Regulatory and governance advice

The regulatory and governance environment for clinical research in general, and clinical trials in particular, is complex. Researchers need to understand and comply with a wide range of legal requirements, most importantly the EU Clinical Trials Directive as translated into UK law, but also the NHS Research Governance Framework, the Data Protection Act and associated confidentiality requirements.

The UKCRN Regulatory and Governance team has been established to provide support and guidance in regulatory and governance issues to staff working on UKCRN studies, to help facilitate high quality clinical research.  The team contributes to the coordination of The UKCRC Regulatory and Governance (R&G) Advice Service  which is a UK-wide resource for those involved in health research (including non-portfolio studies).

UKCRN aims to:

• develop clear national approaches to the implementation of regulatory and governance requirements
• act as a central source for advice, support and guidance
• promote models and examples of best practice, to streamline the clinical research process while ensuring the rights, dignity and safety of patients are protected.