✚ What else should you know about lay summaries? Additional key considerations related to lay summaries. ✚Applicable to Phase 1 through to Phase 4 trials. ✚Prior knowledge of the trial is not to be assumed. ✚Precise formatting requirements must be observed. ✚Should be as short as possible. ✚Use language understandable to a 6th-grade student. ✚Translations of the summaries must be provided in line with the requirements of the regulation. ✚The trial sponsor is responsible for ensuring that the lay summary is developed and submitted. ✚Visual aids can help enhance the understanding of text.
