[Focusing on the steps to follow to initiate a clinical research project]

Abstract

Texts governing clinical research are regularly revised in French law. The knowledge of administrative procedures to enable studies should be available to all interested clinicians. University hospitals are privileged with dedicated structures providing methodological and administrative support but which are sometimes ignored or underutilized. In this paper, we propose to define the categories of clinical research, their respective administrative framework and the steps and documents required for their realization in France. Finally, we specify some rules to follow in order to enable the communication of scientific results in international journals.