Replying at the top level, as nesting getting burdensome…
Overall, my understanding of the Technical Conformance Guide is that the agency did NOT impose a new interpretation on EPOCH, but rather that they have promoted it, for submissions to them, in applicable domains from a Core attribute of Permissible to Expected in SDTM parlance. This is still threading the needle on interpretation, but it seems to make sense from the quoted language. This is how I have understood it, and so would generally disagree with any rule violations around requiring EPOCH in MH if they did occur (documenting as appropriate).
As to the rest, only FDA and Pinnacle21 can really speak to rules or requirements that go beyond compliance/conformance to the base model. For such rules (both FDA and PMDA at this point), my understanding is that these have evolved through agency discussions, both internnaly, and with Pinnacle21 staff. As I have said to Pinnacle21 staff, the challenge with the published FDA rules is that they identify rule messages (as opposed to logic) as they appeared at the time (2014?) in the OpenCDISC software, which is not necessarily sufficient or appropriate to define all rules.
In the absence of a more robust specification, the industry is left with the Pinnacle21 interpretation as de facto guidance, with a need to critically examine the vendor implementation for correctness (a requirement regardless of circumstance or vendor to my mind), and with an avenue for documenting differences in understanding (Reviewer’s Guide).
Regardless of any additional burdens this may impose, I advocate that Reviewer’s Guides not be seen as punative, but rather as a clear line of communication between sponsor and agency.
Regards,
Carlo