Training Course on Advanced GCP Study Monitoring

Date(s) And Time(s):
Sep 19 2011 8:00AM - 4:30

Location:
Marriott Rive Gauche Hotel
17, Blvd Saint-Jacques
75014 Paris
France

Overview:

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

Level of Course
Intermediate - Advanced

Learning Objectives:
Learning Objectives
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

Target Audience:
• 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

Event Code:
11531

Contact Information:
DIA Europe
ELISABETHENANLAGE 25, POSTFACH

4002 BASEL

SWITZERLAND

TEL.: +41 61 225 51 51
FAX: +41 61 225 51 52

E-MAIL: DIAEUROPE@DIAEUROPE.ORG

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