Data Migration Documentation

Calyx RIM 6.0 CHF 4 Data Migration

The Calyx RIM 6.0 CHF 4 database migration provides the following updates.

Data Administration Changes for EU eCTD Module 1 Specification v3.0.1

If the EU region already exists in the Application Maintenance – Region Values section in Data Administration, it will be updated to include the internal code value EU in the database. Otherwise, an error message appears and the script exits.

The EU region will be updated to include the following countries: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, European Union, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom.

If the EDQM country exists, it will be updated to belong to the EU region and the internal code value EDQM will be set in the database. If the EDQM country does not exist, an error message appears in the log and the script does not exit.

If the eu-3-0-1 Assembly DTD/Schema type already exists in the Data Administration section Assembly - Assembly DTD/Schema Types, it will be activated (if inactive) and updated to have the internal code value ‘EU-3-0-1’. Otherwise, the eu-3-0-1 Assembly DTD/Schema will be added.

If they do not already exist, Filing Type Values will be added to the Data Administration section Sequence Maintenance – Filing Type Values. If Filing Type Values already exist, they will be updated with an eCTD Code for the eu-3-0-1 DTD/Schema.

Reasons for Termination/Withdrawal Values Created

If the Application Status ISM.APP_STATUS_TYPE.NAME, selected in the Application entity, is mapped to the internal system status ‘WITHDRAWN’ in Data Administration and there is a value in the ‘Termination/Withdraw Reason’ field ISM.APPLICATION.TERM_WITHDRAW_REASON, then data should migrate as follows:
  • A new value should be added to the Data Administration > Other > Reason for Termination/Withdrawal Values
  • Application Status should have the same value as the initial Application
  • A new field, Reason for Termination/Withdrawal, should have selected values from the Termination/Withdraw Reason field

If Application Status ISM.APP_STATUS_TYPE.NAME, selected in Application entity, is not mapped to the internal system status ‘WITHDRAWN’ in Data Administration and there is a value in the ‘Termination/Withdraw Reason’ field ISM.APPLICATION.TERM_WITHDRAW_REASON, then a pre-migration report will provide notification that data needs to be corrected. Otherwise, the value for Termination/Withdrawal Reason will not migrate.

Procedure Type Values

For the following Procedure Types, the Country column is updated with Liechtenstein OOTB country:
  • EU CP Bio
  • EU CP New API
  • EU CP Orphan

Query Migration

For reports where the field Termination/Withdraw Reason from the Application entity is available, data should migrate only if Application Status is mapped to the internal system status ‘WITHDRAWN’ and there is a value in the ‘Termination/Withdraw Reason’ field. Otherwise, the column should be blank.

EU 3.0 Assemblies Migration

For all Standalone Assemblies, Template Assemblies, Working, Sequence, and Submitted Views, where XML Definitions of the associated APL contains ‘EU-3-0’ and ‘FORM-1-1’, the folder with Number equal to ‘1.2’ and Name equal to ‘EMA-eAF’ and Extension equal to ‘Default’ will be updated to set the Extension to 'XML Application Form' (version 2.0) with the Country attribute set to ‘ema’.