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Tranexamic acid for hyperacute primary IntraCerebral Hemorrhage
(RICH 2)
Final Version 5.0
26 May 2016
Short title:Tranexamic acid for IntraCerebral
Hemorrhage TICH2Acronym:TICH2EudraCT number:201200410837ISRCTN:93732214CTA
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How to fill out statistical analysis plan for
01
Start by understanding the purpose of the statistical analysis plan (SAP). Determine the specific research objectives and the statistical methods that will be used to analyze the data.
02
Outline the key components of the SAP, including the introduction, study design, statistical methods, endpoints and analysis populations.
03
Specify the primary and secondary objectives of the study and describe the statistical hypotheses to be tested.
04
Define the analysis populations, including the intention-to-treat population and other relevant groups.
05
Detail the statistical methods to be used for each analysis, including the choice of statistical tests, adjustments for multiple comparisons, and handling of missing data.
06
Describe the planned sensitivity analyses and subgroup analyses.
07
Specify the endpoints to be evaluated and define how they will be analyzed.
08
Outline the procedures for data cleaning, data transformations, and data monitoring.
09
Include considerations for sample size determination and justification.
10
Finally, review and revise the SAP as necessary, ensuring it is clear, concise, and aligned with the study objectives and protocol.
Who needs statistical analysis plan for?
01
Statistical analysis plan is needed by researchers, scientists, and statisticians involved in conducting clinical trials, observational studies, or any other form of research that requires data analysis.
02
Regulatory authorities and ethics committees also require a statistical analysis plan to ensure the validity and integrity of the study results.
03
Pharmaceutical companies, academic institutions, and research organizations often mandate the development of a statistical analysis plan to maintain consistency, transparency, and reproducibility in their research.
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