Overview
What is a PASS study?
A PASS is a study conducted on an authorised medicinal product which aims to achieve one of the following:
- Identify, characterise, or quantify a safety hazard
- Confirm the safety profile
- Measure the effectiveness of risk management measures
(As described in Guideline on Good Pharmacovigilance Practices (GVP), Module VIII)
The DSRU has conducted dozens of PASS studies since 2012 when Good Pharmacovigilance Practice (GVP) came into force.
The DSRU is a broad pharmacoepidemiological unit which uses a range of study methods and data sources to ensure that the PASS meets the requirements. We use:
- Secondary data sources, such as CPRD
- Registries (both disease and product registries)
- Studies based on chart reviews, such as Event Monitoring, SCEM*, and M-PEM**
- Primary data collection
The DSRU also advises on and implements additional risk minimisation measures where required and monitors their effectiveness.
*SCEM = Specialist Cohort Event Monitoring; **M-PEM = Modified Prescription Event Monitoring