Guidance document: How to write comprehensible patient information and consent forms for research
The comprehensibility of the patient information and consent forms is a prerequisite for good, fair and correct information concerning participation in clinical trials and research projects. The example-based guideline succinctly lists the essential aspects needed for a comprehensible information document: the information must be provided in a step-by-step, coherent and descriptive manner using simple words and layman-comprehensible sentences, as well as appropriate visualizations.