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Feedback on this module
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80% of people completing this module said they would recommend it to their colleagues
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Over 70% gave an overall assessment of this module of 7/10 or better
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Over 70% said that this module met their expectations to a level of 7/10 or better
Overview
This course covers the European Commission Directive 2005/28/EC of 8 April 2005 which lays down principles and detailed guidelines for good clinical practice. With regards to investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products. The Commission Directive is referred to as the GCP Directive and has to be incorporated into national legislation and become law in each Member State (MS).
The course also includes information on the UK-specific requirements as a result of the incorporation of this Directive into UK law under SI 1928. The European perspective is provided through an explanation of the Notice to Applicants, Volume 10, on Good Clinical Practice. This module allows the learner to get an insight into the important requirements of the GCP Directive on the conduct of clinical trials. It also shares the views of various clinical trial personnel on the impact of this Directive on their role.
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 scope of the Directive
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Demonstrate awareness of the requirements of the Directive with emphasis on GCP requirements, TMF and archiving
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Evaluate the impact of the directive on various clinical trial personnel and their roles
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Appreciate the UK and EU perspectives
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Identify the compliance requirements of the Competent Authorities
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Demonstrate the translation of theory of Serious Breaches into application of processes to ensure compliance
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.
