ArticleTrials2019
Implementing monitoring triggers and matching of triggered and control sites in the TEMPER study: a description and evaluation of a triggered monitoring management system.
Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
4 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Monitoring strategies for clinical intervention studies.The Cochrane database of systematic reviews · 2021Pooled it
- Monitoring metrics over time: Why clinical trialists need to systematically collect site performance metrics.Research methods in medicine & health sciences · 2023Article
- Development of a risk-tailored approach and dashboard for efficient management and monitoring of investigator-initiated trials.BMC medical research methodology · 2023Review
- Triggered or routine site monitoring visits for randomised controlled trials: results of TEMPER, a prospective, matched-pair study.Clinical trials (London, England) · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.