概览

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.

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

谁应该参加？

Pharmaceutical, biotechnology and medical device industry

Freelancers, self-employed

Orientated towards the needs of CRAs with, say 2 – 3 years experience in the job who want to acquire
advanced monitoring skills and/or refresh existing ones

Experienced CRAs

Contract Research Organizations

Study coordinators, interested in monitoring from the sponsor’s perspective

学习目标

At the conclusion of this course participants should be able to:

Describe the role and responsibilities of the monitor
Evaluate source documents and electronic records competently
Identify signs that suggest potential misconduct and fraud
Manage monitoring risks proactively
Apply Root Cause Analysis techniques when uncovering site problems
Develop effective Corrective and Preventive Action Plans (CAPA)
Assess the success of corrective action through benchmarking

Advanced GCP Study Monitoring

概览

谁应该参加？

学习目标

获得信息并保持参与