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