Update on the temper study: targeted monitoring, prospective evaluation and refinement

Background On-site monitoring is a high-cost process, particularly if used indiscriminately in a large multicentre clinical trial. Ideally, the focus should be on identification and resolution of serious problems in trial conduct affecting patient safety and/or data quality. Targeted monitoring, where trial data and conduct are scrutinised centrally, with prespecified triggers for site visits, may be an efficient way to prioritise on-site monitoring. Though widely used, this approach has not been formally evaluated.