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Titled Central data monitoring of clinical trials: A survey of the UK Clinical Research Collaboration (UKCRC) registered clinical trial units, the paper reports findings from a national survey exploring how central data monitoring (CDM) is planned, delivered and documented within UKCRC-registered CTUs. The work reflects close collaboration across the UK trial methodology community and contributes to ongoing efforts to improve the conduct and efficiency of clinical research.
The paper will be of interest to trialists, methodologists and research professionals involved in trial design, conduct and oversight, particularly those seeking to strengthen proportionate and effective monitoring strategies.
Central data monitoring refers to a range of activities carried out by trial staff while a study is ongoing, with the aim of safeguarding data quality, integrity and reliability. Unlike on-site monitoring, these activities are performed remotely and often involve routine review of trial data, processes and performance indicators. While CDM is widely recognised as an essential component of good trial conduct, there is limited regulatory guidance on which activities should be undertaken or who should be responsible for them.
To better understand current practices, the research team distributed a structured survey to all UKCRC-registered CTUs on 25 April 2025. The survey asked respondents to indicate whether 16 defined central monitoring activities were carried out on all trials, some trials or not at all, and which staff roles were typically involved in delivering each activity.
The results show considerable variation across CTUs. Central data monitoring is commonly undertaken by statisticians, trial managers and data managers, alongside other trial team members depending on the activity. While some monitoring practices were widely and consistently applied, others were implemented more selectively, often influenced by trial design, risk profile or available resources.
Notably, the authors highlight the lack of detailed regulatory direction as a key factor contributing to this variability. In response, the paper proposes a core set of eight central data monitoring activities that the authors recommend should be considered for inclusion in all clinical trials, providing a potential baseline for more standardised practice.
The authors express their sincere thanks to all CTUs and colleagues who contributed to the survey, recognising the time and expertise required to share detailed information on internal processes.
Read the full paper here.
Find more guidance on monitoring issues here.
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