18R1.4 EDC Data Model Changes

Release Date: July 13, 2018


As part of the 18R1.4 release, 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 future enhancements
  • Added the following fields to the Review State (review_state__v) object to support future enhancements:
    • Study (study__v)
    • Study Country (study_country__v)
    • Site (site__v)
    • Subject (subject__v)
  • 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 new Review (review__v) tab to support future enhancements
  • Added the Sponsor (sponsor__v) field to the Medical Coding Request (mc_request__v) object to support future enhancements
  • Removed the following fields from the Medical Coding Request (mc_request__v) object to support future enhancements:
    • Dictionary Detail MedDRA (dictionary_detail_meddra__v)
    • Dictionary Detail WHODrug (dictionary_detail_whodrug__v)
    • Dictionary Detail Custom (dictionary_detail_custom__v)
    • MPID (mpid__v)
    • Name Specifier (name_specifier__v)
    • Ingredients (ingredients__v)
    • Country of Sale (country_of_sale__v)
    • Marketing Auth Holder (marketing_auth_holder__v)
    • Pharmaceutical Form (pharmaceutical_form__v)
    • Strength (strength__v)
    • Generic (generic__v)
    • Preferred (preferred__v)
  • Added the new Med Coding WHODrugB3 Dictionary Detail (mc_dictionary_detail_whodrugb3__v) object to support future enhancements
  • Renamed the Med Coding WHODrug Dictionary Detail (mc_dictionary_detail_whodrug__v) object to Med Coding WHODrugC3 Dictionary Detail (mc_dictionary_detail_whodrugc3__v) and renamed the following fields:
    • Substance Code (substance_code__v) to Preferred Code (preferred_code__v)
    • Substance Name (substance_name__v) to Preferred Name (preferred_name__v)
    • Ingredients (ingredients__v) to Active Ingredients (active_ingredients__v)
  • Added the following fields to the Med Coding WHODrugC3 Dictionary Detail (mc_dictionary_detail_whodrugc3__v) object to support future enhancements:
    • Company (company__v)
    • Company Country (company_country__v)
    • Reference Country (reference_country__v)
    • Source Country (source_country__v)
    • Reference (reference__v)
    • Year of Reference (year_of_reference__v)
    • Create Date (create_date__v)
    • Date Changed (date_changed__v)
    • Official ATC Code (official_atc_code__v)
    • Sequence Number 3 (sequence_number_3__v)
    • Sequence Number 4 (sequence_number_4__v)
    • Route of Administration (route_of_administration__v)
    • Product Group (product_group__v)
    • Product Type (product_type__v)
  • 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

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