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<\/p>\n\n<ul>\n<li><h3>\u898f\u5236\u57fa\u6e96\u306e\u9075\u5b88<\/h3><\/li>\n<\/ul>\n\n<p>\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff08FDA\uff09\u3084\u6b27\u5dde\u533b\u85ac\u54c1\u5e81\uff08EMA\uff09\u306a\u3069\u306e\u898f\u5236\u6a5f\u95a2\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u30c7\u30fc\u30bf\u306e\u53ce\u96c6\u3001\u7ba1\u7406\u3001\u5831\u544a\u306b\u3064\u3044\u3066\u53b3\u3057\u3044\u8981\u4ef6\u3092\u5b9a\u3081\u3066\u3044\u308b\u3002CDM\u306e\u5b9f\u8df5\u306f\u3001\u30c7\u30fc\u30bf\u304c\u3053\u308c\u3089\u306e\u898f\u5236\u57fa\u6e96\u306b\u6e96\u62e0\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3057\u3001\u65b0\u3057\u3044\u6cbb\u7642\u6cd5\u306e\u627f\u8a8d\u30d7\u30ed\u30bb\u30b9\u3092\u4fc3\u9032\u3059\u308b\u306e\u306b\u5f79\u7acb\u3064\u3002 <\/p>\n\n<ul>\n<li><h3>\u60a3\u8005\u306e\u5b89\u5168<\/h3><\/li>\n<\/ul>\n\n<p>\u81e8\u5e8a\u8a66\u9a13\u4e2d\u306e\u60a3\u8005\u306e\u5b89\u5168\u6027\u3092\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u6b63\u78ba\u3067\u4fe1\u983c\u3067\u304d\u308b\u30c7\u30fc\u30bf\u304c\u4e0d\u53ef\u6b20\u3067\u3042\u308b\u3002\u6709\u5bb3\u4e8b\u8c61\u3092\u8fc5\u901f\u306b\u7279\u5b9a\u3057\u5bfe\u51e6\u3059\u308b\u3053\u3068\u306f\u3001\u8a66\u9a13\u53c2\u52a0\u8005\u306e\u5e78\u798f\u3092\u5b88\u308b\u305f\u3081\u306b\u6975\u3081\u3066\u91cd\u8981\u3067\u3042\u308b\u3002 <\/p>\n\n<ul>\n<li><h3>\u52b9\u7387\u7684\u306a\u30c7\u30fc\u30bf\u53ce\u96c6\u3068\u5165\u529b<\/h3><\/li>\n<\/ul>\n\n<p>CDM\u306b\u306f\u3001\u6a19\u6e96\u5316\u3055\u308c\u305f\u30c7\u30fc\u30bf\u53ce\u96c6\u65b9\u6cd5\u3068\u96fb\u5b50\u30c7\u30fc\u30bf\u53ce\u96c6\uff08EDC\uff09\u30b7\u30b9\u30c6\u30e0\u306e\u958b\u767a\u304c\u542b\u307e\u308c\u308b\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u52b9\u7387\u7684\u3067\u4e00\u8cab\u6027\u306e\u3042\u308b\u30c7\u30fc\u30bf\u5165\u529b\u304c\u4fc3\u9032\u3055\u308c\u3001\u624b\u4f5c\u696d\u306b\u3088\u308b\u30c7\u30fc\u30bf\u8ee2\u8a18\u306b\u4f34\u3046\u30a8\u30e9\u30fc\u306e\u53ef\u80fd\u6027\u304c\u6e1b\u5c11\u3059\u308b\u3002 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<\/p>\n\n<ul>\n<li><h3>\u30ea\u30bd\u30fc\u30b9\u306e\u6700\u9069\u5316<\/h3><\/li>\n<\/ul>\n\n<p>\u52b9\u7387\u7684\u306a\u30c7\u30fc\u30bf\u7ba1\u7406\u306e\u5b9f\u8df5\u306f\u3001\u624b\u4f5c\u696d\u306b\u3088\u308b\u30c7\u30fc\u30bf\u306e\u691c\u8a3c\u3084\u30af\u30ea\u30fc\u30cb\u30f3\u30b0\u306e\u5fc5\u8981\u6027\u3092\u6e1b\u3089\u3059\u3053\u3068\u3067\u3001\u30ea\u30bd\u30fc\u30b9\u306e\u6700\u9069\u5316\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002\u3053\u308c\u306f\u30b3\u30b9\u30c8\u524a\u6e1b\u3068\u81e8\u5e8a\u8a66\u9a13\u30d7\u30ed\u30bb\u30b9\u306e\u5408\u7406\u5316\u306b\u3064\u306a\u304c\u308b\u3002 <\/p>\n\n<h2 class=\"wp-block-heading\">\u81e8\u5e8a\u30c7\u30fc\u30bf\u7ba1\u7406\u306e\u6bb5\u968e<\/h2>\n\n<p>\u81e8\u5e8a\u30c7\u30fc\u30bf\u7ba1\u7406\uff08CDM\uff09\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u30c7\u30fc\u30bf\u306e\u6b63\u78ba\u6027\u3001\u5b8c\u5168\u6027\u3001\u4fe1\u983c\u6027\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306e\u8907\u6570\u306e\u91cd\u8981\u306a\u6bb5\u968e\u3092\u542b\u3080\u5305\u62ec\u7684\u306a\u30d7\u30ed\u30bb\u30b9\u3067\u3042\u308b\u3002\u5404\u6bb5\u968e\u306f\u3001\u9ad8\u54c1\u8cea\u306e\u30c7\u30fc\u30bf\u3092\u7dad\u6301\u3057\u3001\u898f\u5236\u57fa\u6e96\u3092\u9075\u5b88\u3059\u308b\u305f\u3081\u306b\u6975\u3081\u3066\u91cd\u8981\u3067\u3059\u3002   <\/p>\n\n<p>\u81e8\u5e8a\u30c7\u30fc\u30bf\u7ba1\u7406\u30d7\u30ed\u30bb\u30b9\u306e\u4e3b\u306a\u6bb5\u968e\u306f\u4ee5\u4e0b\u306e\u901a\u308a\u3067\u3042\u308b\uff1a<\/p>\n\n<h3 class=\"wp-block-heading\">1.\u30d7\u30ed\u30c8\u30b3\u30eb\u958b\u767a<\/h3>\n\n<p>\u7b2c\u4e00\u6bb5\u968e\u3067\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u76ee\u7684\u3001\u30c7\u30b6\u30a4\u30f3\u3001\u65b9\u6cd5\u8ad6\u3001\u30c7\u30fc\u30bf\u53ce\u96c6\u65b9\u6cd5\u306e\u6982\u8981\u3092\u8a18\u3057\u305f\u8a73\u7d30\u306a\u30d7\u30ed\u30c8\u30b3\u30fc\u30eb\u3092\u4f5c\u6210\u3059\u308b\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u8a66\u9a13\u5168\u4f53\u3092\u901a\u3057\u3066\u306e\u30c7\u30fc\u30bf\u7ba1\u7406\u6d3b\u52d5\u306e\u57fa\u790e\u304c\u78ba\u7acb\u3055\u308c\u308b\u3002 <\/p>\n\n<h3 class=\"wp-block-heading\">2.\u30c7\u30fc\u30bf\u53ce\u96c6<\/h3>\n\n<p>\u30d7\u30ed\u30c8\u30b3\u30eb\u304c\u78ba\u7acb\u3055\u308c\u308b\u3068\u3001\u30c7\u30fc\u30bf\u53ce\u96c6\u304c\u59cb\u307e\u308b\u3002\u3053\u306e\u6bb5\u968e\u3067\u306f\u3001\u60a3\u8005\u8a18\u9332\u3001\u691c\u67fb\u7d50\u679c\u3001\u305d\u306e\u4ed6\u306e\u95a2\u9023\u30c7\u30fc\u30bf\u30dd\u30a4\u30f3\u30c8\u306a\u3069\u3001\u69d8\u3005\u306a\u60c5\u5831\u6e90\u304b\u3089\u60c5\u5831\u3092\u53ce\u96c6\u3059\u308b\u3002\u3053\u306e\u6bb5\u968e\u3067\u306f\u3001\u30c7\u30fc\u30bf\u306e\u6b63\u78ba\u6027\u3068\u5b8c\u5168\u6027\u3092\u78ba\u4fdd\u3059\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3042\u308b\u3002  <\/p>\n\n<h3 class=\"wp-block-heading\">3.\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u306e\u8a2d\u8a08\u3068\u8a2d\u5b9a<\/h3>\n\n<p>\u52b9\u7387\u7684\u306a\u30c7\u30fc\u30bf\u7ba1\u7406\u306b\u306f\u3001\u69cb\u9020\u5316\u3055\u308c\u305f\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u304c\u4e0d\u53ef\u6b20\u3067\u3042\u308b\u3002\u3053\u306e\u6bb5\u968e\u3067\u306f\u3001\u53ce\u96c6\u3057\u305f\u30c7\u30fc\u30bf\u306e\u91cf\u3068\u8907\u96d1\u3055\u306b\u5bfe\u5fdc\u3067\u304d\u308b\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u3092\u8a2d\u8a08\u3059\u308b\u3002\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u306f\u30e6\u30fc\u30b6\u30fc\u30d5\u30ec\u30f3\u30c9\u30ea\u30fc\u3067\u3001\u898f\u5236\u8981\u4ef6\u306b\u6e96\u62e0\u3057\u3066\u3044\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002  <\/p>\n\n<h3 class=\"wp-block-heading\">4.\u30c7\u30fc\u30bf\u5165\u529b\u3068\u30af\u30ea\u30fc\u30cb\u30f3\u30b0<\/h3>\n\n<p>\u30c7\u30fc\u30bf\u5165\u529b\u3067\u306f\u3001\u53ce\u96c6\u3057\u305f\u60c5\u5831\u3092\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u306b\u79fb\u3059\u3002\u30c7\u30fc\u30bf\u306e\u30af\u30ea\u30fc\u30cb\u30f3\u30b0\u306f\u3001\u30a8\u30e9\u30fc\u3001\u4e0d\u6574\u5408\u3001\u6b20\u640d\u5024\u306e\u7279\u5b9a\u3068\u4fee\u6b63\u3092\u542b\u3080\u91cd\u8981\u306a\u30b9\u30c6\u30c3\u30d7\u3067\u3042\u308b\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u30c7\u30fc\u30bf\u306e\u8cea\u304c\u9ad8\u304f\u3001\u5206\u6790\u306b\u4fe1\u983c\u3067\u304d\u308b\u3082\u306e\u3068\u306a\u308b\u3002  <\/p>\n\n<h3 class=\"wp-block-heading\">5.\u54c1\u8cea\u7ba1\u7406\u3068\u4fdd\u8a3c<\/h3>\n\n<p>\u30c7\u30fc\u30bf\u306e\u6b63\u78ba\u6027\u3001\u4e00\u8cab\u6027\u3001\u5b8c\u5168\u6027\u3092\u691c\u8a3c\u3059\u308b\u305f\u3081\u306b\u3001\u53b3\u683c\u306a\u54c1\u8cea\u7ba1\u7406\u63aa\u7f6e\u304c\u5b9f\u65bd\u3055\u308c\u308b\u3002\u3053\u306e\u6bb5\u968e\u306b\u306f\u3001\u30c7\u30fc\u30bf\u306e\u691c\u8a3c\u30c1\u30a7\u30c3\u30af\u3001\u4e0d\u4e00\u81f4\u306e\u7ba1\u7406\u3001\u6a19\u6e96\u4f5c\u696d\u624b\u9806\u66f8\uff08SOP\uff09\u306e\u9075\u5b88\u306e\u78ba\u4fdd\u304c\u542b\u307e\u308c\u308b\u3002 <\/p>\n\n<h3 class=\"wp-block-heading\">6.\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u306e\u30ed\u30c3\u30af\u3068\u5206\u6790<\/h3>\n\n<p>\u30c7\u30fc\u30bf\u306e\u30af\u30ea\u30fc\u30cb\u30f3\u30b0\u3068\u54c1\u8cea\u30c1\u30a7\u30c3\u30af\u304c\u7d42\u308f\u308b\u3068\u3001\u305d\u308c\u4ee5\u4e0a\u306e\u5909\u66f4\u3092\u9632\u3050\u305f\u3081\u306b\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u304c\u30ed\u30c3\u30af\u3055\u308c\u308b\u3002\u30ed\u30c3\u30af\u3055\u308c\u305f\u30c7\u30fc\u30bf\u306f\u7d71\u8a08\u5206\u6790\u306b\u304b\u3051\u3089\u308c\u3001\u7d50\u8ad6\u3092\u5c0e\u304d\u51fa\u3057\u3001\u610f\u5473\u306e\u3042\u308b\u6d1e\u5bdf\u3092\u751f\u307f\u51fa\u3059\u3002 <\/p>\n\n<h3 class=\"wp-block-heading\">7.\u5831\u544a\u304a\u3088\u3073\u63d0\u51fa<\/h3>\n\n<p>\u6700\u7d42\u6bb5\u968e\u3067\u306f\u3001\u7814\u7a76\u7d50\u679c\u3092\u307e\u3068\u3081\u305f\u5305\u62ec\u7684\u306a\u5831\u544a\u66f8\u3092\u4f5c\u6210\u3059\u308b\u3002\u3053\u308c\u3089\u306e\u5831\u544a\u66f8\u306f\u898f\u5236\u5f53\u5c40\u306b\u63d0\u51fa\u3055\u308c\u3001\u627f\u8a8d\u3068\u51fa\u7248\u3092\u53d7\u3051\u3001\u79d1\u5b66\u7684\u77e5\u8b58\u306e\u57fa\u76e4\u306b\u8ca2\u732e\u3059\u308b\u3002   <\/p>\n\n<h2 class=\"wp-block-heading\">\u81e8\u5e8a\u30c7\u30fc\u30bf\u7ba1\u7406\u306b\u4e0d\u53ef\u6b20\u306a\u30c4\u30fc\u30eb<\/h2>\n\n<p>\u81e8\u5e8a\u30c7\u30fc\u30bf\u7ba1\u7406\u5354\u4f1a\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u3084\u7814\u7a76\u4e2d\u306b\u751f\u6210\u3055\u308c\u308b\u30c7\u30fc\u30bf\u3092\u53ce\u96c6\u3001\u6574\u7406\u3001\u7ba1\u7406\u3059\u308b\u3002\u81e8\u5e8a\u30c7\u30fc\u30bf\u306e\u5b8c\u5168\u6027\u3001\u6b63\u78ba\u6027\u3001\u4fe1\u983c\u6027\u3092\u78ba\u4fdd\u3059\u308b\u4e0a\u3067\u6975\u3081\u3066\u91cd\u8981\u3067\u3042\u308b\u3002\u3053\u3053\u3067\u306f\u81e8\u5e8a\u30c7\u30fc\u30bf\u7ba1\u7406\u3067\u4f7f\u7528\u3055\u308c\u308b\u5fc5\u9808\u30c4\u30fc\u30eb\u3092\u3044\u304f\u3064\u304b\u7d39\u4ecb\u3059\u308b\uff1a  <\/p>\n\n<ul>\n<li><h3>\u96fb\u5b50\u30c7\u30fc\u30bf\u30ad\u30e3\u30d7\u30c1\u30e3\uff08EDC\uff09\u30b7\u30b9\u30c6\u30e0<\/h3><\/li>\n<\/ul>\n\n<p>EDC\u30b7\u30b9\u30c6\u30e0\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u30c7\u30fc\u30bf\u3092\u96fb\u5b50\u7684\u306b\u53ce\u96c6\u30fb\u7ba1\u7406\u3059\u308b\u4e0a\u3067\u6975\u3081\u3066\u91cd\u8981\u3067\u3042\u308b\u3002\u3053\u308c\u3089\u306e\u30b7\u30b9\u30c6\u30e0\u306f\u3001\u5f93\u6765\u306e\u7d19\u30d9\u30fc\u30b9\u306e\u30c7\u30fc\u30bf\u53ce\u96c6\u65b9\u6cd5\u306b\u53d6\u3063\u3066\u4ee3\u308f\u308a\u3001\u3088\u308a\u52b9\u7387\u7684\u3067\u6b63\u78ba\u306a\u30c7\u30fc\u30bf\u306e\u53ce\u96c6\u3001\u76e3\u8996\u3001\u7ba1\u7406\u65b9\u6cd5\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002 <\/p>\n\n<ul>\n<li><h3>\u81e8\u5e8a\u8a66\u9a13\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\uff08CTMS\uff09\u3068\u81e8\u5e8a\u30c7\u30fc\u30bf\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\uff08CDMS\uff09<\/h3><\/li>\n<\/ul>\n\n<p>CTMS\u306f\u81e8\u5e8a\u8a66\u9a13\u306e\u8a08\u753b\u3001\u8ffd\u8de1\u3001\u904b\u55b6\u7ba1\u7406\u3092\u652f\u63f4\u3057\u307e\u3059\u3002CTMS\u306b\u306f\u3001\u8a66\u9a13\u8a08\u753b\u3001\u65bd\u8a2d\u9078\u5b9a\u3001\u60a3\u8005\u52df\u96c6\u3001\u8a66\u9a13\u9032\u6357\u72b6\u6cc1\u306e\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u306a\u3069\u306e\u6a5f\u80fd\u304c\u542b\u307e\u308c\u3066\u3044\u307e\u3059\u3002 <\/p>\n\n<p>\u81e8\u5e8a\u30c7\u30fc\u30bf\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u30c7\u30fc\u30bf\u3092\u7ba1\u7406\u3059\u308b\u305f\u3081\u306b\u8a2d\u8a08\u3055\u308c\u305f\u7279\u6b8a\u306a\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30b7\u30b9\u30c6\u30e0\u3067\u3042\u308b\u3002\u30c7\u30fc\u30bf\u306e\u53ce\u96c6\u3001\u691c\u8a3c\u3001\u30af\u30ea\u30fc\u30cb\u30f3\u30b0\u3001\u5831\u544a\u3092\u5bb9\u6613\u306b\u3059\u308b\u3002CDMS\u30c4\u30fc\u30eb\u306f\u30c7\u30fc\u30bf\u306e\u8cea\u3068\u898f\u5236\u57fa\u6e96\u306e\u9075\u5b88\u3092\u7dad\u6301\u3059\u308b\u306e\u306b\u5f79\u7acb\u3064\u3002  <\/p>\n\n<ul>\n<li><h3>\u7121\u4f5c\u70ba\u5316\u304a\u3088\u3073\u6cbb\u9a13\u85ac\u4f9b\u7d66\u7ba1\u7406\uff08RTSM\uff09\u30b7\u30b9\u30c6\u30e0<\/h3><\/li>\n<\/ul>\n\n<p>\u3053\u308c\u3089\u306e\u30b7\u30b9\u30c6\u30e0\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u4e2d\u306b\u60a3\u8005\u3092\u7570\u306a\u308b\u6cbb\u7642\u7fa4\u306b\u7121\u4f5c\u70ba\u306b\u5272\u308a\u4ed8\u3051\u3001\u6cbb\u9a13\u85ac\u3084\u6cbb\u9a13\u6a5f\u5668\u306e\u4f9b\u7d66\u3092\u7ba1\u7406\u3059\u308b\u306e\u306b\u5f79\u7acb\u3064\u3002\u9069\u5207\u306a\u76f2\u691c\u5316\u3068\u6cbb\u7642\u306e\u5272\u308a\u4ed8\u3051\u3092\u4fdd\u8a3c\u3059\u308b\u3002 <\/p>\n\n<ul>\n<li><h3>\u96fb\u5b50\u60a3\u8005\u5831\u544a\u30a2\u30a6\u30c8\u30ab\u30e0\uff08ePRO\uff09\u30b7\u30b9\u30c6\u30e0<\/h3><\/li>\n<\/ul>\n\n<p>ePRO\u30b7\u30b9\u30c6\u30e0\u3067\u306f\u3001\u60a3\u8005\u304c\u81ea\u5206\u306e\u5065\u5eb7\u95a2\u9023\u30c7\u30fc\u30bf\u3092\u96fb\u5b50\u6a5f\u5668\u306b\u76f4\u63a5\u5165\u529b\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u60a3\u8005\u5831\u544a\u30a2\u30a6\u30c8\u30ab\u30e0\u3092\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0\u3067\u53ce\u96c6\u3057\u3001\u30c7\u30fc\u30bf\u5165\u529b\u30a8\u30e9\u30fc\u3092\u6e1b\u3089\u3057\u3001\u30c7\u30fc\u30bf\u306e\u6b63\u78ba\u6027\u3092\u5411\u4e0a\u3055\u305b\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002 <\/p>\n\n<ul>\n<li><h3>\u81e8\u5e8a\u30c7\u30fc\u30bf\u30a6\u30a7\u30a2\u30cf\u30a6\u30b9\u3068\u5206\u6790<\/h3><\/li>\n<\/ul>\n\n<p>\u30c7\u30fc\u30bf\u30a6\u30a7\u30a2\u30cf\u30a6\u30b9\u306f\u5927\u91cf\u306e\u81e8\u5e8a\u8a66\u9a13\u30c7\u30fc\u30bf\u3092\u4fdd\u5b58\u30fb\u6574\u7406\u3057\u3001\u5206\u6790\u306b\u5229\u7528\u3067\u304d\u308b\u3088\u3046\u306b\u3059\u308b\u3002\u5206\u6790\u30c4\u30fc\u30eb\u306f\u3001\u7814\u7a76\u8005\u304c\u30c7\u30fc\u30bf\u304b\u3089\u6d1e\u5bdf\u3092\u5c0e\u304d\u51fa\u3057\u3001\u50be\u5411\u3092\u7279\u5b9a\u3057\u3001\u60c5\u5831\u306b\u57fa\u3065\u3044\u305f\u610f\u601d\u6c7a\u5b9a\u3092\u884c\u3046\u306e\u306b\u5f79\u7acb\u3064\u3002 <\/p>\n\n<ul>\n<li><h3>\u898f\u5236\u9075\u5b88\u30c4\u30fc\u30eb<\/h3><\/li>\n<\/ul>\n\n<p>\u96fb\u5b50\u8a18\u9332\u304a\u3088\u3073\u96fb\u5b50\u7f72\u540d\u304c\u4fe1\u983c\u3067\u304d\u3001\u4fe1\u983c\u6027\u304c\u3042\u308a\u3001\u7d19\u306e\u8a18\u9332\u3068\u540c\u7b49\u3067\u3042\u308b\u3068\u307f\u306a\u3055\u308c\u308b\u57fa\u6e96\u3092\u5b9a\u7fa9\u3057\u305f 21 CFR Part 11 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<\/p>\n\n<ul>\n<li><h3>\u30c7\u30fc\u30bf\u6697\u53f7\u5316\u3068\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3\u30fb\u30c4\u30fc\u30eb<\/h3><\/li>\n<\/ul>\n\n<p>\u81e8\u5e8a\u8a66\u9a13\u30c7\u30fc\u30bf\u306e\u6a5f\u5bc6\u6027\u3092\u8003\u616e\u3059\u308b\u3068\u3001\u6697\u53f7\u5316\u3001\u30a2\u30af\u30bb\u30b9\u5236\u5fa1\u3001\u305d\u306e\u4ed6\u306e\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3\u5bfe\u7b56\u3092\u901a\u3058\u3066\u30c7\u30fc\u30bf\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3\u3092\u78ba\u4fdd\u3059\u308b\u30c4\u30fc\u30eb\u306f\u3001\u60a3\u8005\u306e\u6a5f\u5bc6\u6027\u3068\u8a66\u9a13\u306e\u5b8c\u5168\u6027\u3092\u4fdd\u8b77\u3059\u308b\u305f\u3081\u306b\u4e0d\u53ef\u6b20\u3067\u3042\u308b\u3002<\/p>\n\n<h2 class=\"wp-block-heading\">\u7d50\u8ad6<\/h2>\n\n<p>\u81e8\u5e8a\u30c7\u30fc\u30bf\u7ba1\u7406\u306f\u81e8\u5e8a\u8a66\u9a13\u30d7\u30ed\u30bb\u30b9\u306e\u91cd\u8981\u306a\u8981\u7d20\u3067\u3042\u308a\u3001\u53ce\u96c6\u3055\u308c\u305f\u30c7\u30fc\u30bf\u304c\u6700\u9ad8\u306e\u54c1\u8cea\u3068\u5b8c\u5168\u6027\u3092\u6301\u3064\u3053\u3068\u3092\u4fdd\u8a3c\u3059\u308b\u3002\u30d7\u30ed\u30c8\u30b3\u30fc\u30eb\u4f5c\u6210\u304b\u3089\u5831\u544a\u3001\u63d0\u51fa\u307e\u3067\u306e\u91cd\u8981\u306a\u6bb5\u968e\u306b\u306f\u3001\u7dbf\u5bc6\u306a\u8a08\u753b\u3001\u5b9f\u884c\u3001\u691c\u8a3c\u304c\u542b\u307e\u308c\u307e\u3059\u3002   <\/p>\n\n<p>\u5148\u9032\u7684\u306a\u30c4\u30fc\u30eb\u3068\u30b7\u30b9\u30c6\u30e0\u3092\u6d3b\u7528\u3059\u308b\u3053\u3068\u3067\u3001CDM\u30d7\u30ed\u30bb\u30b9\u306e\u52b9\u7387\u3068\u7cbe\u5ea6\u304c\u5411\u4e0a\u3057\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u6210\u529f\u3068\u533b\u5b66\u77e5\u8b58\u306e\u767a\u5c55\u306b\u8ca2\u732e\u3057\u307e\u3059\u3002  <\/p>\n\n<p>\u30c6\u30af\u30ce\u30ed\u30b8\u30fc\u304c\u9032\u5316\u3057\u7d9a\u3051\u308b\u4e2d\u3001\u81e8\u5e8a\u30c7\u30fc\u30bf\u7ba1\u7406\u8a08\u753b\u5206\u91ce\u306f\u3001\u30d8\u30eb\u30b9\u30b1\u30a2\u3068\u88fd\u85ac\u7814\u7a76\u306e\u672a\u6765\u3092\u5f62\u4f5c\u308b\u4e0a\u3067\u3001\u307e\u3059\u307e\u3059\u91cd\u8981\u306a\u5f79\u5272\u3092\u679c\u305f\u3059\u3053\u3068\u306f\u9593\u9055\u3044\u306a\u3044\u3002<\/p>\n\n<p>QuestionPro\u306f\u3001\u5805\u7262\u306a\u8abf\u67fb\u30fb\u7814\u7a76\u30c4\u30fc\u30eb\u3092\u63d0\u4f9b\u3059\u308b\u3053\u3068\u3067\u3001\u81e8\u5e8a\u30c7\u30fc\u30bf\u7ba1\u7406\u306b\u304a\u3044\u3066\u6975\u3081\u3066\u91cd\u8981\u306a\u5f79\u5272\u3092\u679c\u305f\u3057\u307e\u3059\u3002\u30e6\u30fc\u30b6\u30fc\u30d5\u30ec\u30f3\u30c9\u30ea\u30fc\u306a\u30a4\u30f3\u30bf\u30fc\u30d5\u30a7\u30fc\u30b9\u306f\u3001\u30c7\u30fc\u30bf\u53ce\u96c6\u3092\u5408\u7406\u5316\u3057\u3001\u6b63\u78ba\u6027\u3068\u52b9\u7387\u6027\u3092\u4fdd\u8a3c\u3057\u307e\u3059\u3002   <\/p>\n\n<p>\u81e8\u5e8a\u30c7\u30fc\u30bf\u7ba1\u7406\u8005\u306f\u3001QuestionPro \u306e\u3088\u3046\u306a\u30c4\u30fc\u30eb\u3092\u6d3b\u7528\u3057\u3066\u81e8\u5e8a\u30c7\u30fc\u30bf\u7ba1\u7406\u30d7\u30ed\u30bb\u30b9\u3092\u5408\u7406\u5316\u3057\u3001\u5f37\u5316\u3059\u308b\u3053\u3068\u3067\u3001\u533b\u7642\u60c5\u5831\u306e\u76e3\u7763\u3068\u5b8c\u5168\u6027\u306e\u7dad\u6301\u306b\u91cd\u8981\u306a\u5f79\u5272\u3092\u679c\u305f\u3057\u307e\u3059\u3002  <\/p>\n\n<p>\u9ad8\u5ea6\u3067\u5b89\u5168\u306a\u30c7\u30fc\u30bf\u4fdd\u5b58\u3068\u5206\u6790\u6a5f\u80fd\u3092\u5099\u3048\u305fQuestionPro\u306f\u3001\u7814\u7a76\u8005\u304c\u81e8\u5e8a\u30c7\u30fc\u30bf\u3092\u30b7\u30fc\u30e0\u30ec\u30b9\u306b\u53ce\u96c6\u30fb\u7ba1\u7406\u3067\u304d\u308b\u3088\u3046\u306b\u3057\u3001\u7814\u7a76\u5168\u4f53\u306e\u52b9\u679c\u3092\u9ad8\u3081\u307e\u3059\u3002<\/p>\n\n<p><\/p><p style=\"text-align: center;\"><a href=\"https:\/\/www.questionpro.com\/research-edition-survey-software\/\" target=\"_blank\" rel=\"noopener\"> <button>\u3082\u3063\u3068\u8a73\u3057\u304f<\/button> <\/a> <a href=\"https:\/\/www.questionpro.com\/a\/showEntry.do?classID=1053&amp;sourceRef=blog\" target=\"_blank\" rel=\"noopener\"> <button>\u7121\u6599\u30c8\u30e9\u30a4\u30a2\u30eb<\/button> <\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u81e8\u5e8a\u30c7\u30fc\u30bf\u7ba1\u7406\uff08CDM\uff09\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u30c7\u30fc [&hellip;]<\/p>\n","protected":false},"author":80,"featured_media":823851,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_genesis_hide_title":false,"_genesis_hide_breadcrumbs":false,"_genesis_hide_singular_image":false,"_genesis_hide_footer_widgets":false,"_genesis_custom_body_class":"","_genesis_custom_post_class":"","_genesis_layout":"","footnotes":""},"categories":[1115],"tags":[],"yoast_head":"<!-- This site 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