Calyx RIM for Registrations

Applications

An application is an entity that represents all submissions created for the purpose of obtaining regulatory agency approval for products associated with the application.

Applications define country-specific product registration information. In case of the European Union, product registration information is for one or more countries. The application entity in Calyx RIM tracks data about the country, application type, procedure type, and the products associated with an application.

Applications fall into one of the four categories:

Category Description
National Used to obtain approval for the associated products in one country only.
Centralized Procedure (CP) Used to obtain simultaneous approval for the associated products in the entire EU region.
Decentralized Procedure (DCP) Used for products that have not yet received authorization in an EU country. It is similar to the Mutual Recognition Procedure (MRP), without requiring that a national marketing authorization be granted in one EU country.
Mutual Recognition Procedure (MRP) Used to obtain approval of the associated products in one EU country (an RMS - Reference Member State). The intent is to achieve approval in subsequent EU countries (CMS - Concerned Member States) by having those countries recognize the assessment of the first EU country.

Applications are specific to the following Calyx RIM licensed modules:

  • Electronic Lifecycle Publishing (ELP)
  • Paper Review Publishing (PRP)
  • Product Detail Management (PDM)
  • Registered Document Analysis (RDA)
  • Registration Planing and Tracking (RPT)
  • Submission Planning and Tracking (SPT)

Creating Applications

Use the Create Application wizard to create an application which is the best practice. Alternately, you can also use the Create Application option available on the Applications tab of the Product Family Attributes page.

While creating an application, the application types and procedure types you assign to the application vary by country, based on the values configured by your Data Administrator.

Applications and Registration Types

In Calyx RIM, when a registration is created it is associated with an application. To support the association and tracking of registrations with package sets or with products, you need to specify the registration type. This registration type is mapped to an Calyx RIM internal type of either Package Set or Product.
Note: Calyx RIM can be configured such that the registration type defaults to either the product or package set for applications, and the ability to choose the registration type is disabled.

Tracking Clinical Trial Applications (CTAs)

Calyx RIM enables you to track data for European Clinical Trial Applications, including Comparators, Placebo, and Investigational Medicinal Product (IMP) used in the study.

To track CTA data in an application that is, to have the data attributes related to CTA appear on the Create Application page, the application type selected must be mapped to the Liquent_Cta XML in data administration.
Note: By default, the application type Clinical Trial Authorization is already mapped to this XML, however your data administrator can define custom application types that are mapped to the Liquent_Cta XML.

CT Shared Data

For ease of use, the CT Shared Data entity is created to enable users to consolidate common details about CTA. The CT Shared Data entity is created and maintained at the product family level, making the information available for association with CTA and IND application events. Upon associating the CT Shared Data to a CTA or IND application event, the same information applies to all event-countries associated with the event without the need to re-enter the same information on the application for each event-country.

CT Shared Data is identified by the protocol code number. You can associate the CT Shared Data to more than one CTA or IND application event. However, you can only assign one CT Shared Data entity to an event.

Deleting Applications

  • Only an administrator can delete an application regardless of whether other entities are associated with it.
  • A non-administrator user can delete an application only with the appropriate security privileges and if no other entities are associated with the application.