阜阳市肿瘤医院颍河东路院区顺利通过国家药品监督管理局药物临床试验机构备案
<!----><style type="text/css">html{font-size:375%}</style><link href="https://pic.app.fy169.net/frontend/web/static/publish/css/style.css?v=20240712" rel="stylesheet" position="1" data-qf-origin="/frontend/web/static/publish/css/style.css?v=20240712"><!-- 付费贴--> <div class="preview_article "> <!----> <section style="letter-spacing: 0.578px; white-space: normal; margin-bottom: 0px;"><p style="margin-bottom: 8px; outline: 0px; text-indent: 0em; letter-spacing: 0.578px; line-height: 2em; visibility: visible; font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, Arial, sans-serif;"><img class="rich_pages wxw-img __bg_gif" style="outline: 0px; letter-spacing: 0.544px; text-indent: 0em; font-size: var(--articleFontsize); width: 578px; font-family: system-ui, -apple-system, BlinkMacSystemFont, Arial, sans-serif; visibility: visible !important;" src="https://pic.app.fy169.net/FulZe8nrQayv_6jb1Kr1Yyed4Zds" /></p></section><section><section><section><section style="margin: 10px auto;"><section style="background-color: #f4fcf9; padding: 15px 15px; box-sizing: border-box;"><section style="text-align: justify; line-height: 1.75em; letter-spacing: 1.5px; font-size: 16px; color: #333333; background-color: transparent;"><p style="font-size: 16px; text-indent: 2em; line-height: 2em;"><span style="font-size: 16px; letter-spacing: 0px;">近日，阜阳市肿瘤医院颍河东路院区顺利通过国家药品监督管理局药物临床试验机构备案，此次成功备案标志着医院颍河东路院区（新区）、河滨东路院区（老区）可同时开展II-IV期药物临床试验。</span></p></section></section><section style="width: 100%; height: 1px; border-top: 1px solid #95d7b4; margin-top: 4px; max-width: 100% !important; box-sizing: border-box;"></section><section style="width: 20px; margin-left: auto; margin-top: -11px; margin-right: 20px; box-sizing: border-box; transform: rotateZ(0deg); -webkit-transform: rotateZ(0deg); -moz-transform: rotateZ(0deg); -o-transform: rotateZ(0deg);"></section></section></section><p style="font-size: 16px; line-height: 2em; text-indent: 2em; margin-bottom: 15px; display: block; margin-left: 10px; margin-right: 10px;"><span style="font-size: 16px; letter-spacing: 0px;">5月8日，安徽省药品审评查验中心备案督查组专家组来到阜阳市肿瘤医院，开展了药物临床试验机构备案监督检查。专家组组长王素侠主持首次会议，并宣读了检查纪律和检查流程。机构办公室主任兰恒宾、专业组肿瘤科PI（Principal Investigator，主要研究者）钱和生、伦理委员会主任委员侯德法作情况汇报。首次会议结束后，专家组对我院临床试验相关人员进行现场<span style="caret-color: red; font-size: 16px; letter-spacing: 0px;">抽调考试。</span></span></p><section><section style="text-align: center;"><img class="rich_pages wxw-img" style="vertical-align: baseline; width: 100%; box-sizing: border-box; max-width: 100% !important;" src="https://pic.app.fy169.net/FsOYOLdJtIPI0GKCApZhXCkNKEkt" /></section></section><p style="font-size: 16px; line-height: 2em; text-indent: 2em; margin-bottom: 15px; display: block; margin-left: 10px; margin-right: 10px;"><span style="letter-spacing: 0px; text-align: left; text-indent: 2em; caret-color: red;">专家组完成阅卷后对我院新老区机构办公室、</span><span style="letter-spacing: 0px; text-align: left; text-indent: 2em; caret-color: red;">GCP</span><span style="letter-spacing: 0px; text-align: left; text-indent: 2em; caret-color: red;">中心药房、机构档案室、伦理委员会办公室、伦理委员会档案室等相关设施设备进行检查，查阅机构和专业组的制度文件、人员资质、培训记录、设施设备校验等情况，并对在研临床试验项目进行现场抽查提问。</span></p><p style="text-align: left; font-size: 16px; line-height: 2em; text-indent: 2em; margin-bottom: 15px; display: block; margin-left: 10px; margin-right: 10px;"><span style="font-size: 16px; letter-spacing: 0px;">5月9日上午，督查组举行现场检查末次会议。专家组对我院药物临床试验机构、伦理委员会及相关专业组的工作给予了充分的肯定，也将检查中发现的问题和不足进行了反馈，提出了宝贵的意见和建议。</span></p><section><section style="text-align: center;"><img class="rich_pages wxw-img" style="vertical-align: baseline; width: 100%; box-sizing: border-box; max-width: 100% !important;" src="https://pic.app.fy169.net/Ftj8tYQNWA4s1H4NA_nnoiz-rhMo" /></section></section><p style="text-align: left; font-size: 16px; line-height: 2em; text-indent: 2em; margin-bottom: 15px; display: block; margin-left: 10px; margin-right: 10px;"><span style="letter-spacing: 0px; text-indent: 2em; caret-color: red;">针对专家组反馈问题，药物临床试验机构及时进行整改，并于</span><span style="letter-spacing: 0px; text-indent: 2em; caret-color: red;">5</span><span style="letter-spacing: 0px; text-indent: 2em; caret-color: red;">月</span><span style="letter-spacing: 0px; text-indent: 2em; caret-color: red;">29</span><span style="letter-spacing: 0px; text-indent: 2em; caret-color: red;">日顺利通过药物临床试验机构备案。我院</span><span style="letter-spacing: 0px; text-indent: 2em; caret-color: red;">颍河东路院区顺利通过国家药品监督管理局药物临床试验机构备案，此次成功备案标志着医院新、老院区可同时开展</span><span style="letter-spacing: 0px; text-indent: 2em; caret-color: red;">II-IV</span><span style="letter-spacing: 0px; text-indent: 2em; caret-color: red;">期药物临床试验。</span></p><p style="text-align: left; font-size: 16px; line-height: 2em; text-indent: 2em; margin-bottom: 15px; display: block; margin-left: 10px; margin-right: 10px;"><span style="font-size: 16px; letter-spacing: 0px;">颍河东路院区顺利通过国家药品监督管理局药物临床试验机构备案检查，对提升医院科研学术水平、提高医疗质量水平，创建三级甲等医院等具有重要意义。</span></p><section><section style="margin: 10px auto;"><section style="margin-bottom: 15px;"><section style="display: flex; align-items: flex-end;"><section style="flex-shrink: 0;"><section style="font-size: 34px; color: #95d7b4; text-align: center;"><em><strong>Q</strong></em></section></section><section style="padding-bottom: 5px; box-sizing: border-box;"><section style="font-size: 16px; color: #00986b; text-align: center; padding: 0 12px; box-sizing: border-box;"><strong>通过国家药物临床试验机构备案的意义</strong></section></section></section><section style="border: 1px solid #95d7b4; background-color: #f4fcf9; overflow: hidden; margin-left: 30px; box-sizing: border-box;"><section style="padding: 10px 10px 0; box-sizing: border-box; transform: rotateZ(0deg); -webkit-transform: rotateZ(0deg); -moz-transform: rotateZ(0deg); -o-transform: rotateZ(0deg);"><section style="text-align: justify; line-height: 1.75em; letter-spacing: 1.5px; font-size: 14px; color: #333333; background-color: transparent;"><p style="font-size: 16px; line-height: 2em; text-indent: 2em;"><span style="color: #333333; font-size: 16px; text-align: left; text-indent: 32px; caret-color: #ff0000; text-decoration-thickness: initial; letter-spacing: 0px; font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, Arial, sans-serif; display: inline !important;">国家药物临床试验机构备案是体现医院综合能力的重要指标，也是推动医院高质量发展的内在要求。国家卫生健康委继2020年国家三级公立医院绩效考核操作手册首次将GCP纳入学科建设考核指标后，2023版继续明确纳入，用于评估医院科研创新能力。紧扣三级公立医院绩效考核指挥棒，国家药物临床试验机构建设成为了衡量医疗机构综合能力的一项重要指标，是医院医、教、研一体化发展中不可或缺的部分，体现着医院的临床治疗水平和科研竞争力。</span></p></section></section><section style="width: 60px; margin-left: auto; margin-right: -10px; margin-top: -29px; opacity: 0.8; box-sizing: border-box;"><img class="rich_pages wxw-img" style="width: 100%; display: block; vertical-align: baseline; box-sizing: border-box; max-width: 100% !important;" src="https://pic.app.fy169.net/FmgzO5E9rHK8hWPHkcUGxTworZGT" /></section></section></section></section></section><p style="text-align: left; font-size: 16px; line-height: 2em; text-indent: 2em; margin-bottom: 15px; display: block; margin-left: 10px; margin-right: 10px;"> </p><section><section style="margin: 10px auto;"><section style="margin: 10px auto; display: flex; justify-content: center;"><section style="display: flex; align-items: center;"><section style="border: 1px solid #95d7b4; display: flex; box-sizing: border-box;"><section style="flex-shrink: 0;"><section style="background-color: #00986b; font-size: 16px; color: #ffffff; text-align: center; padding: 0px 7px; height: 100%; display: flex; justify-content: center; align-items: center; box-sizing: border-box;"><em> </em></section></section><section style="background-color: #f4fcf9; padding: 6px 25px; box-sizing: border-box;"><section style="font-size: 16px; color: #00986b; text-align: center;"><strong>机构信息</strong></section></section></section><section style="flex-shrink: 0; margin-left: -15px; box-sizing: border-box;"><section style="width: 35px; box-sizing: border-box;"><img class="rich_pages wxw-img" style="width: 100%; display: block; vertical-align: baseline; box-sizing: border-box; max-width: 100% !important;" src="https://pic.app.fy169.net/FhQ01u82nbIJ3rRIvYikgtBb0gRo" /></section></section></section></section><section style="background-color: #f4fcf9; padding: 10px; box-sizing: border-box;"><section style="text-align: justify; line-height: 1.75em; letter-spacing: 1.5px; font-size: 14px; color: #333333; background-color: transparent; padding: 15px 5px 10px; box-sizing: border-box;"><p style="line-height: 2em;"><strong><span style="font-size: 16px; letter-spacing: 0px;">机构地址：</span></strong></p><p style="line-height: 2em;"><span style="font-size: 16px; letter-spacing: 0px;">1、阜阳市河滨东路146号三号楼五楼机构GCP办公室（老区）</span></p><p style="line-height: 2em;"><span style="font-size: 16px; letter-spacing: 0px;">2、阜阳市颍东区颍河东路1186号9号楼4楼GCP办公室（新区）</span></p><p style="line-height: 2em;"><strong><span style="font-size: 16px; letter-spacing: 0px;">机构办公室电话：</span></strong><span style="font-size: 16px; letter-spacing: 0px;"><br /></span></p><p style="line-height: 2em;"><span style="font-size: 16px; letter-spacing: 0px;">0558-7132192（老区）</span></p><p style="line-height: 2em;"><span style="font-size: 16px; letter-spacing: 0px;">0558-7133225（新区）</span></p><p style="line-height: 2em;"><strong><span style="font-size: 16px; letter-spacing: 0px;">机构办公室主任：<span style="font-weight: normal;">兰恒宾 15105589966</span></span></strong></p><p style="line-height: 2em;"><strong><span style="font-size: 16px; letter-spacing: 0px;">机构办公室秘书：</span></strong><span style="font-size: 16px; letter-spacing: 0px;"><br /></span></p><p style="line-height: 2em;"><span style="font-size: 16px; letter-spacing: 0px;">王建军 19855310025</span></p><p style="line-height: 2em;"><span style="font-size: 16px; letter-spacing: 0px;">卢婷婷 18155850880</span></p><p style="line-height: 2em;"><strong><span style="font-size: 16px; letter-spacing: 0px;">机构邮箱：</span></strong><span style="font-size: 16px; letter-spacing: 0px;">fyszlyygcp@163.com</span></p></section></section><section style="width: 100%; height: 1px; border-top: 1px solid #95d7b4; margin-top: 4px; max-width: 100% !important; box-sizing: border-box;"></section><section style="width: 16px; margin-left: auto; margin-top: -9px; margin-right: 20px; box-sizing: border-box; transform: rotateZ(0deg); -webkit-transform: rotateZ(0deg); -moz-transform: rotateZ(0deg); -o-transform: rotateZ(0deg);"></section></section></section><section><p> </p></section><section><section style="margin: 10px auto;"><section style="margin: 10px auto; display: flex; justify-content: center;"><section style="display: flex; align-items: center;"><section style="border: 1px solid #95d7b4; display: flex; box-sizing: border-box;"><section style="flex-shrink: 0;"><section style="background-color: #00986b; font-size: 16px; color: #ffffff; text-align: center; padding: 0px 7px; height: 100%; display: flex; justify-content: center; align-items: center; box-sizing: border-box;"><em> </em></section></section><section style="background-color: #f4fcf9; padding: 6px 25px; box-sizing: border-box;"><section style="font-size: 16px; color: #00986b; text-align: center;"><strong>伦理办公室信息</strong></section></section></section><section style="flex-shrink: 0; margin-left: -15px; box-sizing: border-box;"><section style="width: 35px; box-sizing: border-box;"><img class="rich_pages wxw-img" style="width: 100%; display: block; vertical-align: baseline; box-sizing: border-box; max-width: 100% !important;" src="https://pic.app.fy169.net/FhQ01u82nbIJ3rRIvYikgtBb0gRo" /></section></section></section></section><section style="background-color: #f4fcf9; padding: 10px; box-sizing: border-box;"><section style="text-align: justify; line-height: 1.75em; letter-spacing: 1.5px; font-size: 14px; color: #333333; background-color: transparent; padding: 15px 5px 10px; box-sizing: border-box;"><p style="line-height: 2em;"><strong style="background-color: transparent; caret-color: red;"><span style="font-size: 16px; letter-spacing: 0px;">伦理办公室地址：</span></strong></p><p style="line-height: 2em;"><span style="font-size: 16px; letter-spacing: 0px;">1、阜阳市河滨东路146号三号楼五楼机构伦理办公室（老区）</span></p><p style="line-height: 2em;"><span style="font-size: 16px; letter-spacing: 0px;">2、阜阳市颍东区颍河东路1186号9号楼4楼伦理办公室（新区）</span></p><p style="line-height: 2em;"><strong><span style="font-size: 16px; letter-spacing: 0px;">伦理办公室电话：</span></strong><span style="font-size: 16px; letter-spacing: 0px;">0558-7132193</span></p><p style="line-height: 2em;"><strong><span style="font-size: 16px; letter-spacing: 0px;">伦理办公室秘书：</span></strong><span style="font-size: 16px; letter-spacing: 0px; background-color: transparent; caret-color: red;"><br /></span></p><p style="line-height: 2em;"><span style="font-size: 16px; letter-spacing: 0px; background-color: transparent; caret-color: red;">孟丽 18130736513</span></p><p style="line-height: 2em;"><span style="font-size: 16px; letter-spacing: 0px; background-color: transparent; caret-color: red;">卜磊磊 15855587712</span></p><p style="line-height: 2em;"><strong><span style="font-size: 16px; letter-spacing: 0px;">伦理办公室邮箱：</span></strong><span style="font-size: 16px; letter-spacing: 0px;">fyszlyyll@126.com</span></p></section></section><section style="width: 100%; height: 1px; border-top: 1px solid #95d7b4; margin-top: 4px; max-width: 100% !important; box-sizing: border-box;"></section><section style="width: 16px; margin-left: auto; margin-top: -9px; margin-right: 20px; box-sizing: border-box; transform: rotateZ(0deg); -webkit-transform: rotateZ(0deg); -moz-transform: rotateZ(0deg); -o-transform: rotateZ(0deg);"></section></section></section><section><p> </p></section><section><section style="margin: 10px auto;"><section style="margin: 10px auto; display: flex; justify-content: center;"><section style="display: flex; align-items: center;"><section style="border: 1px solid #95d7b4; display: flex; box-sizing: border-box;"><section style="flex-shrink: 0;"><section style="background-color: #00986b; font-size: 16px; color: #ffffff; text-align: center; padding: 0px 7px; height: 100%; display: flex; justify-content: center; align-items: center; box-sizing: border-box;"><em> </em></section></section><section style="background-color: #f4fcf9; padding: 6px 25px; box-sizing: border-box;"><section style="font-size: 16px; color: #00986b; text-align: center;"><strong>专业组信息</strong></section></section></section><section style="flex-shrink: 0; margin-left: -15px; box-sizing: border-box;"><section style="width: 35px; box-sizing: border-box;"><img class="rich_pages wxw-img" style="width: 100%; display: block; vertical-align: baseline; box-sizing: border-box; max-width: 100% !important;" src="https://pic.app.fy169.net/FhQ01u82nbIJ3rRIvYikgtBb0gRo" /></section></section></section></section><section style="background-color: #f4fcf9; padding: 10px; box-sizing: border-box;"><section style="text-align: justify; line-height: 1.75em; letter-spacing: 1.5px; font-size: 14px; color: #333333; background-color: transparent; padding: 15px 5px 10px; box-sizing: border-box;"><p style="line-height: 2em;"><strong style="background-color: transparent; caret-color: red;"><span style="font-size: 16px; letter-spacing: 0px;">专业组地址：</span></strong></p><p style="line-height: 2em;"><span style="font-size: 16px; letter-spacing: 0px;">1、阜阳市河滨东路146号新大楼14楼（老区）</span></p><p style="line-height: 2em;"><span style="font-size: 16px; letter-spacing: 0px;">2、阜阳市颍东区颍河东路1186号6号楼15楼（新区）</span></p><p style="line-height: 2em;"><strong><span style="font-size: 16px; letter-spacing: 0px;">专业组负责人：</span></strong><span style="font-size: 16px; letter-spacing: 0px;"><br /></span></p><p style="line-height: 2em;"><span style="font-size: 16px; letter-spacing: 0px;">钱和生 13956814015</span></p><p style="line-height: 2em;"><span style="font-size: 16px; letter-spacing: 0px;">梁万霞 13855834728</span></p><p style="line-height: 2em;"><strong><span style="font-size: 16px; letter-spacing: 0px;">专业组秘书：</span></strong><span style="font-size: 16px; letter-spacing: 0px;"><br /></span></p><p style="line-height: 2em;"><span style="font-size: 16px; letter-spacing: 0px;">廖金花 13139870993（老区）</span></p><p style="line-height: 2em;"><span style="font-size: 16px; letter-spacing: 0px;">赵宇 15855786848（新区）</span></p></section></section><section style="width: 100%; height: 1px; border-top: 1px solid #95d7b4; margin-top: 4px; max-width: 100% !important; box-sizing: border-box;"></section></section></section></section></section><section style="outline: 0px; letter-spacing: 0.544px; text-wrap: wrap; background-color: #ffffff; visibility: visible; margin-bottom: 0px;"><section style="outline: 0px;"><p style="font-family: system-ui, -apple-system, BlinkMacSystemFont, Arial, sans-serif; outline: 0px; caret-color: rgba(0, 0, 0, 0); color: #222222; letter-spacing: 0.544px;"> </p><p style="margin-bottom: 0px; color: #3e3e3e; letter-spacing: 0.544px; caret-color: rgba(0, 0, 0, 0); background-color: #ffffff; font-family: system-ui, -apple-system, BlinkMacSystemFont, Arial, sans-serif; font-size: var(--articleFontsize); outline: 0px;"><span style="color: #888888; font-family: 宋体; font-size: 14px; letter-spacing: normal;">图文｜GCP办公室</span></p><p style="margin-bottom: 0px; color: #3e3e3e; letter-spacing: 0.544px; caret-color: rgba(0, 0, 0, 0); background-color: #ffffff; font-family: system-ui, -apple-system, BlinkMacSystemFont, Arial, sans-serif; font-size: var(--articleFontsize); outline: 0px;"><span style="letter-spacing: normal; color: #888888; font-family: 宋体; font-size: 14px;">编辑｜宋玉洁</span></p><p style="margin-bottom: 0px; color: #3e3e3e; letter-spacing: 0.544px; caret-color: rgba(0, 0, 0, 0); background-color: #ffffff; font-family: system-ui, -apple-system, BlinkMacSystemFont, Arial, sans-serif; font-size: var(--articleFontsize); outline: 0px;"><span style="letter-spacing: normal; color: #888888; font-family: 宋体; font-size: 14px;">审核｜时迎新 兰恒宾 高蓬蓬</span></p><p style="font-family: system-ui, -apple-system, BlinkMacSystemFont, Arial, sans-serif; outline: 0px; caret-color: rgba(0, 0, 0, 0); color: #222222; letter-spacing: 0.544px;"> </p></section></section><section style="outline: 0px; font-family: system-ui, -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif; letter-spacing: 0.544px; text-wrap: wrap; background-color: #ffffff; margin-bottom: 0px;"><section style="outline: 0px;"><section style="outline: 0px; color: #222222; letter-spacing: 0.544px;"><section><section><section><section><section style="width: 6em; display: inline-block;"></section><section style="text-align: center; text-indent: 2em;"><section style="width: 6em; display: inline-block;"><img class="rich_pages wxw-img" style="width: 100%; display: block; vertical-align: inherit;" src="https://pic.app.fy169.net/FqoOIzQseM7DplVGYgleu0dMGIPS" /></section></section></section></section></section></section><p style="text-align: center;"><span style="font-size: 15px;"><a class="normal_text_link" style="font-size: 15px; 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