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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

Who should attend?

  • 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

 

CANCELLATION POLICY
Cancellations must be made in writing and be received at the DIA Europe office five working days prior to the course start date
If DIA cannot verify your membership upon receipt of registration form, you will be charged the non-member fee. Registration fee includes course material. The fee is inclusive
of lunch and coffee breaks of EUR 125.00 per day.
Cancellations are subject to an administrative fee: Full Meeting Cancellation: Industry (Member/Non-member) = € 200.00 - Government/Academia/Non-profit (Member/Non-member) = € 100.00
Registrants who do not cancel five working days prior to the course start date and do not attend, will be responsible for the full registration fee. DIA Europe reserves the right to alter the venue and dates
if necessary. If an event is cancelled DIA Europe is not responsible for airfare, hotel or other costs incurred by registrants. Registrants are responsible for cancelling their own hotel and travel reservations.

Transfer Policy
You may transfer your registration to a colleague prior to the start of the event but membership is not transferable. Substitute registrants will be responsible for the non-member fee, if applicable. Please
notify the DIA Europe office of any such substitutions as soon as possible.

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

Contact us

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