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The objectives of the Checklist developed by ENCePP are:
The Checklist is intended to promote the quality of studies and not their uniformity, as ENCePP welcomes innovative designs and new methods of research.
The original Checklist was developed over a period of several months during 2008 and 2009 by a dedicated ENCePP Working Group consisting of experts in pharmacoepidemiological and pharmacovigilance research representing inter alia academia, regulators, patients’ organisations, health care professionals and learned societies. The document was the result of lengthy and substantive discussions within the Working Group and the ENCePP Plenary as a whole, and a public consultation. The Checklist takes into account acknowledged guidelines and the current state-of-the-art in the area of pharmacoepidemiology and pharmacovigilance.
The first version - the "Checklist of Methodological Standards for ENCePP Study Protocols" - was adopted by the ENCePP Steering Group on 19 March 2010 with the understanding that it is subject to regular review.
On 19 August 2011 the ENCePP Steering Group adopted the first revision - the "ENCePP Checklist for Study Protocols" - as agreed by the relevant ENCePP Working Group. The major outcome of the revision has been to make the Checklist a 'stand-alone' document to reflect its more general use outside the context of an application for ENCePP study status. This does not, however, interfere with the Checklist being a requirement for ENCePP studies and for obtaining an ENCePP seal.
ENCePP Guide on Methodological Standards in Pharmacoepidemiology - REVISION 1
ENCePP has started the first annual revision of the ENCePP Guide on Methodological Standards in Pharmacoepidemiology. In order to collect comments from interested parties, a line- numbered version and a template for comments (Excel worksheet) have been made available on the ENCePP website.
Comments should be sent before 31 March 2012 to: encepp_comments@ema.europa.eu, preferably using the template.
ENCePP thanks you for your collaboration.
Related information:
=> ENCePP Guide on Methodological Standards in Pharmacoepidemiology (line-numbered version)
=> Template for Submission of Comments
The Guide on Methodological Standards in Pharmacoepidemiology is an important tool that reviews and gives direct electronic access to methodological guidance for research in pharmacoepidemiology and pharmacovigilance.
The aim of the ENCePP initiative is to strengthen post-authorisation medicines research by facilitating the conduct of multi-centre, independent and scientifically robust studies focusing on safety and the balance of benefits and risks.
In line with this objective, the guide provides a framework for thinking and learning on study design and methods through the presentation of internationally agreed recommendations and key points from important English-language guidelines, published articles and textbooks.
The intention is to go further than compile an inventory of existing guidelines and to offer the researcher a single overview document and web resource with a brief introduction or overview of the relevant recommendations. Gaps in guidance in areas important to collaborative pharmacoepidemiology research have been addressed with what ENCePP considers as good practice. The guide focuses on scientific rather than regulatory guidance.
The guide has been developed by a dedicated ENCePP Working Group consisting of experts in pharmacoepidemiological and pharmacovigilance research and has been subject to a public consultation. The guide was adopted by the ENCePP Steering Group on 3 May 2011. Updates of the electronic document will be performed regularly with a view to maintaining the dynamic nature of the guide.
