**Source URL:** https://safety.veevavault.help/en/lr/752950/index.md

# Signal Data Sources

Veeva Safety Signal supports signal detection for multiple data sources: 
* _Safety Database_: Pharmacovigilance (PV) data from Veeva Safety
* _Regulatory Database_: Safety data provided by a regulatory database
* _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/lr/935430/#pv-signal-detection">Signal Detection Overview</a> for more information. 

## Regulatory Database 

When you select this data source, you can define the regulatory database from which safety data is provided.

### EVDAS

Unlike other data sources, the EMA's EudraVigilance Data Analysis System (<a href="/en/lr/773430/">EVDAS</a>) data can be based on the active substance and not the product. EVDAS data comes in the form of electronic Reaction Monitoring Reports (eRMRs) and line listing tables. You must extract the data in CSV (UTF-8) format from EVDAS before importing it to Signal for routine and ad-hoc signal reviews. As part of the import, Vault extracts the substance and drug names from the concatenated drug list fields as well as the MedDRA Preferred Term (PT) from the reaction list field. Vault also autocodes events using the active MedDRA version in your Vault; if there's no match, Vault attempts to code the term using the latest version loaded to your Vault, followed by the highest version available. After import, you can then trigger an action to link corresponding eRMR and line listing records.

### 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/lr/896826/#safety-investigation-from-literature-article">Create Safety Investigations for Signal Management</a> for more information.

[1]: #safety-database
[2]: #regultory-database
[3]: #literature