18R1 Data Model Changes: EDC

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

• Added the following items to support the Admin: Job Listing in Study Tools Feature
  • EDC Jobs (edc_job_lifecycle__v) lifecycle
  • EDC Job (edc_job__v) object
  • EDC Job Status (edc_job_status__v) picklist
  • EDC Job Type (edc_job_type__v) picklist
  • Link Status (link_status__v) picklist
• Added the Read-only (read_only__v) value to the Item Type (item_type__v) picklist to support the Read-Only Fields feature.
• Added the Deployed with Error (deployed_with_error__v) and Deployed with Failures (deployed_with_failures__v) values to the Inbound Package Component Status (vault_pkg_comp_status__v) picklist for continued configuration migration support.
• Removed the Short Label (short_label__v) field from the Event Definition (event_def__v) and Form Definition (form_def__v) objects to support Label Override for Design View feature.
• Removed the Hint Label (hint_label__v) field from the Item Definition (item_def__v) object to support object reuse.
• Added the Mirror Query Status (mirror_query_status__v) field to the Query Binding (query_binding__v) object to support the Admin: Query Rules in Study Tools feature.
• Added the following fields related to configuration migration to the Inbound Package Step (vault_package_step__v) object:
  • Step Required (step_required__v)
  • Stop on Errors(stop_on_error__v)
  • Step Type (step_type__v)
• Added the following fields related to performance metrics to the Performance Statistics (perf_stats__v) object:
  • Record Action Count (record_action_count__v)
  • Record Trigger Count (record_trigger_count__v)
  • Total Obj Count (total_obj_count__v)
  • Total Obj Record Count (total_obj_record_count__v)
• Added the EDC > Study Tools > Access permission and the EDC Study tools Permissions permission set. Added the EDC Study Tools Permissions permission set to the EDC Lead Data Manager security profile.
• Added the following items to support the Codelist Versioning feature:
  • Codelist Definition – Codelist Item Def (codelist_def_codelist_item_def__v) object
  • Item Definition – Codelist Definition (item_def_codelist_def__v) object
  • Version (version__v) field on the Codelist Definition (codelist_def__v) object and Codelist Item Definition (codelist_item_def__v) objects
  • Previous Version (prev_version__v) and CDM Key (cdm_key__v) fields on the Codelist Item Definition (codelist_item_def__v) object
• Added the Intentionally Left Blank Reason (intentionally_left_blank_reason__v) field on the Form (form__v), Item Group (item_group__v), and Item (item__v) objects to support the Mark Field as Intentionally Left Blank feature.
• Added the following fields to support the Audit Trail Enhancements for Item History feature:
  • Value Modified Date (value_modified_date__v) on the Item (item__v) object
  • First Response Date (first_response_date__v) on the Query (query__v) object
  • Last Close Date (last_close_date__v) on the Query (query__v) object
  • DMR Date (dmr_date__v) on the Form (form__v) object
  • Frozen Date (frozen_date__v) on the Form (form__v) object
  • Locked Date (locked_date__v) on the Form (form__v) object
  • SDV Date (sdv_date__v) on the Form (form__v) object
  • Signed Date (signed_date__v) on the Form (form__v) object
  • Submit Date (submit_date__v) on the Form (form__v) object
• Removed the EDL (edl__v), EDL Item (edl_item__v), EDL Template (edl_template__v), and EDL Item Template (edl_item_template__v) objects. Documents are not available in EDC application 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)
• Added an Audit Trail (user_role_assignment__v) to the User Role Assignments feature.