Data Migration Documentation

Calyx RIM 6.2 CHF 7 Data Administration Tables

Requirements for the standard migration of Calyx RIM 6.2 Certified Hotfix (CHF) 6 to Calyx RIM 6.2CHF 7 are provided in this topic.

Data Administration Updates: Taiwan

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

Health Authority name for Taiwan country, that already exists in the Application Maintenance – Country Values in Data Administration under the Health Authority tab, must be changed to Taiwan Food and Drug Administration.

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

Data Administration Updates: Assembly DTD/Schema Type

If the TW-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 TW-1-0. Else, TW-1-0 Assembly DTD/Schema will be added.

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 TW-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 TW-1-0 DTD/Schema. If the found Filing Type does not have Taiwan as an associated county, Taiwan 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 TW-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 Taiwan. This list shows the Filing Types added with their eCTD Codes:
    • New
    • Change
    • Extension Filing
    • Expiration

Data Administration Updates: US

If Form FDA 3988: Transmittal of PMR/PMC Submissions for Drugs and Biologics already exists in Application Form Type Values it will be updated with fdaft10 code and set to Active. Else, this record will be created.

If Form FDA 3938: Drug Master File already exist in Application Form Type Values, it will be updated with fdaft11 code and set to Active. Else, this record will be created.

If REMS Supplement already exists in the Filing Type Values, it will be updated with fdaft11 Filing Type eCTD code for us-3-3 DTD, and New Drug Application, Biologic License Application, Abbreviated New Drug Application will be added to Types Valid for Grouped Submissions. Else, this record will be created.

For the United States in the Country Values, the Health Authority Website will be updated to https://www.fda.gov/.