Data Migration Documentation

Calyx RIM 6.2 Data Migration

The Calyx RIM 6.2 database migration provides the following set of changes.

Calyx RIM Data Administration

The Calyx RIM 6.2 database migration provides the following Data Administration changes:
  • A list of Data Administration values has been updated with an Organisation Identifier attribute for the purpose of mapping Organisation in Calyx RIM for Registrations to Organisation in the Organisation Management System (OMS). Additional fields to support the OMS Integration have been added to the MAH/Development Sponsor/Organisation Values table.
  • A SPOR Maintenance section has been added to support the Referentials management service (RMS) integration. A list of Data Administration values has been updated with RMS Term Name attribute for the purpose of mapping Calyx RIM for Registrations values to values in the SPOR Maintenance section.
  • An additional field named IDMP Internal Procedure Code has been added to the Procedure Type Values.
  • The Region Values table in the Application Maintenance section has been updated with a new region named IDMP Integration.
  • The Region Type Values table in the Application Maintenance section has been updated with a new default region type named IDMP.
  • In the Manufacturer Values table, the Country text field has been removed and the Country Code drop-down list has been renamed to be Country drop-down list.
  • This migration will add the Country Specific Detail Type Values and a list of out-of-the-box values for them.
  • This migration will add the Country Specific Detail Values and a list of out-of-the-box values for them.
  • To identify medical devices and also facilitate data exchange between manufacturers, regulators, and healthcare authorities, Global Medical Device Nomenclature (GMDN) Code Values has been introduced in the Data Administration > Product Maintenance section.
  • To identify, process, retrieve, transfer, and communicate data about medical devices, the UMDNS Code Values option has been introduced in the Data Administration > Product Maintenance section.
  • To maintain the applicable standard version, the Applicable Standards Values table has been updated to include the Version of Standard option.

Calyx RIM Entities

The Calyx RIM 6.2 database migration provides the changes that affect uiCalyx RIM entities:
  • Applications. Optionally, a re-runnable migration script should be executed to copy the Application Code value to the Procedure Identifier field on Application so that Procedure Identifier Number in IDMP can be populated based on the integration mapping of the two fields in RIM (Regulatory Information Management).
  • Events. For each event that does not have a unique Event Name and Event Code combination within an application, the Event Name will be updated to have a sequential number appended.
  • Full Product Presentations. The additional fields Formulation Part, Intended Use Part, Target Population Part, Container or Pack Part, Device Part, Time Period Part, Flavour Part, and Countries have been added to the Full Product Presentation entity. The Previous EV Code field has been deleted from the Full Product Presentation entity. If present, values from this field should migrate to the new sub-entity Registration FPP Previous EV Codes, one value per sub-entity. In addition, the comments text field has been updated for the discussion thread field type for Full Product Presentation entity.
  • Registrations:
    • ATC. If there is no specific ATC (Anatomical Therapeutic Chemical) value on the Product Family but it is present on the related Registration, ATC value should be assigned to the Product Family after migration. If there is a specific ATC value on both Product Family and the related Registration, ATC value on Product Family should be displayed on the Assigned ATC box after migration.
    • Legal Basis. The additional field Legal Basis has been added to the Registration Package Set Type. The rule for migration is when there is a value in the Legal Basis field on an Application, all Package Set Registrations related to that application should have the Legal Basis field filled with the same value as the parent Application.
  • Product Detail Sets (PDS):
    • PDS Uniqueness. For each PDS that does not have a unique PDS Name and parent Application ID combination, the PDS Name will be updated to have a sequential number appended.
    • Local Route of Administration. The additional field named Local Route of Administration has been added to the PDS entity. Field is hidden by default, multi-select, and non-required with values from Data Administration > Route of Administration Values list.
  • PDS Templates. For each PDS Template that does not have a unique PDS Template Name and parent Product ID combination, the PDS Template Name will be updated to have a sequential number appended.
  • Tasks. For each Task and Sub-Task that does not have a unique Task Name and parent Entity ID combination, the Task Name will be updated to have a sequential number appended.
  • References. For each Reference that does not have a unique Reference Name and parent Entity ID combination, the Reference Name will be updated to have a sequential number appended.

Calyx RIM 6.2 Pre-Migration Scripts

  • rpt_pre_migration_mpid.sql
  • rpt_pre_migration_ procidentif.sql
  • pre_migration_previousevcodes_authorisedprod.sql
  • pre_migration_event_uniqueness.sql
  • pre_migration_lic_atc.sql
  • pre_migration_task_uniqueness.sql
  • pre_migration_reference_uniqueness.sql
  • pre_migration_pds_uniqueness.sql
  • pre_migration_pds_template_uniqueness.sql

Please refer to the Calyx RIM 6.2 Data Migration Document for detailed information.