## CDISC datasets from R. Why not? [Software]

Hello again :),

» I did that myself before I got Certara’s CDISC-license. Never tried anything else than raw-data (scheduled & actual time points, concentrations) and NCA-results.

I find it easier until date, especially handling PK data from the project and exporting as .XPT, However, with advancements of R, I decided to take up this challenge of trying to work out CDISC datasets on R along with my routine PK and STAT analysis.

» Needs patience and the learning curve is not flat. A coding environment like R-Studio and an account at GitHub greatly helps.

I agree, patience is the key :), I use R studio predominantly and have a GitHub account (need to be more active though).

» ....This is the number of seconds since midnight, January 1, 1960. Why January 1, 1960? One story has it that the founders of SAS wanted to use the approximate birth date of the IBM 370 system, and they chose January 1, 1960 as an easy-to-remember approximation.[/indent]Heck, did they mean the timezone (EST = UTC-5) of Poughkeepsie, NY?
» The man-page of as.POSIX() claims that the origin of SAS’ datetime is 1960-01-01 00:00:00 GMT but I prefer to avoid a second-hand reference.

Woah, thanks for the explanation. Little did I know the background, I believed ISO8601 was majorly the standard time format until SAS complicated it for me. Now I know where things come into place.

» » While No other regulatory mandates datasets for Bio equivalence study, I still keep wondering what really sparked the USFDA in the mid of Dec 2016 to make CDISC datasets mandate for regulatory submission.
»
» Not the slightest idea.

There are many banging their heads with this in place and organizations are having to extend their timelines to review this data prior to submission.

» 2019-03-21 00:00:00 2019-03-20 23:00:00 1553122800 1868742000 20Mar19:23:00:00
» 2019-03-21 12:00:00 2019-03-21 11:00:00 1553166000 1868785200 21Mar19:11:00:00
» 2019-03-21 15:00:00 2019-03-21 14:00:00 1553176800 1868796000 21Mar19:14:00:00
» 2019-03-21 16:03:24 2019-03-21 15:03:24 1553180604 1868799804 21Mar19:15:03:24
»
» To get SAS’ date simply truncate the string with substr(SAS.datetime, 1, 7).
» TODO: Convert SAS.secs and SAS.datetime (in UTC) back to the local date/time.

Thanks for working it out, I tried replicating this and this looks promising for me to try it out further.

Thanks
-Dr Anonymous
(WhiteCoatWriter)

Thanks and Regards
Dr Anonymous
(WhiteCoatWriter)