Learn about the data sources Safety Signal can access for signal detection.
About Signal Data Sources
You can use Safety Signal to detect potential signals from multiple sources.
Safety Signal supports the following data sources for signal detection:
- Safety Database: Pharmacovigilance (PV) data from Vault 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 Vault Safety to produce Product-Event Combinations (PECs) for quantitative analysis. PV data is transferred daily from Vault Safety to the Signal database.
Once PV data is transferred to the Signal database, you can run ad-hoc 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 Data
Safety 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 Safety 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 Vault Safety matching the Worldwide Unique Case Identification (WWUID).
See Signal Detection Using EVDAS Data for more information.
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 Vault SafetyDocs license. Contact your Veeva Representative for more information.
See Signal Management for more information.