Define rule: EligibilityCriteria are ordered correctly within study design and category through use of previous and next relationships.

[rbakercdisc1]

CHK0042: For Eligibility criteria relationships to next and previous and categories, see PBI #48 for informative similar example.

Inclusion and Exclusion criteria have relationship from Eligibility Criteria to Eligibility Criteria (criterion). The inclusion and exclusion criteria are differentiated by category.

Only one Eligibility Criterion can be first (no relationship to a previous Eligibility Criterion). Only one Eligibility Criterion can be last (no relationship to next Eligibility Criterion). This sequence occurs with each category of Eligibility Criteria.

• Inclusion
• Exclusion

[DianeWold]

That a name and a description must be one-to-one is true for multiple classes.

[DianeWold]

In USDM 2.6, the next and previous relationships are not differentiated by category, so the relationships would put the eligibility criteria into one list which would not necessarily separate inclusion and exclusion criteria.

[rbakercdisc1]

Category has a link out to code in the model.

Waiting on feedback from @daveih

[ASL-rmarshall]

In discussion with Berber, we agreed that ordering of eligibility criteria should be defined within category. There will therefore be a set of ordering check component similar to those described in #48, except that any checking specified as "within StudyDesign" should be performed within both StudyDesign and category. Some of the checking for EligibilityCriteria may be handled by the generic rules created for #89

[ASL-rmarshall]

I think this PBI should be just for the ordering defined by the next and previous relationships (which will include reference to the category). If specific checks are needed for category, these should be defined as separate rules - though I can't think of any that wouldn't already be covered by generic checks:

• "every eligibility criterion must have a category" is a cardinality check
• "the specified category must be valid" is a controlled terminology check

[ASL-rmarshall]

Moving this directly to Done because the first of the rules for checking the ordering check components has already been created - see #135 .