Data Migration Documentation

Calyx RIM Versions Prior to 6.0 Data Administration Tables

Improvements and defect fixes for some of the data administration tables in Calyx RIM are included in the migration from 3.6 to 3.6.1, from 3.6 or 3.6.1 to 3.6.2, from 3.6.1 to 4.0.0.1, from 4.5 to 4.6, from 4.6 to 4.7, and from 4.7 to 5.0. These changes reflect regulatory and agency changes, and other critical items. Specifically, these changes are concerned with application types, filing types, countries, and regions.

The upgrade scripts do not remove existing custom values. The scripts only add types or countries if they do not already exist. The scripts were designed this way to prevent upgrading issues and to meet any concerns about existing data used in applications, events, or sequences throughout the system. Nothing in these data administration update scripts will affect your existing data.

The following lists summarize the data administration table changes in these update scripts. This summary is provided should you wish to manually update your custom values to incorporate some of these recommended changes. Manually updating your custom values is entirely optional, with the caveat that (in some cases) values that should go into the eCTD assembly regional envelopes may not be fully transported by the eCTD Wizard if these codes have not been manually updated in cases where a type or country already existed.
  • Lithuania and European Union countries have been added to all Filing Types for the European Union.
  • Newly added countries such as Bulgaria and Romania have been added to all Filing Types for the European Union.
  • New Filing Types for EU 1.4 support have been added.
  • A series of Application Types specific to Japan have been added, but their names in Japanese characters have not – please consult the tables in the Administration Guide for the actual Japanese characters relevant to these new types.
  • Application Types have been split apart by region in some cases. Countries were not removed from the old types, so in some cases it may be advisable to remove these countries from the old types, as long as there are no Applications assigned to the old types for those countries.
  • A new CH region has been added for Switzerland to use the default Swiss eCTD templates, which will enable the use of eCTD wizards.
  • CT Shared Data is a new entity that belongs to the product family. This new entity is where protocol data fields that can be shared across clinical trials is stored. This new entity was introduced in version 5.0
  • Also introduced in version 5.0 is new field mapping for migration of Clinical Trial Applications (CTAs) and CT Shared Data records. Refer to the InSight 5.0 Data Migration Document for more information.
  • The Entity XML for "Clinical Trial Application" has been updated to support enhancements for CTAs in the European Union.
  • Introduced first in version 5.0, a new "Liquent_Ind" Entity XML has been added to manage Investigational New Drugs in the United States and Canada.

Regarding default values, please note that the application types DMF and MASTER both have the same display name value of 'Drug Master File'.