Data Migration Documentation

Calyx RIM 6.2.8 Data Administration Tables

Requirements for the standard migration of Calyx RIM 6.2 Certified Hotfix (CHF) 7 to Calyx RIM 6.2.8 are provided in this topic.

Data Administration Updates: China

If the CN region already exists in the Application Maintenance - Region Values section in Data Administration, it will be updated to include the code value CN in the database. Else, an error message will be generated and the script will skip China updates.

Health Authority name for China country, that already exists in the Application Maintenance – Country Values in Data Administration under the Health Authority tab, must be changed to National Medical Products Administration.

The country value China will be updated to belong to China region, if it does not belong to it already.

Data Administration Updates: Assembly DTD/Schema Type

If the CN-1-0 Assembly DTD /Schema type already exists in the Assembly > Assembly DTD/Schema Types section in Data Administration, it will be activated (if inactive) and updated to have the code value CN-1-0. Else, CN-1-0 Assembly DTD/Schema will be added.

Data Administration Updates: Application Type Values

There will be no changes to Application Maintenance > Application type Values.

Data Administration Updates: Filing Type Values

Filing Type Values that do not already exist are added to the Sequence Maintenance > Filing Type Values section in Data Administration. If they already exist, they will be updated with an eCTD Code for CN-1-0 DTD/Schema depending on the following conditions:

  • For all eCTD Codes from the following table, the Filing Type Value that has the same eCTD Code will be found and updated with the new eCTD Code for the CN-1-0 DTD/Schema. If the found Filing Type does not have China as an associated county, China will be added to the list of Countries.
  • If there are any other Filing Type values found, that are not listed in the table, they are not updated.
  • If more than one Filing Type is found with a matching eCTD Code, the one with the matching Filing Type Name will be updated with the new eCTD Code for the CN-1-0 DTD/Schema. If the Filing Type Name does not match for any Filing Type with a matching eCTD Code, no Filing Type will be updated and the following message will be added to the log: The Filing Type <name> with eCTD Code <code> could not be created/updated within Data Admin, please verify the configuration post-installation.
  • If the Filing Type is not found based on the eCTD Code, a Filiing Type will be created and assigned to China. This list shows the Filing Types added with their eCTD Codes:
    • New Indication and Drug Combination.
    • Record.
    • Development Safety Report.
  • This list shows the Filing Types updated with their eCTD Codes:
    • New Indication - cnrat6.
    • Renewal Filing - cnrat8.
    • Baseline - cnrat9.
    • New Indication and Drug Combination - cnrat5.
    • Record - cnrat3.
    • Development Safety Report - cnrat7.
  • This Filing Type will be deactivated: Periodic Safety Update Report - cnrat5.
  • New Indication and Drug Combination, Development Safety Report Filing Type Values will be associated to Original, Response, Withdrawal Sub Filing Type eCTD Code Values.
  • Periodic Safety Update Report Filing Type Value will be disassociated from Original, Response, Withdrawal Sub Filing Type eCTD Code Values.
  • Application values will be associated to these Filing Type eCTD Code values:
    • Abbreviated New Drug Application to cnrat3.
    • New Drug Application , Abbreviated New Drug Application to cnrat4.
    • New Drug Application , Abbreviated New Drug Application to cnrat8.
    • Investigational New Drug, New Drug Application , Abbreviated New Drug Application to cnrat9.