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Biostatistics
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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