As TIG USER, I want to instruct the Rule Engine on the specific type of data (also known as the "TIG Use Case") to ensure that only relevant rules from the TIG rule catalog are applied to validate my data.

[chowsanthony]

Assumptions, subject to change as the TIG eSub pilot (Pilot) project evolves:

• Use cases: Nonclinical, Product Description, Individual Health, Analysis.
• A submission may contain any or all of the use cases.
• Two submission types are in scope for the Pilot: Premarket Tobacco Product Application (PMTA) and Substantial Equivalence (SE)
• Each use case has its own folder container. Although this is similar to eCTD, CDISC will confirm with FDA CTP about their strategy. Refer to Appendix A in this FDA CTP guidance: Electronic Submission File Formats and Specifications
• Define.xml is not in scope for the Pilot.
• Participants at the Pilot should be able to create custom domains.

[chowsanthony]

Since all SEND and SDTM rules in the TIG rule catalog always include a Class and at least one of the following: Dataset or Domain or Variable information, I support the suggestion that Use Case should be placed with Standards, rather than placed outside of it:

Authorities > Organization > Standards > Name: TIG > Use Case

[eljanssens]

@SFJohnson24 and @chowsanthony: Does this ticket also include that when 1 conformance rule ID is split up in several CORE Rules per for example Use Case, that the 'Use Case' will also be taken into consideration of selecting which domains are in scope of the CORE rule? You don't want output for PROD domains on the INDH rule. Or should I create a separate ticket for that?

[chowsanthony]

I also followed up with Jon N. to ensure that proper care was taken when reusing rules from the SEND and SDTM rule catalogs, particularly in maintaining attributes related to scope. He acknowledged that exceptions could occur but stated they are rare and that he does not recall any deliberate instances.

[chowsanthony]

Does this ticket also include that when 1 conformance rule ID is split up in several CORE Rules per for example Use Case, that the 'Use Case' will also be taken into consideration of selecting which domains are in scope of the CORE rule?

We assume that each [eCTD] folder contains only one type of use case. Please review the FDA CTP document referenced above to see if you reach the same conclusion. I will bring this up at the next FDA CTP meeting to confirm.

[eljanssens]

@chowsanthony : I'm not sure if indeed Product Description Datasets will be submitted separately from the Individual Health Datasets. I think they are both submitted in Module 5. But indeed, FDA CTP can give a better answer.
But, even if the datasets are submitted in another module based on Use Case, you still do not want a TIG conformance rule with Use Case = INDH to run and provide output for datasets on product description. So if Use Case is under 'authorities', which is fine for me, the Use Case should be used as information to run only on the datasets mentioned in the 'Use Case'. So it is similar to 'scope'. And even if you have a selection of rules per Module (which is what this ticket means I think), maybe the industry also wants to use them outside of the FDA environment. Please also note that TIG0002 part B checks a NONCLIN dataset (TX) versus (TO). I asked Christine C if it is a possibility to submit both NONCLIN and INDH datasets in 1 submission and she confirmed so this rule is programmed.
This ticket means that you will be able to select in the Engine to run rules per Use Case but that is in my opinion something different from having 'Use Case' as a scope of the rule and only run on the correct datasets. I'm happy to discuss this further.

[chowsanthony]

Els's point about using it outside the CTP environment is valid. In a way, that itself is another "use case"—no pun intended.

[SFJohnson24]

This was closed with #1556