Preparation study documentation

    Once you have established a research plan, and arranged funding, a research team and any collaborators, the next step is to prepare all necessary study documentation.

    At this stage, several questions arise: which laws and regulations apply to my study? What local procedures should I take into account? How do 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 described in the second step of the Design & Preparation phase.