Monitoring of the quality of study participation and communication
The LATER Central Office developed an extensive data and procedural monitoring program on informed consent procedures and documentation as well as data registration, which started after the inclusion of the first two survivors per center. Annual monitor visits were held at each center, followed by a monitor visit report. This report entailed a summary of the findings, recommendations for improvement, and a list of actions to be resolved. Inclusion rates for all centers and all sub-studies were calculated and visualized quarterly, to monitor sub-study inclusions and to allow for comparison with pre-defined targets. Based on these data, a (subgroup of a) sub-study was closed when a respective study arm was full. In addition to the annual site monitoring, the Central LATER office implemented ongoing monitoring on selected items and activities in all centers, in order to facilitate local sites to continuously improve data quality.