Training Course on Advanced GCP Study Monitoring

Venue: Marriott Rive Gauche Hotel

Location: Paris, ??, France

Event Date/Time: Sep 19, 2011
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Description

Clinical Research Monitors perform a critical role in the conduct of a clinical trial. As the primary liaison between the sponsor and the site, the monitor must verify that the clinical trial is conducted according to Good Clinical Practice, the safety and rights of subjects are protected, the Investigational Medicinal Product is handled correctly and the data is of the highest quality. This course will expand and strengthen the monitoring skills of Clinical Research Associates, enabling them to perform their role more proficiently and effectively.

Using case studies, monitors will learn how to handle monitoring problems and proactively manage risks before they become audit findings later. This course includes an invaluable “shared experience session” which will enable colleagues to discuss monitoring challenges they face.

Key Topics
• Research misconduct
• Risk Management for the Monitor
• Elements of Corrective and Preventive Action Plans
• Advanced Monitoring Techniques and Tools
• Benchmarking for site performance evaluation
• Source document/data evaluation
• Electronic source data verification

Event Code:
11531

Venue

ELISABETHENANLAGE 25, POSTFACH
Paris
??
France
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