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class=\"wp-block-heading\">\u4fe1\u983c\u6027\u306e\u8981\uff1a\u30c7\u30fc\u30bf\u5b8c\u5168\u6027\u3068\u5229\u76ca\u76f8\u53cd\u306e\u53b3\u683c\u306a\u7ba1\u7406<\/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\/article-1773740149475-2-scaled.jpg\" alt=\"\u898b\u51fa\u30572\u7528: \u88fd\u85ac\u4f1a\u793e\u8077\u54e1\u304c\u53c2\u52a0\u3057\u305f\u6cbb\u9a13\u3068\u73fe\u4ee3\u306e\u6cbb\u9a13\uff1a\u4f55\u304c\u5909\u308f\u308a\u3001\u306a\u305c\u5b89\u5168\u306b\u306a\u3063\u305f\u306e\u304b\uff1f - \u30a4\u30e1\u30fc\u30b8\u30a4\u30e9\u30b9\u30c8\" class=\"wp-image-3910\" srcset=\"https:\/\/chiken-net.site\/column\/wp-content\/uploads\/2026\/03\/article-1773740149475-2-scaled.jpg 2560w, https:\/\/chiken-net.site\/column\/wp-content\/uploads\/2026\/03\/article-1773740149475-2-300x164.jpg 300w, https:\/\/chiken-net.site\/column\/wp-content\/uploads\/2026\/03\/article-1773740149475-2-1024x559.jpg 1024w, https:\/\/chiken-net.site\/column\/wp-content\/uploads\/2026\/03\/article-1773740149475-2-768x419.jpg 768w, https:\/\/chiken-net.site\/column\/wp-content\/uploads\/2026\/03\/article-1773740149475-2-1536x838.jpg 1536w, https:\/\/chiken-net.site\/column\/wp-content\/uploads\/2026\/03\/article-1773740149475-2-2048x1117.jpg 2048w\" sizes=\"auto, (max-width: 2560px) 100vw, 2560px\" \/><\/figure>\n\n\n\n<p>\u304b\u3064\u3066\u306e\u6cbb\u9a13\u3068\u73fe\u4ee3\u306e\u6cbb\u9a13\u306e\u6c7a\u5b9a\u7684\u306a\u9055\u3044\u306e\u4e00\u3064\u306f\u3001\u30c7\u30fc\u30bf\u306e\u4fe1\u983c\u6027\u3092\u62c5\u4fdd\u3059\u308b\u305f\u3081\u306e\u30b7\u30b9\u30c6\u30e0\u3068\u76e3\u8996\u4f53\u5236\u306e\u53b3\u683c\u3055\u306b\u3042\u308a\u307e\u3059\u3002\u8077\u54e1\u304c\u88ab\u9a13\u8005\u3068\u306a\u308b\u5834\u5408\u3001\u305d\u3053\u306b\u306f\u300c\u958b\u767a\u306e\u6210\u529f\u3092\u9858\u3046\u300d\u3068\u3044\u3046\u5f37\u3044\u5fc3\u7406\u7684\u504f\u308a\u304c\u50cd\u304d\u3001\u305d\u308c\u304c\u30c7\u30fc\u30bf\u306e\u6063\u610f\u7684\u306a\u9078\u629e\u3084\u6539\u3056\u3093\u306b\u3064\u306a\u304c\u308b\u30ea\u30b9\u30af\u304c\u3001\u6b74\u53f2\u7684\u306a\u4e0d\u6b63\u4e8b\u4ef6\u3092\u901a\u3058\u3066\u6d6e\u304d\u5f6b\u308a\u306b\u306a\u3063\u3066\u304d\u307e\u3057\u305f\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\u5229\u76ca\u76f8\u53cd\u3068\u7d44\u7e54\u7684\u306a\u4e0d\u6b63\u306e\u6559\u8a13<\/h3>\n\n\n\n<p>\u88fd\u85ac\u4f1a\u793e\u306e\u8077\u54e1\u304c\u81ea\u793e\u306e\u6cbb\u9a13\u306b\u53c2\u52a0\u3059\u308b\u3053\u3068\u306f\u3001\u672c\u8cea\u7684\u306b\u5f37\u3044\u300c\u5229\u76ca\u76f8\u53cd\u300d\u72b6\u614b\u3092\u751f\u307f\u51fa\u3057\u307e\u3059\u3002\u88ab\u9a13\u8005\u81ea\u8eab\u304c\u30c7\u30fc\u30bf\u306e\u751f\u6210\u8005\u3067\u3042\u308a\u3001\u304b\u3064\u305d\u306e\u30c7\u30fc\u30bf\u306e\u826f\u3057\u60aa\u3057\u304c\u81ea\u3089\u306e\u6240\u5c5e\u7d44\u7e54\u306e\u5229\u76ca\uff08\u3072\u3044\u3066\u306f\u81ea\u8eab\u306e\u7d66\u4e0e\u3084\u5730\u4f4d\u3001\u7d4c\u6b74\uff09\u306b\u76f4\u7d50\u3059\u308b\u305f\u3081\u3001\u79d1\u5b66\u7684\u5ba2\u89b3\u6027\u304c\u7dad\u6301\u3055\u308c\u306b\u304f\u3044\u306e\u3067\u3059\u3002<\/p>\n\n\n\n<p>\u65e5\u672c\u56fd\u5185\u306b\u304a\u3044\u3066\u3082\u3001\u6cbb\u9a13\u652f\u63f4\u4f1a\u793e\u306b\u304a\u3051\u308b\u5927\u898f\u6a21\u306a\u30c7\u30fc\u30bf\u6539\u3056\u3093\u3084\u3001\u88fd\u85ac\u30e1\u30fc\u30ab\u30fc\u306b\u3088\u308b\u8a66\u9a13\u30c7\u30fc\u30bf\u306e\u7d44\u7e54\u7684\u306a\u4e0d\u6b63\u304c\u767a\u899a\u3057\u305f\u4e8b\u4f8b\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u4e8b\u4ef6\u306f\u3001\u6cbb\u9a13\u696d\u754c\u5168\u4f53\u306b\u5bfe\u3059\u308b\u4fe1\u983c\u3092\u63fa\u308b\u304c\u3057\u3001\u65b0\u85ac\u958b\u767a\u306e\u672a\u6765\u306b\u3082\u5927\u304d\u306a\u5f71\u97ff\u3092\u53ca\u3057\u304b\u306d\u306a\u3044\u554f\u984c\u3068\u3057\u3066\u6df1\u523b\u306b\u53d7\u3051\u6b62\u3081\u3089\u308c\u307e\u3057\u305f\u3002\u3053\u3046\u3057\u305f\u80cc\u666f\u304b\u3089\u3001\u73fe\u4ee3\u306e\u6cbb\u9a13\u3067\u306f\u3001\u6cbb\u9a13\u4f9d\u983c\u8005\uff08\u88fd\u85ac\u4f01\u696d\uff09\u304b\u3089\u72ec\u7acb\u3057\u305f\u5229\u76ca\u76f8\u53cd\u59d4\u54e1\u4f1a\u306e\u8a2d\u7f6e\u3084\u3001\u5916\u90e8\u6a5f\u95a2\u306b\u3088\u308b\u53b3\u683c\u306a\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3001\u76e3\u67fb\u304c\u4e0d\u53ef\u6b20\u306a\u30d7\u30ed\u30bb\u30b9\u3068\u306a\u3063\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">ALCOA+\u539f\u5247\u3068\u30c7\u30b8\u30bf\u30eb\u76e3\u67fb\u8a3c\u8de1\u306b\u3088\u308b\u4e0d\u6b63\u9632\u6b62\u30e1\u30ab\u30cb\u30ba\u30e0<\/h3>\n\n\n\n<p>\u304b\u3064\u3066\u306e\u6cbb\u9a13\u30c7\u30fc\u30bf\u7ba1\u7406\u306f\u3001\u7d19\u30d9\u30fc\u30b9\u306e\u8a18\u9332\u3068\u300c\u95a2\u4fc2\u8005\u306e\u8aa0\u5b9f\u3055\u300d\u306b\u4f9d\u5b58\u3059\u308b\u90e8\u5206\u304c\u5927\u304d\u304b\u3063\u305f\u3067\u3059\u304c\u3001\u30c7\u30b8\u30bf\u30eb\u5316\u304c\u9032\u3093\u3060\u73fe\u4ee3\u3067\u306f\u3001\u30c7\u30fc\u30bf\u306e\u5b8c\u5168\u6027\u3092\u8a3c\u660e\u3059\u308b\u305f\u3081\u306e\u56fd\u969b\u7684\u306a\u6a19\u6e96\u3068\u3057\u3066\u300cALCOA+\u300d\u539f\u5247\u304c\u5c0e\u5165\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>\u5e30\u5c5e\u6027<\/strong>: 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class=\"wp-block-heading\">COVID-19\u4e0b\u3067\u306e\u81ea\u5df1\u5b9f\u9a13\u306e\u518d\u71c3\u3068\u502b\u7406\u7684\u8ad6\u4e89<\/h3>\n\n\n\n<p>2020\u5e74\u4ee5\u964d\u306e\u611f\u67d3\u75c7\u306e\u4e16\u754c\u7684\u6d41\u884c\u306f\u3001\u8fd1\u4ee3\u7684\u306a\u6cbb\u9a13\u306e\u30eb\u30fc\u30eb\u306b\u5bfe\u3057\u3001\u4e00\u7a2e\u306e\u300c\u63fa\u3055\u3076\u308a\u300d\u3092\u304b\u3051\u308b\u4e8b\u614b\u3068\u306a\u308a\u307e\u3057\u305f\u3002\u30ef\u30af\u30c1\u30f3\u306e\u65e9\u671f\u958b\u767a\u3092\u6c42\u3081\u308b\u793e\u4f1a\u7684\u5727\u529b\u306e\u4e0b\u3067\u3001\u4e00\u90e8\u306e\u79d1\u5b66\u8005\u30b0\u30eb\u30fc\u30d7\u306f\u3001\u65e2\u5b58\u306e\u898f\u5236\u30d7\u30ed\u30bb\u30b9\u3092\u56de\u907f\u3057\u3001\u81ea\u5206\u305f\u3061\u3092\u88ab\u9a13\u8005\u3068\u3057\u3066\u7d4c\u9f3b\u30ef\u30af\u30c1\u30f3\u306e\u958b\u767a\u3068\u30c6\u30b9\u30c8\u3092\u81ea\u5f8b\u7684\u306b\u884c\u3044\u307e\u3057\u305f\u3002<\/p>\n\n\n\n<p>\u5f7c\u3089\u306e\u52d5\u6a5f\u306f\u3001\u591a\u304f\u306e\u4eba\u3005\u306e\u82e6\u3057\u307f\u3092\u6e1b\u3089\u3059\u3068\u3044\u3046\u65e9\u671f\u306e\u30a2\u30af\u30bb\u30b9\u78ba\u4fdd\u3068\u30aa\u30fc\u30d7\u30f3\u30bd\u30fc\u30b9\u5316\u306b\u3042\u308a\u307e\u3057\u305f\u304c\u3001\u3053\u306e\u8a66\u307f\u306f\u3001\u73fe\u4ee3\u306e\u300c\u8eab\u4f53\u7684\u81ea\u5f8b\u300d\u306e\u539f\u5247\u3068\u3001\u7814\u7a76\u502b\u7406\u306b\u3088\u308b\u7b2c\u4e09\u8005\u7684\u306a\u898f\u5236\u306e\u30d0\u30e9\u30f3\u30b9\u3092\u3069\u3046\u53d6\u308b\u3079\u304d\u304b\u3068\u3044\u3046\u8b70\u8ad6\u3092\u518d\u71c3\u3055\u305b\u307e\u3057\u305f\u3002\u516c\u7684\u306a\u5be9\u67fb\u3092\u901a\u3055\u306a\u3044\u300c\u79d8\u5bc6\u88cf\u306e\u5b9f\u9a13\u300d\u306f\u3001\u4e88\u671f\u305b\u306c\u5371\u5bb3\u3084\u30c7\u30fc\u30bf\u306e\u4e0d\u900f\u660e\u6027\u3068\u3044\u3046\u3001\u304b\u3064\u3066\u306e\u81ea\u5df1\u5b9f\u9a13\u304c\u62b1\u3048\u3066\u3044\u305f\u30ea\u30b9\u30af\u3092\u518d\u3073\u62db\u304f\u3053\u3068\u306b\u306a\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<h2 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class=\"wp-block-heading\">\u53c2\u8003\u30fb\u51fa\u5178<\/h3>\n\n\n\n<ol class=\"wp-block-list\">\n<li> \uff62\u85ac\u306e\u6cbb\u9a13\uff63\u3067\u5927\u91cf\u6539\u3056\u3093\uff64\u7d44\u7e54\u3050\u308b\u307f\u4e0d\u6b63\u306e\u5516\u7136 \u6cbb\u9a13\u652f\u63f4\u4f1a\u793e\u3067\u6700\u5927123\u4ef6\u306e\u9055\u53cd\u884c\u70ba\u304c\u767a\u899a\uff08\u6771\u6d0b\u7d4c\u6e08\uff09 https:\/\/toyokeizai.net\/articles\/-\/710798<\/li>\n\n\n\n<li> ALCOA+ Principles &amp; Data Integrity In Pharma &#8211; Apotech Consulting https:\/\/apotechconsulting.com\/alcoa-principles-data-integrity\/<\/li>\n\n\n\n<li> \u6226\u5f8c\u306e\u85ac\u5bb3\u4e8b\u4ef6\u306e\u6982\u8981\u3068\u6559\u8a13 &#8211; \u4e00\u822c\u8ca1\u56e3\u6cd5\u4eba \u533b\u85ac\u54c1\u533b\u7642\u6a5f\u5668\uff08PMDA\uff09 https:\/\/www.pmrj.jp\/publications\/02\/shiryo_slides\/yakugai_shiryo_sengo.pdf<\/li>\n\n\n\n<li> \u2162 \u5275\u85ac\u7814\u7a76\u306e\u5b9f\u969b\u3068\u305d\u306e\u898f\u5236 \u300c\u308f\u304c\u56fd\u306b\u304a\u3051\u308b GCP \u57fa\u6e96\u306e\u5c55\u958b\u3068\u5c55\u671b\u300d \u52a0\u85e4\u7950\u4e00\uff08\u5185\u95a3\u5e9c\uff09 https:\/\/hab.or.jp\/committee\/pdf_hito03\/3-3_katoh.pdf<\/li>\n\n\n\n<li> Over-volunteering in Phase I clinical trials: data from a healthy volunteers&#8217; registry in Japan | Medical Research Archives &#8211; European Society of Medicine https:\/\/esmed.org\/MRA\/mra\/article\/view\/7231<\/li>\n\n\n\n<li> TGN1412: From Discovery to Disaster &#8211; PMC &#8211; NIH https:\/\/pmc.ncbi.nlm.nih.gov\/articles\/PMC2964774\/<\/li>\n\n\n\n<li> Inquiry into adverse events in trial blames drug, not study design &#8211; PMC https:\/\/pmc.ncbi.nlm.nih.gov\/articles\/PMC1440637\/<\/li>\n\n\n\n<li> \u91ce\u53e3\u82f1\u4e16\u3068\u9ec4\u71b1\u306e\u6b74\u53f2\u304b\u3089100\u5e74\u3092\u7d4c\u305f\u6559\u8a13\uff08\u4e2d\u8fbc\u6cbb\uff09 | | \u8a18\u4e8b\u4e00\u89a7 | \u533b\u5b66\u754c\u65b0\u805e 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