Data Model Changes in 18R2

Release Date: August 10, 2018

We’ve made the following changes to standard configuration in all Clinical Data Management vaults:

  • Added run-time prompts to the following standard template reports:
    • Standard Template: Overdue Form Entry per Event: Prompts for Study and Overdue Date
    • Standard Template: Query Aging by Site: Prompts for Study
    • Standard Template: Schedule Deviation Report: Prompts for Study
  • Added the new Rule Result (rule_result__v) object to support the Dynamic Form & Event Rule Actions features
  • Added the new Study Setting (study_setting__v) object to support future enhancements
  • Removed the Tabs: Casebooks: View permission from the Base EDC User permission set
  • Added the Tabs: Casebooks: View permission to the Base CRA Permissions, Base Data Manager Permissions, and EDC Reviewer Permissions permission sets
  • Added default Country (country__v) object records to support Study Country Administration in Study Tools
  • Added the new Event Operational Summary (event_operational_summary__v) object to support the Event Operational Summary Report Templates feature
  • Added the Required (required__v) field to the Column Definition Binding (column_definition_binding__v) object to support the Require Data for Row Export feature
  • Added the following standard Change Reason Configuration (change_reason_configuration__v) object records of the Item (item__v) type and Intentionally Left Blank (intentionally left blank__v) subtype to support improvements to the Mark Field as Intentionally Left Blank functionality:
    • ITEM_NotAvailable
    • ITEM_NotDone
    • ITEM_ProcedureNotPerformed
    • ITEM_IllegibleSourceDocument
  • Added the following items to support future application updates:
    • New Coder (coder__v) tab
    • New objects:
      • Med Coding WHODrugC3 Dictionary Detail (mc_Dictionary_detail_whodrugc3__v)
      • Added the new Med Coding WHODrugB3 Dictionary Detail (mc_dictionary_detail_whodrugb3__v) object to support future enhancements
      • Medical Coding Application Setting (mc_application_setting__v)
      • Medical Coding Custom Dictionary Detail (mc_dictionary_detail__custom__v)
      • Medical Coding Dictionary Definition (mc_dictionary_def__v)
      • Medical Coding Dictionary Release (mc_dictionary_release__v)
      • Medical Coding Item Def Related Item (mc_item_def_related_item__v)
      • Medical Coding Item Definition (mc_item_def__v)
      • Medical Coding MedDRA Dictionary Detail (mc_dictionary_detail_meddra__v)
      • Medical Coding Note (mc_request_note__v)
      • Medical Coding Other Property (mc_other_property__v)
      • Medical Coding Query Template (mc_query_template__v)
      • Medical Coding Request (mc_request__v)
      • Medical Coding Request Query (mc_request_query__v)
      • Medical Coding Request Suggestion (mc_request_suggestion__v)
      • Medical Coding Study Setting (mc_study_setting__v)
      • Medical Coding Suggestions Coding Def (mc_suggestions_coding_def__v)
      • Medical Coding Synonym List (mc_synonym_list__v)
      • Medical Coding Synonym List Detail (mc_synonym_list_detail__v)
  • Added the Study Tools (study_tools__v) tab as the Study Tools Tab feature
  • Added the EDC Scheduled Job (edc_scheduled_job__v) object to support the Scheduled Jobs feature
  • Added the URL (url__v) value to the Data Type (data_type__v) picklist to support the URL Link Item Control feature
  • Added the Reason for Change Other Specify (reason_for_change_other_specify__v) field on the Study Configuration (study_configuration__v) object and set the field’s default value to False to support the Reason for Change & Intentionally Left Blank Support Comments feature
  • Added the Review Plan Site (review_plan_site__v) object to support the Site-Specific Review Plans feature
  • Added the Event Operational Summary (event_operational_summary__v) object to support the New Event Window Status, Form Counts & Other Operational Summary Metrics feature
  • Added the following to support the Clinical Data Export in SAS Format feature:
    • SAS Enabled (sas_enabled__v) field on the View Set (view_set__v) object
    • View Status (view_status__v) field on the View (view__v) object
    • Added fields on the Column (column__v) object:
      • Hidden (hidden__v)
      • Column Label (column_label__v)
      • SAS Length (sas_length__v)
      • SAS Type (sas_type__v)
      • SAS Format (sas_format_v)
  • Added the following to support the Subject Milestones & Veeva CTMS Connection feature: 
    • Study (study__v) object reference field on the View Definition (view_definition__v), Column Definition (column_definition__v), and Column Binding Definition (column_binding_definition__v) objects
    • Added the following values to the Subject Status (subject_status__v) picklist:
      • Randomized (randomized__v)
      • End of Treatment (end_of_treatment__v)
      • Complete (complete__v)
    • Added the following fields to the Subject (subject__v) object: 
      • Screened Date (screened_date__v)
      • Screen Failed Date (screen_failed_date__v)
      • Randomized Date (randomized_date__v)
      • Enrolled Date (enrolled_date__v)
      • Withdrawn Date (withdrawn_date__v)
      • End of Treatment Date (end_of_treatment_date__v)
      • End of Study Date (end_of_study_date__v)
    • Added the Basic Status (basic_status__v) picklist
  • Added the following to support the Reviews on Event Dates feature: 
    • Added the Review State Definition (review_state_definition__v) and Review State (review_state__v) objects
    • Added the Review State Definition (review_state_definition__v) field to the Review Plan Object Definition (review_plan_object_definition__v) object
  • Added the new Review (review__v) tab to support the Specialized Application Area for Site Review & Monitoring Feature