Implementing monitoring triggers and matching of triggered and control sites in the TEMPER study: a description and evaluation of a triggered monitoring management system

Carlos Diaz-Montana; William J Cragg; Rahela Choudhury; Nicola Joffe; Matthew R Sydes; Sally P Stenning

doi:10.1186/s13063-019-3301-z

Implementing monitoring triggers and matching of triggered and control sites in the TEMPER study: a description and evaluation of a triggered monitoring management system

Trials. 2019 Apr 17;20(1):227. doi: 10.1186/s13063-019-3301-z.

Authors

Carlos Diaz-Montana¹, William J Cragg^{2

3}, Rahela Choudhury², Nicola Joffe², Matthew R Sydes², Sally P Stenning²

Affiliations

¹ MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, University College London, 90 High Holborn 2nd Floor, London, WC1V 6LJ, UK. c.diaz@ucl.ac.uk.
² MRC Clinical Trials Unit at UCL, Institute of Clinical Trials & Methodology, University College London, 90 High Holborn 2nd Floor, London, WC1V 6LJ, UK.
³ Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.

Abstract

Background: 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. 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.

Methods: The 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.

Results: There 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.

Conclusions: The 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.

Keywords: Data management system; Risk-based monitoring; Triggered monitoring.

MeSH terms

Algorithms
Clinical Trials Data Monitoring Committees / standards
Data Accuracy
Data Collection / standards*
Data Management / standards*
Humans
Multicenter Studies as Topic / standards*
Randomized Controlled Trials as Topic / standards*
Research Design / standards*
Risk Assessment
Risk Factors
Time Factors

Abstract

MeSH terms

Grants and funding