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
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 Signal Detection Using PV Data 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 Signal Detection Using EVDAS Data 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 or patientagegroup |
Patient’s Age at Onset and Age (unit) 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. 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 Signal Management for more information.