Welcome!

Welcome to R for clinical study reports and submission. Clinical study reports (CSR) are essential parts of clinical trial development. A CSR is an “integrated” full scientific report of an individual clinical trial.

The ICH E3: structure and content of clinical study reports provides guidance to assist sponsors in the development of a CSR. In this book, you will learn how to use R to prepare a CSR and how to submit it to regulatory agencies.

This is a work-in-progress draft.