{"id":1527,"date":"2022-10-11T15:00:44","date_gmt":"2022-10-11T07:00:44","guid":{"rendered":"https:\/\/webdept.fjuh.fju.edu.tw\/FjuhDep\/fjuhirb\/?page_id=1527"},"modified":"2022-10-11T15:28:56","modified_gmt":"2022-10-11T07:28:56","slug":"clinicaltrials-gov%e8%b3%87%e6%96%99%e7%99%bb%e9%8c%84%e8%aa%aa%e6%98%8e","status":"publish","type":"page","link":"https:\/\/webdept.fjuh.fju.edu.tw\/FjuhDep\/fjuhirb\/clinicaltrials-gov%e8%b3%87%e6%96%99%e7%99%bb%e9%8c%84%e8%aa%aa%e6%98%8e\/","title":{"rendered":"ClinicalTrials.gov\u8cc7\u6599\u767b\u9304\u8aaa\u660e"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"1527\" class=\"elementor elementor-1527\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-881f0cf elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"881f0cf\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-2bbf2ec\" data-id=\"2bbf2ec\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-9effecf elementor-drop-cap-yes elementor-drop-cap-view-default elementor-widget elementor-widget-text-editor\" data-id=\"9effecf\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;drop_cap&quot;:&quot;yes&quot;}\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li><h3><span style=\"color: #000000\">\u4f9d\u64da\u570b\u969b\u91ab\u5b78\u96dc\u8a8c\u7de8\u8f2f\u59d4\u54e1\u6703\uff08The International Committee of Medical Journal Editors,ICMJE\uff09\u4e4b\u6295\u7a3f\u898f\u5b9a(2005\u5e74\u8d77)\uff0c\u7d93\u4eba\u9ad4\u8a66\u9a57\u59d4\u54e1\u6703\u901a\u904e\u4e4b\u81e8\u5e8a\u8a66\u9a57\u7814\u7a76\u8a08\u756b\u6295\u7a3f\u8005\u9808\u65bc\u62db\u52df\u7b2c\u4e00\u4f4d\u53d7\u8a66\u8005\u53c3\u8207\u8a66\u9a57\u524d\uff0c\u5c07\u901a\u904e\u7814\u7a76\u502b\u7406\u59d4\u54e1\u6703\u5be9\u6838\u4e4b\u81e8\u5e8a\u8a66\u9a57\u8a08\u756b\u8cc7\u6599\u767b\u9304\u65bc\u81e8\u5e8a\u8a66\u9a57\u516c\u958b\u7db2\u7ad9\u3002\u5b8c\u6210\u767b\u9304\u4f5c\u696d\u5f8c\uff0c\u570b\u969b\u91ab\u5b78\u96dc\u8a8c\u7de8\u8f2f\u59d4\u54e1\u6703\uff08ICMJE, International Committee of Medical Journal Editors (ICMJE)\uff0c\u59cb\u53ef\u540c\u610f\u63a5\u53d7\u7814\u7a76\u7d50\u679c\u4e4b\u767c\u8868\u3002<strong>\u203b\u672a\u5b8c\u6210\u81e8\u5e8a\u8a66\u9a57\u767b\u9304\u4e4b\u8a08\u756b\u6848\uff0cICMJE\u6709\u6b0a\u4e0d\u63a5\u53d7\u5176\u6587\u7ae0\u767c\u8868\u3002<\/strong><\/span><\/h3><\/li><li><h3><span style=\"color: #000000\">\u53e6\u4f9dWHO\u5c0d\u300c\u81e8\u5e8a\u8a66\u9a57\u7814\u7a76\u8a08\u756b\u300d\u4e4b\u5b9a\u7fa9\u70ba\uff1a\u300c\u5c0d\u4efb\u4f55\u53d7\u8a66\u8005\u6216\u7279\u5b9a\u65cf\u7fa4\u9032\u884c\u4e00\u500b\u6216\u591a\u500b\u8207\u5065\u5eb7\u6709\u95dc\u7684\u4ecb\u5165\u63aa\u65bd(\u5982\u85e5\u7269\u3001\u5916\u79d1\u624b\u8853\u3001\u5668\u6750\u3001\u884c\u70ba\u6cbb\u7642\u3001\u98f2\u98df\u4ecb\u5165\u6216\u7167\u8b77\u904e\u7a0b\u6539\u8b8a)\u4ee5\u8a55\u4f30\u5c0d\u5065\u5eb7\u5f71\u97ff\u4e4b\u8a08\u756b\u3002\u300d\u5018\u975e\u5c6c\u4e0a\u8ff0\u5b9a\u7fa9\u4e4b\u81e8\u5e8a\u8a66\u9a57\u8a08\u756b\uff0c\u662f\u5426\u767b\u9304\uff0c\u61c9\u7531\u8a08\u756b\u4e3b\u6301\u4eba\u81ea\u884c\u6c7a\u5b9a\u3002<\/span><\/h3><\/li><\/ul><hr \/><hr \/><h3><span style=\"color: #ff0000\">1.\u5e33\u865f\u7533\u8acb\uff1a\u8acb\u586b\u59a5\u4e0b\u5217\u5e33\u865f\u7533\u8acb\u8cc7\u6599\u5f8c\uff0c\u5c07\u8cc7\u6599\u5bc4\u81f3<span style=\"font-size: 16px\">IRB@mail.fjuh.fju.edu.tw\uff0c\u672c\u6703\u5c07\u5354\u52a9\u958b\u555f\u60a8\u7684\u5e33\u865f\u3002<\/span><\/span><\/h3><h2><span style=\"color: #000000\"><span style=\"font-size: 16px\"><span style=\"font-family: Verdana;font-size: 13.3333px;font-style: normal;font-weight: 400\">\u00a0 \u00a0 \u00a0Email \u4e3b\u65e8\uff1aClinicalTrials.gov \u5e33\u865f\u7533\u8acb<\/span><br style=\"font-family: Verdana;font-size: 13.3333px\" \/><span style=\"font-family: Verdana;font-size: 13.3333px;font-style: normal;font-weight: 400\">\u00a0 \u00a0 \u00a0User Login Name\uff1a<\/span><br style=\"font-family: Verdana;font-size: 13.3333px\" \/><span style=\"font-family: Verdana;font-size: 13.3333px;font-style: normal;font-weight: 400\">\u00a0 \u00a0 \u00a0Full User Name\uff1a<\/span><br style=\"font-family: Verdana;font-size: 13.3333px\" \/><span style=\"font-family: Verdana;font-size: 13.3333px;font-style: normal;font-weight: 400\">\u00a0 \u00a0 \u00a0Other User Information\uff1a(\u8acb\u586b\u5beb\u5206\u6a5f\u865f\u78bc \u6216 \u624b\u6a5f)<\/span><br style=\"font-family: Verdana;font-size: 13.3333px\" \/><\/span><span style=\"font-size: 16px\"><span style=\"font-family: Verdana;font-size: 13.3333px;font-style: normal;font-weight: 400\">\u00a0 \u00a0 \u00a0User Email\uff1a(\u8acb\u52d9\u5fc5\u586b\u5beb\u6b63\u78ba)<\/span><\/span><\/span><\/h2><h3><span style=\"color: #000000\">2.\u8acb\u5df2\u63d0\u51fa\u7533\u8acb\u7684PI\u6536\u5230clinicaltrial.gov\u63d0\u4f9b\u7684Organization\u3001User name\u3001Password\u7684\u4fe1\u4ef6\u5f8c\uff0c\u8acb\u81f3<a style=\"color: #000000\" href=\"https:\/\/register.clinicaltrials.gov\/app\/prs\/template\/Login.vm\/ts\/0\">https:\/\/register.clinicaltrials.gov\/app\/prs\/template\/Login.vm\/ts\/0<\/a>\u7db2\u5740\u767b\u9304\u60a8\u7684\u8cc7\u6599\u3002<\/span><\/h3><div><h3><span style=\"color: #000000\">3.\u586b\u5beb\u8aaa\u660e\uff1a<\/span><\/h3><table border=\"1\" cellspacing=\"0\" cellpadding=\"0\"><tbody><tr><td colspan=\"2\" valign=\"top\" width=\"712\"><div align=\"center\"><span style=\"color: #000000\"><b>Study Identification<\/b><\/span><\/div><\/td><\/tr><tr><td valign=\"top\" width=\"287\"><div><span style=\"color: #000000\">Organization&#8217;s Unique Protocol ID<\/span><\/div><\/td><td valign=\"top\" width=\"425\"><div><span style=\"color: #000000\">\u5982\u672a\u81ea\u884c\u8a2d\u5b9a\u8a08\u756b\u7de8\u865f\uff0c\u8acb\u586b\u672c\u6703\u6848\u4ef6\u7de8\u865f<\/span><\/div><\/td><\/tr><tr><td valign=\"top\" width=\"287\"><div><span style=\"color: #000000\">Brief Title<\/span><\/div><\/td><td valign=\"top\" width=\"425\"><div><span style=\"color: #000000\">\u8acb\u586b\u8a08\u756b\u7c21\u77ed\u540d\u7a31(\u9650\u5236120\u5b57\u5143)<\/span><\/div><\/td><\/tr><tr><td valign=\"top\" width=\"287\"><div><span style=\"color: #000000\">Official Title<\/span><\/div><\/td><td valign=\"top\" width=\"425\"><div><span style=\"color: #000000\">\u8acb\u586b\u8a08\u756b\u5b8c\u6574\u540d\u7a31<\/span><\/div><\/td><\/tr><tr><td valign=\"top\" width=\"287\"><div><span style=\"color: #000000\">Approval Numbe<\/span><\/div><\/td><td valign=\"top\" width=\"425\"><div><span style=\"color: #000000\">\u8acb\u586b\u6848\u4ef6\u7de8\u865f<\/span><\/div><\/td><\/tr><tr><td valign=\"top\" width=\"287\"><div><span style=\"color: #000000\">Board Name<\/span><\/div><\/td><td valign=\"top\" width=\"425\"><div><span style=\"color: #000000\">\u8acb\u586bFJUH Institutional Review Board<\/span><\/div><\/td><\/tr><tr><td valign=\"top\" width=\"287\"><div><span style=\"color: #000000\">Board Affiliation<\/span><\/div><\/td><td valign=\"top\" width=\"425\"><span style=\"color: #000000\">\u8acb\u586bFJUH Institutional Review Board<\/span><\/td><\/tr><tr><td valign=\"top\" width=\"287\"><div><span style=\"color: #000000\">Board Contract Phone<\/span><\/div><\/td><td valign=\"top\" width=\"425\"><div><span style=\"color: #000000\">\u8acb\u586b+886-29056234<\/span><\/div><\/td><\/tr><tr><td valign=\"top\" width=\"287\"><div><span style=\"color: #000000\">Board Contract E-mail<\/span><\/div><\/td><td valign=\"top\" width=\"425\"><div><span style=\"color: #000000\">\u8acb\u586bIRB@mail.fjuh.fju.edu.tw<\/span><\/div><\/td><\/tr><tr><td width=\"287\"><div><span style=\"color: #000000\">Business Address<\/span><\/div><\/td><td valign=\"top\" width=\"425\"><div><span style=\"color: #000000\">\u8acb\u586bNo. 69, Guizi Road, Taishan District, New Taipei City, 243, Taiwan (R.O.C.)<\/span><\/div><\/td><\/tr><tr><td colspan=\"2\" valign=\"top\" width=\"712\"><div align=\"center\"><span style=\"color: #000000\"><b>Sponsor\/Collaborators<\/b><\/span><\/div><\/td><\/tr><tr><td width=\"287\"><div><span style=\"color: #000000\">Sponsor<\/span><\/div><\/td><td valign=\"top\" width=\"425\"><div><span style=\"color: #000000\">\u5982\u7121\u5ee0\u5546\u8d0a\u52a9\uff0c\u8acb\u586bFu Jen Catholic University Hospital<\/span><\/div><\/td><\/tr><tr><td colspan=\"2\" width=\"712\"><div align=\"center\"><span style=\"color: #000000\"><b>Oversight<\/b><\/span><\/div><\/td><\/tr><tr><td valign=\"top\" width=\"287\"><div><span style=\"color: #000000\">Oversight Authorities<\/span><\/div><\/td><td valign=\"top\" width=\"425\"><div><span style=\"color: #000000\">\u8acb\u586bTaiwan: Ministry of Health and Welfare<\/span><\/div><\/td><\/tr><tr><td colspan=\"2\" valign=\"top\" width=\"712\"><div align=\"center\"><span style=\"color: #000000\"><b>Study Description<\/b><\/span><\/div><\/td><\/tr><tr><td valign=\"top\" width=\"287\"><div><span style=\"color: #000000\">Brief Summary<\/span><\/div><\/td><td valign=\"top\" width=\"425\"><div><span style=\"color: #000000\">1200\u500b\u5b57\u5143\u9650\u5236<\/span><\/div><\/td><\/tr><tr><td valign=\"top\" width=\"287\"><div><span style=\"color: #000000\">Detail Description<\/span><\/div><\/td><td valign=\"top\" width=\"425\"><div><span style=\"color: #000000\">2500\u500b\u5b57\u5143\u9650\u5236<\/span><\/div><\/td><\/tr><tr><td colspan=\"2\" valign=\"top\" width=\"712\"><div align=\"center\"><span style=\"color: #000000\"><b>Study Design<\/b><\/span><\/div><\/td><\/tr><tr><td valign=\"top\" width=\"287\"><div><span style=\"color: #000000\">Primary Purpose<\/span><\/div><\/td><td valign=\"top\" width=\"425\"><div><span style=\"color: #000000\">\u8acb\u586b\u4e3b\u8981\u7528\u9014<\/span><\/div><\/td><\/tr><tr><td valign=\"top\" width=\"287\"><div><span style=\"color: #000000\">Study Phase<\/span><\/div><\/td><td valign=\"top\" width=\"425\"><div><span style=\"color: #000000\">\u8acb\u586b\u85e5\u7269\u767c\u5c55\u968e\u6bb5<\/span><\/div><\/td><\/tr><tr><td valign=\"top\" width=\"287\"><div><span style=\"color: #000000\">Intervention Model<\/span><\/div><\/td><td valign=\"top\" width=\"425\"><div><span style=\"color: #000000\">\u8acb\u586b\u5e73\u884c\u8a2d\u8a08\/\u4ea4\u53c9\u8a2d\u8a08\/\u5176\u4ed6<\/span><\/div><\/td><\/tr><tr><td valign=\"top\" width=\"287\"><div><span style=\"color: #000000\">Masking<\/span><\/div><\/td><td valign=\"top\" width=\"425\"><div><span style=\"color: #000000\">\u8acb\u586b\u76f2\u6027(\u958b\u653e\/\u55ae\u76f2\/\u96d9\u76f2)<\/span><\/div><\/td><\/tr><tr><td valign=\"top\" width=\"287\"><div><span style=\"color: #000000\">Allocation<\/span><\/div><\/td><td valign=\"top\" width=\"425\"><div><span style=\"color: #000000\">\u8acb\u586b\u96a8\u6a5f\u5206\u6d3e<\/span><\/div><\/td><\/tr><tr><td valign=\"top\" width=\"287\"><div><span style=\"color: #000000\">Enrollment<\/span><\/div><\/td><td valign=\"top\" width=\"425\"><div><span style=\"color: #000000\">\u8acb\u586b\u7d0d\u5165\u8a66\u9a57\u4eba\u6578<\/span><\/div><\/td><\/tr><tr><td colspan=\"2\" valign=\"top\" width=\"712\"><div align=\"center\"><span style=\"color: #000000\"><b>Outcome Measures<\/b><\/span><\/div><\/td><\/tr><tr><td valign=\"top\" width=\"287\"><div><span style=\"color: #000000\">Primary Outcome Measure<\/span><\/div><\/td><td valign=\"top\" width=\"425\"><div><span style=\"color: #000000\">\u8acb\u586b\u4e3b\u8981\u8a55\u4f30\u6307\u6a19<\/span><\/div><\/td><\/tr><tr><td valign=\"top\" width=\"287\"><div><span style=\"color: #000000\">Secondary Outcome Measures<\/span><\/div><\/td><td valign=\"top\" width=\"425\"><div><span style=\"color: #000000\">\u8acb\u586b\u6b21\u8981\u8a55\u4f30\u6307\u6a19<\/span><\/div><\/td><\/tr><tr><td colspan=\"2\" valign=\"top\" width=\"712\"><div align=\"center\"><span style=\"color: #000000\"><b>Eligibility<\/b><\/span><\/div><\/td><\/tr><tr><td valign=\"top\" width=\"287\"><div><span style=\"color: #000000\">Minimum Age\/ Maximum Age<\/span><\/div><\/td><td valign=\"top\" width=\"425\"><div><span style=\"color: #000000\">\u8acb\u586b\u53d7\u8a66\u8005\u6700\u5c0f\u53ca\u6700\u5927\u5e74\u9f61<\/span><\/div><\/td><\/tr><tr><td valign=\"top\" width=\"287\"><div><span style=\"color: #000000\">Gender<\/span><\/div><\/td><td valign=\"top\" width=\"425\"><div><span style=\"color: #000000\">\u8acb\u586b\u53d7\u8a66\u8005\u6027\u5225<\/span><\/div><\/td><\/tr><tr><td valign=\"top\" width=\"287\"><div><span style=\"color: #000000\">Accepts Healthy Volunteers<\/span><\/div><\/td><td valign=\"top\" width=\"425\"><div><span style=\"color: #000000\">\u662f\u5426\u7d0d\u5165\u5065\u5eb7\u53d7\u8a66\u8005<\/span><\/div><\/td><\/tr><tr><td valign=\"top\" width=\"287\"><div><span style=\"color: #000000\">Inclusion Criteria\/Exclusion Criteria<\/span><\/div><\/td><td valign=\"top\" width=\"425\"><div><span style=\"color: #000000\">\u8acb\u586b\u53d7\u8a66\u8005\u7d0d\u5165\/\u6392\u9664\u689d\u4ef6<\/span><\/div><\/td><\/tr><tr><td colspan=\"2\" valign=\"top\" width=\"712\"><div align=\"center\"><span style=\"color: #000000\"><b>Contacts\/Locations<\/b><\/span><\/div><\/td><\/tr><tr><td valign=\"top\" width=\"287\"><div><span style=\"color: #000000\">Study Officials<\/span><\/div><\/td><td valign=\"top\" width=\"425\"><div><span style=\"color: #000000\">\u8acb\u586b\u8a08\u756b\u4e3b\u6301\u4eba\u6216\u6848\u4ef6\u7ba1\u7406\u4eba\u8cc7\u6599<\/span><\/div><\/td><\/tr><\/tbody><\/table><h3><span style=\"color: #000000\">4.\u6ce8\u610f\u4e8b\u9805\uff1a<\/span><\/h3><h3><span style=\"color: #000000\">(1)\u8acb\u4ee5\u82f1\u6587\u586b\u5beb\u3002<\/span><\/h3><h3><span style=\"color: #000000\">(2)\u9700\u65bc\u62db\u52df\u7b2c\u4e00\u4f4d\u53d7\u8a66\u8005\u53c3\u8207\u8a66\u9a57\u524d\u5b8c\u6210\u81e8\u5e8a\u8a66\u9a57\u8a08\u5283\u767b\u9304\u4f5c\u696d\u3002<\/span><\/h3><h3><span style=\"color: #000000\">(3)\u7121\u6cd5\u7576\u6b21\u767b\u9304\u5b8c\u6240\u6709\u8cc7\u6599\u8005\uff0c\u8acb\u5148\u81f3\u756b\u9762\u5de6\u4e0b\u89d2\u6309Main Menu\u2192Modify\u3002Modify\u7db2\u9801\u53ef\u6aa2\u8996\u60a8\u7de8\u8f2f\u672a\u5b8c\u6210\u7684\u6848\u5b50\uff0c\u78ba\u5b9a\u8cc7\u6599\u5b8c\u5584\u5132\u5b58\u5728\u60a8\u5e33\u865f\u4e2d\uff0c\u518d\u6309\u5de6\u4e0b\u89d2Main Menu\u3002\u6309Logout\u53ef\u767b\u51fa\u6b64\u8a08\u756b\u6848\u3002\u8acb\u52ff\u6309Complete\u3002<\/span><\/h3><h3><span style=\"color: #000000\">(4)\u82e5\u8981\u7de8\u8f2f\u5c1a\u672a\u9001\u51fa\u7684\u8a08\u756b\u6848\uff1a\u81f3Main Menu\u2192\u6309Modify\u2192\u6309Edit\u5373\u53ef\u7de8\u8f2f\u6216\u4fee\u6539\u6848\u4ef6\u3002<\/span><\/h3><h3><span style=\"color: #000000\">(5)\u7576\u60a8\u5df2\u9ede\u9078\u300cComplete\u300d\u5f8c\uff0c\u5373\u901a\u77e5\u7cfb\u7d71\u7ba1\u7406\u8005\u78ba\u8a8d\u8a08\u756b\u662f\u5426\u5df2\u5be9\u67e5\u901a\u904e\uff0c\u4e26\u7522\u751f\u7cfb\u7d71ID\uff0c\u72c0\u614b\u5c07\u986f\u793a\u70ba\u201dReleased\u201d\uff0c\u5426\u5247\u70ba\u201dIn Progress\u201d\u3002<\/span><\/h3><h3><span style=\"color: #000000\">(6)\u82e5PI\u6c92\u6709\u6b63\u78ba\u586b\u5beb\u81e8\u5e8a\u8a66\u9a57\u8a08\u756b\u8cc7\u6599\uff0c\u96fb\u8166\u7cfb\u7d71\u5c07\u62d2\u7d55\u6b64\u8a08\u756b\u767b\u9304\u4f5c\u696d\u3002<\/span><\/h3><h3><span style=\"color: #000000\">(7)\u9032\u884c\u4e2d\u7684\u81e8\u5e8a\u8a66\u9a57\u8a08\u756b\uff0c\u9700\u81f3\u5c11\u6bcf6\u500b\u6708\u66f4\u65b0\u6240\u767b\u9304\u7684\u8cc7\u6599\u5167\u5bb9\u3002<\/span><\/h3><h3><span style=\"color: #000000\">(8)\u5df2\u7d50\u6848\u4e4b\u81e8\u5e8a\u8a66\u9a57\u8a08\u756b\u9700\u586b\u5beb\u8a66\u9a57\u7d50\u679c(Result)\u3002<\/span><\/h3><h3><span style=\"color: #000000\">(9)\u8acb\u8a08\u5283\u4e3b\u6301\u4eba\u6ce8\u610f\u8981\u518d\u4e0a\u7db2\u78ba\u8a8d\u767b\u9304\u72c0\u614b\u662f\u5426\u6210\u529f\u3002<\/span><\/h3><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>\u4f9d\u64da\u570b\u969b\u91ab\u5b78\u96dc\u8a8c\u7de8\u8f2f\u59d4\u54e1\u6703\uff08The International Committee of Medical Jo 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