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Code of Conduct

ENCePP Code of Conduct - Revision 2
On 21 November 2011the ENCePP Steering Group adopted the 2nd revision of the Code of Conduct 1 year after its initial launch.
The review also resulted in a revision of the Implementation Guidance for the Sharing of ENCePP Study Data (Annex 4 to the Code) providing further clarification on the Code’s requirement to provide access to data and the introduction of a form to declare interests Data (Annex 5). A summary of the main amendments introduced with the 2nd revision is available here.

The ENCePP Code of Conduct provides a set of rules and principles for pharmacoepidemiology and pharmacovigilance studies as regards:

  • best practice in the relationship between investigators and study funders, including protocol agreement and publication of results, and
  • transparency throughout the research process,
  • thereby promoting scientific independence of such studies.

By applying the principles of transparency and scientific independence, studies adhering to the Code will permit a high level of public scrutiny which ultimately will increase the confidence of the general public, researchers and regulators in the integrity and value of pharmacoepidemiology and pharmacovigilance research. To this end, the Code addresses critical areas in the planning, conduct and reporting of studies and the interaction of investigators and study funders. At its core is the requirement to register studies before they start (see ENCePP Register of Studies) and the obligation to publish all study findings irrespective of positive or negative results.

Whether a study is conducted in line with the Code or not is to be decided by the respective researchers and funder. The use of this Code is only mandatory if a study is to be awarded the title “ENCePP study” (see below).

The Code was initially developed over a period of several months during 2008 and 2009 by a dedicated ENCePP Working Group taking into account acknowledged guidelines in the area of pharmacoepidemiology and pharmacovigilance.


The Code was first launched in May 2010 and since then reviewed and revised on a regular basis taking into account the experience gained so far, in particular qualitative feedback from stakeholders.

Application of the Code in the context of ENCePP Studies

The Code is an integral part of the “ENCePP Study” concept. “ENCePP studies” need to comply with the provisions of the Code in their entirety and investigators seeking the ENCePP study seal need to confirm their intention to do so by submitting a completed and signed Checklist and Declaration on compliance and Declaration of Interest Form as part of their application.

Relevant documents:

 

» See also: Q&A on the ENCePP Code of Conduct