# Configuring eAF Output Reports

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 RIM Registrations, users can download [a series of reports](/en/lr/5062580/) containing available DADI variation and product data presented in the order in which it is entered into the eAF.

Visit the <a class="external-link " href="https://esubmission.ema.europa.eu/cessp/cessp.htm" target="_blank" rel="noopener">EMA's eSubmission portal<i class="fa fa-external-link" aria-hidden="true"></i></a> for more information about the DADI project and the <a class="external-link " href="https://plm-portal.ema.europa.eu/" target="_blank" rel="noopener">Product Lifecycle Management (PLM) Portal<i class="fa fa-external-link" aria-hidden="true"></i></a>.



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      <p><strong>Note</strong>: This feature was formerly known as DADI output reports and was rebranded in 23R2 (23R1.2). They are only available for RIM Registrations. 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.</p>
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## Configuration Overview

1. Configure your Vault for [IDMP data review](/en/lr/60772/). This step includes ensuring your Vault's IDMP [objects and object page layouts](/en/lr/60772/#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][1] 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](/en/lr/43127/#assign-actions) 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](/en/lr/59885/#define-actions) 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](/en/lr/22824/#objectpermissions) 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][2] the [IDMP Viewer](/en/lr/76688/) to allow users to view and compare [complex XML FHIR messages](/en/lr/48830/).

## Configuring eAF Report Types {#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](/en/lr/21543/) and [multi-pass reports](/en/lr/55007/).

<a class="external-link " href="https://support.veeva.com/hc/en-us" target="_blank" rel="noopener">Contact Veeva Support<i class="fa fa-external-link" aria-hidden="true"></i></a> 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.

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      <p><strong>Note</strong>: When users apply filters for <em>Medicinal Product</em>, multi-pass eAF reports display all records which do not meet the filter criteria. For example, when filtering by <em>Medicinal Product</em> &gt; <em>ID</em>, Vault returns all <em>Medicinal Product</em> records regardless of the records’ <em>ID</em> values. This behavior is due to a relationship constraint limitation in Vault multi-pass report types.</p>
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## Configuring eAF Message Viewing & Comparison {#configuring-fhir-message-viewing}


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      <p><strong>Note</strong>: Vault fully supports messages generated using FHIR v5.0.0 only. See additional details about how the IDMP Viewer supports viewing and comparing FHIR messages across versions.</p>
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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 view them in human-readable format in the IDMP Viewer.

To do this:
  1. [Activate](/en/lr/618/#EnablingDocTypes) the _IDMP_ document type and the _eAF FHIR Output_ subtype.
  2. Add the _FHIR Message Version_ [shared document field](/en/lr/4884/#use-shared-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](/en/lr/12339/) 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 applicable message version. Vault references this record when setting the eAF FHIR Output document's _FHIR Message Version_, which is a required field for viewing in the IDMP Viewer. While you can create these records for any version, records for versions other than v5.0.0 are partially only for document metadata purposes due to an IDMP Viewer [limitation](/en/lr/48830/#fhir-version-support).
  5. Enable the **Prompt for FHIR Message Selection in IDMP Viewer** setting in **Admin > Settings > Application Settings**. This [IDMP Viewer Enhancement](/en/lr/60772/#idmp-viewer-enhancements) enables the **Compare Data** dropdown in the IDMP Viewer's **Data View Selection** dialog, allowing users to select and compare messages classified under the *IDMP > eAF FHIR Output* document subtype. Vault allows comparison when the document's *FHIR Message Version* corresponds to an active *Controlled Vocabulary* record for that version.

[1]: #configuring-eaf-report-types
[2]: #configuring-fhir-message-viewing