¶ … monitoring and the role of clinical monitor have become the focus of a growing amount of attention in recent years due to the centrality of these functions to the success of research studies. This paper reviews the literature to determine why the clinical research associate (CRA)/clinical monitor is the most important contact that a site has with a sponsor, how the monitoring function can contribute to the success or failure of a study and what CRAs can do to maximize the effective of their monitoring strategy. Finally, a summary of the research and important findings concerning these issues are presented in the conclusion.
Why is the clinical research associate (CRA)/clinical monitor the most important contact that the site has with the sponsor?
Although every study setting is unique, CRAs are generally tasked with the supervision and support of the administration of a clinical trial and monitoring its progress for a sponsor (CRA certification, 2015). Based on the sponsor's overarching goals of conducting original research concerning various biologics, pharmaceuticals, or medical devices, CRAs may be hired to perform these monitoring services directly or indirectly through contract research organizations or in their capacity as independent contractors or consultants (CRA certification, 2015). In this regard, Hurst and Dennis (2013) advise that, "The primary...
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