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The structure and content of the Clinical Study Report (CSR) is based on "ICH E3: Guideline for Structure and Content of Clinical Study Reports" of the International Conference on Harmonization

Protocol Design

Sample size estimation, randomization and statistical power

Validation and statistical reliability of questionnaires and other measurement instruments

Evaluation of diagnostic tests: sensitivity, specificity, predictive values ​​and ROC curves

Exploratory and descriptive data analysis

Analysis of risk factors or prognosis

Statistical quality control

Application of statistical techniques: Survival analysis, diagnostic tests, association measures and methods for the analysis of contingency tables Longitudinal data analysis, predictive models, time series, generalized linear models, logistic regression analysis, Poisson, Cox models, principal components , multidimensional scaling

Statistical Analysis Plan (SAP)

Efficacy and safety analysis of the Clinical Study data

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