1. Post-Authorisation Safety Studies (PASS)

PASSs can either be clinical trials (interventional) or non-interventional studies. The classification of a post-authorisation study as a PASS is not constrained by the type of design chosen if it fulfils the criteria as set in the definition (see above) in Directive 2001/83/EC Art 1(15).

Interventional PASS are clinical trials and must follow the regulation (EU) No 536/2014 (Directive 2001/20/EC until REG536/2014 becomes applicable).

Non-interventional PASS should cumulatively fulfil the following requirements (see Volume 10 of The Rules Governing Medicinal Products in the European Union, Questions and Answers, Version 11.0, 15 May 2013, Question 1.10)[1]:

• the medicinal product is prescribed in the usual manner in accordance with the terms of the marketing authorisation;

• the assignment of the patient to a particular therapeutic strategy is not decided in advance by a trial protocol but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study; and

• no additional diagnostic or monitoring procedures are applied to the patients and epidemiological methods are used for the analysis of collected data.

In essence, non-interventional PASSs are defined by the methodological approach used and not by their scientific objectives and may for example:

• include database research or review of records where all the events of interest have already happened. This may include case-control, cross-sectional, cohort or other study designs making secondary use of data (these study types are explained in Course 2 Lesson 1), or a systematic literature review or a meta-analysis depending on its aim)

• also include primary data collection (e.g., prospective observational studies and registries in which the data collected derive from routine clinical care). In these studies, interviews, questionnaires, blood samples and patient follow-up may be performed as part of normal clinical practice.

• follow pharmacoepidemiologic approaches (designs) such as