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Feedback on this module
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95% of people completing this module said they would recommend it to their colleagues
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Over 85% gave an overall assessment of this module of 7/10 or better
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Over 75% said that this module met their expectations to a level of 7/10 or better
Overview
The responsibilities of a Monitor are outlined in the ICH GCP E6 guidelines Chapter 5.18. This module will look at the requirements and give practical guidance for the monitoring of data. The role of a Monitor is a practical one and therefore details on how to fulfil the requirements in a practical way are included.
This module allows the learner to get an insight into the practical requirements of a Monitor in the conduct of clinical trials.
Firstly, the ICH GCP responsibilities of a Monitor are explored and an insight into how to fulfil these responsibilities is given. The different types of monitoring visit are also covered. Examples are given of the main activities of the Monitor when conducting a visit and what constitutes a good monitoring report.
The Monitor is judged by several criteria; the two most important being the number of patients entered into the study and the number of data clarification forms (DCFs). Both of these areas are discussed.
The programme is clear and simple in design and gives full instructions for use.
Learning objectives
By the end of this course, you will be able to…
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Describe the roles and responsibilities of a clinical trial Monitor
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Demonstrate an awareness of the different types of monitoring visits and their objectives
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Outline the main activities of a monitoring visit and implement techniques to ensure the correct application of the requirements
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Discuss the practical application of the requirements by means of examples
Certification & CPD
At the end of the course you can complete a 20 question,
multiple choice exam, which will test you on the subject matter of the
module. The pass mark for the exam is 75%, but you can take the exam as
many times as you like.
On passing the exam you will have the option of printing
out a certificate which will certify your successful completion of the
course.
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