Abstract
BackgroundTriggered monitoring in clinical trials is a risk-based monitoring approach where triggers (centrally monitored, predefined key risk and performance indicators) drive the extent, timing, and frequency of monitoring visits. The TEMPER study used a prospective, matched-pair design to evaluate the use of a triggered monitoring strategy, comparing findings from triggered monitoring visits with those from matched control sites. To facilitate this study, we developed a bespoke risk-based monitoring system: the TEMPER Management System.MethodsThe TEMPER Management System comprises a web application (the front end), an SQL server database (the back end) to store the data generated for TEMPER, and a reporting function to aid users in study processes such as the selection of triggered sites. Triggers based on current practice were specified for three clinical trials and were implemented in the system. Trigger data were generated in the system using data extracted from the trial databases to inform the selection of triggered sites to visit. Matching of the chosen triggered sites with untriggered control sites was also performed in the system, while data entry screens facilitated the collection and management of the data from findings gathered at monitoring visits.ResultsThere were 38 triggers specified for the participating trials. Using these, 42 triggered sites were chosen and matched with control sites. Monitoring visits were carried out to all sites, and visit findings were entered into the TEMPER Management System. Finally, data extracted from the system were used for analysis.ConclusionsThe TEMPER Management System made possible the completion of the TEMPER study. It implemented an approach of standardising the automation of current-practice triggers, and the generation of trigger data to inform the selection of triggered sites to visit. It also implemented a matching algorithm informing the selection of matched control sites. We hope that by publishing this paper it encourages other trialists to share their approaches to, and experiences of, triggered monitoring and other risk-based monitoring systems.
Highlights
Triggered monitoring in clinical trials is a risk-based monitoring approach where triggers drive the extent, timing, and frequency of monitoring visits
The approach is encouraged by regulators; the International Conference of Harmonisation (ICH) Good Clinical Practice (GCP) guidance (E6[R2]) advises trialists to “develop a systematic, prioritised, risk-based approach to monitoring clinical trials” [6]
To allow the evaluation of this triggered monitoring strategy for the study, we developed the Targeted Monitoring: Prospective Evaluation and Refinement (TEMPER) Management System (TEMPER-MS), an Risk-based monitoring (RBM) tool to systematically define triggers and summarise their status
Summary
Triggered monitoring in clinical trials is a risk-based monitoring approach where triggers (centrally monitored, predefined key risk and performance indicators) drive the extent, timing, and frequency of monitoring visits. RBM tools support one or both of two components of RBM: an initial risk assessment, which determines the overarching monitoring strategy, and support for ongoing monitoring activities in response to the risks identified [7, 8], including determining the nature and frequency of on-site monitoring visits. Triggered monitoring (or targeted monitoring) is an RBM approach in which the extent, timing, and frequency of monitoring visits are driven by centrally monitored triggers. These can be described as predefined, trial-specific key risk and performance indicators that fire when the metric they observe crosses a pre-set acceptability threshold. Examples of metrics include recruitment levels, data return rates, missing data levels, incidence of protocol deviations, and safety reporting timelines
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