Post Authorisation safety Study
EU: Directive 2001/83/EC – 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 (as per Article 1(c)(15) of Directive 2001/83/EC as amended by Directive 2010/84/EU)
A PASS is non-interventional if the following requirements are cumulatively fulfilled:
- 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.
Non-interventional studies are defined by the methodological approach used and not by its scientific objectives. Non-interventional studies 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). Non-interventional studies also include those involving primary data collection (e.g. prospective observational studies and registries in which the data collected derive from routine clinical care), provided that the conditions set out above are met. In these studies, interviews, questionnaires, blood samples and patient follow-up may be performed as part of normal clinical practice (as per GVP Module VIII).
If a PASS is interventional, the provisions of Directive 2001/20/EC shall apply (as per GVP Module VIII).