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Feedback on this module
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100% of people completing this module said they would recommend it to their colleagues
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Over 90% gave an overall assessment of this module of 7/10 or better
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Over 85% said that this module met their expectations to a level of 7/10 or better
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 & 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.
