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IBA Profile: CT Tumor Volume Change (CTV1)Version 2.2 8 Aug 2012 Status: (PRE)Reviewable of Contents 1. Executive Summary 6 2. Clinical Context and Claims 7 3. Profile Details 7 3.1. Subject Handling 9 3.2.
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Statistical issues in testing refer to potential biases, errors, or unaccounted variables that may affect the interpretation of test results, ensuring that statistical methods used in testing are appropriate and robust.
Entities involved in research, clinical trials, or any form of testing that relies on statistical analysis are typically required to file statistical issues in testing, which includes sponsors, researchers, and regulatory bodies.
To fill out statistical issues in testing, one must provide detailed descriptions of the statistical methods used, any assumptions made, potential biases identified, and how these issues will be addressed in analysis.
The purpose of statistical issues in testing is to ensure transparency and rigor in the testing process, to provide clarity about the methods and assumptions used, and to identify any factors that might impact the validity of the results.
Reported information typically includes the study design, statistical methods used, data analysis plans, any conflicts of interest, assumptions made, limitations of the study, and how potential biases were addressed.
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