CLRA 6160 – Good Clinical Practice (GCP) in Managing and Monitoring Clinical Trials
Through this course, students learn the process and procedures of managing and monitoring a clinical trial from study initiation to closeout. Students examine the basic tenets of good clinical practice (GCP), including historical considerations, compliance, and recruitment of study participants, focusing on quality assurance and data safety monitoring boards (DSMBs). Through discussions and application-based assignments, students investigate and describe the relationship between regulations and GCP; how GCP affects the practical elements of conducting clinical studies; the challenges of multi-center or large-scale trials, such as risk assessment and management; protocol management and amendments; and audits and various considerations for reporting requirements. Students in this course are provided with official guidance on GCP from the International Conference on Harmonization (ICH) as well as operational imperatives of GCP.
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