17R3.4 EDC Data Model Changes

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

• 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.