Introduction to UK Clinical Trial Regulations elearning

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Course Information

This online course provides an introduction to the UK Clinical Trials Regulations (UKSI 2004 No 1031 and UKSI 2006 No 1928). The course is divided into the following seven bite size learning Modules  

• Good Clinical Practice and UK Law
• Good Clinical Practice legal texts in and outside
• ICH Good Clinical Practice and the UKSIs - How do they compare?
• What do the UKSIs require of us?
• Pharmacovigilance
• The UKSIs and investigational medicinal products
• Finding your way around the UKSIs

Each bite-size module is around 30 minutes in duration and includes self assessment to confirm your gained knowledge.

Certificate

Once you have successfully passed the assessment (80% pass mark) you will receive a certificate in PDF format for your records. Please note that you will not have immediate access to this assessment.

Author

David Bailes is a research quality consultant, but in a previous life he was Head of European Quality Assurance at Pfizer. He worked on the ICH Efficacy E6 Task Force which wrote the ICH GCP Guidelines and he watched with interest as the EU Clinical Trial Directive and, in the UK, the relevant Statutory Instruments evolved to bring Good Clinical Practice compliance within the UKs legal framework under the auspices of the MHRA.   

Corporate Licences

Multi-user licences for corporate use are also available, please click here for prices and further information.

Course Demo

Click here for demo (website registration/login required).

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