Impact of daylight saving time shifts on data quality of a pharmacokinetic study

AbstractTwice a year, most areas of North America and Europe observe a time shift. In spring, a positive shift occurs when clocks are reset from 02:00 to 03:00 hours, generally on a Sunday morning. In late autumn, a negative shift occurs when clocks are reset from 03:00 to 02:00 hours, generally on a Sunday morning. These time shifts can have an impact on the data quality if they are not considered appropriately. Especially for pharmacokinetic studies, this can lead to issues and wrong results in the calculation of time-dependent variables like area under the curve (AUC) or terminal half-life (t 1/2). It also affects recording of safety data like adverse events or serial ECGs. This paper describes possible pitfalls in the study set-up and possible impact on data quality and analysis. It also shows traceable data handling options in case a solution in the data collection cannot be achieved.