Course Introduction
The course is made up of seven learning modules and is intended to clarify the key elements of the two United Kingdom Statutory Instruments - 2004 No. 1031 and 2006 No. 1928 - and to explain and summarise the core messages they contain.
Please note that, while the United Kingdom Statutory Instrument 2006 No. 1928 was intended to substantially amend the earlier Statutory Instrument 2004 No. 1031, it is not the only amending Statutory Instrument. Others such as 2006 No. 2984 or 2008 No. 941 also amend the Statutory Instrument 2004 No. 1031.
This course makes occasional reference to other amending Statutory Instruments but is not intended to provide thorough coverage of them.
Course Key Points
The course includes:
- The legal framework for Good Clinical Practice application and enforcement in the UK
- How the UKSIs relate to legislation in other EU Member States and the US Code of Federal Regulations
- Understanding the core requirements for participants in clinical research
- Comparison between the UKSIs and ICH GCP
- How to find your way around the UKSIs
Course Author
David Bailes is a research quality consultant now running South Barn Consulting Ltd but in a previous life he was Head of European Quality Assurance at Pfizer. David worked on the ICH Efficacy E6 Task Force which wrote the ICH GCP Guidelines and he watched with interest as the EU Clinical Trials Directive and, in the UK, the relevant Statutory Instruments evolved to bring Good Clinical Practice compliance within the UK's legal framework under the auspices of the MHRA.
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