Custom configurations with new rules

Pinnacle 21 Support Troubleshooting and Problems
1

https://www.pinnacle21.com/projects/validator/opencdisc-validation-framework

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Hi all,

just wondering if it is possible to add new rules into a custom configuration?

A sponsor we work with has historically had multiple CROs create SDTM datasets. They now want to check for and enforce some standards across those studies - beyond the standard SDTM-IG checks.
e.g.

  • they don’t want to use specific domains
  • they want to restrict variables from being used, e.g. they have decided that some permissable variables should never be present
  • they have their own custom terminology for use when SDTM-IG indicates sponsor terminology should be used
  • some variables are expected to meet a regular expression
  • they have a predefined list of allowable supplemental qualifiers (QNAM/QLABEL)

If I understand correctly it is easy to create a custom configuration with existing rules switched off
e.g

  • create a new folder under *C:\Users<username>\Documents\Pinnacle 21 Community\configs*
  • copy and edit an existing configuration file, deleting any val:ValidationRuleRef tags from within each ItemGroupDef as required

But is it possible to add ‘new’ checks into a configuration?
If so, is there any documentation available on how to do this? and what type of checks can be done.

many thanks for any help on this