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.
- EMA Eu: FAQs Clinical Study Report submission, CTIS Training Programme – Module 13 Version 1.1 – October 2022: https://www.ema.europa.eu/system
