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

• Must be factual and non-promotional

• Should be as short as possible

• Use language understandable to a 6th grade student

• Precise formatting requirements must be observed

• Visual aids can help enhance understanding of text

• 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