Description
There are numerous tasks that a monitor must be able to fulfil within their role, these range from selecting, initiating, routine monitoring and closing out sites through to managing investigators, building relationships and problem solving. There are a multitide of regulations and guidelines that a monitor needs to be aware of whilst fulfilling their role. This module blends theory together with practical hints and tips to provide an essential course for a new or potential CRA/Monitor.
Who is the Module Designed For?
The module is designed for anyone who is new to the role of a monitor or is seeking a position as a CRA/Monitor in either the commercial or non-commercial setting. The module provides the essential foundation to monitoring and contains a practical monitoring exercise to put what you have learned from the module into practice.
Course Content
Introduction
 Monitoring Basics
What is Monitoring?
Who can be a Monitor?
Knowledge, Skills and Attitudes required
How much monitoring?
Types of Monitoring Visit
Site Selection
Before the visit
During the visit
After the Visit
Site Initiation
Before the visit
During the visit
After the visit
Routine Monitoring
Before the visit
During the visit
After the visit
Site Closeout
Before the Visit
During the Visit
After the visit
Report and Letter Writing
What Prior Knowledge is Needed?
This module covers the essential requirements and skills for monitoring clinical research in medicinal products. It does not cover the drug development process, the clinical trial process or the regulatory requirements except for those specifically related to monitoring.
What Prior Knowledge is Needed?
This module covers the essential requirements and skills for monitoring clinical research in medicinal products. It does not cover the drug development process, the clinical trial process or the regulatory requirements except for those specifically related to monitoring. It is recommended that if you are not familiar with these areas that you take these modules or purchase the CRA Development Package. |
