{"id":31808,"date":"2022-08-17T15:36:48","date_gmt":"2022-08-17T06:36:48","guid":{"rendered":"https:\/\/www.enago.com\/academy\/jp\/?p=31808"},"modified":"2022-09-28T09:10:22","modified_gmt":"2022-09-28T00:10:22","slug":"research-protocol-21-elements","status":"publish","type":"post","link":"https:\/\/www.enago.com\/academy\/jp\/research-protocol-21-elements\/","title":{"rendered":"WHO\u63a8\u5968\uff1a\u7814\u7a76\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u66f8\u304d\u8fbc\u308021\u9805\u76ee"},"content":{"rendered":"<p>\u3042\u308b\u5b66\u751f\u306f\u7814\u7a76\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u3064\u3044\u3066\u982d\u3092\u60a9\u307e\u305b\u3066\u3044\u308b\u3088\u3046\u3067\u3059\u3002<\/p>\n<p>\u7814\u7a76\u4e3b\u5bb0\u8005\uff08Principal Investigator : PI\uff09\uff1a\u7814\u7a76\u30d7\u30ed\u30c8\u30b3\u30eb\uff08\u7814\u7a76\u8a08\u753b\u66f8\uff09\u306f\u66f8\u304d\u307e\u3057\u305f\u304b\uff1f<\/p>\n<p>\u5b66\u751f\uff1a\u307e\u3060\u3067\u3059\u3002\u5206\u3089\u306a\u3044\u3053\u3068\u3060\u3089\u3051\u3067\u2026\u305d\u3082\u305d\u3082\u3001\u7814\u7a76\u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u4f5c\u6210\u3059\u308b\u3053\u3068\u304c\u306a\u305c\u91cd\u8981\u306a\u306e\u3067\u3057\u3087\u3046\u304b\uff1f\u7814\u7a76\u30d7\u30ed\u30dd\u30fc\u30b6\u30eb\uff08\u7814\u7a76\u63d0\u6848\u66f8\uff09\u3068\u540c\u3058\u3088\u3046\u306a\u3053\u3068\u3092\u66f8\u3051\u3070\u3044\u3044\u306e\u304b\u3001\u4f55\u3092\u66f8\u304b\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u306e\u304b\u3001\u3069\u306e\u3088\u3046\u306a\u69cb\u6210\u306b\u3057\u305f\u3089\u826f\u3044\u306e\u304b\u2026\u6240\u5b9a\u306e\u66f8\u5f0f\u306b\u5f93\u3063\u3066\u66f8\u3051\u3070\u3088\u3044\u3082\u306e\u3067\u3059\u304b\uff1f<\/p>\n<p>\u7d4c\u9a13\u306e\u6d45\u3044\u7814\u7a76\u8005\u306f\u3001\u7814\u7a76\u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u4f5c\u6210\u3059\u308b\u76ee\u7684\u3084\u91cd\u8981\u6027\u3060\u3051\u3067\u306a\u304f\u3001\u3069\u3046\u3084\u3063\u3066\u66f8\u3051\u3070\u3088\u3044\u306e\u304b\u3082\u7406\u89e3\u3067\u304d\u3066\u3044\u306a\u3044\u3088\u3046\u3067\u3059\u3002\u3053\u306e\u8a18\u4e8b\u3092\u901a\u3057\u3066\u3001\u7814\u7a76\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u66f8\u304d\u65b9\u306b\u3064\u3044\u3066\u7406\u89e3\u3092\u6df1\u3081\u3066\u3044\u304d\u307e\u3057\u3087\u3046\u3002<\/p>\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_74 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">\u76ee\u6b21<\/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\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><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\" 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href=\"https:\/\/www.enago.com\/academy\/jp\/research-protocol-21-elements\/#%E3%81%AA%E3%81%9C%E7%A0%94%E7%A9%B6%E3%83%97%E3%83%AD%E3%83%88%E3%82%B3%E3%83%AB%E3%81%8C%E9%87%8D%E8%A6%81%E3%81%AA%E3%81%AE%E3%81%8B\" >\u306a\u305c\u7814\u7a76\u30d7\u30ed\u30c8\u30b3\u30eb\u304c\u91cd\u8981\u306a\u306e\u304b<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.enago.com\/academy\/jp\/research-protocol-21-elements\/#%E7%A0%94%E7%A9%B6%E3%83%97%E3%83%AD%E3%83%88%E3%82%B3%E3%83%AB%E3%81%A8%E7%A0%94%E7%A9%B6%E3%83%97%E3%83%AD%E3%83%9D%E3%83%BC%E3%82%B6%E3%83%AB%E3%81%AE%E9%81%95%E3%81%84\" >\u7814\u7a76\u30d7\u30ed\u30c8\u30b3\u30eb\u3068\u7814\u7a76\u30d7\u30ed\u30dd\u30fc\u30b6\u30eb\u306e\u9055\u3044<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.enago.com\/academy\/jp\/research-protocol-21-elements\/#%E7%A0%94%E7%A9%B6%E3%83%97%E3%83%AD%E3%83%88%E3%82%B3%E3%83%AB%E3%81%AB%E5%90%AB%E3%82%81%E3%82%8B%E3%81%B9%E3%81%8D%E8%A6%81%E7%B4%A0%EF%BC%8F%E9%A0%85%E7%9B%AE\" >\u7814\u7a76\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u542b\u3081\u308b\u3079\u304d\u8981\u7d20\uff0f\u9805\u76ee<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.enago.com\/academy\/jp\/research-protocol-21-elements\/#1%EF%BC%8EGeneral_Information_%E4%B8%80%E8%88%AC%E6%83%85%E5%A0%B1\" >1\uff0eGeneral Information: \u4e00\u822c\u60c5\u5831<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.enago.com\/academy\/jp\/research-protocol-21-elements\/#2%EF%BC%8ERationale_Background_Information_%E8%AB%96%E7%90%86%E7%9A%84%E6%A0%B9%E6%8B%A0%E3%81%8A%E3%82%88%E3%81%B3%E7%A0%94%E7%A9%B6%E3%81%AE%E8%83%8C%E6%99%AF\" >2\uff0eRationale &amp; Background Information: \u8ad6\u7406\u7684\u6839\u62e0\u304a\u3088\u3073\u7814\u7a76\u306e\u80cc\u666f<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.enago.com\/academy\/jp\/research-protocol-21-elements\/#3%EF%BC%8EStudy_Objectives_%E7%A0%94%E7%A9%B6%E7%9B%AE%E6%A8%99\" >3\uff0eStudy Objectives: \u7814\u7a76\u76ee\u6a19<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.enago.com\/academy\/jp\/research-protocol-21-elements\/#4%EF%BC%8EStudy_Design_%E7%A0%94%E7%A9%B6%E3%83%87%E3%82%B6%E3%82%A4%E3%83%B3\" >4\uff0eStudy Design: \u7814\u7a76\u30c7\u30b6\u30a4\u30f3<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/www.enago.com\/academy\/jp\/research-protocol-21-elements\/#5%EF%BC%8EMethodology_%E6%96%B9%E6%B3%95\" >5\uff0eMethodology: \u65b9\u6cd5<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/www.enago.com\/academy\/jp\/research-protocol-21-elements\/#6%EF%BC%8ESafety_Considerations_%E5%AE%89%E5%85%A8%E6%80%A7%E8%80%83%E5%AF%9F\" >6\uff0eSafety Considerations: \u5b89\u5168\u6027\u8003\u5bdf<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/www.enago.com\/academy\/jp\/research-protocol-21-elements\/#7%EF%BC%8EFollow-up_%E7%B5%8C%E9%81%8E%E8%A6%B3%E5%AF%9F\" >7\uff0eFollow-up: \u7d4c\u904e\u89b3\u5bdf<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/www.enago.com\/academy\/jp\/research-protocol-21-elements\/#8%EF%BC%8EData_Management_and_Statistical_Analysis_%E3%83%87%E3%83%BC%E3%82%BF%E7%AE%A1%E7%90%86%E3%81%8A%E3%82%88%E3%81%B3%E7%B5%B1%E8%A8%88%E7%9A%84%E5%88%86%E6%9E%90\" >8\uff0eData Management and Statistical Analysis: \u30c7\u30fc\u30bf\u7ba1\u7406\u304a\u3088\u3073\u7d71\u8a08\u7684\u5206\u6790<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-13\" href=\"https:\/\/www.enago.com\/academy\/jp\/research-protocol-21-elements\/#9%EF%BC%8EQuality_Assurance_%E5%93%81%E8%B3%AA%E4%BF%9D%E8%A8%BC\" >9\uff0eQuality Assurance: \u54c1\u8cea\u4fdd\u8a3c<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-14\" href=\"https:\/\/www.enago.com\/academy\/jp\/research-protocol-21-elements\/#10%EF%BC%8EExpected_Outcomes_of_the_Study_%E6%9C%9F%E5%BE%85%E3%81%95%E3%82%8C%E3%82%8B%E7%A0%94%E7%A9%B6%E6%88%90%E6%9E%9C\" >10\uff0eExpected Outcomes of the Study: \u671f\u5f85\u3055\u308c\u308b\u7814\u7a76\u6210\u679c<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-15\" href=\"https:\/\/www.enago.com\/academy\/jp\/research-protocol-21-elements\/#11%EF%BC%8EDissemination_of_Results_and_Publication_Policy_%E7%A0%94%E7%A9%B6%E6%88%90%E6%9E%9C%E3%81%AE%E6%99%AE%E5%8F%8A%E3%83%BB%E5%85%AC%E9%96%8B%E6%96%B9%E9%87%9D\" >11\uff0eDissemination of Results and Publication Policy: \u7814\u7a76\u6210\u679c\u306e\u666e\u53ca\u30fb\u516c\u958b\u65b9\u91dd<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-16\" href=\"https:\/\/www.enago.com\/academy\/jp\/research-protocol-21-elements\/#12%EF%BC%8EDuration_of_the_Project_%E7%A0%94%E7%A9%B6%E3%83%97%E3%83%AD%E3%82%B8%E3%82%A7%E3%82%AF%E3%83%88%E3%81%AE%E5%AE%9F%E6%96%BD%E6%9C%9F%E9%96%93\" >12\uff0eDuration of the Project: \u7814\u7a76\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306e\u5b9f\u65bd\u671f\u9593<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-17\" href=\"https:\/\/www.enago.com\/academy\/jp\/research-protocol-21-elements\/#13%EF%BC%8EAnticipated_Problems_%E4%BA%88%E6%83%B3%E3%81%95%E3%82%8C%E3%82%8B%E5%95%8F%E9%A1%8C\" >13\uff0eAnticipated Problems: \u4e88\u60f3\u3055\u308c\u308b\u554f\u984c<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-18\" href=\"https:\/\/www.enago.com\/academy\/jp\/research-protocol-21-elements\/#14%EF%BC%8EProject_Management_%E3%83%97%E3%83%AD%E3%82%B8%E3%82%A7%E3%82%AF%E3%83%88%E7%AE%A1%E7%90%86\" >14\uff0eProject Management: \u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u7ba1\u7406<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-19\" href=\"https:\/\/www.enago.com\/academy\/jp\/research-protocol-21-elements\/#15%EF%BC%8EEthics_%E7%A0%94%E7%A9%B6%E5%80%AB%E7%90%86\" >15\uff0eEthics: \u7814\u7a76\u502b\u7406<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-20\" href=\"https:\/\/www.enago.com\/academy\/jp\/research-protocol-21-elements\/#16%EF%BC%8EBudget_%E4%BA%88%E7%AE%97\" >16\uff0eBudget: \u4e88\u7b97<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-21\" href=\"https:\/\/www.enago.com\/academy\/jp\/research-protocol-21-elements\/#17%EF%BC%8ESupplementary_Support_for_the_Project_%E7%A0%94%E7%A9%B6%E3%83%97%E3%83%AD%E3%82%B8%E3%82%A7%E3%82%AF%E3%83%88%E3%81%B8%E3%81%AE%E8%BF%BD%E5%8A%A0%E6%94%AF%E6%8F%B4\" >17\uff0eSupplementary Support for the Project: \u7814\u7a76\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3078\u306e\u8ffd\u52a0\u652f\u63f4<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-22\" href=\"https:\/\/www.enago.com\/academy\/jp\/research-protocol-21-elements\/#18%EF%BC%8ECollaboration_With_Other_Researchers_or_Institutions_%E4%BB%96%E3%81%AE%E7%A0%94%E7%A9%B6%E8%80%85%E3%81%BE%E3%81%9F%E3%81%AF%E7%A0%94%E7%A9%B6%E6%A9%9F%E9%96%A2%E3%81%A8%E3%81%AE%E5%8D%94%E5%8A%9B\" >18\uff0eCollaboration With Other Researchers or Institutions: \u4ed6\u306e\u7814\u7a76\u8005\u307e\u305f\u306f\u7814\u7a76\u6a5f\u95a2\u3068\u306e\u5354\u529b<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-23\" href=\"https:\/\/www.enago.com\/academy\/jp\/research-protocol-21-elements\/#19%EF%BC%8ECurriculum_Vitae_of_All_Investigators_%E3%81%99%E3%81%B9%E3%81%A6%E3%81%AE%E7%A0%94%E7%A9%B6%E8%80%85%E3%81%AE%E8%81%B7%E5%8B%99%E7%B5%8C%E6%AD%B4%E6%9B%B8%EF%BC%88CV%EF%BC%89\" >19\uff0eCurriculum Vitae of All Investigators: \u3059\u3079\u3066\u306e\u7814\u7a76\u8005\u306e\u8077\u52d9\u7d4c\u6b74\u66f8\uff08CV\uff09<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-24\" href=\"https:\/\/www.enago.com\/academy\/jp\/research-protocol-21-elements\/#20%EF%BC%8EOther_Research_Activities_of_Investigators_%E8%A9%A6%E9%A8%93%E8%B2%AC%E4%BB%BB%E5%8C%BB%E5%B8%AB%E3%83%BB%E7%A0%94%E7%A9%B6%E8%80%85%E3%81%AE%E4%BB%96%E3%81%AE%E7%A0%94%E7%A9%B6%E6%B4%BB%E5%8B%95\" >20\uff0eOther Research Activities of Investigators: \u8a66\u9a13\u8cac\u4efb\u533b\u5e2b\u30fb\u7814\u7a76\u8005\u306e\u4ed6\u306e\u7814\u7a76\u6d3b\u52d5<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-25\" href=\"https:\/\/www.enago.com\/academy\/jp\/research-protocol-21-elements\/#21%EF%BC%8EReferences_%E5%8F%82%E8%80%83%E6%96%87%E7%8C%AE\" >21\uff0eReferences: \u53c2\u8003\u6587\u732e<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-26\" href=\"https:\/\/www.enago.com\/academy\/jp\/research-protocol-21-elements\/#%E7%A0%94%E7%A9%B6%E3%83%97%E3%83%AD%E3%83%88%E3%82%B3%E3%83%AB%E3%81%AE%E6%9B%B8%E3%81%8D%E6%96%B9%EF%BC%88%E7%A0%94%E7%A9%B6%E3%83%97%E3%83%AD%E3%83%88%E3%82%B3%E3%83%AB%E3%81%AE%E6%9B%B8%E5%BC%8F%E3%82%B5%E3%83%B3%E3%83%97%E3%83%AB%EF%BC%89\" >\u7814\u7a76\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u66f8\u304d\u65b9\uff08\u7814\u7a76\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u66f8\u5f0f\u30b5\u30f3\u30d7\u30eb\uff09\u00a0 \u00a0<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-27\" href=\"https:\/\/www.enago.com\/academy\/jp\/research-protocol-21-elements\/#Main_Investigator%E3%80%80%E4%B8%BB%E4%BB%BB%E7%A0%94%E7%A9%B6%E8%80%85%E3%81%BE%E3%81%9F%E3%81%AF%E7%A0%94%E7%A9%B6%E8%B2%AC%E4%BB%BB%E8%80%85%E6%83%85%E5%A0%B1\" >Main Investigator\u3000\u4e3b\u4efb\u7814\u7a76\u8005\u307e\u305f\u306f\u7814\u7a76\u8cac\u4efb\u8005\u60c5\u5831<\/a><\/li><\/ul><\/nav><\/div>\n<h2><span class=\"ez-toc-section\" id=\"%E7%A0%94%E7%A9%B6%E3%83%97%E3%83%AD%E3%83%88%E3%82%B3%E3%83%AB%E3%81%A8%E3%81%AF\"><\/span>\u7814\u7a76\u30d7\u30ed\u30c8\u30b3\u30eb\u3068\u306f<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u7814\u7a76\u30d7\u30ed\u30c8\u30b3\u30eb\u3068\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u80cc\u666f\u3001\u7406\u8ad6\u7684\u6839\u62e0\u3001\u76ee\u7684\u3001\u30c7\u30b6\u30a4\u30f3\u3001\u65b9\u6cd5\u3001\u7d71\u8a08\u7684\u8003\u5bdf\u304a\u3088\u3073\u5b9f\u65bd\u6a5f\u95a2\uff08\u56e3\u4f53\uff09\u306b\u3064\u3044\u3066\u8aac\u660e\u3059\u308b\u6587\u66f8\u3067\u3059\u3002\u81e8\u5e8a\u7814\u7a76\u306e\u8a08\u753b\u306e\u6982\u8981\u3092\u793a\u3059\u3060\u3051\u3067\u306a\u304f\u3001\u7814\u7a76\u8ab2\u984c\u306b\u5bfe\u3057\u3066\u6e80\u8db3\u3067\u304d\u308b\u7b54\u3048\u3092\u793a\u3059\u3088\u3046\u306b\u4f5c\u6210\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u7814\u7a76\u30d7\u30ed\u30c8\u30b3\u30eb\u306f\u3001\u7814\u7a76\u3092\u5b9f\u65bd\u3059\u308b\u305f\u3081\u306e\u8a66\u6599\u3068\u624b\u9806\u3092\u793a\u3059\u6587\u66f8\u306a\u306e\u3067\u3059\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"%E3%81%AA%E3%81%9C%E7%A0%94%E7%A9%B6%E3%83%97%E3%83%AD%E3%83%88%E3%82%B3%E3%83%AB%E3%81%8C%E9%87%8D%E8%A6%81%E3%81%AA%E3%81%AE%E3%81%8B\"><\/span>\u306a\u305c\u7814\u7a76\u30d7\u30ed\u30c8\u30b3\u30eb\u304c\u91cd\u8981\u306a\u306e\u304b<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u6cbb\u9a13\u3084\u81e8\u5e8a\u8a66\u9a13\u306b\u304a\u3044\u3066\u3001\u7814\u7a76\u30d7\u30ed\u30c8\u30b3\u30eb\u306f\u6700\u3082\u91cd\u8981\u306a\u3082\u306e\u3067\u3042\u308a\u3001\u81e8\u5e8a\u7814\u7a76\u306e\u57fa\u76e4\u3068\u306a\u308b\u3082\u306e\u3067\u3059\u3002\u81e8\u5e8a\u8a66\u9a13\u306e\u88ab\u9a13\u8005\u306e\u5b89\u5168\u3068\u53ce\u96c6\u3059\u308b\u30c7\u30fc\u30bf\u306e\u5b8c\u5168\u6027\u3092\u4fdd\u8a3c\u3059\u308b\u305f\u3081\u306e\u6587\u66f8\u3067\u3082\u3042\u308a\u307e\u3059\u3002\u62d8\u675f\u529b\u3092\u6301\u3064\u6587\u66f8\u3067\u3042\u308b\u7814\u7a76\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u4e00\u74b0\u3068\u3057\u3066\u8a31\u53ef\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3001\u3042\u308b\u3044\u306f\u8a31\u53ef\u3055\u308c\u3066\u3044\u306a\u3044\u3053\u3068\u3092\u8a18\u8f09\u3057\u307e\u3059\u3002\u3055\u3089\u306b\u3001\u81ea\u5206\u304c\u6240\u5c5e\u3059\u308b\u7814\u7a76\u6a5f\u95a2\u306e\u7814\u7a76\u502b\u7406\u5be9\u67fb\u59d4\u54e1\u4f1a\uff08IRB\uff09\u306b\u7533\u8acb\u3092\u63d0\u51fa\u3059\u308b\u969b\u3001\u6700\u3082\u91cd\u8981\u306a\u6587\u66f8\u3068\u898b\u306a\u3055\u308c\u308b\u3082\u306e\u3067\u3059\u3002<\/p>\n<p>\u7814\u7a76\u30d7\u30ed\u30c8\u30b3\u30eb\u306f\u3001\u533b\u7642\u5c02\u9580\u5bb6\u3001\u7d71\u8a08\u306e\u5c02\u9580\u5bb6\u3001\u85ac\u7269\u52d5\u614b\u306e\u5c02\u9580\u5bb6\u3001\u81e8\u5e8a\u7814\u7a76\u30b3\u30fc\u30c7\u30a3\u30cd\u30fc\u30bf\u30fc\u3001\u7814\u7a76\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u30de\u30cd\u30fc\u30b8\u30e3\u30fc\u306a\u3069\u304b\u3089\u306e\u60c5\u5831\u3092\u57fa\u306b\u4f5c\u6210\u3057\u307e\u3059\u3002\u7814\u7a76\u306e\u3042\u3089\u3086\u308b\u5074\u9762\u304c\u6700\u7d42\u7684\u306a\u6587\u66f8\u306b\u7db2\u7f85\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u307e\u3057\u3087\u3046\u3002<\/p>\n<h2><span class=\"ez-toc-section\" id=\"%E7%A0%94%E7%A9%B6%E3%83%97%E3%83%AD%E3%83%88%E3%82%B3%E3%83%AB%E3%81%A8%E7%A0%94%E7%A9%B6%E3%83%97%E3%83%AD%E3%83%9D%E3%83%BC%E3%82%B6%E3%83%AB%E3%81%AE%E9%81%95%E3%81%84\"><\/span>\u7814\u7a76\u30d7\u30ed\u30c8\u30b3\u30eb\u3068\u7814\u7a76\u30d7\u30ed\u30dd\u30fc\u30b6\u30eb\u306e\u9055\u3044<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u6df7\u540c\u3055\u308c\u308b\u3053\u3068\u304c\u591a\u3005\u3042\u308a\u307e\u3059\u304c\u3001\u7814\u7a76\u30d7\u30ed\u30c8\u30b3\u30eb\u3068\u7814\u7a76\u30d7\u30ed\u30dd\u30fc\u30b6\u30eb\u306f\u3001\u7570\u306a\u308b\u6587\u66f8\u3067\u3059\u3002\u4e0b\u8868\u306b\u4e8c\u3064\u306e\u76f8\u9055\u70b9\u3092\u4e26\u3079\u3066\u307f\u307e\u3059\u3002<\/p>\n<table>\n<tbody>\n<tr>\n<td width=\"283\">\u7814\u7a76\u30d7\u30ed\u30dd\u30fc\u30b6\u30eb\uff08Research Proposal\uff09<\/td>\n<td width=\"283\">\u7814\u7a76\u30d7\u30ed\u30c8\u30b3\u30eb\uff08Research Protocol\uff09<\/td>\n<\/tr>\n<tr>\n<td width=\"283\">\u7814\u7a76\u30d7\u30ed\u30dd\u30fc\u30b6\u30eb\u306f\u3001\u52a9\u6210\u91d1\u59d4\u54e1\u4f1a\u3001\u6240\u5c5e\u5927\u5b66\uff08\u5b66\u90e8\uff09\u3001\u6307\u5c0e\u6559\u54e1\u306a\u3069\u306b\u7814\u7a76\u306e\u5185\u5bb9\u3092\u8aac\u660e\u3059\u308b\u305f\u3081\u306b\u66f8\u304b\u308c\u308b\u6587\u66f8\u3067\u3059\u3002<\/td>\n<td width=\"283\">\u7814\u7a76\u30d7\u30ed\u30c8\u30b3\u30eb\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u306b\u53c2\u52a0\u3059\u308b\u88ab\u9a13\u8005\u5411\u3051\u306e\u7279\u5b9a\u306e\u502b\u7406\u57fa\u6e96\u3092\u6e80\u305f\u3059\u305f\u3081\u3001\u81e8\u5e8a\u7814\u7a76\u306e\u8a08\u753b\u3092\u8a73\u8ff0\u3059\u308b\u305f\u3081\u306b\u66f8\u304f\u6587\u66f8\u3067\u3059\u3002<\/td>\n<\/tr>\n<tr>\n<td width=\"283\">\u52a9\u6210\u91d1\u3092\u7372\u5f97\u3059\u308b\u305f\u3081\u3001\u3082\u3057\u304f\u306f\u7814\u7a76\u3092\u5b9f\u65bd\u3059\u308b\u305f\u3081\u306e\u8a08\u753b\u3092\u793a\u3059\u3082\u306e\u3002<\/td>\n<td width=\"283\">\u81e8\u5e8a\u8a66\u9a13\u306e\u88ab\u9a13\u8005\u306e\u5b89\u5168\u3092\u5b88\u308b\u305f\u3081\u306b\u5b9a\u3081\u3089\u308c\u3066\u3044\u308b\u6a5f\u95a2\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u6e80\u305f\u3059\u305f\u3081\u306b\u63d0\u6848\u3055\u308c\u305f\u7814\u7a76\u6982\u8981\u3092\u660e\u78ba\u306b\u63d0\u4f9b\u3059\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u3066\u66f8\u304b\u308c\u308b\u6587\u66f8\u3067\u3059\u3002<\/td>\n<\/tr>\n<tr>\n<td width=\"283\">\u52a9\u6210\u91d1\u56e3\u4f53\u306b\u5bfe\u3057\u3066\u63d0\u51fa\u3057\u307e\u3059\u3002<\/td>\n<td width=\"283\">\u5927\u5b66\u304a\u3088\u3073\u7814\u7a76\u6a5f\u95a2\u306e\u7814\u7a76\u502b\u7406\u5be9\u67fb\u59d4\u54e1\u4f1a\uff08IRB\uff09\u306b\u63d0\u51fa\u3057\u307e\u3059\u3002<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<h2><span class=\"ez-toc-section\" id=\"%E7%A0%94%E7%A9%B6%E3%83%97%E3%83%AD%E3%83%88%E3%82%B3%E3%83%AB%E3%81%AB%E5%90%AB%E3%82%81%E3%82%8B%E3%81%B9%E3%81%8D%E8%A6%81%E7%B4%A0%EF%BC%8F%E9%A0%85%E7%9B%AE\"><\/span>\u7814\u7a76\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u542b\u3081\u308b\u3079\u304d\u8981\u7d20\uff0f\u9805\u76ee<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u4e16\u754c\u4fdd\u5065\u6a5f\u95a2\uff08WHO\uff09\u304c\u5b9a\u3081\u308b\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u57fa\u6e96\uff08Good Clinical Practice : GCP\uff09\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u306b\u3088\u308b\u3068\u3001\u7814\u7a76\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u306f\u4ee5\u4e0b\u306e21\u9805\u76ee\u3092\u66f8\u304d\u8a18\u3059\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<p><img decoding=\"async\" class=\"alignleft size-full wp-image-31812 lazyload\" data-src=\"https:\/\/www.enago.com\/academy\/jp\/wp-content\/uploads\/sites\/14\/2022\/08\/ResearchProtocol_E273-2-2.png\" alt=\"\" width=\"873\" height=\"651\" src=\"data:image\/svg+xml;base64,PHN2ZyB3aWR0aD0iMSIgaGVpZ2h0PSIxIiB4bWxucz0iaHR0cDovL3d3dy53My5vcmcvMjAwMC9zdmciPjwvc3ZnPg==\" style=\"--smush-placeholder-width: 873px; --smush-placeholder-aspect-ratio: 873\/651;\" \/><\/p>\n<p>&nbsp;<\/p>\n<h3><span class=\"ez-toc-section\" id=\"1%EF%BC%8EGeneral_Information_%E4%B8%80%E8%88%AC%E6%83%85%E5%A0%B1\"><\/span>1\uff0eGeneral Information: \u4e00\u822c\u60c5\u5831<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li>\u30bf\u30a4\u30c8\u30eb\u3001\u7814\u7a76\u30d7\u30ed\u30c8\u30b3\u30eb\u8b58\u5225\u756a\u53f7\uff08ID\u3001\u3042\u308c\u3070\uff09\u3001\u65e5\u4ed8<\/li>\n<li>\u8cc7\u91d1\u63d0\u4f9b\u8005\u306e\u540d\u524d<\/li>\n<li>\u8a66\u9a13\u8cac\u4efb\u533b\u5e2b\u30fb\u8cac\u4efb\u7814\u7a76\u8005\u306e\u540d\u524d\u304a\u3088\u3073\u9023\u7d61\u5148\u3001\u7814\u7a76\u30b5\u30a4\u30c8\uff08\u5834\u6240\uff09<\/li>\n<li>\u5404\u533b\u5e2b\u30fb\u7814\u7a76\u8005\u306e\u8cac\u4efb<\/li>\n<li>\u8a72\u5f53\u7814\u7a76\u306b\u95a2\u308f\u3063\u305f\u81e8\u5e8a\u691c\u67fb\u5ba4\u3001\u305d\u306e\u4ed6\u306e\u533b\u7642\u304a\u3088\u3073\u6280\u8853\u90e8\u9580\u3001\u7814\u7a76\u6a5f\u95a2\u306e\u540d\u524d\u3068\u4f4f\u6240<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"2%EF%BC%8ERationale_Background_Information_%E8%AB%96%E7%90%86%E7%9A%84%E6%A0%B9%E6%8B%A0%E3%81%8A%E3%82%88%E3%81%B3%E7%A0%94%E7%A9%B6%E3%81%AE%E8%83%8C%E6%99%AF\"><\/span>2\uff0eRationale &amp; Background Information: \u8ad6\u7406\u7684\u6839\u62e0\u304a\u3088\u3073\u7814\u7a76\u306e\u80cc\u666f<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li>\u8ad6\u7406\u7684\u6839\u62e0\u3068\u7814\u7a76\u306e\u80cc\u666f\u3067\u306f\u3001\u7814\u7a76\u984c\u6750\u306b\u3064\u3044\u3066\u306e\u9069\u5207\u306a\u77e5\u8b58\u306b\u7167\u3089\u3057\u3001\u305d\u306e\u7814\u7a76\u3092\u5b9f\u65bd\u3059\u308b\u5177\u4f53\u7684\u306a\u7406\u7531\u3092\u793a\u3059<\/li>\n<li>\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306e\u57fa\u76e4\u3068\u306a\u308b\u8ab2\u984c\u3001\u7814\u7a76\u306b\u304a\u3051\u308b\u554f\u984c\u306e\u539f\u56e0\u3001\u8003\u3048\u3089\u308c\u308b\u89e3\u6c7a\u7b56\u3092\u542b\u3081\u305f\u610f\u898b\u3092\u8ff0\u3079\u308b<\/li>\n<li>\u7814\u7a76\u30c6\u30fc\u30de\u306b\u3064\u3044\u3066\u516c\u958b\uff0f\u51fa\u7248\u3055\u308c\u3066\u3044\u308b\u6700\u3082\u95a2\u9023\u6027\u306e\u9ad8\u3044\u6587\u732e\u306e\u6982\u8981\u3092\u4ed8\u3051\u308b\u3053\u3068\u3067\u88dc\u8db3\u3059\u308b<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"3%EF%BC%8EStudy_Objectives_%E7%A0%94%E7%A9%B6%E7%9B%AE%E6%A8%99\"><\/span>3\uff0eStudy Objectives: \u7814\u7a76\u76ee\u6a19<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li>\u7814\u7a76\u30d7\u30ed\u30dd\u30fc\u30b6\u30eb\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u7814\u7a76\u8005\u304c\u9054\u6210\u3057\u305f\u3044\u7814\u7a76\u76ee\u6a19\u306b\u57fa\u3065\u3044\u3066\u7814\u7a76\u3092\u8a08\u753b\u3059\u308b<\/li>\n<li>\u7814\u7a76\u3092\u63d0\u6848\u3059\u308b\u76ee\u6a19\u306f\u3001\u660e\u78ba\u306b\u5206\u308a\u3084\u3059\u304f\u3001\u304b\u3064\u5177\u4f53\u7684\u3067\u3001\u7814\u7a76\u306e\u5b9f\u65bd\u306b\u5148\u7acb\u3063\u3066\u793a\u3057\u3066\u304a\u304f\u5fc5\u8981\u304c\u3042\u308b<\/li>\n<li>\u7814\u7a76\u8ab2\u984c\u3068\u305d\u306e\u89e3\u6c7a\u7b56\u3068\u306e\u95a2\u4fc2\u6027\u306b\u57fa\u3065\u304d\u3001\u7814\u7a76\u76ee\u6a19\u306f\u4e00\u6b21\u76ee\u6a19\u304a\u3088\u3073\u4e8c\u6b21\u76ee\u6a19\u306b\u5206\u3051\u308b\u3053\u3068\u304c\u3067\u304d\u308b<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"4%EF%BC%8EStudy_Design_%E7%A0%94%E7%A9%B6%E3%83%87%E3%82%B6%E3%82%A4%E3%83%B3\"><\/span>4\uff0eStudy Design: \u7814\u7a76\u30c7\u30b6\u30a4\u30f3<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li>\u7814\u7a76\u30c7\u30b6\u30a4\u30f3\u306f\u3001\u7814\u7a76\u306e\u79d1\u5b66\u7684\u516c\u6b63\u6027\u3068\u4fe1\u983c\u6027\u3092\u6b63\u5f53\u5316\u3059\u308b\u3082\u306e\u3067\u3042\u308b<\/li>\n<li>\u7814\u7a76\u306e\u7a2e\u985e\uff08\u30bf\u30a4\u30d7\uff09\u3001\u5bfe\u8c61\u6570\u307e\u305f\u306f\u30b5\u30f3\u30d7\u30eb\u30d5\u30ec\u30fc\u30e0\uff08\u62bd\u51fa\u67a0\uff09\u3001\u9069\u683c\u57fa\u6e96\uff08\u7d44\u5165\u3001\u9664\u5916\u3001\u53d6\u4e0b\uff09\u3001\u304a\u3088\u3073\u4e88\u6e2c\u3067\u304d\u308b\u7814\u7a76\u671f\u9593\u306b\u95a2\u3059\u308b\u60c5\u5831\u3092\u8a18\u8f09\u3059\u308b<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"5%EF%BC%8EMethodology_%E6%96%B9%E6%B3%95\"><\/span>5\uff0eMethodology: \u65b9\u6cd5<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li>\u65b9\u6cd5\u306f\u3001\u7814\u7a76\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u4e2d\u3067\u3082\u6700\u3082\u91cd\u8981\u306a\u9805\u76ee\u3067\u3042\u308b<\/li>\n<li>\u89b3\u5bdf\u30fb\u4ecb\u5165\u3001\u884c\u3063\u305f\u624b\u9806\u3001\u6e2c\u5b9a\u65b9\u6cd5\u3001\u89b3\u5bdf\u65b9\u6cd5\u3001\u884c\u308f\u308c\u308b\u5b9f\u9a13\u306a\u3069\u306b\u95a2\u3059\u308b\u8a73\u7d30\u60c5\u5831\u3092\u66f8\u304d\u8a18\u3059\u5fc5\u8981\u304c\u3042\u308b<\/li>\n<li>\u8907\u6570\u65bd\u8a2d\uff08\u8a66\u9a13\u6a5f\u95a2\u306a\u3069\uff09\u304c\u7279\u5b9a\u306e\u7814\u7a76\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u95a2\u4e0e\u3057\u3066\u3044\u308b\u5834\u5408\u306b\u306f\u3001\u65b9\u6cd5\u3092\u6a19\u6e96\u5316\u3059\u308b\u3068\u3068\u3082\u306b\u3001\u660e\u78ba\u306b\u5b9a\u7fa9\u3057\u3066\u304a\u304f\u5fc5\u8981\u304c\u3042\u308b<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"6%EF%BC%8ESafety_Considerations_%E5%AE%89%E5%85%A8%E6%80%A7%E8%80%83%E5%AF%9F\"><\/span>6\uff0eSafety Considerations: \u5b89\u5168\u6027\u8003\u5bdf<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li>\u81e8\u5e8a\u8a66\u9a13\u306e\u53c2\u52a0\u8005\u306e\u5b89\u5168\u78ba\u4fdd\u306f\u3001\u81e8\u5e8a\u7814\u7a76\u3092\u5b9f\u65bd\u3059\u308b\u969b\u306e\u6700\u512a\u5148\u8ab2\u984c\u3067\u3042\u308b<\/li>\n<li>\u7814\u7a76\u306e\u5b89\u5168\u6027\u3092\u7cbe\u67fb\u3057\u3001\u7814\u7a76\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u8a18\u8f09\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"7%EF%BC%8EFollow-up_%E7%B5%8C%E9%81%8E%E8%A6%B3%E5%AF%9F\"><\/span>7\uff0eFollow-up: \u7d4c\u904e\u89b3\u5bdf<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li>\u81e8\u5e8a\u8a66\u9a13\u306b\u53c2\u52a0\u3059\u308b\u88ab\u9a13\u8005\u306b\u5bfe\u3059\u308b\u7d4c\u904e\u89b3\u5bdf\u306b\u3064\u3044\u3066\u660e\u78ba\u306b\u793a\u3059<\/li>\n<li>\u7d4c\u904e\u89b3\u5bdf\u306e\u671f\u9593\u306b\u3064\u3044\u3066\u3082\u793a\u3059<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"8%EF%BC%8EData_Management_and_Statistical_Analysis_%E3%83%87%E3%83%BC%E3%82%BF%E7%AE%A1%E7%90%86%E3%81%8A%E3%82%88%E3%81%B3%E7%B5%B1%E8%A8%88%E7%9A%84%E5%88%86%E6%9E%90\"><\/span>8\uff0eData Management and Statistical Analysis: \u30c7\u30fc\u30bf\u7ba1\u7406\u304a\u3088\u3073\u7d71\u8a08\u7684\u5206\u6790<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li>\u30c7\u30fc\u30bf\u306e\u53d6\u308a\u6271\u3044\u65b9\u6cd5\u3001\u30b3\u30f3\u30d4\u30e5\u30fc\u30bf\u30fc\u5206\u6790\u3001\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3001\u691c\u8a3c\u306e\u305f\u3081\u306e\u30b3\u30fc\u30c7\u30a3\u30f3\u30b0\u306a\u3069\u3092\u542b\u3081\u305f\u3001\u30c7\u30fc\u30bf\u7ba1\u7406\u65b9\u6cd5\u306b\u95a2\u3059\u308b\u60c5\u5831\u3092\u8a18\u8f09\u3059\u308b<\/li>\n<li>\u30c7\u30fc\u30bf\u5206\u6790\u306b\u4f7f\u7528\u3059\u308b\u305f\u3081\u306e\u7d71\u8a08\u7684\u624b\u6cd5\u3092\u660e\u78ba\u306b\u6982\u8aac\u3059\u308b<\/li>\n<li>\u5b9a\u6027\u7684\u306a\u30a2\u30d7\u30ed\u30fc\u30c1\u3092\u884c\u3046\u306b\u306f\u3001\u3069\u306e\u3088\u3046\u306b\u30c7\u30fc\u30bf\u3092\u5206\u6790\u3059\u308b\u304b\u5177\u4f53\u7684\u306b\u6307\u5b9a\u3059\u308b<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"9%EF%BC%8EQuality_Assurance_%E5%93%81%E8%B3%AA%E4%BF%9D%E8%A8%BC\"><\/span>9\uff0eQuality Assurance: \u54c1\u8cea\u4fdd\u8a3c<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li>\u54c1\u8cea\u7ba1\u7406\u304a\u3088\u3073\u54c1\u8cea\u4fdd\u8a3c\u30b7\u30b9\u30c6\u30e0\u306b\u3064\u3044\u3066\u660e\u78ba\u306b\u8a18\u8ff0\u3059\u308b<\/li>\n<li>\u3053\u3053\u306b\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u57fa\u6e96\uff08GCP\uff09\u3001\u81e8\u5e8a\u30e2\u30cb\u30bf\u30fc\u306b\u3088\u308b\u7d4c\u904e\u89b3\u5bdf\u3001\u30c7\u30fc\u30bf\u5b89\u5168\u6027\u76e3\u8996\u59d4\u54e1\u4f1a (DSMB) \u3001\u30c7\u30fc\u30bf\u7ba1\u7406\u306a\u3069\u306b\u3064\u3044\u3066\u3082\u8a18\u8f09\u3059\u308b<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"10%EF%BC%8EExpected_Outcomes_of_the_Study_%E6%9C%9F%E5%BE%85%E3%81%95%E3%82%8C%E3%82%8B%E7%A0%94%E7%A9%B6%E6%88%90%E6%9E%9C\"><\/span>10\uff0eExpected Outcomes of the Study: \u671f\u5f85\u3055\u308c\u308b\u7814\u7a76\u6210\u679c<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li>\u8a72\u5f53\u7814\u7a76\u304c\u73fe\u5728\u306e\u77e5\u898b\u306e\u767a\u5c55\u306b\u3044\u304b\u306b\u8ca2\u732e\u3059\u308b\u304b\u3001\u8a66\u9a13\u306e\u7d50\u679c\u304c\u516c\u958b\u3055\u308c\u305f\u5f8c\u306b\u3069\u306e\u3088\u3046\u306b\u5229\u7528\u3055\u308c\u308b\u304b\u3092\u793a\u3059<\/li>\n<li>\u305d\u306e\u7814\u7a76\u304c\u30d8\u30eb\u30b9\u30b1\u30a2\uff08\u533b\u7642\uff09\u3001\u533b\u7642\u30b7\u30b9\u30c6\u30e0\u3001\u307e\u305f\u306f\u533b\u7642\u653f\u7b56\u306b\u3069\u306e\u3088\u3046\u306a\u5f71\u97ff\u3092\u53ca\u307c\u3059\u304b\u306b\u3064\u3044\u3066\u3082\u8a00\u53ca\u3059\u308b<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"11%EF%BC%8EDissemination_of_Results_and_Publication_Policy_%E7%A0%94%E7%A9%B6%E6%88%90%E6%9E%9C%E3%81%AE%E6%99%AE%E5%8F%8A%E3%83%BB%E5%85%AC%E9%96%8B%E6%96%B9%E9%87%9D\"><\/span>11\uff0eDissemination of Results and Publication Policy: \u7814\u7a76\u6210\u679c\u306e\u666e\u53ca\u30fb\u516c\u958b\u65b9\u91dd<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li>\u7814\u7a76\u7d50\u679c\u304c\u79d1\u5b66\u30e1\u30c7\u30a3\u30a2\u3067\u3069\u306e\u3088\u3046\u306b\u53d6\u308a\u4e0a\u3052\u3089\u308c\u3066\u5e83\u3081\u3089\u308c\u308b\u304b\u3060\u3051\u3067\u306a\u304f\u3001\u30b3\u30df\u30e5\u30cb\u30c6\u30a3\uff08\u79d1\u5b66\u754c\uff09\u3042\u308b\u3044\u306f\u6cbb\u9a13\u53c2\u52a0\u8005\u3001\u653f\u7b56\u6c7a\u5b9a\u8005\u306a\u3069\u306b\u5bfe\u3057\u3066\u3069\u3046\u666e\u53ca\u3055\u305b\u308b\u304b\u3082\u6307\u5b9a\u3059\u308b<\/li>\n<li>\u8ab0\u306e\u540d\u524d\u3092\u7814\u7a76\u306b\u8ca2\u732e\u3057\u305f\u3068\u3057\u3066\u8a18\u8f09\u3059\u308b\u304b\u3001\u8ab0\u306b\u8b1d\u8f9e\u3092\u8ff0\u3079\u308b\u304b\u306a\u3069\u3092\u542b\u3081\u305f\u516c\u958b\u65b9\u91dd\u3092\u660e\u78ba\u306b\u5354\u8b70\u3057\u3066\u304a\u304f<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"12%EF%BC%8EDuration_of_the_Project_%E7%A0%94%E7%A9%B6%E3%83%97%E3%83%AD%E3%82%B8%E3%82%A7%E3%82%AF%E3%83%88%E3%81%AE%E5%AE%9F%E6%96%BD%E6%9C%9F%E9%96%93\"><\/span>12\uff0eDuration of the Project: \u7814\u7a76\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306e\u5b9f\u65bd\u671f\u9593<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li>\u7814\u7a76\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306e\u305d\u308c\u305e\u308c\u306e\u30d5\u30a7\u30fc\u30ba\u304c\u5b8c\u4e86\u3059\u308b\u306e\u306b\u8981\u3059\u308b\u3068\u63a8\u5b9a\u3055\u308c\u308b\u6642\u9593\u3092\u660e\u78ba\u306b\u8a18\u8f09\u3057\u3066\u304a\u304f<\/li>\n<li>\u5b9f\u65bd\u9805\u76ee\u3054\u3068\u306e\u8a73\u7d30\u306a\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3\u3082\u63d0\u793a\u3059\u308b<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"13%EF%BC%8EAnticipated_Problems_%E4%BA%88%E6%83%B3%E3%81%95%E3%82%8C%E3%82%8B%E5%95%8F%E9%A1%8C\"><\/span>13\uff0eAnticipated Problems: \u4e88\u60f3\u3055\u308c\u308b\u554f\u984c<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li>\u8a66\u9a13\u8cac\u4efb\u533b\u5e2b\u307e\u305f\u306f\u7814\u7a76\u8005\u306f\u3001\u81e8\u5e8a\u7814\u7a76\u306e\u5b9f\u65bd\u4e2d\u306b\u6570\u3005\u306e\u56f0\u96e3\u306b\u76f4\u9762\u3059\u308b\u3053\u3068\u304c\u3042\u308b\u306e\u3067\u3001\u3053\u306e\u9805\u76ee\u306b\u306f\u3001\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3092\u6210\u529f\u3055\u305b\u308b\u305f\u3081\u306b\u4e88\u60f3\u3055\u308c\u308b\u3042\u3089\u3086\u308b\u554f\u984c\u3092\u66f8\u304d\u51fa\u3057\u3066\u304a\u304f<\/li>\n<li>\u305d\u3046\u3057\u305f\u554f\u984c\u306b\u5bfe\u51e6\u3059\u308b\u305f\u3081\u306e\u8003\u3048\u3089\u308c\u308b\u89e3\u6c7a\u7b56\u3092\u793a\u3057\u3066\u304a\u304f<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"14%EF%BC%8EProject_Management_%E3%83%97%E3%83%AD%E3%82%B8%E3%82%A7%E3%82%AF%E3%83%88%E7%AE%A1%E7%90%86\"><\/span>14\uff0eProject Management: \u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u7ba1\u7406<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li>\u7814\u7a76\u30c1\u30fc\u30e0\u306e\u8a66\u9a13\u8cac\u4efb\u533b\u5e2b\u3084\u7814\u7a76\u8005\u305d\u308c\u305e\u308c\u306e\u5f79\u5272\u3068\u8cac\u4efb\u306b\u3064\u3044\u3066\u8a73\u7d30\u306b\u8a18\u3057\u3066\u304a\u304f<\/li>\n<li>\u7814\u7a76\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306b\u95a2\u308f\u3063\u305f\u3059\u3079\u3066\u306e\u4eba\u306b\u3064\u3044\u3066\u3001\u7814\u7a76\u3092\u5b8c\u4e86\u3055\u305b\u308b\u306b\u3042\u305f\u3063\u3066\u62c5\u3063\u305f\u7279\u5b9a\u306e\u8cac\u52d9\u3068\u3068\u3082\u306b\u8a18\u8f09\u3059\u308b<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"15%EF%BC%8EEthics_%E7%A0%94%E7%A9%B6%E5%80%AB%E7%90%86\"><\/span>15\uff0eEthics: \u7814\u7a76\u502b\u7406<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li>\u7814\u7a76\u306b\u95a2\u9023\u3059\u308b\u502b\u7406\u898f\u5b9a\u3092\u8a18\u8f09\u3059\u308b<\/li>\n<li>\u502b\u7406\u7684\u627f\u8a8d\u3092\u6761\u4ef6\u3068\u3059\u308b\u3053\u3068\u3092\u793a\u3059\u3060\u3051\u3067\u306a\u304f\u3001\u502b\u7406\u7684\u306a\u61f8\u5ff5\u3092\u8d77\u3053\u3059\u53ef\u80fd\u6027\u306e\u3042\u308b\u554f\u984c\u306b\u3082\u8a00\u53ca\u3059\u308b<\/li>\n<li>\u502b\u7406\u9805\u76ee\u306e\u4e2d\u306b\u306f\u3001\u8a66\u9a13\u8cac\u4efb\u533b\u5e2b\uff08\u7814\u7a76\u8005\uff09\u304c\u7814\u7a76\u306e\u53c2\u52a0\u8005\u304b\u3089\u30a4\u30f3\u30d5\u30a9\u30fc\u30e0\u30c9\u30fb\u30b3\u30f3\u30bb\u30f3\u30c8\u3092\u53d6\u5f97\u3059\u308b\u65b9\u6cd5\u306b\u95a2\u3059\u308b\u8aac\u660e\u3082\u66f8\u304d\u3053\u3080<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"16%EF%BC%8EBudget_%E4%BA%88%E7%AE%97\"><\/span>16\uff0eBudget: \u4e88\u7b97<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li>\u5fc5\u8981\u3068\u3059\u308b\u8cc7\u91d1\u306e\u5185\u8a33\uff08\u5fc5\u9700\u54c1\u5225\u3068\u696d\u52d9\u5225\uff09\u3092\u8a18\u3059<\/li>\n<li>\u30ea\u30b9\u30c8\u3057\u305f\u5404\u9805\u76ee\u306e\u7528\u9014\u306e\u6b63\u5f53\u6027\u306b\u3064\u3044\u3066\u3082\u66f8\u304d\u8a18\u3059<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"17%EF%BC%8ESupplementary_Support_for_the_Project_%E7%A0%94%E7%A9%B6%E3%83%97%E3%83%AD%E3%82%B8%E3%82%A7%E3%82%AF%E3%83%88%E3%81%B8%E3%81%AE%E8%BF%BD%E5%8A%A0%E6%94%AF%E6%8F%B4\"><\/span>17\uff0eSupplementary Support for the Project: \u7814\u7a76\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3078\u306e\u8ffd\u52a0\u652f\u63f4<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li>\u7279\u5b9a\u306e\u7814\u7a76\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306b\u5bfe\u3057\u3066\u63d0\u4f9b\u3055\u308c\u305f\u8cc7\u91d1\u304a\u3088\u3073\u305d\u306e\u4ed6\u306e\u4e88\u60f3\u3055\u308c\u308b\u8cc7\u91d1\u63d0\u4f9b\u306b\u95a2\u3059\u308b\u60c5\u5831\u3092\u8a18\u3059<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"18%EF%BC%8ECollaboration_With_Other_Researchers_or_Institutions_%E4%BB%96%E3%81%AE%E7%A0%94%E7%A9%B6%E8%80%85%E3%81%BE%E3%81%9F%E3%81%AF%E7%A0%94%E7%A9%B6%E6%A9%9F%E9%96%A2%E3%81%A8%E3%81%AE%E5%8D%94%E5%8A%9B\"><\/span>18\uff0eCollaboration With Other Researchers or Institutions: \u4ed6\u306e\u7814\u7a76\u8005\u307e\u305f\u306f\u7814\u7a76\u6a5f\u95a2\u3068\u306e\u5354\u529b<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li>\u7814\u7a76\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306b\u53c2\u753b\u3057\u305f\u3059\u3079\u3066\u306e\u7814\u7a76\u8005\u307e\u305f\u306f\u7814\u7a76\u6a5f\u95a2\u306b\u3064\u3044\u3066\u3001\u8a73\u7d30\u3092\u8a18\u8f09\u3059\u308b<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"19%EF%BC%8ECurriculum_Vitae_of_All_Investigators_%E3%81%99%E3%81%B9%E3%81%A6%E3%81%AE%E7%A0%94%E7%A9%B6%E8%80%85%E3%81%AE%E8%81%B7%E5%8B%99%E7%B5%8C%E6%AD%B4%E6%9B%B8%EF%BC%88CV%EF%BC%89\"><\/span>19\uff0eCurriculum Vitae of All Investigators: \u3059\u3079\u3066\u306e\u7814\u7a76\u8005\u306e\u8077\u52d9\u7d4c\u6b74\u66f8\uff08CV\uff09<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li>\u8a66\u9a13\u8cac\u4efb\u533b\u5e2b\u307e\u305f\u306f\u4e3b\u4efb\u7814\u7a76\u8005\uff08PI\uff09\u3068\u3059\u3079\u3066\u306e\u5171\u540c\u7814\u7a76\u8005\u306e\u8077\u52d9\u7d4c\u6b74\u66f8\uff08CV\uff09\u3092\u6dfb\u4ed8\u3059\u308b<\/li>\n<li>\u3059\u3079\u3066\u306e\u8077\u6b74\u3092\u63b2\u8f09\u3057\u305fCV\u306e\u63d0\u51fa\u3092\u8981\u6c42\u3055\u308c\u306a\u3044\u9650\u308a\u3001\u5404\u4eba\u306eCV\u306f\uff11\u30da\u30fc\u30b8\u306b\u53ce\u3081\u308b\u306e\u304c\u7406\u60f3\u7684\u3067\u3042\u308b<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"20%EF%BC%8EOther_Research_Activities_of_Investigators_%E8%A9%A6%E9%A8%93%E8%B2%AC%E4%BB%BB%E5%8C%BB%E5%B8%AB%E3%83%BB%E7%A0%94%E7%A9%B6%E8%80%85%E3%81%AE%E4%BB%96%E3%81%AE%E7%A0%94%E7%A9%B6%E6%B4%BB%E5%8B%95\"><\/span>20\uff0eOther Research Activities of Investigators: \u8a66\u9a13\u8cac\u4efb\u533b\u5e2b\u30fb\u7814\u7a76\u8005\u306e\u4ed6\u306e\u7814\u7a76\u6d3b\u52d5<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li>\u3059\u3079\u3066\u306e\u7814\u7a76\u8005\u304c\u73fe\u5728\u5b9f\u65bd\u3057\u3066\u3044\u308b\u7814\u7a76\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3092\u5168\u90e8\u30ea\u30b9\u30c8\u5316\u3057\u3066\u63b2\u8f09\u3059\u308b<\/li>\n<\/ul>\n<h3><span class=\"ez-toc-section\" id=\"21%EF%BC%8EReferences_%E5%8F%82%E8%80%83%E6%96%87%E7%8C%AE\"><\/span>21\uff0eReferences: \u53c2\u8003\u6587\u732e<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<ul>\n<li>\u76d7\u7528\u30fb\u527d\u7a83\u3092\u907f\u3051\u308b\u305f\u3081\u306b\u3001\u95a2\u9023\u3059\u308b\u3059\u3079\u3066\u306e<a href=\"https:\/\/academicguides.waldenu.edu\/writingcenter\/apa\/references\/examples\" target=\"_blank\" rel=\"noopener noreferrer\">\u53c2\u8003\u6587\u732e<\/a>\u306b\u8a00\u53ca\u3057\u3001\u7684\u78ba\u306b\u5f15\u7528\u3059\u308b<\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"%E7%A0%94%E7%A9%B6%E3%83%97%E3%83%AD%E3%83%88%E3%82%B3%E3%83%AB%E3%81%AE%E6%9B%B8%E3%81%8D%E6%96%B9%EF%BC%88%E7%A0%94%E7%A9%B6%E3%83%97%E3%83%AD%E3%83%88%E3%82%B3%E3%83%AB%E3%81%AE%E6%9B%B8%E5%BC%8F%E3%82%B5%E3%83%B3%E3%83%97%E3%83%AB%EF%BC%89\"><\/span>\u7814\u7a76\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u66f8\u304d\u65b9\uff08\u7814\u7a76\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u66f8\u5f0f\u30b5\u30f3\u30d7\u30eb\uff09<strong style=\"color: #4a4a4a;font-size: 16px;text-transform: initial\">\u00a0 \u00a0<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<div style=\"border: 3px solid #CCC;padding: 10px;border-radius: 10px\">\n<h2><span class=\"ez-toc-section\" id=\"Main_Investigator%E3%80%80%E4%B8%BB%E4%BB%BB%E7%A0%94%E7%A9%B6%E8%80%85%E3%81%BE%E3%81%9F%E3%81%AF%E7%A0%94%E7%A9%B6%E8%B2%AC%E4%BB%BB%E8%80%85%E6%83%85%E5%A0%B1\"><\/span><strong style=\"color: #4a4a4a;font-size: 16px;text-transform: initial\">Main Investigator\u3000\u4e3b\u4efb\u7814\u7a76\u8005\u307e\u305f\u306f\u7814\u7a76\u8cac\u4efb\u8005\u60c5\u5831<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Name\u3000\u6c0f\u540d<\/p>\n<p>Address\u3000\u4f4f\u6240<\/p>\n<p>Phone\/Fax\u3000\u96fb\u8a71\uff0fFax<\/p>\n<p>E-mail\u3000\u30e1\u30fc\u30eb\u30a2\u30c9\u30ec\u30b9<\/p>\n<p><strong>Number of Involved Centers (for multi-centric studies)<br \/>\n\u7814\u7a76\u306b\u95a2\u4e0e\u3057\u305f\u6a5f\u95a2\u306e\u6570\uff08\u8907\u6570\u306e\u7814\u7a76\u6a5f\u95a2\u3084\u56e3\u4f53\u304c\u7814\u7a76\u306b\u95a2\u308f\u3063\u3066\u3044\u308b\u5834\u5408\uff09<br \/>\n<\/strong><\/p>\n<p>Indicate the reference center\u3000\u30ea\u30d5\u30a1\u30ec\u30f3\u30b9\u30bb\u30f3\u30bf\u30fc\uff08\u554f\u3044\u5408\u308f\u305b\u5148\uff09<\/p>\n<p><strong>Title of the Study\u3000\u7814\u7a76\uff0f\u8a66\u9a13\u30bf\u30a4\u30c8\u30eb<\/strong><\/p>\n<p><strong>Protocol ID (acronym)\u3000\u30d7\u30ed\u30c8\u30b3\u30ebID\uff08\u3042\u308c\u3070\uff09<\/strong><\/p>\n<p><strong>Keywords (up to 7 specific keywords)\u3000\u30ad\u30fc\u30ef\u30fc\u30c9\uff08\u7279\u5b9a\u306e\u30ad\u30fc\u30ef\u30fc\u30c9\u3092\uff17\u3064\u3050\u3089\u3044\uff09<\/strong><\/p>\n<p><strong>Rationale\u3000\u8ad6\u7406\u7684\u6839\u62e0<\/strong><\/p>\n<p><strong>Study Design\u3000\u7814\u7a76\u30c7\u30b6\u30a4\u30f3<\/strong><\/p>\n<p>Mono-centric\/multi-centric\u3000\u5358\u5fc3\u6027\uff0f\u591a\u4e2d\u5fc3\u6027<\/p>\n<p>Perspective\/retrospective\u3000\u5927\u5c40\u7684\uff0f\u9061\u53ca\u7684<\/p>\n<p>Controlled\/uncontrolled\u3000\u5236\u5fa1\u578b\uff0f\u7121\u5236\u5fa1\u578b<\/p>\n<p>Open-label\/single-blinded or double-blinded<br \/>\n\u76f2\u691c\u5316\u30ec\u30d9\u30eb\uff08\u975e\u76f2\u691c\uff0f\u5358\u76f2\u691c\u30fb\u4e8c\u91cd\u76f2\u691c\uff09<\/p>\n<p>Randomized\/non-randomized\u3000\u30e9\u30f3\u30c0\u30e0\u5316\u306e\u6709\u7121\uff08\u30e9\u30f3\u30c0\u30e0\u5316\uff0f\u975e\u30e9\u30f3\u30c0\u30e0\u5316\uff09<\/p>\n<p>n parallel branches\/n overlapped branches\u3000\u30d1\u30e9\u30ec\u30eb\u8a66\u9a13 \/\u30af\u30ed\u30b9\u30aa\u30fc\u30d0\u30fc\u8a66\u9a13<\/p>\n<p>Experimental\/observational\u3000\u5b9f\u9a13\u7684\uff0f\u89b3\u5bdf\u7684<\/p>\n<p><strong>Objectives\u3000\u76ee\u6a19<\/strong><\/p>\n<p><strong>Endpoints (main primary and secondary endpoints to be listed)<br \/>\n\u30a8\u30f3\u30c9\u30dd\u30a4\u30f3\u30c8\uff08\u4e3b\u306a\u30d7\u30e9\u30a4\u30de\u30ea\u30fc\u30a8\u30f3\u30c9\u30dd\u30a4\u30f3\u30c8\u3068\u30bb\u30ab\u30f3\u30c0\u30ea\u30fc\u30a8\u30f3\u30c9\u30dd\u30a4\u30f3\u30c8\u3092\u8a18\u8f09\u3059\u308b\uff09<br \/>\n<\/strong><\/p>\n<p><strong>Expected Results\u3000\u4e88\u6e2c\u3055\u308c\u308b\u7d50\u679c\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0\u00a0<\/strong><\/p>\n<p><strong>Analyzed Criteria\u3000\u5206\u6790\u57fa\u6e96<\/strong><\/p>\n<p>Main variables\/endpoints of the primary analysis\u3000\u4e3b\u8981\u5909\u6570\uff0f\u4e00\u6b21\u8a55\u4fa1\u9805\u76ee<\/p>\n<p>Main variables\/endpoints of the secondary analysis\u3000\u4e3b\u8981\u5909\u6570\uff0f\u4e8c\u6b21\u8a55\u4fa1\u9805\u76ee<\/p>\n<p>Safety variables\u3000\u5b89\u5168\u5909\u6570<\/p>\n<p><strong>Health Economy (if applicable)\u3000\u30d8\u30eb\u30b9\u30fb\u30a8\u30b3\u30ce\u30df\u30fc\uff08\u4fdd\u5065\u7d4c\u6e08\u5b66\uff09\uff08\u8a72\u5f53\u304c\u3042\u308c\u3070\uff09<\/strong><\/p>\n<p><strong>Visits and Examinations\u3000\u8a2a\u554f\u3068\u691c\u67fb<\/strong><\/p>\n<p>Therapeutic plan and goals\u3000\u6cbb\u7642\u8a08\u753b\u3068\u76ee\u6a19<\/p>\n<p>Visits\/controls schedule (also with graphics)\u3000\u8a2a\u554f\uff0f\u7ba1\u7406\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\uff08\u56f3\u3092\u542b\u3080\uff09<\/p>\n<p>Comparison to treatment products (if applicable)\u3000\u6cbb\u7642\u7528\u533b\u85ac\u54c1\u3068\u306e\u6bd4\u8f03\uff08\u8a72\u5f53\u304c\u3042\u308c\u3070\uff09<\/p>\n<p>Dose and dosage for the study duration (if applicable)\u3000\u7814\u7a76\u671f\u9593\u4e2d\u306e\u7528\u91cf\u3068\u6295\u4e0e\u91cf\uff08\u8a72\u5f53\u304c\u3042\u308c\u3070\uff09<\/p>\n<p>Formulation and power of the studied drugs (if applicable)\u3000\u3000\u7814\u7a76\u5bfe\u8c61\u306e\u85ac\u7269\u306e\u51e6\u65b9\u3068\u6709\u52b9\u6027\uff08\u8a72\u5f53\u304c\u3042\u308c\u3070\uff09<\/p>\n<p>Method of administration of the studied drugs (if applicable)\u3000\u7814\u7a76\u85ac\u7269\u306e\u6295\u4e0e\u65b9\u6cd5\uff08\u8a72\u5f53\u304c\u3042\u308c\u3070\uff09<\/p>\n<p><strong>Informed Consent\u3000\u30a4\u30f3\u30d5\u30a9\u30fc\u30e0\u30c9\u30fb\u30b3\u30f3\u30bb\u30f3\u30c8<\/strong><\/p>\n<p><strong>Study Population\u3000\u8abf\u67fb\u5bfe\u8c61\u306e\u6bcd\u96c6\u56e3\uff08\u8abf\u67fb\u5bfe\u8c61\u4eba\u6570\uff09<\/strong><\/p>\n<p>Short description of the main inclusion, exclusion, and withdrawal criteria\u3000\u4e3b\u306a\u542b\u6709\u3001\u9664\u5916\u3001\u304a\u3088\u3073\u53d6\u4e0b\u57fa\u6e96\u306e\u7c21\u5358\u306a\u8aac\u660e<\/p>\n<p><strong>Sample Size\u3000\u30b5\u30f3\u30d7\u30eb\u30b5\u30a4\u30ba<\/strong><\/p>\n<p><strong>Estimated Duration of the Study\u3000\u7814\u7a76\u306e\u7d99\u7d9a\u671f\u9593<\/strong><\/p>\n<p><strong>Safety Advisory\u3000\u5b89\u5168\u52e7\u544a<\/strong><\/p>\n<p><strong>Classification Needed\u3000\u5fc5\u8981\u5206\u985e<\/strong><\/p>\n<p><strong>Requested Funds\u3000\u5fc5\u8981\u306a\u8cc7\u91d1<\/strong><\/p>\n<p><strong>Additional Features (based on study objectives)\u3000\u8ffd\u52a0\u4e8b\u9805\uff08\u7814\u7a76\u76ee\u7684\u306b\u57fa\u3065\u304f\uff09<\/strong><\/p>\n<p><strong>References\u3000\u53c2\u8003\u6587\u732e<\/strong><\/p>\n<\/div>\n<p><a href=\"https:\/\/www.enago.com\/academy\/wp-content\/uploads\/2022\/07\/ResearchProtocolTemplate.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">\u7814\u7a76\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u30b5\u30f3\u30d7\u30eb\u66f8\u5f0f\u306e\u30c0\u30a6\u30f3\u30ed\u30fc\u30c9\u306f\u3053\u3061\u3089\u304b\u3089<\/a><\/p>\n<p>\u81e8\u5e8a\u7814\u7a76\u3092\u5b9f\u65bd\u3059\u308b\u306b\u306f\u3001\u8a73\u7d30\u306a\u7814\u7a76\u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u4f5c\u6210\u3057\u3066\u6e96\u5099\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u3053\u3053\u306b\u66f8\u3044\u305f\u3088\u3046\u306b\u3001\u96e3\u3057\u3044\u3053\u3068\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u3053\u306e\u8a18\u4e8b\u304c\u3001\u7814\u7a76\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u4f5c\u6210\u306b\u5f79\u7acb\u3064\u3053\u3068\u3092\u7948\u3063\u3066\u3044\u307e\u3059\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u3042\u308b\u5b66\u751f\u306f\u7814\u7a76\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u3064\u3044\u3066\u982d\u3092\u60a9\u307e\u305b\u3066\u3044\u308b\u3088\u3046\u3067\u3059\u3002 \u7814\u7a76\u4e3b\u5bb0\u8005\uff08Principal Investigator : PI\uff09\uff1a\u7814\u7a76\u30d7\u30ed\u30c8\u30b3\u30eb\uff08\u7814\u7a76\u8a08\u753b\u66f8\uff09\u306f\u66f8\u304d\u307e\u3057\u305f\u304b\uff1f \u5b66\u751f\uff1a\u307e\u3060\u3067\u3059\u3002\u5206\u3089\u306a\u3044\u3053\u3068\u3060\u3089\u3051\u3067\u2026\u305d\u3082\u305d\u3082\u3001\u7814\u7a76\u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u4f5c\u6210\u3059\u308b\u3053\u3068\u304c\u306a\u305c\u91cd\u8981\u306a\u306e\u3067\u3057\u3087\u3046\u304b\uff1f\u7814\u7a76\u30d7\u30ed\u30dd\u30fc\u30b6\u30eb\uff08\u7814\u7a76\u63d0\u6848\u66f8\uff09\u3068\u540c\u3058\u3088\u3046\u306a\u3053\u3068\u3092\u66f8\u3051\u3070\u3044\u3044\u306e\u304b\u3001\u4f55\u3092\u66f8\u304b\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u306e\u304b\u3001\u3069\u306e\u3088\u3046\u306a\u69cb\u6210\u306b\u3057\u305f\u3089\u826f\u3044\u306e\u304b\u2026\u6240\u5b9a\u306e\u66f8\u5f0f\u306b\u5f93\u3063\u3066\u66f8\u3051\u3070\u3088\u3044\u3082\u306e\u3067\u3059\u304b\uff1f \u7d4c\u9a13\u306e\u6d45\u3044\u7814\u7a76\u8005\u306f\u3001\u7814\u7a76\u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u4f5c\u6210\u3059\u308b\u76ee\u7684\u3084\u91cd\u8981\u6027\u3060\u3051\u3067\u306a\u304f\u3001\u3069\u3046\u3084\u3063\u3066\u66f8\u3051\u3070\u3088\u3044\u306e\u304b\u3082\u7406\u89e3\u3067\u304d\u3066\u3044\u306a\u3044\u3088\u3046\u3067\u3059\u3002\u3053\u306e\u8a18\u4e8b\u3092\u901a\u3057\u3066\u3001\u7814\u7a76\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u66f8\u304d\u65b9\u306b\u3064\u3044\u3066\u7406\u89e3\u3092\u6df1\u3081\u3066\u3044\u304d\u307e\u3057\u3087\u3046\u3002 \u7814\u7a76\u30d7\u30ed\u30c8\u30b3\u30eb\u3068\u306f \u7814\u7a76\u30d7\u30ed\u30c8\u30b3\u30eb\u3068\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u80cc\u666f\u3001\u7406\u8ad6\u7684\u6839\u62e0\u3001\u76ee\u7684\u3001\u30c7\u30b6\u30a4\u30f3\u3001\u65b9\u6cd5\u3001\u7d71\u8a08\u7684\u8003\u5bdf\u304a\u3088\u3073\u5b9f\u65bd\u6a5f\u95a2\uff08\u56e3\u4f53\uff09\u306b\u3064\u3044\u3066\u8aac\u660e\u3059\u308b\u6587\u66f8\u3067\u3059\u3002\u81e8\u5e8a\u7814\u7a76\u306e\u8a08\u753b\u306e\u6982\u8981\u3092\u793a\u3059\u3060\u3051\u3067\u306a\u304f\u3001\u7814\u7a76\u8ab2\u984c\u306b\u5bfe\u3057\u3066\u6e80\u8db3\u3067\u304d\u308b\u7b54\u3048\u3092\u793a\u3059\u3088\u3046\u306b\u4f5c\u6210\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u7814\u7a76\u30d7\u30ed\u30c8\u30b3\u30eb\u306f\u3001\u7814\u7a76\u3092\u5b9f\u65bd\u3059\u308b\u305f\u3081\u306e\u8a66\u6599\u3068\u624b\u9806\u3092\u793a\u3059\u6587\u66f8\u306a\u306e\u3067\u3059\u3002 \u306a\u305c\u7814\u7a76\u30d7\u30ed\u30c8\u30b3\u30eb\u304c\u91cd\u8981\u306a\u306e\u304b \u6cbb\u9a13\u3084\u81e8\u5e8a\u8a66\u9a13\u306b\u304a\u3044\u3066\u3001\u7814\u7a76\u30d7\u30ed\u30c8\u30b3\u30eb\u306f\u6700\u3082\u91cd\u8981\u306a\u3082\u306e\u3067\u3042\u308a\u3001\u81e8\u5e8a\u7814\u7a76\u306e\u57fa\u76e4\u3068\u306a\u308b\u3082\u306e\u3067\u3059\u3002\u81e8\u5e8a\u8a66\u9a13\u306e\u88ab\u9a13\u8005\u306e\u5b89\u5168\u3068\u53ce\u96c6\u3059\u308b\u30c7\u30fc\u30bf\u306e\u5b8c\u5168\u6027\u3092\u4fdd\u8a3c\u3059\u308b\u305f\u3081\u306e\u6587\u66f8\u3067\u3082\u3042\u308a\u307e\u3059\u3002\u62d8\u675f\u529b\u3092\u6301\u3064\u6587\u66f8\u3067\u3042\u308b\u7814\u7a76\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u4e00\u74b0\u3068\u3057\u3066\u8a31\u53ef\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3001\u3042\u308b\u3044\u306f\u8a31\u53ef\u3055\u308c\u3066\u3044\u306a\u3044\u3053\u3068\u3092\u8a18\u8f09\u3057\u307e\u3059\u3002\u3055\u3089\u306b\u3001\u81ea\u5206\u304c\u6240\u5c5e\u3059\u308b\u7814\u7a76\u6a5f\u95a2\u306e\u7814\u7a76\u502b\u7406\u5be9\u67fb\u59d4\u54e1\u4f1a\uff08IRB\uff09\u306b\u7533\u8acb\u3092\u63d0\u51fa\u3059\u308b\u969b\u3001\u6700\u3082\u91cd\u8981\u306a\u6587\u66f8\u3068\u898b\u306a\u3055\u308c\u308b\u3082\u306e\u3067\u3059\u3002 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