Article(id=1322180248851042308, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322180233244038010, 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=1614700800000, acceptedDateStr=2021-03-03, onlineDate=1793161936247, onlineDateStr=2026-10-28, pubDate=1631635200000, pubDateStr=2021-09-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793161936247, onlineIssueDateStr=2026-10-28, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793161936247, creator=13701087609, updateTime=1793161936247, updator=13701087609, issue=Issue{id=1322180233244038010, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='17', pageStart='1537', pageEnd='1632', issueExtLink='null', onlineDate='null', pubDate='1631635200000', pubDateStr='2021-09-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=0, createTime=1793161932525, creator='13701087609', updateTime=1793162118166, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322181011941732619, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322180233244038010, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322181011945926924, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322180233244038010, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1574, endPage=1578, ext={EN=ArticleExt(id=1322180248997842949, articleId=1322180248851042308, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Risk of medical records quality in clinical studies and coping strategies, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective: To identify the quality risks of medical records in clinical research and propose strategies according to the risk levels.
Methods: By analyzing the quality inspection findings of clinical research in the recent 3 years, the quality risks of medical records in clinical research were identified. The risk coefficient was obtained by multiplying the degree of risk influence with the possibility of occurrence, and the risk grade was evaluated according to the risk coefficient.
Results: A total of 54 risks were identified, mostly medium and low risks. The only high risk is inconsistent recording of the same data in different source files. Incomplete records, insufficient records to determine the clinical significance of detection outliers, missing adverse events and incomplete or incorrect records of adverse event elements are common risks of medical record quality, and the risk coefficient of which is second to the only high risk. Other risks with low risk coefficients are infrequently met.
Conclusion: The risk of medical record quality exists in every link of clinical study. Clinical research related personnel can establish the initial priority of risk treatment according to risk level and coefficient.
, authors=Xin KANG, Jun-mei LIU, Ting YANG, Xin-ling BI, Li ZHANG, Jin NI, Na-ping ZHAO, Ting-ting CAI, Hai-ping MA, Jian-ping XIU, Shen GAO, authorsList=Xin KANG, Jun-mei LIU, Ting YANG, Xin-ling BI, Li ZHANG, Jin NI, Na-ping ZHAO, Ting-ting CAI, Hai-ping MA, Jian-ping XIU, Shen GAO, authorCompany=null, correspAuthors=Shen GAO, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1322180249383718919, articleId=1322180248851042308, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=临床研究病历质量风险及应对策略, columnId=1236331161786569054, journalTitle=中国新药杂志, columnName=重大新药创制专项巡礼, runingTitle=null, highlight=null, articleAbstract=
目的： 识别临床研究病历质量风险并根据风险等级提出应对策略。
方法： 分析近3年临床研究检查结果，识别出临床研究病历质量风险，通过风险影响程度与发生可能性的乘积得到风险系数，根据风险系数评价风险等级。
结果： 识别出54项风险，大多为中、低风险。同一数据在不同源文件中记录不一致是唯一的高风险。记录不完整、检测异常值临床意义判断依据记录不充分、漏记不良事件（AE）、AE要素记录不完整或记录错误是常见的病历质量风险，风险系数仅次于高风险。其他风险的风险系数较低且不常发生。
结论： 病历质量风险存在于临床研究的每个环节。临床研究相关人员可以根据风险级别和系数制定风险处理的起始优先顺序。
, authors=康新, 柳俊梅, 杨婷, 毕新岭, 张黎, 倪瑾, 赵娜萍, 蔡婷婷, 马海萍, 修建平, 高申, authorsList=康新, 柳俊梅, 杨婷, 毕新岭, 张黎, 倪瑾, 赵娜萍, 蔡婷婷, 马海萍, 修建平, 高申, authorCompany=null, correspAuthors=高申, authorNote=
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康新，女，硕士研究生，主要从事临床试验质量管理和I期临床研究。联系电话：（021）31162332，E-mail：chgcpkx@163.com。
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康新，女，硕士研究生，主要从事临床试验质量管理和I期临床研究。联系电话：（021）31162332，E-mail：chgcpkx@163.com。
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