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