Friday, May 3, 2019

CDISC Submission Validation Software: There is a new Kid in Town


A few days ago, I was informed that there is a new free validation software available for validating SDTM, SEND and ADaM submissions to the FDA and PMDA.
The company behind this free software is named PointCross Life Sciences, located in California, and the product is name "MySEND". The name may a bit confusing, as it suggests it is only for SEND submissions, but this is not correct, as one can validate SEND submissions as well as SDTM and ADaM (1.1 not supported yet) submissions. The latest release notes (2019-05-01) however suggest that there will be a name change to "eDataValidator".
The software is free but not open source. It is written In Java, but currently only runs on Windows systems.
In this blog, I will describe my first impressions and experiences with the software.
Until recently, there was only one submissions validation software freely available, the "Pinnacle21 Community" validation software. The last release (v.2.2.0) was in September 2016, with no intermediate bug fixes available. A new major version (3.0.0) has however been announced for the coming weeks. 

Most of you know my opinion about this software, well described in a number of my previous blogs, so I will not repeat anything here, but concentrate on the new PointCross MySEND software. Once the new Pinnacle21 release is available, I am intending to make a comparison: comparing the new MySEND with the old Pinnacle21 v.2.2.0 would not be fair.

After starting the software, the graphical user interface is displayed: 


For "Validation", there are three parts: the upper part allows to drag-and-drop the submission files, including the define.xml (it is automatically recognized, even when the name is different).
The second part allows you to set the validation parameters. This is how it looks today (May 5th):
 
 


With near the bottom:  
 


Currently, only FDA and PMDA rules can be worked with, CDISC rules (like for SDTMIG 3.2 and the ADaM Conformance Rules v2.0 (March 2019) are not (yet) available.
A nice feature I soon found out and liked, is that when a new version of the software or a bug fix has been released, a message appears when starting the software, and asking whether you would want to install the new version or bug fix. According to the release notes, there seems to have been 4 such updates in the last year. Timely bug fixes are so important in validation software!
 

Also, I was informed that a similar mechanism will apply for updates of controlled terminology files. That is of course a very good idea, especially as there have been discussions about changed CT files with the Pinnacle21 validator. 


After clicking the "Validate" button, validation starts (it is very fast - however, I prefer quality over speed) and an Excel report becomes available. A nice feature I personally would like to see is an option for making the validation report additionally available as an XML document, which can the be transformed in almost anything.