VigiBase Extract Case Level
For users who need to perform repeated searches, working with multiple substances or using differing variables, VigiBase Extract Case Level may be the ideal solution.
What is VigiBase Extract Case Level?
VigiBase Extract Case Level is an extract of the VigiBase dataset (anonymised and limited in case details to protect privacy of patients and healthcare providers). With this service, a filtered view of the full VigiBase dataset is provided as flat text files for customers to import into their own relational database for local search and analysis. The data is updated four times per year and billed as an annual licence fee. Users of this service will require some IT capacity, as the extracted files need to be set up in a relational database model.
The value of using VigiBase Extract Case Level
With VigiBase Extract Case Level, users combine the power and insight of a uniquely diverse and comprehensive global dataset with the convenience of their own systems and methods.
VigiBase is the largest set of medicines and vaccine safety data available. The contributors to VigiBase are national pharmacovigilance centres representing 99% of the global population, and the data includes the public datasets of spontaneous reports from the US databases FAERS and VAERS, Europe’s EudraVigilance, and many national databases from across Asia, Africa, Latin America, and Oceania.
VigiBase data also provides users with an unmatched view of geographic and ethnic diversity, with data from low- and middle-income countries currently making up 15% of the total, and growing.
As authorities increasingly require consultation with available sources, VigiBase Extract Case Level helps users proactively meet their regulatory compliance needs for risk management and signal detection. Users of VigiBase Extract Case Level also save time and money, as the data is already coded and structured to WHODrug and MedDRA standards.
Like other VigiBase Services, VigiBase Extract Case Level is backed by UMC’s expert guidance and support. As the custodians of VigiBase, signal detection and method development are at the core of our operations – they inform the services we offer and the support we provide.
VigiBase Extract Case Level is licensed as a subscription with an annual fee, with different licence models designed for end users, vendors, and academia.
Fees for all VigiBase Services are set on a cost recovery basis to support the operation and development of VigiBase and offer equitable access and value for users. Contact us to discuss the appropriate licence model and fee level for your needs.
Using VigiBase Extract Case Level
Users of VigiBase Extract Case Level include contract research organisations, marketing authorisation holders, software vendors, national pharmacovigilance centres, academics, and researchers from various other sectors.
Common applications include using the service as a reference dataset for signal management, hypothesis testing, risk management, or methodological research.
Limitations on the data and its use
The data in VigiBase contains private and sensitive information. Furthermore, its analysis and interpretation requires specialised medical or scientific expertise. Therefore, UMC follows a strict evaluation process before providing access to VigiBase Extract Case Level data.
The data provided through this service is not the entire VigiBase dataset. Confidential information, such as narratives, medical history, lab tests, and other similar data is not included in the downloadable files. Also, due to legal requirements on data protection and agreements among WHO PIDM members, we are unable to provide age or country-specific information. Instead, age groups and regions are provided.
Every release of data from VigiBase is subject to the terms of a caveat document that describes the nature and limitations of the data. Any use of VigiBase data in scientific publications should be informed by the study guidelines document.
To learn more about VigiBase Extract Case Level features, licensing, and limitations – or discuss whether VigiBase Extract Case Level is the right service for your needs – get in touch with UMC’s experts today.