Recent Cochrane Methodology Reviews

In December 2021, we published a new Cochrane Methodology Review of studies comparing different monitoring strategies for clinical trials. It identified eight eligible studies, which were grouped into five comparisons: (1) Risk‐based versus extensive on‐site monitoring (two studies); (2) Central monitoring with triggered on‐site visits versus regular on‐site visits (two studies); (3) Central statistical monitoring and local monitoring performed by site staff with annual on‐site visits versus central statistical monitoring and local monitoring only (one study); (4) Traditional 100% source data verification (SDV) versus targeted or remote SDV (two studies); and (5) Systematic on‐site initiation visit versus on‐site initiation visit upon request (one study). The authors concluded that the available evidence base is limited in terms of quantity and quality, and call for additional comparative monitoring studies nested in clinical trials. However, they note that the current results are promising in regard to the use of risk‐based, targeted, and mainly central monitoring. The review is available at