Amendment Reason update

[BSnoeijerCD]

As discussed during he scrum meeting on 31 October 2024, the use of Other in CDISC CT is not encouraged. However, M11 uses Other in their CT lists in many cases.

We discussed that if a CDISC Extended CT is used, the extended values not aligning to standard M11 CT can be mapped to `Other´ in M11 and then the specific value in the CT can be filled in the attribute of ´Other, Specify´. If more text is needed, then narrative content can be utilized for that.

With regards to amendment reason this implies that

• the current CT list should become extended.
• the attribute otherReason which was not not aligning with CT can be removed from the StudyAmendmentReason class
• the attribute Not applicable which is in M11 should be added
• At least 1 secondary reason is required (which may be set to not applicable).
• rules need to indicate what is required
  • not applicable not for primary reason

[BSnoeijerCD]

@dih-cdisc Based on the scrum discussion yesterday, @ASL-rmarshall and I discussed the potential updates. We still have some concerns which are depicted in the diagram below together with suggested updates.