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Article(id=1236342823465832987, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236342820131361209, articleNumber=null, orderNo=null, doi=null, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1670860800000, acceptedDateStr=2022-12-13, onlineDate=1772696699252, onlineDateStr=2026-03-05, pubDate=1677513600000, pubDateStr=2023-02-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772696699252, onlineIssueDateStr=2026-03-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772696699252, creator=13701087609, updateTime=1772696699252, updator=13701087609, issue=Issue{id=1236342820131361209, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='4', pageStart='329', pageEnd='440', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1772696698458, creator=13701087609, updateTime=1772696766437, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236343105318875204, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236342820131361209, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236343105318875205, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236342820131361209, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=404, endPage=409, ext={EN=ArticleExt(id=1236342823704908323, articleId=1236342823465832987, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Exploration and practice of informatization of clinical trial institution management in Northwest China, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective:

To improve the relatively backward condition and level of clinical trial institutions in Northwest China by relying on advanced clinical research management concepts and adopting information technology, and explore solutions for the uneven development of clinical trial institutions in China.

Methods:

Based on the daily work requirements and management experience of the clinical trial institution in the First Affiliated Hospital of Xi'an Jiaotong University, we developed the Clinical Trial Institution Management System (CTIMS) meeting the regulatory requirements in the new period and provided solutions for the improvement of research ability and management level of clinical trial institutions in Northwest China.

Results:

By using the CTIMS, the clinical trial institutions in Northwest China can obtain standardized, digital, and intelligent clinical trial management methods, so that they can enter the "fast lane" of clinical research and achieve the goal of narrowing the capacity gap with clinical trial institutions in developed areas.

Conclusion:

Through the application of the CTIMS, the clinical research capacity, management efficiency and level of clinical trial institutions, as well as the relatively backward situation of clinical trial development in Northwest China will be improved.

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目的：

依托先进的临床研究管理理念，采用信息化技术手段，改变我国西北地区临床试验机构条件与水平相对落后的局面，探索解决我国临床试验发展不均衡的问题。

方法：

结合西安交通大学第一附属医院临床试验机构日常工作需求和管理经验，开发建立符合新时期监管要求的临床试验机构管理信息化平台（clinical trial institution management system, CTIMS），并为西北地区临床试验机构的临床研究能力和管理水平的提升提供解决方案。

结果：

西北地区临床试验机构通过临床试验机构信息化平台，可获得规范化、数字化、智能化的临床试验管理方式，使其进入临床研究的“快车道”，达到缩小与沿海发达地区临床研究机构能力差距的目的。

结论：

通过临床试验机构管理系统的应用，提升西北地区临床试验机构临床研究能力和管理效率及水平，改善西北地区临床试验发展相对落后的局面。

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陆明莹，女，硕士，主要从事临床试验管理和学科建设工作。联系电话：(029)85324783，E-mail: 。
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刘妤，女，硕士，主要从事医院临床试验管理工作。联系电话：(029)85324094，E-mail: 。

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刘妤，女，硕士，主要从事医院临床试验管理工作。联系电话：(029)85324094，E-mail: 。

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刘妤，女，硕士，主要从事医院临床试验管理工作。联系电话：(029)85324094，E-mail: 。

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我国西北地区临床试验机构信息化管理的探索与实践
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刘妤 1 , 张彩霞 1 , 易秋月 1 , 卫荣 1 , 刘清悦 1 , 刘霞 1 , 张亚妮 1 , 刘欣然 1 , 马现福 2 , 阎昭 3 , 陆明莹 1
中国新药杂志 | 重大新药创制专项巡礼 2023,32(4): 404-409
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中国新药杂志 | 重大新药创制专项巡礼 2023, 32(4): 404-409
我国西北地区临床试验机构信息化管理的探索与实践
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刘妤1 , 张彩霞1, 易秋月1, 卫荣1, 刘清悦1, 刘霞1, 张亚妮1, 刘欣然1, 马现福2, 阎昭3, 陆明莹1
作者信息
  • 1西安交通大学第一附属医院，西安 710061
  • 2天津阿贝斯努科技有限公司，天津 300000
  • 3中国抗癌协会，天津 300384

    • 刘妤，女，硕士，主要从事医院临床试验管理工作。联系电话：(029)85324094，E-mail: 。

通讯作者:

陆明莹，女，硕士，主要从事临床试验管理和学科建设工作。联系电话：(029)85324783，E-mail: 。
Exploration and practice of informatization of clinical trial institution management in Northwest China
Yu LIU1 , Cai-xia ZHANG1, Qiu-yue YI1, Rong WEI1, Qing-yue LIU1, Xia LIU1, Ya-ni ZHANG1, Xin-ran LIU1, Xian-fu MA2, Zhao YAN3, Ming-ying LU1
Affiliations
  • 1The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an 710061, China
  • 2Tianjin Abeisinu Technology Co., Ltd., Tianjin 300000, China
  • 3China Anti-Cancer Association, Tianjin 300384, China
出版时间: 2023-02-28
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摘要
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目的：

依托先进的临床研究管理理念，采用信息化技术手段，改变我国西北地区临床试验机构条件与水平相对落后的局面，探索解决我国临床试验发展不均衡的问题。

方法：

结合西安交通大学第一附属医院临床试验机构日常工作需求和管理经验，开发建立符合新时期监管要求的临床试验机构管理信息化平台（clinical trial institution management system, CTIMS），并为西北地区临床试验机构的临床研究能力和管理水平的提升提供解决方案。

结果：

西北地区临床试验机构通过临床试验机构信息化平台，可获得规范化、数字化、智能化的临床试验管理方式，使其进入临床研究的“快车道”，达到缩小与沿海发达地区临床研究机构能力差距的目的。

结论：

通过临床试验机构管理系统的应用，提升西北地区临床试验机构临床研究能力和管理效率及水平，改善西北地区临床试验发展相对落后的局面。

临床试验  /  信息化平台  /  西北地区
Objective:

To improve the relatively backward condition and level of clinical trial institutions in Northwest China by relying on advanced clinical research management concepts and adopting information technology, and explore solutions for the uneven development of clinical trial institutions in China.

Methods:

Based on the daily work requirements and management experience of the clinical trial institution in the First Affiliated Hospital of Xi'an Jiaotong University, we developed the Clinical Trial Institution Management System (CTIMS) meeting the regulatory requirements in the new period and provided solutions for the improvement of research ability and management level of clinical trial institutions in Northwest China.

Results:

By using the CTIMS, the clinical trial institutions in Northwest China can obtain standardized, digital, and intelligent clinical trial management methods, so that they can enter the "fast lane" of clinical research and achieve the goal of narrowing the capacity gap with clinical trial institutions in developed areas.

Conclusion:

Through the application of the CTIMS, the clinical research capacity, management efficiency and level of clinical trial institutions, as well as the relatively backward situation of clinical trial development in Northwest China will be improved.

clinical trials  /  information platform  /  Northwest China
刘妤, 张彩霞, 易秋月, 卫荣, 刘清悦, 刘霞, 张亚妮, 刘欣然, 马现福, 阎昭, 陆明莹. 我国西北地区临床试验机构信息化管理的探索与实践. 中国新药杂志, 2023 , 32 (4) : 404 -409 .
Yu LIU, Cai-xia ZHANG, Qiu-yue YI, Rong WEI, Qing-yue LIU, Xia LIU, Ya-ni ZHANG, Xin-ran LIU, Xian-fu MA, Zhao YAN, Ming-ying LU. Exploration and practice of informatization of clinical trial institution management in Northwest China[J]. Chinese Journal of New Drugs, 2023 , 32 (4) : 404 -409 .
基金
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  • 国家“重大新药创制”科技重大专项资助项目：西北地区恶性肿瘤新药临床评价示范性技术平台建设(2020ZX09201020)
2023年第32卷第4期
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  • 首发时间：2026-03-05
  • 出版时间：2023-02-28
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  • 录用日期：2022-12-13
基金
国家“重大新药创制”科技重大专项资助项目：西北地区恶性肿瘤新药临床评价示范性技术平台建设(2020ZX09201020)
作者信息
    1西安交通大学第一附属医院，西安 710061
    2天津阿贝斯努科技有限公司，天津 300000
    3中国抗癌协会，天津 300384

通讯作者:

陆明莹，女，硕士，主要从事临床试验管理和学科建设工作。联系电话：(029)85324783，E-mail: 。
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2种不同金属材料的力学参数
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多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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