BACKGROUND Despite the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) encouraging the use of risk-based monitoring for trials in 2013, there remains a lack of evidence-based guidelines on how to monitor. We surveyed the academic United Kingdom Clinical Research Collaboration (UKCRC) registered clinical trials units (CTUs) to find out their policy on monitoring of phase III randomised clinical trials of an investigational medicinal product (CTIMPs). METHODS An online survey of monitoring policy with sections on the CTU, central monitoring and on-site monitoring was sent to all 50 UKCRC registered CTUs in November 2018. Descriptive data analysis and tabulations are reported using the total number answering each question. RESULTS A total of 43/50 (86%) of CTUs responded with 38 conducting phase III randomised CTIMP trials. Of these 38 CTUs, 34 finished the survey. Most CTUs (36/37, 97%) use a central monitoring process to guide, target or supplement site visits. More than half (19/36, 53%) of CTUs do not use an automated monitoring report when centrally monitoring trials and all units use trial team knowledge to make a final decision on whether an on-site visit is required. A total of 31/34 (91%) CTUs used triggers to decide whether or not to conduct an on-site monitoring visit. On-site, a mixture of source data verification and checking of processes was carried out. The CTUs overwhelmingly (27/34, 79%) selected optimising central monitoring as their most pressing concern. CONCLUSION The survey showed a wide variation in phase III randomised CTIMP trial monitoring practices by academic clinical trials units within a single research-active country. We urgently need to develop evidence-based regulator-agreed guidance for CTUs on best practice for both central and on-site monitoring and to develop tools for all CTUs to use.

中文翻译：

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实践中的监测——如何监测英国学术临床试验？一项调查。

背景 尽管美国食品和药物管理局 (FDA) 和欧洲药品管理局 (EMA) 在 2013 年鼓励在试验中使用基于风险的监测，但仍然缺乏关于如何监测的循证指南。我们调查了学术英国临床研究合作组织 (UKCRC) 注册的临床试验单位 (CTU)，以了解他们对研究药物产品 (CTIMP) 的 III 期随机临床试验的监测政策。方法 2018 年 11 月，向所有 50 个 UKCRC 注册的货运单元发送了关于货运单元、中央监控和现场监控部分的监控政策在线调查。描述性数据分析和表格使用回答每个问题的总数报告。结果 共有 43/50 (86%) 的 CTU 响应了 38 项进行的 III 期随机 CTIMP 试验。在这 38 个货运单元中，有 34 个完成了调查。大多数货运单元 (36/37, 97%) 使用中央监控流程来指导、定位或补充现场访问。超过一半 (19/36, 53%) 的 CTU 在集中监控试验时不使用自动监控报告，所有单位都使用试验团队的知识来最终决定是否需要现场访问。共有 31/34 (91%) 个货运单元使用触发器来决定是否进行现场监测访问。在现场，混合进行了源数据验证和流程检查。绝大多数 CTU (27/34, 79%) 选择优化中央监控作为他们最紧迫的问题。结论 调查显示，在一个研究活跃的国家内，学术临床试验单位的 III 期随机 CTIMP 试验监测实践存在很大差异。