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 Signal Detection Overview 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 (EVDAS) 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 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; 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 Create Safety Investigations for Signal Management for more information.