18R1 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 18R1.

As part of standardizing the configuration across all RIM applications, we’ve made the following changes to standard configuration in all RIM vaults:

  • Added the following fields to the Coded Indication object to support the MedDRA Dictionary Loader feature:
    • Current In
    • Non-Current In
    • First Added In
    • Last Modified In
    • Latest Modification Type
    • Previous Term Names
    • Term Code
    • Preferred Term Name

  • Added the following items for the xEVMPD Support: Data Model Changes feature:

    • Added the EV Code field to the following objects:
      • Active Substance
      • Inactive Ingredient
      • Controlled Vocabulary
      • Organization
      • Medicinal Product
      • Registration Packaging
    • Added new fields to the Medicinal Product object:
      • EV Code
      • Local Sender Code
      • Master File Location
      • Qualified Person for Pharmacovigilance
    • Added the Adjuvant Use field to the Active Substance object
    • Added new fields to the Registration object:
      • Date Suspension Lifted
      • xEVMPD Authorisation Status
    • Added the Concentration Type field to the Product Detail Active Substance and Product Detail Inactive Ingredient  join objects.
    • Added new objects:
      • Regulated Document
      • Active Substance Translation
      • Inactive Ingredient Translation
    • Added the Medicinal Product Regulated Document and Medicinal Product Coded Indication join objects
    • Added new object types to the Classification System object:
      • Paediatric Indication
      • Reason for Nullification
      • Medicinal Product Type
      • ATC Code
      • Legal Basis
  • Added the following new fields to the Controlled Vocabulary object to support features in a later release:
    • SPOR ID
    • Current Term
    • SPOR Status
  • Added the following new fields to the Organization object to support features in a later release:
    • SPOR Organisation ID
    • SPOR Location ID
    • SPOR Location Status
  • Enabled object types on the Registrations object and created the new Investigational object type
  • Added various new fields to the Investigational object type for the Registrations object:
    • Clinical Study Number
    • Clinical Hold
    • Clinical Hold Start Date
    • Clinical Hold End Date
  • Added Comparator Product field to the Drug Product object
  • Added Investigational Packaging field to the Packaging object
  • Added the Clinical Trial Authorization Scope picklist field to the Country object
  • Added the Registered Clinical Study join object
  • Added the Event Clinical Study join object