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This document outlines the Statistical Analysis Plan (SAP) for a multi-site, phase I/II, dose-escalation trial investigating the safety and immunogenicity of four prophylactic SARS-CoV-2 RNA vaccines against COVID-19. It details the study design, sample size determination, statistical hypotheses, and data analysis methods, including various analysis sets and endpoints.

How to fill out statistical analysis plan

How to fill out statistical analysis plan

1. Begin with a title page that includes the title of the plan, the authors, and the date.
2. Define the objectives of the statistical analysis clearly.
3. Identify the study design and methodology.
4. List the primary and secondary endpoints of the study.
5. Specify the sample size and justification for it.
6. Outline the statistical methods that will be used for analysis.
7. Include details about how data will be collected and managed.
8. Describe how missing data will be handled.
9. Define the significance level and any statistical tests to be used.
10. Provide a timeline for the analysis and reporting.
11. Conclude with any potential limitations of the analysis.

Who needs statistical analysis plan?

1. Researchers conducting clinical trials or studies.
2. Statisticians involved in data analysis.
3. Regulatory bodies reviewing study protocols.
4. Grant applicants seeking funding for research projects.
5. Ethics committees evaluating study proposals.

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What is statistical analysis plan?

A statistical analysis plan (SAP) is a document that outlines the statistical methodology and analysis that will be applied to data collected in a study, ensuring that the analysis is pre-defined and consistent with the study objectives.

Who is required to file statistical analysis plan?

Typically, sponsors of clinical trials, researchers, and institutions conducting studies that require regulatory approval, including drug and device trials, are required to file a statistical analysis plan.

How to fill out statistical analysis plan?

To fill out a statistical analysis plan, one should describe the study design, define the statistical methods to be used, specify the data collection procedures, outline the analysis of primary and secondary outcomes, and detail how missing data will be handled.

What is the purpose of statistical analysis plan?

The purpose of a statistical analysis plan is to provide a clear framework for the analysis of data to ensure that the analysis is unbiased, systematic, and transparent, thereby enhancing the credibility of the study findings.

What information must be reported on statistical analysis plan?

The statistical analysis plan must report the study objectives, hypotheses, statistical methods, sample size calculations, variables definitions, data handling procedures, and plans for interim analyses.