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.
|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|
This book is licensed to you under Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.