ADVANCE Code of Conduct for post-authorisation vaccine monitoring studies
The ADVANCE Code of Conduct was tested in the 6 proof of concept studies that were conducted as part of the ADVANCE project and the final version includes 45 recommendations in 10 topics (Scientific integrity, Scientific independence, Transparency, Conflicts of interest, Study protocol, Study report, Publication, Subject privacy, Sharing of study data, Research contract) (Sturkenboom et al., 2019).
Journal editors are encouraged to use reference to the ADVANCE Code of Conduct as an indication that good principles of public health, science and transparency were followed throughout the study.
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ADVANCE code of conduct10 January 2024
ADVANCE vs ENCePP Code of Conduct
Like the ADVANCE CoC, the ENCePP Code sets out rules and principles for studies, primarily pharmacoepidemiology and pharmacovigilance studies, with an emphasis on non-interventional post-authorisation studies. The ENCePP CoC is created and updated by ENCePP.
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ENCePP Code of Conduct10 January 2024
While the legal framework of the ADVANCE and ENCePP codes of conduct is the same, there are key differences between the two. Importantly,the ENCePP CoC restricts the roles of persons with a financial conflict of interest while in the ADVANCE CoC, declarations of interest are made, and roles are divided over multiple stakeholders, using transparency as a key guiding principle.
In VAC4EU the study requester may choose whether to use the ADVANCE or ENCePP code of conduct. VAC4EU Members may or may not participate with ADVANCE Code of Conduct based on own policies. All members are able to work according to the ENCePP CoC.