This course outlines the contours of Quality Control (QC) reviews, with particular attention devoted to QC’s evaluation of how informed consent, inclusion/exclusion criteria, eligibility checkpoints, adverse events, and protocol deviations are documented. It illustrates QC’s functions through an examination of six categories of common QC findings. The course pays close attention to the use and review of Corrective and Preventative Action (CAPA) plans.
Language Availability: English
Suggested Audiences: Clinical Research Associates (CRAs), Clinical Research Coordinators (CRCs), Contract Research Organizations (CROs), Faculty, Principal Investigators (PIs), Quality Control/Quality Management Professionals, Regulatory Affairs Professionals, Research Administrators, Sponsors, Study Sites
Organizational Subscription Price: $675 per year/per site for government and non-profit organizations; $750 per year/per site for for-profit organizations
Independent Learner Price: $99.39 per person