Data processing and monitoring
Referred
EVENT
All study data will be:Screened for out-of-range data, with cross-checks made for conflicting data within and between data collection forms by a data manager.Referred back to the relevant center for clarification in the event of missing items or uncertainty. A record of all discrepancies and resolutions will be kept by the data manager.The chief investigator and trial statistician will review the results generated for logic and for patterns or problems. Outlier data will be investigated.