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A Summary of Results is a mandatory document per Regulation (EU) 536/2014 that summarizes the Clinical Trial Report and is submitted together with a summary understandable to a layperson (Lay Summary of Results). Per the United States Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11), submission of summary results information is required for certain trials. The purpose of the Summary of Results is to ensure a sufficient level of transparency on data obtained in clinical trials.
The Summary of Results should be uploaded on a publicly available clinical trial register within 1 year after completion of the trial (or within 6 months after completion of a pediatric trial) in the European Union and no later than 12 months after the primary completion date (in general) in the United States.
This document contains the following elements: clinical trial information, participant disposition, baseline characteristics, endpoints, adverse events, and additional information.
Generally, the Summary of Results is developed once when the final Clinical Trial Report is generated and is not updated. If the Summary of Results was developed for interim analyses, it needs to be updated with final results.
The Emtex Medical Writer can help you with the document development process (eg, writing, circulating for review, implementing comments), after or during development of the Clinical Trial Report.
FAQ: Summary of Results
What is a Summary of Results?
A Summary of Results is a document that summarizes the key findings of a clinical trial and is submitted to a publicly accessible platform to promote transparency in clinical research.
What information is included in a Summary of Results?
A Summary of Results is based on the Clinical Trial Report and includes the key efficacy and safety findings of a clinical trial, together with information on the study population, trial conduct, and other relevant trial information.
When is a Summary of Results needed?
A Summary of Results is mandatory for all clinical trials in the EU and for certain clinical trials in the US. It needs to be uploaded on a publicly available platform within 1 year after completion of the trial (in general), or within 6 months after completion of a pediatric trial in the EU.
How can Emtex Life Science support the preparation of the Summary of Results?
Emtex Life Science can support the preparation of Summary of Results documents by drafting content, coordinating team reviews, and ensuring consistency with the Clinical Trial Report.
Why is professional medical writing support valuable for the Summary of Results?
Professional medical writers help summarize clinical trial results clearly, accurately, and consistently, supporting transparent communication of study findings.