The MRCT Center updated the MRCT Center Return of Aggregate Results Guidance Document and the MRCT Center Return of Aggregate Results Toolkit to incorporate and reflect the EU Guidelines on Summaries of Clinical Trial Results for Laypersons.
In particular, the updates focused on restructuring the content for plain language summaries and the template for returning aggregate results to correspond with the structure and headings that will be required by the EU guidelines. In addition, we updated terminology by adding “aggregate” to the title of the document and referring to Plain Language Summaries rather than research results summaries. We also added additional health literacy resources and links to external resources.