A Summary of Results is a mandatory document per Regulation (EU) 536/2014 that summarizes the Clinical Study 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 Study 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 Study Report.