Trial safety oversight helps to safeguard trial participants while allowing independent evaluation of the risks and benefits of the research. This guidance describes different structures for networks when considering trial safety oversight and is intended to help researchers decide whether a Data Safety Monitoring Board (DSMB) is required. The guidance also explores alternative structures that can be used for trial safety oversight when a DSMB is not required.
ACTA Trial Safety Oversight Guidance
This document is intended to assist clinical trial networks (CTNs) in establishing a data safety monitoring board (DSMB) for safety oversight of a trial, or multiple trials, conducted by the network.PDF