Module 10-3: Please include these in your DSMB reports (11:08 mins)

This module provides a practical overview of DSMB meetings and reports in pragmatic trials. It walks through how meetings are structured, how open and closed sessions differ, and how reports should be designed to support clear, unbiased decision-making. 

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DSMB Open Report Template 

This document is a multi-site open-session DSMB report template for clinical trials. It outlines a standardized structure for summarizing trial status, protocol changes, recruitment, enrollment, screen failures, protocol deviations, data quality, safety events, deaths, laboratory findings, and site-specific reporting. It is designed to support consistent preparation of DSMB materials across participating sites while allowing protocol-specific customization. The template was downloaded from the National Institute on Aging website for reference and adaptation by study teams only.