Pre-Release Date: July 11, 2022 | Release Date: July 29, 2022 & August 5, 2022

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 22R2.

Data Model Updates

Added the Gateway Profiles (gateway_profiles__v) field to the Organization (organization__rim) object to support the Multiple Gateway Support feature.

Added the Generate compliant Viewable Rendition for Source PDFs (preprocess_pdf__sys) field to the Rendition Profile (rendition_profile__sys) object to support the RIM PDF Standardization feature.

Added the following fields to the Application Country (application_country__rim) object:

  • Entry Date (entry_date__v)
  • Role (role__v)
  • Withdrawn Date (withdrawn_date__v)

Added the Intended Effect (intended_effect1__v) field to the following objects:

  • IDMP Therapeutic Indication Element (idmp_therapeutic_indication_element__v)
  • Indication Grouping (indication_grouping__v)

Added the EURD ID (eurd_id__v) field to the Product (drug_product__v) object and its object type Simple Drug Product (simple_product__rim).

Increased the Product Detail Strength (product_detail_strength__v) field length to 100 characters. (Object: Product Detail (product_detail__v))

Added the EU Procedural Authority Role (eu_procedural_authority_role__v) value to the Controlled Vocabulary Type (controlled_vocabulary_type__rim) picklist.

Enabled hierarchical copy on the Application (application__v) field within the following objects:

  • Application Active Substance (application_active_substance__v)
  • Application Clinical Study (application_clinical_study__v)
  • Application Inactive Ingredient (application_inactive_ingredient__v)
  • Application Nonclinical Study (application_nonclinical_study__v)
  • Application Packaging (application_packaging__v)
  • Application Packaging Characteristic (application_packaging_characteristic__v)
  • Application Pharmaceutical Product (application_pharmaceutical_product__v)
  • Application Product Characteristic (application_product_characteristic__v)
  • Application Product Classification (application_product_classification__v)
  • Application Shelf Life Storage (application_shelf_life_storage__v)
  • Application Contact (application_contact__v)

Enabled the System manages field value (read-only) configuration for the Name (name__v) field within the following objects:

  • Submission (submission__v)
  • Therapeutic Coded Indications (therapeutic_coded_indications__rim)
  • Application Active Substance (application_active_substance__v)
  • Application Clinical Study (application_clinical_study__v)
  • Application Inactive Ingredient (application_inactive_ingredient__v)
  • Application Nonclinical Study (application_nonclinical_study__v)
  • Application Packaging (application_packaging__v)
  • Application Packaging Characteristic (application_packaging_characteristic__v)
  • Application Pharmaceutical Product (application_pharmaceutical_product__v)
  • Application Product Characteristic (application_product_characteristic__v)
  • Application Product Classification (application_product_classification__v)
  • Application Contact (application_contact__v)

Updated the PMS ID (pms_id__v) field within the Medicinal Product (medicinal_product__rim) object to require values to be unique.

Enabled the User must always enter a value (required) configuration for the below object fields:

  • Indication Translation (indication_translation__v) object fields:
    • Language (language__v)
    • Full Indication Text Translation (full_indication_text_translation__v)
  • IDMP Full Indication Text (full_indication_text_idmp__v) object fields:
    • Country (country__v)
    • Full Indication Text (full_indication_text__v)
    • Language (language__v)
    • Product (product__v)
    • Therapeutic Indication (therapeutic_indication__v)
  • Indication Grouping (indication_grouping__v) object fields:_
    • Disease Symptom Procedure (disease_symptom_procedure__v)
    • Intended Effect (intended_effect__v)
  • Application Clinical Study (application_clinical_study__v) object fields:
    • Clinical Study Type (clinical_study_type__v)
    • Clinical Study Subtype (clinical_study_subtype__v)
  • Application Inactive Ingredient (application_inactive_ingredient__v) object field Manufacturer (manufacturer__v)
  • Application Nonclinical Study (application_nonclinical_study__v) object fields:
    • Nonclinical Study Type (nonclinical_study_type__v)
    • Nonclinical Study Subtype (nonclinical_study_subtype__v)
  • Product Detail Active Substance (product_detail_active_substance__rim) object field Role (role__v)
  • Product Detail Inactive Ingredient (product_detail_inactive_ingredient__rim) object field Role (role__v)
  • Packaging Product Detail (packaging_product_detail__rim) object field Unit of Presentation (unit_of_presentation__v)
  • Administered Product Active Substance (admin_prod_active_substance__rim) object field Role (role__v)
  • Administered Product Inactive Ingredient (administered_product_inactive_ingredient__rim) object field Role (role__v)
  • Application Active Substance (application_active_substance__v) object field Manufacturer (manufacturer__v)
  • Application Packaging (application_packaging__v) object field Drug Product (drug_product__v)
  • Application Pharmaceutical Product (application_pharmaceutical_product__v) object field Manufacturer (manufacturer__v) Added the Kosovo (XK) (country_xk__v) field to the Active Dossier Item (active_dossier_item__v) object. Inactivated the Content Plan (edl__v) object field Iterations without Updates (Deprecated) (iterations_without_updates__v).

Added the following components to support the Publish & Merge Submission Content Plan feature:

  • Added the Merged PDF Document Number (merged_pdf_document_number__v) field to the Submission (submission__v) object.
  • Added the Merge in Progress (merge_in_progress__v) value to the Dossier Status (dossier_status__v) picklist. Added the following components to support the EU UDI Submission Viewer feature:
  • Added the following object actions for the UDI Submission (udi_submission__v) object:
    • Review UDI Submission (review_udi_submission__c)
    • UDI Submission Accepted by HA (udi_submission_accepted_by_ha__c)
    • UDI Submission Rejected by HA (udi_submission_reject_by_ha__c)
  • Added the UDI Submission (udi_submission__v) document lifecycle.
  • Added the following object state types:
    • UDI Submission Data Failed to Generate (udi_submission_data_failed_to_generate__v)
    • UDI Submission Ready to Review (udi_submission_ready_to_review__v)
    • UDI Submission Canceled (udi_submission_canceled__v)
    • UDI Submission Ready to Submit (udi_submission_ready_to_submit__v)
    • UDI Submission Rejected by HA (udi_submission_rejected_by_ha__v)
  • Added the Additional UDI-DI Registration (additional_udi_submission__v) object type to the UDI Submission (udi_submission__v) object.
  • Added the Version (version__v) field to the Registered Device Identifier (registered_device_identifier__v) object.
  • Added the Medical Device Type (medical_device_type__v) field to the UDI Submission (udi_submission__v) object.