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

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.