ENCePP Checklist for Study Protocols - Revision 4

The ENCePP WG1 has finalised Revision 4 of the ENCePP Checklist for Study Protocols and it is now published on ENCePP website.

As a reminder, the EMA Guidance for the format and content of the protocol of non-interventional post-authorisation safety studies requires that a copy of the ENCePP Checklist for Study protocols, completed and signed by the main author of the study protocol, should be included in Annex 2 of the PASS study protocols.

Related information:

» ENCePP Checklist for Study Protocols (Revision 4)