1\"><b>\u4f8b\uff1a<\/b>\u88ab\u9a13\u8005\u306e\u52df\u96c6\u3068\u4fdd\u6301\u306e\u78ba\u8a8d\u306b\u4f7f\u7528\u3059\u308b\u6587\u66f8\u3084\u30c4\u30fc\u30eb\u306b\u3064\u3044\u3066\u7406\u89e3\u3059\u308b<\/td><td class=\"column-2\"><b>\u4f8b\uff1a<\/b>\u5e74\u9f62\u30fb\u6027\u5225\u30fb\u5c45\u4f4f\u5730\u306a\u3069\u306e\u8a66\u9a13\u6bcd\u96c6\u56e3\u306e\u8981\u4ef6\u3092\u6e80\u305f\u3059\u3088\u3046\u306a(\u88ab\u9a13\u8005)\u52df\u96c6\u30d7\u30e9\u30f3\u3092\u4f5c\u6210\u3057\u3001\u52df\u96c6\u306e\u52a9\u3051\u3068\u306a\u308b\u3088\u3046\u306a\u53c2\u52a0\u52df\u96c6\u30c1\u30e9\u30b7\u3092\u4f5c\u6210\u3057\u3066IRB\u306b\u63d0\u51fa\u3059\u308b<\/td><td class=\"column-3\"><b>\u4f8b\uff1a<\/b>(\u88ab\u9a13\u8005\u306e)\u52df\u96c6\u307e\u305f\u306f\u4fdd\u6301\u304c\u958b\u59cb\u3057\u305f\u3070\u304b\u308a\u306e\u8a66\u9a13\u306b\u304a\u3044\u3066\u30a8\u30d3\u30c7\u30f3\u30b9\u306b\u57fa\u3065\u3044\u305f\u3001\u307e\u305f\u5230\u9054\u3059\u308b\uff0f\u7d44\u307f\u5165\u308c\u308b\u3053\u3068\u304c\u96e3\u3057\u3044\u96c6\u56e3\u306b\u5bfe\u3057\u3066\u500b\u5225\u306b\u5fc5\u8981\u306a\u4e8b\u67c4\u3092\u660e\u78ba\u306b\u3057\u305f\u4e0a\u3067\u3001\u9769\u65b0\u7684\u306a\u89e3\u6c7a\u7b56\u3092\u751f\u307f\u51fa\u3059\u3002\u89e3\u6c7a\u7b56\u306b\u306f\u6226\u7565\u306e\u6210\u529f\u5ea6\u5408\u3044\u3092\u983b\u7e41\u306b\u78ba\u8a8d\u3059\u308b\u3053\u3068\u3082\u542b\u3080<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-135 from cache -->[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;5.5 \u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u306b\u95a2\u308f\u308b\u6cd5\u7684\u8cac\u4efb\u30fb\u7fa9\u52d9\u30fb\u8aac\u660e\u8cac\u4efb\u3092\u7279\u5b9a\u3059\u308b&#8221; tab_id=&#8221;1577735954094-337ba75b-048d&#8221;][vc_column_text]\n<table id=\"tablepress-136\" class=\"tablepress tablepress-id-136\">\n<thead>\n<tr class=\"row-1 odd\">\n\t<th class=\"column-1\">A.\u57fa\u790e\u30ec\u30d9\u30eb<\/th><th class=\"column-2\">B. \u4e2d\u7d1a\u30ec\u30d9\u30eb<\/th><th class=\"column-3\">C. \u4e0a\u7d1a\u30ec\u30d9\u30eb<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-hover\">\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\"><b>A1.<\/b>\u898f\u5236\u30fb\u65bd\u8a2d\u306e\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u76e3\u67fb\u306e\u305f\u3081\u306e\u898f\u5236\u95a2\u9023\u6587\u66f8\u3068\u88dc\u52a9\u91d1\u30fb\u5951\u7d04\u95a2\u9023\u6587\u66f8\u3092\u6574\u7406\u3057\u4fdd\u83c5\u3059\u308b<\/td><td class=\"column-2\"><b>B1.<\/b>\u6cd5\u7684\u6587\u66f8\uff08\u5951\u7d04\u66f8\u3001\u7814\u7a76\u8a66\u6599\u63d0\u4f9b\u5951\u7d04\u66f8\u3001\u4e88\u7b97\u5831\u544a\u66f8\u3001\u88dc\u511f\u5408\u610f\u66f8\u3001\u79d8\u5bc6\u4fdd\u6301\u5951\u7d04\u66f8\u3001\u5229\u76ca\u76f8\u53cd\u5831\u544a\u66f8\uff09\u3092\u6574\u7406\u3057\u9069\u5207\u306b\u51e6\u7406\u3059\u308b<\/td><td class=\"column-3\"><b>C1. <\/b>\u7d44\u7e54\u306b\u304a\u3051\u308b\u81e8\u5e8a\u7814\u7a76\u304c\u78ba\u5b9f\u306b\u6cd5\u7684\u30fb\u502b\u7406\u7684\u8981\u4ef6\u3092\u6e80\u305f\u3057\u3066\u5b9f\u65bd\u3055\u308c\u308b\u3088\u3046\u3001\u30b7\u30b9\u30c6\u30e0\u3092\u76e3\u8996\u30fb\u7ba1\u7406\u3057\u7d44\u7e54\u306e\u5404\u90e8\u9580\u3068\u5354\u529b\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\"><b>A2. <\/b>\u898f\u5236\u306b\u6e96\u62e0\u3059\u308b\u65bd\u8a2d\u306b\u304a\u3051\u308b\u3001\u8a66\u9a13\u306b\u95a2\u308f\u308b\u5404\u6cd5\u7684\u6587\u66f8\uff08\u5951\u7d04\u66f8\u3001\u4e88\u7b97\u3001\u88dc\u511f\u3001\u79d8\u5bc6\u4fdd\u6301\u5951\u7d04\u3001\u5229\u76ca\u76f8\u53cd\u5831\u544a\u66f8\u3001IRB\u627f\u8a8d\uff09\u306e\u76ee\u7684\u3092\u7406\u89e3\u3059\u308b<\/td><td class=\"column-2\"><b>B2.<\/b>\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u306b\u304a\u3044\u3066\u6cd5\u7684\u30ea\u30b9\u30af\u3092\u4f4e\u6e1b\u3059\u308b\u305f\u3081\u306e\u6a19\u6e96\u696d\u52d9\u624b\u9806\u66f8\u3092\u4f5c\u6210\u3057\u3001\u305d\u3057\u3066\uff0f\u307e\u305f\u306f\u6e96\u62e0\u3059\u308b<\/td><td class=\"column-3\"><b>C2. <\/b>\u30ea\u30b9\u30af\u4f4e\u6e1b\u6226\u7565\u3068\u95a2\u9023\u3059\u308b\u884c\u52d5\u8a08\u753b\u3001\u3068\u554f\u984c\u89e3\u6c7a\u7b56\u3092\u7acb\u6848\u3057\u5ba2\u89b3\u7684\u306b\u8a55\u4fa1\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-4 even\">\n\t<td class=\"column-1\"><\/td><td class=\"column-2\"><\/td><td class=\"column-3\"><b>C3.<\/b>\u6cd5\u7684\u5951\u7d04\u66f8\uff08\u4e88\u7b97\u3092\u542b\u3080\uff09\u3001\u79d8\u5bc6\u4fdd\u6301\u5951\u7d04\u3001\u5229\u76ca\u76f8\u53cd\u6587\u66f8\u306b\u95a2\u3057\u3066\u5354\u8b70\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-5 odd\">\n\t<td class=\"column-1\"><b>\u4f8b\uff1a<\/b>\u691c\u4f53\u691c\u67fb\u3092\u30d9\u30fc\u30b9\u3068\u3057\u305f\u7814\u7a76\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306b\u304a\u3044\u3066\u3001\u8cac\u4efb\u533b\u5e2b\u304c\u51b7\u51cd\u4fdd\u7ba1\u5eab\u304b\u3089\u691c\u4f53\u3092\u5165\u624b\u3057\u4ed6\u306e\u8cac\u4efb\u533b\u5e2b\u306b\u9001\u4ed8\u3059\u308b\u3053\u3068\u3092\u4f9d\u983c\u3057\u3066\u304d\u305f\u5834\u5408\u3001\u691c\u4f53\u306e\u767a\u9001\u524d\u306b\u7814\u7a76\u8a66\u6599\u63d0\u4f9b\u5951\u7d04\u66f8\u304c\u7de0\u7d50\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u305f\u3081\u3001\u8ffd\u52a0\u306e\u52a9\u8a00\u3092\u5f97\u308b\u624b\u6bb5\u3092\u77e5\u3063\u3066\u3044\u308b<\/td><td class=\"column-2\"><b>\u4f8b\uff1a<\/b>\u540c\u610f\u8aac\u660e\u6587\u66f8\u3092\u30ec\u30d3\u30e5\u30fc\u3057\u3001\u6cbb\u9a13\u5951\u7d04\u66f8\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u4fdd\u969c\u3084\u8ce0\u511f\u306b\u95a2\u3059\u308b\u6587\u8a00\u304c\u3001\u30d7\u30ed\u30c8\u30b3\u30eb\u3084\u540c\u610f\u8aac\u660e\u6587\u66f8\u3001\u65bd\u8a2d\u306e\u30dd\u30ea\u30b7\u30fc\u306e\u8a18\u8f09\u306b\u6cbf\u3063\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b<\/td><td class=\"column-3\"><b>\u4f8b\uff1a<\/b>\u65bd\u8a2d\u306e\u5229\u76ca\u76f8\u53cd\u59d4\u54e1\u3068\u3057\u3066\u5f93\u4e8b\u3059\u308b<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-136 from cache -->[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;5.6 \u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u306b\u95a2\u9023\u3059\u308b\u6cbb\u9a13\u8cac\u4efb\u533b\u5e2b\u30fb\u6cbb\u9a13\u4f9d\u983c\u8005\u30fbCRO\u30fb\u898f\u5236\u5f53\u5c40\u306b\u6c42\u3081\u3089\u308c\u308b\u7279\u5b9a\u306e\u624b\u7d9a\u304d\u30fb\u8a18\u9332\u30fb\u76e3\u7763\u306e\u8981\u4ef6\u3092\u7279\u5b9a\u3057\u8aac\u660e\u3059\u308b&#8221; tab_id=&#8221;1577736565663-d7ecc7ae-77ac&#8221;][vc_column_text]\n<table id=\"tablepress-137\" class=\"tablepress tablepress-id-137\">\n<thead>\n<tr class=\"row-1 odd\">\n\t<th class=\"column-1\">A.\u57fa\u790e\u30ec\u30d9\u30eb<\/th><th class=\"column-2\">B. \u4e2d\u7d1a\u30ec\u30d9\u30eb<\/th><th class=\"column-3\">C. \u4e0a\u7d1a\u30ec\u30d9\u30eb<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-hover\">\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\"><b>A1.<\/b>\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u306b\u304a\u3044\u3066\u3001\u6cbb\u9a13\u8cac\u4efb\u533b\u5e2b\u30fb\u6cbb\u9a13\u4f9d\u983c\u8005\u30fbCRO\u30fb\u898f\u5236\u5f53\u5c40\u306b\u9069\u7528\u3055\u308c\u308b\u5fc5\u9808\u8981\u4ef6\u3092\u8a18\u3057\u305f\u898f\u5236\u3084\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u7279\u5b9a\u3059\u308b<\/td><td class=\"column-2\"><b>B1.<\/b>\u9069\u7528\u3055\u308c\u308b\u898f\u5236\u3092\u7406\u89e3\u3057\u660e\u78ba\u306b\u8ff0\u3079\u308b\u3002\u307e\u305f\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u5fb9\u5e95\u3059\u308b\u305f\u3081\u306b\u78ba\u7acb\u3055\u308c\u305f\u30d7\u30ed\u30bb\u30b9\u3092\u6b63\u78ba\u306b\u884c\u3046<\/td><td class=\"column-3\"><b>C1. <\/b>\u898f\u5236\u306b\u95a2\u3059\u308b\u9ad8\u5ea6\u306a\u77e5\u8b58\u3068\u3001\u898f\u5236\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u6b63\u78ba\u306b\u89e3\u91c8\u3059\u308b\u80fd\u529b\u3092\u6d3b\u7528\u3059\u308b\u3002\u898f\u5236\u3092\u65e5\u3005\u306e\u5b9f\u8df5\u306b\u7d50\u3073\u4ed8\u3051\u308b\u65b9\u6cd5\u306b\u3064\u3044\u3066\u6307\u5c0e\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\"><b>A2. <\/b>\u6cbb\u9a13\u8cac\u4efb\u533b\u5e2b\u3092\u542b\u3080\u65bd\u8a2d\u30c1\u30fc\u30e0\u30e1\u30f3\u30d0\u30fc\u30fb\u6cbb\u9a13\u4f9d\u983c\u8005\u30fbCRO\u30fb\u6a5f\u95a2\u30fbFDA\u7b49\u306e\u5f79\u5272\u306b\u3064\u3044\u3066\u8aac\u660e\u3059\u308b<\/td><td class=\"column-2\"><b>B2.<\/b>\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306b\u6e96\u3058\u305f\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u306b\u304a\u3044\u3066\u767a\u751f\u3059\u308b\u30c1\u30fc\u30e0\u306e\u69d8\u3005\u306a\u5f79\u5272\uff08\u6cbb\u9a13\u4f9d\u983c\u8005\u3001\u6cbb\u9a13\u8cac\u4efb\u533b\u5e2b\uff09\u3068\u305d\u308c\u305e\u308c\u306e\u8cac\u4efb\u306b\u3064\u3044\u3066\u8aac\u660e\u3059\u308b<\/td><td class=\"column-3\"><b>C2. <\/b>\u90e8\u9580\u307e\u305f\u306f\u65bd\u8a2d\u30ec\u30d9\u30eb\u3067\u898f\u5236\u306e\u9806\u5b88\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306e\u6226\u7565\u30fb\u30dd\u30ea\u30b7\u30fc\u30fb\u624b\u9806\u3092\u4f5c\u6210\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-4 even\">\n\t<td class=\"column-1\"><\/td><td class=\"column-2\"><b>B3.<\/b>\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u304c\u3001\u5b89\u5168\u3067\u502b\u7406\u7684\u306a\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u306b\u4e0e\u3048\u308b\u5f71\u97ff\u306b\u3064\u3044\u3066\u8aac\u660e\u3059\u308b<\/td><td class=\"column-3\"><b>C3.<\/b>\u81e8\u5e8a\u8a66\u9a13\u306e\u30b9\u30bf\u30c3\u30d5\u3068\u6cbb\u9a13\u8cac\u4efb\u533b\u5e2b\u306e\u9593\u3067\u5b9f\u65bd\u3059\u308b\u5b9a\u671f\u7684\u306a\u8a66\u9a13\u95a2\u9023\u306e\u30df\u30fc\u30c6\u30a3\u30f3\u30b0\u3092\u8a08\u753b\u3057\u7ba1\u7406\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-5 odd\">\n\t<td class=\"column-1\"><b>\u4f8b\uff1a<\/b>IRB\u3078\u306e\u63d0\u51fa\u304c\u5fc5\u8981\u306a\u540c\u610f\u8aac\u660e\u6587\u66f8\u3001\u88ab\u9a13\u8005\u52df\u96c6\u95a2\u9023\u6587\u66f8\u3092\u542b\u3080\u5168\u3066\u306e\u898f\u5236\u95a2\u9023\u6587\u66f8\u3092\u5206\u985e\u30fb\u4fdd\u7ba1\u3059\u308b<\/td><td class=\"column-2\"><b>\u4f8b\uff1a<\/b>\u65b0\u898f\u6cbb\u9a13\u3092IRB\u306b\u63d0\u51fa\u3059\u308b\u30d7\u30ed\u30bb\u30b9\u306b\u5bfe\u5fdc\u3059\u308b<\/td><td class=\"column-3\"><b>\u4f8b\uff1a<\/b>\u5404\u3005\u306e\u8cac\u4efb\u30ec\u30d9\u30eb\u3068\u696d\u52d9\u306e\u76ee\u7684\u306b\u5fdc\u3058\u3066\u3001\u8a66\u9a13\u306e\u5b9f\u65bd\u306b\u304a\u3051\u308b\u30b9\u30bf\u30c3\u30d5\u306e\u5f79\u5272\u3092\u660e\u78ba\u306b\u8a18\u8f09\u3057\u305f\u30c7\u30ea\u30b2\u30fc\u30b7\u30e7\u30f3\u30ed\u30b0\u3092\u4f5c\u6210\u3059\u308b<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-137 from cache -->[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Section 2&#8243; tab_id=&#8221;1577717219294-6fada670-2f6f&#8221;][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row][vc_row][vc_column width=&#8221;1\/6&#8243;][vc_single_image image=&#8221;320&#8243;][\/vc_column][vc_column width=&#8221;5\/6&#8243;][vc_column_text el_id=&#8221;domain6&#8243;]<\/p>\n<h2><strong>\u30c7\u30fc\u30bf\u30de\u30cd\u30b8\u30e1\u30f3\u30c8<\/strong><strong>\u3068\u30a4\u30f3\u30d5\u30a9\u30de\u30c6\u30a3\u30af\u30b9\uff08<\/strong><strong>\u60c5\u5831\u79d1\u5b66\uff09<\/strong><\/h2>\n<p>\u81e8\u5e8a\u8a66\u9a13\u5b9f\u65bd\u4e2d\u306e\u30c7\u30fc\u30bf\u306e\u53d6\u5f97\u30fb\u7ba1\u7406\u65b9\u6cd5\u3002\u539f\u30c7\u30fc\u30bf\u3001\u30c7\u30fc\u30bf\u5165\u529b\u3001\u30af\u30a8\u30ea\u3001\u54c1\u8cea\u7ba1\u7406\u3001\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u56fa\u5b9a\u306e\u6982\u5ff5\u304a\u3088\u3073\u4fee\u6b63\u3002[\/vc_column_text][vc_tta_accordion active_section=&#8221;0&#8243; collapsible_all=&#8221;true&#8221;][vc_tta_section title=&#8221;6.1 \u81e8\u5e8a\u8a66\u9a13\u306b\u304a\u3051\u308b\u7d71\u8a08\u3068\u30a4\u30f3\u30d5\u30a9\u30de\u30c6\u30a3\u30af\u30b9\u306e\u5f79\u5272\u3068\u91cd\u8981\u6027\u3092\u8aac\u660e\u3059\u308b&#8221; tab_id=&#8221;1577736830901-380d6a1b-68a4&#8243;][vc_column_text]\n<table id=\"tablepress-138\" class=\"tablepress tablepress-id-138\">\n<thead>\n<tr class=\"row-1 odd\">\n\t<th class=\"column-1\">A.\u57fa\u790e\u30ec\u30d9\u30eb<\/th><th class=\"column-2\">B. \u4e2d\u7d1a\u30ec\u30d9\u30eb<\/th><th class=\"column-3\">C. \u4e0a\u7d1a\u30ec\u30d9\u30eb<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-hover\">\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\"><b>A1.<\/b>\u81e8\u5e8a\u8a66\u9a13\u306b\u9069\u7528\u3055\u308c\u308b\u7d71\u8a08\u3068\u30a4\u30f3\u30d5\u30a9\u30de\u30c6\u30a3\u30af\u30b9\u306e\u57fa\u672c\u7684\u306a\u76ee\u7684\u3092\u7406\u89e3\u3059\u308b\uff08\u7121\u4f5c\u70ba\u5316\u3001\u75c7\u4f8b\u6570\u3001\u6709\u5bb3\u4e8b\u8c61\u3001\u5206\u6790\u3001\u7d50\u679c\u7b49\uff09<\/td><td class=\"column-2\"><b>B1.<\/b>\u7121\u4f5c\u70ba\u5316\u3092\u5b9f\u65bd\u3057\u3001\u65b0\u898f\u306b\u767b\u9332\u3055\u308c\u305f\u88ab\u9a13\u8005\u3092\u6b63\u78ba\u306b\u9078\u5225\u3059\u308b<\/td><td class=\"column-3\"><b>C1. <\/b>\u81e8\u5e8a\u8a66\u9a13\u306e\u7d71\u8a08\u5206\u6790\u3068\u30c7\u30fc\u30bf\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u8a08\u753b\u3092\u4f5c\u6210\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\"><\/td><td class=\"column-2\"><b>B2.<\/b>\u30d7\u30ed\u30c8\u30b3\u30eb\u3067\u8a2d\u5b9a\u3055\u308c\u305f\u8ab2\u984c\uff08\u4eee\u8aac\uff09\u306b\u5fdc\u3048\u308b\u305f\u3081\u306e\u7d71\u8a08\u4e0a\u306e\u5fc5\u9808\u8981\u4ef6\u3092\u8aac\u660e\u3059\u308b<\/td><td class=\"column-3\"><\/td>\n<\/tr>\n<tr class=\"row-4 even\">\n\t<td class=\"column-1\"><b>\u4f8b\uff1a<\/b>\u30d7\u30ed\u30c8\u30b3\u30eb\u3068\u75c7\u4f8b\u5831\u544a\u66f8\u3092\u30ec\u30d3\u30e5\u30fc\u3059\u308b\u969b\u3001\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u306e\u30a8\u30f3\u30c9\u30dd\u30a4\u30f3\u30c8\u306e\u5206\u6790\u306b\u95a2\u9023\u3059\u308b\u30c7\u30fc\u30bf\u30dd\u30a4\u30f3\u30c8\u3092\u8a8d\u8b58\u3059\u308b<\/td><td class=\"column-2\"><b>\u4f8b\uff1a<\/b>\u30b9\u30bf\u30c3\u30d5\u5411\u3051\u306e\u30d7\u30ec\u30bc\u30f3\u30c6\u30fc\u30b7\u30e7\u30f3\u3067\u8a66\u9a13\u306b\u304a\u3051\u308b\u7d44\u307f\u5165\u308c\u3068\u5b89\u5168\u6027\u306e\u30c7\u30fc\u30bf\u3092\u308f\u304b\u308a\u3084\u3059\u304f\u8a18\u8f09\u3059\u308b\u305f\u3081\u3001\u8a18\u8ff0\u7d71\u8a08\u3092\u5b9f\u65bd\u3059\u308b<\/td><td class=\"column-3\"><b>\u4f8b\uff1a<\/b>\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u6cbf\u3063\u3066\u6b63\u78ba\u306a\u30c7\u30fc\u30bf\u304c\u78ba\u5b9f\u306b\u53ce\u96c6\u3067\u304d\u308b\u3088\u3046\u3001\u6cbb\u9a13\u306e\u75c7\u4f8b\u5831\u544a\u66f8\u3092\u4f5c\u6210\u3057\u3001\u8a18\u8f09\u306e\u305f\u3081\u306e\u6ce8\u91c8\u3092\u3064\u3051\u308b<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-138 from cache -->[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;6.2 \u81e8\u5e8a\u8a66\u9a13\u3092\u901a\u3057\u3066\u30c7\u30fc\u30bf\u306e\u539f\u672c\u30fb\u6d41\u308c\u30fb\u7ba1\u7406\u3092\u8aac\u660e\u3059\u308b&#8221; tab_id=&#8221;1577974806539-0730455a-2bd6&#8243;][vc_column_text]\n<table id=\"tablepress-139\" class=\"tablepress tablepress-id-139\">\n<thead>\n<tr class=\"row-1 odd\">\n\t<th class=\"column-1\">A.\u57fa\u790e\u30ec\u30d9\u30eb<\/th><th class=\"column-2\">B. \u4e2d\u7d1a\u30ec\u30d9\u30eb<\/th><th class=\"column-3\">C. \u4e0a\u7d1a\u30ec\u30d9\u30eb<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-hover\">\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\"><b>A1.<\/b>\u81e8\u5e8a\u30c7\u30fc\u30bf\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306e\u57fa\u672c\u30b3\u30f3\u30bb\u30d7\u30c8\u3092\u8aac\u660e\u3059\u308b<\/td><td class=\"column-2\"><b>B1.<\/b>\u5b9f\u65bd\u4e2d\u306e\u81e8\u5e8a\u8a66\u9a13\u306b\u304a\u3051\u308b\u30c7\u30fc\u30bf\u306e\u6d41\u308c\uff08\u65bd\u8a2d\u304b\u3089\u81e8\u5e8a\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u3078\u306e\u6d41\u308c\u3001\u81e8\u5e8a\u691c\u67fb(\u7d50\u679c)\u306e\u30a2\u30c3\u30d7\u30ed\u30fc\u30c9\u3084\u96fb\u5b50\u30ab\u30eb\u30c6\u306e\u60c5\u5831\u306e\u8ee2\u9001\u3068\u3044\u3063\u305f\u4ed6\u306e\u60c5\u5831\u6e90\u304b\u3089\u306e\u30c7\u30fc\u30bf\u306e\u6d41\u308c\u306a\u3069\uff09\u306b\u95a2\u3057\u3066\u81e8\u5e8a\u30c7\u30fc\u30bf\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u8a08\u753b\u306e\u5168\u8981\u7d20\u3092\u9069\u7528\u3059\u308b\u3002<\/td><td class=\"column-3\"><b>C1. <\/b>\u81e8\u5e8a\u8a66\u9a13\u306e\u305f\u3081\u306e\u81e8\u5e8a\u30c7\u30fc\u30bf\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u8a08\u753b\u3092\u4f5c\u6210\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\"><b>A2.<\/b>\u81e8\u5e8a\u8a66\u9a13\u306b\u5bc4\u4e0e\u3059\u308b\u69d8\u3005\u306a\u30c7\u30fc\u30bf\u306e\u60c5\u5831\u6e90\u3092\u7279\u5b9a\u3057\u3001\u30c7\u30fc\u30bf\u306e\u53d6\u308a\u6271\u3044\u3092\u5de6\u53f3\u3059\u308b\u95a2\u9023\u3059\u308b\u696d\u754c\u306e\u69d8\u3005\u306a\u57fa\u6e96\u3092\u533a\u5225\u3067\u304d\u308b<\/td><td class=\"column-2\"><b>B2.<\/b>\u30af\u30a8\u30ea\u3092\u7ba1\u7406\u3057\u3001\u81e8\u5e8a\u30c7\u30fc\u30bf\u306e\u6d41\u308c\u3068\u8cea\u304c\u3001\u81e8\u5e8a\u30c7\u30fc\u30bf\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u8a08\u753b\u304c\u5b9a\u3081\u308b\u57fa\u6e96\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u304b\u52a9\u8a00\u3059\u308b<\/td><td class=\"column-3\"><b>C2.<\/b>\u30c7\u30fc\u30bf\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d7\u30ed\u30bb\u30b9\u306b\u304a\u3051\u308b\u65b0\u6280\u8853\u307e\u305f\u306f\u696d\u754c\u5168\u4f53\u3067\u306e\u65b0\u305f\u306a\u53d6\u308a\u7d44\u307f\uff08\u30c7\u30fc\u30bf\u306e\u900f\u660e\u6027\u3068clinicaltrials.gov\u306e\u767b\u9332\u8981\u4ef6\u3001\u307e\u305f\u306f\u30c7\u30fc\u30bf\u30b7\u30a7\u30a2\u30ea\u30f3\u30b0\u306b\u3088\u308bMRCT\u306e\u65b0\u305f\u306a\u53d6\u308a\u7d44\u307f\u306a\u3069\uff09\u3092\u5c0e\u5165\u30fb\u5b9f\u65bd\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u969b\u306b\u3001\u65e2\u5b58\u306e\u6a19\u6e96\u696d\u52d9\u624b\u9806\u66f8\u3092\u5206\u6790\u3057\u6539\u8a02\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-4 even\">\n\t<td class=\"column-1\"><\/td><td class=\"column-2\"><\/td><td class=\"column-3\"><b>C3.<\/b>\u81e8\u5e8a\u7814\u7a76\u4e8b\u696d\u306e\u5168\u3066\u306e\u89b3\u70b9\u304b\u3089\u3001\u81e8\u5e8a\u30c7\u30fc\u30bf\u306e\u5b9f\u65bd\u3068\u7ba1\u7406\u306b\u95a2\u308f\u308b\u8005\u306e\u5f79\u5272\u3068\u8cac\u4efb\u306b\u3064\u3044\u3066\u6559\u80b2\u3057\u6307\u5c0e\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-5 odd\">\n\t<td class=\"column-1\"><b>\u4f8b\uff1a<\/b>\u30c7\u30fc\u30bf\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d7\u30e9\u30f3\u3067\u5b9a\u7fa9\u3055\u308c\u3066\u3044\u308b\u30d7\u30ed\u30bb\u30b9\u306e\u696d\u52d9\u30d5\u30ed\u30fc\u3068\u540c\u69d8\u306b\u76ee\u7684\u3068\u7bc4\u56f2\u3092\u7406\u89e3\u3059\u308b<\/td><td class=\"column-2\"><b>\u4f8b\uff1a<\/b>\u4e8b\u524d\u306b\u5b9a\u7fa9\u3057\u305f\u4ed5\u69d8\u306b\u57fa\u3065\u3044\u305f\u6b63\u3057\u3044\u30c7\u30fc\u30bf\u306e\u8ee2\u9001\u3092\u78ba\u5b9f\u306b\u5b9f\u884c\u3059\u308b\u305f\u3081\u306b\u3001\u69d8\u3005\u306a\u60c5\u5831\u6e90(\u96fb\u5b50\u7684\u306a\u539f\u8cc7\u6599\u3001\u7b2c\u4e09\u8005\u306e\u60c5\u5831\u6e90\u306a\u3069)\u304b\u3089\u306e\u30c7\u30fc\u30bf\u306e\u6d41\u308c\u3092\u78ba\u8a8d\u3059\u308b<\/td><td class=\"column-3\"><b>\u4f8b\uff1a<\/b>\u30c7\u30fc\u30bf\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d7\u30ed\u30bb\u30b9\u3068\u305d\u306e\u30d7\u30ed\u30bb\u30b9\u306b\u304a\u3051\u308b\u8cac\u4efb\u533b\u5e2b\u30fb\u65bd\u8a2d\u305d\u308c\u305e\u308c\u306e\u5f79\u5272\u3092\u78ba\u8a8d\u3059\u308b\u305f\u3081\u306e\u4f1a\u8b70\u306b\u53c2\u52a0\u3059\u308b<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-139 from cache -->[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;6.3 \u30c7\u30fc\u30bf\u306e\u53ce\u96c6\u3001\u4fdd\u5b58\u3001\u7ba1\u7406\u3001\u5206\u6790\u3001\u5831\u544a\u306e\u6a19\u6e96\u5316\u306b\u5fc5\u8981\u306a\u30ea\u30bd\u30fc\u30b9\u3068\u6700\u826f\u306e\u65b9\u6cd5\u3092\u8aac\u660e\u3059\u308b&#8221; tab_id=&#8221;1577976002725-780509b9-1cb5&#8243;][vc_column_text]\n<table id=\"tablepress-140\" class=\"tablepress tablepress-id-140\">\n<thead>\n<tr class=\"row-1 odd\">\n\t<th class=\"column-1\">A.\u57fa\u790e\u30ec\u30d9\u30eb<\/th><th class=\"column-2\">B. \u4e2d\u7d1a\u30ec\u30d9\u30eb<\/th><th class=\"column-3\">C. \u4e0a\u7d1a\u30ec\u30d9\u30eb<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-hover\">\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\"><b>A1.<\/b>\u81e8\u5e8a\u8a66\u9a13\u306e\u30c7\u30fc\u30bf\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306b\u95a2\u3059\u308b\u6a19\u6e96\u7684\u306a\u65b9\u6cd5\u3068(\u3088\u308a\u52b9\u7387\u306e\u826f\u3044)\u6700\u826f\u306e\u65b9\u6cd5\u3092\u7279\u5b9a\u3057\u9069\u7528\u3059\u308b<\/td><td class=\"column-2\"><b>B1.<\/b>\u81e8\u5e8a\u8a66\u9a13\u306e\u30c7\u30fc\u30bf\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306e\u305f\u3081\u306e\u3001\u696d\u754c\u30fb\u9023\u90a6\u30fbGCP\u3067\u8a8d\u3081\u3089\u308c\u3066\u3044\u308b\u6a19\u6e96\u7684\u306a\u65b9\u6cd5\u3068\u6700\u826f\u306e\u65b9\u6cd5\u3092\u5b9f\u65bd\u3059\u308b<\/td><td class=\"column-3\"><b>C1. <\/b>\u696d\u754c\u3068\u3057\u3066\u8a8d\u3081\u3089\u308c\u3066\u3044\u308b\u57fa\u6e96\u3001\u307e\u305f\u306f\u6700\u826f\u306e\u65b9\u6cd5\u3092\u9069\u7528\u3057\u305f\u30c7\u30fc\u30bf\u53ce\u96c6\u30fb\u4fdd\u5b58\u30fb\u7ba1\u7406\u30fb\u5206\u6790\u30fb\u5831\u544a\u306e\u6a19\u6e96\u8a08\u753b\u3092\u542b\u3080\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u305f\u3081\u306e\u30c7\u30fc\u30bf\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u8a08\u753b\u3092\u4f5c\u6210\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\"><b>A2.<\/b>\u81e8\u5e8a\u8a66\u9a13\u306b\u304a\u3051\u308b\u30c7\u30fc\u30bf\u53ce\u96c6\u3001\u4fdd\u5b58\u3001\u7ba1\u7406\u3001\u5206\u6790\u3001\u5831\u544a\u306b\u95a2\u3059\u308b\u6a19\u6e96\u7684\u306a\u65b9\u6cd5\u3068\u6700\u826f\u306e\u65b9\u6cd5\u306b\u95a2\u9023\u3059\u308b\u6587\u66f8\u3084\u30ea\u30bd\u30fc\u30b9\u3092\u7279\u5b9a\u3059\u308b<\/td><td class=\"column-2\"><b>B2.<\/b>\u30d7\u30ed\u30c8\u30b3\u30eb\u6bce\u306e\u539f\u8cc7\u6599\u306e\u4f5c\u6210\u304b\u3089\u30c7\u30fc\u30bf\u306e\u53ce\u96c6\u30fb\u5165\u529b\u3001\u54c1\u8cea\u76e3\u67fb\u306e\u5b9f\u65bd\u307e\u3067\u3001\u81e8\u5e8a\u8a66\u9a13\u5168\u4f53\u306b\u304a\u3051\u308b\u30c7\u30fc\u30bf\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u3092\u5b9f\u65bd\u3059\u308b<\/td><td class=\"column-3\"><\/td>\n<\/tr>\n<tr class=\"row-4 even\">\n\t<td class=\"column-1\"><b>\u4f8b\uff1a<\/b>\u6a19\u6e96\u5316\u3055\u308c\u305f\u72b6\u6cc1\u306b\u304a\u3044\u3066(\u30c7\u30fc\u30bf\u306e\u53ce\u96c6\u3001\u8a18\u9332\u3001\u7ba1\u7406\u3001\u5206\u6790\u3001\u5831\u544a\u306b\u95a2\u3057\u3066)\u6a19\u6e96\u7684\u306a\u53c8\u306f\u6700\u826f\u306e\u65b9\u6cd5\u3092\u8b58\u5225\u3067\u304d\u308b<\/td><td class=\"column-2\"><b>\u4f8b\uff1a<\/b>\u30c7\u30fc\u30bf\u3092\u53ce\u96c6\u3057\u3001\u65b0\u898f\u306e\u96fb\u5b50\u7684\u306a\u30c7\u30fc\u30bf\u5165\u529b\u30d5\u30a9\u30fc\u30e0\u306b\u3001\u30bf\u30a4\u30e0\u30ea\u30fc\u30fb\u6b63\u78ba\u306b\u5165\u529b\u3057\u3001\u304b\u3064\u30af\u30a8\u30ea\u306e\u767a\u751f\u7387\u304c\u4f4e\u3044\u72b6\u6cc1\u3092\u4f5c\u308b\u3053\u3068\u304c\u3067\u304d\u308b<\/td><td class=\"column-3\"><b>\u4f8b\uff1a<\/b>\u7279\u5b9a\u306e\u8a66\u9a13\u306b\u3064\u3044\u3066\u3001\u30c7\u30fc\u30bf\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u8a08\u753b\u306b\u5f93\u3063\u3066CRF\u3068\u8a18\u8f09\u306e\u305f\u3081\u306e\u6ce8\u91c8\u3092\u4f5c\u6210\u3059\u308b<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-140 from cache -->[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;6.4 \u30c7\u30fc\u30bf\u306e\u54c1\u8cea\u3092\u4fdd\u8a3c\u3059\u308b\u305f\u3081\u306e\u30d7\u30ed\u30bb\u30b9\u3092\u8aac\u660e\u3001\u4f5c\u6210\u3001\u5b9f\u65bd\u3059\u308b&#8221; tab_id=&#8221;1577976516307-413b75bf-8e99&#8243;][vc_column_text]\n<table id=\"tablepress-141\" class=\"tablepress tablepress-id-141\">\n<thead>\n<tr class=\"row-1 odd\">\n\t<th class=\"column-1\">A.\u57fa\u790e\u30ec\u30d9\u30eb<\/th><th class=\"column-2\">B. \u4e2d\u7d1a\u30ec\u30d9\u30eb<\/th><th class=\"column-3\">C. \u4e0a\u7d1a\u30ec\u30d9\u30eb<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-hover\">\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\"><b>A1.<\/b>\u30c7\u30fc\u30bf\u306e\u54c1\u8cea\u3092\u4fdd\u8a3c\u3059\u308b\u305f\u3081\u306e\u30d7\u30ed\u30bb\u30b9\u3092\u7279\u5b9a\u3057\u7406\u89e3\u3059\u308b<\/td><td class=\"column-2\"><b>B1.<\/b>\u30c7\u30fc\u30bf\u306e\u54c1\u8cea\u95a2\u9023\u306e\u6a19\u6e96\u696d\u52d9\u624b\u9806\u66f8\u3092\u78ba\u5b9f\u306b\u9075\u5b88\u3059\u308b<\/td><td class=\"column-3\"><b>C1. <\/b>\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u306b\u304a\u3051\u308b\u3001\u30c7\u30fc\u30bf\u306e\u54c1\u8cea\u306b\u95a2\u9023\u3059\u308b\u6a19\u6e96\u696d\u52d9\u624b\u9806\u66f8\u3001\u307e\u305f\u306f\u8a66\u9a13\u306b\u7279\u5316\u3057\u305f\u624b\u9806\u66f8\u3092\u4f5c\u6210\u30fb\u5b9a\u7fa9\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\"><b>A2.<\/b>\u81e8\u5e8a\u8a66\u9a13\u3067\u96c6\u3081\u305f\u500b\u3005\u306e\u30c7\u30fc\u30bf\u306e\u5e30\u5c5e\u53ef\u80fd\u6027\u3001\u6b63\u78ba\u6027\u3001\u5b8c\u5168\u6027\u3001\u539f\u30c7\u30fc\u30bf\u304b\u3089\u306e\u691c\u8a3c\u6027\u3092\u8a8d\u8b58\u3059\u308b<\/td><td class=\"column-2\"><b>B2.<\/b>\u30c7\u30fc\u30bf\u306e\u54c1\u8cea\u3068\u95a2\u9023\u3059\u308b\u30d7\u30ed\u30bb\u30b9\u306b\u95a2\u3057\u3066\u3001\u7a4d\u6975\u7684\u30fb\u53d7\u52d5\u7684\u306b\u610f\u898b\u3092\u8ff0\u3079\u3001\u81ea\u5206\u306e\u8003\u3048\u3084\u77e5\u898b\u3092\u4e3b\u4f53\u7684\u304b\u3064\u5354\u8abf\u6027\u3092\u3082\u3063\u3066\u5171\u6709\u3059\u308b<\/td><td class=\"column-3\"><b>C2.<\/b>\u81e8\u5e8a\u8a66\u9a13\u30c1\u30fc\u30e0\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u30c7\u30fc\u30bf\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u95a2\u4fc2\u306e\u30d7\u30ed\u30bb\u30b9\u306b\u3064\u3044\u3066\u30c7\u30fc\u30bf\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30c1\u30fc\u30e0\u306b\u52a9\u8a00\u3057\u3001\u5186\u6ed1\u3067\u5efa\u8a2d\u7684\u306a\u5354\u529b\u95a2\u4fc2\u30fb\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u3092\u7bc9\u304f<\/td>\n<\/tr>\n<tr class=\"row-4 even\">\n\t<td class=\"column-1\"><\/td><td class=\"column-2\"><\/td><td class=\"column-3\"><b>C3.<\/b>\u30c7\u30fc\u30bf\u54c1\u8cea\u95a2\u9023\u306e\u624b\u9806\u306b\u3064\u3044\u3066\u8a66\u9a13\u30b9\u30bf\u30c3\u30d5\u3092\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u3057\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u9055\u53cd\u306e\u7591\u3044\u3084\u30ea\u30b9\u30af\u304c\u3042\u308b\u969b\u306b\u306f\u76e3\u7763\u3057\u3001\u30b5\u30dd\u30fc\u30c8\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-5 odd\">\n\t<td class=\"column-1\"><b>\u4f8b\uff1a<\/b>\u539f\u8cc7\u6599\u304b\u3089\u96fb\u5b50\u7684\u306a\u30c7\u30fc\u30bf\u53ce\u96c6\u30d5\u30a9\u30fc\u30e0\u306b\u30c7\u30fc\u30bf\u3092\u5165\u529b\u3057\u3001\u4fee\u6b63\u3059\u308b<\/td><td class=\"column-2\"><b>\u4f8b\uff1a<\/b>\u30af\u30a8\u30ea\u306e\u518d\u767a\u3092\u9632\u3050\u305f\u3081\u3001eCRF(\u96fb\u5b50\u7684\u75c7\u4f8b\u5831\u544a\u66f8)\u306e\u30c7\u30b6\u30a4\u30f3\u5909\u66f4\u3092\u6cbb\u9a13\u4f9d\u983c\u8005\u306b\u63d0\u6848\u3059\u308b<\/td><td class=\"column-3\"><b>\u4f8b\uff1a<\/b>\u65bd\u8a2d\u3084\u4f01\u696d\u304c\u5b9a\u7fa9\u3059\u308b\u30c7\u30fc\u30bf\u306e\u8cea\u306e\u6a19\u6e96\u5316\u306b\u6e96\u62e0\u3059\u308b\u3088\u3046\u3001eCRF\u3092\u4f5c\u6210\u3059\u308b<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-141 from cache -->[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Section 2&#8243; tab_id=&#8221;1577736830936-66e97ee9-f49a&#8221;][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row][vc_row][vc_column width=&#8221;1\/6&#8243;][vc_single_image image=&#8221;321&#8243;][\/vc_column][vc_column width=&#8221;5\/6&#8243;][vc_column_text el_id=&#8221;domain7&#8243;]<\/p>\n<h2><strong>\u30ea\u30fc\u30c0\u30fc\u30b7\u30c3\u30d7\u3068\u5c02\u9580\u6027<\/strong><\/h2>\n<p>\u81e8\u5e8a\u7814\u7a76\u306b\u304a\u3051\u308b\u30ea\u30fc\u30c0\u30fc\u30b7\u30c3\u30d7\u304a\u3088\u3073\u5c02\u9580\u6027\u306e\u539f\u5247\u3068\u5b9f\u8df5\u3002[\/vc_column_text][vc_tta_accordion active_section=&#8221;0&#8243; collapsible_all=&#8221;true&#8221;][vc_tta_section title=&#8221;7.1\u81e8\u5e8a\u8a66\u9a13\u306b\u304a\u3051\u308b\u3001\u30ea\u30fc\u30c0\u30fc\u30b7\u30c3\u30d7\u3001\u7ba1\u7406\u3001\u6307\u5c0e\u306e\u539f\u5247\u3068\u5b9f\u8df5\u306b\u3064\u3044\u3066\u8aac\u660e\u3057\u9069\u7528\u3059\u308b&#8221; tab_id=&#8221;1577976795762-fad34ec9-ca5f&#8221;][vc_column_text]\n<table id=\"tablepress-142\" class=\"tablepress tablepress-id-142\">\n<thead>\n<tr class=\"row-1 odd\">\n\t<th class=\"column-1\">A.\u57fa\u790e\u30ec\u30d9\u30eb<\/th><th class=\"column-2\">B. \u4e2d\u7d1a\u30ec\u30d9\u30eb<\/th><th class=\"column-3\">C. \u4e0a\u7d1a\u30ec\u30d9\u30eb<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-hover\">\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\"><b>A1.<\/b>. \u8077\u5834\u306b\u304a\u3044\u3066\u3001\u8eab\u3060\u3057\u306a\u307f\u30fb\u614b\u5ea6\u30fb\u8077\u52d9\u502b\u7406\u30fb\u88fd\u54c1\u306e\u54c1\u8cea\u306b\u5bfe\u3059\u308b\u5c02\u9580\u5bb6\u3068\u3057\u3066\u306e\u614b\u5ea6\u3092\u793a\u3059<\/td><td class=\"column-2\"><b>B1.<\/b>\u52b9\u679c\u7684\u306a\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u624b\u6bb5\u3068\u6587\u66f8\u3092\u4f7f\u7528\u3057\u3001\u8a66\u9a13\u7ba1\u7406\u306e\u69d8\u3005\u306a\u5074\u9762\u306b\u304a\u3044\u3066\u3057\u3066\u30b5\u30dd\u30fc\u30c8\u3059\u308b<\/td><td class=\"column-3\"><b>C1. <\/b>\u7814\u7a76\u90e8\u9580\u306b\u304a\u3051\u308b\u30ea\u30fc\u30c0\u30fc\u306e\u5f79\u5272\u3092\u62c5\u3046<\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\"><b>A2.<\/b>\u7d44\u7e54\u306e\u30ea\u30fc\u30c0\u30fc\u30b7\u30c3\u30d7\u306e\u4f53\u5236\u3092\u7279\u5b9a\u3059\u308b<\/td><td class=\"column-2\"><b>B2.<\/b>\u57fa\u790e\u30ec\u30d9\u30eb\u306e\u30b9\u30bf\u30c3\u30d5\u306e\u7814\u4fee\u3092\u884c\u3044\u3001\u76e3\u7763\u3059\u308b<\/td><td class=\"column-3\"><b>C2.<\/b>\u65b0\u3057\u3044\u30b9\u30bf\u30c3\u30d5\u3068\u30c1\u30fc\u30e0\u30e1\u30f3\u30d0\u30fc\u306b\u7814\u4fee\u3092\u884c\u3044\u3001\u6307\u5c0e\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-4 even\">\n\t<td class=\"column-1\"><b>A3.<\/b>\u7814\u7a76\u90e8\u9580\u306e\u6a19\u6e96\u696d\u52d9\u624b\u9806\u66f8\u3092\u793a\u3057\u3001\u7406\u89e3\u3057\u3001\u9806\u5b88\u3059\u308b<\/td><td class=\"column-2\"><b>B3.<\/b>\u8907\u6570\u306e\u7814\u7a76\u95a2\u9023\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3092\u7ba1\u7406\u3059\u308b\u969b\u306b\u52b9\u679c\u7684\u306a\u6642\u9593\u7ba1\u7406\u3068\u512a\u5148\u9806\u4f4d\u4ed8\u3051\u306b\u3088\u3063\u3066\u7d44\u7e54\u3092\u307e\u3068\u3081\u308b\u80fd\u529b\u3092\u793a\u3059<\/td><td class=\"column-3\"><b>C3.<\/b>\u8907\u6570\u306e\u8907\u96d1\u306a\u7814\u7a76\u696d\u52d9\u3092\u7ba1\u7406\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-5 odd\">\n\t<td class=\"column-1\"><b>A4.<\/b>\u7814\u7a76\u306e\u8077\u52d9\u3092\u5b9f\u65bd\u3059\u308b\u969b\u3001\u81ea\u767a\u6027\u3068\u30c1\u30fc\u30e0\u3078\u306e\u5354\u8abf\u6027\u3092\u793a\u3059<\/td><td class=\"column-2\"><\/td><td class=\"column-3\"><b>C4.<\/b>\u8a66\u9a13\u306e\u6226\u7565\u7684\u306a\u8a08\u753b\u306e\u76ee\u6a19\u30fb\u76ee\u7684\u3092\u8a2d\u5b9a\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-6 even\">\n\t<td class=\"column-1\"><b>\u4f8b\uff1a<\/b>\u6642\u9593\u901a\u308a\u306b\u51fa\u52e4\u3057\u3001\u53e3\u982d\u53ca\u3073\u6587\u66f8\u306e\u4e21\u65b9\u3067\u7c21\u6f54\u30fb\u9069\u5207\u306a\u65b9\u6cd5\u3067\u60c5\u5831\u3092\u660e\u78ba\u306b\u8ff0\u3079\u3001\u8cea\u554f\u304c\u3042\u308b\u3068\u304d\u306b\u306f\u6307\u793a\u3084\u6307\u5c0e\u3092\u4ef0\u3050<\/td><td class=\"column-2\"><b>\u4f8b\uff1a<\/b>\u30d7\u30ed\u30c8\u30b3\u30eb\u5b9f\u65bd\u306e\u305f\u3081\u306e\u4f1a\u8b70\u3092\u8a08\u753b\u30fb\u5b9f\u65bd\u3059\u308b<\/td><td class=\"column-3\"><b>\u4f8b\uff1a<\/b>\u8a66\u9a13\u30c1\u30fc\u30e0\u3092\u7ba1\u7406\u3057\u3001\u4e88\u7b97\u3092\u7acb\u3066\u3001\u81e8\u5e8a\u7814\u7a76\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306e\u5951\u7d04\u7de0\u7d50\u3092\u624b\u52a9\u3051\u3059\u308b<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-142 from cache -->[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;7.2 \u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u306b\u95a2\u308f\u308b\u502b\u7406\u9762\u3068\u79d1\u5b66\u6027\u306e\u5bfe\u7acb\u3092\u7279\u5b9a\u3057\u3001\u305d\u306e\u767a\u751f\u3092\u4e88\u9632\u307e\u305f\u306f\u7ba1\u7406\u3059\u308b\u305f\u3081\u306e\u624b\u9806\u3092\u5b9f\u8df5\u3059\u308b&#8221; tab_id=&#8221;1577977181751-d3f94694-e8c1&#8243;][vc_column_text]\n<table id=\"tablepress-143\" class=\"tablepress tablepress-id-143\">\n<thead>\n<tr class=\"row-1 odd\">\n\t<th class=\"column-1\">A.\u57fa\u790e\u30ec\u30d9\u30eb<\/th><th class=\"column-2\">B. \u4e2d\u7d1a\u30ec\u30d9\u30eb<\/th><th class=\"column-3\">C. \u4e0a\u7d1a\u30ec\u30d9\u30eb<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-hover\">\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\"><b>A1.<\/b>\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u306b\u304a\u3051\u308b\u502b\u7406\u9762\u3068\u79d1\u5b66\u6027\u306e\u5bfe\u7acb\u306e\u672c\u8cea\u3068\u3001\u904e\u53bb\u306b\u8d77\u304d\u305f\u4e8b\u4f8b\u3092\u8aac\u660e\u3059\u308b<\/td><td class=\"column-2\"><b>B1.<\/b>\u81e8\u5e8a\u8a66\u9a13\u306b\u304a\u3044\u3066\u502b\u7406\u9762\u3068\u79d1\u5b66\u6027\u306e\u5bfe\u7acb\u306e\u30ea\u30b9\u30af\u3092\u6700\u5c0f\u5316\u3059\u308b\u305f\u3081\u306e\u624b\u9806\u3092\u8a8d\u8b58\u30fb\u5b9f\u65bd\u30fb\u7ba1\u7406\u3059\u308b<\/td><td class=\"column-3\"><b>C1. <\/b>\u81e8\u5e8a\u8a66\u9a13\u306b\u5185\u5728\u3059\u308b\u502b\u7406\u9762\u3068\u79d1\u5b66\u6027\u306e\u5bfe\u7acb\u306e\u30ea\u30b9\u30af\u3092\u8a55\u4fa1\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\"><b>A2.<\/b>\u502b\u7406\u9762\u3067\u306e\u885d\u7a81\u3092\u9632\u304e\u3001\u30ea\u30b9\u30af\u7ba1\u7406\u6226\u7565\u3092\u30b5\u30dd\u30fc\u30c8\u3059\u308b\u305f\u3081\u306b\u5b9f\u65bd\u3055\u308c\u3066\u3044\u308b\u624b\u9806\u3092\u8aac\u660e\u3059\u308b<\/td><td class=\"column-2\"><b>B2.<\/b>\u5f79\u5272\u306b\u5fdc\u3058\u305f\u8cac\u4efb\u7bc4\u56f2\u306b\u304a\u3044\u3066\u30ea\u30b9\u30af\u7ba1\u7406\u6226\u7565\u3092\u5b9f\u8df5\u3059\u308b<\/td><td class=\"column-3\"><b>C2.<\/b>\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u30c1\u30fc\u30e0\u3068\u6a5f\u80fd\u7684\u9818\u57df\u5168\u822c\u306b\u304a\u3044\u3066\u3001\u502b\u7406\u9762\u3068\u79d1\u5b66\u6027\u306e\u5bfe\u7acb\u306e\u30ea\u30b9\u30af\u3092\u7ba1\u7406\u3059\u308b\u305f\u3081\u306b\u5b9f\u65bd\u3059\u308b\u6226\u7565\u3068\u30dd\u30ea\u30b7\u30fc\u3092\u4f5c\u6210\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-4 even\">\n\t<td class=\"column-1\"><b>\u4f8b\uff1a<\/b>\u6b74\u53f2\u7684\u306a\u6587\u66f8(\u30cb\u30e5\u30eb\u30f3\u30d9\u30eb\u30af\u7db1\u9818\u3001\u30d8\u30eb\u30b7\u30f3\u30ad\u5ba3\u8a00\u3001CIOMS\uff1a\u4eba\u3092\u5bfe\u8c61\u3068\u3059\u308b\u7814\u7a76\u306b\u304a\u3051\u308b\u56fd\u969b\u502b\u7406\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3)\u306b\u304a\u3051\u308b\u7814\u7a76\u502b\u7406\u306b\u95a2\u3059\u308b\u6982\u5ff5\u304c\u3069\u306e\u3088\u3046\u306b\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u7d44\u307f\u8fbc\u307e\u308c\u3066\u3044\u308b\u304b\u3092\u8aac\u660e\u3059\u308b<\/td><td class=\"column-2\"><b>\u4f8b\uff1a<\/b>\u81e8\u5e8a\u8a66\u9a13\u306e\u6b63\u78ba\u6027\u306b\u5bfe\u3059\u308b\u502b\u7406\u9762\u30fb\u79d1\u5b66\u6027\u306e\u30ea\u30b9\u30af\u3092\u4f4e\u6e1b\u3059\u308b\u65b9\u6cd5\u3067\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u542b\u307e\u308c\u308b\u5b9f\u65bd\u4e8b\u9805(\u88ab\u9a13\u8005\u52df\u96c6\u6226\u7565\u3084\u540c\u610f\u8aac\u660e\u306a\u3069)\u3092\u6574\u7406\u30fb\u5b9f\u65bd\u3059\u308b\u3068\u3068\u3082\u306b\u3001\u8a66\u9a13\u30c1\u30fc\u30e0\u306e\u30ea\u30b9\u30af\u7ba1\u7406\u306e\u8a08\u753b\u306b\u53c2\u753b\u3059\u308b<\/td><td class=\"column-3\"><b>\u4f8b\uff1a<\/b>\u81e8\u5e8a\u7814\u7a76\u30fb\u8a66\u9a13\u306e\u5b9f\u65bd\u306b\u3042\u305f\u308a\u5b58\u5728\u3059\u308b(\u502b\u7406\u9762\u30fb\u79d1\u5b66\u6027\u4e21\u65b9\u306e)\u6f5c\u5728\u7684\u306a\u30ea\u30b9\u30af\u3092\u660e\u78ba\u306b\u8ff0\u3079\u3001\u90e8\u7f72\u307e\u305f\u306f\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u30c1\u30fc\u30e0\u3067\u306e\u30ea\u30b9\u30af\u7ba1\u7406\u8a08\u753b\u3092\u4f5c\u6210\u3059\u308b<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-143 from cache -->[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;7.3 \u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u306b\u9069\u7528\u3055\u308c\u308b\u5c02\u9580\u7684\u306a\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3068\u502b\u7406\u898f\u5b9a\u3092\u7279\u5b9a\u3057\u9069\u7528\u3059\u308b&#8221; tab_id=&#8221;1577977636508-b232c270-bd9e&#8221;][vc_column_text]\n<table id=\"tablepress-144\" class=\"tablepress tablepress-id-144\">\n<thead>\n<tr class=\"row-1 odd\">\n\t<th class=\"column-1\">A.\u57fa\u790e\u30ec\u30d9\u30eb<\/th><th class=\"column-2\">B. \u4e2d\u7d1a\u30ec\u30d9\u30eb<\/th><th class=\"column-3\">C. \u4e0a\u7d1a\u30ec\u30d9\u30eb<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-hover\">\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\"><b>A1.<\/b>\u81e8\u5e8a\u8a66\u9a13\u304c\u502b\u7406\u7684\u304b\u3064\u79d1\u5b66\u7684\u306b\u5b9f\u65bd\u3055\u308c\u308b\u305f\u3081\u306e\u898f\u5236\u306e\u57fa\u76e4\u3068\u306a\u308b\u91cd\u8981\u306a\u6587\u66f8\u3092\u8a8d\u8b58\u3059\u308b<\/td><td class=\"column-2\"><b>B1.<\/b>\u81e8\u5e8a\u8a66\u9a13\u306e\u5168\u3066\u306e\u5074\u9762\u306b\u5c02\u9580\u7684\u30fb\u502b\u7406\u7684\u898f\u5236\u3068\u56fd\u969b\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u9069\u7528\u3059\u308b<\/td><td class=\"column-3\"><b>C1. <\/b>\u7d44\u7e54\u306e\u502b\u7406\u898f\u5b9a\u304c\u78ba\u5b9f\u306b\u56fd\u306e\u6cd5\u30fb\u898f\u5236\u304a\u3088\u3073\uff0f\u307e\u305f\u306f\u56fd\u969b\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u6e96\u3058\u305f\u3082\u306e\u3068\u306a\u308b\u3088\u3046\u306b\u3001\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u5185\u90e8\u30dd\u30ea\u30b7\u30fc\u3084\u624b\u9806\u3092\u8a55\u4fa1\u3057\u6539\u8a02\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\"><b>A2.<\/b>\u81e8\u5e8a\u8a66\u9a13\u306e\u502b\u7406\u898f\u5b9a\u3092\u793a\u3059\u9023\u90a6\u898f\u5236\u3068\u56fd\u969b\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u8a18\u3055\u308c\u308b\u3001\u502b\u7406\u7684\u306a\u3001\u5c02\u9580\u5bb6\u3068\u3057\u3066\u306e\u884c\u52d5\u306e\u610f\u5473\u3092\u7279\u5b9a\u3057\u7406\u89e3\u3059\u308b<\/td><td class=\"column-2\"><b>B2.<\/b>\u81e8\u5e8a\u7814\u7a76\u671f\u9593\u3092\u901a\u3057\u3066\u5c02\u9580\u6027\u3092\u767a\u63ee\u3057\u3001\u502b\u7406\u9762\u306b\u914d\u616e\u3057\u305f\u5b9f\u65bd\u304c\u306a\u3055\u308c\u308b\u70ba\u306b\u3001\u9069\u5207\u306a\u624b\u9806\u3084\u30d7\u30ed\u30bb\u30b9\u304c\u5fc5\u8981\u3067\u3042\u308b\u4e8b\u3092\u884c\u52d5\u3084\u6587\u66f8\u306b\u3088\u3063\u3066\u793a\u3059<\/td><td class=\"column-3\"><b>C2.<\/b>\u81e8\u5e8a\u8a66\u9a13\u306e\u5168\u5074\u9762\u304c\u502b\u7406\u898f\u5b9a\u306e\u7bc4\u56f2\u5185\u3067\u5b9f\u65bd\u3055\u308c\u308b\u305f\u3081\u306e\u5185\u90e8\u30d7\u30ed\u30bb\u30b9\u3084\u624b\u9806\u306b\u95a2\u3057\u3001\u95a2\u308f\u308b\u8a66\u9a13\u30c1\u30fc\u30e0\u3068\u30b9\u30bf\u30c3\u30d5\u3092\u6559\u80b2\u3057\u3001\u6307\u5c0e\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-4 even\">\n\t<td class=\"column-1\"><b>\u4f8b\uff1a<\/b>FDA\u3084ICH\u306e\u6587\u66f8\u306e\u4e2d\u3067\u81e8\u5e8a\u8a66\u9a13\u306e\u502b\u7406\u7684\u306a\u5b9f\u65bd\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306e\u4e3b\u8981\u306a\u898f\u5236\u3084\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u7279\u5b9a\u3059\u308b<\/td><td class=\"column-2\"><b>\u4f8b\uff1a<\/b>\u65e5\u3005\u306e\u696d\u52d9\u3084\u4f5c\u696d\u306e\u4e2d\u3067\u3001\u5168\u3066\u306e\u78ba\u7acb\u3055\u308c\u305f\u30d7\u30ed\u30bb\u30b9\u3084\u624b\u9806\u3001\u898f\u5236\u3001\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306e\u9069\u7528\u3092\u901a\u3057\u3066\u5c02\u9580\u7684\u306a\u632f\u308b\u821e\u3044\u3084\u502b\u7406\u9762\u3067\u306e\u4e00\u8cab\u6027\u3092\u793a\u3059<\/td><td class=\"column-3\"><b>\u4f8b\uff1a<\/b>\u65b0\u898f\u3042\u308b\u3044\u306f\u6539\u8a02\u3055\u308c\u305f\u3059\u3079\u3066\u306e\u898f\u5236\u3084\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u53cd\u6620\u3059\u308b\u305f\u3081\u306b\u78ba\u7acb\u3057\u305f\u624b\u9806\u3084\u30d7\u30ed\u30bb\u30b9\u3001\u4f5c\u696d\u30d5\u30ed\u30fc(\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u6587\u66f8\u306a\u3069)\u3092\u63a1\u7528\u3057\u3001\u3059\u3079\u3066\u306e\u56fd\u30fb\u5730\u57df\u5225\u3042\u308b\u3044\u306f\u56fd\u969b\u7684\u306a\u898f\u5236\u3084\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u304c\u78ba\u5b9f\u306b\u6a19\u6e96\u696d\u52d9\u624b\u9806\u66f8\u3084\u30d7\u30ed\u30bb\u30b9\u306b\u53cd\u6620\u3055\u308c\u308b\u3088\u3046\u306b\u3059\u308b<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-144 from cache -->[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;7.4 \u81e8\u5e8a\u8a66\u9a13\u306e\u30c7\u30b6\u30a4\u30f3\u304a\u3088\u3073\u5b9f\u65bd\u306b\u3001\u5730\u57df\u306e\u591a\u69d8\u6027\u304c\u4e0e\u3048\u308b\u5f71\u97ff\u3092\u8aac\u660e\u3057\u3001\u7570\u306a\u308b\u6587\u5316\u3092\u6301\u3064\u4eba\u540c\u58eb\u306e\u95a2\u4fc2\u6027\u3092\u7406\u89e3\u3059\u308b\u80fd\u529b\u3092\u793a\u3059&#8221; tab_id=&#8221;1577977827452-6762711a-ec4a&#8221;][vc_column_text]\n<table id=\"tablepress-145\" class=\"tablepress tablepress-id-145\">\n<thead>\n<tr class=\"row-1 odd\">\n\t<th class=\"column-1\">A.\u57fa\u790e\u30ec\u30d9\u30eb<\/th><th class=\"column-2\">B. \u4e2d\u7d1a\u30ec\u30d9\u30eb<\/th><th class=\"column-3\">C. \u4e0a\u7d1a\u30ec\u30d9\u30eb<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-hover\">\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\"><b>A1.<\/b>\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u306b\u969b\u3057\u3001\u5730\u57df\u7684\u30fb\u6587\u5316\u7684\u591a\u69d8\u6027\u3092\u52a0\u5473\u3057\u305f\u6226\u7565\u3092\u53d6\u308a\u5165\u308c\u308b\u3053\u3068\u306e\u91cd\u8981\u6027\u306b\u3064\u3044\u3066\u8aac\u660e\u3059\u308b<\/td><td class=\"column-2\"><b>B1.<\/b>\u8a66\u9a13\u3092\u30c7\u30b6\u30a4\u30f3\u30fb\u5b9f\u65bd\u3059\u308b\u969b\u306b\u3001\u5730\u57df\u30fb\u56fd\u304a\u3088\u3073\u6587\u5316\u7684\u306b\u8003\u616e\u3059\u3079\u304d\u3053\u3068\u3092\u9069\u7528\u3059\u308b<\/td><td class=\"column-3\"><b>C1. <\/b>\u8907\u6570\u306e\u56fd\u3084\u5730\u57df\u3067\u8a66\u9a13\u3092\u5b9f\u65bd\u30fb\u30c7\u30b6\u30a4\u30f3\u3059\u308b\u5834\u5408\u306b\u3001\u6587\u5316\u304a\u3088\u3073\u5730\u57df\u30fb\u56fd\u3092\u8003\u616e\u3059\u308b\u305f\u3081\u306e\u6226\u7565\u3084\u65b9\u6cd5\u3092\u7acb\u6848\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\"><b>A2.<\/b>\u591a\u69d8\u6027\u307e\u305f\u306f\u7570\u306a\u308b\u6587\u5316\u3092\u6301\u3064\u4eba\u540c\u58eb\u306e\u95a2\u4fc2\u6027\u3092\u7406\u89e3\u3059\u308b\u80fd\u529b(cultural competency)\u304c\u6f5c\u5728\u7684\u306b\u4e0e\u3048\u3046\u308b\u5f71\u97ff\u306e\u4f8b\u3092\u5206\u985e\u3059\u308b<\/td><td class=\"column-2\"><b>B2.<\/b>\u56fd\u969b\u5171\u540c\u8a66\u9a13\u306e\u5b9f\u65bd\u306b\u304a\u3044\u3066\u3001\u9069\u5207\u306a\u898f\u5236\u306e\u5fc5\u9808\u8981\u4ef6\u3092\u7d44\u307f\u8fbc\u3080<\/td><td class=\"column-3\"><b>C2.<\/b>\u56fd\u969b\u5171\u540c\u8a66\u9a13\u306e\u8a66\u9a13\u30c7\u30b6\u30a4\u30f3\u306b\u3001\u95a2\u9023\u898f\u5236\u306e\u5fc5\u9808\u8981\u4ef6\u304c\u7d44\u307f\u8fbc\u307e\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u7acb\u8a3c\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-4 even\">\n\t<td class=\"column-1\"><b>\u4f8b\uff1a<\/b>\u591a\u69d8\u6027(\u5e74\u9f62\u3001\u6c11\u65cf\u6027\u3001\u4eba\u7a2e\u3001\u6027\u5225\u3084\u5b97\u6559)\u306e\u3042\u308b\u88ab\u9a13\u8005\u5019\u88dc\u3092\u5bfe\u8c61\u3068\u3057\u305f\u81e8\u5e8a\u8a66\u9a13\u3067\u591a\u69d8\u6027\u3068cultural competence\u306b\u53d6\u308a\u7d44\u3080\u305f\u3081\u306e\u6226\u7565\u3092\u63d0\u6848\u3059\u308b<\/td><td class=\"column-2\"><b>\u4f8b\uff1a<\/b>\u7814\u7a76\u306e\u30a2\u30a4\u30c7\u30a3\u30a2\u3092\u56fd\u969b\u5171\u540c\u8a66\u9a13\u3078\u3068\u767a\u5c55\u3055\u305b\u308b\u969b\u306b\u3001\u6587\u5316\u3084\u591a\u69d8\u6027\u306b\u95a2\u3059\u308b\u8ab2\u984c\u3092\u8a8d\u8b58\u3059\u308b<\/td><td class=\"column-3\"><b>\u4f8b\uff1a<\/b>\u305d\u308c\u305e\u308c\u306e\u56fd\u3084\u5730\u57df\u3067\u63a1\u7528\u3059\u308b\u3053\u3068\u306e\u3067\u304d\u308b\u500b\u5225\u306e\u6226\u7565\u3092\u63d0\u6848\u3057\u3001\u65b0\u898f\u306e\u81e8\u5e8a\u8a66\u9a13\u3092\u958b\u59cb\u3059\u308b\u969b\u306b\u6587\u5316\u7684\u30fb\u5730\u57df\u7684\u306a\u7279\u6027\u3078\u306e\u914d\u616e\u3092\u78ba\u4fdd\u3059\u308b<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-145 from cache -->[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Section 2&#8243; tab_id=&#8221;1577976795795-f9762798-801b&#8221;][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row][vc_row][vc_column width=&#8221;1\/6&#8243;][vc_single_image image=&#8221;322&#8243;][\/vc_column][vc_column width=&#8221;5\/6&#8243;][vc_column_text el_id=&#8221;domain8&#8243;]<\/p>\n<h2><strong>\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u3068\u30c1\u30fc\u30e0\u30ef\u30fc\u30af<\/strong><\/h2>\n<p>\u81e8\u5e8a\u8a66\u9a13\u5b9f\u65bd\u65bd\u8a2d\u5185\u304a\u3088\u3073\u65bd\u8a2d\u3068\u6cbb\u9a13\u4f9d\u983c\u8005\u30fbCRO (Contract Research Organization)\u30fb\u898f\u5236\u5f53\u5c40\u306e\u9593\u3067\u306e\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u5168\u822c\u3002\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u306b\u5fc5\u8981\u306a\u30c1\u30fc\u30e0\u30ef\u30fc\u30af\u30b9\u30ad\u30eb\u306e\u7406\u89e3\u3002<\/p>\n<p>[\/vc_column_text][vc_tta_accordion active_section=&#8221;0&#8243; collapsible_all=&#8221;true&#8221;][vc_tta_section title=&#8221;8.1 \u6cbb\u9a13\u4f9d\u983c\u8005\u3001CRO\u3001\u65bd\u8a2d\u9593\u306e\u95a2\u4fc2\u6027\u3068\u9069\u5207\u306a\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u306b\u3064\u3044\u3066\u7406\u89e3\u3059\u308b&#8221; tab_id=&#8221;1577978439960-5200df93-332b&#8221;][vc_column_text]\n<table id=\"tablepress-146\" class=\"tablepress tablepress-id-146\">\n<thead>\n<tr class=\"row-1 odd\">\n\t<th class=\"column-1\">A.\u57fa\u790e\u30ec\u30d9\u30eb<\/th><th class=\"column-2\">B. \u4e2d\u7d1a\u30ec\u30d9\u30eb<\/th><th class=\"column-3\">C. \u4e0a\u7d1a\u30ec\u30d9\u30eb<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-hover\">\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\"><b>A1.<\/b>\u898f\u5236\u5f53\u5c40\u30fb\u6cbb\u9a13\u4f9d\u983c\u8005\u30fbCRO\u30fb\u65bd\u8a2d\u306e\u9593\u306e\u95a2\u4fc2\u6027\u3068\u3001\u9069\u5207\u306a\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u306e\u624b\u6bb5\u306b\u3064\u3044\u3066\u7406\u89e3\u3057\u8aac\u660e\u3059\u308b<\/td><td class=\"column-2\"><b>B1.<\/b>\u66f8\u9762\u304a\u3088\u3073\u53e3\u982d\u3067\u5c02\u9580\u7684\u306a\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u3092\u53d6\u308b\u3053\u3068\u306b\u3088\u308a\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u6642\u306b\u95a2\u4fc2\u8005\u3068\u306e\u6cd5\u7684\u306a\u95a2\u4fc2\u304a\u3088\u3073\u751f\u7523\u6027\u306e\u9ad8\u3044\u95a2\u4fc2\u304c\u7dad\u6301\u3067\u304d\u308b\u3088\u3046\u306b\u3059\u308b<\/td><td class=\"column-3\"><b>C1. <\/b>\u5b9f\u65bd\u4e2d\u3001\u53ca\u3073\u5c06\u6765\u306e\u81e8\u5e8a\u8a66\u9a13\u304c\u52b9\u7387\u7684\u30fb\u52b9\u679c\u7684\u3067\u6301\u7d9a\u53ef\u80fd\u306a\u3082\u306e\u3067\u3042\u308a\u7d9a\u3051\u308b\u305f\u3081\u306b\u3001\u7814\u7a76\u4e8b\u696d\u306b\u643a\u308f\u308b\u5168\u3066\u306e\u95a2\u4fc2\u8005\u3068\u9577\u671f\u306b\u6e21\u308b\u826f\u597d\u306a\u95a2\u4fc2\u3092\u7bc9\u304d\u3001\u7dad\u6301\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\"><b>\u4f8b\uff1a<\/b>\u81e8\u5e8a\u7814\u7a76\u696d\u52d9\u306b\u304a\u3044\u3066\u95a2\u4fc2\u8005\u9593\u306e\u66f8\u9762\u304a\u3088\u3073\u53e3\u982d\u3067\u306e\u9069\u5207\u306a\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u3092\u53d6\u308b<br \/>\n<\/td><td class=\"column-2\"><b>\u4f8b\uff1a<\/b>\u8a66\u9a13\u306e\u5b9f\u65bd\u306b\u5f71\u97ff\u3092\u53ca\u307c\u3059\u3088\u3046\u306a\u30c1\u30fc\u30e0\u306b\u95a2\u9023\u3059\u308b\u8ab2\u984c\u3092\u89e3\u6c7a\u3059\u308b\u305f\u3081\u306b\u6587\u66f8\u53ca\u3073\u53e3\u982d\u3067\u306e\u7a4d\u6975\u7684\u306a\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u3092\u9032\u5c55\u3055\u305b\u3001\u8ab2\u984c\u3092\u89e3\u6c7a\u3059\u308b\u305f\u3081\u306e\u65b9\u7b56\u306b\u3064\u3044\u3066\u76f8\u4e92\u7684\u306a\u5408\u610f\u304c\u5f97\u3089\u308c\u308b\u3088\u3046\u306b\u3059\u308b<\/td><td class=\"column-3\"><b>\u4f8b\uff1a<\/b>\u7814\u7a76\u306b\u53c2\u753b\u3059\u308b\u3059\u3079\u3066\u306e\u95a2\u4fc2\u8005\u306e\u30cb\u30fc\u30ba\u3092\u7d44\u307f\u53d6\u308a\u3001\u4ee5\u524d\u306e\uff08\u8a66\u9a13\u306e\uff09\u4e0d\u5341\u5206\u306a\u7d50\u679c\u304c\u3082\u305f\u3089\u3059\u56f0\u96e3\u306a\u72b6\u6cc1\u306e\u969b\u306b\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u306e\u307e\u3068\u3081\u5f79\u3068\u3057\u3066\u8ca2\u732e\u3059\u308b<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-146 from cache -->[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;8.2\u65e2\u5b58\u306e\u5b66\u8853\u8ad6\u6587\u306e\u8981\u7d20\u3092\u8aac\u660e\u3059\u308b&#8221; tab_id=&#8221;1577979309642-ffde1484-aa0d&#8221;][vc_column_text]\n<table id=\"tablepress-147\" class=\"tablepress tablepress-id-147\">\n<thead>\n<tr class=\"row-1 odd\">\n\t<th class=\"column-1\">A.\u57fa\u790e\u30ec\u30d9\u30eb<\/th><th class=\"column-2\">B. \u4e2d\u7d1a\u30ec\u30d9\u30eb<\/th><th class=\"column-3\">C. \u4e0a\u7d1a\u30ec\u30d9\u30eb<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-hover\">\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\"><b>A1.<\/b>\u5b66\u8853\u8ad6\u6587\u306e\u4e3b\u8981\u306a\u69cb\u6210\u8981\u7d20\u3068\u3001\u5404\u69cb\u6210\u8981\u7d20\u306e\u4e00\u822c\u7684\u306a\u76ee\u7684\u3092\u7279\u5b9a\u3059\u308b<\/td><td class=\"column-2\"><b>B1.<\/b>\u8ad6\u6587\u767a\u8868\u3055\u308c\u305f\u7814\u7a76\u3067\u4f7f\u308f\u308c\u305f\u65b9\u6cd5\u3092\u8aac\u660e\u3057\u3001\u305d\u306e\u7d50\u679c\u306b\u3088\u308a\u5c0e\u304d\u51fa\u3055\u308c\u305f\u7d50\u8ad6\u306e\u6839\u62e0\u3092\u7406\u89e3\u3059\u308b<\/td><td class=\"column-3\"><b>C1. <\/b>\u65e2\u5b58\u306e\u5b66\u8853\u8ad6\u6587\u306e\u5168\u3066\u306e\u4e3b\u8981\u69cb\u6210\u8981\u7d20\u306e\u5185\u5bb9\u3092\u7406\u89e3\u30fb\u8a55\u4fa1\u3057\u3001\u6df1\u3044\u7406\u89e3\u306b\u57fa\u3065\u3044\u305f\u5185\u5bb9\u3092\u4f1d\u3048\u308b<\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\"><b>A2.<\/b>\u65e2\u5b58\u306e\u5b66\u8853\u8ad6\u6587\u306f\u3001\u4e00\u822c\u5316\u53ef\u80fd\u306a\u77e5\u8b58\u3068\u30a8\u30d3\u30c7\u30f3\u30b9\u306b\u57fa\u3065\u3044\u305f\u5b9f\u8df5\u306b\u5bc4\u4e0e\u3059\u308b\u305f\u3081\u3001\u4f53\u7cfb\u7684\u304b\u3064\u7cfb\u7d71\u7acb\u3066\u3066\u7814\u7a76\u7d50\u679c\u3092\u8a18\u8f09\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u7406\u89e3\u3059\u308b<\/td><td class=\"column-2\"><b>B2. <\/b>\u7279\u5b9a\u306e\u984c\u6750\u306b\u95a2\u3059\u308b\u8ad6\u6587\u3092\u3001\u30ad\u30fc\u30ef\u30fc\u30c9\u3092\u4f7f\u3044\u691c\u7d22\u3059\u308b<\/td><td class=\"column-3\"><b>C2.<\/b>\u81e8\u5e8a\u8a66\u9a13\u306e\u7d50\u679c\u3068\u3001\u5bfe\u8c61\u3068\u306a\u308b\u6bcd\u96c6\u56e3\u304a\u3088\u3073\u73fe\u5728\u306e\u533b\u7642\u4e8b\u60c5\u3068\u306e\u95a2\u4fc2\u6027\u3092\u8aac\u660e\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-4 even\">\n\t<td class=\"column-1\"><\/td><td class=\"column-2\"><b>B3.<\/b>\u5c02\u9580\u7684\u306a\u6587\u732e\u3092\u5f15\u7528\u3059\u308b\u969b\u306e\u4e00\u6b21\u8cc7\u6599\u3068\u4e8c\u6b21\u8cc7\u6599\u306e\u9055\u3044\u3092\u8aac\u660e\u3059\u308b<\/td><td class=\"column-3\"><b>C3.<\/b>\u8ad6\u6587\u3092\u66f8\u304d\u7de8\u96c6\u3057\u3001\u307e\u305f\u8ad6\u6587\u306e\u7de8\u96c6\u306e\u969b\u306b\u69d8\u3005\u306a\u30b8\u30e3\u30fc\u30ca\u30eb\u306e\u5f15\u7528\u30b9\u30bf\u30a4\u30eb\u3092\u9069\u7528\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-5 odd\">\n\t<td class=\"column-1\"><b>\u4f8b\uff1a<\/b>\u5b9f\u65bd\u4e2d\u306e\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u95a2\u9023\u3059\u308b\u767a\u8868\u6e08\u307f\u306e\u8a66\u9a13\u3092\u30ec\u30d3\u30e5\u30fc\u3057\u3001\u5354\u8b70\u3059\u308b<\/td><td class=\"column-2\"><b>\u4f8b\uff1a<\/b>\u4e00\u6b21\u8cc7\u6599\u306e\u30c7\u30fc\u30bf\u3092\u7528\u3044\u3066\u6b63\u78ba\u306b\u6587\u732e\u3092\u5f15\u7528\u3057(\u539f\u672c\u3067\u3042\u308b\u4e00\u6b21\u8cc7\u6599\uff08\u5f15\u7528\u5143\uff09\u306b\u623b\u308b\u3068\u3001\u4e8c\u6b21\u8cc7\u6599(\u5f15\u7528\u5148\u306e\u60c5\u5831)\u3092\u63a2\u3057\u51fa\u3059\u3053\u3068\u304c\u3067\u304d\u308b)\u3001\u8ad6\u6587\u767a\u8868\u3084\u5c02\u9580\u5bb6\u306b\u5411\u3051\u305f\u30d7\u30ec\u30bc\u30f3\u30c6\u30fc\u30b7\u30e7\u30f3\u8cc7\u6599\u306e\u305f\u3081\u306e\u30a2\u30d6\u30b9\u30c8\u30e9\u30af\u30c8(\u8981\u7d04)\u3092\u69cb\u6210\u3059\u308b<\/td><td class=\"column-3\"><b>\u4f8b\uff1a<\/b>\u81e8\u5e8a\u8a66\u9a13\u306e\u7d50\u679c\u3092\u5143\u306b\u3001\u539f\u7a3f\u3092\u57f7\u7b46\u30fb\u7de8\u96c6\u3057\u3001\u304b\u3064\uff0f\u307e\u305f\u306f\u7de8\u96c6\u8005\u304b\u3089\u306e\u30b3\u30e1\u30f3\u30c8\u3084\u63d0\u6848\u306b\u5bfe\u5fdc\u3057\u3001\u5c02\u9580\u8a8c\u306b\u53d7\u3051\u5165\u308c\u3089\u308c\u308b\u3001\u6700\u7d42\u5316\u3055\u308c\u305f\u8ad6\u6587\u3092\u4f5c\u6210\u3059\u308b<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-147 from cache -->[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;8.3 \u81e8\u5e8a\u8a66\u9a13\u306e\u7d50\u679c\u3068\u610f\u5473\u3092\u5354\u50cd\u3059\u308b\u4eba\u3005\u3001\u60c5\u5831\u767a\u4fe1\u3059\u308b\u7acb\u5834\u306b\u3042\u308b\u4eba\u3005\u3001\u4e00\u822c\u306e\u4eba\u3005\u3078\u52b9\u679c\u7684\u306b\u4f1d\u3048\u308b&#8221; tab_id=&#8221;1577979516798-1e60333c-3bbb&#8221;][vc_column_text]\n<table id=\"tablepress-148\" class=\"tablepress tablepress-id-148\">\n<thead>\n<tr class=\"row-1 odd\">\n\t<th class=\"column-1\">A.\u57fa\u790e\u30ec\u30d9\u30eb<\/th><th class=\"column-2\">B. \u4e2d\u7d1a\u30ec\u30d9\u30eb<\/th><th class=\"column-3\">C. \u4e0a\u7d1a\u30ec\u30d9\u30eb<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-hover\">\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\"><b>A1.<\/b>\u5b66\u8853\u8ad6\u6587\u306e\u69cb\u6210\u3068\u5185\u5bb9\u3092\u8aac\u660e\u3059\u308b<\/td><td class=\"column-2\"><b>B1.<\/b>\u5c02\u9580\u7684\u306a\u30d7\u30ec\u30bc\u30f3\u30c6\u30fc\u30b7\u30e7\u30f3\u304a\u3088\u3073\u305d\u306e\u4ed6\u306e\u53e3\u982d\u307e\u305f\u306f\u8a18\u8ff0\u306e\u624b\u6bb5\u3092\u7528\u3044\u3066\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u5185\u5bb9\u3068\u4fa1\u5024\u3092\u5354\u50cd\u3059\u308b\u4eba\u3005\u3084\u4e00\u822c\u306e\u4eba\u3005\u306b\u4f1d\u3048\u308b<\/td><td class=\"column-3\"><b>C1. <\/b>\u79d1\u5b66\u5206\u91ce\u306e\u4eba\u3005\u307e\u305f\u306f\u4e00\u822c\u306e\u4eba\u3005\u3078\u5411\u3051\u305f \u81e8\u5e8a\u8a66\u9a13\u30c7\u30fc\u30bf\u3092\u89e3\u91c8\u30fb\u8aac\u660e\u3059\u308b\u305f\u3081\u306e\u5831\u544a\u66f8\u3092\u30c7\u30b6\u30a4\u30f3\u3057\u3001\u81e8\u5e8a\u8a66\u9a13\u5831\u544a\u66f8\u306e\u91cd\u8981\u6027\u3092\u8a55\u4fa1\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\"><b>A2.<\/b>\u79d1\u5b66\u5206\u91ce\u306e\u4eba\u3005\u307e\u305f\u306f\u4e00\u822c\u306e\u4eba\u3005\u306b\u81e8\u5e8a\u8a66\u9a13\u306e\u7d50\u679c\u3092\u4f1d\u3048\u308b\u305f\u3081\u306e\u4fe1\u983c\u3067\u304d\u308b\u60c5\u5831\u6e90\u3092\u7279\u5b9a\u3057\u5229\u7528\u3059\u308b<\/td><td class=\"column-2\"><\/td><td class=\"column-3\"><b>C2.<\/b>\u5354\u50cd\u3059\u308b\u4eba\u3005\u3001\u60c5\u5831\u767a\u4fe1\u3059\u308b\u7acb\u5834\u306b\u3042\u308b\u4eba\u3005\u3001\u4e00\u822c\u306e\u4eba\u3005\u306b\u5bfe\u3057\u3066\u30d7\u30ed\u30c8\u30b3\u30eb\u3068\u305d\u306e\u7d50\u679c\u3092\u5468\u77e5\u3057\u3001\u3088\u308a\u6df1\u3044\u7406\u89e3\u3092\u4fc3\u3059<\/td>\n<\/tr>\n<tr class=\"row-4 even\">\n\t<td class=\"column-1\"><b>\u4f8b\uff1a<\/b>\u4e00\u822c\u306e\u4eba\u3005\u304c\u7406\u89e3\u3067\u304d\u308b\u3088\u3046\u306b\u81e8\u5e8a\u8a66\u9a13\u306e\u79d1\u5b66\u7684\u6839\u62e0\u3092\u8aac\u660e\u3059\u308b<\/td><td class=\"column-2\"><b>\u4f8b\uff1a<\/b>\u8a18\u8005\u30af\u30e9\u30d6\u3084\u88ab\u9a13\u8005\u5019\u88dc\u306e\u96c6\u56e3\u306e\u305f\u3081\u306b\u7814\u7a76\u30fb\u3000\u8a66\u9a13\u306e\u975e\u5c02\u9580\u5bb6\u5411\u3051\u30b5\u30de\u30ea\u30fc\u3092\u8a18\u8f09\u3059\u308b<\/td><td class=\"column-3\"><b>\u4f8b\uff1a<\/b>\u81e8\u5e8a\u7814\u7a76\u30fb\u8a66\u9a13\u306e\u7d50\u679c\u3092\u6cbb\u9a13\u4f9d\u983c\u8005\u3001\u5354\u50cd\u3059\u308b\u4eba\u3005\u3001\u4e00\u822c\u306e\u4eba\u3005\u306b\u4f1d\u3048\u308b<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-148 from cache -->[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;8.4 \u96c6\u5b66\u7684\u30c1\u30fc\u30e0\uff08\u30c1\u30fc\u30e0\u30b5\u30a4\u30a8\u30f3\u30b9\uff09\u306e\u91cd\u8981\u6027\u304a\u3088\u3073\u96c6\u5b66\u7684\u30fb\u8907\u6570\u306e\u5c02\u9580\u8077\u304b\u3089\u306a\u308b\u7814\u7a76\u30c1\u30fc\u30e0\u304c\u52b9\u7387\u7684\u306b\u50cd\u304f\u305f\u3081\u306e\u65b9\u6cd5\u3092\u8aac\u660e\u3059\u308b&#8221; tab_id=&#8221;1577979625824-fd167ef4-e5ce&#8221;][vc_column_text]\n<table id=\"tablepress-149\" class=\"tablepress tablepress-id-149\">\n<thead>\n<tr class=\"row-1 odd\">\n\t<th class=\"column-1\">A.\u57fa\u790e\u30ec\u30d9\u30eb<\/th><th class=\"column-2\">B. \u4e2d\u7d1a\u30ec\u30d9\u30eb<\/th><th class=\"column-3\">C. \u4e0a\u7d1a\u30ec\u30d9\u30eb<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-hover\">\n<tr class=\"row-2 even\">\n\t<td class=\"column-1\"><b>A1.<\/b>\u96c6\u5b66\u7684\u30c1\u30fc\u30e0\u306e\u91cd\u8981\u6027\u3068\u305d\u308c\u305e\u308c\u306e\u30e1\u30f3\u30d0\u30fc\u304c\u81e8\u5e8a\u8a66\u9a13\u306b\u3082\u305f\u3089\u3059\u3053\u3068\u306e\u3067\u304d\u308b\u4fa1\u5024\u3092\u8aac\u660e\u3057\u7406\u89e3\u3059\u308b<\/td><td class=\"column-2\"><b>B1.<\/b>\u81e8\u5e8a\u8a66\u9a13\u671f\u9593\u4e2d\u3092\u901a\u3057\u3066\u52b9\u679c\u7684\u306a\u30c1\u30fc\u30e0\u904b\u55b6\u3092\u4fdd\u8a3c\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u4e0d\u53ef\u6b20\u306a\u30e1\u30f3\u30d0\u30fc\u540c\u58eb\u3067\u306e\u60c5\u5831\u5171\u6709\u306e\u8981\u3068\u306a\u308b\u6d3b\u52d5\u3092\u7279\u5b9a\u3057\u3001\u305d\u306e\u6d3b\u52d5\u3092\u4fc3\u9032\u3059\u308b<\/td><td class=\"column-3\"><b>C1. <\/b>\u8907\u6570\u306e\u5c02\u9580\u8077\u304b\u3089\u306a\u308b\u81e8\u5e8a\u8a66\u9a13\u30c1\u30fc\u30e0\u306b\u304a\u3044\u3066\u6700\u3082\u52b9\u679c\u7684\u306b\u50cd\u304f\u305f\u3081\u306e\u65b9\u6cd5\u3092\u6307\u5c0e\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-3 odd\">\n\t<td class=\"column-1\"><b>A2.<\/b>\u30c1\u30fc\u30e0\u5185\u306e\u5168\u3066\u306e\u30e1\u30f3\u30d0\u30fc\u3001\u304a\u3088\u3073\u30e1\u30f3\u30d0\u30fc\u306e\u5f79\u5272\u3068\u8cac\u4efb\u3092\u7279\u5b9a\u30fb\u8a8d\u8b58\u3057\u3001\u81e8\u5e8a\u8a66\u9a13\u30c1\u30fc\u30e0\u5185\u306e\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u304c\u8a66\u9a13\u306e\u6210\u529f\u306b\u5fc5\u8981\u4e0d\u53ef\u6b20\u3067\u3042\u308b\u3053\u3068\u3092\u7406\u89e3\u3059\u308b<\/td><td class=\"column-2\"><b>B2.<\/b> \u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u8a08\u753b\u306e\u7b56\u5b9a\u306b\u304a\u3051\u308b\u591a\u8077\u7a2e\u6a2a\u65ad\u578b\u306e\u30c1\u30fc\u30e0\u306b\u3064\u3044\u3066\u7406\u89e3\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u793a\u3059<\/td><td class=\"column-3\"><b>C2.<\/b>\u81e8\u5e8a\u8a66\u9a13\u30c1\u30fc\u30e0\u306e\u57fa\u76e4\u3092\u7bc9\u304d\u3001\u52b9\u679c\u7684\u3067\u52b9\u7387\u7684\u306a\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u3068\u30c1\u30fc\u30e0\u30ef\u30fc\u30af\u304c\u78ba\u5b9f\u306b\u884c\u308f\u308c\u308b\u3088\u3046\u306b\u3059\u308b<\/td>\n<\/tr>\n<tr class=\"row-4 even\">\n\t<td class=\"column-1\"><\/td><td class=\"column-2\"><\/td><td class=\"column-3\"><b>C3.<\/b>\u96c6\u5b66\u7684\u306a\u30b9\u30ad\u30eb\u3092\u7814\u7a76\u30c1\u30fc\u30e0\u306b\u53d6\u308a\u5165\u308c\u308b<\/td>\n<\/tr>\n<tr class=\"row-5 odd\">\n\t<td class=\"column-1\"><b>\u4f8b\uff1a<\/b>\u81e8\u5e8a\u8a66\u9a13\u30c1\u30fc\u30e0\u306e\u3059\u3079\u3066\u306e\u30e1\u30f3\u30d0\u30fc\u306e\u5c02\u9580\u7684\u306a\u5f79\u5272\u3068\u81e8\u5e8a\u696d\u52d9\u306e\u9818\u57df\u3092\u7406\u89e3\u3059\u308b<\/td><td class=\"column-2\"><b>\u4f8b\uff1a<\/b>\u52b9\u679c\u7684\u306a\u30c1\u30fc\u30e0\u904b\u55b6\u306b\u5fc5\u8981\u4e0d\u53ef\u6b20\u306a\u3001\u65e5\u3005\u306e\u5b9f\u52d9\u7684\u306a\u6d3b\u52d5(\u4f1a\u8b70\u306e\u8a2d\u5b9a\u3001\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u8a08\u753b\u306e\u7b56\u5b9a\u3001\u30c1\u30fc\u30e0\u5185\u5916\u306e\u4e3b\u8981\u306a\u9023\u7d61\u5148\u306e\u7279\u5b9a)\u3092\u5b9f\u65bd\u3059\u308b\u80fd\u529b\u3092\u793a\u3059<\/td><td class=\"column-3\"><b>\u4f8b\uff1a<\/b>\u30c1\u30fc\u30e0\u3067\u306e\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u3001\u4ed6\u8077\u7a2e\u9593\u306e\u77e5\u8b58\u306e\u5171\u6709\u3001\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u8a18\u9332\u306e\u7dad\u6301\u7ba1\u7406\u7b49\u3092\u5b9f\u65bd\u3059\u308b\u305f\u3081\u3001\u4f5c\u696d\u904b\u7528\u30d5\u30ed\u30fc\u3092\u78ba\u7acb\u3057\u3001\u8a66\u9a13\u30c1\u30fc\u30e0\u3092\u4f5c\u308b\u3002\u30c1\u30fc\u30e0\u304c\u305d\u306e\u52b9\u679c\u3092\u6700\u5927\u9650\u767a\u63ee\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u5834\u5408\u3001\u6307\u5c0e\u3092\u884c\u3046<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-149 from cache -->[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Section 2&#8243; 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[&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":0,"parent":11,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"template-sub.php","meta":{"footnotes":""},"class_list":["post-980","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.0 (Yoast SEO v25.0) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Domains (Japanese) - Joint Task Force for Clinical Trial Competency<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/mrctcenter.org\/clinical-trial-competency\/framework\/domains-japanese\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Domains (Japanese)\" \/>\n<meta property=\"og:description\" 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