Product designation - Jira ticket

[BSnoeijerCD]

See JIRA ticket 526: The diagram in Section 4.16, Study Interventions has a 1:1 cardinality on the "product designation" link to Code . This would seem to imply that a study intervention involves a product, though the cardinality of the "administrations" link between Study Intervention Agent Administration allows for zero Agent Administrations.

=> consider to move relationship productDesignation to AdministrableProduct class.

[ASL-rmarshall]

@EMuhlbradt @czwickl I happened to be looking at the codelist for productDesignation (C207418) in the published DDF Terminology spreadsheet (not the USDM_CT spreadsheet) and noticed that it has the following attributes that are not specified in the USDM_CT spreadsheet:

• Codelist Name: Study Intervention Product Designation Value Set Terminology
• Description: The terminology relevant to the study intervention product designation value set.

Now that we're moving the productDesignation relationship from StudyIntervention to AdministrableProduct, I was wondering how this will be handled:

• Will these codelist-level attributes just be updated to reference "administrable product" instead of "study intervention",
• Will they be left as originally defined,
• Will it be necessary to create a new codelist (with a new C-code) and deprecate the old one, or
• Are terminology changes like this handled in different way?

[ASL-rmarshall]

We discussed this at the scrum meeting on 2024-11-21. The C-code for the codelist will be retained and the codelist name and description will be updated to remove the reference to the class - e.g., the Codelist Name will become "Product Designation Value Set Terminology", which is appropriate for use with both:

• StudyIntervention.productDesignation (for anyone still using USDM v3.8.0 or before) and
• AdministrableProduct.productDesignation (for anyone using USDM v3.9.0 or after).