This course focuses on the legislation governing clinical trials in the UK and the approvals framework specific to UK trials.
We cover all the Statutory Instruments but concentrate on the two key documents, 2004; 1036 and 2006; 1928. The training summarises the requirements of the legislation and the differences from other countries.
We also talk about the Ethical and Health Service R&D approval (HRA approval) and the Clinical Trials Authorisation (MHRA approval)
Objectives:
To provide delegates with an understanding of:
- The regulatory framework governing clinical trials in the UK.
- The content of clinical trial legislation in the UK.
- The implications of this legislation on clinical trial conduct.
Duration:
One day
Training Methods:
Delivery of the course will consist of a combination of presentations by the trainer, group discussion and case studies.
This course will also be supported by additional resources available through the PharmaSchool Learning Management Centre.
Who is it suitable for?
This course is essential for anyone involved in running clinical trials with sites in the UK, for example Senior Managers, Project Managers, CRAs, CTAs
Content:
Background and History of Clinical Research Legislation in the UK
- European legislation and its impact on the UK
- Development of UK legislation
- UK regulatory and advisory bodies
- Brexit
Approvals processes in the UK
- MHRA Approval
- HRA (Ethics and R&D) Approval
- Capability and Capacity assessment
- CWoW
Statutory Instrument 2004 no. 1031
- Structure
- Contents
- Workshop session on implications for Sponsors, Monitors and Investigators
Statutory Instruments 2005 no.2754 and no.2759
- Structure
- Contents
Statutory Instruments 2006 no. 1928 and no. 2984
- Structure
- Contents
- Workshop session on implications for Sponsors, Monitors and Investigators
Statutory Instruments 2008 no.941 and 2009 no.1164
- Structure
- Contents
MHRA Guidance
- Serious Breaches
- Responding to Inspections
- The Grey Guide
Please contact me for more information and to organise your course.
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