17R3.5 EDC Data Model Changes

As part of standardizing the configuration, we’ve made the following changes to standard configuration in all EDC vaults:

• Removed the SDV Mode (sdv_mode__v) field from the following objects. This field was not used for the SDV feature.
  • Event (event__v)
  • Form (form__v)
  • Item Group (item_group__v)
• The Unit Definition (unit_definition__v) field is no longer required on the Unit Item Definition (unit_item_def__v) object.
• Added the Study (study__v) field on the Codelist Item Definition (codelist_def_item_def__v) object to support versioning features.
• Added the following items to support the Data Manager Review feature:
  • Added the DMR (dmr__v) value to the Review Plan Type (review_plan_type__v) picklist
  • Added the DMR Mode (dmr_mode__v) field to the Item (item__v) object
• Added the following items to support the Unit Versioning feature:
  • Item Unit Definition (item_def_unit_def__v) object
  • Unit Definition - Unit Item __Def (unit_def_unit_item_def__v) object
  • New fields on the Unit Item Definition (unit_item_def__v) object:
    • Version (version__v)
    • CDM Key (cdm_key__v)
    • Previous Version (previous_version__v)
    • Study (study__v)
• Added the Validating (validating__v) and Validated (validated__v) values to the Definition Status (definition_status__v) picklist to support the Casebook Validations feature.
• Added the Definition Status (definition_status__v) field, with the default value In Progress (in_progress__v) on the following objects:
  • View Definition (view_definition__v)
  • Rule Definition (rule_definition__v)
  • Review Plan (review_plan__v)