Article(id=1236346469570106253, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236346464578891843, 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=1663776000000, acceptedDateStr=2022-09-22, onlineDate=1772697568552, onlineDateStr=2026-03-05, pubDate=1684080000000, pubDateStr=2023-05-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772697568552, onlineIssueDateStr=2026-03-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772697568552, creator=13701087609, updateTime=1772697568552, updator=13701087609, issue=Issue{id=1236346464578891843, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='9', pageStart='865', pageEnd='968', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1772697567361, creator=13701087609, updateTime=1772697682369, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236346947028701631, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236346464578891843, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236346947028701632, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236346464578891843, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=921, endPage=926, ext={EN=ArticleExt(id=1236346469905650594, articleId=1236346469570106253, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Exploration and practice of remote supervision and inspection in drug clinical trial institutions, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

In recent years, with the continuous innovation and transformation of the pharmaceutical industry, high-quality and efficient clinical trials have become one of the most important demands of the pharmaceutical industry at present. The drug clinical trial business is complicated and data volume is huge, putting forward higher requirements for drug supervision. Therefore, innovative regulatory methods and intelligent transformation are extremely in need. In order to meet various development requirements in the era of COVID-19, after years of exploration and practice, our province has started the construction of the supervision information system of drug clinical trial institutions in Hebei province, established a vertical supervision system from top to bottom, and realized the whole-process reengineering of the supervision of clinical trial institutions by means of information technology. We initiated the remote supervision mode of drug clinical trial institutions and explored the "on-site inspection-remote inspection" hybrid supervision and inspection mode. With the assistance of this system, the risk in the clinical trial process reduced, the personnel gathering under the COVID-19 epidemic reduced, while the efficiency of supervision and inspection is improved, the listing process of new and good drugs is accelerated, makingpeople easily access to good drugs as soon as possible.

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近年来，随着医药产业的不断创新转型，高质量、高效率的临床试验成为当下医药行业最重要的需求。药物临床试验业务复杂，数据庞大，对药品监管提出了更高要求，因此，创新监管方式、智能化转型便迫在眉睫。为了适应新型冠状病毒肺炎疫情时代下的各种发展需求，我省经过多年的探索与实践，启动了河北省药物临床试验机构监管信息系统的建设，建立了由上而下的垂直监管体系，借助信息化手段实现临床试验机构监管全流程再造，首创药物临床试验机构远程监管模式，探索“现场检查+远程检查”混合监督检查模式。在该系统的辅助下，降低了临床试验实施过程中的风险，减少了新型冠状病毒肺炎疫情下的人员聚集，同时提高了监督检查效率，加快新药好药的上市进程，让百姓都能尽快用到好药。

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朱军杰，女，学士，主要从事药物临床试验管理研究。联系电话：(0311)83720058，E-mail: 2554337848@qq.com。

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朱军杰，女，学士，主要从事药物临床试验管理研究。联系电话：(0311)83720058，E-mail: 2554337848@qq.com。

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共同第一作者：董臻，女，硕士，主要从事药品审评工作。联系电话：(0311)67305138，E-mail: cpuskydz@126.com。

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共同第一作者：董臻，女，硕士，主要从事药品审评工作。联系电话：(0311)67305138，E-mail: cpuskydz@126.com。

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