Ennov InSight Registrations 7.1

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 Ennov InSight tracks data about the country, application type, procedure type, and the products associated with an application.

Application 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. EU Clinical Trial Regulation Procedure (EU CTR) is mapped to MRP.
Applications are specific to the following Ennov InSight 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)

Create Applications

It is best practice to use the Create Application wizard to create an application.

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

Applicable rules:
  • You can associate any Product to an Application, regardless of the Product Family, except for products with the status of "Not Approved" and "Withdrawn". This enables the submission of products from different product families as part of the same submission for an application.
  • You cannot complete an Application without associating a Product.
  • The Product Selection field displays only those Product values of the Product Families that are assigned to the appropriate Reviewing Country in Security Administration.
  • More than one Product Family can be associated with an Application through the associated products.
  • You cannot create or update an application with the same Application Name and Application Code twice because the Application Name and Application Code must be unique. Uniqueness rule combinations:
    • For CTA and CTR Application type: Application Code + Study Number
    • For Non-CTA Application type: Application Code + Application Name

Applications and Registration Types

In Ennov InSight, 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 a Ennov InSight internal type of either Package Set or Product.
Note: Ennov InSight 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)

Ennov InSight 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.

Tracking Clinical Trial Regulation Applications (CTRs)

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

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

CT Shared Data

For ease of use, the CT Shared Data entity is created to enable users to consolidate common details about CTA and CTR. The CT Shared Data entity is created and maintained at the product family level, making the information available for association with CTA, CTR and IND application events. Upon associating the CT Shared Data to a CTA, CTR 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, CTR or IND application event. However, you can only assign one CT Shared Data entity to an event. The product you select determines the values for the CT Shared Data field.

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.