# Prepare EVDAS Data for Signal Detection

Perform signal detection on EudraVigilance Data Analysis System (EVDAS) data by [extracting][1] and [loading][2] the adverse event data in the form of electronic Reaction Monitoring Reports (eRMRs) and line listings. 

## Prerequisites

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

## Extract Data from the EVDAS Database {#extract}

Before you can prepare EVDAS data for signal detection in Safety Signal, you must follow your business processes to extract eRMR and line listing data from the EVDAS database.

## Load EVDAS Data to Safety {#load}

After obtaining the data from the EVDAS database, follow the sections below to prepare and load the data into Safety for signal detection.

### Prepare Data

Before loading the EVDAS eRMR and line listings data, you must do the following:
* Ensure the active substance in the eRMR and line listings exists in the Safety _Substance_ library.
* Configure a _Signal Reporting Period_ record for the _Product Family_ that aligns with the substance in the eRMR and line listings. To do this, navigate to the **Reporting Period** tab and select **Create**. Ensure the _Start Date_ and _End Date_ fields match the eRMR and line listings reporting period.
* In both the eRMR and line listings file, add a first column, _Signal Reporting Period ID_. Populate this column using the applicable _ID_ field value from the newly created reporting period.

### Load EVDAS eRMR and Line Listings Data

To load EVDAS eRMR and line listings data to Safety, navigate to **Business Admin (Quick Acess) > Load** to use Vault Loader. Follow the steps in <a href="/en/lr/26607/#loading-object-records">Vault Loader: Create, Update & Delete Object Records</a> to load each file and consider the following when loading the EVDAS eRMR and line listings:
* For _Object Type_, select one of the following depending on the file you are loading:
  * **EVDAS eRMRs (evdas_ermr_data__v)**
  * **EVDAS Line Listings (evdas_line_listing__v)**
* For _Action Type_, select **Create**.
* Ensure the _Signal Report ID_ in the eRMR and line listing file is mapped to the related reporting period _ID_ field value.
* Ensure all remaining fields in the eRMR and line listing file are mapped to the corresponding fields in Vault.

**Results: EVDAS eRMR**

Vault imports the EVDAS eRMR and creates a new _EVDAS eRMR Data_ record. Using the mapped _Signal Report ID_ from the file, Vault sets the following fields on the _EVDAS eRMR Data_ record:
* _Signal Reporting Period_
* _Product Family_ or _Aggregate Reporting Group_

**Results: EVDAS Line Listings**

Vault imports the EVDAS line listings and creates a new _EVDAS Line Listing_ record. Using the mapped _Signal Reporting Period ID_ from the file, Vault sets the following fields on the _EVDAS Line Listing_ record:
* _Signal Reporting Period_
* _Product Family_ or _Aggregate Reporting Group_

## Update the MedDRA Term

If you plan to run _Signal Calculations_ on EVDAS data, you must set the appropriate MedDRA term on the _EVDAS eRMR Data_ records: 
1. Navigate to **EVDAS eRMRs > [EVDAS eRMR Data]**. 
2. Select **Edit**.
3. In the _MedDRA Term_ field, select an option from the drop-down or select the **Advanced Search** (<img class="inline" src="https://platform.veevavault.help/assets/images/saf-binoculars-icon.png" alt="binoculars-icon" style="" />) icon to use filters and refine your search.

To update MedDRA terms in bulk, contact your Veeva Representative.

## Next Steps

After preparing the EVDAS data, see the following resources:
* To learn about how Vault links EVDAS line listing cases to Safety _Case_ versions, see <a href="/en/lr/773430/">Signal Detection Using EVDAS Data</a>. 
* To learn about running calculations, creating _Statistical Data_ records, and running alerts on EVDAS data, see the <a href="/en/lr/935430/">Signal Detection Overview</a>. To perform these actions on EVDAS data, the _EVDAS eRMR Data_ records must include a _Reporting Period_ associated with a _Product Family_ or _Aggregate Reporting Group_ and a _MedDRA Term_.

[1]: #extract
[2]: #load