CLINICAL TRIAL SUMMARIES: Draft a clinical study report synopsis for a medicinal product clinical trial of your choice. Translate the technical information contained in your synopsis to develop a brief lay summary of the trial that can be easily understood by patients and caregivers. Please submit both the synopsis and lay summary.
Please review the attached sample of a clinical study report analysis for more details on the contents and requirements of a clinical study report synopsis (Sample clinical study report synopsis).
Please review the attached guidance document on how to craft a lay summary for non-technical and non-scientific readers (DIA_LAY SUMMARY GUIDANCE).
Please review the attached file for information regarding the core content that should be included and/or evaluated when crafting a lay summary (DIA_CORE CONTENT FOR A LAY SUMMARY).
Please review the attached guidance document on Structure and Content of Clinical Study Reports.
Compose the lay summary at a 6th to 8th grade reading level using the Flesch-Kincaid tool available in Microsoft Word, and limited to 300 words.
Any questions, please contact me.
Use as many sources as needed, there is no minimum or maximum.