The ENCePP Code of Conduct provides a set of rules and principles for pharmacoepidemiology and pharmacovigilance studies to promote
The Code is aimed at permitting a high level of public scrutiny which ultimately will increase the confidence of the general public, researchers and regulators in the integrity and value of pharmacoepidemiology and pharmacovigilance research.
To this end, the Code promotes best practice standards for the interaction of investigators and study funders in critical areas such as planning, conduct and reporting of studies.
As a core transparency measure, and whether or not studies fully comply with the Code, the protocols of all pharmacoepidemiology and pharmacovigilance studies should be registered in the EU PAS Register ideally before they start, and study findings published irrespective of positive or negative results.
Whether a study is conducted in adherence with the Code is a voluntary decision by investigators and funders. The use of the Code is only mandatory if a study is seeking the ENCePP Study Seal.
The Code is also referenced as good practice in Module VIII of the good pharmacovigilance practices (GVP) on post-authorisation safety studies (PASS) (Rev1) relating to authorised medicinal products, published by the European Medicines Agency (EMA).
The Code was first launched in May 2010 and is reviewed on a regular basis taking into account the experience from stakeholders. For a summary of the main amendments introduced with the current 3rd revision of the Code please click here.
The Code is an integral part of the “ENCePP Study Seal” concept. “ENCePP Seal Studies” need to comply with the provisions of the Code in their entirety and investigators seeking the ENCePP Study Seal need to confirm their intention to do so by submitting a completed and signed Checklist and Declaration on compliance and Declaration of Interest Form as part of their application.