Calyx RIM Administration

Country Value Maintenance

A country is associated with an application and is designated at the time an application is created or modified. The table on the Country List page displays ALL countries in the system, and enables you to create or modify the country values that are used in the system.

The proper data administration access privileges are required to view or modify country values.

Using data administration, you can:
  • Add new country values to the system
  • Modify country values
  • Add health authority values to a country
  • Associate country with a region
  • Set the default application type or procedure type for a country
  • Set the status of a country to active or inactive

The application created for a country by the Copy Application function will include the default application type and the default procedure type that have been defined for that country.

To set a default application type or default procedure type for a country, the country must first be associated with an application type or procedure type in data administration.

Each country must be associated with a region. The default region for a country is the Rest of World (ROW) region of Regulatory Region type.

To associate country with a region, remove or change the existing associations, the following options can be used:
  • County Values (Region tab on the Country Attributes page)
  • Region Values (Region Attributes page)

eCTD code and eCTD authority are necessary to add eCTD attributes in the Module 1 administrative metadata automatically. The eCTD attributes are included based on the ICH specification, and are necessary because the country code and agency names may differ between the eCTD and other specifications. This enables the Create eCTD Wizard to identify the correct values from the controlled value lists when there are discrepancies between specifications.