**Source URL:** https://safety.veevavault.help/en/lr/773430/index.md

# Signal Detection Using EVDAS Data

Signal can support _Product-Event Combinations_ (PECs) from the EudraVigilance Data Analysis System (EVDAS), an EMA regulatory database.

EMA provides data in the following formats available for download from the EVDAS portal:
* Electronic Monitoring Reports (eRMRs): This summary report includes the active substance, and statistical scores and report counts, for example, the total number of serious _Cases_.
* Line Listings: This table accompanies the eRMR and is a list of Individual Case Safety Reports (ICSRs) that contributed to the _Case_ counts and statistical scores in the eRMR. Information also includes other important values, such as adverse event reactions and the _Worldwide UID_ (WWUID), to help identify _Cases_.

As part of routine signal surveillance, your Admin can <a href="/en/lr/773463/#complete-routine-requests">create a _Signal Data Request_</a> to import EVDAS data for a _Signal Reporting Period_. As part of an ad-hoc review, you can [create a _Signal Data Request_ for a _Safety Investigation_][1]. 

## Prerequisites

Consider the following prerequisites:
* Before you can perform signal analysis on EVDAS data in Signal, your Admin must <a href="/en/lr/795474/">enable EVDAS data import</a> and <a href="/en/lr/773463/">import EVDAS data</a> for signal detection.
* To perform signal detection on EVDAS data in the same PEC with other supported data sources, your Admin must <a href="/en/lr/1005912/">enable Multi-Source Signal Data Consolidation</a>.

## Request EVDAS Data {#request-ad-hoc-evdas}

To review EVDAS data outside of a routine schedule, for example, as part of a _Safety Investigation_ validation step, create an ad-hoc _Signal Data Request_ from a _Safety Investigation_:
1. Navigate to the **Safety Investigations** tab and select the **Safety Investigation** to which you want to import EVDAS data for an ad-hoc review.
2. Expand the **Data Requests** section and select **Create**.
3. In the _Create Signal Data Request_ window, complete the [applicable fields][2].
4. From the **Workflow State Change** menu (<img class="inline" src="https://platform.veevavault.help/assets/images/saf-workflow-state-change.png" alt="workflow-state-change-icon" style=" width: 2.5rem;" />), update the _Signal Data Request_ lifecycle state to _Open_. 
5. After your Admin <a href="/en/lr/773463/#complete-ad-hoc-requests">completes your request</a> and imports EVDAS data, you can review it from the _Safety Investigation_.

After EVDAS data import, Vault attempts to [match][3] each case listing to a _Case_ version in your Vault. 

### Signal Data Request Fields {#data-request-fields}

The following fields may be available: 

<table>
    <thead>
        <tr>
            <th>Field</th>
            <th>Description</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td><em>Safety Investigation</em></td>
            <td>When creating the <em>Signal Data Request</em> from a <em>Safety Investigation</em>, Vault populates this field. Otherwise, select a <em>Safety Investigation</em> from the drop-down or select the <strong>Advanced Search</strong> (<img class="inline" src="https://platform.veevavault.help/assets/images/saf-binoculars-icon.png" alt="advanced search icon" style="" />) icon to use filters and refine your search.</td>
        </tr>
        <tr>
            <td><em>Reporting Period</em></td>
            <td>When creating the <em>Signal Data Request</em> from a <em>Signal Reporting Period</em>, Vault populates this field. Otherwise, select a reporting period from the drop-down or select the <strong>Advanced Search</strong> icon to use filters and refine your search.</td>
        </tr>
        <tr>
            <td><em>Request Purpose</em></td>
            <td>Select the purpose for your request from the picklist.</td>
        </tr>
        <tr>
            <td><em>Request Priority</em></td>
            <td>Select the priority of this request from the picklist.</td>
        </tr>
        <tr>
            <td><em>Reference Period Start Date</em></td>
            <td>When you populate the <em>Reporting Period</em> field, Vault populates the start date of the <em>Signal Reporting Period</em>. For ad-hoc requests, enter the search criteria start date.</td>
        </tr>
        <tr>
            <td><em>Reference Period End Date</em></td>
            <td>When you populate the <em>Reporting Period</em> field, Vault populates the end date of the <em>Signal Reporting Period</em>. For ad-hoc requests, enter the search criteria end date.</td>
        </tr>
        <tr>
            <td><em>Request Data Source</em></td>
            <td>Select <strong>EMA - EVDAS</strong> from the drop-down.</td>
        </tr>
        <tr>
            <td><em>Due Date</em></td>
            <td>Select the date this request is due from the calendar or enter the date manually.</td>
        </tr>
        <tr>
            <td><em>Request Summary</em></td>
            <td>Provide additional details about the data request as needed, for example, if you are requesting either or both eRMR data and case line listing data, or specific MedDRA terms.</td>
        </tr>
    </tbody>
</table>

<div class="note-border alert-info">
  <div class="alert alert-info" role="alert">
    <div><i class="far fa-info-circle"></i></div>
    <div class="alert-text">
      <p><strong>Note</strong>: Vault supports automated <em>Signal Data Requests</em> for the EVDAS database only. Support for additional data sources will be available in a future release.</p>
    </div>
  </div>
</div>



## How Vault Links the EVDAS Line Listings to a Safety Case {#line-listing-case-matching}

After your Admin imports EVDAS line listings to Signal, Vault attempts to link each case listing to a _Case_ version in your Vault using the _WWUID_. The following scenarios occur depending on the matching parameters:

### WWUID Matches a Single Case in Safety

If the EVDAS Line Listing _WWUID_ matches a single _Case_, Vault sets the latest related _Case Version_ and _Case Number_ fields on the _EVDAS Line Listing_ record.

### WWUID Matches Multiple Cases in Safety

If the EVDAS Line Listing _WWUID_ matches multiple _Cases_ with different _Case_ numbers, Vault chooses the latest _Case_ version based on the _Case_ record with the most recent creation date. Vault then sets the latest related _Case Version_ and _Case Number_ fields on the _EVDAS Line Listing_ record.

### WWUID Does Not Match

If the EVDAS Line Listing _WWUID_ does not match any _Case_ records, Vault does not link the _EVDAS Line Listing_ case to any _Case_ in Safety.

[1]: #request-ad-hoc-evdas
[2]: #data-request-fields
[3]: #line-listing-case-matching