A summary of the results of the clinical trial is a document that the sponsor will have to submit within one year from the end of a clinical trial in all Member States concerned or within six months for a trial in pediatric population, irrespective of the outcome of a clinical trial.
The summary of results shall be accompanied by a summary written in a manner that is understandable to laypersons (lay summary). These two documents are to be provided by the sponsors after the end of each clinical trial in the EU.
Glossary
Summary of results
