Category Clinical Trial Fundamentals

Clinical Documentation, Clinical Trial Fundamentals, FDA / EMA / ICH, General, Regulatory & Compliance

Statistical Analysis Plan Template: A Guide for Clinical Trials Documentation

A statistical analysis plan template is a standardized, regulatory-aligned framework that details the specific methods for analyzing clinical trial data. It serves as a comprehensive blueprint for the analysis, ensuring all procedures are prospectively defined, objective, and reproducible. This technical…

mitch
December 25, 2025

Clinical Documentation, Clinical Trial Fundamentals, FDA / EMA / ICH, General, Protocols & Study Design, Regulatory & Compliance

A Guide to the Clinical Study Report Template for Regulatory Submissions

A clinical study report (CSR) template serves as the standardized framework for authoring the comprehensive account of a clinical trial for regulatory authorities. This structured blueprint, designed in accordance with guidelines like ICH E3, ensures that all critical information is…

mitch
December 24, 2025