CTJ Sagepub: May 3, 2013
Background Minimizing the risk to study participants is an essential requirement of ethical research. Respecting the rights of subjects is also paramount, which includes respecting their autonomy by making available important information about the evolving safety profile of an investigational product as the trial progresses. Little is known about what trial participants understand and expect regarding monitoring and communication of serious adverse events during the conduct of a trial in which they have agreed to participate.
Purpose To explore understanding and expectations of potential trial participants concerning monitoring and communication of serious adverse events during a clinical trial. Read more