The ENCePP Code of Conduct provides a set of rules and principles for pharmacoepidemiology and pharmacovigilance studies to promote
- scientific independence and
- transparency throughout the research process.
To this end, the Code permits a high level of public scrutiny, which will ultimately increase the confidence of the general public, researchers and regulators in the integrity and value of pharmacoepidemiology and pharmacovigilance research.
The Code also promotes the implementation of best practice standards in the relationship between investigators, study funders, and contract research organisations (CROs)/coordinating study entities, from protocol agreement to publication of results.
Regardless of whether they are fully compliant with the Code, all pharmacoepidemiology and pharmacovigilance studies should be registered in the HMA-EMA Catalogue of real-world studies, ideally before they start, and protocols and study results should be made public.
The provisions of the Code apply to research that is (fully or partially) financed from external sources, e.g. studies commissioned by pharmaceutical companies, research grants etc. where researchers, study funders and other involved parties agree to adhere to the Code. Self-funded studies should also adhere to the Code.
Adherence to the Code is mandatory for studies seeking the ENCePP Seal.
The Code is referenced 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).
Since its launch in 2010, the Code has been reviewed on a regular basis. The ENCePP Steering Group adopted revision 4 in March 2018 based on feed-back from stakeholders including pharmaceutical industry, contract research organisations, learned societies and regulatory authorities conducting collaborative research.
For a summary of the main changes introduced with the current 4th revision of the Code please click
here.
Application of the Code in the context of the ENCePP Seal
The Code is an integral part of the ENCePP Seal concept. ENCePP Seal studies need to comply with the provisions of the Code in their entirety and investigators seeking the ENCePP 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.
Related Documents
Note: The documents linked to this section have not been updated and still reference the EU PAS Register. Where reference is made to the EU PAS Register, the HMA-EMA Catalogue of real-world studies references need to be used.
