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 portal. In Vault Registrations, you can download a series of reports containing available variation and product data presented in the order in which you’ll enter it into the eAF.
Visit the EMA’s eSubmission portal for more information about the DADI project.
Note: This feature was formerly known as DADI output reports and was rebranded in 23R2 (23R1.2). They are only available on RIM Registrations Vaults and must be configured by an Admin. Vault currently supports the variations form for human medicinal products, and we will continue to support DADI as the EMA releases eAFs for additional procedures.
About eAF Output Reports
eAF Reports are Vault reports you can generate directly from a Regulatory Objective record with related Medicinal Products. They contain the variation and product output data in your Vault that you’ll use to input the proposed data values in the eAF portal. The reports are configurable, and the structure and content can be updated to meet your organization’s requirements.
Each time you execute the Generate eAF Report action, Vault refreshes the data in the existing report and sends a notification and email with a link. The latest-generated version is also stored in your Vault’s Reports tab.
Depending on your Vault’s configuration, you’ll receive one or more of the following eAF output reports when you execute the action:
- Human Variations
- Administered Product
- Product Variant
Generating an eAF Output Report
- Navigate to a Regulatory Objective record containing the data you’d like to view. eAF output reports are available for Regulatory Objectives with related Medicinal Products.
- From the Actions menu, select Generate eAF Report. Depending on your Vault’s configuration, the action may be available only in relevant lifecycle states, such as Planned. Use the Select Report Types for eAF Product Reports setting to select which reports will run.
Vault begins processing the request. When finished, you’ll receive a Vault notification and email containing a CSV file with links to each successfully-created report, as well as error details for reports Vault could not create. You can also find the latest-generated version directly in your Vault’s Reports tab. Any configured Human Variation Report(s) will run in addition to the selected product report types.
Note: When you apply filters for Medicinal Product, multi-pass eAF reports display all records which do not meet the filter criteria. For example, when filtering by Medicinal Product > ID, Vault returns all Medicinal Product records regardless of the records’ ID values. This behavior is due to a relationship constraint limitation in Vault multi-pass report types.
Viewing FHIR Messages
When you input and export the proposed data values from the eAF portal, the FHIR XML messages are added to the PDF export as attachments. To read the complex XML, you can upload the attachments to your Vault’s Library and view in the IDMP Viewer when configured by an Admin. See Viewing FHIR Messages for more information.