Working with Applications

Applications allow you to organize your data and documents across multiple submissions. Applications are used to create submissions, which are then used to create submission content plans.

Diagram of Submissions and Content Plans created from an Application

Applications in Vault RIM Basics can contain multiple submissions. The application represents a set of documents that seek approval from a specific regulatory authority to market and sell a product in certain locations. The submission is an instance of that set of documentation sent to a regulatory authority. Over the life of a product, multiple submissions will be made from the associated application.

Because each submission requires the same core data throughout the lifetime of an application, Vault allows you to manage the application data in one place and apply that application data to any newly created submissions.

Vault Admins and Submission Managers have access to the Applications tab, while Document Managers do not.

Viewing Applications

Complete the following steps to view applications:

  1. Navigate to the Submission Mgmt > Applications tab to view a list of applications.
  2. Select the Application Name of the application you want to view. The application and its details are displayed on the Application page.
  3. Select Submissions on the left panel to display the Submissions section and view any submissions that have been created from the application.
  4. Expand or collapse each application relationship section on the Application page to view more information about the relationship.

Creating Applications

Complete the following steps to create an application:

  1. In the Submission Mgmt > Applications tab, click Create.
  2. In the Create Application dialog, select the Type of Application and click Continue.
  3. On the Create Application page, enter the Application Name.
  4. Select the Lead Market and the associated Region for the lead market. If only one region is available for your selected lead market, Vault automatically selects that region.
  5. Select the Application Type. Vault lists the application types available for your selected lead market and region. If only one application type is available for your selected lead market and region, Vault automatically selects that application type.
  6. Select the Primary Product Family.
  7. Enter the Application Folder Name as it appears at the Health Authority, if applicable.
  8. Optional: Enter any additional information in the fields displayed based on your selected lead market, region, and application type.
  9. From the Dossier Format drop-down, select eCTD or Non-eCTD.
  10. Enter any additional information in the fields displayed in the Content Plan Details section. The available values depend on your selected lead market, region, and dossier format.
  11. Click Save. Vault creates the application and displays its information on the Application page.

Adding Application Relationships

Once you create your application, you can begin adding application relationships. The information available to add is created by your organization’s Vault Admins.

Complete the following steps to add application relationships:

  1. In the Submission Mgmt > Applications tab, click the Application Name of the application to which you want to add relationships.
  2. On the Application page, click Product Families in the left panel to display the Application Relationships sections.
  3. Complete the following steps to add a product family:
    1. In the Product Families section on the Application page, click Add.
    2. In the Search: Product Family dialog, select the checkbox for the product family you want to add.
    3. Click OK. Vault adds the product family to the application.
  4. Complete the following steps to add a product:
    1. In the Products section on the Application page, click Create.
    2. In the Create Application Drug Product dialog, select the Product.
    3. Select the Product Variant and Manufacturer. The available values depend on the product you selected.
    4. If you want to use this product when creating a content plan, select Yes for Use for Content Planning. Otherwise, select No.
    5. Click Save. Vault adds the product to the application.
  5. Complete the following steps to add an active substance:
    1. In the Active Substances section on the Application page, click Create.
    2. In the Create Application Active Substance dialog, select the Active Substance and Manufacturer.
    3. If you want to use this active substance when creating a content plan, select Yes for Use for Content Planning. Otherwise, select No.
    4. Click Save. Vault adds the active substance to the application.
  6. Complete the following steps to add an inactive ingredient:
    1. In the Inactive Ingredients section on the Application page, click Create.
    2. In the Create Application Inactive Ingredient dialog, select the Inactive Ingredient and Manufacturer.
    3. If you want to use this inactive ingredient when creating a content plan, select Yes for Use for Content Planning. Otherwise, select No.
    4. Click Save. Vault adds the inactive ingredient to the application.
  7. Complete the following steps to add a therapeutic indication:
    1. In the Therapeutic Indications section on the Application page, click Add.
    2. In the Search: Therapeutic Indication dialog, select the Name of the therapeutic indication you want to add.
    3. Click OK. Vault adds the therapeutic indication to the application.
  8. Complete the following steps to add a clinical study:
    1. In the Clinical Studies section on the Application page, click Add.
    2. In the Search: Clinical Study dialog, select the Clinical Study Number of the clinical study you want to add.
    3. Click OK. Vault adds the clinical study to the application.
  9. Complete the following steps to add a nonclinical study:
    1. In the Nonclinical Studies section on the Application page, click Add.
    2. In the Search: Nonclinical Study dialog, select the Nonclinical Study Number of the nonclinical study you want to add.
    3. Click OK. Vault adds the nonclinical study to the application.

Editing Applications

Complete the following steps to edit an application:

  1. In the Submission Mgmt > Applications tab, click the Application Name of the application you want to edit.
  2. On the Application page, click Edit. Vault makes the fields in the Application Details sections available to edit.
  3. Edit the information as needed and click Save. Vault saves your updated information.
  4. To edit an application relationship, navigate to the section of the relationship you want to edit.
  5. From the Actions menu to the right of the relationship name, select Edit, Delete, or Remove. The available actions are different for each relationship type.
  6. If you select Edit, edit the information you want to change and click Save. Vault saves the updated information.
  7. If you select Delete or Remove click Continue in the dialog to confirm that you want to delete or remove the record.

Changing Application Types

You can change an application’s type from Marketing to Investigational, or from Investigational to Marketing.

Complete the following steps to change an application’s type:

  1. In the Submission Mgmt > Applications tab, click the Application Name of the application you want to change.
  2. On the Application page, select Change Type from the All Actions menu.
  3. In the Change Application Type dialog, confirm that you are changing the type to Marketing or Investigational and click Continue.
  4. On the Application page, select the new Application Type for your Marketing or Investigational application. The available values depend on the selected product type, lead market, and region.
  5. Click Save. Vault saves your changes and updates the application type.

Deactivating & Reactivating Applications

If an application is no longer needed and should not be used to create any further submissions, you can deactivate it. The Submission Wizard is unavailable for Inactive applications. You can also reactivate Inactive applications if needed.

Complete the following steps to deactivate or reactivate an application:

  1. In the Submission Mgmt > Applications tab, click the Application Name of the Active application you want to deactivate.
  2. From the Workflow Actions menu, select Change State to Inactive. Vault displays a dialog asking you to confirm that you want to change the state to Inactive.
  3. Click Yes. Vault updates the application status to Inactive.
  4. To reactivate an Inactive application, select Change State to Active from the Workflow Actions menu. Vault displays a dialog asking you to confirm that you want to change the state to Active.
  5. Click Yes. Vault updates the application status to Active.