Data (and metadata, if feasible) are first extracted from EDC, IRT and other electronic systems and provided in a format (e.g. Excel) that can be uploaded to SAS.
Data points considered for analysis include “Standard Data” such as Visit Dates, Height, Weight, Vital Signs, ECG, number of Adverse Events, number of Concomitant Medication entries. However, “Protocol-specific Data” such as Primary and Secondary Endpoints can be utilised as well.
The data is then statistically analysed with regards to, for example, digit preference, inliers, outliers, rounding, inter-patient and intra-patient analysis, correlations, under reporting, over reporting, distributions and so on.