# Enable EVDAS Data Import for Signal Detection

With the 24R3 release, users can import EudraVigilance Data Analysis System (EVDAS) data into Vault in the form of electronic Reaction Monitoring Reports (eRMRs) and line listings. Users can then perform signal detection in compliance with EMA regulations.

After you have configured this feature, see the following articles for more information:
* <a href="/en/lr/773463/">Prepare EVDAS Data for Signal Detection</a>
* <a href="/en/lr/752950/#health-authority">Signal Data Sources</a>
* <a href="/en/lr/773430/">Signal Detection Using EVDAS Data</a>

## Create Custom Object Layouts

Create custom layouts for the following objects:
* _EVDAS eRMR Data_
* _EVDAS eRMR Data Line Listing_
* _EVDAS Line Listing_

To do this:

1. Navigate to **Admin > Configuration > Objects > [Object] > Layouts**.
2. Do one of the following:
    * <a href="/en/lr/26387/#save-as-layout">Copy</a> the applicable standard layout, set the new custom layout as the <a href="/en/lr/26387/#set-a-default-layout">default</a>, and <a href="/en/lr/26387/#delete-a-layout">delete</a> any other existing custom layouts that are no longer needed.
    * On the _Layouts_ tab, select **Create** and use the sections below to configure the object layouts.

### EVDAS eRMR Data

To configure the _EVDAS eRMR Data_ <a href="/en/lr/26387/#how-to-access-page-layouts">layout</a>:
1. Ensure the _Details_ section includes the following <a href="/en/lr/26387/#how-to-add-object-fields">fields</a>: 
    * _Reporting Period_
    * _Product Family_
    * _Active Substance_
    * _Product-Event Combination_
    * _PEC Period_
    * _MedDRA Term_
    * _PT_
    * _MedDRA Query_
    * _SMQ Narrow_
    * _Alert_
    * _Changes_
    * _Listed_
    * _IME/DME_
    * _Safety Investigation_
    * _Detection Date_
    * _Current Disposition_
    * _Current Disposition Date_
2. After the _Details_ section, insert the _SDR_ <a href="/en/lr/26387/#how-to-add-detail-forms">detail form section</a> with the following information: 
    * **Section Label**: Enter `SDR`.
    * **Section Name**: Enter `sdr`.
3. Ensure the _SDR_ section includes the following <a href="/en/lr/26387/#how-to-add-object-fields">fields</a>: 
    * _SDR All_
    * _SDR Paed_
    * _SDR Geriatr_
4. After the _SDR_ section, insert the _Data_ <a href="/en/lr/26387/#how-to-add-detail-forms">detail form section</a> with the following information: 
    * **Section Label**: Enter `Data`.
    * **Section Name**: Enter `statistical_data`.
    * **Section Layout**: From the drop-down, select **Detail Form - Two Columns**.
5. Ensure the _Data_ section includes the following <a href="/en/lr/26387/#how-to-add-object-fields">fields</a>:
    * _New EEA_
    * _New +RC_
    * _New Spont_
    * _New Fatal_
    * _New Serious_
    * _New Paed_
    * _New Geriatr_
    * _New Lit_
    * _New EVPM_
    * _Tot EEA_
    * _Tot +RC_
    * _Tot Spont_
    * _Tot Fatal_
    * _Tot Serious_
    * _Tot Paed_
    * _Tot Geriatr_
    * _Tot Lit_
    * _Tot EVPM_
    * _Relative ROR (-) Paed vs Others_
    * _Relative ROR (-) Geriatr vs Others_
    * _ROR (-) All_
6. After the _Data_ section, insert the _EVDAS eRMR Data Line Listing > EVDAS Line Listing_ <a href="/en/lr/26387/#related-object">related object section</a> with the following information:
    * **Section Label**: Enter `Line Listings`. 
    * **Section Name**: Enter `evdas_line_listings`. 
    * **Creation Option**: Select **Create record in pop-up dialog**.
7. Optional: In the _Line Listings_ section, <a href="/en/lr/26387/#columns">edit the default columns</a> to appear as follows:
    * _Name_
    * _Product Family_
    * _Reporting Period_
    * _EU Local Number_
    * _Worldwide Unique Case Identification_
    * _Case Number_
    * _Case Version_
    * _EV Gateway Receipt Date_
    * _Report Type_
    * _Literature Reference_
    * _Parent Child Report_
    * _Patient Age Group_
    * _Patient Age Group (as per reporter)_
    * _Patient Sex_
    * _Primary Source Qualification_
    * _Primary Source Country for Reg. Purposes_
8. After the _Workflow Timeline_ section, insert the _System_ <a href="/en/lr/26387/#how-to-add-detail-forms">detail form section</a> with the following information: 
    * **Section Label**: Enter `System`.
    * **Section Name**: Enter `system`.
    * **Section Layout**: From the drop-down, select **Detail Form - Two Columns**.
9. Ensure the _System_ section includes the following <a href="/en/lr/26387/#how-to-add-object-fields">fields</a>: 
    * _EVDAS eRMR Unique Name_
    * _Created By_
    * _Created Date_
    * _Lifecycle State_
    * _Last Modified By_
    * _Last Modified Date_

### EVDAS eRMR Data Line Listing

To configure the _EVDAS eRMR Data Line Listing_ <a href="/en/lr/26387/#how-to-access-page-layouts">layout</a>, ensure the _Details_ section includes the _EVDAS eRMR Data_ and the _EVDAS Line Listing_ <a href="/en/lr/26387/#how-to-add-object-fields">fields</a>.

### EVDAS Line Listing

To configure the _EVDAS Line Listing_ <a href="/en/lr/26387/#how-to-access-page-layouts">layout</a>, ensure the _Details_ section includes the following <a href="/en/lr/26387/#how-to-add-object-fields">fields</a>:
* _Reporting Period_
* _Product Family_
* _EU Local Number_
* _Worldwide Unique Case Identification_
* _Case Version_
* _Report Type_
* _EV Gateway Receipt Date_
* _Primary Source Qualification_
* _Primary Source Country for Reg. Purposes_
* _Literature Reference_
* _Patient Age Group_
* _Patient Age Group (as per reporter)_
* _Patient Sex_
* _Parent Child Report_
* _Reaction List PT_
* _Suspect/interacting Drug List_
* _Concomitant/Not Administered Drug List_
* _ICSR Form (Text)_

## Update Object Layouts

For the _Safety Investigation_ and _Signal Reporting Period_ object <a href="/en/lr/26387/#how-to-access-page-layouts">layouts</a>, insert the _EVDAS eRMR Data_ <a href="/en/lr/26387/#related-object">related object section</a> with the following information: 
* **Section Label**: Enter `EVDAS eRMRs`.
* **Section Name**: Enter `evdas_ermrs`.
* **Creation Option**: Select **Create record in pop-up dialog**.

## Update the EVDAS eRMR Data Object

To update the _EVDAS eRMR Data_ object, navigate to **Admin > Configuration > Objects > EVDAS eRMR Data** and update [field settings][4] and the [list layout][5]. 

### Update Fields {#evdas-ermr-data-fields}

To update the _Active Substance_ and _PT_ fields to display in default lists and hovercards, navigate to the **Fields** tab and in the applicable fields, select the **Display in default lists and hovercards** checkbox.

### Update the List Layout {#evdas-ermr-data-list-layout}

To update the _EVDAS eRMR Data_ list layout:
1. Navigate to the **List Layout** tab and select **Reorder**.
2. Drag field names so the list layout appears in the following order:
    * _EVDAS eRMR Unique Name_
    * _Product Family_
    * _MedDRA Term_
    * _MedDRA Query_
    * _Active Substance_
    * _PT_
    * _Alert_
    * _Changes_
    * _Listed_
    * _IME/DME_
    * _SDR All_
    * _SDR Geriatr_
    * _SDR Paed_
    * _New EEA_
    * _Tot EEA_
    * _New EVPM_
    * _Tot EVPM_
    * _New Fatal_
    * _Tot Fatal_
    * _New Geriatr_
    * _Tot Geriatr_
    * _New Paed_
    * _Tot Paed_
    * _New +RC_
    * _Tot +RC_
    * _New Serious_
    * _Tot Serious_
    * _New Spont_
    * _Tot Spont_
    * _ROR (-) All_
    * _Reporting Period_
    * _Current Disposition_
    * _Safety Investigation_
    * _Detection Date_
3. Select **Save**.

## Grant Object Permissions

Ensure your <a href="/en/lr/22824/#objectpermissions">permission sets</a> are updated to grant the appropriate level of access for users to objects and fields according to your organization's process. Manage object permissions from **Admin > Users & Groups > Permission Sets > [Permission Set] > Objects > [Object]**.

In the applicable permission sets, grant _Read_, _Create_, _Edit_, and _Delete_ permissions for the following objects:
* _EVDAS eRMR Data_
* _EVDAS eRMR Data Line Listing_
* _EVDAS Line Listing_

[1]: #evdas-ermr-data
[2]: #evdas-ermr-data-line-listing
[3]: #evdas-line-listing
[4]: #evdas-ermr-data-fields
[5]: #evdas-ermr-data-list-layout