Data Model Changes in 18R3

Pre-Release Date: October 29, 2019 | Release Date: November 30, 2018

Release Date: November 30, 2018

We’ve made the following changes to standard configuration in all CDMS vaults:

  • Added the following values to the EDC Job Types (edc_job_type__v) picklist to support the Re-assign SDV & DMR from EDC Tools > Jobs feature:
    • DMR Re-assignment (tdmr__v)
    • SDV Re-assignment (tsdv__v)
  • Added the Order (order__v) field to the Item Group Definition - Item Definition (itemgroup_def_item_def__v) object to support the Views Editor Enhancements feature
  • Added the CDM Key (cdm_key__v) field to the following objects in support of future enhancements:
    • View Set Definition (view_set_def__v)
    • View Definition (view_def__v)
    • Column Definition</em< (column_def__v)
    • Column Binding Definition (column_binding_def__v)
  • Removed the “User must always enter a value (required)” setting from the Value (value__v) field on the Medical Coding Application Settings (mc_application_settings__v) object
  • Added the Approval Status (approval_status__v) to the Medical Coding Synonym List Detail (mc_synonym_list_detail__v) object to support the Synonym List Management feature
  • Added the following objects to support Stop List Management:
    • Medical Coding Stop List (mc_stop_list__v)
    • Medical Coding Stop List Detail (mc_stop_list_detail__v)
    • Medical Coding Stop List Item Def Rel (mc_stop_list_def_rel__v)
  • Gave Read, Create, Edit & Delete permission on the EDC Job (edc_job__v) and EDC Scheduled Job (edc_scheduled_job__v) objects to the EDC Data Manager and EDC Lead Data Manager security profiles to support the Ad Hoc Data Exports feature
  • Added the following fields to the Medical Coding Synonym List (mc_synonym_list__v) and Medical Coding Synonym List Detail (mc_synonym_list_detail__v) objects to support the Upversion a Study’s Forms & Synonym Lists feature:
    • Medical Coding Dictionary Definition (dictionary_def__v)
    • Medical Coding Dictionary Release (dictionary_release__v)
    • Medical Coding Object Status (object_status__v) - Medicial Coding Synonym List object only
  • Added Page Links to the Review tab as a general enhancement
  • Gave Read permission to the Review for Signature (rev_sign__v) field on the following objects to allow the EDC CRC security profile to view the Signed Form icon:
    • Event (event__v)
    • Form (form__v)
    • Item Group (item_group__v)
    • Item (item__v)
  • Added the following fields to the Event (event__v) object to support the Event-Level SDV amd DMR Timestamps feature:
    • External ID (external_id__v)
    • Event SDV Date (sdv_datetime__v)
    • Event DMR Date (dmr_datetime__v)
  • Added the Event Group Repeating Label Definitions object to support the Manage Repeating Event Group Labels feature
  • Additional changes to support future enhancements:
    • Added the Integration Mode (mc_integration_mode__v) picklist
    • Added the Approval Workflow (mc_approval_workflow__v) picklist
    • Added the Approval Status (mc_approval_status__v) picklist
    • Added the MedDRA Coding Level (mc_meddra_coding_level__v) picklist