Quality Assurance and Associated Challenges at the Resource Limited, Rural Research Site

Abstract

Clinical trial oversight is a critical element in clinical research conduct, it ensures the protection of research participants and the integrity of study data. FDA governs clinical research. Several key parties contribute to and work with complementary coinciding responsibilities such as study sponsor, research site, IRB, independent monitoring committees, contract research organization, and site management organization as applicable. The efficiency, and knowledge coherence to guide and direct each other among these groups is crucial for the successful conduct of a clinical trial. Challenges lie in this area of fields in various aspects. In this paper, the researcher has reviewed several elements at the research site with particular emphasis on resource-limited research sites. The researcher discussed some of the strategies to achieve quality conduct of clinical trials while achieving significant study enrollment at the resource-restricted research sites.