In 2022, the European Medicines Agency (EMA) introduced its Digital Application Dataset Integration (DADI) project to replace PDF-based electronic application forms (eAFs) used for regulatory submissions with web forms in a new eAF portal. In Vault Registrations, users can download a series of reports containing available DADI variation and product data presented in the order in which it is entered into the eAF.

Visit the EMA’s eSubmission portal for more information about the DADI project.

Configuration Overview

  1. Configure your Vault for IDMP data review. This step includes ensuring your Vault’s IDMP objects and object page layouts are configured with the required fields for collecting eAF output report data.
  2. Set up any report types and multi-pass report views that you want to use for eAF output reports.
  3. Navigate to Admin > Settings > Application Settings and select Enable configurable eAF Reports under Registrations Features. Within the list of configurable reports, use the dropdowns to select the eAF Report types to be used for each, based upon the reports created in Step 2.
  4. Assign the Generate eAF Report action to the Regulatory Objective object, then make the action available for users. To do this, you can configure a user action in the Regulatory Objective object lifecycle for the relevant states, such as Planned and In Progress. Alternatively, when assigning the action to the object, you can check the Available in All Lifecycle States option and allow users to execute the action in some or all lifecycle states.
  5. Review your Vault’s security configuration. To generate eAF Reports, users must have a permission set with the ability to view the Regulatory Objective object and its relationships. These users must also be able to execute the user action. To view eAF Reports, users must have a permission set with the ability to view reports.
  6. Optional: Configure your Vault to allow users to view complex XML FHIR messages in the IDMP Viewer.

Configuring eAF Report Types

Before you enable configurable eAF Reports, navigate to Admin > Configuration > Report Types and Report Views to set up any report types and views that you want to use for eAF output data in your Vault. See detailed instructions about configuring report types and multi-pass reports.

Contact Veeva Support for a VPK that includes report types, report views, and multi-pass reports. With assistance from the assigned Product Support Engineer, you can deploy the VPKs and modify the reports to suit your organization’s requirements.

Configuring FHIR Message Viewing

When users input and export the proposed data values in the eAF portal, the accompanying complex XML FHIR messages are added to the PDF export as attachments. You can configure your Vault to allow users to upload these attachments in the Library, then open them in human-readable format in the IDMP Viewer.

To do this:

  1. Activate the IDMP document type and the eAF FHIR Output subtype.
  2. Add the FHIR Message Version shared document field to the eAF FHIR Output subtype. This field references Controlled Vocabulary object records with the Controlled Vocabulary Type set to FHIR Message Version and captures the FHIR standard version used to generate the message.
  3. Review your Vault’s document lifecycle configuration. In the lifecycle used for the IDMP > eAF FHIR Output document type (for example, the General lifecycle), define the Generate Data Viewer File and Open Data Viewer custom document actions on the steady state. Additionally, ensure the lifecycle configuration allows documents of this type to be moved to the steady state, as the actions are available only for this state type.
  4. Create a Controlled Vocabulary record with the Controlled Vocabulary Type set to FHIR Message Version, one for each FHIR message version your organization wishes to include in the eAF FHIR Output document metadata. While you can create these records for any version, records for any non-supported versions are for metadata purposes only and are not subject to this feature’s functionality. Vault currently only supports viewing FHIR v4.6.0 messages in the IDMP Viewer.