Performing statistical analysis
Statistical analyses of study data are done according to the specifications of a previously created statistical analysis plan (SAP). This is done by using a validated statistical programming software, e.g., “R” or “STATA”. This ensures that the results are traceable and reproducible. All results are described in a statistical analysis report (SAR).
Analyses should be validated, i.e. a second biostatistician (or statistical programmer) independently programs the critical and decisive parts of the analysis. The results of the two programmers are then compared to assure the correctness.
