Preparation study documentation
After you have performed a feasability analysis and set up a research plan, the next step is to prepare all study documentation.
But which laws and regulations apply? What local procedures should I take into account? How do I record agreements with the various parties involved? How to handle the collected research data? How do I request informed consent from potential participants? And what additional steps are required for the conduct of medicines, medical devices or Biobank research?
The answers to these questions are described in the second step of the design & preparation phase.