What does the lay summary include?

The clinical trial lay summary will contain the following ten elements:

  1. Clinical trial identification (including title of the trial, protocol number, EU trial number and other identifiers)

  2. Name and contact details of the sponsor

  3. General information about the trial (where and when it was conducted, main objectives, and an explanation of the reasons for conducting it)

  4. Population of patients (number from Member State concerned, the Union and third countries; age and gender breakdown; inclusion/exclusion criteria)

  5. Investigational medicinal products used

  6. Description of adverse reactions and their frequency

  7. Overall results of the clinical trial

  8. Comments on the outcome of the clinical trial

  9. Indication if follow-up clinical trials are foreseen

  10. Indication where additional information can be found