Post-authorisation safety study (PASS)

Any study relating to an authorised medicinal product conducted with the aim of identifying, characterising or quantifying a safety hazard, confirming the safety profile of the medicinal product, or of measuring the effectiveness of risk management measures [DIR 2001/83/EC Art 1(15)].

A post-authorisation safety study may be an interventional clinical trial or may follow an observational, noninterventional study design.

See also Clinical trial, Non-interventional study