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Feedback on this module
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94% of people completing this module said they would recommend it to their colleagues
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Over 75% 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 course was designed to increase subject knowledge for Sponsors, especially of non-commercial studies. By the end of this module, the learner will know what the requirements of the Sponsor are under ICH GCP. Its aim is to explain what the ICH GCP guidelines are and explore the meaning of requirements.
This course describes the requirements of ICH GCP and shows the responsibilities from the point of view of the Sponsor.
Successfully completing the course will provide evidence that you are aware of ICH GCP guidelines. This evidence could strengthen your case when trying to obtain a Clinical Trial Approval or Marketing Authorisation.
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 ICH GCP requirements and their impact on the role of the Sponsor
- Demonstrate awareness of appropriate processes, systems and regulatory requirements in clinical research
- Evaluate and implement the key requirements of the guidelines
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.
