It is a common misperception that FDA "approves" software other than the software used to drive medical devices such as pacemakers. You can use any software to make FDA submissions. FDA gets submissions in Minitab and Excel, for example. That being said, base R is CFR11 compliant (see www.r-project.org).
We developed the rreport package for R for clinical trials reporting including FDA submission. rreport includes several very high-level functions for baseline stats, labs, AEs, etc. Once you marry R with LaTeX the sky is the limit. And the graphics in R can be used to convert many tired old listings to graphics as we have done for AEs. See http://biostat.mc.vanderbilt.edu/Rreport and http://biostat.mc.vanderbilt.edu/wiki/pub/Main/StatGraphCourse/graphscourse.pdf Frank Orin Richards wrote: > > Dear All, > I am fairly new to R. I work mainly in SAS. Now, I know that SAS is > approved > by the FDA for submissions. My question is, does the FDA approve {R} for > clinical trial submissions. Also has anyone ever tried to produce TFL's > using > R. I would like to know how difficult it to produce the TFL's in R as > compared > to SAS. I know that in SAS it is not difficult once you know what you are > doing > and what is required. My limited knowledge of R suggests that it may be > a bit > more difficult. Can anyone please provide me with some guidance or sample > code > for producing a standard table or listing. A good starting point can be a > demography table. I can produce a demog table quite easily in SAS. My R > knowledge is limited that's why I have ask for some sample code. > > > > Thanks for your help. > > > Orin > > ______________________________________________ > R-devel@r-project.org mailing list > https://stat.ethz.ch/mailman/listinfo/r-devel > ----- Frank Harrell Department of Biostatistics, Vanderbilt University -- View this message in context: http://r.789695.n4.nabble.com/Table-Figures-and-Listings-tp3560634p3560653.html Sent from the R devel mailing list archive at Nabble.com. ______________________________________________ R-devel@r-project.org mailing list https://stat.ethz.ch/mailman/listinfo/r-devel