Electronic Register of Studies

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).

In this context EU PAS Register refers to the publicly available register in Good Pharmacovigilance Practices (GVP) for the registration of studies under EU legislation which is the same database as the ENCePP E-Register of Studies.

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:

  • Reduce publication bias
  • Increase transparency
  • Promote information exchange
  • Facilitate collaborations within the scientific community.

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.

To register a study please click on the button below:

If you wish to resume a draft application saved previously (but not submitted yet) or update a returned application, please follow the link:
Resume Draft/Returned application.

If you wish to update a study record in the ENCePP E-Register of Studies (EU PAS Register) please click on 'Edit Study' below:

To search for studies registered in the database, please click on the button below:

For assistance please contact us at: encepp_studies@ema.europa.eu