All opinions expressed are those of the presenter and do not represent any organization.
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Oct. 2022
All opinions expressed are those of the presenter and do not represent any organization.
Some slides need to be scrolled down to see the full content.
“FDA does not require use of any specific software for statistical analyses, and statistical software is not explicitly discussed in Title 21 of the Code of Federal Regulations [e.g., in 21CFR part 11]. However, the software package(s) used for statistical analyses should be fully documented in the submission, including version and build identification.”
As an organization, we need to ensure compliance and reduce the risk of using R and R packages in regulatory deliverables.
gsDesign
: an R package for group sequential design under proportional hazards.gsDesign2
: experimental R packages for group sequential design under non-proportional hazards