Current Users
If you have already purchased this product and are attempting to access it, please return to the main eLearning page and click on the module you require under the heading 'Accessing Your Modules'.
Course Overview
This course covers the 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
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.
Price
Non-member - £78 per licence
ICR Member - £65 per licence
Non-member NHS/Academic - £62 per licence
ICR Member NHS/Academic - £52 per licence
This offer can be used to purchase any combination of 10 licences. It cannot be used in conjunction with any other offers. To purchase modules using this offer, complete the order form below and fax back to +44 1628 530641.
Discounts are available for multiple licence purchases (of 10 licences or more). Please enquire for further details.
Purchasing Information
If you would like to purchase a licence for this or any of our eLearning modules please use our online shop. If you are purchasing multiple licences please complete an order form.
Please contact the Training and Education Co-ordinator for more information or call
+44 1628 536967.
