I have a legacy SDTMIGv3.1.3 study which is planned for inclusion in an upcoming submission. eSUB package was unfortunately not created at the time of study completion.
It seems FDA Legacy engine 2204.1 was the last available for validating SDTMIGv3.1.3 in community. Though I see the config files, It does not show in my ‘Engine’ drop down in P21C. Is there a way to force this engine to be available for use since I have the config for it?
There is currently no way to force the use of an expired Engine. We only maintain 1 legacy version of FDA engine.
It’s worth noting, you can add the old .xml config under a custom folder. It’s described on our FAQ page.
Q: Can I use a custom config with Pinnacle 21 Community?
A: Yes! To use custom configurations of standards, you will need to create a subfolder called “custom” inside of the “configs” folder (alongside the engine versions). An example of this path would be: C:\Users\\Documents\Pinnacle 21 Community\configs\custom\. Any custom XML files you place in here will be picked up automatically next time the application starts.
Please note that utilization of custom config files is “off-label use” practice. It could be conflict between new engine and config files from different older engine. Some rules may be not executed or the whole validation process may fail. So, use it only on your own risk.
Check if you company has Enterprise license. It will be a simple and secure solution for the discussed problem.