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