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 module highlights the differences between ICH GCP and the EU Directive.
It assumes knowledge of ICH GCP, and familiarity with the terms used in clinical trials.
The module details how the Directive affects the clinical trial life cycle and what this will mean in practice. The course also gives an interpretation of what the Directive actually means in the work environment. Please bear in mind that the detailed interpretation of the Directive and the Notes to Guidance will be company specific, and will be incorporated into standard operating procedures.
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…
- Describe the scope of the Directive and its definitions
- Review the provision for protection of subjects
- Outline the clinical trial lifecycle and the requirements for commencement, conduct and end of a trial
- State the requirement for IEC approval and CA approval
- Discuss information exchange and clinical trial databases with emphasis on Adverse Event reporting
- Outline the requirements for suspension or infringements of a trial.
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.
