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Feedback on this module
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95% 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 objective of ICH GCP is to provide a unified standard for the European Union (EU), Japan and the United States (US), to facilitate the mutual acceptance of clinical data by the regulatory authorities in these regions.
This module provides an insight into the principles of ICH GCP. It describes the purpose of GCP, looks at the key features of the guideline, the roles and responsibilities involved and the requirements of essential documentation.
It is a course introducing ICH GCP but also a refresher for those who feel they need it.
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 history and purpose of GCP
- Discuss the roles and responsibilities of clinical trial staff and ethics committees according to ICH GCP
- Describe the requirements of essential documentation
- Discuss the practical application of ICH GCP to the clinical trial process
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.
