The purpose of the central monitoring plan is to maximize data quality. This will be done by identifing centres with
1) missing data, and
2) centres with predefined quality deficiencies or noteworthy data deviations as identified by visual inspection of data distributions.
Every month will generate a report on outliers for clinical data. The data report will be assessed and results from the monitoring will be logged in a 'central monitoring log' by the monitoring group. Two months before completion of the study and at the end of the study, a data report focusing on quality deficiencies and noteworthy data deviations, will be generated after extraction of data from the eCRF. Deviations will prompt contact with investigators. As both reports include study IDs it will not be published.
Central monitoring plan for the SafeBoosC-III follow up study (pdf, opens in a new tab)
Neurodevelopmental tests used in the SafeBoosC-III follow up study (pdf, opens in a new tab)