Statistical Analysis Plan
A Statistical Analysis Plan is a document that describes the statistical methods used to analyze data collected in a research study.
A SAP describes the planned statistical analyses and contains:
- Variables and outcomes that are collected
- primary outcomes
- secondary outcomes
- Hypotheses
- Analysis data set
- Planned analysis
- primary analysis
- secondary analysis
- descriptive analysis
- Handling of missing data and dropouts
Difference between Study Protocol and SAP
- A protocol defines the research questions, the study population, the outcomes, but the statistical analyses are only briefly described.
- SAP’s include a detailed technical characterization of all the planned analyses, handling of missing data, etc.,
Who writes SAP?
SAP is written through a collaboration between Principal Investigator and Statistician.
Why SAP is required?
- Increases reproducibility
- The documents adds clarity in the communication between investigator and statistician
- Increase efficiency of research at the time of data analysis
When to write SAP?
SAP can be completed along with Study Protocol but must be completed before data analysis.
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