Statistical Analysis Plan (SAP)

A Statistical Analysis Plan (SAP) is a document that outlines the statistical methods that will be used to analyze the data collected during a clinical study.

• See: Clinical Study Report.

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References

2023

• • Q: What is a Statistical Analysis Plan (SAP)?
  • A: A Statistical Analysis Plan (SAP) is a document that outlines the statistical methods that will be used to analyze the data collected during a clinical study. The SAP typically includes details on the study design, data management and cleaning procedures, variables to be analyzed, and the statistical tests that will be performed. The SAP is an important part of the clinical study process, as it helps to ensure that the statistical analysis of the data is conducted in a consistent and transparent manner.

    The SAP is typically developed by a statistician or a team of statisticians, in collaboration with the study investigators. It is usually developed before the study begins, and is reviewed and approved by the study sponsor and regulatory authorities before the study is initiated. The SAP serves as a roadmap for the statistical analysis of the study data, and helps to ensure that the analysis is conducted in a rigorous and scientifically sound manner. It is also used to document and justify the statistical methods that were used in the study, and to facilitate the review and interpretation of the study results by regulatory authorities and the scientific community.

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