PharmaSchool: Monitoring for Non-commercial Clinical Trials

Please contact Jo Burmester at jo.burmester@pharmaschool.co.uk to find out more about in-house courses and discuss your specific needs.

Course Code: CTC003

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Duration: 1 day

Description:

Monitoring is now required for all clinical trials, including those not sponsored by the pharmaceutical industry.  However, without access to the resources of a commercial organisation the practical implementation of this for non-commercial research has to operate within certain constraints.  This course provides the following:

Information on the responsibilities of the monitor under GCP
Practical advice on fulfilling these within the non-commercial environment
Tools for risk assessment and monitoring strategy.

Who it is suitable for:

This course is aimed at those who conduct monitoring roles within non-commercial organisations, such as R&D departments, clinical departments and medical charities.

Example content:
Introduction to Monitoring

Why do we monitor?
What is monitoring?
When should we monitor?
What needs to be done?

Risk Assessment and Monitoring Plan

Types of Monitoring Visits

Essential Monitoring Skills

Subject Recruitment & Informed Consent
Pharmacovigilance
Drug Accountability
CRF review & SDV
Problem Solving

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to train a group of your employees at a location of your choice.
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