Introduction to Clinical Research Regulations

1/2 day

This workshop will introduce researchers to the national regulations governing clinical research, specifically the Research Governance Framework for Health and Social Care and the Medicines for Human Use (Clinical Trial) Regulations 2004, as well as addressing some of the over-riding principles of good clinical practice. The primary focus will be on explaining the internal and external processes necessary for obtaining approval for projects which involve NHS patients, staff and facilities. By the end of the workshop participants should have an understanding of:

• the background to Research Governance in the NHS;
• how to get a sponsor;
• the Trust R&D Project Registration and Review - what? and why?;
• getting ethical approval in Wales; and
• the Clinical Trials Directive.

The workshop is suitable for all those who manage or undertake research involving NHS patients, staff or facilities or clinical trials of a medicinal product. 

25 October 2012
09:30 - 12:30
Tremorfa Room, 11th Floor, 30 - 36 Newport Road

Provider: HUMRS
Target Audience: S & PGR