How Clinical Research Associates Ensure Trial Success

¶ … 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 role of the Clinical Research Associate (CRA) is to monitor clinical trials. To accomplish this role, the CRA works directly with the organization sponsoring the clinical trial or with a contract research organization" (p.

104) How can the monitoring function contribute to the success or failure of the study? In any study situation, monitoring the progress of the research represents a fundamental aspect of successful outcomes by ensuring that constraints to success are identified and resolved (Hurst & Dennis, 2013).

What can a CRA do to maximize the effectiveness of his or her monitoring strategy? There are a number of different approaches that CRAs can use to help ensure that researchers comply with relevant clinical trial protocols including (1) conducting visits at clinical sites (this strategy provides empirical observations concerning the actual progress being made), (2) reviewing case report forms (this strategy helps to ensure that the study is conducted according to established guidelines), and (3) collaborating with the clinical research coordinator and principal investigator (this strategy helps to ensure that miscommunications are not allowed to erode research progress (Hurst & Dennis, 2013).

Conclusion The research showed that clinical research associates play an important role.