One of the ENCePP guiding principles is transparency to the general public about ongoing research relating to medicines used in clinical practice. The Declaration of Helsinki, last amended in October 2013, requires that every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject. A means to achieve these objectives is the registration of protocols and reports of studies conducted with medicines for human use in the publicly accessible ENCePP E-Register of Studies (EU PAS Register).
As a resource for the registration of pharmacoepidemiological and pharmacovigilance studies with a focus on observational research, the purpose of the ENCePP E-Register of Studies (EU PAS Register) is to:
Any pharmacoepidemiological and pharmacovigilance studies can be registered. The registration is voluntary, free of charge and the application can be submitted by researchers or any individual on their behalf.
Post-authorisation safety studies (PASS) in relation to a medicinal product which are initiated, managed or financed by marketing authorisation holders (MAH) voluntarily or pursuant to an obligation imposed by a competent authority should also be registered in the ENCePP E-Register of Studies acting temporarily as the EU PAS Register. For more information please refer to the EU PAS Register section.
The registration of studies applying for the “ENCePP Study Seal” is mandatory.