Rule blocked: CORERULES-9870

[aniemes]

Define-positive.txt

unit-test-coreid-FB0405-positive1.xlsx

Links to related JIRA Tickets

• https://jira.cdisc.org/projects/CORERULES/issues/CORERULES-9870

Rule Information

• Standard: FDA SDTM
• Rule ID: FB0405
• Rule Description: Define.xml does not contain ItemGroupDef for the respective Domain
  with attribute def:HasNoData marked as "Yes"

Describe the problem
The engine will need a way to check if a particular domain exists in the list of domains in the ItemGroupDefs in the Define xml. I am hoping to use a new operator that is a listing of all the dataset_names but from the define instead.

Proposed rule logic

Check:
  all:
    - name: define_dataset_names
      operator: not_exists
      value: 'LB'
Core:
  Status: Draft
  Version: '1'
Description: 'Define.xml does not contain ItemGroupDef for the respective Domain
  with attribute def:HasNoData marked as "Yes"'
Executability: Fully Executable
Outcome:
  Message: 'Dataset LB is missing'
  Output Variables:
    - define_dataset_names
Rule Type: Define Item Group Metadata Check

Screenshots
If applicable, add screenshots to help explain your problem and solution.

[OGarcia11]

Maybe the merge needs to be change to a full outer join.

[eljanssens]

@SFJohnson24 to be able to complete this rule, a new metadata variable needs to be created similar to id=define_variable_has_no_data
ItemGroupDef.ItemRef.HasNoData

but then at dataset level:
define_dataset_has_no_data
ItemGroupDef.HasNoData

This also needs an update to
define_dataset_name
ItemGroupDef.Domain

Domain is the domain value, Name is the dataset name:
define_dataset_name
ItemGroupDef.Name

define_dataset_domain
ItemGroupDef.Name

Rule should do something like this: (example is for SE, but other domains are applicable as well LB, PP, PC,...

Check:
all:

• name: ItemGroupDef.Name
  operator: equal_to
  value: "SE"
  value_is_literal: True
• name: ItemGroupDef.HasNoData
  operator: not_exists
• name: SE
  operator: not_exists

So it needs to look in the define-xml for the correct dataset (ItemGroupDef.Name) and then check if data are collected (if data are not collected then ItemGroupDef.HasNoData is present) and then check if the dataset itself exists.

Rule Type --> I guess this is Dataset Metadata against Define-XML

Is this something you can look into or should we discuss during next developers meeting who will take this one?

[eljanssens]

It seems to exist in the code 'define_dataset_has_no_data' but:

• but needs to be updated in the schema as well.
• and in the reference guide
• Plus it should be possible to have a rule type that works with define_has_no_data and domain exists as it seems that define_dataset_has_no_data doesn't work with Domain Presence Check as rule type.

[gerrycampion]

I would expect to see this variable with any rule type where we see the variable define_dataset_name

[eljanssens]

@OGarcia11 as this ticket is assigned to Sam, can yo please unassign me?