VigiBase Custom Searches

For users who need to build need specific set of reference data for signal detection or data mining.

What are VigiBase Custom Searches?

VigiBase Custom Searches are the perfect option for users with a one-off or limited need for specific data. Organisations or qualified professionals can request UMC’s expert staff to perform a custom search of VigiBase. UMC will customise the query and output depending on the purpose of the request. By default, search results are delivered as tab‐delimited text files, allowing easy, flexible import into other applications for analysis or viewing. VigiBase data is updated twice each week so your search results will always include the most up-to-date data possible.

The value of using VigiBase Custom Searches?

Users requesting VigiBase Custom Searches benefit from the insights of VigiBase’s uniquely diverse and comprehensive global dataset and the assurance of sophisticated search queries crafted by UMC’s pharmacovigilance experts.

VigiBase Custom Searches draw upon the largest set of medicines and vaccine safety data available, with reports contributed by national pharmacovigilance centres representing 99% of the global population. VigiBase 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.

VigiBase data is coded and structured to WHODrug and MedDRA standards. Save time and effort by selecting from our range of report layouts a format that best suits your needs.

Fees

VigiBase Custom Search fees depend on the complexity of search query. For eligible non-profit organisations, such as universities, searches are charged at a discounted hourly rate. UMC will provide an estimate of the total fee for confirmation before the search begins.

WHO PIDM members in need of a specific query that cannot be performed in VigiLyze can request a VigiBase Custom Search free of charge.

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 our fees in more detail.

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Using VigiBase Custom Searches

Users of VigiBase Custom Search include contract research organisations, marketing authorisation holders, national pharmacovigilance centres, academics, and researchers from various other sectors. Individual healthcare professionals, such as physicians, dentists and pharmacists, may also use this service.

VigiBase Custom Searches are generally used to request a limited set of data for specific studies.

Limitations on the data and its use

The data in VigiBase contains private and sensitive information. Furthermore, its analysis and interpretation require specialised medical or scientific expertise. Individuals seeking custom searches will be required to establish their professional qualifications.

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 are 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.

As with all pharmacovigilance reporting databases, it is appropriate to use VigiBase data for generating but not testing hypotheses. The data in VigiBase are subject to reporting biases, duplication, confounding issues and heterogeneity, over time and across regions.

In addition, access to information on global use of a medicine can be limited. Furthermore, the number of reports with a drug and ADR can be subject to lower or higher levels of under-reporting than with another drug with the same ADR. VigiBase reports cannot be treated as a sample from a population of patients, as one does in a clinical trial or an observational study.

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.

Caveat Document Study Guideline

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Contact UMC to learn more about applying VigiBase Custom Searches to your needs.

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Last modified on: December 17, 2021