19R1 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 data model. These data model updates are automatically included in all Vaults, but Admins must make configuration changes to make them available. For information on feature functionality, see What’s New in 19R1.

As part of Vault’s efforts to provide better functionality, each release introduces various data model items related to features that may not be enabled in every customer vault. These items will appear in Admin, but will not have any related functionality unless the related feature is enabled.

Updates to Existing Vaults

Added or modified the following components to support xEVMPD:

  • Added the Ingredient Product Report Item object with high-level fields:
    • Active Substance (active_substance__v) and Active Substance Code(active_substance_code__v) as references to Administered Product Active Substance.
    • Inactive Ingredient (inactive_ingredient__v) and Inactive Ingredient Code (inactive_ingredient_code__v) as references to Administered Product Inactive Substance.
    • Concentration Type (concentration_type__v) and Concentration Type Code(concentration_type_code__v).
    • Set of fields to track lower presentation strength numerator value, broken into xEVMPD components and corresponding codes:
      • PLR Denominator Unit (plr_denominator_unit__v)
      • PLR Denominator Unit Code (plr_denominator_unit_code__v)
      • PLR Denominator Unit Code Text (plr_denominator_unit_code_text__v)
      • PLR Denominator Unit Prefix (plr_denominator_unit_prefix__v)
      • PLR Denominator Unit Prefix Code (plr_denominator_unit_prefix_code__v)
      • PLR Denominator Unit Prefix Code Text (plr_denominator_unit_prefix_code_text__v)
      • PLR Denominator Value (plr_denominator_value__v)
      • PLR Denominator Value Text (plr_denominator_value_text__v)
      • PLR Numerator Unit (plr_numerator_unit__v)
      • PLR Numerator Unit Code (plr_numerator_unit_code__v)
      • PLR Numerator Unit Code Text (plr_numerator_unit_code_text__v)
      • PLR Numerator Unit Prefix (plr_numerator_unit_prefix__v)
      • PLR Numerator Unit Prefix Code (plr_numerator_unit_prefix_code__v)
      • PLR Numerator Unit Prefix Code Text (plr_numerator_unit_prefix_code_text__v)
      • PLR Numerator Value Text (plr_numerator_value_text__v)
    • Set of fields to track upper presentation strength numerator value, broken into xEVMPD components and corresponding codes:
      • PHR Denominator Unit (phr_denominator_unit__v)
      • PHR Denominator Unit Code (phr_denominator_unit_code__v)
      • PHR Denominator Unit Code Text (phr_denominator_unit_code_text__v)
      • PHR Denominator Unit Prefix (phr_denominator_unit_prefix__v)
      • PHR Denominator Unit Prefix Code (phr_denominator_unit_prefix_code__v)
      • PHR Denominator Unit Prefix Code Text (phr_denominator_unit_prefix_code_text__v)
      • PHR Denominator Value (phr_denominator_value__v)
      • PHR Denominator Value Text (phr_denominator_value_text__v)
      • PHR Numerator Unit (phr_numerator_unit__v)
      • PHR Numerator Unit Code (phr_numerator_unit_code__v)
      • PHR Numerator Unit Code Text (phr_numerator_unit_code_text__v)
      • PHR Numerator Unit Prefix (phr_numerator_unit_prefix__v)
      • PHR Numerator Unit Prefix Code (phr_numerator_unit_prefix_code__v)
      • PHR Numerator Unit Prefix Code Text (phr_numerator_unit_prefix_code_text__v)
      • PHR Numerator Value Text (phr_numerator_value_text__v)
    • Set of fields to track lower concentration strength numerator value, broken into xEVMPD components and corresponding codes:
      • CLR Denominator Unit (clr_denominator_unit__v)
      • CLR Denominator Unit Code (clr_denominator_unit_code__v)
      • CLR Denominator Unit Code Text (clr_denominator_unit_code_text__v)
      • CLR Denominator Unit Prefix (clr_denominator_unit_prefix__v)
      • CLR Denominator Unit Prefix Code (clr_denominator_unit_prefix_code__v)
      • CLR Denominator Unit Prefix Code Text (clr_denominator_unit_prefix_code_text__v)
      • CLR Denominator Value (clr_denominator_value__v)
      • CLR Denominator Value Text (clr_denominator_value_text__v)
      • CLR Numerator Unit (clr_numerator_unit__v)
      • CLR Numerator Unit Code (clr_numerator_unit_code__v)
      • CLR Numerator Unit Code Text (clr_numerator_unit_code_text__v)
      • CLR Numerator Unit Prefix (clr_numerator_unit_prefix__v)
      • CLR Numerator Unit Prefix Code (clr_numerator_unit_prefix_code__v)
      • CLR Numerator Unit Prefix Code Text (clr_numerator_unit_prefix_code_text__v)
      • CLR Numerator Value Text (clr_numerator_value_text__v)
    • Set of fields to track upper concentration strength numerator value, broken into xEVMPD components and corresponding codes:
      • CHR Denominator Unit (chr_denominator_unit__v)
      • CHR Denominator Unit Code (chr_denominator_unit_code__v)
      • CHR Denominator Unit Code Text (chr_denominator_unit_code_text__v)
      • CHR Denominator Unit Prefix (chr_denominator_unit_prefix__v)
      • CHR Denominator Unit Prefix Code (chr_denominator_unit_prefix_code__v)
      • CHR Denominator Unit Prefix Code Text (chr_denominator_unit_prefix_code_text__v)
      • CHR Denominator Value (chr_denominator_value__v)
      • CHR Denominator Value Text (chr_denominator_value_text__v)
      • CHR Numerator Unit (chr_numerator_unit__v)
      • CHR Numerator Unit Code (chr_numerator_unit_code__v)
      • CHR Numerator Unit Code Text (chr_numerator_unit_code_text__v)
      • CHR Numerator Unit Prefix (chr_numerator_unit_prefix__v)
      • CHR Numerator Unit Prefix Code (chr_numerator_unit_prefix_code__v)
      • CHR Numerator Unit Prefix Code Text (chr_numerator_unit_prefix_code_text__v)
      • CHR Numerator Value Text (chr_numerator_value_text__v)
  • Added the following object types and corresponding page layouts for Ingredient Product Report:
    • Active Substance
    • Adjuvant
    • Excipient
  • Added Controlled Vocabulary Type picklist values:
    • xEVMPD Prefix Unit (xevmpd_prefix_unit__v)
    • xEVMPD Denominator Unit (xevmpd_denominator_unit__v)
    • xEVMPD Numerator Unit (xevmpd_numerator_unit__v)
  • Added fields to Strength Unit and Denominator object:
    • xEVMPD Denominator Prefix (xevmpd_denominator_prefix__v)
    • xEVMPD Denominator Unit (xevmpd_denominator_unit__v)
    • xEVMPD Numerator Prefix (xevmpd_numerator_prefix__v)
    • xEVMPD Numerator Unit (xevmpd_numerator_unit__v)
  • Added fields to Product Report object:
    • Administered Pharmaceutical Form (administered_pharmaceutical_form__v) (replaces existing lookup field)
    • Language (language__v)
    • Packaging (packaging__v)
    • Medicinal Product Registration (medicinal_product_registration__v)
  • Added fields to Medicinal Product Registration object:
    • Country (country__v)
    • EV Code (ev_code__v)
    • Language (language__v)
    • Previous EV Codes (previous_ev_codes__v)
    • Medicinal Product Full Name (medicinal_product_full_name__v)
    • Additionally, we have added constraints to ensure the packaging selected on a Medicinal Product Registration record must be related to the Registration selected on the same record.
  • Added fields to Product Report Item object:
    • Country (country__v)
    • EV Code (ev_code__v)
    • Language (language__v)
    • Packaging (packaging__v)
    • Authorised Dosage Form (authorised_dosage_form__v)
    • Authorised Dosage Form Code (authorised_dosage_form_code__v)
    • Authorised Dosage Form Code Text (authorisation_status_code_text__v)
    • Medicinal Product Full Name (medicinal_product_full_name__v)
    • Medicinal Product Full Name Text (product_name_text__v)
    • Previous EV Code (previous_ev_code__v)
    • Previous EV Code Text (previous_ev_code_text__v)
  • Added object type to Product Report Item object:
    • Authorised Dosage Form
  • Modified fields on the Administered Product Active Substance object:
    • Added the Adjuvant Use (adjuvant_use__v) field.
    • Additionally, we have modified the Concentration Type field to constrain object records based on Controlled Vocabulary Type.
  • Modified the Administered Product Inactive Ingredient object:
    • Modified the Concentration Type field to constrain based on Controlled Vocabulary Type.
  • Modified the Medicinal Product Full Name object:
    • Added Medicinal Product Full Name (medicinal_product_full_name__v) field as a long text to collect name per xEVMPD standards (2000 characters).
  • Modified the Medicinal Product Name Part object:
    • Applied auto-naming
    • Added Name Part Text (name_part_text__v) field that meets xEVMPD requirements (up to 2000 characters for some parts).
  • Added record validation rule to ensure that name parts for xEVMPD comply to the length of Name Part Type (name_part_type__rim).

Added the following components to support xEVMPD Message Generation and Validation:

  • Added the Product Report Validation Result (product_report_validation_result__v) object as a child of Product Data Submission to track the number of validation results discovered per Product Report section
  • Added the Validation Result Detail (validation_result_detail__v) object to track detailed validation rules violated in the Product Report data
  • Added the Product Data Message (product_data_message__v) object as a child of Product Data Submission to capture message-specific details and serve as a location to attach the xEVPRM ZIP file

Added or modified the following components to support EU EMA v3.0.3 (DTD 3.0.1) Specification Support:

  • Added the eCTD Country Code (ectd_country_code__v) field to the Country object
  • Added the Application UUID (application_uuid__v) field to the Application object
  • Added the Primary Health Authority (primary_health_authority__v) field to the Country object
  • Added the Health Authority Code (health_authority_code__v) field to the Health Authority object
  • Added a new Worksharing Type (worksharing_type__v) picklist value to the Controlled Vocabulary Type picklist
  • Added a new Worksharing Type (worksharing_type__v) field to the Related Submission object
  • Added the following picklist values to the Group picklist:
    • ICH DTD (ich_dtd__v)
    • ICH Stylesheet (ich_stylesheet__v)
    • M1 DTD (m1_dtd__v)
    • M1 Leaf (m1_leaf_mod_file__v)
    • M1 Envelope (m1_envelope_mod__v)
    • M1 Stylesheet (m1_stylesheet__v)
    • Index XML (index_xml__v)
    • Index MD5 (index_md5__v)
    • Regional XML (regional_xml__v)
    • Structure (structure__v)
    • Leaf Attributes (leaf_attributes__v)
    • ICH Attributes (ich_attributes__v)
    • Node Extensions (node_extensions_v)
    • Sequence Number (sequence_number__v)
    • Envelope (envelope__v)
    • Files/Folders (files_folders_v)
  • Modified the maximum length of the Filename (filename__v) field on the EDL Item Template object
  • Modified the maximum length of the XML xlinkhref (xml_xlinkhref__v) field of the EDL Item object

Added the following components to support Submissions Administrative Information Management:

  • Added the Submission Administrative Information page layout section to the Submission Country join object
  • Added the Submission Administrative Information (submission_administrative_information__v) object

Additionally, we’ve added the following components to the RIM data model:

  • Added the Product (product__v) field to the following objects:
    • Application
    • Content Plan
    • Report Level Content Plan
    • Drug Product
    • Active Substance
    • Clinical Study
    • Nonclinical Study
  • Added the Product (product__v) lookup field to the Content Plan object on the Content Plan Item object
  • Added the following fields to the Report Level Content Plan object:
    • Primary Clinical Study (primary_clinical_study__v)
    • Primary Nonclinical Study (primary_nonclinical_study__v)
  • Added the following values to the Controlled Vocabulary Type picklist:
    • Dossier Format (dossier_format__v)
    • Storage Conditions (storage_conditions__v)
  • Added the Constraint Scope (constraint_scope__v) field on the Constraint object
  • Added the following fields to the Submission object:
    • Dossier Format (dossier_format__v)
    • Procedure Type (procedure_type__v)
  • Added the Vault RIM UUID (vault_rim_uuid__v) field to the following objects:
    • Country
    • Region
    • Health Authority

Changes to New Vaults Only

In vaults created after the 19R1 release, the following objects will be relabeled to better support medical devices:

  • Relabeled the Product (product__v) object to Product Family
  • Relabeled the Product Detail (product_detail__v) object to Product Variant
  • Relabeled the Drug Product (drug_product__v) object to Product