临床实验监查员的职责都有哪些职责
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><img src="//q9.itc.cn/q_70/images01/20240516/58a9031752fd49dcbae99219cfccb369.jpeg" style="width: 50%; margin-bottom: 20px;"></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;"><strong style="color: blue;">监查员的职责<span style="color: black;">包含</span>：</strong></p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">（一）监查员应当<span style="color: black;">熟练</span><span style="color: black;">实验</span>用<span style="color: black;">药物</span>的<span style="color: black;">关联</span>知识，<span style="color: black;">熟练</span><span style="color: black;">实验</span><span style="color: black;">方法</span>、知情同意书及其他<span style="color: black;">供给</span>给受试者的书面资料的内容，<span style="color: black;">熟练</span>临床<span style="color: black;">实验</span>标准操作规程和本规范等<span style="color: black;">关联</span>法规。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">（二）监查员应当<span style="color: black;">根据</span>申办者的<span style="color: black;">需求</span>认真履行监查职责，<span style="color: black;">保证</span>临床<span style="color: black;">实验</span><span style="color: black;">根据</span><span style="color: black;">实验</span><span style="color: black;">方法</span>正确地实施和记录。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">（三）监查员是申办者和<span style="color: black;">科研</span>者之间的<span style="color: black;">重点</span>联系人。在临床<span style="color: black;">实验</span>前确认<span style="color: black;">科研</span>者具备足够的资质和资源来完成<span style="color: black;">实验</span>，临床<span style="color: black;">实验</span><span style="color: black;">公司</span>具备完成<span style="color: black;">实验</span>的适当<span style="color: black;">要求</span>，<span style="color: black;">包含</span>人员配备与培训<span style="color: black;">状况</span>，实验室设备齐全、运转良好，具备<span style="color: black;">各样</span>与<span style="color: black;">实验</span><span style="color: black;">相关</span>的<span style="color: black;">检测</span><span style="color: black;">要求</span>。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">（四）监查员应当核实临床<span style="color: black;">实验</span>过程中<span style="color: black;">实验</span>用<span style="color: black;">药物</span>在有效期内、<span style="color: black;">保留</span><span style="color: black;">要求</span>可接受、供应充足；<span style="color: black;">实验</span>用<span style="color: black;">药物</span>是<span style="color: black;">根据</span><span style="color: black;">实验</span><span style="color: black;">方法</span>规定的剂量只<span style="color: black;">供给</span>给合适的受试者；受试者收到正确<span style="color: black;">运用</span>、处理、贮存和归还<span style="color: black;">实验</span>用<span style="color: black;">药物</span>的说明；临床<span style="color: black;">实验</span><span style="color: black;">公司</span>接收、<span style="color: black;">运用</span>和返还<span style="color: black;">实验</span>用<span style="color: black;">药物</span>有适当的管控和记录；临床<span style="color: black;">实验</span><span style="color: black;">公司</span>对未<span style="color: black;">运用</span>的<span style="color: black;">实验</span>用<span style="color: black;">药物</span>的处置符合<span style="color: black;">关联</span>法律法规和申办者的<span style="color: black;">需求</span>。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">（五）监查员核实<span style="color: black;">科研</span>者在临床<span style="color: black;">实验</span>实施中对<span style="color: black;">实验</span><span style="color: black;">方法</span>的执行<span style="color: black;">状况</span>；确认在<span style="color: black;">实验</span>前所有受试者<span style="color: black;">或</span>其监护人均签署了知情同意书；<span style="color: black;">保证</span><span style="color: black;">科研</span>者收到最新版的<span style="color: black;">科研</span>者手册、所有<span style="color: black;">实验</span><span style="color: black;">关联</span>文件、<span style="color: black;">实验</span><span style="color: black;">必要</span>用品，并<span style="color: black;">根据</span><span style="color: black;">关联</span>法律法规的<span style="color: black;">需求</span>实施；<span style="color: black;">保准</span><span style="color: black;">科研</span>人员对临床<span style="color: black;">实验</span>有充分的<span style="color: black;">认识</span>。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">（六）监查员核实<span style="color: black;">科研</span>人员履行<span style="color: black;">实验</span><span style="color: black;">方法</span>和合同中规定的职责，以及这些职责<span style="color: black;">是不是</span>委派给未经授权的人员；确认入选的受试者合格并<span style="color: black;">报告</span>入组率及临床<span style="color: black;">实验</span>的<span style="color: black;">发展</span><span style="color: black;">状况</span>；确认数据的记录与报告正确完整，<span style="color: black;">实验</span>记录和文件实时更新、<span style="color: black;">保留</span>完好；核实<span style="color: black;">科研</span>者<span style="color: black;">供给</span>的所有医学报告、记录和文件都是可溯源的、清晰的、同步记录的、原始的、准确的和完整的、注明日期和<span style="color: black;">实验</span>编号的。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">（七）监查员核对病例报告表录入的准确性和完整性，并与源文件比对。监查员应当<span style="color: black;">重视</span>核对<span style="color: black;">实验</span><span style="color: black;">方法</span>规定的数据在病例报告表中有准确记录，并与源文件一致；确认受试者的剂量改变、治疗变更、不良事件、合并用药、并发症、失访、<span style="color: black;">检测</span>遗漏等在病例报告表中均有记录；确认<span style="color: black;">科研</span>者未能做到的随访、未实施的<span style="color: black;">实验</span>、未做的<span style="color: black;">检测</span>，以及<span style="color: black;">是不是</span>对错误、遗漏做出纠正等在病例报告表中均有记录；核实入选受试者的退出与失访已在病例报告表中均有记录并说明。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">（八）监查员对病例报告表的填写错误、遗漏<span style="color: black;">或</span>字迹不清楚应当<span style="color: black;">通告</span><span style="color: black;">科研</span>者；监查员应当<span style="color: black;">保证</span>所作的更正、添加<span style="color: black;">或</span>删除<span style="color: black;">是由于</span><span style="color: black;">科研</span>者<span style="color: black;">或</span>被授权人操作，并且有修改人签名、注明日期，必要时说明修改理由。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">（九）监查员确认不良事件<span style="color: black;">根据</span><span style="color: black;">关联</span>法律法规、<span style="color: black;">实验</span><span style="color: black;">方法</span>、伦理委员会、申办者的<span style="color: black;">需求</span>，在规定的期限内进行了报告。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">（十）监查员确认<span style="color: black;">科研</span>者<span style="color: black;">是不是</span><span style="color: black;">根据</span>本规范<span style="color: black;">保留</span>了<span style="color: black;">必须</span>文件。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">（十一）监查员对偏离<span style="color: black;">实验</span><span style="color: black;">方法</span>、标准操作规程、<span style="color: black;">关联</span>法律法规<span style="color: black;">需求</span>的<span style="color: black;">状况</span>，应当<span style="color: black;">即时</span>与<span style="color: black;">科研</span>者沟通，并采取适当<span style="color: black;">办法</span>防止再次<span style="color: black;">出现</span>。</p>
<p style="font-size: 16px; color: black; line-height: 40px; text-align: left; margin-bottom: 15px;">监查员在每次监查后，应当<span style="color: black;">即时</span>书面报告申办者；报告应当<span style="color: black;">包含</span>监查日期、地点、监查员姓名、监查员接触的<span style="color: black;">科研</span>者和其他人员的姓名等；报告应当<span style="color: black;">包含</span>监查工作的摘要、<span style="color: black;">发掘</span>临床<span style="color: black;">实验</span>中的问题和事实<span style="color: black;">描述</span>、与<span style="color: black;">实验</span><span style="color: black;">方法</span>的偏离和缺陷，以及监查结论；报告应当说明对监查中<span style="color: black;">发掘</span>的问题已采取的<span style="color: black;">或</span>拟采用的纠正<span style="color: black;">办法</span>，为<span style="color: black;">保证</span><span style="color: black;">实验</span>遵守<span style="color: black;">实验</span><span style="color: black;">方法</span>实施的<span style="color: black;">意见</span>；报告应该<span style="color: black;">供给</span>足够的细节，以便审核<span style="color: black;">是不是</span>符合监查计划。中心化监查报告<span style="color: black;">能够</span>与现场监查报告分别提交。申办者应当对监查报告中的问题审核和跟进，并形成文件<span style="color: black;">保留</span>。<a style="color: black;"><span style="color: black;">返回</span></a><span style="color: black;">外链论坛：www.fok120.com</span>，查看<span style="color: black;">更加多</span></p>
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