Standards and Guidance

ENCePP seeks to promote and support high standards throughout the post-authorisation research process based on valid methodologies, transparency and scientific independence.

The need for investigators to consistently consider methodological issues arising in observational research resulted in the development of the ENCePP Checklist for Study Protocols complemented by the ENCePP Guide on Methodological Standards in Pharmacoepidemiology.

Both documents are referenced in Module VIII of the good pharmacovigilance practices (GVP) on post-authorisation safety studies (PASS) relating to authorised medicinal products, published by the European Medicines Agency (EMA).

Related information:

» Checklist for Study Protocols

» Methodological Guide