What does the lay summary include?
The clinical trial lay summary will contain the following ten elements:
-
Clinical trial identification (including title of the trial, protocol number, EU trial number and other identifiers)
-
Name and contact details of the sponsor
-
General information about the trial (where and when it was conducted, main objectives, and an explanation of the reasons for conducting it)
-
Population of patients (number from Member State concerned, the Union and third countries; age and gender breakdown; inclusion/exclusion criteria)
-
Investigational medicinal products used
-
Description of adverse reactions and their frequency
-
Overall results of the clinical trial
-
Comments on the outcome of the clinical trial
-
Indication if follow-up clinical trials are foreseen
-
Indication where additional information can be found