# Signal Data Sources

Learn about the data sources Signal can access for signal detection.

## About Signal Data Sources

You can use Signal to detect potential signals from multiple sources.

Signal supports the following data sources for signal detection: 
* _Safety Database_: Pharmacovigilance (PV) data from Safety
* _Health Authority_: Safety data provided by a health authority
* _Literature_: Data obtained from a literature database

## Safety Database

Pharmacovigilance (PV) data is transferred daily from Safety to a Signal database. The _Safety Database_ data source uses _Cases_ (PV data) from Safety to produce _Product-Event Combinations_ (PECs) for quantitative analysis. PV data is transferred daily from Safety to the Signal database.

Once PV data is transferred to the Signal database, you can run calculations to detect PECs.

See the <a href="/en/gr/935430/#pv-signal-detection">Signal Detection Overview</a> for more information. 

## Health Authority

The _Health Authority_ data source provides safety data from a health authority database. When you select this data source, you can define the health authority database from which safety data is provided, such as the EMA's EVDAS eRMR.

### EVDAS

Signal supports EMA's EudraVigilance Data Analysis System (EVDAS) data as a source for signal detection.

You must manually download the EVDAS eRMR (electronic Reaction Monitoring Report) data and line listings in CSV format and load them into Signal.

The eRMR is a summary report that includes the active substance, the MedDRA adverse events, and some signal scores. Unlike other data sources, EVDAS data can be based on the active substance and not the product.

Vault links the EVDAS Line Listing to the latest _Case_ version in Safety matching the _Worldwide Unique Case Identification_ (_WWUID_).

See <a href="/en/gr/773430/">Signal Detection Using EVDAS Data</a> for more information.

### FAERS

The FDA Adverse Event Reporting System (FAERS) is a public FDA database that contains millions of cases. As a large data set, FAERS is a reliable source for signal calculations.

The FDA releases new FAERS data every quarter, which Veeva prepares and makes available as a _Signal Source_. As part of the preparation, Veeva cleans the data (for example, removing trailing spaces and invalid characters), auto-codes events using the latest published MedDRA dictionary, and codes products using the FDA's National Drug Code (NDC) Directory. Veeva uses the latest published NDC Directory at the time of product coding and does not update the NDC Directory between the FAERS quarterly ingestions.

Veeva also removes duplicate cases. A case is considered a duplicate if the case number and case version match, or if the following case fields match:

| FAERS Case Field             | Corresponding Safety Case Field          |
| ---------------------------- | ---------------------------------------- |
| reportercountry              | Reporter's _Country_                     |
| patientsex                   | Patient's _Sex_                          |
| receiptdate                  | _Receipt Date_                           |
| patientonsetage and patientonsetageunit <br> or patientagegroup | Patient's _Age at Onset_ and _Age (unit)_ <br> or patient's _Age Group_ |
| reactionmeddrapt             | _Event (Reported)_                       |
| medicinalproduct             | _Product (Coded)_                        |
| activesubstancename          | _Product (Coded)_                        |
| drugindication               | _Indication (Reported)_                  |

### VAERS

The Vaccine Adverse Event Reporting System (VAERS) is a public FDA database used to detect potential safety issues in vaccines licensed in the United States. The VAERS database contains millions of cases, providing a large data set for signal calculations.

The FDA releases new VAERS data every month, which Veeva prepares and makes available as a _Signal Source_; Veeva ingests only the first _Case_ versions. As part of the preparation, Veeva codes events using the latest published MedDRA version. If a reported event cannot be coded using the latest MedDRA version, these terms are manually coded by Veeva. VAERS products are not coded to any drug directory.

## Literature

The _Literature_ data source uses literature articles to identify _Products_ in SafetyDocs Vaults. When you select this data source, you can define the literature database, such as JPIC. 

Once you have determined that the investigation review outcome results in _New Safety Information_, you can create a _Safety Investigation_ directly from the _Literature Article_.

To use _Literature_ as a data source requires a SafetyDocs license. Contact your Veeva Representative for more information.

See <a href="/en/gr/896826/#safety-investigation-from-literature-article">Create Safety Investigations for Signal Management</a> for more information.

[1]: #safety-database
[2]: #health-authority
[3]: #literature