Regulatory acceptance of PowerTOST [Software]

posted by DavidManteigas – Portugal, 2016-06-03 11:05  – Posting: # 16389
Views: 6,837

(edited by Ohlbe on 2016-06-03 13:54)

Hi,

As far as I understand, regulatory authorities in Europe are not that troublesome with software as FDA. They don't even ask the sponsor to send the datasets of the study or the Logs of the statistical software execution. I believe that in some countries, you could state in the Protocol and in the SAP that you will used Winonlin and SAS in your analysis and use R in all of them and never have a problem in submission's nor in inspections. For instance, regulatory inspections in Portugal care only about GCP compliance in the clinical site. They don't even check in detail eDC software or data management & analysis process. Lack of qualified resources I think.
Nevertheless, my personal opinion is that you should always "validate" yourself the results of the software. For instance, when I use a new R package to implement a new statistical method I always validate the results with SAS, being the job for regulatory purposes or not. I also do that when I'm doing an analysis I'm not very comfortable with and I store both outputs (R and SAS) for my own protection in case of questions (the main trouble with R arises from the clients, much of them used to SAS and don't want to take the risk of using R just by "superstition").

Regards,
David


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]

Complete thread:

Activity
 Admin contact
20,237 posts in 4,258 threads, 1,395 registered users;
online 4 (0 registered, 4 guests [including 4 identified bots]).
Forum time (Europe/Vienna): 02:42 CET

There are no routine statistical questions,
only questionable statistical routines.    David R. Cox

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5