{"id":2708,"date":"2026-03-07T23:32:06","date_gmt":"2026-03-07T14:32:06","guid":{"rendered":"https:\/\/chiken-net.site\/column\/?p=2708"},"modified":"2026-05-03T06:06:27","modified_gmt":"2026-05-02T21:06:27","slug":"clinical-trial-professionals","status":"publish","type":"post","link":"https:\/\/chiken-net.site\/column\/clinical-trial-professionals\/","title":{"rendered":"\u6cbb\u9a13\u306e\u88cf\u5074\u3092\u652f\u3048\u308b\u5c02\u9580\u5bb6\u305f\u3061\uff1a\u65b0\u85ac\u958b\u767a\u3092\u52d5\u304b\u3059\u8077\u7a2e\u3068\u5f79\u5272\u3092\u5fb9\u5e95\u89e3\u8aac"},"content":{"rendered":"\n<p>\u79c1\u305f\u3061\u304c\u5b89\u5fc3\u3057\u3066\u85ac\u3092\u4f7f\u3048\u308b\u306e\u306f\u3001\u305d\u306e\u88cf\u5074\u3067\u591a\u304f\u306e\u5c02\u9580\u5bb6\u304c\u9023\u643a\u3057\u3001\u53b3\u3057\u3044\u57fa\u6e96\u3092\u5b88\u308a\u306a\u304c\u3089\u65b0\u85ac\u958b\u767a\u3092\u9032\u3081\u3066\u3044\u308b\u304b\u3089\u3067\u3059\u3002\u6cbb\u9a13\u306f\u3001\u88fd\u85ac\u4f1a\u793e\u3084\u533b\u7642\u6a5f\u95a2\u3060\u3051\u3067\u306a\u304f\u3001\u3055\u307e\u3056\u307e\u306a\u8077\u7a2e\u306e\u30d7\u30ed\u30d5\u30a7\u30c3\u30b7\u30e7\u30ca\u30eb\u304c\u529b\u3092\u5408\u308f\u305b\u308b\u300c\u30d0\u30c8\u30f3\u30ea\u30ec\u30fc\u300d\u306e\u3088\u3046\u306a\u3082\u306e\u3002\u3053\u306e\u8a18\u4e8b\u3067\u306f\u3001\u6cbb\u9a13\u3068\u3044\u3046\u58ee\u5927\u306a\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3092\u652f\u3048\u308b\u4eba\u3005\u306e\u8077\u7a2e\u3068\u3001\u305d\u306e\u91cd\u8981\u306a\u696d\u52d9\u5185\u5bb9\u3092\u308f\u304b\u308a\u3084\u3059\u304f\u89e3\u8aac\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<p><strong>\u3010\u6cbb\u9a13\u30cd\u30c3\u30c8\u304b\u3089\u306e\u91cd\u8981\u306a\u304a\u77e5\u3089\u305b\u3011<\/strong><\/p>\n\n\n\n<p><strong>\u672c\u8a18\u4e8b\u3067\u63d0\u4f9b\u3059\u308b\u533b\u7642\u60c5\u5831\u306f\u3001\u4e00\u822c\u7684\u306a\u77e5\u8b58\u306e\u63d0\u4f9b\u3092\u76ee\u7684\u3068\u3057\u3066\u304a\u308a\u3001\u7279\u5b9a\u306e\u75be\u60a3\u306e\u8a3a\u65ad\u3001\u6cbb\u7642\u3001\u307e\u305f\u306f\u4e88\u9632\u3092\u610f\u56f3\u3059\u308b\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u6cbb\u9a13\u3078\u306e\u53c2\u52a0\u3092\u3054\u691c\u8a0e\u3055\u308c\u308b\u969b\u306f\u3001\u5fc5\u305a\u533b\u5e2b\u3084\u5c02\u9580\u5bb6\u306b\u3054\u76f8\u8ac7\u306e\u4e0a\u3001\u3054\u81ea\u8eab\u306e\u5224\u65ad\u3068\u8cac\u4efb\u306b\u304a\u3044\u3066\u6c7a\u5b9a\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/strong><\/p>\n\n\n\n<div class=\"trial-summary\" data-filter=\"all\" style=\"background:#f0faf0;border-left:4px solid #43A047;padding:16px 20px;margin:20px 0;border-radius:0 8px 8px 0\"><p style=\"margin:0;color:#333;line-height:1.8\">\u73fe\u5728\u3001\u6cbb\u9a13\u30fb\u30e2\u30cb\u30bf\u30fc\u3067\u306f<strong>30\u4ef6<\/strong>\u306e\u6cbb\u9a13\u30fb\u30e2\u30cb\u30bf\u30fc\u6848\u4ef6\u304c\u52df\u96c6\u4e2d\u3067\u3059\uff08\u8ca0\u62c5\u8efd\u6e1b\u8cbb: 7\u4e076\u5343\u5186\u301c34\u4e075\u5343\u5186\uff09\u3002BMI\u57fa\u6e96\u7de9\u3081\u30fb\u4e5d\u5dde\u30fb\u975e\u55ab\u7159\u8005\u9650\u5b9a\u7b49\u306e\u6848\u4ef6\u304c\u3042\u308a\u307e\u3059\u3002\u5b9f\u65bd\u30a8\u30ea\u30a2\u306f\u4e5d\u5dde\u30fb\u95a2\u6771\u30fb\u798f\u5ca1\u30fb\u95a2\u897f\u30fb\u6771\u4eac\u3067\u3059\u3002<\/p><p style=\"margin:4px 0 0;font-size:0.8em;color:#888\">\u203b2026-05-03\u6642\u70b9\u3002\u6700\u65b0\u72b6\u6cc1\u306f\u8a18\u4e8b\u672b\u5c3e\u306e\u6848\u4ef6\u4e00\u89a7\u3092\u3054\u78ba\u8a8d\u304f\u3060\u3055\u3044\u3002<\/p><\/div>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"2560\" height=\"1396\" src=\"https:\/\/chiken-net.site\/column\/wp-content\/uploads\/2026\/03\/image-2-real-1772892916785-scaled.jpg\" alt=\"\u30a2\u30a4\u30ad\u30e3\u30c3\u30c1\u753b\u50cf\" class=\"wp-image-2711\" srcset=\"https:\/\/chiken-net.site\/column\/wp-content\/uploads\/2026\/03\/image-2-real-1772892916785-scaled.jpg 2560w, https:\/\/chiken-net.site\/column\/wp-content\/uploads\/2026\/03\/image-2-real-1772892916785-300x164.jpg 300w, https:\/\/chiken-net.site\/column\/wp-content\/uploads\/2026\/03\/image-2-real-1772892916785-1024x559.jpg 1024w, https:\/\/chiken-net.site\/column\/wp-content\/uploads\/2026\/03\/image-2-real-1772892916785-768x419.jpg 768w, https:\/\/chiken-net.site\/column\/wp-content\/uploads\/2026\/03\/image-2-real-1772892916785-1536x838.jpg 1536w, https:\/\/chiken-net.site\/column\/wp-content\/uploads\/2026\/03\/image-2-real-1772892916785-2048x1117.jpg 2048w\" sizes=\"auto, (max-width: 2560px) 100vw, 2560px\" \/><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\">\u6cbb\u9a13\u306b\u643a\u308f\u308b\u4eba\u305f\u3061\u306e\u8077\u7a2e\u3068\u696d\u52d9\u5185\u5bb9\uff1a\u30c1\u30fc\u30e0\u3067\u672a\u6765\u306e\u533b\u7642\u3092\u7bc9\u304f<\/h2>\n\n\n\n<p>\u6cbb\u9a13\u306f\u3001\u65b0\u3057\u3044\u85ac\u304c\u4e16\u306b\u51fa\u308b\u307e\u3067\u306e\u6700\u7d42\u6bb5\u968e\u3067\u3042\u308a\u3001\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u614e\u91cd\u306b\u78ba\u8a8d\u3059\u308b\u30d7\u30ed\u30bb\u30b9\u3067\u3059\u3002\u3053\u306e\u8907\u96d1\u306a\u9053\u306e\u308a\u3092\u3001\u4e00\u3064\u306e\u4f01\u696d\u3084\u533b\u7642\u6a5f\u95a2\u3060\u3051\u3067\u5b8c\u7d50\u3055\u305b\u308b\u3053\u3068\u306f\u3067\u304d\u307e\u305b\u3093\u3002\u88fd\u85ac\u4f1a\u793e\u3001\u533b\u7642\u6a5f\u95a2\u3001\u305d\u3057\u3066\u305d\u308c\u3089\u3092\u5c02\u9580\u7684\u306b\u652f\u63f4\u3059\u308b\u5916\u90e8\u7d44\u7e54\u304c\u3001\u305d\u308c\u305e\u308c\u306e\u5f79\u5272\u3092\u679c\u305f\u3059\u3053\u3068\u3067\u3001\u521d\u3081\u3066\u65b0\u85ac\u304c\u60a3\u8005\u3055\u3093\u306e\u3082\u3068\u306b\u5c4a\u304f\u306e\u3067\u3059\u3002<\/p>\n\n\n\n<p>\u6cbb\u9a13\u306b\u95a2\u308f\u308b\u4e3b\u306a\u7d44\u7e54\u306f\u4ee5\u4e0b\u306e\u901a\u308a\u3067\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u6cbb\u9a13\u4f9d\u983c\u8005\uff08\u88fd\u85ac\u4f1a\u793e\uff09<\/strong>: \u65b0\u85ac\u958b\u767a\u306e\u4f01\u753b\u3001\u8cc7\u91d1\u63d0\u4f9b\u3001\u6700\u7d42\u7684\u306a\u627f\u8a8d\u7533\u8acb\u3001\u88fd\u9020\u8ca9\u58f2\u3092\u884c\u3044\u307e\u3059\u3002\u533b\u85ac\u54c1\u306e\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u306e\u57fa\u6e96\uff08GCP\uff09\u3068\u547c\u3070\u308c\u308b\u3001\u88ab\u9a13\u8005\u306e\u4eba\u6a29\u3068\u5b89\u5168\u306e\u78ba\u4fdd\u3001\u81e8\u5e8a\u30c7\u30fc\u30bf\u306e\u4fe1\u983c\u6027\u306e\u78ba\u4fdd\u3092\u76ee\u7684\u3068\u3057\u305f\u539a\u751f\u52b4\u50cd\u7701\u4ee4\u3092\u9075\u5b88\u3059\u308b\u7fa9\u52d9\u304c\u3042\u308a\u307e\u3059\u3002<\/li>\n\n\n\n<li><strong>\u958b\u767a\u696d\u52d9\u53d7\u8a17\u6a5f\u95a2\uff08CRO\uff09<\/strong>: \u88fd\u85ac\u4f1a\u793e\u306e\u696d\u52d9\u306e\u4e00\u90e8\u3001\u4f8b\u3048\u3070\u6cbb\u9a13\u306e\u9032\u6357\u76e3\u8996\u3084\u30c7\u30fc\u30bf\u7ba1\u7406\u306a\u3069\u3092\u4ee3\u884c\u3057\u307e\u3059\u3002CRO\u306f\u533b\u85ac\u54c1\u958b\u767a\u306e\u69d8\u3005\u306a\u696d\u52d9\u3092\u53d7\u8a17\u3059\u308b\u7d44\u7e54\u3067\u3042\u308a\u3001\u56fd\u5185\u5e02\u5834\u306f\u62e1\u5927\u50be\u5411\u306b\u3042\u308a\u307e\u3059\u3002<\/li>\n\n\n\n<li><strong>\u6cbb\u9a13\u65bd\u8a2d\u652f\u63f4\u6a5f\u95a2\uff08SMO\uff09<\/strong>: \u6cbb\u9a13\u3092\u884c\u3046\u533b\u7642\u6a5f\u95a2\u306e\u4e8b\u52d9\u4f5c\u696d\u3092\u652f\u63f4\u3057\u3001\u6cbb\u9a13\u30b3\u30fc\u30c7\u30a3\u30cd\u30fc\u30bf\u30fc\uff08CRC\uff09\u3092\u6d3e\u9063\u3057\u307e\u3059\u3002\u533b\u7642\u6a5f\u95a2\u304cGCP\u306b\u57fa\u3065\u304d\u9069\u6b63\u3067\u5186\u6ed1\u306a\u6cbb\u9a13\u3092\u5b9f\u65bd\u3067\u304d\u308b\u3088\u3046\u3001\u533b\u7642\u6a5f\u95a2\u306b\u304a\u3044\u3066\u7169\u96d1\u306a\u6cbb\u9a13\u696d\u52d9\u3092\u652f\u63f4\u3057\u307e\u3059\u3002<\/li>\n\n\n\n<li><strong>\u5b9f\u65bd\u533b\u7642\u6a5f\u95a2\uff08\u75c5\u9662\u30fb\u30af\u30ea\u30cb\u30c3\u30af\uff09<\/strong>: \u5b9f\u969b\u306b\u6cbb\u9a13\u3092\u884c\u3044\u3001\u88ab\u9a13\u8005\u306e\u8a3a\u7642\u3084\u6cbb\u9a13\u85ac\u306e\u6295\u4e0e\u3001\u533b\u5b66\u7684\u5224\u65ad\u3092\u884c\u3044\u307e\u3059\u3002<\/li>\n<\/ul>\n\n\n\n<p>\u3053\u308c\u3089\u306e\u7d44\u7e54\u304c\u9023\u643a\u3057\u3001\u88ab\u9a13\u8005\u306e\u5b89\u5168\u3092\u6700\u512a\u5148\u3057\u306a\u304c\u3089\u3001\u4fe1\u983c\u3067\u304d\u308b\u30c7\u30fc\u30bf\u3092\u751f\u307f\u51fa\u3059\u8cac\u4efb\u3092\u5171\u6709\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u6cbb\u9a13\u306e\u54c1\u8cea\u3092\u7ba1\u7406\u3059\u308b\u300c\u81e8\u5e8a\u958b\u767a\u30e2\u30cb\u30bf\u30fc\uff08CRA\uff09\u300d\u306e\u5f79\u5272<\/h2>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"2560\" height=\"1396\" src=\"https:\/\/chiken-net.site\/column\/wp-content\/uploads\/2026\/03\/image-1-real-1772892898647-scaled.jpg\" alt=\"\u6cbb\u9a13\u306e\u54c1\u8cea\u3092\u7ba1\u7406\u3059\u308b\u300c\u81e8\u5e8a\u958b\u767a\u30e2\u30cb\u30bf\u30fc\uff08CRA\uff09\u300d\u306e\u5f79\u5272\" class=\"wp-image-2710\" srcset=\"https:\/\/chiken-net.site\/column\/wp-content\/uploads\/2026\/03\/image-1-real-1772892898647-scaled.jpg 2560w, https:\/\/chiken-net.site\/column\/wp-content\/uploads\/2026\/03\/image-1-real-1772892898647-300x164.jpg 300w, https:\/\/chiken-net.site\/column\/wp-content\/uploads\/2026\/03\/image-1-real-1772892898647-1024x559.jpg 1024w, https:\/\/chiken-net.site\/column\/wp-content\/uploads\/2026\/03\/image-1-real-1772892898647-768x419.jpg 768w, https:\/\/chiken-net.site\/column\/wp-content\/uploads\/2026\/03\/image-1-real-1772892898647-1536x838.jpg 1536w, https:\/\/chiken-net.site\/column\/wp-content\/uploads\/2026\/03\/image-1-real-1772892898647-2048x1117.jpg 2048w\" sizes=\"auto, (max-width: 2560px) 100vw, 2560px\" \/><\/figure>\n\n\n\n<p>\u300c\u81e8\u5e8a\u958b\u767a\u30e2\u30cb\u30bf\u30fc\u300d\uff08CRA: Clinical Research Associate\uff09\u306f\u3001\u6cbb\u9a13\u304c\u56fd\u306e\u5b9a\u3081\u305f\u57fa\u6e96\uff08GCP\uff09\u3084\u6cbb\u9a13\u5b9f\u65bd\u8a08\u753b\u66f8\uff08\u30d7\u30ed\u30c8\u30b3\u30fc\u30eb\uff09\u901a\u308a\u306b\u9032\u3081\u3089\u308c\u3066\u3044\u308b\u304b\u3092\u300c\u76e3\u8996\u300d\u3059\u308b\u91cd\u8981\u306a\u5f79\u5272\u3092\u62c5\u3044\u307e\u3059\u3002\u4e3b\u306b\u88fd\u85ac\u4f1a\u793e\u3084CRO\u306b\u6240\u5c5e\u3057\u3001\u533b\u7642\u6a5f\u95a2\u3092\u5916\u90e8\u304b\u3089\u30c1\u30a7\u30c3\u30af\u3059\u308b\u54c1\u8cea\u7ba1\u7406\u306e\u8981\u3068\u306a\u308b\u5b58\u5728\u3067\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">CRA\u306e\u4e3b\u306a\u696d\u52d9\u5185\u5bb9<\/h3>\n\n\n\n<p>\u81e8\u5e8a\u958b\u767a\u30e2\u30cb\u30bf\u30fc\u306e\u696d\u52d9\u306f\u3001\u6cbb\u9a13\u306e\u5404\u6bb5\u968e\u3067\u591a\u5c90\u306b\u308f\u305f\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li> <strong>\u6cbb\u9a13\u958b\u59cb\u524d\u306e\u6e96\u5099<\/strong>: \u6cbb\u9a13\u3092\u884c\u3046\u306e\u306b\u3075\u3055\u308f\u3057\u3044\u533b\u7642\u6a5f\u95a2\u3092\u9078\u3073\u3001\u533b\u5e2b\u306e\u6cbb\u9a13\u7d4c\u9a13\u3084\u5bfe\u8c61\u60a3\u8005\u306e\u72b6\u6cc1\u3001\u6cbb\u9a13\u85ac\u306e\u4fdd\u7ba1\u8a2d\u5099\u306a\u3069\u3092\u8a55\u4fa1\u3057\u307e\u3059\u3002\u305d\u306e\u5f8c\u3001\u533b\u7642\u30b9\u30bf\u30c3\u30d5\u5168\u54e1\u306b\u6cbb\u9a13\u306e\u8a73\u7d30\u3084\u7dca\u6025\u6642\u306e\u5bfe\u5fdc\u3092\u8aac\u660e\u3059\u308b\u4f1a\u8b70\u3092\u884c\u3044\u307e\u3059\u3002<\/li>\n\n\n\n<li> <strong>\u6cbb\u9a13\u5b9f\u65bd\u4e2d\u306e\u78ba\u8a8d<\/strong>: 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<strong>\u6cbb\u9a13\u7d42\u4e86\u6642\u306e\u624b\u7d9a\u304d<\/strong>: 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class=\"wp-block-heading\">\u88ab\u9a13\u8005\u3068\u533b\u7642\u6a5f\u95a2\u3092\u3064\u306a\u3050\u300c\u6cbb\u9a13\u30b3\u30fc\u30c7\u30a3\u30cd\u30fc\u30bf\u30fc\uff08CRC\uff09\u300d\u306e\u5f79\u5272<\/h2>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"2560\" height=\"1396\" src=\"https:\/\/chiken-net.site\/column\/wp-content\/uploads\/2026\/03\/image-0-real-1772892880467-scaled.jpg\" alt=\"\u88ab\u9a13\u8005\u3068\u533b\u7642\u6a5f\u95a2\u3092\u3064\u306a\u3050\u300c\u6cbb\u9a13\u30b3\u30fc\u30c7\u30a3\u30cd\u30fc\u30bf\u30fc\uff08CRC\uff09\u300d\u306e\u5f79\u5272\" class=\"wp-image-2709\" srcset=\"https:\/\/chiken-net.site\/column\/wp-content\/uploads\/2026\/03\/image-0-real-1772892880467-scaled.jpg 2560w, https:\/\/chiken-net.site\/column\/wp-content\/uploads\/2026\/03\/image-0-real-1772892880467-300x164.jpg 300w, https:\/\/chiken-net.site\/column\/wp-content\/uploads\/2026\/03\/image-0-real-1772892880467-1024x559.jpg 1024w, https:\/\/chiken-net.site\/column\/wp-content\/uploads\/2026\/03\/image-0-real-1772892880467-768x419.jpg 768w, https:\/\/chiken-net.site\/column\/wp-content\/uploads\/2026\/03\/image-0-real-1772892880467-1536x838.jpg 1536w, https:\/\/chiken-net.site\/column\/wp-content\/uploads\/2026\/03\/image-0-real-1772892880467-2048x1117.jpg 2048w\" sizes=\"auto, (max-width: 2560px) 100vw, 2560px\" \/><\/figure>\n\n\n\n<p>\u300c\u6cbb\u9a13\u30b3\u30fc\u30c7\u30a3\u30cd\u30fc\u30bf\u30fc\u300d\uff08CRC: Clinical Research Coordinator\uff09\u306f\u3001\u6cbb\u9a13\u304c\u30b9\u30e0\u30fc\u30ba\u306b\u9032\u3080\u3088\u3046\u306b\u3001\u533b\u5e2b\u3001\u88ab\u9a13\u8005\u3001\u81e8\u5e8a\u958b\u767a\u30e2\u30cb\u30bf\u30fc\u3001\u305d\u3057\u3066\u75c5\u9662\u5185\u306e\u5404\u90e8\u7f72\u306e\u9593\u3092\u53d6\u308a\u6301\u3064\u300c\u6247\u306e\u8981\u300d\u306e\u3088\u3046\u306a\u5b58\u5728\u3067\u3059\u3002\u770b\u8b77\u5e2b\u3001\u85ac\u5264\u5e2b\u3001\u81e8\u5e8a\u691c\u67fb\u6280\u5e2b\u306a\u3069\u306e\u533b\u7642\u8cc7\u683c\u3092\u6301\u3064\u4eba\u304c\u3001\u305d\u306e\u5c02\u9580\u77e5\u8b58\u3092\u6d3b\u304b\u3057\u3066\u50cd\u304f\u3053\u3068\u304c\u4e00\u822c\u7684\u3067\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">CRC\u306e\u4e3b\u306a\u696d\u52d9\u5185\u5bb9<\/h3>\n\n\n\n<p>\u6cbb\u9a13\u30b3\u30fc\u30c7\u30a3\u30cd\u30fc\u30bf\u30fc\u306e\u696d\u52d9\u306f\u3001\u88ab\u9a13\u8005\u3078\u306e\u76f4\u63a5\u7684\u306a\u30b5\u30dd\u30fc\u30c8\u304b\u3089\u3001\u533b\u5e2b\u306e\u4e8b\u52d9\u7684\u306a\u88dc\u52a9\u3001\u75c5\u9662\u5185\u306e\u8abf\u6574\u307e\u3067\u3001\u591a\u5c90\u306b\u308f\u305f\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li> <strong>\u88ab\u9a13\u8005\u3078\u306e\u30b5\u30dd\u30fc\u30c8<\/strong>: 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Associate\uff09\u3067\u3059\u3002\u6cbb\u9a13\u30b3\u30fc\u30c7\u30a3\u30cd\u30fc\u30bf\u30fc\u304c\u73fe\u5834\u306e\u62c5\u5f53\u8005\u3067\u3042\u308b\u306a\u3089\u3001\u6cbb\u9a13\u4e8b\u52d9\u5c40\u62c5\u5f53\u8005\u306f\u7d44\u7e54\u306e\u62c5\u5f53\u8005\u3067\u3042\u308a\u3001\u6cd5\u7684\u306a\u5951\u7d04\u3084\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\uff08\u6cd5\u4ee4\u9075\u5b88\uff09\u3092\u7ba1\u7406\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u4e3b\u306a\u696d\u52d9\u306f\u3001\u88fd\u85ac\u4f1a\u793e\u3068\u306e\u6cbb\u9a13\u5951\u7d04\u306e\u7de0\u7d50\u3001\u6cbb\u9a13\u8cbb\u7528\u306e\u8a08\u7b97\u30fb\u8acb\u6c42\u7ba1\u7406\u3001\u75c5\u9662\u5185\u3067\u306e\u6cbb\u9a13\u5b9f\u65bd\u306b\u95a2\u3059\u308b\u6a19\u6e96\u7684\u306a\u624b\u9806\u66f8\uff08SOP\uff09\u306e\u4f5c\u6210\u306a\u3069\u3067\u3059\u3002\u307e\u305f\u3001\u6cbb\u9a13\u304c\u502b\u7406\u7684\u306b\u9069\u5207\u3067\u79d1\u5b66\u7684\u306b\u59a5\u5f53\u3067\u3042\u308b\u304b\u3092\u5be9\u67fb\u3059\u308b\u300c\u6cbb\u9a13\u5be9\u67fb\u59d4\u54e1\u4f1a\uff08IRB\uff09\u300d\u306e\u4e8b\u52d9\u5c40\u3092\u62c5\u3044\u3001\u59d4\u54e1\u4f1a\u306e\u904b\u55b6\u88dc\u52a9\u3084\u5be9\u67fb\u7533\u8acb\u66f8\u985e\u306e\u4f5c\u6210\u652f\u63f4\u3092\u884c\u3046\u91cd\u8981\u306a\u5f79\u5272\u3082\u679c\u305f\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<h3 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class=\"wp-block-heading\">\u5b89\u5168\u6027\u60c5\u5831\uff08PV\uff09\u62c5\u5f53\u8005<\/h3>\n\n\n\n<p>\u6cbb\u9a13\u306e\u9032\u884c\u4e2d\u3001\u5e38\u306b\u91cd\u8996\u3055\u308c\u308b\u306e\u304c\u300c\u5b89\u5168\u6027\u300d\u3067\u3059\u3002\u3053\u308c\u3092\u5c02\u9580\u306b\u6271\u3046\u306e\u304c\u300c\u5b89\u5168\u6027\u60c5\u5831\u300d\uff08PV: Pharmacovigilance\uff09\u62c5\u5f53\u8005\u3067\u3059\u3002\u6cbb\u9a13\u4e2d\u306b\u767a\u751f\u3057\u305f\u3042\u3089\u3086\u308b\u597d\u307e\u3057\u304f\u306a\u3044\u4e8b\u8c61\uff08\u6709\u5bb3\u4e8b\u8c61\uff09\u306f\u3001\u76f4\u3061\u306b\u88fd\u85ac\u4f1a\u793e\u306e\u5b89\u5168\u6027\u60c5\u5831\u90e8\u9580\u3078\u5831\u544a\u3055\u308c\u307e\u3059\u3002\u5b89\u5168\u6027\u60c5\u5831\u62c5\u5f53\u8005\u306f\u3001\u305d\u306e\u4e8b\u8c61\u304c\u6cbb\u9a13\u85ac\u3068\u306e\u56e0\u679c\u95a2\u4fc2\u304c\u3042\u308b\u304b\u3001\u307e\u305f\u3001\u3053\u308c\u307e\u3067\u306b\u77e5\u3089\u308c\u3066\u3044\u306a\u3044\u65b0\u3057\u3044\u30bf\u30a4\u30d7\u306e\u30ea\u30b9\u30af\u3067\u306f\u306a\u3044\u304b\u3092\u8a55\u4fa1\u3057\u307e\u3059\u3002\u3082\u3057\u91cd\u7be4\u306a\u526f\u4f5c\u7528\u304c\u767a\u751f\u3057\u305f\u5834\u5408\u306b\u306f\u3001\u533b\u85ac\u54c1\u533b\u7642\u6a5f\u5668\u7dcf\u5408\u6a5f\u69cb\uff08PMDA\uff09\u3084\u539a\u751f\u52b4\u50cd\u7701\u3078\u7dca\u6025\u5831\u544a\u3059\u308b\u7fa9\u52d9\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<h3 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class=\"wp-block-heading\">\u6cbb\u9a13\u30d7\u30ed\u30bb\u30b9\u306e\u30d0\u30c8\u30f3\u30ea\u30ec\u30fc\uff1a\u65b0\u85ac\u304c\u5c4a\u304f\u307e\u3067\u306e\u9053\u306e\u308a<\/h2>\n\n\n\n<p>\u6cbb\u9a13\u306f\u3001\u4e00\u3064\u306e\u8077\u7a2e\u304c\u5b8c\u7d50\u3055\u305b\u308b\u3082\u306e\u3067\u306f\u306a\u304f\u3001\u30d0\u30c8\u30f3\u3092\u7e4b\u3044\u3067\u3044\u304f\u30ea\u30ec\u30fc\u305d\u306e\u3082\u306e\u3067\u3059\u3002\u3053\u306e\u30d0\u30c8\u30f3\u306e\u3064\u306a\u304c\u308a\u3092\u7406\u89e3\u3059\u308b\u3053\u3068\u3067\u3001\u65b0\u85ac\u304c\u3069\u306e\u3088\u3046\u306b\u3057\u3066\u79c1\u305f\u3061\u306e\u624b\u5143\u306b\u5c4a\u304f\u306e\u304b\u3001\u305d\u306e\u672c\u8cea\u304c\u898b\u3048\u3066\u304d\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u65b0\u85ac\u958b\u767a\u306b\u304a\u3051\u308b\u30d0\u30c8\u30f3\u30ea\u30ec\u30fc\u306f\u3001\u88ab\u9a13\u8005\u306e\u65b9\u3005\u306e\u5b89\u5168\u3068\u3001\u96c6\u3081\u3089\u308c\u308b\u30c7\u30fc\u30bf\u306e\u4fe1\u983c\u6027\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306b\u3001\u5404\u6bb5\u968e\u3067\u53b3\u5bc6\u306a\u78ba\u8a8d\u4f5c\u696d\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002\u5404\u8077\u7a2e\u304c\u305d\u306e\u5f79\u5272\u3092\u679c\u305f\u3059\u3053\u3068\u3067\u3001\u6cbb\u9a13\u53c2\u52a0\u8005\u306e\u65b9\u3005\u304c\u5b89\u5fc3\u3057\u3066\u6cbb\u9a13\u306b\u81e8\u3080\u3053\u3068\u304c\u3067\u304d\u3001\u307e\u305f\u3001\u305d\u306e\u300c\u6642\u9593\u306e\u6295\u8cc7\u300d\u304c\u672a\u6765\u306e\u533b\u7642\u306b\u78ba\u304b\u306a\u4fa1\u5024\u3068\u3057\u3066\u9084\u5143\u3055\u308c\u308b\u306e\u3067\u3059\u3002<\/p>\n\n\n\n<p>\u6cbb\u9a13\u30c7\u30fc\u30bf\u306e\u751f\u6210\u304b\u3089\u627f\u8a8d\u7533\u8acb\u307e\u3067\u306e\u60c5\u5831\u306e\u6d41\u308c\u306f\u4ee5\u4e0b\u306e\u901a\u308a\u3067\u3059\u3002<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><thead><tr><th>\u30d5\u30a7\u30fc\u30ba<\/th><th>\u60c5\u5831\u306e\u751f\u6210\u30fb\u52a0\u5de5<\/th><th>\u4e3b\u306a\u62c5\u5f53\u8077\u7a2e<\/th><th>\u5f79\u5272\u306e\u30ad\u30fc\u30ef\u30fc\u30c9<\/th><th>\u6cbb\u9a13\u53c2\u52a0\u8005\u3078\u306e\u5f71\u97ff\uff08\u6cbb\u9a13\u30cd\u30c3\u30c8\u306e\u8996\u70b9\uff09<\/th><\/tr><\/thead><tbody><tr><td><strong>\u767a\u751f<\/strong><\/td><td>\u88ab\u9a13\u8005\u306e\u8a3a\u5bdf\u3001\u691c\u67fb\u5024\u306e\u7b97\u51fa<\/td><td>\u533b\u5e2b\u3001\u770b\u8b77\u5e2b\u3001\u6cbb\u9a13\u30b3\u30fc\u30c7\u30a3\u30cd\u30fc\u30bf\u30fc<\/td><td>\u6b63\u78ba\u306a\u6e2c\u5b9a\u3001\u9069\u683c\u6027\u5224\u65ad<\/td><td>\u9069\u5207\u306a\u88ab\u9a13\u8005\u9078\u5b9a\u306b\u3088\u308a\u3001\u53c2\u52a0\u8005\u306e\u5b89\u5168\u3068\u8a66\u9a13\u306e\u6b63\u78ba\u6027\u3092\u78ba\u4fdd\u3002<\/td><\/tr><tr><td><strong>\u8a18\u9332<\/strong><\/td><td>\u30ab\u30eb\u30c6\u3078\u306e\u8a18\u8f09\u3001\u30c7\u30fc\u30bf\u5165\u529b<\/td><td>\u533b\u5e2b\u3001\u6cbb\u9a13\u30b3\u30fc\u30c7\u30a3\u30cd\u30fc\u30bf\u30fc<\/td><td>\u6f0f\u308c\u306e\u306a\u3044\u8a18\u9332\u3001\u4e8b\u5b9f\u306e\u56fa\u5b9a<\/td><td>\u6b63\u78ba\u306a\u8a18\u9332\u3067\u3001\u53c2\u52a0\u8005\u306e\u5065\u5eb7\u72b6\u614b\u304c\u9069\u5207\u306b\u7ba1\u7406\u3055\u308c\u307e\u3059\u3002<\/td><\/tr><tr><td><strong>\u691c\u8a3c<\/strong><\/td><td>\u5143\u8cc7\u6599\u3068\u306e\u7167\u5408\u3001\u78ba\u8a8d\u4f5c\u696d<\/td><td>\u81e8\u5e8a\u958b\u767a\u30e2\u30cb\u30bf\u30fc<\/td><td>\u5ba2\u89b3\u7684\u88cf\u4ed8\u3051\u3001\u30eb\u30fc\u30eb\u306e\u9075\u5b88<\/td><td>\u30c7\u30fc\u30bf\u306e\u4fe1\u983c\u6027\u3092\u4fdd\u8a3c\u3057\u3001\u53c2\u52a0\u8005\u306e\u8ca0\u62c5\u8efd\u6e1b\u3068\u5229\u76ca\u306b\u76f4\u7d50\u3002<\/td><\/tr><tr><td><strong>\u7cbe\u88fd<\/strong><\/td><td>\u554f\u3044\u5408\u308f\u305b\u5bfe\u5fdc\u3001\u30c7\u30fc\u30bf\u6574\u7406<\/td><td>\u30c7\u30fc\u30bf\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u62c5\u5f53\u8005\u3001\u81e8\u5e8a\u958b\u767a\u30e2\u30cb\u30bf\u30fc\u3001\u6cbb\u9a13\u30b3\u30fc\u30c7\u30a3\u30cd\u30fc\u30bf\u30fc<\/td><td>\u30c7\u30fc\u30bf\u306e\u6574\u5408\u6027\u3001\u6a19\u6e96\u5316<\/td><td>\u8907\u96d1\u306a\u533b\u7642\u30c7\u30fc\u30bf\u3092\u6574\u7406\u3057\u3001\u53c2\u52a0\u8005\u306e\u8ca2\u732e\u304c\u660e\u78ba\u306a\u5f62\u3067\u6d3b\u304b\u3055\u308c\u307e\u3059\u3002<\/td><\/tr><tr><td><strong>\u5206\u6790<\/strong><\/td><td>\u7d71\u8a08\u8a08\u7b97\u3001\u7d50\u679c\u306e\u89e3\u91c8<\/td><td>\u7d71\u8a08\u89e3\u6790\u62c5\u5f53\u8005<\/td><td>\u79d1\u5b66\u7684\u7acb\u8a3c\u3001\u6709\u610f\u5dee\u306e\u691c\u8a3c<\/td><td>\u79d1\u5b66\u7684\u6839\u62e0\u306b\u57fa\u3065\u304d\u3001\u65b0\u85ac\u306e\u6709\u52b9\u6027\u3068\u5b89\u5168\u6027\u304c\u8a55\u4fa1\u3055\u308c\u307e\u3059\u3002<\/td><\/tr><tr><td><strong>\u5b8c\u6210<\/strong><\/td><td>\u5831\u544a\u66f8\u4f5c\u6210\u3001\u627f\u8a8d\u7533\u8acb\u8cc7\u6599\u306e\u7d71\u5408<\/td><td>\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30bf\u30fc\u3001\u81e8\u5e8a\u958b\u767a\u30e2\u30cb\u30bf\u30fc\u3001\u85ac\u4e8b\u62c5\u5f53\u8005<\/td><td>\u30a8\u30d3\u30c7\u30f3\u30b9\u306e\u4f53\u7cfb\u5316<\/td><td>\u6cbb\u9a13\u306e\u6210\u679c\u304c\u56fd\u306b\u6b63\u3057\u304f\u4f1d\u3048\u3089\u308c\u3001\u65b0\u85ac\u627f\u8a8d\u3078\u3068\u7e4b\u304c\u308a\u307e\u3059\u3002<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>\u3053\u306e\u30ea\u30ec\u30fc\u306b\u304a\u3044\u3066\u3001\u3069\u3053\u304b\u4e00\u7b87\u6240\u3067\u3082\u30d0\u30c8\u30f3\u304c\u843d\u3061\u308c\u3070\uff08\u4e0d\u9069\u5207\u306a\u30c7\u30fc\u30bf\u304c\u3042\u308c\u3070\uff09\u3001\u6cbb\u9a13\u5168\u4f53\u306e\u4fe1\u983c\u6027\u304c\u5931\u308f\u308c\u3001\u6700\u60aa\u306e\u5834\u5408\u306f\u305d\u308c\u307e\u3067\u306e\u81a8\u5927\u306a\u6295\u8cc7\u3068\u6b73\u6708\u304c\u7121\u306b\u5e30\u3059\u3053\u3068\u3082\u3042\u308a\u307e\u3059\u3002\u5404\u8077\u7a2e\u304c\u3001\u6b21\u306e\u8d70\u8005\u304c\u8d70\u308a\u3084\u3059\u3044\u3088\u3046\u306b\u3001\u305d\u3057\u3066\u6700\u7d42\u7684\u306a\u30b4\u30fc\u30eb\uff08\u60a3\u8005\u3055\u3093\u3078\u306e\u63d0\u4f9b\uff09\u3092\u898b\u636e\u3048\u3066\u3001\u6b63\u78ba\u306a\u30d0\u30c8\u30f3\u3092\u7e4b\u3050\u3053\u3068\u304c\u6cbb\u9a13\u306e\u6210\u529f\u306e\u9375\u306a\u306e\u3067\u3059\u3002<\/p>\n\n\n\n<h2 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\u4eba\u306e\u6c17\u6301\u3061\u306b\u5bc4\u308a\u6dfb\u3048\u308b\u3001\u5171\u611f\u529b\u306e\u3042\u308b\u4eba\u304c\u5411\u3044\u3066\u3044\u307e\u3059\u3002\u88ab\u9a13\u8005\u306e\u308f\u305a\u304b\u306a\u4f53\u8abf\u5909\u5316\u306b\u6c17\u3065\u304f\u89b3\u5bdf\u773c\u3068\u3001\u75c5\u9662\u3068\u3044\u3046\u8907\u96d1\u306a\u7d44\u7e54\u306e\u4e2d\u3067\u7acb\u3061\u56de\u308b\u8abf\u6574\u529b\u304c\u5f37\u307f\u306b\u306a\u308a\u307e\u3059\u3002\u770b\u8b77\u5e2b\u3084\u85ac\u5264\u5e2b\u306a\u3069\u306e\u81e8\u5e8a\u7d4c\u9a13\u3092\u3001\u65b0\u85ac\u958b\u767a\u3068\u3044\u3046\u5927\u304d\u306a\u8996\u70b9\u3067\u6d3b\u304b\u3057\u305f\u3044\u3068\u8003\u3048\u308b\u4eba\u306b\u3068\u3063\u3066\u3001\u7406\u60f3\u7684\u306a\u8077\u7a2e\u3067\u3059\u3002CRC\u306e\u5e73\u5747\u5e74\u53ce\u306f\u30012025\u5e74\u5ea6\u3067\u7d04407\u4e07\u5186\u3068\u5831\u544a\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/li>\n\n\n\n<li><strong>\u30c7\u30fc\u30bf\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u62c5\u5f53\u8005\u30fb\u7d71\u8a08\u89e3\u6790\u62c5\u5f53\u8005<\/strong>: \u7d30\u304b\u3044\u6570\u5b57\u306e\u77db\u76fe\u3092\u898b\u9003\u3055\u306a\u3044\u96c6\u4e2d\u529b\u3068\u3001\u5730\u9053\u306a\u4f5c\u696d\u3092\u3044\u3068\u308f\u306a\u3044\u6839\u6c17\u5f37\u3055\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002\u30c7\u30fc\u30bf\u306e\u88cf\u306b\u3042\u308b\u771f\u5b9f\u3092\u63a2\u6c42\u3059\u308b\u597d\u5947\u5fc3\u3068\u3001\u30d7\u30ed\u30b0\u30e9\u30df\u30f3\u30b0\u3084\u6570\u5b66\u306e\u5c02\u9580\u30b9\u30ad\u30eb\u3092\u78e8\u304d\u7d9a\u3051\u3089\u308c\u308b\u4eba\u304c\u3001\u3053\u306e\u5206\u91ce\u3067\u6d3b\u8e8d\u3067\u304d\u307e\u3059\u3002<\/li>\n<\/ul>\n\n\n\n<p>\u73fe\u5728\u306e\u6cbb\u9a13\u306f\u3001\u30c6\u30af\u30ce\u30ed\u30b8\u30fc\u306e\u9032\u5316\u306b\u3088\u308a\u3001\u30a6\u30a7\u30a2\u30e9\u30d6\u30eb\u30c7\u30d0\u30a4\u30b9\u3092\u4f7f\u3063\u305f\u30c7\u30fc\u30bf\u53ce\u96c6\u3084\u3001AI\u306b\u3088\u308b\u30c7\u30fc\u30bf\u51e6\u7406\u306a\u3069\u3001\u30c7\u30b8\u30bf\u30eb\u5316\u304c\u6025\u901f\u306b\u9032\u3093\u3067\u3044\u307e\u3059\u3002\u3057\u304b\u3057\u3001\u3069\u308c\u307b\u3069\u30c6\u30af\u30ce\u30ed\u30b8\u30fc\u304c\u9032\u6b69\u3057\u3066\u3082\u3001\u300c\u88ab\u9a13\u8005\u306e\u4eba\u6a29\u3092\u5b88\u308b\u300d\u3068\u3044\u3046\u502b\u7406\u7684\u306a\u5224\u65ad\u3084\u3001\u300c\u30c7\u30fc\u30bf\u306e\u4fe1\u983c\u6027\u3092\u78ba\u4fdd\u3059\u308b\u300d\u3068\u3044\u3046\u8aa0\u5b9f\u306a\u59ff\u52e2\u306f\u3001\u4eba\u9593\u306b\u3057\u304b\u62c5\u3048\u307e\u305b\u3093\u3002\u6cbb\u9a13\u306b\u643a\u308f\u308b\u4eba\u3005\u306f\u3001\u79d1\u5b66\u306e\u9032\u5316\u3092\u652f\u3048\u308b\u8077\u4eba\u3067\u3042\u308a\u3001\u540c\u6642\u306b\u751f\u547d\u502b\u7406\u306e\u5b88\u8b77\u8005\u3067\u3042\u308b\u3068\u3044\u3046\u3001\u5d07\u9ad8\u306a\u4f7f\u547d\u3092\u6301\u3061\u7d9a\u3051\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u79d1\u5b66\u3068\u502b\u7406\u304c\u4ea4\u5dee\u3059\u308b\u73fe\u5834\u306e\u30d7\u30ed\u30d5\u30a7\u30c3\u30b7\u30e7\u30ca\u30ea\u30ba\u30e0<\/h2>\n\n\n\n<p>\u6cbb\u9a13\u306b\u643a\u308f\u308b\u591a\u7a2e\u591a\u69d8\u306a\u8077\u7a2e\u3092\u4fef\u77b0\u3059\u308b\u3068\u3001\u4e00\u3064\u306e\u85ac\u306e\u88cf\u5074\u306b\u5b58\u5728\u3059\u308b\u3001\u5727\u5012\u7684\u306a\u307e\u3067\u306e\u300c\u78ba\u8a8d\u300d\u3068\u300c\u691c\u8a3c\u300d\u306e\u7a4d\u307f\u91cd\u306d\u304c\u898b\u3048\u3066\u304d\u307e\u3059\u3002\u88fd\u85ac\u4f1a\u793e\u3001\u958b\u767a\u696d\u52d9\u53d7\u8a17\u6a5f\u95a2\u3001\u6cbb\u9a13\u65bd\u8a2d\u652f\u63f4\u6a5f\u95a2\u3001\u305d\u3057\u3066\u533b\u7642\u6a5f\u95a2\u3002\u7acb\u5834\u306e\u7570\u306a\u308b\u7d44\u7e54\u306b\u5c5e\u3059\u308b\u5c02\u9580\u8077\u305f\u3061\u304c\u3001\u5171\u901a\u306e\u30eb\u30fc\u30eb\uff08GCP\uff09\u3092\u7528\u3044\u3066\u3001\u4e00\u3064\u306e\u30c7\u30fc\u30bf\u306e\u59a5\u5f53\u6027\u3092\u5de1\u3063\u3066\u8b70\u8ad6\u3057\u3001\u5354\u529b\u3057\u3001\u6642\u306b\u306f\u53b3\u3057\u304f\u6307\u6458\u3057\u5408\u3044\u307e\u3059\u3002\u3053\u306e\u7dca\u5f35\u611f\u3042\u308b\u5354\u50cd\u3053\u305d\u304c\u3001\u79c1\u305f\u3061\u304c\u624b\u306b\u3059\u308b\u85ac\u306e\u300c\u5b89\u5fc3\u300d\u306e\u6b63\u4f53\u3067\u3059\u3002<\/p>\n\n\n\n<p>\u81e8\u5e8a\u958b\u767a\u30e2\u30cb\u30bf\u30fc\u306e\u76e3\u8996\u3001\u6cbb\u9a13\u30b3\u30fc\u30c7\u30a3\u30cd\u30fc\u30bf\u30fc\u306e\u652f\u63f4\u3001\u6cbb\u9a13\u4e8b\u52d9\u5c40\u62c5\u5f53\u8005\u306e\u7d71\u6cbb\u3001\u30c7\u30fc\u30bf\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u62c5\u5f53\u8005\u3084\u7d71\u8a08\u89e3\u6790\u62c5\u5f53\u8005\u306b\u3088\u308b\u8a3c\u660e\u3001\u5b89\u5168\u6027\u60c5\u5831\u62c5\u5f53\u8005\u306b\u3088\u308b\u76e3\u8996\u3001\u305d\u3057\u3066\u533b\u5e2b\u306e\u6c7a\u65ad\u3002\u3053\u308c\u3089\u306e\u3069\u308c\u304c\u6b20\u3051\u3066\u3082\u3001\u73fe\u4ee3\u306e\u9ad8\u5ea6\u306a\u533b\u7642\u306f\u6210\u7acb\u3057\u307e\u305b\u3093\u3002\u6cbb\u9a13\u306b\u643a\u308f\u308b\u3059\u3079\u3066\u306e\u4eba\u3005\u306f\u3001\u76ee\u306e\u524d\u306e\u60a3\u8005\u3055\u3093\u306e\u547d\u3068\u3001\u307e\u3060\u898b\u306c\u672a\u6765\u306e\u4f55\u4e07\u4eba\u3082\u306e\u60a3\u8005\u3055\u3093\u306e\u547d\u3092\u3001\u540c\u6642\u306b\u80cc\u8ca0\u3063\u3066\u30d0\u30c8\u30f3\u3092\u7e4b\u3044\u3067\u3044\u307e\u3059\u3002\u6cbb\u9a13\u671f\u9593\u4e2d\u306b\u88ab\u9a13\u8005\u306e\u8ca0\u62c5\u3092\u8efd\u6e1b\u3059\u308b\u305f\u3081\u3001\u901a\u9662\u3084\u691c\u67fb\u56de\u6570\u306e\u5897\u52a0\u306b\u4f34\u3046\u691c\u67fb\u8cbb\u7528\u306e\u4e00\u90e8\u3084\u4ea4\u901a\u8cbb\u306e\u88dc\u52a9\u306a\u3069\u3001\u69d8\u3005\u306a\u914d\u616e\u304c\u306a\u3055\u308c\u308b\u3053\u3068\u3082\u3042\u308a\u307e\u3059\u3002\u305d\u306e\u5c02\u9580\u6027\u306e\u9ad8\u3044\u696d\u52d9\u5185\u5bb9\u3092\u77e5\u308b\u3053\u3068\u306f\u3001\u79c1\u305f\u3061\u304c\u4eab\u53d7\u3059\u308b\u533b\u7642\u306e\u4fa1\u5024\u3092\u518d\u8a8d\u8b58\u3059\u308b\u3053\u3068\u306b\u4ed6\u306a\u308a\u307e\u305b\u3093\u3002\u65b0\u85ac\u958b\u767a\u3068\u3044\u3046\u58ee\u5927\u306a\u30c9\u30e9\u30de\u306f\u3001\u3053\u308c\u3089\u540d\u3082\u306a\u304d\u30d7\u30ed\u30d5\u30a7\u30c3\u30b7\u30e7\u30ca\u30eb\u305f\u3061\u306e\u3001\u8aa0\u5b9f\u306a\u65e5\u3005\u306e\u7a4d\u307f\u91cd\u306d\u306b\u3088\u3063\u3066\u7d21\u304c\u308c\u3066\u3044\u308b\u306e\u3067\u3059\u3002<\/p>\n\n\n\n<p><strong>\u6cbb\u9a13\u30cd\u30c3\u30c8\u306b\u3064\u3044\u3066<\/strong><\/p>\n\n\n\n<p>\u300c\u6642\u9593\u3092\u3001\u4fa1\u5024\u306b\u5909\u3048\u308b\u3002\u672a\u6765\u3092\u3001\u5065\u5eb7\u3067\u3064\u306a\u3050\u3002\u300d<\/p>\n\n\n\n<p>\u6cbb\u9a13\u30cd\u30c3\u30c8\u306f\u3001\u6cbb\u9a13\u3078\u306e\u53c2\u52a0\u3092\u300c\u6642\u9593\u306e\u6295\u8cc7\u300d\u3068\u6349\u3048\u3001\u7d0d\u5f97\u3067\u304d\u308b\u60c5\u5831\u63d0\u4f9b\u3092\u5927\u5207\u306b\u3057\u3066\u3044\u307e\u3059\u3002\u30ef\u30af\u30c1\u30f3\u30fb\u751f\u6d3b\u7fd2\u6163\u75c5\u30fb\u7f8e\u5bb9\u306a\u3069\u5e45\u5e83\u3044\u5206\u91ce\u306e\u52df\u96c6\u60c5\u5831\u3092\u63b2\u8f09\u4e2d\u3002\u672c\u8a18\u4e8b\u3067\u89e3\u8aac\u3057\u305f\u5c02\u9580\u5bb6\u305f\u3061\u306e\u5b58\u5728\u306f\u3001\u6cbb\u9a13\u30cd\u30c3\u30c8\u304c\u76ee\u6307\u3059\u300c\u308f\u304b\u308a\u3084\u3059\u304f\u3001\u4fa1\u5024\u3042\u308b\u81ea\u5df1\u6295\u8cc7\u306e\u5834\u300d\u3092\u3001\u53c2\u52a0\u8005\u306e\u65b9\u3005\u304c\u5b89\u5fc3\u3057\u3066\u6d3b\u7528\u3067\u304d\u308b\u57fa\u76e4\u3068\u306a\u3063\u3066\u3044\u307e\u3059\u3002\u4f1a\u54e1\u767b\u9332\uff08\u7121\u6599\uff09\u3067\u3001\u3042\u306a\u305f\u306e\u6761\u4ef6\u306b\u5408\u3063\u305f\u6848\u4ef6\u3092\u78ba\u8a8d\u3067\u304d\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u2192 <a href=\"https:\/\/chiken-net.site\/entry\">\u4f1a\u54e1\u767b\u9332\u30da\u30fc\u30b8\u3078<\/a><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\u53c2\u8003\u30fb\u51fa\u5178<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\uff12\uff0e\u6cbb\u9a13\u306e\u30eb\u30fc\u30eb\u300cGCP\u300d &#8211; \u539a\u751f\u52b4\u50cd\u7701\uff08\u6cbb\u9a13\u306e\u57fa\u672c\u7684\u306a\u30eb\u30fc\u30eb\u3067\u3042\u308bGCP\u306e\u6982\u8981\u3001\u304a\u3088\u3073\u6cbb\u9a13\u306b\u95a2\u308f\u308b\u7d44\u7e54\u306e\u8cac\u4efb\u306b\u3064\u3044\u3066\u89e3\u8aac\u3055\u308c\u3066\u3044\u307e\u3059\u3002\uff09<\/li>\n\n\n\n<li>\u6cbb\u9a13\u4e8b\u52d9\u5c40\u62c5\u5f53\u8005\uff08SMA\uff09\u306e\u4ed5\u4e8b\u5185\u5bb9 &#8211; CRC\u3070\u3093\u304f\uff08SMA\u306e\u5177\u4f53\u7684\u306a\u696d\u52d9\u5185\u5bb9\u3001IRB\u904b\u55b6\u652f\u63f4\u3001\u5404\u7a2e\u6587\u66f8\u4f5c\u6210\u652f\u63f4\u306b\u3064\u3044\u3066\u8a73\u3057\u304f\u8aac\u660e\u3055\u308c\u3066\u3044\u307e\u3059\u3002\uff09<\/li>\n\n\n\n<li>\u4fe1\u983c\u3067\u304d\u308b\u30e1\u30c7\u30a3\u30ab\u30eb\u60c5\u5831\u3092\u898b\u3064\u3051\u308b\u306b\u306f\uff1f\u6ce8\u610f\u3059\u3079\u304d\u30dd\u30a4\u30f3\u30c8\u3092\u3054\u7d39\u4ecb | MedInfo\u682a\u5f0f\u4f1a\u793e\uff08\u4fe1\u983c\u3067\u304d\u308b\u533b\u7642\u60c5\u5831\u306e\u898b\u5206\u3051\u65b9\u3001\u79d1\u5b66\u7684\u6839\u62e0\u306e\u91cd\u8981\u6027\u306b\u3064\u3044\u3066\u89e3\u8aac\u3055\u308c\u3066\u3044\u307e\u3059\u3002\uff09<\/li>\n\n\n\n<li>CRC\u304c\u62c5\u5f53\u3059\u308b\u306e\u306f\u6cbb\u9a13\u306e\u307f\uff1f \u62c5\u5f53\u3059\u308b\u65bd\u8a2d\u6570\u3084\u60a3\u8005\u3055\u3093\u6570\u306f\uff1f &#8211; CRC\u3070\u3093\u304f\uff08CRC\u304c\u62c5\u5f53\u3059\u308b\u6cbb\u9a13\u6570\u3001\u65bd\u8a2d\u6570\u3001\u88ab\u9a13\u8005\u6570\u306e\u5e73\u5747\u5024\u306b\u95a2\u3059\u308b\u5177\u4f53\u7684\u306a\u30c7\u30fc\u30bf\u304c\u793a\u3055\u308c\u3066\u3044\u307e\u3059\u3002\uff09<\/li>\n\n\n\n<li>\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u306e\u57fa\u6e96(GCP) &#8211; SciSpace\uff08GCP\u306e\u76ee\u7684\u3001\u539a\u751f\u52b4\u50cd\u7701\u4ee4\u3068\u3057\u3066\u306e\u4f4d\u7f6e\u4ed8\u3051\u3001\u4eba\u6a29\u3068\u5b89\u5168\u306e\u78ba\u4fdd\u3001\u30c7\u30fc\u30bf\u306e\u4fe1\u983c\u6027\u78ba\u4fdd\u306e\u91cd\u8981\u6027\u306b\u3064\u3044\u3066\u89e3\u8aac\u3055\u308c\u3066\u3044\u307e\u3059\u3002\uff09<\/li>\n\n\n\n<li>\u3010\u30b3\u30e9\u30e0\u3011\u4fe1\u983c\u6027\u306e\u9ad8\u3055\u304c\u30dd\u30a4\u30f3\u30c8\uff01\u672c\u5f53\u306b\u5f79\u7acb\u3064\u533b\u7642\u60c5\u5831\u306e\u5224\u65ad\u57fa\u6e96 &#8211; \u30e1\u30f3\u30d0\u30fc\u30ba\u30e1\u30c7\u30a3\u30ab\u30eb\u30de\u30fc\u30b1\u30c6\u30a3\u30f3\u30b0\u30ab\u30f3\u30d1\u30cb\u30fc\uff08\u4fe1\u983c\u6027\u306e\u9ad8\u3044\u533b\u7642\u60c5\u5831\u306e\u5224\u65ad\u57fa\u6e96\u3001\u516c\u7684\u6a5f\u95a2\u304b\u3089\u306e\u60c5\u5831\u53c2\u7167\u306e\u91cd\u8981\u6027\u306b\u3064\u3044\u3066\u8ff0\u3079\u3089\u308c\u3066\u3044\u307e\u3059\u3002\uff09<\/li>\n\n\n\n<li>CRA\uff08\u81e8\u5e8a\u958b\u767a\u30e2\u30cb\u30bf\u30fc\uff09\u3068\u306f\uff1f\u4ed5\u4e8b\u5185\u5bb9\u304b\u3089\u30ad\u30e3\u30ea\u30a2\u5f62\u6210\u307e\u3067\u8a73\u3057\u304f\u7d39\u4ecb &#8211; \u30d8\u30a4\u30ba\u30fb\u30b8\u30e3\u30d1\u30f3\uff08CRA\u306e\u65e5\u5e38\u696d\u52d9\u3001\u533b\u7642\u6a5f\u95a2\u8a2a\u554f\u983b\u5ea6\u3001\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u696d\u52d9\u306e\u8a73\u7d30\u306b\u3064\u3044\u3066\u8aac\u660e\u3055\u308c\u3066\u3044\u307e\u3059\u3002\uff09<\/li>\n\n\n\n<li>\u30a4\u30f3\u30bf\u30fc\u30cd\u30c3\u30c8\u306b\u304a\u3051\u308b\u533b\u7642\u30fb\u5065\u5eb7\u60c5\u5831\u306e\u898b\u6975\u3081\u65b9 | \u5065\u5eb7\u9577\u5bff\u30cd\u30c3\u30c8\uff08\u30a4\u30f3\u30bf\u30fc\u30cd\u30c3\u30c8\u4e0a\u306e\u533b\u7642\u30fb\u5065\u5eb7\u60c5\u5831\u306e\u898b\u6975\u3081\u65b9\u3001\u4fe1\u983c\u3067\u304d\u308b\u60c5\u5831\u6e90\u306e\u512a\u5148\u9806\u4f4d\u306b\u3064\u3044\u3066\u539a\u751f\u52b4\u50cd\u7701\u306e\u898b\u89e3\u3082\u4ea4\u3048\u3066\u89e3\u8aac\u3055\u308c\u3066\u3044\u307e\u3059\u3002\uff09<\/li>\n\n\n\n<li>\u5b9f\u8df5\u7814\u7a76 \u30a4\u30f3\u30bf\u30fc\u30cd\u30c3\u30c8\u691c\u7d22\u306b\u3088\u3063\u3066\u5f97\u3089\u308c\u308b\u300c\u304c\u3093\u306b\u95a2\u3059\u308b\u60c5\u5831\u300d\u306f\u6b63\u3057\u3044\u304b \u2015\u300c\u526f\u4f5c\u7528\u300d\uff08\u4fe1\u983c\u6027\u306e\u9ad8\u3044\u533b\u7642\u60c5\u5831\u63d0\u4f9b\u306e\u5fc5\u8981\u6027\u3001\u30a4\u30f3\u30bf\u30fc\u30cd\u30c3\u30c8\u30b5\u30a4\u30c8\u306e\u8a55\u4fa1\u57fa\u6e96\u306b\u3064\u3044\u3066\u89e6\u308c\u3089\u308c\u3066\u3044\u307e\u3059\u3002\uff09<\/li>\n\n\n\n<li>\u6cbb\u9a13\u304b\u3089\u627f\u8a8d\u307e\u3067\u3092\u652f\u3048\u308bPMDA\u3068\u306f\uff1f\uff5cNIPP\u30ab\u30c6\u30fc\u30c6\u30eb\u306b\u3088\u308b\u30ac\u30f3\u6cbb\u7642 &#8211; note\uff08PMDA\u306e\u5f79\u5272\u3001\u627f\u8a8d\u30d7\u30ed\u30bb\u30b9\u3001\u6cbb\u9a13\u306b\u304a\u3051\u308bGCP\u9075\u5b88\u306e\u91cd\u8981\u6027\u306b\u3064\u3044\u3066\u89e3\u8aac\u3055\u308c\u3066\u3044\u307e\u3059\u3002\uff09<\/li>\n\n\n\n<li>\u73fe\u5728\u62c5\u5f53\u3057\u3066\u3044\u308b\u30d7\u30ed\u30c8\u30b3\u30eb\u6570\u306e\u5e73\u5747\u306f 4.57 \u672c\u3067\u3042\u3063\u305f\u3002\u6700\u3082\u591a\u304b\u3063\u305f\u56de\u7b54\u306f\u300c2 \u672c\u300d\uff08CRC\u306e\u62c5\u5f53\u30d7\u30ed\u30c8\u30b3\u30eb\u6570\u3001\u88ab\u9a13\u8005\u6570\u3001\u62c5\u5f53\u65bd\u8a2d\u6570\u306b\u95a2\u3059\u308b\u8abf\u67fb\u30c7\u30fc\u30bf\u304c\u63d0\u4f9b\u3055\u308c\u3066\u3044\u307e\u3059\u3002\uff09<\/li>\n\n\n\n<li>CRA\uff08\u81e8\u5e8a\u958b\u767a\u30e2\u30cb\u30bf\u30fc\uff09\u306e\u4e00\u65e5\u3068\u4e00\u9031\u9593 &#8211; CRA\u3070\u3093\u304f\uff08CRA\u306e\u5177\u4f53\u7684\u306a\u4e00\u65e5\u306e\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u3001\u533b\u7642\u6a5f\u95a2\u8a2a\u554f\u306e\u983b\u5ea6\u3001\u51fa\u5f35\u306b\u3064\u3044\u3066\u8a73\u7d30\u306b\u8aac\u660e\u3055\u308c\u3066\u3044\u307e\u3059\u3002\uff09<\/li>\n\n\n\n<li>\u8ce2\u3044\u60a3\u8005\u306e\u3059\u3059\u3081\uff08\uff12\uff09\uff1a\u533b\u7642\u60c5\u5831\u3001\u3069\u3053\u307e\u3067\u4fe1\u7528\u3067\u304d\u308b\uff1f \u2014 \u60c5\u5831\u306e\u691c\u7d22\u65b9\u6cd5\u3068\u898b\u6975\u3081\u65b9 &#8211; \u30a8\u30fc\u30eb\u5728\u5b85\u8a3a\u7642\u6240\uff08\u30a4\u30f3\u30bf\u30fc\u30cd\u30c3\u30c8\u533b\u7642\u60c5\u5831\u306e\u4fe1\u983c\u6027\u5224\u65ad\u57fa\u6e96\u3001\u516c\u7684\u6a5f\u95a2\u60c5\u5831\u306e\u63a8\u5968\u306b\u3064\u3044\u3066\u89e3\u8aac\u3055\u308c\u3066\u3044\u307e\u3059\u3002\uff09<\/li>\n\n\n\n<li>SMA\uff08\u6cbb\u9a13\u4e8b\u52d9\u5c40\u62c5\u5f53\u8005\uff09 | EPNextS\u30b0\u30eb\u30fc\u30d7 \u533b\u7642\u30fb\u6cbb\u9a13\u696d\u754c \u5c31\u8077\u60c5\u5831\u30b5\u30a4\u30c8\uff08SMA\u306e\u4ed5\u4e8b\u5185\u5bb9\u3001IRB\u904b\u55b6\u30b5\u30dd\u30fc\u30c8\u3001\u6587\u66f8\u4f5c\u6210\u30fb\u7ba1\u7406\u306b\u3064\u3044\u3066\u5177\u4f53\u7684\u306b\u89e3\u8aac\u3055\u308c\u3066\u3044\u307e\u3059\u3002\uff09<\/li>\n\n\n\n<li>CRA\u3068\u306f\uff1f\u81e8\u5e8a\u958b\u767a\u30e2\u30cb\u30bf\u30fc\u306e\u696d\u52d9\u3084\u5e74\u53ce\u3001\u5fc5\u8981\u306a\u30b9\u30ad\u30eb\u3092\u7d39\u4ecb &#8211; MIKARU\uff08CRA\u306e\u4e3b\u306a\u696d\u52d9\u5185\u5bb9\u3001GCP\u306e\u9075\u5b88\u3001\u88fd\u85ac\u4f1a\u793e\u3084CRO\u3067\u306e\u50cd\u304d\u65b9\u306b\u3064\u3044\u3066\u8aac\u660e\u3055\u308c\u3066\u3044\u307e\u3059\u3002\uff09<\/li>\n\n\n\n<li>\uff14\uff0e\u6cbb\u9a13\u306b\u53c2\u52a0\u3055\u308c\u308b\u3068\u304d\u306b\u60a3\u8005\u3055\u3093\u306b\u5b88\u3063\u3066\u3044\u305f\u3060\u304f\u3053\u3068 &#8211; \u539a\u751f\u52b4\u50cd\u7701\uff08\u6cbb\u9a13\u53c2\u52a0\u8005\u304c\u5b88\u308b\u3079\u304d\u4e8b\u9805\u3001\u6cbb\u9a13\u85ac\u306e\u670d\u7528\u65b9\u6cd5\u3001\u4f53\u8abf\u5909\u5316\u6642\u306e\u5bfe\u5fdc\u306a\u3069\u306b\u3064\u3044\u3066\u8aac\u660e\u3055\u308c\u3066\u3044\u307e\u3059\u3002\uff09<\/li>\n\n\n\n<li>\u55b6\u696d\u7d4c\u9a13\u3092\u533b\u7642\u696d\u754c\u3067\u6d3b\u304b\u3059\uff5c\u6cbb\u9a13\u4e8b\u52d9\u5c40\u62c5\u5f53\u8005\uff08SMA\uff09\u3068\u306f\u3010\u4ed5\u4e8b\u5185\u5bb9\u30fb\u3084\u308a\u304c\u3044\u30fb\u30ad\u30e3\u30ea\u30a2\u3011\uff08SMA\u306eIRB\u7533\u8acb\u30fb\u627f\u8a8d\u652f\u63f4\u3001\u5951\u7d04\u7de0\u7d50\u30b5\u30dd\u30fc\u30c8\u3001\u6cbb\u9a13\u904b\u55b6\u30d5\u30a9\u30ed\u30fc\u306b\u3064\u3044\u3066\u89e3\u8aac\u3055\u308c\u3066\u3044\u307e\u3059\u3002\uff09<\/li>\n\n\n\n<li>CRA\u306f\u6708\u306b\u4f55\u56de\u3050\u3089\u3044\u51fa\u5f35\u3059\u308b\u306e\u3067\u3057\u3087\u3046\u304b\u3002 &#8211; CRA\u3070\u3093\u304f\uff08CRA\u306e\u51fa\u5f35\u983b\u5ea6\u3084\u305d\u306e\u91cd\u8981\u6027\u306b\u3064\u3044\u3066\u8aac\u660e\u3055\u308c\u3066\u3044\u307e\u3059\u3002\uff09<\/li>\n\n\n\n<li>\uff12 \u5b9f\u65bd\u533b\u7642\u6a5f\u95a2\u306e\u9577\u53c8\u306f\u8a18\u9332\u4fdd\u5b58\u8cac\u4efb\u8005\u306f &#8211; \u539a\u751f\u52b4\u50cd\u7701\uff08\u6cbb\u9a13\u8cac\u4efb\u533b\u5e2b\u306e\u8cac\u52d9\u3001\u6709\u5bb3\u4e8b\u8c61\u5831\u544a\u3001\u88ab\u9a13\u8005\u3078\u306e\u60c5\u5831\u63d0\u4f9b\u3068\u540c\u610f\u53d6\u5f97\u306b\u95a2\u3059\u308b\u8a73\u7d30\u306a\u898f\u5b9a\u304c\u793a\u3055\u308c\u3066\u3044\u307e\u3059\u3002\uff09<\/li>\n\n\n\n<li>\u696d\u754c\u7814\u7a76 \uff5e\u6cbb\u9a13\u696d\u754c\uff08CRO\u30fbSMO\uff09\u7de8\uff5e\uff5c\u85ac\u5b66\u751f\u306e\u305f\u3081\u306e\u5c31\u8077\u60c5\u5831\u30b5\u30a4\u30c8\u3010\u85ac\u30ad\u30e3\u30ea1st\u3011\uff08CRO\u3068SMO\u306e\u5f79\u5272\u3001\u6cbb\u9a13\u696d\u754c\u306e\u73fe\u72b6\u3068\u5c55\u671b\u306b\u3064\u3044\u3066\u89e3\u8aac\u3055\u308c\u3066\u3044\u307e\u3059\u3002\uff09<\/li>\n\n\n\n<li>\u533b\u85ac\u54c1\u306e\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u306e\u57fa\u6e96\uff08\uff27\uff23\uff30\uff1aGood Clinical Practice\uff09 \u306b\u3064\u3044\u3066\uff08GCP\u7b56\u5b9a\u306e\u7d4c\u7def\u3001\u65b0GCP\u306e\u7279\u5fb4\u3001\u88ab\u9a13\u8005\u306e\u4eba\u6a29\u4fdd\u8b77\u3001\u30c7\u30fc\u30bf\u4fe1\u983c\u6027\u78ba\u4fdd\u306e\u76ee\u7684\u306b\u3064\u3044\u3066\u8a73\u7d30\u306b\u89e3\u8aac\u3055\u308c\u3066\u3044\u307e\u3059\u3002\uff09<\/li>\n\n\n\n<li>\uff27\uff23\uff30\uff1a\u533b\u85ac\u54c1\u306e\u81e8\u5e8a\u8a66\u9a13\u306e \u5b9f\u65bd\u306e\u57fa\u6e96\uff08GCP\u7701\u4ee4\u306b\u304a\u3051\u308b\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3001\u6cbb\u9a13\u85ac\u306e\u7ba1\u7406\u3001\u76e3\u67fb\u306b\u95a2\u3059\u308b\u57fa\u6e96\u306b\u3064\u3044\u3066\u898f\u5b9a\u3055\u308c\u3066\u3044\u307e\u3059\u3002\uff09<\/li>\n\n\n\n<li>\uff33\uff2d\uff21\uff08\u6cbb\u9a13\u4e8b\u52d9\u5c40\u62c5\u5f53\u8005\uff09\u306e\u8077\u7a2e\u7d39\u4ecb | \u30bb\u30fc\u30de\u682a\u5f0f\u4f1a\u793e\uff08SMA\u306e\u4ed5\u4e8b\u306e\u9b45\u529b\u3001\u6c42\u3081\u3089\u308c\u308b\u8cc7\u8cea\u3001\u6cbb\u9a13\u5b9f\u65bd\u65bd\u8a2d\u3078\u306e\u6848\u4ef6\u6253\u8a3a\u306e\u91cd\u8981\u6027\u306b\u3064\u3044\u3066\u8aac\u660e\u3055\u308c\u3066\u3044\u307e\u3059\u3002\uff09<\/li>\n\n\n\n<li>\u30c7\u30fc\u30bf\u30de\u30cd\u30fc\u30b8\u30e1\u30f3\u30c8\u8077\uff5c \u5869\u91ce\u7fa9\u88fd\u85ac &#8211; Shionogi\uff08\u30c7\u30fc\u30bf\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306e\u696d\u52d9\u5185\u5bb9\u3001\u30c7\u30fc\u30bf\u53ce\u96c6\u30b7\u30b9\u30c6\u30e0\u306e\u69cb\u7bc9\u30fb\u904b\u7528\u3001\u30c7\u30fc\u30bf\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306b\u3064\u3044\u3066\u89e3\u8aac\u3055\u308c\u3066\u3044\u307e\u3059\u3002\uff09<\/li>\n\n\n\n<li>\u81e8\u5e8a\u8a66\u9a13\u30c7\u30fc\u30bf\u30de\u30cd\u30b8\u30e1\u30f3\u30c8 CRO\u30b5\u30fc\u30d3\u30b9 | \u30ea\u30cb\u30ab\u30eb &#8211; Linical\uff08\u30c7\u30fc\u30bf\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306e\u76ee\u7684\u3001EDC\u30b7\u30b9\u30c6\u30e0\u306e\u8a2d\u8a08\u3001\u30c7\u30fc\u30bf\u30ec\u30d3\u30e5\u30fc\u306e\u91cd\u8981\u6027\u306b\u3064\u3044\u3066\u8aac\u660e\u3055\u308c\u3066\u3044\u307e\u3059\u3002\uff09<\/li>\n\n\n\n<li>\u6cbb\u9a13\u4e8b\u52d9\u5c40\u62c5\u5f53\u8005\uff08SMA\uff09\u306b\u3064\u3044\u3066\u89e3\u8aac\uff08SMA\u306e\u5f79\u5272\u3001\u6cbb\u9a13\u30b3\u30fc\u30c7\u30a3\u30cd\u30fc\u30bf\u30fc\u3068\u306e\u9055\u3044\u3001\u591a\u65bd\u8a2d\u62c5\u5f53\u306e\u72b6\u6cc1\u306b\u3064\u3044\u3066\u89e3\u8aac\u3055\u308c\u3066\u3044\u307e\u3059\u3002\uff09<\/li>\n\n\n\n<li>\u6cbb\u9a13\u30b3\u30fc\u30c7\u30a3\u30cd\u30fc\u30bf\u30fc\u3068\u95a2\u308f\u308b\u4eba\u6570\u3092\u6559\u3048\u3066\u4e0b\u3055\u3044\u3002 &#8211; CRC\u3070\u3093\u304f\uff08CRC\u304c\u95a2\u308f\u308b\u88ab\u9a13\u8005\u6570\u3084\u533b\u7642\u5f93\u4e8b\u8005\u6570\u306e\u76ee\u5b89\u306b\u3064\u3044\u3066\u8aac\u660e\u3055\u308c\u3066\u3044\u307e\u3059\u3002\uff09<\/li>\n\n\n\n<li>DM\u30fb\u30c7\u30fc\u30bf\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306e\u4ed5\u4e8b\u5185\u5bb9 &#8211; CRA\u3070\u3093\u304f\uff08\u30c7\u30fc\u30bf\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u306e\u5177\u4f53\u7684\u306a\u4ed5\u4e8b\u5185\u5bb9\u3001\u30c7\u30fc\u30bf\u306e\u5165\u529b\u3001\u30b3\u30fc\u30c7\u30a3\u30f3\u30b0\u3001\u30c1\u30a7\u30c3\u30af\u3001\u56fa\u5b9a\u306b\u3064\u3044\u3066\u89e3\u8aac\u3055\u308c\u3066\u3044\u307e\u3059\u3002\uff09<\/li>\n\n\n\n<li>\u85ac\u5264\u627f\u8a8d\u306e\u4ed5\u7d44\u307f\u306b\u3064\u3044\u3066 &#8211; \u72ec\u7acb\u884c\u653f\u6cd5\u4eba \u533b\u85ac\u54c1\u533b\u7642\u6a5f\u5668\u7dcf\u5408\u6a5f\u69cb\uff08PMDA\u306e\u5f79\u5272\u3001\u85ac\u5264\u627f\u8a8d\u306e\u4ed5\u7d44\u307f\u3001GCP\u306e\u91cd\u8981\u6027\u306b\u3064\u3044\u3066\u56f3\u89e3\u3067\u89e3\u8aac\u3055\u308c\u3066\u3044\u307e\u3059\u3002\uff09<\/li>\n\n\n\n<li>SMO\u306e\u5f79\u5272\u3068\u4e3b\u306a\u696d\u52d9 | \u6cbb\u9a13\u3068SMO &#8211; \u65e5\u672cSMO\u5354\u4f1a\uff08SMO\u306e\u5f79\u5272\u3001GCP\u306b\u57fa\u3065\u3044\u305f\u6cbb\u9a13\u652f\u63f4\u3001\u533b\u7642\u6a5f\u95a2\u3067\u306e\u6cbb\u9a13\u958b\u59cb\u30fb\u5b9f\u65bd\u88dc\u52a9\u306b\u3064\u3044\u3066\u8aac\u660e\u3055\u308c\u3066\u3044\u307e\u3059\u3002\uff09<\/li>\n\n\n\n<li>\u6cbb\u9a13\u8cac\u4efb\u533b\u5e2b\u306e\u7ba1\u7406\u6a29\u9650\u3092\u4fdd\u6301\u3057\u3001 \u30a2\u30af\u30bb\u30b9\u6a29\u9650\u3092\u4fdd\u8a3c\u3059\u308b &#8211; ICR\u81e8\u5e8a\u7814\u7a76\u5165\u9580\uff08\u6cbb\u9a13\u8cac\u4efb\u533b\u5e2b\u306e\u7ba1\u7406\u6a29\u9650\u3068\u75c7\u4f8b\u5831\u544a\u66f8\u306e\u4fdd\u5b58\u7fa9\u52d9\u306b\u3064\u3044\u3066\u89e6\u308c\u3089\u308c\u3066\u3044\u307e\u3059\u3002\uff09<\/li>\n\n\n\n<li>\u696d\u754c\u60c5\u5831 CRO\u30fbSMO\u3068\u306f\uff1f &#8211; \u88fd\u85ac\u5c02\u9580\u306e\u8ee2\u8077\u7d39\u4ecb\u30fb\u6c42\u4eba\u6848\u5185\u306a\u3089\u682a\u5f0f\u4f1a\u793e\u30e1\u30c7\u30a3\u30b5\u30fc\u30c1\uff08CRO\u3068SMO\u306e\u5f79\u5272\u3001\u6cbb\u9a13\u306e\u73fe\u72b6\u3001\u56fd\u969b\u5171\u540c\u6cbb\u9a13\u306e\u5897\u52a0\u306b\u3064\u3044\u3066\u89e3\u8aac\u3055\u308c\u3066\u3044\u307e\u3059\u3002\uff09<\/li>\n\n\n\n<li>\u6cbb\u9a13\u8cac\u4efb\u533b\u5e2b\u53c8\u306f\u6cbb\u9a13\u5206\u62c5\u533b\u5e2b\u306f\u3001\u540c\u610f\u3092\u5f97\u308b\u524d\u306b\u3001\u88ab\u9a13\u8005\u3068\u306a\u308b\u3079\u304d\u8005\uff08\u4ee3\u8afe\u8005 &#8211; \u539a\u751f\u52b4\u50cd\u7701\uff08\u6cbb\u9a13\u8cac\u4efb\u533b\u5e2b\u306b\u3088\u308b\u30a4\u30f3\u30d5\u30a9\u30fc\u30e0\u30c9\u30fb\u30b3\u30f3\u30bb\u30f3\u30c8\u306e\u30d7\u30ed\u30bb\u30b9\u3001\u8aac\u660e\u6587\u66f8\u306b\u8a18\u8f09\u3059\u3079\u304d\u4e8b\u9805\u306b\u3064\u3044\u3066\u8a73\u7d30\u306b\u898f\u5b9a\u3055\u308c\u3066\u3044\u307e\u3059\u3002\uff09<\/li>\n\n\n\n<li>\u533b\u85ac\u54c1\u306e\u958b\u767a\u30d7\u30ed\u30bb\u30b9\u3068 PMDA &#8211; \u4e00\u822c\u793e\u56e3\u6cd5\u4eba \u65e5\u672c\u814e\u81d3\u5b66\u4f1a\uff08\u533b\u85ac\u54c1\u306e\u958b\u767a\u30d7\u30ed\u30bb\u30b9\u3001PMDA\u306e\u627f\u8a8d\u5be9\u67fb\u30fb\u6cbb\u9a13\u76f8\u8ac7\u696d\u52d9\u3001GCP\u9069\u5408\u6027\u691c\u8a0e\u306b\u3064\u3044\u3066\u89e3\u8aac\u3055\u308c\u3066\u3044\u307e\u3059\u3002\uff09<\/li>\n\n\n\n<li>2026\u5e74\u5ea6\u6700\u65b0\uff01CRC(\u6cbb\u9a13\u30b3\u30fc\u30c7\u30a3\u30cd\u30fc\u30bf\u30fc)\u306e\u5e74\u53ce\u304c\u308f\u304b\u308b\u30ea\u30a2\u30eb\u306a\u7d66\u4e0e\u4e8b\u60c5 &#8211; CRCJOB\uff08CRC\u306e\u904e\u53bb3\u5e74\u9593\u306e\u5e73\u5747\u5e74\u53ce\u30c7\u30fc\u30bf\u304c\u63d0\u4f9b\u3055\u308c\u3066\u3044\u307e\u3059\u3002\uff09<\/li>\n\n\n\n<li>\uff16\uff0e\u6cbb\u9a13\u306b\u53c2\u52a0\u3044\u305f\u3060\u304f\u60a3\u8005\u3055\u3093\u306e\u305f\u3081\u306b &#8211; \u539a\u751f\u52b4\u50cd\u7701\uff08\u6cbb\u9a13\u53c2\u52a0\u8005\u306e\u8ca0\u62c5\u8efd\u6e1b\u306e\u305f\u3081\u306e\u914d\u616e\u3001\u691c\u67fb\u8cbb\u7528\u3084\u4ea4\u901a\u8cbb\u88dc\u52a9\u306e\u53ef\u80fd\u6027\u306b\u3064\u3044\u3066\u8aac\u660e\u3055\u308c\u3066\u3044\u307e\u3059\u3002\uff09<\/li>\n\n\n\n<li>\u300a\u66f4\u65b0\u300b\u3010\u53c2\u8003\u3011\u539a\u751f\u52b4\u50cd\u7701\uff0f\u300c\u300c\u533b\u85ac\u54c1\u306e\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u306e\u57fa\u6e96\u306b\u95a2\u3059\u308b\u7701\u4ee4\u300d\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306b\u3064\u3044\u3066\u300d\u306e\u6539\u6b63\u306b\u3064\u3044\u3066 | GMP Platform\uff08GCP\u7701\u4ee4\u3068\u30ac\u30a4\u30c0\u30f3\u30b9\u306e\u91cd\u8981\u6027\u306b\u3064\u3044\u3066\u89e6\u308c\u3089\u308c\u3066\u3044\u307e\u3059\u3002\uff09<\/li>\n\n\n\n<li>\u7b2c62\u6761 \u6cbb\u9a13\u8cac\u4efb\u533b\u5e2b\u306f &#8211; \u539a\u751f\u52b4\u50cd\u7701\uff08\u6cbb\u9a13\u8cac\u4efb\u533b\u5e2b\u306e\u6cbb\u9a13\u5b9f\u65bd\u8a08\u753b\u66f8\u304b\u3089\u306e\u9038\u8131\u884c\u70ba\u306e\u8a18\u9332\u7fa9\u52d9\u3001\u539a\u751f\u52b4\u50cd\u7701\u4ee4\u3067\u5b9a\u3081\u308b\u57fa\u6e96\u306b\u3064\u3044\u3066\u898f\u5b9a\u3055\u308c\u3066\u3044\u307e\u3059\u3002\uff09<\/li>\n\n\n\n<li>\u30ea\u30f3\u30af\u96c6 &#8211; \u65e5\u672cCRO\u5354\u4f1a\uff08PMDA\u3001\u539a\u751f\u52b4\u50cd\u7701\u3001\u65e5\u672cSMO\u5354\u4f1a\u306a\u3069\u3001\u95a2\u9023\u3059\u308b\u516c\u7684\u6a5f\u95a2\u3084\u696d\u754c\u56e3\u4f53\u306e\u30ea\u30f3\u30af\u96c6\u3067\u3059\u3002\uff09<\/li>\n\n\n\n<li>\u6cbb\u9a13\u30b3\u30fc\u30c7\u30a3\u30cd\u30fc\u30bf\u30fc\uff08CRC\uff09\u3068\u306f\uff1f\u5411\u3044\u3066\u3044\u308b\u4eba\u3084\u5e74\u53ce\u30fb\u5c06\u6765\u6027\u306b\u3064\u3044\u3066\u89e3\u8aac\uff08CRC\u306e\u5f79\u5272\u3001\u5c02\u9580\u77e5\u8b58\u3001\u8a8d\u5b9a\u5236\u5ea6\u306b\u3064\u3044\u3066\u89e3\u8aac\u3055\u308c\u3066\u3044\u307e\u3059\u3002\uff09<\/li>\n<\/ul>\n\n\n\n<h2 style=\"color:#43A047;font-size:1.4em;margin-bottom:16px;border-bottom:3px solid #43A047;padding-bottom:8px\">\u6cbb\u9a13\u30fb\u30e2\u30cb\u30bf\u30fc\u306e\u52df\u96c6\u4e2d\u6848\u4ef6<\/h2>\n\n\n\n<table style=\"width:100%;border-collapse:collapse;background:#fff;border-radius:8px;overflow:hidden;box-shadow:0 1px 3px rgba(0,0,0,0.08)\"><thead><tr style=\"background:#43A047;border-bottom:2px solid #43A047\"><th style=\"padding:14px;text-align:left;color:#fff;font-weight:600;font-size:0.9em\">\u6848\u4ef6\u540d<\/th><th style=\"padding:14px;text-align:left;color:#fff;font-weight:600;font-size:0.9em\">\u5730\u57df<\/th><th style=\"padding:14px;text-align:left;color:#fff;font-weight:600;font-size:0.9em\">\u5bfe\u8c61<\/th><th style=\"padding:14px;text-align:left;color:#fff;font-weight:600;font-size:0.9em\">\u8ca0\u62c5\u8efd\u6e1b\u8cbb<\/th><th style=\"padding:14px;text-align:left;color:#fff;font-weight:600;font-size:0.9em\">\u65e5\u7a0b<\/th><th style=\"padding:14px;text-align:center;color:#fff;font-weight:600;font-size:0.9em\">\u72b6\u6cc1<\/th><\/tr><\/thead><tbody>\n<tr style=\"background:#fff;border-bottom:1px solid #e8e8e8\"><td style=\"padding:12px 14px\"><a href=\"https:\/\/chiken-net.site\/products\/detail\/1003194\" target=\"_blank\" rel=\"noopener\" style=\"color:#2e7d32;text-decoration:none;font-weight:500\">\u975e\u55ab\u7159\u8005\u9650\u5b9a\uff085\u670831\u65e5\uff5e\uff09<\/a><\/td><td style=\"padding:12px 14px;white-space:nowrap\">\u4e5d\u5dde<\/td><td style=\"padding:12px 14px;white-space:nowrap\">\u7537\u6027<\/td><td style=\"padding:12px 14px;white-space:nowrap;font-weight:500\">148,000\u5186<\/td><td style=\"padding:12px 14px;white-space:nowrap;font-size:0.9em\">7\u6cca\uff0b\u901a\u96621\u56de<\/td><td style=\"padding:12px 14px;text-align:center\"><span style=\"color:#fff;background:#43A047;padding:2px 10px;border-radius:4px;font-size:0.85em;font-weight:bold\">\u52df\u96c6\u4e2d<\/span><\/td><\/tr>\n<tr style=\"background:#fff;border-bottom:1px solid #e8e8e8\"><td style=\"padding:12px 14px\"><a href=\"https:\/\/chiken-net.site\/products\/detail\/1003063\" target=\"_blank\" rel=\"noopener\" style=\"color:#2e7d32;text-decoration:none;font-weight:500\">\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u6cbb\u9a13\uff086\u67083\u65e5\uff5e\uff09<\/a><\/td><td style=\"padding:12px 14px;white-space:nowrap\">\u4e5d\u5dde<\/td><td style=\"padding:12px 14px;white-space:nowrap\">\u7537\u6027<\/td><td style=\"padding:12px 14px;white-space:nowrap;font-weight:500\">160,000\u5186<\/td><td style=\"padding:12px 14px;white-space:nowrap;font-size:0.9em\">4\u6cca\u00d72\u56de\uff0b\u901a\u96621\u56de<\/td><td style=\"padding:12px 14px;text-align:center\"><span style=\"color:#fff;background:#43A047;padding:2px 10px;border-radius:4px;font-size:0.85em;font-weight:bold\">\u52df\u96c6\u4e2d<\/span><\/td><\/tr>\n<tr style=\"background:#fff;border-bottom:1px solid #e8e8e8\"><td style=\"padding:12px 14px\"><a href=\"https:\/\/chiken-net.site\/products\/detail\/1000234\" target=\"_blank\" rel=\"noopener\" style=\"color:#2e7d32;text-decoration:none;font-weight:500\">\u65e9\u3044\u3082\u306e\u52dd\u3061\uff085\u670827\u65e5\uff5e\uff09<\/a><\/td><td style=\"padding:12px 14px;white-space:nowrap\">\u4e5d\u5dde<\/td><td style=\"padding:12px 14px;white-space:nowrap\">\u7537\u6027<\/td><td style=\"padding:12px 14px;white-space:nowrap;font-weight:500\">345,000\u5186<\/td><td style=\"padding:12px 14px;white-space:nowrap;font-size:0.9em\">8\u6cca+7\u6cca<\/td><td style=\"padding:12px 14px;text-align:center\"><span style=\"color:#fff;background:#43A047;padding:2px 10px;border-radius:4px;font-size:0.85em;font-weight:bold\">\u52df\u96c6\u4e2d<\/span><\/td><\/tr>\n<tr style=\"background:#fff;border-bottom:1px solid #e8e8e8\"><td style=\"padding:12px 14px\"><a href=\"https:\/\/chiken-net.site\/products\/detail\/1003199\" target=\"_blank\" rel=\"noopener\" style=\"color:#2e7d32;text-decoration:none;font-weight:500\">\u77ed\u671f\u5165\u9662\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u6cbb\u9a13\uff085\u670820\u65e5\uff5e\uff09<\/a><\/td><td style=\"padding:12px 14px;white-space:nowrap\">\u95a2\u6771<\/td><td style=\"padding:12px 14px;white-space:nowrap\">\u5973\u6027<\/td><td style=\"padding:12px 14px;white-space:nowrap;font-weight:500\">162,000\u5186<\/td><td style=\"padding:12px 14px;white-space:nowrap;font-size:0.9em\">3\u6cca\u00d72\u56de\uff0b\u901a\u96621\u56de<\/td><td style=\"padding:12px 14px;text-align:center\"><span style=\"color:#fff;background:#43A047;padding:2px 10px;border-radius:4px;font-size:0.85em;font-weight:bold\">\u52df\u96c6\u4e2d<\/span><\/td><\/tr>\n<tr style=\"background:#fff;border-bottom:1px solid #e8e8e8\"><td style=\"padding:12px 14px\"><a href=\"https:\/\/chiken-net.site\/products\/detail\/1002995\" target=\"_blank\" rel=\"noopener\" 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