2 - Process for Choosing Test Databases
Task: Develop a process for choosing test databases, useful for the nation’s pharmacovigilance capability
Database description
a. Develop the key characteristics of any candidate database
OMOP personnel or a person/organization funded by OMOP funded by OMOP will develop and lead a team of pharmacoepidemiologists, including FDA scientists. They will use their own experience, a consensus process, and then broad input/review from the pharmacoepidemiology and health services research communities, to develop a list of characteristics required to understand the strengths and weaknesses of databases which might be useful for post-marketing safety and benefit analyses.
b. Describe key characteristics of databases that are considered for inclusion in OMOP activities. This will include consideration of access to source medical records and their potential utility and application across the initial identification (hypothesis generation), initial exploration of the predictive value of the event, and the full evaluation of the drug-event association.
OMOP will fund the collection of data on databases that are interested in participating in OMOP work.