Authorship, sources, and acknowledgments
Acknowledgments
Thank you to the communities that build in the open and make a book like this possible: the pharmaverse maintainers and the Roche, GSK, Novartis, and Atorus teams behind its core packages; the R Validation Hub for giving “fit for use” a shared vocabulary; the R Consortium Submissions Working Group for proving the case with real pilot submissions; and CDISC for maintaining the standards everything here answers to. Readers who filed corrections and argued about the checklist tables improved every chapter.
This book has no official affiliation with or endorsement from CDISC, the R Consortium, R Validation Hub, or any company whose open-source packages it teaches.
Using the sources
Chapters link to official package documentation, standards, and community resources rather than reproducing them; Further reading explains what each resource contributes. Package documentation and standards retain their own licenses. Simulated data is used throughout; no chapter contains patient data.
License and editions
This book’s original content is published under CC-BY-SA 4.0. This is a maintained online practice edition. Changes can be traced in the version history; report corrections through the issue tracker.
Archived releases are preserved on Zenodo and citable as: Yan, J. (2026). Clinical R in Practice: The Open-Source Stack Behind Regulated Drug Development. Zenodo. https://doi.org/10.5281/zenodo.23085878.