22R1 Data Model Changes: Regulatory

With every release, we update the data model to better support evolving needs and new feature functionality. With this release, we’ve added the following components to the Regulatory data model. These data model updates are automatically included in all Regulatory Vaults, but Admins must make configuration changes to make them available. For information on feature functionality, see What’s New in 22R1.

Added the Submitted (submitted__v) picklist value to the Active Dossier Status (active_dossier_status__v) field to support the Capture Active Dossier Submitted Status feature.

Added the IDMP Grouping (idmp_grouping__v) object to support the IDMP Viewer feature.

Added the TOC Edited by User (toc_edited_by_user__v) field to the Content Plan Item (edl_item__v) object to support the Manage & Edit Table of Contents (TOC) feature

Added the following components to support the Label Process Improvements feature:

• Added the following fields to the Labeling Concept (labeling_concept__v) object:
  • Document to be Updated (document_to_be_updated__v)
  • Updated Document (updated_document__v)
  • Contains Core Safety Information (contains_core_safety_information__v)
• Added the following fields to the Labeling Deviation (labeling_deviation__v) object:
  • Resulting Local Label (resuling_local_label__v)
  • Deviation Review Disposition (deviation_review_disposition__v)
• Added the Labeling Deviation (labeling_deviation__v) shared document field.
• Added the following fields to the Activity (activity__rim) object:
  • Impacts Artwork (impacts_artwork__v)
  • Safety Category (safety_category__v)
  • Lead Reference Market Due Date (lead_reference_market_due_date__v)
  • Due Date (due_date__v)
• Added the Lead Dependency (lead_dependency__v) field to the Activity Dependency (activity_dependency__v) object.
• Added the following join objects and components, available in RIM Registrations Vaults only:
  • HAQ-Labeling Deviation (haqlabeling_deviation__v)
  • Activity-Labeling Concept (activity_labeling_concept__v) with an associated object lifecycle, Activity Labeling Concept (activity_labeling_concept_lifecycle__v)
• Added the Local Concept Disposition (local_concept_disposition__v) picklist.
• Added the Multiple Lead Dependencies Identified (multiple_lead_dependencies_identified__v) object message.

Added or updated the following components to support the Create Related Records Enhancements feature:

• Added the Event Authorization (event_authorization__v) object with the following object types:
  • Device Certificate (device_certificate__v)
  • Device Listing (device_listing__v)
  • Device Premarket Submission (device_premarket_submission__v)
• Added the following components to the Event Site Organization (event_site_organization__v) object:
  • Fields:
    • Product (product__v)
    • Make Contact Details Public (make_contact_details_public__v)
  • Object Types:
    • Product Organization (product_organization__v)
    • Site Organization (site_organization__v)
• Added the following components to the Event Product Characteristic (event_product_characteristic__v) object:
  • Fields:
    • Administers or Removes Medicinal Product (administers_or_removes_medicinal_product__v)
    • Clinical Size (clinical_size__v)
    • Companion Diagnostic (companion_diagnostic__v)
    • Device is a Combination Product (device_is_a_combination_product__v)
    • Device is a Kit (device_is_a_kit__v)
    • Device Model or Version (device_model_or_version__v)
    • Device Name (device_name__v)
    • Exempt from Direct Marking (exempt_from_direct_marking__v)
    • Exempt from Premarket Submission (exempt_from_premarket_submission__v)
    • For Near-Patient Testing (for_nearpatient_testing__v)
    • For Patient Self-Testing (for_patient_selftesting__v)
    • For Professional Testing (for_professional_testing__v)
    • For Single-Use (for_singleuse__v)
    • Implantable IIb Exception (implantable_iib_exception__v)
    • Maximum Number of Reuses (maximum_number_of_reuses__v)
    • New Device According to EU IVDR (new_device_according_to_eu_ivdr__v)
    • Non-Medical Purpose (nonmedical_purpose__v)
    • Over the Counter (over_the_counter__v)
    • Prescription Use (prescription_use__v)
    • Product Information URL (product_information_url__v)
    • Production Identification Method (production_identification_method__v)
    • Reusable Surgical Instrument (reusable_surgical_instrument__v)
    • Special Device Type (special_device_type__v)
  • Object Types:
    • Device Clinical Size (device_clinical_size__v)
    • Device Non-Medical Purpose (nonmedical_purpose__v)
    • Device Product Characteristics (device_product_characteristics__v)
    • Device Product Variant Characteristics (device_product_variant_characteristic__v)
    • Device Product Identification Method (device_production_identification_meth__v)
• Updated the Event Product Characteristic (event_product_characteristic__v) object field Characteristic Value (characteristic_value__v) to allow configuration as a required field.
• Added the following components to the Event Packaging Characteristic (event_packaging_characteristic__v) object:
  • Fields:
    • Labeled as Not Made With Natural Latex (labeled_as_not_made_with_natural_latex__v)
    • MRI Safety Status (mri_safety_status__v)
    • Package Type (package_type__v)
    • Packaged as Sterile (packaged_as_sterile__v)
    • Reprocessed Single-Use Device (reprocessed_singleuse_device__v)
    • Requires Sterilization Prior to Use (requires_sterilization_prior_to_use__v)
    • Smallest Saleable Unit (smallest_salable_unit__v)
    • Sterilization Method (sterilization_method__v)
  • Object Types:
    • Packaged Device Characteristics (packaged_device_characteristics__v)
    • Packaged Device Sterilization Method (packaged_device_sterilization_method__v)
• Updated the Event Packaging Characteristic (event_packaging_characteristic__v) object field Characteristic Value (characteristic_value__v) to allow configuration as a required field.
• Added the Substance Classification (substance_classification__v) field to the Event Active Substance (event_active_substance__rim) object.
• Added the Medical Device Type (medical_device_type__v) field to the Event Product (event_drug_product__rim) object.

Added the following components to support the Submission Wizard feature:

• Objects:
  • Application Active Substance (application_active_substance__v)
  • Application Product (application_pharmaceutical_product__v)
  • Application Inactive Ingredient (application_inactive_ingredient__v)
  • Application Packaging (application_packaging__v)
  • Application Clinical Study (application_clinical_study__v)
  • Application Nonclinical Study (application_nonclinical_study__v)
  • Application Contact (application_contact__v)
  • Application Packaging Characteristic (application_packaging_characteristic__v)
  • Application Product Characteristic (application_product_characteristic__v)
  • Application Product Classification (application_product_classification__v)
  • Application Site Contact (application_site_contact__v)
  • Application Organization (application_site_organization__v)
  • Application Site Role (application_site_role__v)
  • Application Regulatory Text (application_regulatory_text__v)
  • Application Shelf Life or Condition (application_shelf_life_storage__v)
  • Application Authorization (application_authorization__v) 
• Added the Application Source (application_source__v) field to the following Submission join objects:
  • Submission Active Substance (submission_active_substance__rim)
  • Submission Product (submission_pharmaceutical_product__rim)
  • Submission Inactive Ingredient (submission_inactive_ingredient__rim)
  • Submission Packaging (submission_packaging__rim)
  • Submission Indication (submission_indication__rim)
  • Submission Clinical Study (submission_clinical_study__rim)
  • Submission Nonclinical Study (submission_nonclinical_study__rim)
  • Submission Contact (submission_contact__rim)
  • Submission Packaging Characteristic (submission_packaging_characterisstic__v)
  • Submission Product Characteristic (submission_product_characteristic__v)
  • Submission Product Classification (submission_product_classification__v)
  • Submission Site Contact (submission_site_contact__rim)
  • Submission Organization (submission_site_organization__v)
  • Submission Site Role (submission_site_role__v)
  • Submission Regulatory Text (submission_regulatory_text__v)
  • Submission Shelf Life or Condition (submission_shelf_life_storage__v)
  • Submission Authorization (submission_authorization__v)
• Added the Application Source (application_source__v) field to the following Regulatory Objective join objects:
  • Regulatory Objective Active Substance (regulatory_objective_active_substance__v)
  • Regulatory Objective Clinical Study (regulatory_objective_clinical_study__v)
  • Regulatory Objective Inactive Ingredient (regulatory_objective_inactive_ingredient__v)
  • Regulatory Objective Indication (regulatory_objective_indication__v)
  • Regulatory Objective Nonclinical Study (regulatory_objective_nonclinical_study__v)
  • Regulatory Objective Packaging (regulatory_objective_packaging__v)
  • Regulatory Objective Product (regulatory_objective_drug_product__v)
  • Regulatory Objective Regulatory Text (regulatory_objective_regulatory_text__v)
  • Regulatory Objective ShelfLife Condition (regulatory_objective_shelf_life_storage__v)
  • Regulatory Objective Site Contact (regulatory_objective_site_contact__v)
  • Regulatory Objective Organization (regulatory_objective_site_organization__v)
  • Regulatory Objective Site Role (regulatory_objective_site_role__v)
  • Reg Objective Packaging Characteristic (reg_objective_packaging_characteristic__v)
  • Reg Objective Product Characteristic (reg_objective_product_characteristic__v)
  • Reg Objective Product Classification (reg_objective_product_classification__v)
  • Regulatory Objective Authorization (regulatory_objective_authorization__v)
• Added the Use for Content Planning (use_for_content_planning__v) field to the Application Pharmaceutical Form object (application_pharmaceutical_form__v) object.
• Added the Regulatory Objective Product (regulatory_objective_product__v) field to the Regulatory Objective Inactive Ingredient (regulatory_objective_inactive_ingredient__v) object.
• Added the Regulatory Objective Indication (regulatory_objective_indication__v) field to the Regulatory Objective Clinical Study (regulatory_objective_clinical_study__v) object.
• Unlocked the Object Type Mapping (object_type_mapping__v) object for all RIM applications.

The following component updates also support the Submission Wizard feature:

• Updated the Application Country (application_country__rim) object per the below. Note: At the 22R1 General Release, the data model changes described will only be applied to Vaults where Relate Multiple Records is not already enabled. System managed naming will be enabled only in Vaults where Values must be unique is enabled on the Name. Additionally, Name value formats will not be set if one is already defined.
  • Added object fields:
    • XML Country Code (xml_country_code__v)
    • Use for Content Planning (use_for_content_planning__v)
  • Enabled the Relate Multiple Records object configuration option.
  • Updated the Name (name__v) field to be system-managed (System manages field value configuration option) with Value Format set to {country_rimr.name_v}-{##}.
• Updated the Application Indication (application_indication__rim) object per the below. Note: At the 22R1 General Release, the data model changes described will only be applied to Vaults where Relate Multiple Records is not already enabled. System managed naming will be enabled only in Vaults where Values must be unique is enabled on the Name. Additionally, Name value formats will not be set if one is already defined.
  • Added object fields:
    • XML Indication (xml_indication__v)
    • Use for Content Planning (use_for_content_planning__v)
  • Enabled the Relate Multiple Records object configuration option.
  • Updated the Name (name__v) field to be system-managed (System manages field value configuration option) with Value Format set to {therapeutic_indication_rimr.name_v}-{##}.

Added the following components to support the Global Content Plan feature:

• Added the Event Pharmaceutical Form (event_pharmaceutical_form__v) object
• Added the Global Application (application__v.global_application__v) object type to the Application (application__v) object
• Added the Global Submission (submission__v.global_submission__v) object type to the Submission (submission__v) object
• Added the Submission Grouping (submission_grouping__v) field to the following objects:
  • Activity (activity__rim)
  • Country (country__v)
  • Content Plan Item (edl_item__v)
• Added the Use for Content Planning (use_for_content_planning__v) field to the following objects:
  • Event Active Substance (event_active_substance__rim)
  • Event Clinical Study (event_clinical_study__v)
  • Event Indication (event_indication__rim)
  • Event Product (event_drug_product__rim)
  • Event Inactive Ingredient (event_inactive_ingredient__rim)
  • Event Nonclinical Study (event_nonclinical_study__v)
• Added the Event Source (event_source__v) field to the following objects:
  • Submission Active Substance (submission_active_substance__rim)
  • Submission Clinical Study (submission_clinical_study__rim)
  • Submission Indication (submission_indication__rim)
  • Submission Product (submission_pharmaceutical_product__rim)
  • Submission Inactive Ingredient (submission_inactive_ingredient__rim)
  • Submission Nonclinical Study (submission_nonclinical_study__rim)
  • Submission Pharmaceutical Form (submission_pharmaceutical_form__v)
• Added the following fields to the Event (event__rim) object:
  • Global Content Plan (global_content_plan__v)
  • Content Plan Template (content_plan_template__v)
  • Global Application (global_application__v)
  • Global Submission (global_submission__v)
  • Event Complete Date (event_complete_date__v)
  • Initial Dispatch Date (initial_dispatch_date__v)
  • Last Dispatch Date (last_dispatch_date__v)
• Added the following fields to the Content Plan Item Template (edl_item_template__v) object:
  • Active Dossier Template (active_dossier_template__v)
  • Exclude Match from Active Dossier (exclude_match_from_active_dossier__v)
• Added the Event Indication (event_indication__v) field to the Event Clinical Study (event_clinical_study__v) object
• Added the Event Product (event_product__v) field to the Event Inactive Ingredient (event_inactive_ingredient__rim) object

The below components were added or updated to support data model changes for RIM Vaults in 22R1:

• If Common Application Countries (EU and GCC) do not exist, Country records for these countries will not be created by the Automatic creation of Application Country records RIM Setting.
• Updated component security as follows:
  • Contact (contact__rim) object field QPPV Code (qppv_code__v) values must be unique
  • Shelf Life (shelf_life__rim) object fields Shelf Life Period (shelf_life_period__rim) and Shelf Life Unit of Measurement (shelf_life_unit_of_measurement__v) are required
  • Hierarchical copy is allowed for the following object fields (relationships):
    • Application Country (application_country__rim) on the Application (application__rim) object
    • Application Regulatory Objective (application_regulatory_objective__v) on the Application (application__rim) and Regulatory Objective (regulatory_objective__v) objects
    • Submission Regulatory Objective (submission_regulatory_objective__v) on the Regulatory Objective (regulatory_objective__v) object
    • Submission Language (submission_language__rim) on the Submission (submission__rim) object
• Increased the maximum number of characters on the following fields:
  • • XML Clinical Study Title (xml_nonclinical_study_title__v) increased to 1000 (Object: Submission Nonclinical Study (submission_nonclinical_study__rim))
    • XML Nonclinical Study Title (xml_nonclinical_study_title__v) increased to 1000 (Object: Submission Nonclinical Study (submission_nonclinical_study__rim) 
    • External ID (external_id__v) increased from 50 to 60 (Object: Submission (submission__v))
    • Description of Change (description_of_change__rim) increased from 200 to 1500 (Object: Regulatory Objective (regulatory_objective__rim))
    • Related Change Control Number (related_change_control_number__rim) increased from 128 to 260 (Object: Event (event__rim))
    • Invented Name (invented_name__rim) increased to 250 (Object: Registration (registration__rim))
• Added the following fields to the Registration (registration__rim) object:
  • Expiration Date (expiration_date__v)
  • Renewal Due Date (renewal_due_date__v)
  • Sunset Clause Date (sunset_clause_date__v)
• The Registration (registration__rim) object rimobjectconfiguraton is updated to allow the following fields to be editable within the Manage Registered Details wizard:
  • Expiration Date (expiration_date__v)
  • Renewal Due Date (renewal_due_date__v)
  • Sunset Clause Date (sunset_clause_date__v)
• Added the Full Commitment Text (full_commitment_text__v) field to the Commitment (commitment__rim) object.
• Added the following fields to the Health Authority Question (health_authority_question__rim) object:
  • Full Question (full_question__v)
  • Full Response (full_response__v)
  • Product (drug_product__rim)
• Added the Report Component Type (report_component_type__v) picklist with picklist values:
  • Legacy Study Report (legacy_study_report__c)
  • Synopsis (synopsis__c)
  • Study Report Body (study_report_body__c)
  • Protocol or Amendment (protocol_or_amendment__c)
  • Sample Case Report Form (sample_case_report_form__c)
  • IEC IRB Consent Form List (iec_irb_consent_form_list__c)
  • List Description Investigator Site (list_descroption_investigator_site__c)
  • Signatures Investigators (signatures_investigators__c)
  • List Patients with Batches (list_patients_with_batches__c)
  • Randomsation Scheme (randomisation_scheme__c)
  • Audit Certificates Report (audit_certificates_report__c)
  • Statistical Methods Interim Analysis Plan (statistical_methods_interim_analysis_pla__c)
  • Inter-Laboratory Standardisation Methods Quality Assurance (interlaboratory_standardisation_methods__c)
  • Publications Based on Study (publications_based_on_study__c)
  • Publications Referenced in Report (publications_referenced_in_report__c)
  • Discontinued Patients (discontinued_patients__c)
  • Protocol Deviations (protocol_deviations__c)
  • Patients Excluded from Efficacy Analysis (patients_excluded_from_efficacy_analysis__c)
  • Demographic Data (demographic_data__c)
  • Compliance and Drug Concentration Data (compliance_and_drug_concentration_data__c)
  • Individual Efficacy Response Data (individual_efficacy_response_data__c)
  • Listing Individual Laboratory Measurements by Patient (listing_individual_laboratory_measuremen__c)
  • Case Report Forms (case_report_forms__c)