In its current form, under the influence of the dominant social forces, the European construction may have produced some degree of institutional harmonisation, and generalised some fundamental rights, which is not negligible, but, contrary to the stated goals, it has not produced a convergent evolution of national economies, a zone of shared prosperity.
Its revival largely coincides with Poland's accession to the European Union in 2004 and the subsequent institutional and normative harmonisation of the agricultural sector in line with the requirements of the Common Agricultural Policy CAPP).
Potential models for improvement include harmonisation of ethical and institutional approvals systems, including aligned hospital contracting and greater visibility of centres of excellence, which may bring significantly more clinical research to Europe.
The studies were conducted in accordance with applicable regulations of the FDA and the Good Clinical Practice guidelines of the International Conference on Harmonisation and approved by the institutional review board at each study center.
The study protocol, amendments and informed consent requiring pre-approval were reviewed and approved by a national, regional or independent ethics committee or institutional review board, in accordance with the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Good Clinical Practice and applicable country-specific requirements.
The protocol was approved by the institutional review board at each participating institution and conducted in accordance with the ethical principles of the Declaration of Helsinki and also the Good Clinical Practice guidelines, as defined by the International Conference on Harmonisation.
The SAGE trial was conducted in compliance with the ethical principles originating from the Declaration of Helsinki (Revised South Africa, 1996) and in compliance with the institutional review board/independent ethics committee, informed consent regulations, and International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines.
The study was carried out in accordance with the International Conference on Harmonisation Good Clinical Practice guidelines and was approved by an institutional review board.
The study was approved by the appropriate institutional review boards/ethics committees and was conducted in accordance with International Conference on Harmonisation Good Clinical Practice and local regulations.
Both studies were conducted in compliance with the current revision of the Declaration of Helsinki and the International Conference on Harmonisation Guideline on Good Clinical Practice, and were approved by the institutional review board or ethics committee of each trial centre.
This study was conducted in compliance with the Declaration of Helsinki and its amendments and relevant International Conference on Harmonisation of Good Clinical Practice guidelines, and in agreement with the institutional boards.
