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临床试验机构管理系统
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临床试验机构管理系统（简称：机构管理系统V2.0）由北京赛德盛医药科技有限公司于在国家版权中心登记注册,登记号：。有关于临床试验机构管理系统著作权归北京赛德盛医药科技有限公司所有，根据《计算机软件保护条例》和《计算机软件著作权登记办法》的规定，受到法律保护。
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临床试验机构
简称:机构管理系统
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版权所有：西安弈聪信息技术有限公司　公司地址：陕西西安曲江会展国际F座15层　Email：：710100
联系电话：,　信产部网站备案：陕ICP备号　法律顾问：信诚律师事务所(张宏彬律师)　当前在线4839人临床试验登记与信息公示平台常见问题分析
&<span style="text-indent: 2 font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 max-width: 100%; color: rgb(255, 255, 255); background-color: rgb(255, 0, 0); word-wrap: break-word !im box-sizing: border-box !im">编者按：日，国家食品药品监督管理总局发布第28号《关于药物临床试验信息平台的公告》，要求所有获其批准的药物临床试验均需在药品审评中心搭建的&药物临床试验登记与信息公示平台&上登记和公示信息。这一要求是监管部门遵照国际惯例加强药物临床试验监督管理，推进药物临床试验信息公开透明，保护受试者权益与安全的一项重要举措。本文对该平台的设计思路及搭建过程予以介绍，并针对广大登记人在应用平台登记试验过程中遇到的常见问题进行答复说明，以利于帮助登记人更好地理解和做好这项工作。
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im">&
<hr align="left" size="2" noshade="" data-mce-style="font-family: 微软雅黑; font-weight: margin: 0px 0px 5" style="max-width: 100%; color: rgb(62, 62, 62); line-height: 19 margin: 0px 0px 5 font-family: 微软雅黑; font-weight: word-wrap: break-word !im box-sizing: border-box !im"/>
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im">&
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体;">《赫尔辛基宣言》是人体医学研究的国际伦理准则，其要求临床试验信息必须在首例受试者入组前对公众公示，还要求不论阳性或阴性的试验结果均须公示。通过对试验研究信息的公示，有助于药物研发人员了解整个行业的研发动态，了解和借鉴他人的研发理念和技术方法。此外，对临床试验进行登记和信息公示也是研究人员和监管部门对社会负有的道义责任。
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im">&
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体;">2013<span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体;">年9月6日，国家食品药品监督管理总局(CFDA)发布《关于药物临床试验信息平台的公告》(简称&第28号公告&)，要求所有获其批准的药物临床试验均需在药品审评中心(CDE)搭建的&药物临床试验登记和信息公示平台&(简称&平台&)上进行登记和公示信息，要求试验信息必须在第1例受试者入组前完成首次社会公示。这一要求是监管部门遵照国际惯例加强药物临床试验监督管理，推进药物临床试验信息公开透明，保护受试者权益与安全的一项重要举措。
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im">&
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体;">这项工作开展以来，我们发现登记人在平台登记和信息填写的具体操作中，存在一些常见的共性问题，为此有必要对平台的设计思路和搭建过程予以介绍，同时针对广大登记人遇到的常见问题进行答复说明，希望帮助相关人员更好地理解和做好这项工作。
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im">&
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><strong style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体; color:">1<strong style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体; color:">、平台搭建的设计思路和简要过程
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im">&
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体;">2011<span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体;">年国家药品审评中心承担了国家十二五科技重大专项课题，其中内容之一就是搭建《临床试验登记和信息公示平台》，工作组首先集中对国际上3个主要的临床试验网站进行了广泛深入的调研工作，包括世界卫生组织临床试验网站(WHOIC-TRP)、美国临床试验网站(ClinicalTrials. gov ) 和欧盟临床试验网站(EU-CTR)(待发表)。
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im">&
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体;">通过对其简要发展史、信息公示的主页及基本项目、登记步骤和流程、登记的主体人、登记的信息内容、信息审核的主体人和主要关注点、网站的管理与维护等多方面多维度进行了调查研究。
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im">&
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体;">其后，在充分认知国际现状和掌握WHO对于临床试验公示的20条基本信息要求的基础上，结合我国研发和监管的实际情况，我们将登记和公示的试验信息范围作为设计时的重点考虑，确定的设计思想是:①试验关键信息向社会公众公示，保证受试者知情权和社会伦理性。②试验申办者逐个登记获批的每个试验，利于试验的开展及与审评、监管工作的互动。③审评人员更好地掌握相应药物的试验动态，为技术审评提供支持。
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im">&
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体;">因此，公示信息应至少满足公众可获知试验的一般性信息和方案关键设计的要求，比如申办者名称和受试者年龄、试验入排标准、研究机构等，而登记信息还需包括其他用于监管目的的信息，若其中涉及或可能涉及企业机密可考虑不公示。最终确定涵盖范围为所有用于药物注册的临床试验；基于中心既有的审评申报数据库，以结论为同意批准临床试验的临床批件为驱动源；每个试验对应1个方案编号，进行1次登记；每个受理号及审评结论与相应的试验方案编号相关联；遵照赫尔辛基宣言要求，在首例受试者入组前开始登记信息；用户模块分为社会公众、申办者用户及CDE用户；功能模块包括搜索引擎、登记端日、审核模块、简单统计和帮助的实现方案。
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im">&
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体;">2012<span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体;">年8-9月完成方案论证，10月完成平台初步搭建，并于11月1日在CDE官网中第1次上线实现试运行，其时的登记人需通过中心&申请人之窗&入日进行试验登记和管理。经过约1年的试运行尝试，征集和吸纳了不少登记人反馈的使用和改进建议，工作组又重新完善了设计思路，更换招标专业网站设计公司于2013年11月进行了一次改版和重要升级，并配合国家局28号公告的具体要求，以独立网站方式上线(注册域名为www. china-)，特别考虑了公众和试验登记人等不同用户的操作便捷性和合理性，以及临床试验过程的复杂性等对功能设计进行大幅度更改和完善。截至日，平台已公示试验1468个。以下从网络操作和登记表填写2个方面对登记和公示工作中的常见问题进行归类分析。
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im">&
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><strong style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体; color:">2<strong style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体; color:">、平台登记和公示工作中的常见问题分析
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im">&
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体; color:">2. 1<span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体; color:">网络操作过程中的主要问题
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im">&
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体; color:">2.1.1<span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体; color:">注册账户失败
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im">&
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体;">出现失败的主要原因是填写账户身份信息与药审中心既有数据库信息不一致。为加强试验登记管理，切实保证由临床试验批件持有者负责试验登记，在平台注册账户时须进行身份验证。平台会自动将登记人填写的验证信息与CDE数据库内既有的相应信息进行比对和验证，这些相应信息来源于申请人当初申请该临床试验时提交的申请表和受理通知书。注册账户时，只有填写的身份验证信息与上述文件中的相应信息完全一致，才能通过身份验证，只有通过验证的用户才能成功注册账户。
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im">&
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体;">注册账户时，首先填写一个申办者名称，之后填写5项身份验证信息:
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im">&
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体;">①受理号:若含中文，如CXHL2012056川，则需将汉字删除，只填写&CXHL2012056&。
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体;">②药物名称:应填写申请表中的药物名称(即使该名称与批件中的名称不一致，若发生该情况，可与CDE工作组联系)。
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体;">③企业注册地址:需与申请表中的该申办者的注册地址完全一致。
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体;">④企业联系人:需与申请表中的该申办者的联系人完全一致，多个联系人时，只填写其中任一即可。
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体;">⑤受理日期:需填写受理通知书上的&受理日期&项信息，若无此项时，应填写受理通知书的颁发日期。其中企业注册地址和联系人二者之一填写正确即可。
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im">&
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体;">若上述验证信息均填写正确仍无法通过身份验证时，则可能与批件类型和获得时间等有关系，可联系CDE解决。
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im">&
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体; color:">2.1.2<span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体; color:">预登记时提示该企业无此受理号或已经预登
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im">&
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体;">记预登记时出现以上提示，主要原因有:
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im">&
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体;">①受理时间过旱，在中心数据库内无该受理号信息导致预登记失败。②已被该试验的共同申请人预登记成功:因为1个试验的登记管理应由1个申办者主要负责，因此系统设定1个受理号只能预登记1次；若某批件被多个共同申请人所有，其中1个申请人成功预登记后，其他的申请人则无法再预登记。
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体;">③已在初建平台登记过试验的受理号(即使未完成信息公示)，在现平台预登记时有时会发生该情况，原因同前。
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im">&
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体; color:">2.1.3<span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体; color:">子账户与主账户的区别以及多个子账户能否合并管理
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im">&
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体;">为了主账户管理多个试验时的实操性和便捷性，平台设计了&子账户&功能，即允许主账户将一个或多个不同试验的登记权限分配给不同的登记人进行管理。子账户创建成功后，与主账户相同，均从平台的试验登记模块进入其子账户中。初次进入子账户时，可直接看到主账户分配的相关&受理号表格&并进行相应操作。
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im">&
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体;">子账户对其下创建试验的管理功能与主账户的相同。但是，子账户只能对其下创建的试验进行管理，不能查看主账户中的其他信息，包括主账户的企业信息、联系人信息以及其他试验信息等。另外，每个子账户只能单独管理，不能合并。
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im">&
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体; color:">2.1.4<span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体; color:">转让方进行变更试验申办者操作时找不到该功能键以及转让方能否看到受让方填写的试验信息
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im">&
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体;">登记表中的&申办者名称&系来源于CDE数据库&申请表&中的申请人名称，由系统自动关联，且登记人不可修改。若发生批件转让，会导致自动关联的申办者名称与实际批件持有人不符。为解决该问题，系统设置了&变更试验申办者&功能。发生批件转让时，可以通过该功能将登记表内的&申办者名称&项变更为受让方名称。
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im">&
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体;">变更操作必须在转让方账户内进行，需在该试验的&受理号表格&中点击&变更试验申办者&按键进行。但需注意，该操作必须在获得第1个相关试验的CTR号之前进行，一旦获得CTR号，该功能键将不再可用。变更成功后，在转让方账户内只保留有变更的操作记录，转让方无法再查看该试验的登记表，即无法看到受让方填写的试验信息。
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im">&
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体; color:">2.1.5<span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体; color:">上传附件失败
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im">&
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体;">当前在平台上传附件时，失败原因主要有:
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im">&
<p style="margin: 0px 0px 0px 24 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体;">①<span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 9">&<span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体;">附件过大。
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体;">②附件名称包含特殊字符。
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体;">③附件进行PDF文件转换过程中发生问题。
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体;">④登记人本地网速过慢。在上传附件时，应注意不大于20M，名称中应避免特殊字符，或尝试更换不同的PDF文件转换程序转换文件或更换网络进行尝试。排除上述原因后，一般均可上传成功。
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im">&
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体; color:">2.1.6<span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体; color:">无法进入网站、在正常浏览/操作过程中网页无反应或显示&无法打开&
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im">&
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体;">若在平台上填写了某些特殊字符，则可能被CDE防火墙视为安全问题而拦截，但一段时间后可自行解除并可重新访问和使用平台。若无任何填写操作，则可能与本地网络或电脑设置有关。此时，应由信息技术人员排查原因并解决。
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im">&
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体; color:">2. 2<span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体; color:">登记表填写的主要问题
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im">&
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体;">&登记表&的所有信息都是每个临床试验必须在平台登记的信息，包含了试验方案的大部分关键信息。目前，CDE平台工作人员将对登记人提交的试验信息进行规范性审核，只有通过审核的试验才能在平台公示。CDE开展审核工作时主要依据《药物临床试验登记填写指南V1.0))，若发现某项信息的填写与之要求不符时，会将这些问题形成明确的&审核意见&退给登记人。登记人需根据审核意见逐项修改并再提交审核，直至审核通过并公示。
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im">&
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体; color:">2.2.1<span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体; color:">填写相关登记号和相关受理号的必要性
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im">&
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体;">登记号是由系统根据填写的试验信息第1次保存的时间顺序自动生成的顺序号，无法更改，1个试验1个登记号。相关登记号需由登记人填写，指的是该试验药的其他所有临床试验在平台获得的登记号。如此，通过该试验的登记号和所有相关登记号，即可实现将该试验药的所有临床试验关联。这两项公示信息有助于了解该试验药的整体试验状况。
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im">&
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体;">在某试验登记表内，受理号是系统根据登记人在预登记时填写的受理号而与CDE数据库自动关联，只显示且只能显示1个受理号。若该试验包含其他受理号而未被登记人用以选择进行预登记的，即未自动关联入登记表的受理号，则需由登记人填入&相关受理号&项内。登记人可以选择不公示这两项信息；但即使不对公众公示，该信息也有助于监管部门管理所有受理号。
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im">&
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体; color:">2.2.2<span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体; color:">化药3类的验证性临床试验分期定义
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im">&
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体;">大部分化药3类的临床试验包括1个药动学(PK)试验和1个验证性临床试验。在&试验分期&项中，前者属于&PK试验&，后者属于&111期试验&。两个试验应有不同的试验方案编号，分别进行登记。
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<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体; color:">2.2.3<span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体; color:">申办者名称来源及修改
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im">&
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体;">如上&2. 1. 4&解释，&申办者名称&由申请表中的&申请人&自动关联，登记人不能修改。若企业获得批件后更名，当前系统无法修改为现名称。
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im">&
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体; color:">2.2.4<span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体; color:">其他
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im">&
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体;">在登记表页面执行保存或提交操作时页面无响应，且此后一段时间内无法登陆网站，即使未执行任何操作有时也会发生这种情况。导致该现象的原因基本与本文&2.1.6&的问题一致。建议在填写登记表过程中，经常进行保存操作，可帮助登记人排查导致问题出现的项目。
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im">&
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><strong style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体; color:">3<strong style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体; color:">结语
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im">&
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体;">对药物临床试验进行登记和信息公示是监管部门遵照国际惯例加强药物临床试验监督管理，推进药物临床试验信息公开透明，保护受试者权益与安全的一项重要举措。
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im">&
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体;">初建平台于2012年上线后，收到业界大量电子邮件和电话咨询等反馈意见，结合这些意见，平台工作组不断跟踪国际相关发展，经过反复认真讨论于去年底完成平台大幅度升级改版，改版后以主账号和分账号设计不再需要通过&申请人之窗&登陆和登记；增加了变更申请人、上传文件和图片、保存和打印查询结果等功能；同时发布了相应使用指南性文件，用于指导登记人填写&I}床试验信息登记表&(简称&登记表&)，设置了反馈邮箱和咨询电话及时解答登记和公示中遇到的有关问题。
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im">&
<p style="margin: 0 max-width: 100%; word-wrap: min-height: 1 color: rgb(62, 62, 62); font-family: 'Helvetica Neue', Helvetica, 'Hiragino Sans GB', 'Microsoft YaHei', ??????, Arial, sans- font-size: 16 line-height: 25 text-indent: 0 box-sizing: border-box !im"><span style="max-width: 100%; word-wrap: break-word !im box-sizing: border-box !im font-size: 19 font-family: 宋体;">由于临床试验管理和运行过程的高度复杂性，平台工作需要不断完善和持续改进，我们也会根据广大登记人的积极反馈和合理建议总结归纳，提取常见共性问题，及时处理和解决，不断完善该平台建设工作。
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