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I need to capture more information from the user when they create a freeze.

  • Review schema/USDM_API_v4.0.0.json and the python module usdm and create pydantic models in src/soa_builder/web/schemas.py for study_amendment, study_amendment_impact, study_amendment_reason
  • Add a checkbox that the user can use when creating a freeze to identify a freeze as a protocol amendment (freezes.py & freezes.html)
  • If the user identifies the freeze as a protocol amendment, the user must be presented with a form to add properties for the amendment that correspond to study_amendment
    • The UID for an Amendment must be "StudyAmendment_{n}"
    • A primary reason must be required when creating an amendment
    • The UID for a primaryReason must be "StudyAmendmentReason_{n}"
    • The user must choose the code for a primaryReason from a drop-down select populated with submission_value from API call to the DDF terminology with codelist_code=C207415.
    • If the user chooses codelist_code=C207415 and code=C17649, the user must complete an text box containing the value for otherReason.
    • The user can create 0..n secondaryReasons for an amendment. This is optional.
    • The UID for a secondaryReason must be "StudyAmendmentReason_{n}"
    • The user must choose the code for a secondaryReason from a drop-down select populated with submission_value from API call to the DDF terminology with codelist_code=C207415.
    • If the user chooses codelist_code=C207415 and code=C17649, the user must complete an text box containing the value for otherReason.
    • The user must be able to enter 0..n changes to be associated with the amendment.
    • The UID for a change must be "StudyChange_{n}"
    • The user must be able to add 0..n changeSections
    • The UID for a changedSection must be "DocumentContentReference_{n}"
    • The user must be able to add impacts to an Amendment.
    • The UID for an impact must be "SteudyAmendmentImpact_{n}"
    • The use must choose a type for an impact from a drop-down select populated with submission_value from API call to the DDF terminology with codelist_code=C215481
    • Defer implmentation of geographicScopes, enrollments and dateValues
  • Create new database objects as required and follow the same design principals used elsewhere in the project.

Coding Notes:

  • UIDs are auto-generated monotonically, scanning live + audit tables so deleted UIDs are never recycled.
  • Follow the design principals used for other classes in the USDM.
  • Use caching where appropriate to prevent multiple calls to the API and enhance performance of the application.