P21 Version 2.2

b Bharath

on June 24, 2020

We delivered a Clinical study in 2018 and have used P21 V2.2 for SDTM validation. Now, its more than 2 years since we have delivered and made a very minor change in the DM dataset's site Variable as part of request. Upon using the same version of P21 validator (configuration) and the same set of XPT files for validation, I see good number of increase in the error and warning counts. Can anyone clarify this?

Forums: Troubleshooting and Problems

r Robert

on June 24, 2020

Changes to DM dataset site variable changes validation

Thank you for the question.

A first step would be to revert the variable changes, run the validation again, then compare those results with those from the original delivery validation.

Could you please let us know what you find if you're able to make that comparison?

Thank you again, Rob