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