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.

Events

Venue Type Date Materials
R/Pharma Conference Workshop 2021-10-28 Slides
China-R Conference Talk 2021-11-20 Slides
ASA Princeton-Trenton Chapter Short course 2021-12-02 Slides
GWU Biostatistics Center Talk 2022-01-21 Slides
RStudio Pharma Meetup Series Talk 2022-05-17 Slides
ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop Talk 2022-09-20 Slides
PSI Webinar Series: Showcasing R use in Pharma Talk 2022-10-25 Slides