[Rd] Table Figures and Listings

Frank Harrell f.harrell at vanderbilt.edu
Mon May 30 14:49:52 CEST 2011

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

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


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
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Frank Harrell
Department of Biostatistics, Vanderbilt University
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