Data Migration Documentation

Calyx RIM 6.2 CHF 6 Data Administration Tables

Requirements for the standard migration of Calyx RIM 6.2 Certified Hotfix (CHF) 5 to Calyx RIM 6.2CHF 6 are provided in this topic.

Data Administration Updates: Default Flag for Statuses

The updated System Process Default Flag (Yes/No values) provides the ability to assign several external statuses to the same Internal System Status in Data Administration for Registration Status Values. You can see the assigned status after running the wizard or when the Event is closed manually. Before, the system randomly selected the first status that was mapped to the Internal System Status and you could not define which statuses would show after the updates. The field is added to

Data Administration Updates: Region

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

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

Data Administration Updates: Assembly DTD/Schema Type

If the JO-1-1 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 JO-1-1. Otherwise, JO-1-1 Assembly DTD/Schema will be added.

Data Administration Updates: Filing Type Values

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

  • 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 JO-1-1 DTD/Schema. If the found Filing Type does not have Jordan as an associated county, Jordan will be added to the list of Countries.
  • 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 JO-1-1 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, one will be created and assigned to Jordan. This list shows the Filing Types added with their eCTD Codes:
    • ASMF Filing
    • Biological Allergen
    • Biological Bio-similar
    • Biological Blood Product
    • Biological Drug
    • Biological Vaccine
    • CEP Submission
    • Extension Filing
    • Generics
    • Generic Narcotics
    • Generic Vitamin Drug
    • Herbal Drug
    • MAA - Originator Drug
    • MAA - Originator Vitamine Drug
    • New Drug
    • New Narcotics
    • New Vitamin Drug
    • None
    • Notification with pricing
    • Notification without pricing
    • Originator Narcotics
    • Periodic Safety Update Report
    • Plasma Master File
    • PSUR single assessment procedure
    • Radiopharmaceutical Non-Radioactive Components (kits)
    • Radiopharmaceutical Ready-for-use Radioactive Product
    • Registration Department approval
    • Renewal Filing
    • Risk Management Plan Filing
    • Technical committee approval
    • Transfer MA Filing
    • USR Filing
    • Value added medicine
    • Veterinary drug
    • Withdrawal Filing
    • Periodic Benefit-Risk Evaluation Report