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
Customised In-house Courses are designed for organisations wishing
to train a group of your employees at a location of your choice.
For information about Open Courses click here or for
online learning click here
Over the last 12 years PharmaSchool has provided a free weekly GCP & Clinical Research related challenge. With nearly 3 quarters of a million attempts at these Challenges they are used across the World to test, learn and document knowledge.