Loews Philadelphia Hotel, Philadelphia, PA USA
Nov 7 2011 8:00AM - Nov 8 2011 4:45PM
This blended learning offering provides a two-part webinar series focusing on the fundamental concepts of clinical research monitoring and GCPs followed by a live two day course of interactive lectures and hands-on workshop training methods that will provide you with the tools to effectively monitor clinical studies. What You Will Learn • Good Clinical Practices (GCP) • Regulatory requirements for clinical research • The role of the IRB and IRB interactions • The importance of the Informed Consent Document and tips for improving readability • Clinical research methodology and its role in drug development • CRA’s role in clinical research • How to identify and handle adverse events at the site • Monitoring clinical trials to ensure valid and useful study data • Practical tips for successful monitoring • Investigator selection and evaluation • FDA audits • Basic HIPAA requirements • How to fix common problems found during monitoring visits • Basic protocol development
Event Code:
11443
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