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.