{"id":624,"date":"2026-05-12T14:18:16","date_gmt":"2026-05-12T05:18:16","guid":{"rendered":"https:\/\/mksinc.co.jp\/?page_id=624"},"modified":"2026-06-19T10:56:32","modified_gmt":"2026-06-19T01:56:32","slug":"%e5%a4%9a%e6%96%bd%e8%a8%ad%e8%87%a8%e5%ba%8a%e7%a0%94%e7%a9%b6%e6%94%af%e6%8f%b4%e3%82%b7%e3%82%b9%e3%83%86%e3%83%a0winesr%ef%bc%9a%e3%82%af%e3%83%a9%e3%82%a6%e3%83%89%e7%89%88","status":"publish","type":"page","link":"https:\/\/mksinc.co.jp\/?page_id=624","title":{"rendered":"\u591a\u65bd\u8a2d\u81e8\u5e8a\u7814\u7a76\u652f\u63f4\u30b7\u30b9\u30c6\u30e0(WINEs-R\uff1a\u30af\u30e9\u30a6\u30c9\u7248)"},"content":{"rendered":"\n<p>\u30ec\u30b8\u30b9\u30c8\u30ea\u7279\u5316\u578b \u81e8\u5e8a\u7814\u7a76\u30c7\u30fc\u30bf\u53ce\u96c6\u30b7\u30b9\u30c6\u30e0\u3067\u3059\u3002\u5b89\u4fa1\u3067\u3001\u5b9f\u7528\u7684\u306a\u3001\u30ec\u30b8\u30b9\u30c8\u30ea\u306b\u7279\u5316\u3057\u305f\u30c7\u30fc\u30bf\u53ce\u96c6\u30b7\u30b9\u30c6\u30e0\u3067\u3059\u3002\u591a\u65bd\u8a2d\u3067\u306e\u81e8\u5e8a\u7814\u7a76\u306b\u5bfe\u5fdc\u3057\u3066\u3044\u307e\u3059\u3002\u5927\u962a\u81e8\u5e8a\u7814\u7a76\u30cd\u30c3\u30c8\u30ef\u30fc\u30af(OCR\u30cd\u30c3\u30c8)\u30672013\u5e74\u304b\u3089\u904b\u7528\u3044\u305f\u3060\u3044\u3066\u3044\u308bCDCS(Clinical Study Data Collecting System)\u5c0e\u5165\u3067\u5f97\u305f\u77e5\u898b\u3092\u3082\u3068\u306b\u3001\u5fc5\u8981\u306a\u6a5f\u80fd\u3092\u7d5e\u3063\u3066\u30af\u30e9\u30a6\u30c9\u7248\u306e\u591a\u65bd\u8a2d\u81e8\u5e8a\u7814\u7a76\u652f\u63f4\u30b7\u30b9\u30c6\u30e0\u3092\u958b\u767a\u3057\u307e\u3057\u305f\u3002WINEs-R\uff08Wise Input Navigation and Entry system Registry\uff1a\u30ef\u30a4\u30f3\u30ba\u30a2\u30fc\u30eb\uff09\u3068\u540d\u4ed8\u3051\u307e\u3057\u305f\u3002<br><\/p>\n\n\n\n<h2>\u6982\u8981(\u60f3\u5b9a\u3059\u308b\u7814\u7a76\u3068\u8cbb\u7528)<\/h2>\n\n\n\n<figure class=\"wp-block-table is-style-stripes\"><table><tbody><tr><td>\u30c7\u30fc\u30bf\u53ce\u96c6\u671f\u9593<\/td><td>3\u5e74\u9593\uff08\u7814\u7a76\u671f\u9593\u5168\u4f53\uff09\u4ee5\u5185<\/td><\/tr><tr><td>\u65bd\u8a2d\u6570<\/td><td>30\u65bd\u8a2d\u4ee5\u5185<\/td><\/tr><tr><td>\u30e6\u30fc\u30b6\u6570<\/td><td>100\u30e6\u30fc\u30b6\u4ee5\u5185<\/td><\/tr><tr><td>\u75c7\u4f8b\u6570<\/td><td>3,000\u75c7\u4f8b\u4ee5\u5185<\/td><\/tr><tr><td>\u30c7\u30fc\u30bf\u53ce\u96c6\u9805\u76ee<\/td><td>150\u9805\u76ee\u4ee5\u5185<\/td><\/tr><tr><td>\u8cbb\u7528<\/td><td>300\u4e07\u5186\u3000\uff0a\u30a2\u30ab\u30c7\u30df\u30a2\u7279\u5225\u4fa1\u683c<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>\u7814\u7a76\u306e\u898f\u6a21\u3001\u671f\u9593\u3068\u8cbb\u7528\u611f\u306f\u4e0a\u8a18\u306b\u306a\u308a\u307e\u3059\u3002\u81e8\u5e8a\u7814\u7a76\u3054\u3068\u306b\u898b\u7a4d\u3092\u884c\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<h2>\u7279\u5fb4<\/h2>\n\n\n\n<ul><li>3\u5e74\u9593\u30013000\u75c7\u4f8b\u300130\u65bd\u8a2d\u3001100\u30e6\u30fc\u30b6\u3067\u3001300\u4e07\u5186\u3067\u306e\u30b5\u30fc\u30d3\u30b9\u63d0\u4f9b\u3092\u76ee\u6307\u3057\u3066\u3044\u307e\u3059\u3002OSS\uff08\u30aa\u30fc\u30d7\u30f3\u30bd\u30fc\u30b9\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\uff09\u3092\u4f7f\u3044\u3001\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3\u306b\u914d\u616e\u3057\u306a\u304c\u3089\u3001\u5b89\u4fa1\u306b\u30b5\u30fc\u30d3\u30b9\u63d0\u4f9b\u3057\u3088\u3046\u3068\u8003\u3048\u3066\u3044\u307e\u3059\u3002<\/li><li>\u5b9f\u7528\u7684\u306aeCRF\uff08eCRF\uff1aelectronic Clinical Report Form\u96fb\u5b50\u75c7\u4f8b\u5831\u544a\u66f8\uff09\u306e\u5165\u529b\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u304a\u3088\u3073\u30c7\u30fc\u30bf\u51fa\u529b\u304c\u3067\u304d\u308b\u30b7\u30b9\u30c6\u30e0\u3067\u3059\u3002<\/li><\/ul>\n\n\n\n<p><\/p>\n\n\n\n<h2>\u5bfe\u8c61\u7814\u7a76<\/h2>\n\n\n\n<p>\u81e8\u5e8a\u7814\u7a76\u306e\u3046\u3061\u3001GCP\u6e96\u62e0\u304c\u6c42\u3081\u3089\u308c\u308b\u4ecb\u5165\u8a66\u9a13\u3001\u6cbb\u9a13\u3067\u306f\u306a\u304f\u3001\u89b3\u5bdf\u7814\u7a76\u306e\u4e2d\u3067\u3082\u30ec\u30b8\u30b9\u30c8\u30ea\u7814\u7a76\u3092\u5bfe\u8c61\u3068\u3057\u3066\u3044\u307e\u3059\u3002\u4e0b\u8a18\u306e\u9ec4\u8272\u306e\u7814\u7a76\u304c\u5bfe\u8c61\u3067\u3059\u3002<\/p>\n\n\n\n<figure class=\"wp-block-image size-large is-resized\"><img loading=\"lazy\" src=\"https:\/\/mksinc.co.jp\/wp\/wp-content\/uploads\/2026\/05\/20260515\u81e8\u5e8a\u7814\u7a76-1024x576.png\" alt=\"\" class=\"wp-image-719\" width=\"675\" height=\"380\" srcset=\"https:\/\/mksinc.co.jp\/wp\/wp-content\/uploads\/2026\/05\/20260515\u81e8\u5e8a\u7814\u7a76-1024x576.png 1024w, https:\/\/mksinc.co.jp\/wp\/wp-content\/uploads\/2026\/05\/20260515\u81e8\u5e8a\u7814\u7a76-300x169.png 300w, https:\/\/mksinc.co.jp\/wp\/wp-content\/uploads\/2026\/05\/20260515\u81e8\u5e8a\u7814\u7a76-768x432.png 768w, https:\/\/mksinc.co.jp\/wp\/wp-content\/uploads\/2026\/05\/20260515\u81e8\u5e8a\u7814\u7a76-320x180.png 320w, https:\/\/mksinc.co.jp\/wp\/wp-content\/uploads\/2026\/05\/20260515\u81e8\u5e8a\u7814\u7a76.png 1157w\" sizes=\"(max-width: 675px) 100vw, 675px\" \/><\/figure>\n\n\n\n<p><\/p>\n\n\n\n<h2>\u30b7\u30b9\u30c6\u30e0\u69cb\u6210<\/h2>\n\n\n\n<p>\u30b7\u30b9\u30c6\u30e0\u69cb\u6210\u306f\u4e0b\u8a18\u306e\u7dd1\u306e\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3067\u69cb\u6210\u3055\u308c\u307e\u3059\u3002\u30af\u30e9\u30a4\u30a2\u30f3\u30c8\u7aef\u672b\u306f Windows 11 \u3092\u524d\u63d0\u3068\u3057\u3066\u3044\u307e\u3059\u3002\u30af\u30e9\u30a4\u30a2\u30f3\u30c8\u7aef\u672b\u3092\u6e96\u5099\u3044\u305f\u3060\u304d\u3001\u75c7\u4f8b\u767b\u9332\u5c02\u7528\u30bd\u30d5\u30c8\u3092\u30a4\u30f3\u30b9\u30c8\u30fc\u30eb\u3057\u307e\u3059\u3002\u30b5\u30fc\u30d0\u306f\u56fd\u5185\u30af\u30e9\u30a6\u30c9\u3092\u4f7f\u7528\u3057\u307e\u3059\u3002\u30b5\u30fc\u30d0\u8a3c\u660e\u66f8\u3001\u30af\u30e9\u30a4\u30a2\u30f3\u30c8\u8a3c\u660e\u66f8\u3092\u4f7f\u7528\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<figure class=\"wp-block-image size-large is-resized\"><img loading=\"lazy\" src=\"https:\/\/mksinc.co.jp\/wp\/wp-content\/uploads\/2026\/05\/\u30b7\u30b9\u30c6\u30e0\u69cb\u6210.png\" alt=\"\" class=\"wp-image-630\" width=\"855\" height=\"388\" srcset=\"https:\/\/mksinc.co.jp\/wp\/wp-content\/uploads\/2026\/05\/\u30b7\u30b9\u30c6\u30e0\u69cb\u6210.png 626w, https:\/\/mksinc.co.jp\/wp\/wp-content\/uploads\/2026\/05\/\u30b7\u30b9\u30c6\u30e0\u69cb\u6210-300x136.png 300w\" sizes=\"(max-width: 855px) 100vw, 855px\" \/><\/figure>\n\n\n\n<p><\/p>\n\n\n\n<h2>\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3\u5bfe\u7b56<\/h2>\n\n\n\n<p>mTLS\uff08\u76f8\u4e92TLS\u8a8d\u8a3c\uff09\u306b\u3064\u3044\u3066<\/p>\n\n\n\n<p>\u672c\u30b7\u30b9\u30c6\u30e0\u3067\u306f\u3001\u901a\u5e38\u306eHTTPS\/TLS\u901a\u4fe1\u306b\u52a0\u3048\u3001\u30af\u30e9\u30a4\u30a2\u30f3\u30c8\u8a3c\u660e\u66f8\u306b\u3088\u308b\u300c\u76f8\u4e92TLS\u8a8d\u8a3c\uff08mTLS\uff09\u300d\u3092\u63a1\u7528\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u30b5\u30fc\u30d0\u3060\u3051\u3067\u306a\u304f\u63a5\u7d9a\u3059\u308b\u533b\u7642\u6a5f\u95a2\u7aef\u672b\u5074\u3082\u8a8d\u8a3c\u3055\u308c\u3001\u8a31\u53ef\u3055\u308c\u305f\u7aef\u672b\u306e\u307f\u304c\u30b7\u30b9\u30c6\u30e0\u3078\u63a5\u7d9a\u53ef\u80fd\u3067\u3059\u3002<\/p>\n\n\n\n<p>\u60a3\u8005ID\u3068\u533f\u540d\u5316ID\uff08\u88ab\u9a13\u8005\u756a\u53f7\uff09\u306e\u7ba1\u7406\u306f\u4ee5\u4e0b\u3067\u3059\u3002<\/p>\n\n\n\n<ul><li>\u60a3\u8005ID\u3068\u533f\u540d\u5316ID\u306e\u5bfe\u5fdc\u8868\u306e\u30af\u30e9\u30a4\u30a2\u30f3\u30c8\u5074\u4fdd\u7ba1\uff1a\u60a3\u8005ID\u3068\u533f\u540d\u5316ID\uff08\u88ab\u9a13\u8005\u756a\u53f7\uff09\u306e\u5bfe\u5fdc\u8868\u306f\u3001\u30af\u30e9\u30a4\u30a2\u30f3\u30c8\u5074\uff08\u533b\u7642\u6a5f\u95a2\u5074\uff09\u306b\u306e\u307f\u4fdd\u7ba1\u3057\u307e\u3059\u3002\u3053\u306e\u5bfe\u5fdc\u8868\u306f\u30af\u30e9\u30a6\u30c9\u5074\u306b\u306f\u9001\u4fe1\u3057\u307e\u305b\u3093\u3002<\/li><li>\u30af\u30e9\u30a6\u30c9\u5074\u3078\u306e\u9001\u4fe1\u30c7\u30fc\u30bf\uff1a\u30af\u30e9\u30a6\u30c9\u3078\u306f\u533f\u540d\u5316ID\uff08\u88ab\u9a13\u8005\u756a\u53f7\uff09\u306e\u307f\u3092\u9001\u4fe1\u3057\u3001\u60a3\u8005\u3092\u7279\u5b9a\u3067\u304d\u308b\u60c5\u5831\u306f\u542b\u307e\u308c\u307e\u305b\u3093\u3002\u60a3\u8005ID\u5bfe\u5fdc\u8868\u3092\u30af\u30e9\u30a6\u30c9\u3078\u4fdd\u5b58\u3057\u306a\u3044\u3053\u3068\u3067\u3001\u60a3\u8005\u7279\u5b9a\u30ea\u30b9\u30af\u306e\u4f4e\u6e1b\u3092\u56f3\u3063\u3066\u3044\u307e\u3059\u3002<\/li><\/ul>\n\n\n\n<p><\/p>\n\n\n\n<h2>\u30a2\u30af\u30bb\u30b9\u65b9\u6cd5\u3001\u8a8d\u8a3c\u65b9\u5f0f<\/h2>\n\n\n\n<figure class=\"wp-block-table is-style-stripes\"><table><tbody><tr><td>\u30a2\u30af\u30bb\u30b9\u65b9\u6cd5<\/td><td>Web\u30d6\u30e9\u30a6\u30b6\u306b\u3088\u308b\u7ba1\u7406\u6a5f\u80fd\uff0b\u75c7\u4f8b\u767b\u9332\u5c02\u7528\u30bd\u30d5\u30c8(eCRF\u767b\u9332)<\/td><\/tr><tr><td>\u8a8d\u8a3c\u65b9\u5f0f<\/td><td>\u30af\u30e9\u30a4\u30a2\u30f3\u30c8\u8a3c\u660e\u66f8\u8a8d\u8a3c\uff08mTLS\uff09\u304a\u3088\u3073ID\/\u30d1\u30b9\u30ef\u30fc\u30c9\u8a8d\u8a3c<\/td><\/tr><tr><td>\u30c7\u30fc\u30bf\u4fdd\u5b58\u5148<\/td><td>\u56fd\u5185\u30c7\u30fc\u30bf\u30bb\u30f3\u30bf\u30fc\u306b\u3066\u4fdd\u7ba1<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><\/p>\n\n\n\n<h2>\u5c0e\u5165\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\uff08\u76ee\u5b89\uff09<\/h2>\n\n\n\n<figure class=\"wp-block-table is-style-stripes\"><table><tbody><tr><td><strong>\u30d5\u30a7\u30fc\u30ba<\/strong><\/td><td><strong>\u671f\u9593<\/strong><\/td><td><strong>\u4e3b\u306a\u4f5c\u696d<\/strong><\/td><\/tr><tr><td><strong>\u8981\u4ef6\u5b9a\u7fa9<\/strong><\/td><td>3\u301c6\u9031\u9593<\/td><td>\u53ce\u96c6\u30c7\u30fc\u30bf\u9805\u76ee\u30fb\u753b\u9762\u8a2d\u8a08\u30fb\u7814\u7a76\u8a08\u753b\u66f8\u7b49\u306e\u8cc7\u6599\u78ba\u8a8d<\/td><\/tr><tr><td><strong>\u74b0\u5883\u69cb\u7bc9<\/strong><\/td><td>3\u301c8\u9031\u9593<\/td><td>\u30b5\u30fc\u30d0\u69cb\u7bc9\u30fb\u8a2d\u5b9a\u3001\u75c7\u4f8b\u767b\u9332\u5c02\u7528\u30bd\u30d5\u30c8\u306e\u30a4\u30f3\u30b9\u30c8\u30fc\u30e9\u30fc\u4f5c\u6210\u3001eCRF(\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u5165\u529b\u753b\u9762)\u4f5c\u6210<\/td><\/tr><tr><td><strong>\u8a3c\u660e\u66f8\u767a\u884c<\/strong><\/td><td>3\u301c6\u9031\u9593<\/td><td>\u30af\u30e9\u30a4\u30a2\u30f3\u30c8\u8a3c\u660e\u66f8\u767a\u884c\u30fb\u81e8\u5e8a\u7814\u7a76\u4e8b\u52d9\u5c40\u3078\u914d\u5e03\u30fb\u30a4\u30f3\u30b9\u30c8\u30fc\u30eb\u30b5\u30dd\u30fc\u30c8<\/td><\/tr><tr><td><strong>\u52d5\u4f5c\u78ba\u8a8d\u30fb\u691c\u53ce<\/strong><\/td><td>3\u301c6\u9031\u9593<\/td><td>\u52d5\u4f5c\u78ba\u8a8d\u30fb\u53d7\u5165\u30c6\u30b9\u30c8(\u30e6\u30fc\u30b6\u69d8\u3067\u306e\u52d5\u4f5c\u78ba\u8a8d)<\/td><\/tr><tr><td><strong>\u672c\u756a\u904b\u7528\u958b\u59cb<\/strong><\/td><td>\u7814\u7a76\u958b\u59cb\u306b\u5408\u308f\u305b\u308b<\/td><td>\u904b\u7528\u958b\u59cb\u30fb\u30d8\u30eb\u30d7\u30c7\u30b9\u30af\u5bfe\u5fdc\u958b\u59cb<\/td><\/tr><\/tbody><\/table><figcaption>\u5c0e\u5165\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u4f8b\u3067\u3059\u3002\u81e8\u5e8a\u7814\u7a76\u3054\u3068\u306b\u76f8\u8ac7\u3055\u305b\u3066\u3044\u305f\u3060\u304d\u307e\u3059\u3002<\/figcaption><\/figure>\n\n\n\n<p><\/p>\n\n\n\n<h2>\u904b\u7528\u60f3\u5b9a<\/h2>\n\n\n\n<p>\u81e8\u5e8a\u7814\u7a76\u4e8b\u52d9\u5c40\u306e\u65b9\u304c\u75c7\u4f8b\u767b\u9332\u5c02\u7528\u30bd\u30d5\u30c8\u306e\u914d\u5e03\u3001ID\/\u30d1\u30b9\u30ef\u30fc\u30c9\u306e\u914d\u5e03\u3001\u4e00\u6b21\u554f\u3044\u5408\u308f\u305b\u5bfe\u5fdc\u3092\u884c\u3046\u60f3\u5b9a\u3067\u3059\u3002\u30c7\u30fc\u30bf\u51fa\u529b\u306f\u7d71\u8a08\u89e3\u6790\u62c5\u5f53\u306e\u65b9\u304c\u884c\u3063\u3066\u3044\u305f\u3060\u304f\u60f3\u5b9a\u3067\u3059\u3002<\/p>\n\n\n\n<p><\/p>\n\n\n\n<h2>eCRF \u6a5f\u80fd\u4ed5\u69d8\u3000\u5165\u529b\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3<\/h2>\n\n\n\n<p>\u96fb\u5b50\u75c7\u4f8b\u5831\u544a\u66f8\uff08eCRF\uff1aelectronic Clinical Report Form\uff09\u306e\u57fa\u672c\u7684\u306a\u30c7\u30fc\u30bf\u578b\u30fb\u7bc4\u56f2\u30c1\u30a7\u30c3\u30af<\/p>\n\n\n\n<ul><li>\u30c7\u30fc\u30bf\u578b\u30c1\u30a7\u30c3\u30af\uff1a\u6570\u5024\u9805\u76ee\u306b\u5168\u89d2\u6587\u5b57\u3084\u30a2\u30eb\u30d5\u30a1\u30d9\u30c3\u30c8\u304c\u5165\u3089\u306a\u3044\u3088\u3046\u306b\u5236\u9650\u3057\u307e\u3059\u3002<\/li><li>\u7bc4\u56f2\u30c1\u30a7\u30c3\u30af\uff08Range Check\uff09\uff1a\u533b\u5b66\u7684\u306b\u3042\u308a\u5f97\u306a\u3044\u6570\u5024\u3092\u5165\u529b\u4e0d\u53ef\u3068\u3057\u307e\u3059\u3002\u4f8b\u3048\u3070\u3001\u8840\u5727\uff08\u53ce\u7e2e\u671f\uff09\u304c 0 \u3084 300 \u3092\u8d85\u3048\u308b\u5024\u3001\u8eab\u9577\u304c 300 cm \u3092\u8d85\u3048\u308b\u5024\u306a\u3069\u3002<\/li><li>\u5fc5\u9808\u9805\u76ee\u30c1\u30a7\u30c3\u30af\uff1a\u89e3\u6790\u306b\u4e0d\u53ef\u6b20\u306a\u4e3b\u8981\u8a55\u4fa1\u9805\u76ee\uff08Primary Endpoint\uff09\u304c\u7a7a\u6b04\u306e\u307e\u307e\u4fdd\u5b58\u3055\u308c\u308b\u306e\u3092\u9632\u304e\u307e\u3059\u3002<\/li><\/ul>\n\n\n\n<p>\u533b\u5b66\u7684\u8ad6\u7406\u30c1\u30a7\u30c3\u30af\uff08\u30ed\u30b8\u30ab\u30eb\u30c1\u30a7\u30c3\u30af\uff09<\/p>\n\n\n\n<ul><li>\u65e5\u4ed8\u306e\u524d\u5f8c\u95a2\u4fc2\uff1a\u6642\u7cfb\u5217\u306e\u77db\u76fe\u3092\u30c1\u30a7\u30c3\u30af\u3057\u307e\u3059\u3002\u4f8b\u3048\u3070\u3001\u300c\u540c\u610f\u53d6\u5f97\u65e5 \u2264 \u89b3\u5bdf\u958b\u59cb\u65e5\u300d\u300c\u624b\u8853\u65e5 \u2264 \u9000\u9662\u65e5\u300d\u3092\u30c1\u30a7\u30c3\u30af\u3057\u307e\u3059\u3002<\/li><li>\u6d3e\u751f\u8a08\u7b97\u306e\u81ea\u52d5\u5316\uff1a\u4f8b\u3048\u3070\u3001\u8eab\u9577\u3068\u4f53\u91cd\u304b\u3089 BMI \u3092\u81ea\u52d5\u8a08\u7b97\u3057\u3001\u624b\u5165\u529b\u306b\u3088\u308b\u8a08\u7b97\u30df\u30b9\u3092\u6392\u9664\u3057\u307e\u3059\u3002<\/li><li>\u30b9\u30ad\u30c3\u30d7\u30ed\u30b8\u30c3\u30af\uff08\u6761\u4ef6\u4ed8\u304d\u8868\u793a\uff09\uff1a\u8a73\u7d30\u9805\u76ee\u3092\u6761\u4ef6\u4ed8\u304d\u3067\u30b9\u30ad\u30c3\u30d7\u3057\u305f\u308a\u3001\u8868\u793a\u3055\u305b\u305f\u308a\u3067\u304d\u307e\u3059\u3002\u4f8b\u3048\u3070\u3001\u300c\u5408\u4f75\u75c7\uff1a\u3042\u308a\u300d\u3092\u9078\u629e\u3057\u305f\u5834\u5408\u306e\u307f\u3001\u5177\u4f53\u7684\u306a\u5408\u4f75\u75c7\u540d\u306e\u5165\u529b\u6b04\u3092\u8868\u793a\u3057\u307e\u3059\u3002\u300c\u5408\u4f75\u75c7\uff1a\u306a\u3057\u300d\u3092\u9078\u629e\u3057\u305f\u5834\u5408\u306f\u3001\u4e0d\u8981\u306a\u5165\u529b\u6b04\u3092\u96a0\u3059\u3053\u3068\u3067\u3001\u8aa4\u5165\u529b\u3092\u7269\u7406\u7684\u306b\u6e1b\u3089\u3057\u307e\u3059\u3002<\/li><\/ul>\n\n\n\n<p><\/p>\n\n\n\n<h2>\u30c7\u30fc\u30bf\u51fa\u529b\u306b\u3064\u3044\u3066<\/h2>\n\n\n\n<ul><li>\u5165\u529b\u30c7\u30fc\u30bf\u306f\u6c4e\u7528\u7684\u306a CSV \u30d5\u30a1\u30a4\u30eb\u3068\u3057\u3066\u62bd\u51fa\u53ef\u80fd\u3067\u3059\u3002R\u30fbSAS\u30fbSPSS \u306a\u3069\u4e3b\u8981\u306a\u7d71\u8a08\u89e3\u6790\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3078\u305d\u306e\u307e\u307e\u8aad\u307f\u8fbc\u3081\u308b\u305f\u3081\u3001\u30c7\u30fc\u30bf\u5909\u63db\u306e\u624b\u9593\u306a\u304f\u89e3\u6790\u4f5c\u696d\u306b\u79fb\u884c\u3067\u304d\u307e\u3059\u3002<\/li><li>\u9078\u629e\u80a2\u3092\u30b3\u30fc\u30c9\u5316\u3055\u308c\u305f\u5024\u3068\u3057\u3066\u62bd\u51fa\u3067\u304d\u307e\u3059\u3002\u4f8b\u3048\u3070\u3001\u7537\u3092 M\u3001\u5973\u3092 F \u306a\u3069\u3067\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u7d71\u8a08\u89e3\u6790\u30bd\u30d5\u30c8\u3078\u306e\u53d6\u308a\u8fbc\u307f\u6642\u306b\u30e9\u30d9\u30eb\u4ed8\u3051\u4f5c\u696d\u304c\u4e0d\u8981\u3068\u306a\u308a\u3001\u89e3\u6790\u62c5\u5f53\u8005\u306e\u5de5\u6570\u3092\u524a\u6e1b\u3057\u307e\u3059\u3002<\/li><\/ul>\n\n\n\n<p><\/p>\n\n\n\n<h2>\u5236\u9650\u4e8b\u9805<\/h2>\n\n\n\n<p>\u6a5f\u80fd\u3092\u7d5e\u308b\u3053\u3068\u3067\u8cbb\u7528\u9013\u6e1b\u3092\u5b9f\u73fe\u3057\u3066\u3044\u307e\u3059\u3002\u4ee5\u4e0b\u306e\u6a5f\u80fd\u306f\u5bfe\u5fdc\u3057\u3066\u3044\u307e\u305b\u3093\u306e\u3067\u5236\u9650\u4e8b\u9805\u306b\u306a\u308a\u307e\u3059\u3002\u30c7\u30fc\u30bf\u53ce\u96c6\u9805\u76ee\u304c\u56fa\u5b9a\u3055\u308c\u305f\u30ec\u30b8\u30b9\u30c8\u30ea\u306b\u7279\u5316\u3059\u308b\u3053\u3068\u3067\u30b3\u30b9\u30c8\u3092\u6291\u3048\u3066\u3044\u307e\u3059\u3002\u904b\u7528\u958b\u59cb\u5f8c\u306e\u9805\u76ee\u8ffd\u52a0\u7b49\u306e\u30d5\u30a9\u30fc\u30e0\u6539\u7248\u306f\u539f\u5247\u884c\u308f\u306a\u3044\u524d\u63d0\u3067\u3059\u3002\u307e\u305f\u5f0a\u793e\u3067\u306e\u30b5\u30dd\u30fc\u30c8\u4f53\u5236\u3092\u52d8\u6848\u3057\u3066\u3001eCRF\u75c7\u4f8b\u767b\u9332\u6642\u9593\u3092\u5348\u524d7\u6642\u304b\u308922\u6642\u307e\u3067\u3068\u3055\u305b\u3066\u3044\u305f\u3060\u304d\u307e\u3059\u3002<\/p>\n\n\n\n<ul><li>\u30d5\u30a9\u30fc\u30e0\u6539\u7248\uff08eCRF \u306e\u5909\u66f4\uff09\u975e\u5bfe\u5fdc\uff1a\u904b\u7528\u958b\u59cb\u5f8c\u306e\u30d5\u30a9\u30fc\u30e0\u6539\u7248\uff08eCRF \u306e\u5909\u66f4\uff09\u306b\u306f\u5bfe\u5fdc\u3057\u3066\u3044\u307e\u305b\u3093\u3002<\/li><li>ER\/ES \u6307\u91dd\u3084 21 CFR Part 11 \u306b\u6e96\u62e0\u3057\u305f\u76e3\u67fb\u8a3c\u8de1\uff08Audit 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class=\"wp-block-image size-large is-resized\"><img loading=\"lazy\" src=\"https:\/\/mksinc.co.jp\/wp\/wp-content\/uploads\/2026\/05\/image-1024x598.png\" alt=\"\" class=\"wp-image-641\" width=\"700\" height=\"409\" srcset=\"https:\/\/mksinc.co.jp\/wp\/wp-content\/uploads\/2026\/05\/image-1024x598.png 1024w, https:\/\/mksinc.co.jp\/wp\/wp-content\/uploads\/2026\/05\/image-300x175.png 300w, https:\/\/mksinc.co.jp\/wp\/wp-content\/uploads\/2026\/05\/image-768x449.png 768w, https:\/\/mksinc.co.jp\/wp\/wp-content\/uploads\/2026\/05\/image-1536x898.png 1536w, https:\/\/mksinc.co.jp\/wp\/wp-content\/uploads\/2026\/05\/image.png 1853w\" sizes=\"(max-width: 700px) 100vw, 700px\" 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