Definition:
A statistical analysis plan (SAP) is a detailed document that outlines the statistical methods and techniques that will be used to analyse data collected in a clinical study. It serves as a blueprint for the statistical analysis and provides a clear and structured approach to data handling and interpretation.
The roles of a statistical analysis plan are to provide guidance for analysis, enhance the transparency of a study and assist in ensuring regulatory compliance. A well-structured SAP can also facilitate reproducibility.
More information: