Article(id=1291706987679601517, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291706966187991876, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.24.023, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1763740800000, receivedDateStr=2025-11-22, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785896544617, onlineDateStr=2026-08-05, pubDate=1766851200000, pubDateStr=2025-12-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785896544617, onlineIssueDateStr=2026-08-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785896544617, creator=13701087609, updateTime=1785896544617, updator=13701087609, issue=Issue{id=1291706966187991876, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='24', pageStart='3451', pageEnd='3600', issueExtLink='null', onlineDate='null', pubDate='1766851200000', pubDateStr='2025-12-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785896539494, creator='13701087609', updateTime=1785998798662, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292135872292479273, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291706966187991876, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292135872296673578, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291706966187991876, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=3594, endPage=3600, ext={EN=ArticleExt(id=1291706987918676846, articleId=1291706987679601517, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Analysis of clinical trial visit windows and risk classification-based management strategies from the perspective of the institutional office, columnId=1291704889697137247, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Special Column of Clinical Trials Administration, runingTitle=null, highlight=null, articleAbstract=
Objective To conduct a statistical analysis of clinical trial visit time windows and propose targeted recommendations based on risk management from the perspective of the institutional office, so as to provide references for clinical research practice.
Methods Data of drug clinical trial projects undertaken by a single institution from 2018 to 2024 were collected. Visit time windows were statistically analyzed and compared across the screening phase, visit phase, and follow-up phase. A risk classification standard for time windows was established by integrating management practice, regulatory requirements, and relevant literature. Corresponding recommendations were put forward for sponsors, researchers, participants, and the institutional office based on this classification.
Results A total of 137 projects were included, with the number of visits ranging from 1 to unlimited. Visit modalities included on-site visits and remote visits (telephone visits). The most prevalent time windows in each phase were 28 days (45.99%) for the screening phase, 3 days (62.26%) for the visit phase, and 7 days (68.93%) for the follow-up phase. The risk classification results were as follows: extremely high-risk time windows (1 to 30 minutes in the visit phase), high-risk time windows (42 to 183 days: before screening in the screening phase, 1 to 24 hours in the visit phase, and 1 to 3 days in the follow-up phase), medium-risk time windows (1 to 7 days: before screening in the screening phase, 1 to 3 days in the visit phase, and 5 to 10 days in the follow-up phase), and low-risk time windows (14 to 35 days: before screening in the screening phase, 4 to 14 days in the visit phase, and 14 to 30 days in the follow-up phase). Compared phase Ⅱ with phase Ⅲ or phase Ⅳ, statistically significant differences were all observed in the distribution of visit windows during the visit phase (all P<0.05). Based on this classification, the institutional office recommends that all parties adopt strategies of scientific design, risk-based response, and closed-loop management, and deeply understand and actively cooperate with each other for different risk levels of time windows.
Conclusion Significant differences exist in visit time windows across different phases of clinical trials. Risk classification and targeted responses from all parties can effectively ensure the quality of clinical trial data and the rights and interests of participants.
, authors=Tao-tao YANG, Jun-min GU, Rong-bin YU, Ling-na LI, Jia-huan CHEN, Dai-rong CHEN, authorsList=Tao-tao YANG, Jun-min GU, Rong-bin YU, Ling-na LI, Jia-huan CHEN, Dai-rong CHEN, authorCompany=null, correspAuthors=Jun-min GU, 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=1291706988170335087, articleId=1291706987679601517, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=临床试验访视窗分析及机构办视域下基于风险分级的管理应对探讨, columnId=1291704889869103713, journalTitle=中国临床药理学杂志, columnName=临床试验管理专栏, runingTitle=null, highlight=null, articleAbstract=
目的 对临床试验访视窗进行统计分析，并从机构办视角基于风险管理提出建议，以提供参考。
方法 对某机构2018年至2024年承接的药物临床试验项目的访视窗统计分析，按筛选期、访视期和跟踪期做分析对比，根据管理实践结合法规和文献对窗时间提出风险分级，并据此对申办方、研究者、参与者和机构办提出建议。
结果 共有137个项目纳入研究，访视次数从1次到不限次；形式有现场访视和电话访视（远程访视）。按研究进程可分为筛选期、访视期和跟踪期，窗时间分别以28 d（45.99%）、3 d（55.26%）和7 d（39.39%）最高；基于风险可分为极高风险型窗（访视期1~30 min）、高风险型窗（筛选期-42~-183 d、访视期1~24 h和跟踪期1~3 d）、中风险型窗（筛选期-1~-7 d、访视期1~3 d和跟踪期5~10 d）和低风险型窗（筛选期-14~-35 d、访视期4~14 d和跟踪期14~30 d），Ⅱ期与Ⅲ期、Ⅱ期与Ⅳ期比较，访视期的窗分布在统计学上差异均有统计学意义（均P<0.05）；并据此从机构办视角提出申办方、研究者、参与者及机构办应根据不同风险窗充分考量、合理设计、提前谋划、分级应对、闭环管理、深刻理解并积极配合。
结论 临床试验不同阶段访视窗具有明显差异，申办方、研究者及机构办应基于访视窗的风险进行分级并做相应的风险控制措施，以更好保障临床试验数据质量和参与者权益。
, authors=杨涛涛, 顾军民, 虞荣斌, 李玲娜, 陈佳欢, 陈代绒, authorsList=杨涛涛, 顾军民, 虞荣斌, 李玲娜, 陈佳欢, 陈代绒, authorCompany=null, correspAuthors=顾军民, authorNote=
杨涛涛（1989-），男，主管中药师，主要从事医院药学和临床试验管理
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