{"id":7269,"date":"2020-03-23T14:37:00","date_gmt":"2020-03-23T14:37:00","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=7269"},"modified":"2022-11-14T07:22:18","modified_gmt":"2022-11-14T07:22:18","slug":"how-to-write-a-clinical-trial-protocol","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-write-a-clinical-trial-protocol\/","title":{"rendered":"Writing a Clinical Trial Protocol: Expert Tips"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_45_1 counter-flat ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\">table of contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" area-label=\"ez-toc-toggle-icon-1\"><label for=\"item-6a2db6a4bca6c\" aria-label=\"Table of Content\"><span style=\"display: flex;align-items: center;width: 35px;height: 30px;justify-content: center;direction:ltr;\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewbox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewbox=\"0 0 24 24\" version=\"1.2\" baseprofile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/label><input  type=\"checkbox\" id=\"item-6a2db6a4bca6c\"><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1' ><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-write-a-clinical-trial-protocol\/#What_is_a_clinical_trial_protocol\" title=\"\u6cbb\u9a13\u5b9f\u65bd\u8a08\u753b\u66f8\u3068\u306f\u4f55\u3067\u3059\u304b\uff1f\">\u6cbb\u9a13\u5b9f\u65bd\u8a08\u753b\u66f8\u3068\u306f\u4f55\u3067\u3059\u304b\uff1f<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-write-a-clinical-trial-protocol\/#Why_is_the_clinical_trial_protocol_needed\" title=\"\u6cbb\u9a13\u5b9f\u65bd\u8a08\u753b\u66f8\u306f\u306a\u305c\u5fc5\u8981\u306a\u306e\u304b\uff1f\">\u6cbb\u9a13\u5b9f\u65bd\u8a08\u753b\u66f8\u306f\u306a\u305c\u5fc5\u8981\u306a\u306e\u304b\uff1f<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-write-a-clinical-trial-protocol\/#Preparing_the_clinical_trial_protocol\" title=\"\u81e8\u5e8a\u8a66\u9a13\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u4f5c\u6210\">\u81e8\u5e8a\u8a66\u9a13\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u4f5c\u6210<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-write-a-clinical-trial-protocol\/#Topics_included_in_a_clinical_trial_protocol\" title=\"\u81e8\u5e8a\u8a66\u9a13\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u542b\u307e\u308c\u308b\u9805\u76ee\">\u81e8\u5e8a\u8a66\u9a13\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u542b\u307e\u308c\u308b\u9805\u76ee<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-write-a-clinical-trial-protocol\/#A_team_effort\" title=\"\u30c1\u30fc\u30e0\u30ef\u30fc\u30af\u306e\u826f\u3055\">\u30c1\u30fc\u30e0\u30ef\u30fc\u30af\u306e\u826f\u3055<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-write-a-clinical-trial-protocol\/#The_SPIRIT_Statement\" title=\"SPIRIT\u5ba3\u8a00\">SPIRIT\u5ba3\u8a00<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-write-a-clinical-trial-protocol\/#Protocol_deviations_violations_andor_amendments\" title=\"\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u9038\u8131\u3001\u9055\u53cd\u3001\u4fee\u6b63\">\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u9038\u8131\u3001\u9055\u53cd\u3001\u4fee\u6b63<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-write-a-clinical-trial-protocol\/#Tips_for_writing_a_clinical_trial_protocol\" title=\"\u81e8\u5e8a\u8a66\u9a13\u30d7\u30ed\u30c8\u30b3\u30eb\u4f5c\u6210\u306e\u30dd\u30a4\u30f3\u30c8\">\u81e8\u5e8a\u8a66\u9a13\u30d7\u30ed\u30c8\u30b3\u30eb\u4f5c\u6210\u306e\u30dd\u30a4\u30f3\u30c8<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-write-a-clinical-trial-protocol\/#The_importance_of_public_availability_of_clinical_trial_protocols\" title=\"\u81e8\u5e8a\u8a66\u9a13\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u516c\u958b\u306e\u91cd\u8981\u6027\">\u81e8\u5e8a\u8a66\u9a13\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u516c\u958b\u306e\u91cd\u8981\u6027<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-write-a-clinical-trial-protocol\/#Additional_references_and_resources\" title=\"\u305d\u306e\u4ed6\u306e\u53c2\u8003\u6587\u732e\u30fb\u8cc7\u6599\">\u305d\u306e\u4ed6\u306e\u53c2\u8003\u6587\u732e\u30fb\u8cc7\u6599<\/a><\/li><\/ul><\/nav><\/div>\n<p><b><i>\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306e\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30bf\u30fc <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/laura-moro\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=ClinicalTrialProtocol\">\u30ed\u30fc\u30e9\u30fb\u30e2\u30ed\u3001MSc\u3001PhD<\/a> \u3092\u6e96\u5099\u3059\u308b\u305f\u3081\u306e\u5c02\u9580\u7684\u306a\u30d2\u30f3\u30c8\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-trial-protocol-writing\">clinical trial protocol writing<\/a> \u30d0\u30a4\u30aa\u30c6\u30c3\u30af\u3001\u88fd\u85ac\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u5411\u3051\u306e\u00a0<\/i><\/b><\/p>\n<h2><span class=\"ez-toc-section\" id=\"What_is_a_clinical_trial_protocol\"><\/span><b>\u6cbb\u9a13\u5b9f\u65bd\u8a08\u753b\u66f8\u3068\u306f\u4f55\u3067\u3059\u304b\uff1f<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u3042\u306a\u305f\u304c\u81e8\u5e8a\u7814\u7a76\u306b\u643a\u308f\u3063\u3066\u3044\u308b\u5834\u5408\u3001\u81e8\u5e8a\u8a66\u9a13\u8a08\u753b\u66f8\u306e\u4f5c\u6210\u306b\u8ca2\u732e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u304b\u3082\u3057\u308c\u307e\u305b\u3093\u3002\u6cbb\u9a13\u5b9f\u65bd\u8a08\u753b\u66f8\u3068\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u304c\u3069\u306e\u3088\u3046\u306b\u884c\u308f\u308c\u308b\u304b\u3092\u8a18\u8ff0\u3057\u305f\u6587\u66f8\u3067\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-trials?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=ClinicalTrialProtocol\">\u81e8\u5e8a\u8a66\u9a13<\/a> will be conducted, including the objective(s), design, methodology, statistical considerations, and organization of the trial to guarantee the safety of the participants and the integrity of the collected data. The protocol also provides the background and rationale for conducting the study and the <a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">\u30ea\u30b5\u30fc\u30c1<\/a> questions that it addresses, as well as considerations on ethical issues. The format and content of clinical trial protocols are standardized and follow the<\/span><a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/ich-e-6-r2-guideline-good-clinical-practice-step-5_en.pdf\"> <span style=\"font-weight: 400;\">\u30b0\u30c3\u30c9\u30fb\u30af\u30ea\u30cb\u30ab\u30eb\u30fb\u30d7\u30e9\u30af\u30c6\u30a3\u30b9\uff08GCP\uff09\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3<\/span><\/a><span style=\"font-weight: 400;\"> (1995\u5e74\u521d\u7248\u30012016\u5e74\u6700\u7d42\u66f4\u65b0\uff09\u306b\u5f93\u3063\u3066\u3001\u30d2\u30c8\u7528\u533b\u85ac\u54c1\u306e\u767b\u9332\u306b\u95a2\u3059\u308b\u6280\u8853\u7684\u8981\u4ef6\u306e\u8abf\u548c\u306b\u95a2\u3059\u308b\u56fd\u969b\u4f1a\u8b70(<\/span><a href=\"https:\/\/www.ich.org\/\"><span style=\"font-weight: 400;\">ICH<\/span><\/a><span style=\"font-weight: 400;\">).<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Why_is_the_clinical_trial_protocol_needed\"><\/span><b>\u6cbb\u9a13\u5b9f\u65bd\u8a08\u753b\u66f8\u306f\u306a\u305c\u5fc5\u8981\u306a\u306e\u304b\uff1f<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u30d7\u30ed\u30c8\u30b3\u30fc\u30eb\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u3059\u3079\u3066\u306e\u5074\u9762\u306b\u304a\u3044\u3066\u91cd\u8981\u306a\u54c1\u8cea\u7ba1\u7406\u30c4\u30fc\u30eb\u3067\u3042\u308a\u3001\u3044\u304f\u3064\u304b\u306e\u7406\u7531\u3067\u5fc5\u8981\u3068\u306a\u308a\u307e\u3059\u3002<\/span><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\">\u3059\u3079\u3066\u306e\u7814\u7a76\u53c2\u52a0\u8005\u306e\u5065\u5eb7\u3068\u5b89\u5168\u3092\u78ba\u4fdd\u3057\u307e\u3059\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">I<\/span><span style=\"font-weight: 400;\">\u7dfb\u5bc6\u306a\u5b66\u7fd2\u30d7\u30e9\u30f3\u3092\u63d0\u4f9b<\/span><\/li>\n<li><span style=\"font-weight: 400;\">I<\/span><span style=\"font-weight: 400;\">\u8a66\u9a13\u3092\u5b9a\u7fa9\u3057\u3001\u7ba1\u7406\u3059\u308b\u3082\u306e\u3067\u3042\u308b\u305f\u3081\u3001\u3059\u3079\u3066\u306e\u7814\u7a76\u8005\u304c\u53b3\u5bc6\u306b\u5f93\u3046\u3079\u304d\u3082\u306e\u3067\u3042\u308b\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">I<\/span><span style=\"font-weight: 400;\">\u30c7\u30fc\u30bf\u306e\u5b8c\u5168\u6027\u304c\u4fdd\u8a3c\u3055\u308c\u3001\u3059\u3079\u3066\u306e\u7814\u7a76\u8005\u304a\u3088\u3073\/\u307e\u305f\u306f\u7814\u7a76\u65bd\u8a2d\u3067\u306e\u30c7\u30fc\u30bf\u306e\u7d44\u307f\u5408\u308f\u305b\u3068\u6bd4\u8f03\u304c\u53ef\u80fd\u3067\u3042\u308b\u3053\u3068\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">I<\/span><span style=\"font-weight: 400;\">\u7814\u7a76\u7ba1\u7406\u8005\uff08\u591a\u304f\u306e\u5834\u5408\u3001CRO\uff08\u533b\u85ac\u54c1\u958b\u767a\u696d\u52d9\u53d7\u8a17\u6a5f\u95a2\uff09\uff09\u306b\u9023\u7d61\u3059\u308b\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">I<\/span><span style=\"font-weight: 400;\">\u7814\u7a76\u502b\u7406\u59d4\u54e1\u4f1a\u3084IRB\uff08Institutional Review Board\uff09\u304b\u3089\u502b\u7406\u7684\u627f\u8a8d\u3092\u5f97\u308b\u5fc5\u8981\u304c\u3042\u308b\u5834\u5408\u3002<\/span><\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"Preparing_the_clinical_trial_protocol\"><\/span><b>\u81e8\u5e8a\u8a66\u9a13\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u4f5c\u6210<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u30d7\u30ed\u30c8\u30b3\u30fc\u30eb\u30b7\u30ce\u30d7\u30b7\u30b9\u306f\u3001\u5b8c\u5168\u306a\u81e8\u5e8a\u8a66\u9a13\u30d7\u30ed\u30c8\u30b3\u30fc\u30eb\u3092\u66f8\u304f\u305f\u3081\u306e\u57fa\u790e\u3068\u306a\u308b\u3082\u306e\u3067\u3001\u901a\u5e38\u3001\u30b9\u30dd\u30f3\u30b5\u30fc\u307e\u305f\u306f\u30b9\u30dd\u30f3\u30b5\u30fc\u3068CRO\u304c\u5171\u540c\u3067\u4f5c\u6210\u3059\u308b\u3002\u30b7\u30ce\u30d7\u30b7\u30b9\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u4e3b\u306a\u76ee\u7684\u3068\u526f\u6b21\u7684\u306a\u76ee\u7684\u3092\u8a18\u8f09\u3057\u3001\u8a66\u9a13\u30c7\u30b6\u30a4\u30f3\u306e\u6982\u8981\u3068\u6cbb\u7642\u306b\u95a2\u3059\u308b\u8a73\u7d30\u3092\u63d0\u4f9b\u3059\u308b\u77ed\u3044\u6587\u66f8\u3067\u3059\u3002\u4e16\u754c\u4fdd\u5065\u6a5f\u95a2\uff08WHO\uff09\u306b\u3088\u308b\u30d7\u30ed\u30c8\u30b3\u30fc\u30eb\u30b7\u30ce\u30d7\u30b7\u30b9\u306e\u4f8b\u3092\u4ee5\u4e0b\u306b\u7d39\u4ecb\u3057\u307e\u3059\u3002<\/span><a href=\"https:\/\/www.who.int\/immunization\/research\/implementation\/infant_schedule_synopsis_rct.pdf?ua=1\"> <span style=\"font-weight: 400;\">\u30ea\u30f3\u30af<\/span><\/a><span style=\"font-weight: 400;\">.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u30d7\u30ed\u30c8\u30b3\u30fc\u30eb\u30b7\u30ce\u30d7\u30b7\u30b9\u53ca\u3073\u30d7\u30ed\u30c8\u30b3\u30fc\u30eb\u6587\u66f8\u5168\u4f53\u306f\u3001ICH E6\u306b\u6e96\u62e0\u3057\u305f\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u306b\u6cbf\u3063\u3066\u4f5c\u6210\u3057\u3001\u4e00\u8cab\u6027\u3092\u4fdd\u3061\u3001\u5168\u3066\u306e\u91cd\u8981\u306a\u8981\u7d20\u3092\u542b\u3080\u3088\u3046\u306b\u3059\u308b\u3053\u3068\u3002\u30d7\u30ed\u30c8\u30b3\u30fc\u30eb\u30b7\u30ce\u30d7\u30b7\u30b9\u306b\u306f\u3001\u4ee5\u4e0b\u306e\u60c5\u5831\u304c\u542b\u307e\u308c\u308b\uff1a\u8a66\u9a13\u540d\u3001\u88fd\u54c1\u3001\u81e8\u5e8a\u6bb5\u968e\u3001\u30d7\u30ed\u30c8\u30b3\u30fc\u30eb\u756a\u53f7\u3001\u75be\u60a3\u9069\u5fdc\u3001\u8a66\u9a13\u8b58\u5225\u756a\u53f7\u3001\u30b9\u30dd\u30f3\u30b5\u30fc\u53ca\u3073\u6cbb\u9a13\u8cac\u4efb\u533b\u5e2b\u306b\u95a2\u3059\u308b\u60c5\u5831\u3001\u81e8\u5e8a\u65bd\u8a2d\u306b\u95a2\u3059\u308b\u60c5\u5831\u3002\u3055\u3089\u306b\u3001\u30b7\u30ce\u30d7\u30b7\u30b9\u306b\u306f\u3001\u76ee\u7684\u3001\u8a66\u9a13\u30c7\u30b6\u30a4\u30f3\u3001\u8a66\u9a13\u5bfe\u8c61\u8005\u3001\u30b5\u30f3\u30d7\u30eb\u30b5\u30a4\u30ba\u3001\u9069\u683c\u6027\u57fa\u6e96\uff08\u7d44\u307f\u5165\u308c\u3001\u9664\u5916\uff09\u3001\u6cbb\u7642\u6cd5\u3001\u76ee\u7684\u306b\u57fa\u3065\u304f\u8a55\u4fa1\u306e\u7a2e\u985e\u3068\u6642\u671f\uff08\u660e\u78ba\u306a\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u307e\u305f\u306f\u30d5\u30ed\u30fc\u30c1\u30e3\u30fc\u30c8\u3067\uff09\u304c\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u3002\u76ee\u7684\u3084\u7814\u7a76\u30c7\u30b6\u30a4\u30f3\u3092\u6b63\u78ba\u306b\u5b9a\u7fa9\u3059\u308b\u3053\u3068\u3067\u3001\u57f7\u7b46\u306e\u52b9\u7387\u304c\u4e0a\u304c\u308a\u3001\u77db\u76fe\u3092\u907f\u3051\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002\u30b5\u30f3\u30d7\u30eb\u30b5\u30a4\u30ba\u306e\u8a08\u7b97\u306f\u3001\u4e3b\u76ee\u7684\u306b\u57fa\u3065\u3044\u3066\u884c\u3044\u3001\u8ffd\u52a0\u306e\u76ee\u7684\u306f\u526f\u6b21\u7684\u306a\u3082\u306e\u306b\u5206\u985e\u3055\u308c\u308b\u3079\u304d\u3067\u3042\u308b\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u6982\u8981\u3092\u4f5c\u6210\u3057\u305f\u5f8c\u3001\u30d7\u30ed\u30c8\u30b3\u30eb\u5168\u4f53\u3092\u4f5c\u6210\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002\u5b8c\u5168\u306a\u30d7\u30ed\u30c8\u30b3\u30fc\u30eb\u306b\u306f\u3001\u5c0e\u5165\u90e8\uff08\u81e8\u5e8a\u304a\u3088\u3073\u975e\u81e8\u5e8a\u30c7\u30fc\u30bf\u3092\u542b\u3080\uff09\u3001\u6839\u62e0\u3001\u8a55\u4fa1\u306e\u3088\u308a\u8a73\u7d30\u306a\u8aac\u660e\u3001\u7d71\u8a08\u7684\u624b\u6cd5\u306e\u8aac\u660e\u3001\u5148\u884c\u6cbb\u7642\u307e\u305f\u306f\u4f75\u7528\u6cbb\u7642\u3001\u8a66\u9a13\u306e\u4e2d\u65ad\u307e\u305f\u306f\u4e2d\u6b62\u304c\u5fc5\u8981\u306a\u6761\u4ef6\u306a\u3069\u306e\u8ffd\u52a0\u8981\u7d20\uff08\u4ee5\u4e0b\u306e\u30ea\u30b9\u30c8\uff09\u304c\u542b\u307e\u308c\u308b\u3002<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Topics_included_in_a_clinical_trial_protocol\"><\/span><b>\u81e8\u5e8a\u8a66\u9a13\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u542b\u307e\u308c\u308b\u9805\u76ee<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u306e\u3067\u3059\u3002<\/span><a href=\"https:\/\/ichgcp.net\/6-clinical-trial-protocol-and-protocol-amendments\/\"> <span style=\"font-weight: 400;\">ICH\u30a6\u30a7\u30d6\u30b5\u30a4\u30c8<\/span><\/a><span style=\"font-weight: 400;\"> \u306f\u3001\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u542b\u307e\u308c\u308b\u3079\u304d\u30c8\u30d4\u30c3\u30af\u306e\u5168\u30ea\u30b9\u30c8\u3092\u5831\u544a\u3059\u308b\u3002\u306a\u304a\u3001\u30b5\u30a4\u30c8\u56fa\u6709\u306e\u60c5\u5831\u306f\u5225\u306e\u5951\u7d04\u66f8\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u5834\u5408\u304c\u3042\u308a\u3001\u307e\u305f\u3001\u4ee5\u4e0b\u306b\u793a\u3059\u60c5\u5831\u306e\u4e00\u90e8\u306f\u3001\u6cbb\u9a13\u8cac\u4efb\u533b\u5e2b\u306e\u30d1\u30f3\u30d5\u30ec\u30c3\u30c8\u306a\u3069\u3001\u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u53c2\u7167\u3059\u308b\u4ed6\u306e\u6587\u66f8\u306b\u542b\u307e\u308c\u3066\u3044\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002\u4e88\u60f3\u3055\u308c\u308b\u7814\u7a76\u30c7\u30b6\u30a4\u30f3\u306b\u5fdc\u3058\u3066\u3001\u3055\u307e\u3056\u307e\u306a\u5177\u4f53\u7684\u306a\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u304c\u4f5c\u6210\u3055\u308c\u3066\u304a\u308a\u3001\u305d\u306e\u307b\u3068\u3093\u3069\u304c\u30ab\u30d0\u30fc\u3059\u3079\u304d\u9805\u76ee\u306e\u5b8c\u5168\u306a\u30ea\u30b9\u30c8\u3092\u542b\u3093\u3067\u3044\u307e\u3059\u3002\u4f8b\u3068\u3057\u3066\u3001\u7c73\u56fd\u56fd\u7acb\u304c\u3093\u7814\u7a76\u6240\u306eCancer Therapy Evaluation Program\u304b\u3089\u4e00\u822c\u7684\u306a\u30d7\u30ed\u30c8\u30b3\u30eb\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\u3092\u30c0\u30a6\u30f3\u30ed\u30fc\u30c9\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/span><a href=\"https:\/\/ctep.cancer.gov\/protocolDevelopment\/templates_applications.htm\"> <span style=\"font-weight: 400;\">\u3053\u308c<\/span><\/a><span style=\"font-weight: 400;\">.<\/span><\/p>\n<ol>\n<li><b><\/b><span style=\"font-weight: 400;\"> \u00a0<\/span><b>\u30bf\u30a4\u30c8\u30eb\u30da\u30fc\u30b8\uff08\u4e00\u822c\u60c5\u5831<br \/>\n<\/b><span style=\"font-weight: 400;\">\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u30bf\u30a4\u30c8\u30eb\u3001\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u8b58\u5225\u756a\u53f7\u3001\u65e5\u4ed8\u3001\u4fee\u6b63\u306e\u53ef\u80fd\u6027\uff08\u4fee\u6b63\u306b\u3064\u3044\u3066\u306f\u6b21\u306e\u30bb\u30af\u30b7\u30e7\u30f3\u3067\u8a73\u3057\u304f\u8aac\u660e\u3057\u307e\u3059\uff09\u3001\u30b9\u30dd\u30f3\u30b5\u30fc\u3001\u30e2\u30cb\u30bf\u30fc\u3001\u533b\u5b66\u5c02\u9580\u5bb6\u3001\u6cbb\u9a13\u8cac\u4efb\u533b\u5e2b\u3001\u305d\u306e\u4ed6\u306e\u95a2\u4fc2\u6a5f\u95a2\u306e\u540d\u524d\u3068\u9023\u7d61\u5148\u3092\u542b\u307f\u307e\u3059\u3002<\/span><\/li>\n<li><b><\/b><b>\u80cc\u666f\u60c5\u5831<br \/>\n<\/b><span style=\"font-weight: 400;\">\u6cbb\u9a13\u85ac\u306e\u540d\u79f0\u3068\u8aac\u660e\u3001\u975e\u81e8\u5e8a\u8a66\u9a13\u304a\u3088\u3073\u305d\u306e\u4ed6\u306e\u81e8\u5e8a\u8a66\u9a13\u3067\u5f97\u3089\u308c\u305f\u7d50\u679c\u306e\u6982\u8981\u3001\u65e2\u77e5\u304a\u3088\u3073\u6f5c\u5728\u7684\u306a\u30ea\u30b9\u30af\u3068\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u3001\u6295\u4e0e\u7d4c\u8def\u3068\u7528\u6cd5\u7528\u91cf\u306e\u8aac\u660e\u3001\u30d7\u30ed\u30c8\u30b3\u30eb\u3001GCP\u304a\u3088\u3073\u898f\u5236\u8981\u4ef6\u3078\u306e\u6e96\u62e0\u3092\u4fdd\u8a3c\u3059\u308b\u58f0\u660e\u3001\u5bfe\u8c61\u8005\u306e\u8aac\u660e\u3001\u95a2\u9023\u6587\u732e\u306e\u53c2\u7167\u3092\u542b\u3080\u3002<\/span><\/li>\n<li><b><\/b><b>\u76ee\u7684\u30fb\u76ee\u6a19<br \/>\n<\/b><span style=\"font-weight: 400;\">\u76ee\u7684\u3084\u6cbb\u9a13\u306e\u76ee\u7684\u3092\u8a73\u3057\u304f\u8aac\u660e\u3057\u305f\u3082\u306e\u3002<\/span><b><\/b><\/li>\n<li><b>\u7814\u7a76\u30c7\u30b6\u30a4\u30f3<br \/>\n<\/b><span style=\"font-weight: 400;\">\u4e3b\u8981\u8a55\u4fa1\u9805\u76ee\u304a\u3088\u3073\u526f\u6b21\u8a55\u4fa1\u9805\u76ee\u306b\u95a2\u3059\u308b\u60c5\u5831\u3001\u8a66\u9a13\u30c7\u30b6\u30a4\u30f3\u306e\u8aac\u660e\u3001\u30d0\u30a4\u30a2\u30b9\u3092\u6700\u5c0f\u5316\u3059\u308b\u305f\u3081\u306e\u624b\u6bb5\uff08\u7121\u4f5c\u70ba\u5316\u304a\u3088\u3073\u76f2\u691c\u5316\u3092\u542b\u3080\uff09\u306e\u8aac\u660e\u3001\u6cbb\u7642\u6cd5\u304a\u3088\u3073\u6295\u4e0e\u6cd5\u306e\u8aac\u660e\u3001\u88ab\u9a13\u8005\u306e\u4e88\u60f3\u53c2\u52a0\u671f\u9593\u3001\u4e2d\u6b62\u57fa\u6e96\u306e\u8aac\u660e\u3001\u8aac\u660e\u8cac\u4efb\u306e\u624b\u9806\u306a\u3069\u3092\u542b\u3080\u3002<\/span><\/li>\n<li><b><\/b><b>\u88ab\u9a13\u8005\u306e\u9078\u629e\u3068\u9664\u5916<br \/>\n<\/b><span style=\"font-weight: 400;\">\u7d44\u307f\u5165\u308c\u57fa\u6e96\u3001\u9664\u5916\u57fa\u6e96\u3001\u53d6\u308a\u4e0b\u3052\u57fa\u6e96\u3001\u53d6\u308a\u4e0b\u3052\u624b\u9806\u306e\u8aac\u660e\u3002<\/span><\/li>\n<li><b><\/b><span style=\"font-weight: 400;\"> \u00a0<\/span><b>\u88ab\u9a13\u8005\u306e\u6271\u3044<br \/>\n<\/b><span style=\"font-weight: 400;\">\u6cbb\u7642\u306b\u95a2\u3059\u308b\u60c5\u5831\uff08\u88fd\u54c1\u540d\u3001\u7528\u91cf\u3001\u6295\u4e0e\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u3001\u7d4c\u8def\u3001\u6cbb\u7642\u671f\u9593\u3001\u30d5\u30a9\u30ed\u30fc\u30a2\u30c3\u30d7\uff09\u3001\u305d\u306e\u4ed6\u306e\u8a31\u53ef\u3055\u308c\u3066\u3044\u308b\u307e\u305f\u306f\u8a31\u53ef\u3055\u308c\u3066\u3044\u306a\u3044\u85ac\/\u6cbb\u7642\u6cd5\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u76e3\u8996\u3059\u308b\u305f\u3081\u306e\u624b\u9806\u3002<\/span><\/li>\n<li><b><\/b><span style=\"font-weight: 400;\"> \u00a0<\/span><b>\u6709\u52b9\u6027\u306e\u8a55\u4fa1<br \/>\n<\/b><span style=\"font-weight: 400;\">\u6709\u52b9\u6027\u306e\u30d1\u30e9\u30e1\u30fc\u30bf\u3001\u306a\u3089\u3073\u306b\u305d\u306e\u8a55\u4fa1\u3001\u8a18\u9332\u3001\u5206\u6790\u306e\u65b9\u6cd5\u3068\u6642\u671f\u306e\u6307\u5b9a\u3002<\/span><\/li>\n<li><b><\/b><span style=\"font-weight: 400;\"> \u00a0<\/span><b>\u5b89\u5168\u6027\u306e\u8a55\u4fa1<br \/>\n<\/b><span style=\"font-weight: 400;\">\u5b89\u5168\u6027\u30d1\u30e9\u30e1\u30fc\u30bf\u306e\u898f\u5b9a\u3001\u5b89\u5168\u6027\u30d1\u30e9\u30e1\u30fc\u30bf\u306e\u8a55\u4fa1\u30fb\u8a18\u9332\u30fb\u5206\u6790\u306e\u65b9\u6cd5\u3068\u6642\u671f\u3001\u6709\u5bb3\u4e8b\u8c61\u306e\u5831\u544a\u3068\u30d5\u30a9\u30ed\u30fc\u30a2\u30c3\u30d7\u3002<\/span><\/li>\n<li><b><\/b><span style=\"font-weight: 400;\"> \u00a0<\/span><b>\u7d71\u8a08\u60c5\u5831<br \/>\n<\/b><span style=\"font-weight: 400;\">\u63a1\u7528\u3059\u308b\u7d71\u8a08\u624b\u6cd5\u306e\u8aac\u660e\u3001\u30b5\u30f3\u30d7\u30eb\u30b5\u30a4\u30ba\u3001\u7d42\u4e86\u57fa\u6e96\u3001\u6b20\u640d\u3001\u672a\u4f7f\u7528\u3001\u30b9\u30d7\u30ea\u30a2\u30b9\u30c7\u30fc\u30bf\u3092\u8003\u616e\u3059\u308b\u624b\u9806\u3001\u9038\u8131\u3092\u5831\u544a\u3059\u308b\u624b\u9806\u3001\u5206\u6790\u306b\u542b\u3081\u308b\u88ab\u9a13\u8005\u306e\u9078\u629e\u3002<\/span><\/li>\n<li><b><\/b><span style=\"font-weight: 400;\"> \u00a0<\/span><b>\u30bd\u30fc\u30b9\u30c7\u30fc\u30bf\/\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u3078\u306e\u76f4\u63a5\u30a2\u30af\u30bb\u30b9<br \/>\n<\/b><span style=\"font-weight: 400;\">\u6cbb\u9a13\u4f9d\u983c\u8005\u306f\u3001\u6cbb\u9a13\u8cac\u4efb\u533b\u5e2b\u53ca\u3073\u65bd\u8a2d\u304c\u6cbb\u9a13\u95a2\u9023\u306e\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3001\u76e3\u67fb\u3001IRB 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400;\">\u30c7\u30fc\u30bf\u306e\u8cea\u3092\u4fdd\u8a3c\u3059\u308b\u305f\u3081\u306b\u5b9f\u65bd\u3055\u308c\u305f\u54c1\u8cea\u4fdd\u8a3c\u304a\u3088\u3073\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u306e\u8aac\u660e\uff08\u7814\u4fee\u4f1a\u3001\u6cbb\u9a13\u8cac\u4efb\u533b\u5e2b\u306e\u76e3\u8996\u3001\u6307\u793a\u66f8\u3001\u72ec\u7acb\u3057\u305f\u5185\u90e8\u307e\u305f\u306f\u5916\u90e8\u306e\u76e3\u67fb\u624b\u9806\u306e\u4f7f\u7528\u306a\u3069\u3092\u542b\u3080\uff09\u3002<\/span><\/li>\n<li><b><\/b><span style=\"font-weight: 400;\"> \u00a0<\/span><b>\u502b\u7406<br \/>\n<\/b><span style=\"font-weight: 400;\">\u502b\u7406\u57fa\u6e96\u306e\u9075\u5b88\u3092\u8aac\u660e\u3057\u305f\u3001\u8a66\u9a13\u306b\u95a2\u9023\u3059\u308b\u502b\u7406\u7684\u914d\u616e\u306e\u8a18\u8ff0\u3002\u4f8b\u3048\u3070\u3001\u7dca\u6025\u4e8b\u614b\uff08\u53c2\u52a0\u8005\u306e\u4e8b\u524d\u306e\u540c\u610f\u304c\u5f97\u3089\u308c\u306a\u3044\u5834\u5408\u306a\u3069\uff09\u306b\u304a\u3044\u3066\u3001\u95a2\u9023\u3059\u308b\u502b\u7406\u7684\u61f8\u5ff5\u306b\u3069\u306e\u3088\u3046\u306b\u9069\u5207\u306b\u5bfe\u51e6\u3057\u3001\u8a66\u9a13\u306b\u9069\u7528\u3055\u308c\u308b\u898f\u5236\u8981\u4ef6\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u304b\u3092\u8aac\u660e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u5c0f\u5150\u3092\u5bfe\u8c61\u3068\u3057\u305f\u533b\u85ac\u54c1\u306e\u81e8\u5e8a\u8a66\u9a13\u306b\u304a\u3051\u308b\u502b\u7406\u7684\u914d\u616e\u306b\u3064\u3044\u3066\u306eEU\u6587\u66f8\u306f\u3001\u4ee5\u4e0b\u306e\u30da\u30fc\u30b8\u3067\u3054\u89a7\u3044\u305f\u3060\u3051\u307e\u3059\u3002<\/span><a href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-10\/ethical_considerations_en.pdf\"> <span style=\"font-weight: 400;\">\u3053\u306e\u30ea\u30f3\u30af<\/span><\/a><span style=\"font-weight: 400;\">.<\/span><\/li>\n<li><b><\/b> <b>\u30c7\u30fc\u30bf\u306e\u53d6\u308a\u6271\u3044\u3068\u8a18\u9332\u4fdd\u6301<br \/>\n<\/b><span style=\"font-weight: 400;\">\u3053\u306e\u30bb\u30af\u30b7\u30e7\u30f3\u3067\u306f\u3001\u96fb\u5b50\u30c7\u30fc\u30bf\u51e6\u7406\u30b7\u30b9\u30c6\u30e0\u304c\u3001\u5b8c\u5168\u6027\u3001\u6b63\u78ba\u6027\u3001\u4fe1\u983c\u6027\u3001\u304a\u3088\u3073\u4e00\u8cab\u3057\u3066\u610f\u56f3\u3055\u308c\u305f\u6027\u80fd\u306b\u95a2\u3059\u308b\u30b9\u30dd\u30f3\u30b5\u30fc\u306e\u78ba\u7acb\u3057\u305f\u8981\u4ef6\u306b\u9069\u5408\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3059\u308b\u3002\u307e\u305f\u3001\u8a66\u9a13\u306e\u9032\u6357\u72b6\u6cc1\u3092\u8a55\u4fa1\u3059\u308b\u305f\u3081\u306b\u72ec\u7acb\u3057\u305f\u30c7\u30fc\u30bf\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u59d4\u54e1\u4f1a\u304c\u8a2d\u7f6e\u3055\u308c\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u306b\u3064\u3044\u3066\u3082\u8a00\u53ca\u3059\u3079\u304d\u3067\u3042\u308b\u3002<\/span><\/li>\n<li><b><\/b><span style=\"font-weight: 400;\"> \u00a0<\/span><b>\u878d\u8cc7\u3068\u4fdd\u967a<br \/>\n<\/b><span style=\"font-weight: 400;\">\u81e8\u5e8a\u8a66\u9a13\u306e\u8cc7\u91d1\u8abf\u9054\u3084\u3001\u591a\u304f\u306e\u56fd\u3067\u52a0\u5165\u304c\u7fa9\u52d9\u4ed8\u3051\u3089\u308c\u3066\u3044\u308b\u81e8\u5e8a\u8a66\u9a13\u53c2\u52a0\u8005\u306e\u4fdd\u967a\u306b\u3064\u3044\u3066\u306e\u8a73\u7d30\u3002<\/span><\/li>\n<li><b><\/b><span style=\"font-weight: 400;\">\u00a0<\/span><b>\u51fa\u7248\u65b9\u91dd<br \/>\n<\/b><span style=\"font-weight: 400;\">GCP\u304a\u3088\u3073\u9069\u7528\u3055\u308c\u308b\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3078\u306e\u6e96\u62e0\u3092\u5ba3\u8a00\u3057\u305f\u4e0a\u3067\u306e\u3001\u81e8\u5e8a\u30c7\u30fc\u30bf\uff08\u67fb\u8aad\u4ed8\u304d\u79d1\u5b66\u96d1\u8a8c\u306b\u63b2\u8f09\u3055\u308c\u305f\u539f\u7a3f\u3001\u6284\u9332\u3001\u30dd\u30b9\u30bf\u30fc\u3001\u53e3\u982d\u767a\u8868\u3001\u7dcf\u8aac\u306a\u3069\uff09\u306e\u516c\u8868\u306b\u95a2\u3059\u308b\u65b9\u91dd\u306e\u8a18\u8ff0\u3002 <\/span><span style=\"font-weight: 400;\">(\u6ce8\uff1a13\uff5e15\u306e\u9805\u76ee\u306f\u3001\u5225\u306e\u5951\u7d04\u66f8\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u306a\u3044\u5834\u5408\u3001\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u542b\u3081\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059)<\/span><\/li>\n<li>\u00a0<b style=\"font-size: 14px;\">\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306e\u30bf\u30a4\u30e0\u30c6\u30fc\u30d6\u30eb\/\u30d5\u30ed\u30fc\u30c1\u30e3\u30fc\u30c8<br \/>\n<\/b><span style=\"font-weight: 400;\">\u4e88\u5b9a\u3055\u308c\u3066\u3044\u308b\u8a66\u9a13\u306e\u958b\u59cb\u3068\u7d42\u4e86\u3092\u542b\u3080\u3001\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3\u306e\u8a18\u8ff0\u3002<\/span><\/li>\n<li><b><\/b><span style=\"font-weight: 400;\"> \u00a0 <\/span><b>\u30ea\u30d5\u30a1\u30ec\u30f3\u30b9<\/b><\/li>\n<li><b><\/b><span style=\"font-weight: 400;\"> \u00a0 <\/span><b>\u30b5\u30d7\u30ea\u30e1\u30f3\u30c8\uff0f\u30a2\u30da\u30f3\u30c7\u30a3\u30c3\u30af\u30b9<\/b><\/li>\n<\/ol>\n<h2><span class=\"ez-toc-section\" id=\"A_team_effort\"><\/span><b>\u30c1\u30fc\u30e0\u30ef\u30fc\u30af\u306e\u826f\u3055<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u81e8\u5e8a\u8a66\u9a13\u306e\u30d7\u30ed\u30c8\u30b3\u30eb\u306f\u901a\u5e38\u3001\u4e00\u4eba\u306e\u4eba\u9593\u304c\u4f5c\u6210\u3059\u308b\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u305d\u306e\u4ee3\u308f\u308a\u306b\u3001\u533b\u5b66\u5c02\u9580\u5bb6\u3001\u7d71\u8a08\u5b66\u8005\u3001\u85ac\u7269\u52d5\u614b\u5b66\u5c02\u9580\u5bb6\u3001\u7814\u7a76\u8005\u306a\u3069\u306e\u591a\u5206\u91ce\u306b\u308f\u305f\u308b\u30c1\u30fc\u30e0\u306b\u3088\u3063\u3066\u4f5c\u6210\u3055\u308c\u307e\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/services\/clinical-research-consulting?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=ClinicalTrialProtocol\">\u81e8\u5e8a\u7814\u7a76\u30b3\u30fc\u30c7\u30a3\u30cd\u30fc\u30bf\u30fc<\/a>\u3001\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u30de\u30cd\u30fc\u30b8\u30e3\u30fc\u3001\u305d\u3057\u3066\u3059\u3079\u3066\u306e\u30a4\u30f3\u30d7\u30c3\u30c8\u3092\u6700\u7d42\u7684\u306a\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u306b\u76db\u308a\u8fbc\u3080\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30bf\u30fc\u306a\u3069\u306e\u5c02\u9580\u5bb6\u304c\u3044\u307e\u3059\u3002<\/span><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\"> \u306e\u3067\u3059\u3002 <\/span><b>\u30e1\u30c7\u30a3\u30ab\u30eb\u30a8\u30ad\u30b9\u30d1\u30fc\u30c8<\/b><span style=\"font-weight: 400;\"> \u306f\u6587\u66f8\u4f5c\u6210\u306b\u304a\u3044\u3066\u91cd\u8981\u306a\u5f79\u5272\u3092\u679c\u305f\u3057\u3066\u304a\u308a\u3001\u8a66\u9a13\u30c7\u30b6\u30a4\u30f3\u3001\u76ee\u7684\u3068\u30a8\u30f3\u30c9\u30dd\u30a4\u30f3\u30c8\u3001\u9078\u629e\u57fa\u6e96\u3001\u8a55\u4fa1\u624b\u9806\u306a\u3069\u306e\u30bb\u30af\u30b7\u30e7\u30f3\u306b\u8ca2\u732e\u3057\u3066\u3044\u307e\u3059\u3002\u307e\u305f\u3001\u30e1\u30c7\u30a3\u30ab\u30eb\u30a8\u30ad\u30b9\u30d1\u30fc\u30c8\u306f\u3001\u4f75\u7528\u7642\u6cd5\u306e\u4f7f\u7528\u3084\u7528\u91cf\u6f38\u5897\u8a66\u9a13\u3067\u9069\u7528\u3055\u308c\u308b\u4e2d\u6b62\u30eb\u30fc\u30eb\u306b\u3064\u3044\u3066\u3082\u610f\u898b\u3092\u8ff0\u3079\u307e\u3059\u3002 <\/span><i><span style=\"font-weight: 400;\">\u533b\u7642\u5c02\u9580\u5bb6\u306e\u5f79\u5272\u306f\u901a\u5e38\u3001\u5916\u90e8\u306b\u59d4\u8a17\u3055\u308c\u308b\u3053\u3068\u306f\u3042\u308a\u307e\u305b\u3093\u3002<\/span><\/i><\/li>\n<li><span style=\"font-weight: 400;\"> \u306e\u3067\u3059\u3002 <\/span><b>\u30b9\u30bf\u30c6\u30a3\u30b9\u30c6\u30a3\u30b7\u30e3\u30f3 <\/b><span style=\"font-weight: 400;\">\u306f\u3001\u30b5\u30f3\u30d7\u30eb\u30b5\u30a4\u30ba\u3068\u7814\u7a76\u306e\u691c\u51fa\u529b\uff08\u6cbb\u7642\u7fa4\u9593\u306e\u81e8\u5e8a\u7684\u306b\u610f\u5473\u306e\u3042\u308b\u5dee\u3092\u6c7a\u5b9a\u3059\u308b\u305f\u3081\u306b\u91cd\u8981\uff09\u306e\u8a08\u7b97\u3092\u884c\u3044\u3001\u76ee\u7684\u3068\u30a8\u30f3\u30c9\u30dd\u30a4\u30f3\u30c8\u306e\u8a2d\u5b9a\u306b\u8ca2\u732e\u3057\u307e\u3059\u3002\u7d71\u8a08\u62c5\u5f53\u8005\u306f\u3001\u3059\u3079\u3066\u306e\u7d71\u8a08\u624b\u9806\u306e\u5b9f\u65bd\u306b\u8cac\u4efb\u3092\u6301\u3061\u3001\u8a66\u9a13\u306b\u304a\u3051\u308b\u6f5c\u5728\u7684\u306a\u5909\u52d5\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u308b\u3088\u3046\u306b\u3057\u307e\u3059\u3002 <\/span><i><span style=\"font-weight: 400;\">\u7d71\u8a08\u62c5\u5f53\u8005\u306e\u5f79\u5272\u306f\u3001\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306e\u7d71\u8a08\u62c5\u5f53\u8005\u306b\u59d4\u8a17\u3057\u305f\u308a <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/biostatistics?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=ClinicalTrialProtocol\">\u751f\u7269\u7d71\u8a08\u5b66\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8<\/a>t.<\/span><\/i><\/li>\n<li><span style=\"font-weight: 400;\"> \u306e\u3067\u3059\u3002 <\/span><b>\u85ac\u7269\u52d5\u614b\u30a8\u30ad\u30b9\u30d1\u30fc\u30c8<\/b><span style=\"font-weight: 400;\"> \u3053\u306e\u5c02\u9580\u5bb6\u306f\u3001\u85ac\u5264\u306e\u5fc5\u9808\u85ac\u7269\u52d5\u614b\u8981\u4ef6\u3092\u7279\u5b9a\u3059\u308b\u76ee\u7684\u3084\u30a8\u30f3\u30c9\u30dd\u30a4\u30f3\u30c8\u3001\u6295\u4e0e\u65b9\u6cd5\u306e\u6c7a\u5b9a\u306b\u8ca2\u732e\u3057\u307e\u3059\u3002\u307e\u305f\u3001\u3053\u306e\u5c02\u9580\u5bb6\u306f\u3001\u85ac\u7269\u52d5\u614b\u30c7\u30fc\u30bf\u3092\u8a55\u4fa1\u3059\u308b\u305f\u3081\u306e\u7d71\u8a08\u7684\u624b\u9806\u306e\u78ba\u7acb\u3084\u3001\u5358\u56de\u304b\u3089\u8907\u6570\u56de\u306e\u6607\u9806\u6295\u4e0e\u8a66\u9a13\u306b\u304a\u3051\u308b\u6295\u4e0e\u983b\u5ea6\u306e\u6c7a\u5b9a\u306b\u3082\u53c2\u52a0\u3057\u3066\u3044\u307e\u3059\u3002 <\/span><i><span style=\"font-weight: 400;\">\u85ac\u7269\u52d5\u614b\u306e\u5c02\u9580\u5bb6\u306e\u5f79\u5272\u306f\u5916\u90e8\u306b\u59d4\u8a17\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/span><\/i><\/li>\n<li><span style=\"font-weight: 400;\"> \u306e\u3067\u3059\u3002 <\/span><b>\u81e8\u5e8a\u7814\u7a76\u30b3\u30fc\u30c7\u30a3\u30cd\u30fc\u30bf\u30fc<\/b><span style=\"font-weight: 400;\"> \u306f\u3001\u5b9f\u9a13\u5ba4\u306e\u5b89\u5168\u6027\u3084\u30b5\u30f3\u30d7\u30eb\u306e\u30ed\u30b8\u30b9\u30c6\u30a3\u30c3\u30af\u30b9\u306a\u3069\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u7ba1\u7406\u3068\u30ed\u30b8\u30b9\u30c6\u30a3\u30c3\u30af\u30b9\u306b\u8ca2\u732e\u3057\u307e\u3059\u3002\u3055\u3089\u306b\u3001\u30b3\u30fc\u30c7\u30a3\u30cd\u30fc\u30bf\u30fc\u306f\u3001\u3055\u307e\u3056\u307e\u306a\u8a55\u4fa1\u306e\u5b9f\u65bd\u53ef\u80fd\u6027\u3092\u6c7a\u5b9a\u3057\u3001\u305d\u306e\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u3068\u8aac\u660e\u3092\u6e96\u5099\u3059\u308b\u5f79\u5272\u3082\u62c5\u3063\u3066\u3044\u307e\u3059\u3002 <\/span><i><span style=\"font-weight: 400;\">\u81e8\u5e8a\u7814\u7a76\u30b3\u30fc\u30c7\u30a3\u30cd\u30fc\u30bf\u30fc\u306e\u5f79\u5272\u306f\u3001\u901a\u5e38\u3001\u5916\u90e8\u306b\u59d4\u8a17\u3055\u308c\u308b\u3053\u3068\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u00a0<\/span><\/i><\/li>\n<li><span style=\"font-weight: 400;\"> \u306e\u3067\u3059\u3002 <\/span><b>\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u30de\u30cd\u30fc\u30b8\u30e3\u30fc<\/b><span style=\"font-weight: 400;\"> \u306f\u3001\u30c7\u30fc\u30bf\u7ba1\u7406\u306b\u52a0\u3048\u3066\u3001\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u8a73\u7d30\u306a\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u3084\u8a66\u9a13\u306e\u30bb\u30c3\u30c8\u30a2\u30c3\u30d7\u306b\u95a2\u3059\u308b\u8981\u4ef6\u306e\u7b56\u5b9a\u3092\u62c5\u5f53\u3057\u307e\u3059\u3002\u307e\u305f\u3001\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u30de\u30cd\u30fc\u30b8\u30e3\u30fc\u306f\u3001\u30b9\u30dd\u30f3\u30b5\u30fc\u306e\u671f\u5f85\u5024\u3092\u660e\u3089\u304b\u306b\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002 <\/span><i><span style=\"font-weight: 400;\">\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u30de\u30cd\u30fc\u30b8\u30e3\u30fc\u306e\u5f79\u5272\u306f\u5916\u90e8\u306b\u59d4\u8a17\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/span><\/i><\/li>\n<li><span style=\"font-weight: 400;\"> \u4ed6\u306b\u3082\u3001\u85ac\u4e8b\u62c5\u5f53\u8005\uff08\u85ac\u4e8b\u6307\u91dd\u306e\u9075\u5b88\u3001\u5f53\u5c40\u3068\u306e\u9023\u7d61\u3001\u6cbb\u9a13\u85ac\u6982\u8981\u66f8\u306e\u63d0\u51fa\u306a\u3069\uff09\u3001\u691c\u67fb\u62c5\u5f53\u8005\uff08\u691c\u4f53\u306e\u53d6\u308a\u6271\u3044\u3001\u691c\u67fb\u306e\u5b9f\u65bd\u306a\u3069\uff09\u3001\u6709\u5bb3\u4e8b\u8c61\u306e\u5831\u544a\u3092\u7ba1\u7406\u3059\u308b\u533b\u4e8b\u30fb\u30d5\u30a1\u30fc\u30de\u30b3\u30d3\u30b8\u30e9\u30f3\u30b9\u62c5\u5f53\u8005\u306a\u3069\u304c\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u8ca2\u732e\u3057\u3066\u3044\u307e\u3059\u3002 <\/span><i><span style=\"font-weight: 400;\">\u3053\u308c\u3089\u306e\u5f79\u5272\u306e\u4e2d\u306b\u306f\u3001\u5916\u90e8\u306b\u59d4\u8a17\u3067\u304d\u308b\u3082\u306e\u3082\u3042\u308a\u307e\u3059\u3002<\/span><\/i><\/li>\n<li><span style=\"font-weight: 400;\"> \u306e\u3067\u3059\u3002 <\/span><a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-writing?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=ClinicalTrialProtocol\"><b>\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30bf\u30fc<\/b><\/a><span style=\"font-weight: 400;\">\u30c1\u30fc\u30e0\u306e\u4ed6\u306e\u30e1\u30f3\u30d0\u30fc\u304b\u3089\u306e\u60c5\u5831\u3092\u3082\u3068\u306b\u3001\u81e8\u5e8a\u8a66\u9a13\u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u4f5c\u6210\u3057\u3001\u6587\u66f8\u5168\u4f53\u306e\u60c5\u5831\u306e\u4e00\u8cab\u6027\u3092\u78ba\u4fdd\u3057\u307e\u3059\u3002 <\/span><i><span style=\"font-weight: 400;\">\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30bf\u30fc\u306e\u5f79\u5272\u306f\u5916\u90e8\u306b\u59d4\u8a17\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/span><\/i><\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"The_SPIRIT_Statement\"><\/span><b>SPIRIT\u5ba3\u8a00<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u5185\u5bb9\u3068\u8cea\u3092\u5411\u4e0a\u3055\u305b\u308b\u305f\u3081\u306b\u3001\u56fd\u969b\u7684\u306a\u5c02\u9580\u5bb6\u30b0\u30eb\u30fc\u30d7\u304c\u300cStandard Protocol Items\u300d\u3092\u4f5c\u6210\u3057\u307e\u3057\u305f\u3002Interventional Trials\u306e\u305f\u3081\u306e\u63a8\u5968\u4e8b\u9805(<\/span><a href=\"https:\/\/www.spirit-statement.org\/\"><span style=\"font-weight: 400;\">SPIRIT<\/span><\/a><span style=\"font-weight: 400;\">) 2013\u5e74\u306e\u30b9\u30c6\u30fc\u30c8\u30e1\u30f3\u30c8\u3002SPIRIT\u30b9\u30c6\u30fc\u30c8\u30e1\u30f3\u30c8\u3067\u306f\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u5f62\u3067\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u3002<\/span><a href=\"http:\/\/www.spirit-statement.org\/wp-content\/uploads\/2013\/01\/SPIRIT-Checklist-download-8Jan13.pdf\"> <span style=\"font-weight: 400;\">\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8<\/span><\/a><span style=\"font-weight: 400;\"> \u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u30d7\u30ed\u30c8\u30b3\u30eb\u304a\u3088\u3073\u95a2\u9023\u6587\u66f8\u306b\u8a18\u8f09\u3059\u3079\u304d\u63a8\u5968\u9805\u76ee\u3092\u307e\u3068\u3081\u305f\u3082\u306e\u3067\u3059\u3002\u672c\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u7528\u3044\u3066\u6cbb\u9a13\u5b9f\u65bd\u8a08\u753b\u66f8\u3092\u4f5c\u6210\u3059\u308b\u3053\u3068\u3067\u3001\u5831\u544a\u306e\u8cea\u3092\u6700\u9069\u5316\u3057\u3001\u67fb\u8aad\u30d7\u30ed\u30bb\u30b9\u3092\u5186\u6ed1\u306b\u9032\u3081\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002SPIRIT\u306f\u3001\u96fb\u5b50\u30c4\u30fc\u30eb\uff08SPIRIT Electronic Protocol Tool &amp; Resource,<\/span><a href=\"https:\/\/www.spirit-statement.org\/septre\/\"> <span style=\"font-weight: 400;\">SEPTRE<\/span><\/a><span style=\"font-weight: 400;\">)\u3092\u7528\u3044\u3066\u3001\u7814\u7a76\u8005\u304cSPIRIT\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u7528\u3044\u3066\u8cea\u306e\u9ad8\u3044\u81e8\u5e8a\u8a66\u9a13\u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u4f5c\u6210\u3059\u308b\u3053\u3068\u3092\u652f\u63f4\u3057\u3066\u3044\u307e\u3059\u3002<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Protocol_deviations_violations_andor_amendments\"><\/span><b>\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u9038\u8131\u3001\u9055\u53cd\u3001\u4fee\u6b63<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><a href=\"https:\/\/mmcri.org\/deptPages\/hrpp\/downloads\/defineprotocoldeviation.pdf\"><span style=\"font-weight: 400;\">\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u9038\u8131<\/span><\/a><span style=\"font-weight: 400;\"> \u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u9038\u8131\u3068\u306f\u3001\u5076\u767a\u7684\u307e\u305f\u306f\u975e\u610f\u56f3\u7684\u306a\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u5909\u66f4\u3001\u307e\u305f\u306f\u7814\u7a76\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u4e0d\u9075\u5b88\u3068\u5b9a\u7fa9\u3055\u308c\u3001\u30ea\u30b9\u30af\u306e\u5897\u52a0\u3084\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u306e\u6e1b\u5c11\u3092\u3082\u305f\u3089\u3055\u305a\u3001\u5bfe\u8c61\u8005\u306e\u6a29\u5229\u3001\u5b89\u5168\u6027\u3001\u798f\u7949\u3001\u304a\u3088\u3073\uff0f\u307e\u305f\u306f\u30c7\u30fc\u30bf\u306e\u5b8c\u5168\u6027\u306b\u91cd\u5927\u306a\u5f71\u97ff\u3092\u53ca\u307c\u3055\u306a\u3044\u3082\u306e\u3092\u3044\u3046\u3002\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u9038\u8131\u306f\u3001\u5bfe\u8c61\u8005\u53c8\u306f\u7814\u7a76\u30b9\u30bf\u30c3\u30d5\u306e\u884c\u70ba\u306b\u8d77\u56e0\u3059\u308b\u3002\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u9038\u8131\u306e\u4f8b\u3068\u3057\u3066\u306f\u3001\u7814\u7a76\u8a2a\u554f\u306e\u65e5\u7a0b\u5909\u66f4\u3084\u88dc\u52a9\u7684\u306a\u81ea\u5df1\u5831\u544a\u30a2\u30f3\u30b1\u30fc\u30c8\u306e\u672a\u56de\u53ce\u306a\u3069\u304c\u3042\u308b\u3002\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u9038\u8131\u306e\u4f8b\u3068\u3057\u3066\u306f\u3001\u30a4\u30f3\u30d5\u30a9\u30fc\u30e0\u30c9\u30fb\u30b3\u30f3\u30bb\u30f3\u30c8\u3092\u5f97\u308b\u524d\u306b\u30d0\u30a4\u30bf\u30eb\u30b5\u30a4\u30f3\u3092\u6e2c\u5b9a\u3059\u308b\u3053\u3068\u304c\u6319\u3052\u3089\u308c\u308b\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u9038\u8131\u306f\u3001\u6b21\u306e\u3088\u3046\u306b\u533a\u5225\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/span><a href=\"https:\/\/mmcri.org\/deptPages\/hrpp\/downloads\/defineprotocoldeviation.pdf\"> <span style=\"font-weight: 400;\">\u30d7\u30ed\u30c8\u30b3\u30eb\u9055\u53cd<\/span><\/a><span style=\"font-weight: 400;\">\u9055\u53cd\u3068\u306f\u3001\u30b9\u30dd\u30f3\u30b5\u30fc\u304a\u3088\u3073IRB\u306e\u4e8b\u524d\u627f\u8a8d\u306a\u3057\u306b\u3001\u5076\u767a\u7684\u307e\u305f\u306f\u975e\u610f\u56f3\u7684\u306b\u30d7\u30ed\u30c8\u30b3\u30fc\u30eb\u3092\u5909\u66f4\u3059\u308b\u3053\u3068\u3001\u307e\u305f\u306fIRB\u304c\u627f\u8a8d\u3057\u305f\u30d7\u30ed\u30c8\u30b3\u30fc\u30eb\u3092\u9075\u5b88\u3057\u306a\u3044\u3053\u3068\u3067\u3042\u308b\u3002\u9055\u53cd\u306f\u4e00\u822c\u7684\u306b\u3001\u30ea\u30b9\u30af\u306e\u5897\u52a0\u307e\u305f\u306f\u5229\u76ca\u306e\u6e1b\u5c11\u3001\u5bfe\u8c61\u8005\u306e\u6a29\u5229\u3001\u5b89\u5168\u3001\u798f\u7949\u3001\u307e\u305f\u306f\u30c7\u30fc\u30bf\u306e\u5b8c\u5168\u6027\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u3002\u30d7\u30ed\u30c8\u30b3\u30eb\u9055\u53cd\u306e\u4f8b\u3068\u3057\u3066\u306f\u3001\u4e0d\u9069\u5207\u306a\u30a4\u30f3\u30d5\u30a9\u30fc\u30e0\u30c9\u30fb\u30b3\u30f3\u30bb\u30f3\u30c8\u306e\u4f7f\u7528\u3001\u7d44\u307f\u5165\u308c\u57fa\u6e96\u304a\u3088\u3073\uff0f\u307e\u305f\u306f\u9664\u5916\u57fa\u6e96\u3092\u6e80\u305f\u3055\u306a\u3044\u88ab\u9a13\u8005\u306e\u767b\u9332\u3001\u7981\u6b62\u85ac\u7269\u306e\u4f7f\u7528\u306a\u3069\u304c\u3042\u308b\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u8a66\u9a13\u306e\u767a\u5c55\u3084\u60a3\u8005\u306e\u5229\u76ca\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u3001\u3042\u308b\u3044\u306f\u60a3\u8005\u306e\u5b89\u5168\u6027\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u5909\u66f4\uff08\u8a66\u9a13\u76ee\u7684\u3001\u8a66\u9a13\u30c7\u30b6\u30a4\u30f3\u3001\u60a3\u8005\u96c6\u56e3\u3001\u9069\u683c\u57fa\u6e96\u3001\u30b5\u30f3\u30d7\u30eb\u30b5\u30a4\u30ba\u3001\u8a66\u9a13\u624b\u9806\u3001\u307e\u305f\u306f\u91cd\u8981\u306a\u7ba1\u7406\u9762\u3067\u306e\u5909\u66f4\u3092\u542b\u3080\uff09\u306b\u306f\u3001\u4ee5\u4e0b\u304c\u5fc5\u8981\u3068\u306a\u308a\u307e\u3059\u3002<\/span><a href=\"https:\/\/www.spirit-statement.org\/protocol-amendments\/\"> <span style=\"font-weight: 400;\">\u6b63\u5f0f\u306a\u4fee\u6b63<\/span><\/a><span style=\"font-weight: 400;\"> \u3092\u5831\u544a\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u5831\u544a\u304c\u5fc5\u8981\u306a\u30d7\u30ed\u30c8\u30b3\u30fc\u30eb\u306e\u5909\u66f4\u306e\u4f8b\u3068\u3057\u3066\u306f\u3001\u85ac\u5264\u306e\u6295\u4e0e\u91cf\u3084\u66dd\u9732\u671f\u9593\u306e\u5897\u52a0\u3001\u767b\u9332\u3055\u308c\u308b\u88ab\u9a13\u8005\u6570\u306e\u5927\u5e45\u306a\u5897\u52a0\u3001\u65b0\u3057\u3044\u8a66\u9a13\u65b9\u6cd5\u3001\u30de\u30eb\u30c1\u30bb\u30f3\u30c8\u30ea\u30c3\u30af\u8a66\u9a13\u306b\u304a\u3051\u308b\u65b0\u3057\u3044\u6cbb\u9a13\u8cac\u4efb\u533b\u5e2b\u306e\u53c2\u52a0\u306a\u3069\u304c\u3042\u308a\u307e\u3059\u3002\u4f8b\u3068\u3057\u3066\u3001EU\u306b\u304a\u3051\u308b\u5927\u5e45\u306a\u5909\u66f4\u901a\u77e5\u66f8\u306f\u4ee5\u4e0b\u306e\u901a\u308a\u3067\u3059\u3002<\/span><a href=\"https:\/\/ec.europa.eu\/health\/sites\/health\/files\/files\/eudralex\/vol-10\/substantial_amendment_notification_form_.pdf\"> <span style=\"font-weight: 400;\">\u3053\u308c<\/span><\/a><span style=\"font-weight: 400;\">.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u4e00\u65b9\u3001\u8a66\u9a13\u306e\u5b9f\u65bd\u65b9\u6cd5\u306b\u5f71\u97ff\u3092\u53ca\u307c\u3055\u306a\u3044\u8efd\u5fae\u306a\u4fee\u6b63\u304a\u3088\u3073\/\u307e\u305f\u306f\u660e\u78ba\u5316\u306f\u3001\u7ba1\u7406\u4e0a\u306e\u5909\u66f4\u3068\u307f\u306a\u3055\u308c\u3001\u30e1\u30e2\u30e9\u30f3\u30c0\u30e0\u306b\u6587\u66f8\u5316\u3055\u308c\u308b\u3079\u304d\u3067\u3042\u308b\u3002<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Tips_for_writing_a_clinical_trial_protocol\"><\/span><b>\u81e8\u5e8a\u8a66\u9a13\u30d7\u30ed\u30c8\u30b3\u30eb\u4f5c\u6210\u306e\u30dd\u30a4\u30f3\u30c8<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u81e8\u5e8a\u8a66\u9a13\u8a08\u753b\u66f8\u306f\u3001\u8a66\u9a13\u306e\u91cd\u8981\u306a\u5074\u9762\u3092\u3059\u3079\u3066\u306e\u95a2\u4fc2\u8005\u306b\u78ba\u5b9f\u306b\u4f1d\u3048\u308b\u552f\u4e00\u306e\u91cd\u8981\u306a\u6587\u66f8\u3067\u3042\u308b\u305f\u3081\u3001\u305d\u306e\u4f5c\u6210\u306b\u306f\u5341\u5206\u306a\u6642\u9593\u3092\u304b\u3051\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3055\u3089\u306b\u3001\u8a66\u9a13\u306e\u76ee\u7684\u3001\u30c7\u30b6\u30a4\u30f3\u3001\u8a55\u4fa1\u306e\u7a2e\u985e\u3068\u30bf\u30a4\u30df\u30f3\u30b0\u306b\u7279\u306b\u6ce8\u610f\u3092\u6255\u3044\u3001\u6700\u7d42\u7684\u306a\u6587\u66f8\u306b\u77db\u76fe\u304c\u751f\u3058\u306a\u3044\u3088\u3046\u306b\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3088\u304f\u66f8\u304b\u308c\u305f\u8a73\u7d30\u306a\u30d7\u30ed\u30c8\u30b3\u30fc\u30eb\u306f\u3001\u5fe0\u5b9f\u5ea6\u306e\u9ad8\u3044\u30c7\u30fc\u30bf\u304c\u5f97\u3089\u308c\u308b\u53ef\u80fd\u6027\u3092\u9ad8\u3081\u3001\u30d7\u30ed\u30c8\u30b3\u30fc\u30eb\u306e\u4fee\u6b63\u306e\u5fc5\u8981\u6027\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u3001\u7814\u7a76\u8a08\u753b\u66f8\u306a\u3069\u306e\u4ed6\u306e\u6587\u66f8\u306e\u4f5c\u6210\u3092\u5bb9\u6613\u306b\u3057\u307e\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/manuscript-and-journal-article-writing\">manuscript writing<\/a>\u3084\u30d7\u30ec\u30bc\u30f3\u30c6\u30fc\u30b7\u30e7\u30f3\u306a\u3069\u3002 <\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u3044\u304f\u3064\u304b\u306e\u95a2\u9023\u3059\u308b<\/span><a href=\"https:\/\/orra.rutgers.edu\/sites\/orra.rutgers.edu\/files\/HSPP\/HealthSci\/10_Kinetiq_WP_BestPracticesinClinicalResearchProtocolWriting-EighttipsfromanIRBmember_020416%281%29.pdf\"> <span style=\"font-weight: 400;\">\u30c1\u30c3\u30d7\u30b9<\/span><\/a><span style=\"font-weight: 400;\"> \u81e8\u5e8a\u8a66\u9a13\u306e\u30d7\u30ed\u30c8\u30b3\u30eb\u4f5c\u6210\u306e\u305f\u3081\u306b\u306f\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u3082\u306e\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\">\u5fc5\u305a\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u5185\u5bb9\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u6cbf\u3063\u3066\u3001\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u542b\u307e\u308c\u308b\u3059\u3079\u3066\u306e\u9805\u76ee\u306b\u5bfe\u5fdc\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u80cc\u666f\u306b\u306f\u3001\u767a\u8868\u6e08\u307f\u304a\u3088\u3073\u672a\u767a\u8868\u306e\u30c7\u30fc\u30bf\u3092\u542b\u3080\u3001\u3059\u3079\u3066\u306e\u95a2\u9023\u3059\u308b\u524d\u81e8\u5e8a\u304a\u3088\u3073\u81e8\u5e8a\u30c7\u30fc\u30bf\u306b\u3064\u3044\u3066\u8a00\u53ca\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u7814\u7a76\u306b\u95a2\u9023\u3059\u308b\u3059\u3079\u3066\u306e\u6d3b\u52d5\u306f\u3001\u30d7\u30ed\u30c8\u30b3\u30eb\u3068\u540c\u610f\u66f8\u306b\u8a73\u7d30\u3092\u8a18\u8f09\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u4e21\u6587\u66f8\u306e\u6574\u5408\u6027\u3092\u78ba\u4fdd\u3059\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3042\u308b\u3002\u3055\u3089\u306b\u3001\u7814\u7a76\u95a2\u9023\u306e\u6d3b\u52d5\u306f\u3001\u7814\u7a76\u76ee\u7684\u306b\u7d50\u3073\u3064\u3044\u3066\u3044\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u53c2\u52a0\u8005\u304c\u53d7\u3051\u308b\u3059\u3079\u3066\u306e\u7814\u7a76\u6d3b\u52d5\u3092\u8a73\u7d30\u306b\u8aac\u660e\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u7814\u7a76\u8a08\u753b\u306b\u76f4\u63a5\u95a2\u4e0e\u3057\u3066\u3044\u306a\u3044\u540c\u50da\u304b\u3089\u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u72ec\u7acb\u3057\u3066\u30ec\u30d3\u30e5\u30fc\u3057\u3066\u3082\u3089\u3046\u3053\u3068\u306f\u975e\u5e38\u306b\u6709\u52b9\u3067\u3059\u3002\u898f\u5236\u5f53\u5c40\u3084IRB\u304c\u554f\u984c\u3068\u3059\u308b\u3088\u3046\u306a\u3001\u6f5c\u5728\u7684\u306b\u300c\u4e0d\u660e\u77ad\u300d\u306a\u90e8\u5206\u3092\u7279\u5b9a\u3059\u308b\u306e\u306b\u3082\u5f79\u7acb\u3061\u307e\u3059\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u898f\u5236\u6a5f\u95a2\uff08\u4e3b\u306b\u300c\u516c\u5171\u306e\u5229\u76ca\u300d\u306b\u7126\u70b9\u3092\u5f53\u3066\u3066\u3044\u308b\uff09\u3068IRB\uff08\u88ab\u9a13\u8005\u500b\u4eba\u306e\u6a29\u5229\u3068\u798f\u7949\u306b\u95a2\u5fc3\u304c\u3042\u308b\uff09\u306e\u8996\u70b9\u3092\u8003\u616e\u3059\u308b\u3002\u4e21\u8005\u306e\u8996\u70b9\u306f\u88dc\u5b8c\u7684\u3067\u3042\u308b\u304c\u3001\u7570\u306a\u308b\u3082\u306e\u3067\u3042\u308b\u3002\u4fb5\u8972\u7684\u306a\u51e6\u7f6e\u3084\u6cbb\u7642\u306f\u6700\u5c0f\u9650\u306b\u3068\u3069\u3081\u308b\u3079\u304d\u3067\u3042\u308b\u3002\u30ea\u30b9\u30af\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u308b\u3053\u3068\u306f\u3001\u5b50\u3069\u3082\u3084\u305d\u306e\u4ed6\u306e\u5f31\u3044\u7acb\u5834\u306e\u4eba\u3005\u306b\u304a\u3044\u3066\u7279\u306b\u91cd\u8981\u3067\u3059\u3002\u5834\u5408\u306b\u3088\u3063\u3066\u306f\u3001IRB\u898f\u5236\u62c5\u5f53\u306e\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u306b\u30a2\u30c9\u30d0\u30a4\u30b9\u3092\u6c42\u3081\u308b\u5fc5\u8981\u304c\u3042\u308b\u304b\u3082\u3057\u308c\u307e\u305b\u3093\u3002<\/span><\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"The_importance_of_public_availability_of_clinical_trial_protocols\"><\/span><b>\u81e8\u5e8a\u8a66\u9a13\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u516c\u958b\u306e\u91cd\u8981\u6027<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u5171\u6709\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u6279\u5224\u7684\u8a55\u4fa1\uff08\u5185\u90e8\u304a\u3088\u3073\u5916\u90e8\u306e\u59a5\u5f53\u6027\uff09\u3092\u4fc3\u9032\u3057\u3001\u7d50\u679c\u3084\u5206\u6790\u306e\u9078\u629e\u7684\u5831\u544a\u3092\u7279\u5b9a\u304a\u3088\u3073\u9632\u6b62\u3059\u308b\u306e\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002\u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u516c\u958b\u3059\u308b\u3053\u3068\u3067\u3001\u7814\u7a76\u306e\u900f\u660e\u6027\u3092\u9ad8\u3081\u308b\u3068\u3068\u3082\u306b\u3001\u79d1\u5b66\u8005\u3084\u53c2\u52a0\u5e0c\u671b\u8005\u304c\u9032\u884c\u4e2d\u306e\u81e8\u5e8a\u8a66\u9a13\u306b\u3064\u3044\u3066\u77e5\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u3057\u304b\u3057\u3001\u30d7\u30ed\u30c8\u30b3\u30fc\u30eb\u306e\u5171\u6709\u306f\u307e\u3060\u6bd4\u8f03\u7684\u5c11\u306a\u3044\u306e\u304c\u73fe\u72b6\u3067\u3059\uff08\u8ab2\u984c\u306b\u3064\u3044\u3066\u306f<\/span><a href=\"https:\/\/trialsjournal.biomedcentral.com\/articles\/10.1186\/s13063-018-2510-1\"> <span style=\"font-weight: 400;\">\u3053\u308c<\/span><\/a><span style=\"font-weight: 400;\">).\u306a\u3069\u3001\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u6295\u7a3f\u30fb\u516c\u958b\u3092\u63a8\u5968\u3057\u3066\u3044\u308b\u30aa\u30fc\u30d7\u30f3\u30a2\u30af\u30bb\u30b9\u30b8\u30e3\u30fc\u30ca\u30eb\u304c\u3042\u308a\u307e\u3059\u3002 <\/span><i><span style=\"font-weight: 400;\">\u30c8\u30e9\u30a4\u30a2\u30eb <\/span><\/i><span style=\"font-weight: 400;\">(\u516c\u958b\u3055\u308c\u3066\u3044\u308b\u8a66\u9a13\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u534a\u5206\u4ee5\u4e0a\u304c\u516c\u958b\u3055\u308c\u3066\u3044\u308b\uff09\u3002 <\/span><i><span style=\"font-weight: 400;\">\u30c8\u30e9\u30a4\u30a2\u30eb<\/span><\/i><span style=\"font-weight: 400;\"> \u306e\u4f7f\u7528\u3082\u63a8\u9032\u3057\u3066\u3044\u307e\u3059\u3002<\/span><a href=\"https:\/\/trialsjournal.biomedcentral.com\/submission-guidelines\/preparing-your-manuscript\/study-protocol\/structured-study-protocol-template\"> <span style=\"font-weight: 400;\">\u69cb\u9020\u5316\u30d7\u30ed\u30c8\u30b3\u30eb\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8<\/span><\/a><span style=\"font-weight: 400;\"> \u7121\u4f5c\u70ba\u5316\u8a66\u9a13\u306e\u5834\u5408\uff09\u3002) <\/span><i><span style=\"font-weight: 400;\">BMJ\u30aa\u30fc\u30d7\u30f3<\/span><\/i><span style=\"font-weight: 400;\">\u3068\u3057\u3066\u3044\u307e\u3059\u3002 <\/span><i><span style=\"font-weight: 400;\">JMIR\u30ea\u30b5\u30fc\u30c1\u30d7\u30ed\u30c8\u30b3\u30eb<\/span><\/i><span style=\"font-weight: 400;\">.\u306e\u3088\u3046\u306a\u3044\u304f\u3064\u304b\u306e\u533b\u5b66\u5c02\u9580\u8a8c\u304c\u3042\u308b\u3053\u3068\u3092\u8003\u616e\u3057\u3066\u304f\u3060\u3055\u3044\u3002 <\/span><i><span style=\"font-weight: 400;\">The Lancet<\/span><\/i><span style=\"font-weight: 400;\"> \u305d\u3057\u3066 <\/span><i><span style=\"font-weight: 400;\">PLOS\u30e1\u30c7\u30a3\u30b7\u30f3<\/span><\/i><span style=\"font-weight: 400;\">- \u306f\u3001\u81e8\u5e8a\u7814\u7a76\u8ad6\u6587\u3092\u6295\u7a3f\u3059\u308b\u969b\u306b\u3001\u81e8\u5e8a\u8a66\u9a13\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u8a18\u8f09\u3092\u7fa9\u52d9\u4ed8\u3051\u3066\u3044\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u81e8\u5e8a\u8a66\u9a13\u8a08\u753b\u66f8\u3092\u6b63\u78ba\u306b\u4f5c\u6210\u3057\u3001\u516c\u958b\u3059\u308b\u3053\u3068\u306f\u3001\u60a3\u8005\u3055\u3093\u3092\u306f\u3058\u3081\u3068\u3059\u308b\u81e8\u5e8a\u8a66\u9a13\u306e\u30a8\u30d3\u30c7\u30f3\u30b9\u306e\u5229\u7528\u8005\u306b\u5927\u304d\u306a\u30e1\u30ea\u30c3\u30c8\u3092\u3082\u305f\u3089\u3057\u307e\u3059\u3002<\/span><\/p>\n<blockquote><p><strong>\u3092\u63a1\u7528\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-trial-protocol-writing\">\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u306e\u81e8\u5e8a\u8a66\u9a13\u30d7\u30ed\u30c8\u30b3\u30eb\u30e9\u30a4\u30bf\u30fc<\/a>?Kolabtree\u306b\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3092\u6295\u7a3f\u3059\u308b\u3068\u3001\u5c02\u9580\u5bb6\u304b\u3089\u7121\u6599\u3067\u898b\u7a4d\u3082\u308a\u304c\u3082\u3089\u3048\u307e\u3059\u3002<\/strong><\/p><\/blockquote>\n<h3><span class=\"ez-toc-section\" id=\"Additional_references_and_resources\"><\/span><strong>\u305d\u306e\u4ed6\u306e\u53c2\u8003\u6587\u732e\u30fb\u8cc7\u6599<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li><span style=\"font-weight: 400;\">\u30a2\u30eb\u30fb\u30b8\u30e5\u30f3\u30c7\u30a3A.\u3068\u30b5\u30c3\u30abS.\u81e8\u5e8a\u7814\u7a76\u306b\u304a\u3051\u308b\u30d7\u30ed\u30c8\u30b3\u30eb\u30e9\u30a4\u30c6\u30a3\u30f3\u30b0\u3002J Clin Diagn Res.2016 Nov; 10(11):ZE10-ZE13\u3067\u3059\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Chan AW. and Hr\u00f3bjartsson A. Promoting public access to clinical trial protocols: challenges and recommendations.Trials.2018; 19: 116.<\/span><\/li>\n<li><span style=\"font-weight: 400;\">SPIRIT 2013\u30b9\u30c6\u30fc\u30c8\u30e1\u30f3\u30c8\uff1a\u81e8\u5e8a\u8a66\u9a13\u306e\u6a19\u6e96\u30d7\u30ed\u30c8\u30b3\u30eb\u9805\u76ee\u306e\u5b9a\u7fa9\u3002Ann Intern Med.2013 Feb 5;158(3):200-7.<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Chen AW., et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials.BMJ.2013\u5e741\u67088\u65e5;346:e7586<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Cipriani A. and Barbui C. \u81e8\u5e8a\u8a66\u9a13\u30d7\u30ed\u30c8\u30b3\u30eb\u3068\u306f\u4f55\u304b\uff1fEpidemiol Psichiatr Soc. 2010 Apr-Jun;19(2):116-7.<\/span><\/li>\n<li><a href=\"https:\/\/hub.ucsf.edu\/protocol-development\"><span style=\"font-weight: 400;\">\u81e8\u5e8a\u8a66\u9a13\u30d7\u30ed\u30c8\u30b3\u30eb\u958b\u767a<\/span><\/a><span style=\"font-weight: 400;\"> (\u6700\u7d42\u6539\u5b9a2017\u5e74\uff09\u3092\u884c\u3063\u3066\u3044\u307e\u3059\u3002)Clinical Research Resource HUB, UCSF.<\/span><\/li>\n<li><a href=\"https:\/\/health.usf.edu\/-\/media\/Files\/Medicine\/Research\/OCR\/Guidelinesfordesigningaclinicalstudyprotocoldoc.ashx?la=en&amp;hash=B89A666103DECD23880D5C2D0B359FF1FF0FBCAA\"><span style=\"font-weight: 400;\">\u81e8\u5e8a\u8a66\u9a13\u30d7\u30ed\u30c8\u30b3\u30eb\u8a2d\u8a08\u306e\u305f\u3081\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3<\/span><\/a><span style=\"font-weight: 400;\">.UCSF\u306eClinical Research Resource HUB\u3067\u3059\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u30f4\u30a1\u30f3\u30fb\u30d0\u30d9\u30ebE.<\/span><a href=\"http:\/\/www.appliedclinicaltrialsonline.com\/multidisciplinary-approach-protocol-writing?pageID=2\"> <span style=\"font-weight: 400;\">\u30d7\u30ed\u30c8\u30b3\u30eb\u4f5c\u6210\u306e\u305f\u3081\u306e\u5b66\u969b\u7684\u30a2\u30d7\u30ed\u30fc\u30c1<\/span><\/a><span style=\"font-weight: 400;\">.\u5fdc\u7528\u81e8\u5e8a\u8a66\u9a13\u30012016\u5e74<\/span><\/li>\n<\/ul>","protected":false},"excerpt":{"rendered":"<p>Freelance medical writer Laura Moro, MSc, PhD provides expert tips on preparing a clinical trial protocol writing for biotech, pharma and medical device organizations.\u00a0 What is a clinical trial protocol? If you are involved in clinical investigation, you may need to contribute to the preparation of a clinical trial protocol. A clinical trial protocol is a document describing how a clinical trial will be conducted, including the objective(s), design, methodology, statistical considerations, and organization of the trial to guarantee the safety of the participants and the integrity of the collected data. The protocol also provides the background and rationale for conducting the study and the research questions that it addresses,<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-write-a-clinical-trial-protocol\/\" title=\"\u7d9a\u304d\u3092\u8aad\u3080\">\u7d9a\u304d\u3092\u8aad\u3080<\/a><\/div>","protected":false},"author":12,"featured_media":7278,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[442,443,540,653],"tags":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.1 (Yoast SEO v20.1) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Writing a Clinical Trial Protocol: Expert Tips - The Kolabtree Blog<\/title>\n<meta name=\"description\" content=\"Expert tips on writing a clinical trial protocol including topics to be included, team members involved, and protocol deviations.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-write-a-clinical-trial-protocol\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Writing a Clinical Trial Protocol: Expert Tips\" \/>\n<meta property=\"og:description\" content=\"Expert tips on writing a clinical trial protocol including topics to be included, team members involved, and protocol deviations.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.kolabtree.com\/blog\/ja\/how-to-write-a-clinical-trial-protocol\/\" \/>\n<meta property=\"og:site_name\" content=\"The Kolabtree Blog\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/kolabtree\" \/>\n<meta property=\"article:published_time\" content=\"2020-03-23T14:37:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2022-11-14T07:22:18+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/03\/photo-1463171379579-3fdfb86d6285.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1350\" \/>\n\t<meta property=\"og:image:height\" content=\"900\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Ramya Sriram\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@kolabtree\" \/>\n<meta name=\"twitter:site\" content=\"@kolabtree\" \/>\n<meta name=\"twitter:label1\" content=\"\u57f7\u7b46\u8005\" \/>\n\t<meta name=\"twitter:data1\" content=\"Ramya Sriram\" \/>\n\t<meta name=\"twitter:label2\" content=\"\u63a8\u5b9a\u8aad\u307f\u53d6\u308a\u6642\u9593\" \/>\n\t<meta name=\"twitter:data2\" content=\"12\u5206\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Writing a Clinical Trial Protocol: Expert Tips - 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