Preparation study documentation

    Once you have completed a feasibility analysis and established a research plan, the next step is to prepare all necessary study documentation.

    At this stage, several questions arise: which laws and regulations apply to my research? What local procedures should I take into account? How should I document agreements with the various parties involved? How to handle the collected research data? How do I obtain informed consent from potential participants? And what additional steps are required for research involving medicinal products, medical devices or biobank samples?

    The answers to these questions are outlined in the second step of the Design & Preparation phase.