R for Clinical Study Reports and Submission

Learn how to prepare tables, listings, and figures for clinical study report and submit to regulatory agencies, the essential part of clinical trial development.


Yilong Zhang

Nan Xiao

Keaven Anderson

Yalin Zhu


Welcome to R for Clinical Study Reports and Submission. Clinical study reports (CSR) are crucial components in clinical trial development. A CSR is an “integrated” full scientific report of an individual clinical trials.

The ICH E3: Structure and Content of Clinical Study Reports offers comprehensive instructions to sponsors on the creation of a CSR. This book is a clear and straightforward guide on using R to streamline the process of preparing CSRs. Additionally, it provides detailed guidance on the submission process to regulatory agencies. Whether you are a beginner or an experienced R programmer, this book is an indispensable asset in your clinical reporting toolkit.

This is a work-in-progress draft.


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 Short course 2022-09-20 Slides
PSI Webinar Series: Showcasing R use in Pharma Talk 2022-10-25 Slides